Oneness Biotech（ONEA）株式概要株式会社ワンネスバイオテックは、主に台湾で新薬、医薬品、健康食品の研究、開発、販売を行っている。 詳細ONEA ファンダメンタル分析スノーフレーク・スコア評価2/6将来の成長0/6過去の実績0/6財務の健全性6/6配当金0/6リスク分析過去5年間で収益は年間30.9%減少しました。 Luxembourg市場と比較した過去 3 か月間の株価の変動意味のある収益がありません ( NT$141M )すべてのリスクチェックを見るONEA Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair ValueUS$Current PriceUS$8.40123.4k% 割高 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-1b1b2016201920222025202620282031Revenue NT$46.7mEarnings NT$6.9mAdvancedSet Fair ValueView all narrativesOneness Biotech Co., Ltd. 競合他社Zhejiang Wecome PharmaceuticalSymbol: SZSE:300878Market cap: CN¥4.8bHeilongjiang ZBD PharmaceuticalSymbol: SHSE:603567Market cap: CN¥7.2bHainan HaiyaoSymbol: SZSE:000566Market cap: CN¥5.6bMezzion PharmaLtdSymbol: KOSDAQ:A140410Market cap: ₩2.3t価格と性能株価の高値、安値、推移の概要Oneness Biotech過去の株価現在の株価NT$8.4052週高値NT$052週安値NT$0ベータ0.791ヶ月の変化4.35%3ヶ月変化-12.50%1年変化-16.00%3年間の変化-76.54%5年間の変化-77.54%IPOからの変化-83.56%最新ニュースお知らせ • Mar 23Oneness Biotech Co., Ltd.(TPEX:4743) dropped from FTSE All-World Index (USD)Oneness Biotech Co., Ltd.(TPEX:4743) dropped from FTSE All-World Index (USD)お知らせ • Jan 14Oneness Biotech Co., Ltd., Annual General Meeting, May 20, 2026Oneness Biotech Co., Ltd., Annual General Meeting, May 20, 2026. Location: 8 floor no,11, chung shan s. rd., jhongjheng district, taipei city Taiwanお知らせ • Jan 06Oneness Biotech Co., Ltd. Receives Medical Device Marketing Authorization Approval for All Indications in Wounds by EDA EgyptOneness Biotech Co., Ltd. has received notification from the agent that the Bonvadis topical cream received medical device marketing authorization approval for all indications in wounds under EDA imported registration license number R275954Irg25V1 and with permission to be marketed in the Egypt. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: NA. After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: To plan for marketing and distribution. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Oneness shall pay the licensor sales royalties at a certain percentage according to the licensing contract once the product is commercialized. With a population of approximately 108 million and a diabetic population of approximately 11 million, Egypt's wound care market has great potential. Oneness implements a dual regulatory strategy, marketing the wound care product as both a drug and a medical device so that it may receive approval for commercialization in major countries and regions by 2025/2026. Oneness continues to progress the market access and collaboration in the major target markets according to the plan. Bonvadis obtained commercial approval for the indication of acute wounds in September 2024. For extending the indications of Bonvadis, the clearance of Bonvadis is for all indications of wounds, including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for chronic wounds include partial and full thickness wounds, 1st and 2nd degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation.お知らせ • Dec 20Oneness Biotech Co., Ltd. Receives Medical Device Import License for All Indications in Wound Dressing for IndiaOneness BiotECH Co., Ltd. announced that the Bonvadis topical cream received medical device import license for all indications in wounds under import license no. IMP/MD/2025/000739 and with permission to be marketed in India. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: NA. After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: To plan for marketing and distribution. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Upcoming development plan: Scheduled completion date:NA. Estimated responsibilities: Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is commercialized. The clearance on Bonvadis is for all indications of wounds including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for acute wounds include partial and full thickness wounds, first and second degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for a clinical trial to domestic or overseas regulatory authorities with respect to its receiving approval or approval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), and/or receiving approval or approval on drug license application.お知らせ • May 18Oneness Biotech Co., Ltd. and Microbio (Shanghai) Co., Ltd. Selects Sns812 for Oral Presentation At the 2025 American Thoracic Society International ConferenceThe broad-spectrum antiviral siRNA drug SNS812, co-developed by Oneness Biotech and Microbio (Shanghai), has been selected for oral presentation at the prestigious 2025 American Thoracic Society (ATS) International Conference. The presentation will deliver the latest clinical data to leading global experts in the fields of respiratory and infectious diseases. SNS812 is the world's first fully modified siRNA drug, clinically validated and administered via aerosol inhalation, demonstrating potent and broad-spectrum inhibitory activity against the SARS-CoV-2 virus. Results from a Phase II clinical trial show that SNS812 significantly reduces viral load, accelerates the resolution of key symptoms such as shortness of breath, and effectively shortens the recovery time of smell and taste loss. These results indicate a strong potential for preventing severe disease progression and offering neuroprotective effects. Furthermore, SNS812 has shown excellent safety and tolerability, with no serious adverse events reported, making it a promising candidate as an inhalable broad-spectrum COVID-19 therapy. The presentation will be delivered in a Mini Symposium, the highest-tier session format at the ATS conference. This premier session is reserved for studies demonstrating exceptional scientific originality, clinical significance, and contributions to global health, and inclusion requires rigorous scientific review. The selection of SNS812 affirms the international recognition of Oneness Biotech and Microssio (Shanghai) for their technological platform in nucleic acid drug development and their innovative capabilities in precision antiviral therapy. Oneness Biotech and MicroBio (Shanghai) continue to advance the global clinical development and licensing collaborations for SNS812, accelerating its path to commercialization, and expanding siRNA applications across major infectious diseases and global public health challenges-- bringing transformative solutions to human health.お知らせ • May 03Oneness Biotech Co., Ltd. to Report Q1, 2025 Results on May 12, 2025Oneness Biotech Co., Ltd. announced that they will report Q1, 2025 results on May 12, 2025最新情報をもっと見るRecent updatesお知らせ • Mar 23Oneness Biotech Co., Ltd.(TPEX:4743) dropped from FTSE All-World Index (USD)Oneness Biotech Co., Ltd.(TPEX:4743) dropped from FTSE All-World Index (USD)お知らせ • Jan 14Oneness Biotech Co., Ltd., Annual General Meeting, May 20, 2026Oneness Biotech Co., Ltd., Annual General Meeting, May 20, 2026. Location: 8 floor no,11, chung shan s. rd., jhongjheng district, taipei city Taiwanお知らせ • Jan 06Oneness Biotech Co., Ltd. Receives Medical Device Marketing Authorization Approval for All Indications in Wounds by EDA EgyptOneness Biotech Co., Ltd. has received notification from the agent that the Bonvadis topical cream received medical device marketing authorization approval for all indications in wounds under EDA imported registration license number R275954Irg25V1 and with permission to be marketed in the Egypt. