View Future GrowthOneness Biotech 과거 순이익 실적과거 기준 점검 0/6Oneness Biotech 의 수입은 연평균 -30.9%의 비율로 감소해 온 반면, Pharmaceuticals 산업은 연평균 8.8%의 비율로 증가했습니다. 매출은 연평균 19.8%의 비율로 감소해 왔습니다.핵심 정보-30.94%순이익 성장률-29.88%주당순이익(EPS) 성장률Pharmaceuticals 산업 성장률20.98%매출 성장률-19.78%자기자본이익률-10.24%순이익률-735.17%최근 순이익 업데이트31 Mar 2026최근 과거 실적 업데이트공고 • 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, 2025공고 • 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, 2025공고 • 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, 2024모든 업데이트 보기Recent updates공고 • 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)공고 • 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 Taiwan공고 • 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.공고 • 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.공고 • 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.공고 • 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, 2025공고 • 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.공고 • 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.공고 • 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.공고 • 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 Taiwan공고 • 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, 2025공고 • 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).공고 • 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, 2024공고 • 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.공고 • 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.공고 • 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: 22,755,261공고 • 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.공고 • 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.공고 • 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.공고 • 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.공고 • 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.공고 • 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.매출 및 비용 세부 내역Oneness Biotech가 돈을 벌고 사용하는 방법. 최근 발표된 LTM 실적 기준.순이익 및 매출 추이BDL:ONEA 매출, 비용 및 순이익 (TWD Millions)날짜매출순이익일반관리비연구개발비31 Mar 26141-1,03323660931 Dec 25129-1,04523360630 Sep 25117-1,40322465030 Jun 25113-1,90622277631 Mar 25117-1,23522584531 Dec 24118-1,16522492530 Sep 24112-1,25922098030 Jun 24102-97919895931 Mar 2490-1,14118096531 Dec 2387-1,31317795330 Sep