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: NA. After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: To plan for marketing and distribution. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Oneness shall pay the licensor sales royalties at a certain percentage according to the licensing contract once the product is commercialized. With a population of approximately 108 million and a diabetic population of approximately 11 million, Egypt's wound care market has great potential. Oneness implements a dual regulatory strategy, marketing the wound care product as both a drug and a medical device so that it may receive approval for commercialization in major countries and regions by 2025/2026. Oneness continues to progress the market access and collaboration in the major target markets according to the plan. Bonvadis obtained commercial approval for the indication of acute wounds in September 2024. For extending the indications of Bonvadis, the clearance of Bonvadis is for all indications of wounds, including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for chronic wounds include partial and full thickness wounds, 1st and 2nd degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation.お知らせ • Dec 20Oneness Biotech Co., Ltd. Receives Medical Device Import License for All Indications in Wound Dressing for IndiaOneness BiotECH Co., Ltd. announced that the Bonvadis topical cream received medical device import license for all indications in wounds under import license no. IMP/MD/2025/000739 and with permission to be marketed in India. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: NA. After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: To plan for marketing and distribution. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Upcoming development plan: Scheduled completion date:NA. Estimated responsibilities: Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is commercialized. The clearance on Bonvadis is for all indications of wounds including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for acute wounds include partial and full thickness wounds, first and second degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for a clinical trial to domestic or overseas regulatory authorities with respect to its receiving approval or approval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), and/or receiving approval or approval on drug license application.お知らせ • May 18Oneness Biotech Co., Ltd. and Microbio (Shanghai) Co., Ltd. Selects Sns812 for Oral Presentation At the 2025 American Thoracic Society International ConferenceThe broad-spectrum antiviral siRNA drug SNS812, co-developed by Oneness Biotech and Microbio (Shanghai), has been selected for oral presentation at the prestigious 2025 American Thoracic Society (ATS) International Conference. The presentation will deliver the latest clinical data to leading global experts in the fields of respiratory and infectious diseases. SNS812 is the world's first fully modified siRNA drug, clinically validated and administered via aerosol inhalation, demonstrating potent and broad-spectrum inhibitory activity against the SARS-CoV-2 virus. Results from a Phase II clinical trial show that SNS812 significantly reduces viral load, accelerates the resolution of key symptoms such as shortness of breath, and effectively shortens the recovery time of smell and taste loss. These results indicate a strong potential for preventing severe disease progression and offering neuroprotective effects. Furthermore, SNS812 has shown excellent safety and tolerability, with no serious adverse events reported, making it a promising candidate as an inhalable broad-spectrum COVID-19 therapy. The presentation will be delivered in a Mini Symposium, the highest-tier session format at the ATS conference. This premier session is reserved for studies demonstrating exceptional scientific originality, clinical significance, and contributions to global health, and inclusion requires rigorous scientific review. The selection of SNS812 affirms the international recognition of Oneness Biotech and Microssio (Shanghai) for their technological platform in nucleic acid drug development and their innovative capabilities in precision antiviral therapy. Oneness Biotech and MicroBio (Shanghai) continue to advance the global clinical development and licensing collaborations for SNS812, accelerating its path to commercialization, and expanding siRNA applications across major infectious diseases and global public health challenges-- bringing transformative solutions to human health.お知らせ • May 03Oneness Biotech Co., Ltd. to Report Q1, 2025 Results on May 12, 2025Oneness Biotech Co., Ltd. announced that they will report Q1, 2025 results on May 12, 2025お知らせ • Apr 24Oneness Biotech Co., Ltd. Announces EDA Accepts Medical Device Registration Application of Bonvadis for All Indications in Wounds in EgyptOneness Biotech Co., Ltd. announced that the medical device registration application of Bonvadis for all indications in wounds has been accepted by Egypt EDA. Date of occurrence of the event: April 23, 2025. For extending the indications of Bonvadis, the application of Bonvadis is for all indications of wounds including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for chronic wounds include partial and full thickness wounds, first and second degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation.お知らせ • Apr 17Oneness Biotech Co., Ltd. Announces the Medical Device Registration Application of Bonvadis for All Indications of Wound DressingOneness BiOTECH Co., Ltd. announced that the medical device registration application of Bonvadis for all indications of wounds has been accepted by TGA in Australia. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur:NA. After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: N. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Upcoming development plan: Scheduled completion date: The review timeline will be determined based on the regulatory authority's review process. Estimated responsibilities:Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is marketed.お知らせ • Mar 19Oneness Biotech Co., Ltd. Announces Medical Device Registration Application of Bonvadis for All Indications in Wounds Has Been Accepted by UAE MOHAPDate of occurrence of the event: March 18, 2025 . New drug name or code: Bonvadis. Indication: Wound Dressing. Planned development stages: NA5. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Oneness has received notification by the agent that the medical device registration application of Bonvadis for all indications has been accepted by MOHAP in UAE. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: NA. After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: NA. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Upcoming development plan. Scheduled completion date: The review timeline will be determined based on the regulatory authority's review process. Estimated responsibilities: Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is marketed. Market situation: The advanced wound care market in the Middle East is showing stable growth, primarily driven by the increasing number of chronic wound cases, particularly DFU. Data indicates that the advanced wound caremarket in the Middle East is expected to reach USD 4.8 billion by 2028, with a compound annual growth rate (CAGR) of 5.8%. The rising prevalence of diabetes remains a key factor driving market growth,leading to an increased demand for innovative wound care solutions. Any other matters that need to be specified: Oneness implements a dual regulatory strategy, marketing the wound care product as both a drug and a medical device so that it may receive approval for commercialization in major countries and regions by 2025. Oneness continues to progress the market access and collaboration in the major target markets according to the plan. The application on Bonvadis by the MOHAP in UAE is for all indications of wounds including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for chronic wounds include partial and full thickness wounds, first and second degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for a clinical trial to domestic or overseas regulatory authorities with respect to its receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), and/or receiving approval or disapproval on drug license application. New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks. The investors are advised to exercise caution and conduct thorough evaluation.お知らせ • Mar 03Oneness Biotech Co., Ltd., Annual General Meeting, May 22, 2025Oneness Biotech Co., Ltd., Annual General Meeting, May 22, 2025. Location: 8 floor no,11, chung shan s. rd., jhongjheng district, taipei city Taiwanお知らせ • Feb 20Oneness Biotech Co., Ltd. to Report Fiscal Year 2024 Results on Feb 27, 2025Oneness Biotech Co., Ltd. announced that they will report fiscal year 2024 results on Feb 27, 2025お知らせ • Jan 10Oneness Biotech Co., Ltd. Receives GMP Compliance Assessment of Foreign Pharmaceutical Manufacturers Reviewed by the Drug Administration of VietnamOneness Biotech Co., Ltd. announced that company has been notified by the local agent that Oneness Nanchou manufacturing site has passed the GMP compliance assessment of foreign pharmaceutical manufacturers reviewed by the Drug Administration of Vietnam (DAV).お知らせ • Aug 04Oneness Biotech Co., Ltd. to Report Q2, 2024 Results on Aug 12, 2024Oneness Biotech Co., Ltd. announced that they will report Q2, 2024 results on Aug 12, 2024お知らせ • May 18Oneness Biotech Co., Ltd. Agrees to Withdraw the 510(K) for Bonvadis Chronic Wound and Resubmit After the Supplementing Animal Study DataOneness Biotech Co., Ltd. announced that Bonvadis has obtained 510(K) Acute wound medical device approval and is currently applying for 510(k) Chronic wound medical device. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Bonvadis has obtained 510(K) Acute wound medical device approval and is currently applying for 510(k) Chronic wound medical device. Upcoming development plan: Scheduled completion date: In accordance with U.S FDA suggestion, company will submit the 510(k) chronic wound medical device after supplementing the required animal study data. The company submitted technical documents in April 2024 in accordance with the U.S. FDA's review requirements in November 2023. The U.S. FDA temporarily notified the company to hold a conference call last night and requested additional animal study data. The company responded to the FDA's suggestion and will withdraw the application. After completing the animal study and obtaining the data this year, the company will resubmit the 510(k) chronic wound medical device application. The regulatory authority will conduct the final review. Bonvadis is one of the wound medical devices developed by company. It has obtained 510(k) approval for acute wound indications. After supplementing animal study data as required by the U.S FDA, the chronic wound application will be submitted in second half of 2024 and commercialization arrangements will be made simultaneously. Application will not affect the company's business. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application. New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks. The investors are advised to exercise caution and conduct thorough evaluation.お知らせ • May 10US FDA Agrees Oneness Biotech Co., Ltd.'s S.C. Injection Formulation of FB825 to Proceed with Phase 2 Clinical Trial to Treat Moderate-To-Severe Atopic DermatitisOneness Biotech Co., Ltd. announced that S.C. injection formulation of FB825 has been agreed by US FDA to proceed with Phase 2 clinical trial to treat moderate-to-severe atopic dermatitis. Indication: Treatment for moderate-to-severe atopic dermatitis, allergic asthma and other IgE-mediated allergic diseases. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Subcutaneous injection formulation of FB825, anti-CemX antibody, has been agreed by US FDA to proceed with Phase 2 clinical trial. Accumulated investment expenditure incurred: No disclosure of investment expenditure at the moment in consideration of future marketing strategies and to protect the interests of the company and investors. Market situation: Atopic dermatitis is a chronic and heterogeneous skin condition characterized by intense itching and eczematous lesions. It is the most common inflammatory skin disease in developed countries. According to the Global Report on Atopic Dermatitis 2022 by the International Eczema Council, up to 20% of children and 10% of adults in developed nations suffer from this condition. The market for atopic dermatitis is gradually gaining attention, becoming one of the target indications for pharmaceutical companies. According to a report from Mordor Intelligence, the atopic dermatitis treatment market is estimated to be $10.06 billion in 2024, with a projected compound annual growth rate (CAGR) of 7.18%, reaching $14.23 billion by 2029. On April 22, 2024, subcutaneous injection formulation of FB825 to treat moderate-to-severe atopic dermatitis was greenlighted by TFDA to proceed with a phase II clinical trial. The trial is jointly conducted with international partner and will be concurrently implemented in multiple medical centers in the United States and Taiwan. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application.お知らせ • Mar 01Oneness Biotech Co., Ltd. has filed a Follow-on Equity Offering.Oneness Biotech Co., Ltd. has filed a Follow-on Equity Offering. Security Name: Shares Security Type: Common Stock Securities Offered: 22,755,261お知らせ • Jan 31Oneness Biotech Co., Ltd. Announces Submission of A Phase II Clinical Trial Protocol Forsubcutaneous Injection Formulation of FB825 in Patientswith Moderate-To-Severe Atopic DermatitisOneness Biotech Co., Ltd. announced the Submission of a phase II clinical trial protocol forsubcutaneous injection formulation of FB825 in patientswith moderate-to-severe atopic dermatitis. Current development stage: FB825 has successfully developed a subcutaneous injection formulation and completed the enrollment of a bridging trial involving both intravenous and subcutaneous formulations among healthy subjects in the United States. Initial findings have affirmed the safety of the subcutaneous injection formulation. A phase 2 clinical trial application for the subcutaneous injection formulation of FB825 in patients with moderate-to-severe atopic dermatitis has been submitted via IND to the US FDA. The primary objectives of this study are to investigate the efficacy, safety, and pharmacokinetics associated with FB825's subcutaneous injection formulation in moderate-to-severe atopic dermatitis patients.お知らせ • Jan 21Oneness Biotech Co., Ltd. Obtains Import License in Thailand from Thai Food and Drug AdministrationOneness Biotech Co., Ltd. announced that the Bonvadis, the wound care topical cream has been approved for import of medical device by Thai Food and Drug Administration (Thai FDA) in Thailand with registration number 67-2-2-2-0000197 and permission for market distribution in Thailand. After obtaining official approval or the results the future strategy is to proceed planning for marketing and distribution. Upcoming development plan: Extensions of indications will be applied. A. Scheduled completion date: The review timeline is subject to the review process regulated by competent authorities in each country. B. Estimate responsibilities: Oneness shall pay the licensor sales royalties according to the licensing contract once the product is put onto the market. Oneness implements dual strategies of both medicinal products and medical devices for development and marketing of wound care products. Each type of product will comply with corresponding regulatory requirements to get earlier access to the markets. New drug Fespixon Cream has been approved with medicine licenses for Taiwan, Singapore, Malaysia, and China markets, as well as under the process of pre-market reviews or preparation of submissions for other countries. Bonvadis as a medical device has been approved with medical device licenses for wound management in the US, India, New Zealand, South Africa and Thailand as well as for scar management in European Union.お知らせ • Nov 10Oneness Biotech Co., Ltd. Announces Approval of FESPIXONOneness Biotech Co., Ltd. announced that it has been approved as Class 1.1 natural new drug by National Medical Products Administration (NMPA) in China. Product: FESPIXON, a new drug for the treatment of diabetic foot ulcers, has a generic name approved in China as Xianglei Tangzu Gao. Effect on company finances and business: New drug name or code: FESPIXON (research code: ON101). Purpose: Treatment of diabetic foot ulcers. Planned development stages: The second phase 3 clinical trial (ON101CLCT04) in the US, and other exploratory studies for new indications. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): The new drug application (NDA) of FESPIXON, the new drug in treatment of diabetic foot ulcers. The approved generic name is Xianglei Tangzu Go, and the approval number is ZC20230001. Once disapproved by competent authority or each of clinical trials (include interim analyses) results less than statistically significant sense, the risks and the associated measures the Company may occur: After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Microbio (Shanghai) Co. Ltd. will be responsible for the marketing and sales of FESPIXON. Accumulated investment expenditure incurred: No disclosure of the investment expenditure at the moment in consideration of the future marketing strategies. Upcoming development plan: Scheduled completion date: The second phase 3 trial in the US is scheduled to complete in 3-4 years after initiation accroding to the current plan. Estimate responsibilities: After product commercialization, the company shall pay the licensor a certain percentage of royalties according to the agreement during the validity of licensed patents.お知らせ • Sep 01Oneness Biotech Co., Ltd. Submits 510(k) Application to the U.S. FDA to Expand the Intended Patient Population and Add Multiple Chronic Wound Indications for BonvadisOneness Biotech Co., Ltd. has submitted a 510(k) application to the U.S. FDA to expand the intended patient population and add multiple chronic wound indications for Bonvadis. Scheduled completion date: The review timeline is subject to the review process regulated by competent authorities in each country. Estimate responsibilities: Oneness shall pay the licensor sales royalties according to the licensing contract once the product is put onto the market. Oneness implements dual strategies of both medicine products and medical devices for development and marketing of wound care products. Each type of product will comply with corresponding regulatory requirements to get quick access of the markets. New drug Fespixon Cream has been approved with medicine licenses for Taiwan and Singapore markets, as well as under the process of pre-market reviews or preparation of submissions for other countries. Bonvadis as a medical device for wound management has been granted with market approvals for the US, India, and New Zealand, and for scar management in European Union. This 510(k) application to the U.S. FDA to expand the intended patient population and add multiple indications, will be followed by the submission of market access applications in countries where the company plan to market the medical device. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application. It takes considerable time and expenses to develop a new drug of which success can't be guaranteed. Investors shall bear such investment risk that warrants careful assessment before making investment decisions.お知らせ • Aug 05Oneness Biotech Co., Ltd. Announces Submission of Registration Application for Bonvadis, the Wound Care Topical Cream to the Drug Regulatory Authority of Pakistan (DRAP)Oneness Biotech Co., Ltd. Announces submission of registration application for Bonvadis, the wound care topical cream to the Drug Regulatory Authority of Pakistan (DRAP). New drug name or code: Bonvadis. Purpose: Wound Dressing. Planned development stages-GNA. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Regulatory Agent in Pakistan has notified Oneness that Bonvadis topical cream for wound care has submitted a registration application to the Drug Regulatory Authority of Pakistan (DRAP). Oneness implements dual strategies of both medicine products and medical devices for development and marketing of company's wound care products. Each type of product will comply with corresponding regulatory requirements to get quick access of the markets. New drug Fespixon Cream has been approved with medicine licenses for Taiwan, Singapore, Malaysia markets, as well as under the process of pre-market reviews or preparation of submissions for other countries. Bonvadis as a medical device for wound management has been granted with market approvals for the US, India, and New Zealand, and for scar management in European Union. The subsequent market access plan with medical device submissions in other countries are ongoing.お知らせ • Aug 03US FDA agrees to proceed with Phase 2 clinical trial for SNS812, a broad-spectrum siRNA for COVID-19 infection, co-developed by Oneness & Microbio (Shanghai)US FDA agreed to proceed with Phase 2 clinical trial for SNS812, a broad-spectrum siRNA for COVID-19 infection, co-developed by Oneness & Microbio (Shanghai). Planned development stages:Phase II clinical trial/Phase III clinical trial/NDA. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis):SNS812, a broad-spectrum siRNA for treatment of SARS- COV-2 infection, has been agreed by the US FDA to proceed with the phase 2 clinical trial. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: Not applicable. C. After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Not applicable Upcoming development plan: phase II /III clinical trial. A. Scheduled completion date: The actual timeline will depend on the progress of the trial and the review of the regulatory agency. B. Estimate responsibilities: SNS812, a broad-spectrum antiviral siRNA for COVID-19, is developed jointly by Oneness Biotech Co., Ltd. and Microbio (Shanghai) Co., Ltd.株主還元ONEALU PharmaceuticalsLU 市場7D5.7%0%0%1Y-16.0%0%0%株主還元を見る業界別リターン: ONEA過去 1 年間で13 % の収益を上げたLuxembourg Pharmaceuticals業界を下回りました。リターン対市場: ONEAは、過去 1 年間で20 % のリターンを上げたLuxembourg市場を下回りました。価格変動Is ONEA's price volatile compared to industry and market?ONEA volatilityONEA Average Weekly Movement6.6%Pharmaceuticals Industry Average Movement0%Market Average Movement0%10% most volatile stocks in LU Market0%10% least volatile stocks in LU Market0%安定した株価: ONEAの株価は、 Luxembourg市場と比較して過去 3 か月間で変動しています。時間の経過による変動: ONEAの weekly volatility ( 7% ) は過去 1 年間安定していますが、依然としてLuxembourgの株式の 75% よりも高くなっています。会社概要設立従業員CEO（最高経営責任者ウェブサイト2008n/aShuling Chengwww.onenessbio.com台湾を中心に新薬、医薬品、健康食品の研究・開発・販売を行っている。同社は、糖尿病性足潰瘍用のFespixonクリームを提供している。同社は、慢性糖尿病性足潰瘍の治療薬として第III相臨床試験中のON101、第I相臨床試験中の抗がん剤OB318を開発している。また、アトピー性皮膚炎とアレルギー性喘息の治療薬として第IIa相臨床試験中のFB825、関節リウマチの治療薬として第I相臨床試験を終了したFB704A、antrodia cinnamomeaの抗がん植物薬OB318、第II相臨床試験中のCOVID-19治療薬SNS812、体重減少や代謝性疾患の治療薬SNS851を開発している。また、農業の栽培管理、貿易事業、農産物の生産・販売も行っている。ワンネスバイオテック社は2008年に設立され、台湾の台北市に本社を置いている。もっと見るOneness Biotech Co., Ltd. 基礎のまとめOneness Biotech の収益と売上を時価総額と比較するとどうか。ONEA 基礎統計学時価総額US$807.07m収益（TTM）-US$32.83m売上高(TTM)US$4.47m180.7xP/Sレシオ-24.6xPER（株価収益率ONEA は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計ONEA 損益計算書（TTM）収益NT$140.52m売上原価NT$100.88m売上総利益NT$39.65mその他の費用NT$1.07b収益-NT$1.03b直近の収益報告Mar 31, 2026次回決算日該当なし一株当たり利益（EPS）-2.16グロス・マージン28.21%純利益率-735.17%有利子負債／自己資本比率0%ONEA の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/24 19:22終値2026/05/22 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Oneness Biotech Co., Ltd. 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。3 アナリスト機関null nullKGI Securities Co. Ltd.Hsuan ChenKGI Securities Co. Ltd.Evana ChenMasterlink Securities Investment Advisory
お知らせ • Mar 23Oneness Biotech Co., Ltd.(TPEX:4743) dropped from FTSE All-World Index (USD)Oneness Biotech Co., Ltd.(TPEX:4743) dropped from FTSE All-World Index (USD)
お知らせ • Jan 14Oneness Biotech Co., Ltd., Annual General Meeting, May 20, 2026Oneness Biotech Co., Ltd., Annual General Meeting, May 20, 2026. Location: 8 floor no,11, chung shan s. rd., jhongjheng district, taipei city Taiwan
お知らせ • Jan 06Oneness Biotech Co., Ltd. Receives Medical Device Marketing Authorization Approval for All Indications in Wounds by EDA EgyptOneness Biotech Co., Ltd. has received notification from the agent that the Bonvadis topical cream received medical device marketing authorization approval for all indications in wounds under EDA imported registration license number R275954Irg25V1 and with permission to be marketed in the Egypt. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: NA. After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: To plan for marketing and distribution. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Oneness shall pay the licensor sales royalties at a certain percentage according to the licensing contract once the product is commercialized. With a population of approximately 108 million and a diabetic population of approximately 11 million, Egypt's wound care market has great potential. Oneness implements a dual regulatory strategy, marketing the wound care product as both a drug and a medical device so that it may receive approval for commercialization in major countries and regions by 2025/2026. Oneness continues to progress the market access and collaboration in the major target markets according to the plan. Bonvadis obtained commercial approval for the indication of acute wounds in September 2024. For extending the indications of Bonvadis, the clearance of Bonvadis is for all indications of wounds, including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for chronic wounds include partial and full thickness wounds, 1st and 2nd degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation.
お知らせ • Dec 20Oneness Biotech Co., Ltd. Receives Medical Device Import License for All Indications in Wound Dressing for IndiaOneness BiotECH Co., Ltd. announced that the Bonvadis topical cream received medical device import license for all indications in wounds under import license no. IMP/MD/2025/000739 and with permission to be marketed in India. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: NA. After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: To plan for marketing and distribution. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Upcoming development plan: Scheduled completion date:NA. Estimated responsibilities: Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is commercialized. The clearance on Bonvadis is for all indications of wounds including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for acute wounds include partial and full thickness wounds, first and second degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for a clinical trial to domestic or overseas regulatory authorities with respect to its receiving approval or approval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), and/or receiving approval or approval on drug license application.
お知らせ • May 18Oneness Biotech Co., Ltd. and Microbio (Shanghai) Co., Ltd. Selects Sns812 for Oral Presentation At the 2025 American Thoracic Society International ConferenceThe broad-spectrum antiviral siRNA drug SNS812, co-developed by Oneness Biotech and Microbio (Shanghai), has been selected for oral presentation at the prestigious 2025 American Thoracic Society (ATS) International Conference. The presentation will deliver the latest clinical data to leading global experts in the fields of respiratory and infectious diseases. SNS812 is the world's first fully modified siRNA drug, clinically validated and administered via aerosol inhalation, demonstrating potent and broad-spectrum inhibitory activity against the SARS-CoV-2 virus. Results from a Phase II clinical trial show that SNS812 significantly reduces viral load, accelerates the resolution of key symptoms such as shortness of breath, and effectively shortens the recovery time of smell and taste loss. These results indicate a strong potential for preventing severe disease progression and offering neuroprotective effects. Furthermore, SNS812 has shown excellent safety and tolerability, with no serious adverse events reported, making it a promising candidate as an inhalable broad-spectrum COVID-19 therapy. The presentation will be delivered in a Mini Symposium, the highest-tier session format at the ATS conference. This premier session is reserved for studies demonstrating exceptional scientific originality, clinical significance, and contributions to global health, and inclusion requires rigorous scientific review. The selection of SNS812 affirms the international recognition of Oneness Biotech and Microssio (Shanghai) for their technological platform in nucleic acid drug development and their innovative capabilities in precision antiviral therapy. Oneness Biotech and MicroBio (Shanghai) continue to advance the global clinical development and licensing collaborations for SNS812, accelerating its path to commercialization, and expanding siRNA applications across major infectious diseases and global public health challenges-- bringing transformative solutions to human health.
お知らせ • May 03Oneness Biotech Co., Ltd. to Report Q1, 2025 Results on May 12, 2025Oneness Biotech Co., Ltd. announced that they will report Q1, 2025 results on May 12, 2025
お知らせ • Mar 23Oneness Biotech Co., Ltd.(TPEX:4743) dropped from FTSE All-World Index (USD)Oneness Biotech Co., Ltd.(TPEX:4743) dropped from FTSE All-World Index (USD)
お知らせ • Jan 14Oneness Biotech Co., Ltd., Annual General Meeting, May 20, 2026Oneness Biotech Co., Ltd., Annual General Meeting, May 20, 2026. Location: 8 floor no,11, chung shan s. rd., jhongjheng district, taipei city Taiwan
お知らせ • Jan 06Oneness Biotech Co., Ltd. Receives Medical Device Marketing Authorization Approval for All Indications in Wounds by EDA EgyptOneness Biotech Co., Ltd. has received notification from the agent that the Bonvadis topical cream received medical device marketing authorization approval for all indications in wounds under EDA imported registration license number R275954Irg25V1 and with permission to be marketed in the Egypt. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: NA. After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: To plan for marketing and distribution. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Oneness shall pay the licensor sales royalties at a certain percentage according to the licensing contract once the product is commercialized. With a population of approximately 108 million and a diabetic population of approximately 11 million, Egypt's wound care market has great potential. Oneness implements a dual regulatory strategy, marketing the wound care product as both a drug and a medical device so that it may receive approval for commercialization in major countries and regions by 2025/2026. Oneness continues to progress the market access and collaboration in the major target markets according to the plan. Bonvadis obtained commercial approval for the indication of acute wounds in September 2024. For extending the indications of Bonvadis, the clearance of Bonvadis is for all indications of wounds, including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for chronic wounds include partial and full thickness wounds, 1st and 2nd degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation.
お知らせ • Dec 20Oneness Biotech Co., Ltd. Receives Medical Device Import License for All Indications in Wound Dressing for IndiaOneness BiotECH Co., Ltd. announced that the Bonvadis topical cream received medical device import license for all indications in wounds under import license no. IMP/MD/2025/000739 and with permission to be marketed in India. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: NA. After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: To plan for marketing and distribution. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Upcoming development plan: Scheduled completion date:NA. Estimated responsibilities: Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is commercialized. The clearance on Bonvadis is for all indications of wounds including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for acute wounds include partial and full thickness wounds, first and second degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for a clinical trial to domestic or overseas regulatory authorities with respect to its receiving approval or approval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), and/or receiving approval or approval on drug license application.
お知らせ • May 18Oneness Biotech Co., Ltd. and Microbio (Shanghai) Co., Ltd. Selects Sns812 for Oral Presentation At the 2025 American Thoracic Society International ConferenceThe broad-spectrum antiviral siRNA drug SNS812, co-developed by Oneness Biotech and Microbio (Shanghai), has been selected for oral presentation at the prestigious 2025 American Thoracic Society (ATS) International Conference. The presentation will deliver the latest clinical data to leading global experts in the fields of respiratory and infectious diseases. SNS812 is the world's first fully modified siRNA drug, clinically validated and administered via aerosol inhalation, demonstrating potent and broad-spectrum inhibitory activity against the SARS-CoV-2 virus. Results from a Phase II clinical trial show that SNS812 significantly reduces viral load, accelerates the resolution of key symptoms such as shortness of breath, and effectively shortens the recovery time of smell and taste loss. These results indicate a strong potential for preventing severe disease progression and offering neuroprotective effects. Furthermore, SNS812 has shown excellent safety and tolerability, with no serious adverse events reported, making it a promising candidate as an inhalable broad-spectrum COVID-19 therapy. The presentation will be delivered in a Mini Symposium, the highest-tier session format at the ATS conference. This premier session is reserved for studies demonstrating exceptional scientific originality, clinical significance, and contributions to global health, and inclusion requires rigorous scientific review. The selection of SNS812 affirms the international recognition of Oneness Biotech and Microssio (Shanghai) for their technological platform in nucleic acid drug development and their innovative capabilities in precision antiviral therapy. Oneness Biotech and MicroBio (Shanghai) continue to advance the global clinical development and licensing collaborations for SNS812, accelerating its path to commercialization, and expanding siRNA applications across major infectious diseases and global public health challenges-- bringing transformative solutions to human health.
お知らせ • May 03Oneness Biotech Co., Ltd. to Report Q1, 2025 Results on May 12, 2025Oneness Biotech Co., Ltd. announced that they will report Q1, 2025 results on May 12, 2025
お知らせ • Apr 24Oneness Biotech Co., Ltd. Announces EDA Accepts Medical Device Registration Application of Bonvadis for All Indications in Wounds in EgyptOneness Biotech Co., Ltd. announced that the medical device registration application of Bonvadis for all indications in wounds has been accepted by Egypt EDA. Date of occurrence of the event: April 23, 2025. For extending the indications of Bonvadis, the application of Bonvadis is for all indications of wounds including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for chronic wounds include partial and full thickness wounds, first and second degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation.
お知らせ • Apr 17Oneness Biotech Co., Ltd. Announces the Medical Device Registration Application of Bonvadis for All Indications of Wound DressingOneness BiOTECH Co., Ltd. announced that the medical device registration application of Bonvadis for all indications of wounds has been accepted by TGA in Australia. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur:NA. After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: N. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Upcoming development plan: Scheduled completion date: The review timeline will be determined based on the regulatory authority's review process. Estimated responsibilities:Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is marketed.
お知らせ • Mar 19Oneness Biotech Co., Ltd. Announces Medical Device Registration Application of Bonvadis for All Indications in Wounds Has Been Accepted by UAE MOHAPDate of occurrence of the event: March 18, 2025 . New drug name or code: Bonvadis. Indication: Wound Dressing. Planned development stages: NA5. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Oneness has received notification by the agent that the medical device registration application of Bonvadis for all indications has been accepted by MOHAP in UAE. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: NA. After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: NA. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Upcoming development plan. Scheduled completion date: The review timeline will be determined based on the regulatory authority's review process. Estimated responsibilities: Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is marketed. Market situation: The advanced wound care market in the Middle East is showing stable growth, primarily driven by the increasing number of chronic wound cases, particularly DFU. Data indicates that the advanced wound caremarket in the Middle East is expected to reach USD 4.8 billion by 2028, with a compound annual growth rate (CAGR) of 5.8%. The rising prevalence of diabetes remains a key factor driving market growth,leading to an increased demand for innovative wound care solutions. Any other matters that need to be specified: Oneness implements a dual regulatory strategy, marketing the wound care product as both a drug and a medical device so that it may receive approval for commercialization in major countries and regions by 2025. Oneness continues to progress the market access and collaboration in the major target markets according to the plan. The application on Bonvadis by the MOHAP in UAE is for all indications of wounds including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for chronic wounds include partial and full thickness wounds, first and second degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for a clinical trial to domestic or overseas regulatory authorities with respect to its receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), and/or receiving approval or disapproval on drug license application. New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks. The investors are advised to exercise caution and conduct thorough evaluation.
お知らせ • Mar 03Oneness Biotech Co., Ltd., Annual General Meeting, May 22, 2025Oneness Biotech Co., Ltd., Annual General Meeting, May 22, 2025. Location: 8 floor no,11, chung shan s. rd., jhongjheng district, taipei city Taiwan
お知らせ • Feb 20Oneness Biotech Co., Ltd. to Report Fiscal Year 2024 Results on Feb 27, 2025Oneness Biotech Co., Ltd. announced that they will report fiscal year 2024 results on Feb 27, 2025
お知らせ • Jan 10Oneness Biotech Co., Ltd. Receives GMP Compliance Assessment of Foreign Pharmaceutical Manufacturers Reviewed by the Drug Administration of VietnamOneness Biotech Co., Ltd. announced that company has been notified by the local agent that Oneness Nanchou manufacturing site has passed the GMP compliance assessment of foreign pharmaceutical manufacturers reviewed by the Drug Administration of Vietnam (DAV).
お知らせ • Aug 04Oneness Biotech Co., Ltd. to Report Q2, 2024 Results on Aug 12, 2024Oneness Biotech Co., Ltd. announced that they will report Q2, 2024 results on Aug 12, 2024
お知らせ • May 18Oneness Biotech Co., Ltd. Agrees to Withdraw the 510(K) for Bonvadis Chronic Wound and Resubmit After the Supplementing Animal Study DataOneness Biotech Co., Ltd. announced that Bonvadis has obtained 510(K) Acute wound medical device approval and is currently applying for 510(k) Chronic wound medical device. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Bonvadis has obtained 510(K) Acute wound medical device approval and is currently applying for 510(k) Chronic wound medical device. Upcoming development plan: Scheduled completion date: In accordance with U.S FDA suggestion, company will submit the 510(k) chronic wound medical device after supplementing the required animal study data. The company submitted technical documents in April 2024 in accordance with the U.S. FDA's review requirements in November 2023. The U.S. FDA temporarily notified the company to hold a conference call last night and requested additional animal study data. The company responded to the FDA's suggestion and will withdraw the application. After completing the animal study and obtaining the data this year, the company will resubmit the 510(k) chronic wound medical device application. The regulatory authority will conduct the final review. Bonvadis is one of the wound medical devices developed by company. It has obtained 510(k) approval for acute wound indications. After supplementing animal study data as required by the U.S FDA, the chronic wound application will be submitted in second half of 2024 and commercialization arrangements will be made simultaneously. Application will not affect the company's business. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application. New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks. The investors are advised to exercise caution and conduct thorough evaluation.
お知らせ • May 10US FDA Agrees Oneness Biotech Co., Ltd.'s S.C. Injection Formulation of FB825 to Proceed with Phase 2 Clinical Trial to Treat Moderate-To-Severe Atopic DermatitisOneness Biotech Co., Ltd. announced that S.C. injection formulation of FB825 has been agreed by US FDA to proceed with Phase 2 clinical trial to treat moderate-to-severe atopic dermatitis. Indication: Treatment for moderate-to-severe atopic dermatitis, allergic asthma and other IgE-mediated allergic diseases. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Subcutaneous injection formulation of FB825, anti-CemX antibody, has been agreed by US FDA to proceed with Phase 2 clinical trial. Accumulated investment expenditure incurred: No disclosure of investment expenditure at the moment in consideration of future marketing strategies and to protect the interests of the company and investors. Market situation: Atopic dermatitis is a chronic and heterogeneous skin condition characterized by intense itching and eczematous lesions. It is the most common inflammatory skin disease in developed countries. According to the Global Report on Atopic Dermatitis 2022 by the International Eczema Council, up to 20% of children and 10% of adults in developed nations suffer from this condition. The market for atopic dermatitis is gradually gaining attention, becoming one of the target indications for pharmaceutical companies. According to a report from Mordor Intelligence, the atopic dermatitis treatment market is estimated to be $10.06 billion in 2024, with a projected compound annual growth rate (CAGR) of 7.18%, reaching $14.23 billion by 2029. On April 22, 2024, subcutaneous injection formulation of FB825 to treat moderate-to-severe atopic dermatitis was greenlighted by TFDA to proceed with a phase II clinical trial. The trial is jointly conducted with international partner and will be concurrently implemented in multiple medical centers in the United States and Taiwan. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application.
お知らせ • Mar 01Oneness Biotech Co., Ltd. has filed a Follow-on Equity Offering.Oneness Biotech Co., Ltd. has filed a Follow-on Equity Offering. Security Name: Shares Security Type: Common Stock Securities Offered: 22,755,261
お知らせ • Jan 31Oneness Biotech Co., Ltd. Announces Submission of A Phase II Clinical Trial Protocol Forsubcutaneous Injection Formulation of FB825 in Patientswith Moderate-To-Severe Atopic DermatitisOneness Biotech Co., Ltd. announced the Submission of a phase II clinical trial protocol forsubcutaneous injection formulation of FB825 in patientswith moderate-to-severe atopic dermatitis. Current development stage: FB825 has successfully developed a subcutaneous injection formulation and completed the enrollment of a bridging trial involving both intravenous and subcutaneous formulations among healthy subjects in the United States. Initial findings have affirmed the safety of the subcutaneous injection formulation. A phase 2 clinical trial application for the subcutaneous injection formulation of FB825 in patients with moderate-to-severe atopic dermatitis has been submitted via IND to the US FDA. The primary objectives of this study are to investigate the efficacy, safety, and pharmacokinetics associated with FB825's subcutaneous injection formulation in moderate-to-severe atopic dermatitis patients.
お知らせ • Jan 21Oneness Biotech Co., Ltd. Obtains Import License in Thailand from Thai Food and Drug AdministrationOneness Biotech Co., Ltd. announced that the Bonvadis, the wound care topical cream has been approved for import of medical device by Thai Food and Drug Administration (Thai FDA) in Thailand with registration number 67-2-2-2-0000197 and permission for market distribution in Thailand. After obtaining official approval or the results the future strategy is to proceed planning for marketing and distribution. Upcoming development plan: Extensions of indications will be applied. A. Scheduled completion date: The review timeline is subject to the review process regulated by competent authorities in each country. B. Estimate responsibilities: Oneness shall pay the licensor sales royalties according to the licensing contract once the product is put onto the market. Oneness implements dual strategies of both medicinal products and medical devices for development and marketing of wound care products. Each type of product will comply with corresponding regulatory requirements to get earlier access to the markets. New drug Fespixon Cream has been approved with medicine licenses for Taiwan, Singapore, Malaysia, and China markets, as well as under the process of pre-market reviews or preparation of submissions for other countries. Bonvadis as a medical device has been approved with medical device licenses for wound management in the US, India, New Zealand, South Africa and Thailand as well as for scar management in European Union.
お知らせ • Nov 10Oneness Biotech Co., Ltd. Announces Approval of FESPIXONOneness Biotech Co., Ltd. announced that it has been approved as Class 1.1 natural new drug by National Medical Products Administration (NMPA) in China. Product: FESPIXON, a new drug for the treatment of diabetic foot ulcers, has a generic name approved in China as Xianglei Tangzu Gao. Effect on company finances and business: New drug name or code: FESPIXON (research code: ON101). Purpose: Treatment of diabetic foot ulcers. Planned development stages: The second phase 3 clinical trial (ON101CLCT04) in the US, and other exploratory studies for new indications. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): The new drug application (NDA) of FESPIXON, the new drug in treatment of diabetic foot ulcers. The approved generic name is Xianglei Tangzu Go, and the approval number is ZC20230001. Once disapproved by competent authority or each of clinical trials (include interim analyses) results less than statistically significant sense, the risks and the associated measures the Company may occur: After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Microbio (Shanghai) Co. Ltd. will be responsible for the marketing and sales of FESPIXON. Accumulated investment expenditure incurred: No disclosure of the investment expenditure at the moment in consideration of the future marketing strategies. Upcoming development plan: Scheduled completion date: The second phase 3 trial in the US is scheduled to complete in 3-4 years after initiation accroding to the current plan. Estimate responsibilities: After product commercialization, the company shall pay the licensor a certain percentage of royalties according to the agreement during the validity of licensed patents.
お知らせ • Sep 01Oneness Biotech Co., Ltd. Submits 510(k) Application to the U.S. FDA to Expand the Intended Patient Population and Add Multiple Chronic Wound Indications for BonvadisOneness Biotech Co., Ltd. has submitted a 510(k) application to the U.S. FDA to expand the intended patient population and add multiple chronic wound indications for Bonvadis. Scheduled completion date: The review timeline is subject to the review process regulated by competent authorities in each country. Estimate responsibilities: Oneness shall pay the licensor sales royalties according to the licensing contract once the product is put onto the market. Oneness implements dual strategies of both medicine products and medical devices for development and marketing of wound care products. Each type of product will comply with corresponding regulatory requirements to get quick access of the markets. New drug Fespixon Cream has been approved with medicine licenses for Taiwan and Singapore markets, as well as under the process of pre-market reviews or preparation of submissions for other countries. Bonvadis as a medical device for wound management has been granted with market approvals for the US, India, and New Zealand, and for scar management in European Union. This 510(k) application to the U.S. FDA to expand the intended patient population and add multiple indications, will be followed by the submission of market access applications in countries where the company plan to market the medical device. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application. It takes considerable time and expenses to develop a new drug of which success can't be guaranteed. Investors shall bear such investment risk that warrants careful assessment before making investment decisions.
お知らせ • Aug 05Oneness Biotech Co., Ltd. Announces Submission of Registration Application for Bonvadis, the Wound Care Topical Cream to the Drug Regulatory Authority of Pakistan (DRAP)Oneness Biotech Co., Ltd. Announces submission of registration application for Bonvadis, the wound care topical cream to the Drug Regulatory Authority of Pakistan (DRAP). New drug name or code: Bonvadis. Purpose: Wound Dressing. Planned development stages-GNA. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Regulatory Agent in Pakistan has notified Oneness that Bonvadis topical cream for wound care has submitted a registration application to the Drug Regulatory Authority of Pakistan (DRAP). Oneness implements dual strategies of both medicine products and medical devices for development and marketing of company's wound care products. Each type of product will comply with corresponding regulatory requirements to get quick access of the markets. New drug Fespixon Cream has been approved with medicine licenses for Taiwan, Singapore, Malaysia markets, as well as under the process of pre-market reviews or preparation of submissions for other countries. Bonvadis as a medical device for wound management has been granted with market approvals for the US, India, and New Zealand, and for scar management in European Union. The subsequent market access plan with medical device submissions in other countries are ongoing.
お知らせ • Aug 03US FDA agrees to proceed with Phase 2 clinical trial for SNS812, a broad-spectrum siRNA for COVID-19 infection, co-developed by Oneness & Microbio (Shanghai)US FDA agreed to proceed with Phase 2 clinical trial for SNS812, a broad-spectrum siRNA for COVID-19 infection, co-developed by Oneness & Microbio (Shanghai). Planned development stages:Phase II clinical trial/Phase III clinical trial/NDA. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis):SNS812, a broad-spectrum siRNA for treatment of SARS- COV-2 infection, has been agreed by the US FDA to proceed with the phase 2 clinical trial. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: Not applicable. C. After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Not applicable Upcoming development plan: phase II /III clinical trial. A. Scheduled completion date: The actual timeline will depend on the progress of the trial and the review of the regulatory agency. B. Estimate responsibilities: SNS812, a broad-spectrum antiviral siRNA for COVID-19, is developed jointly by Oneness Biotech Co., Ltd. and Microbio (Shanghai) Co., Ltd.
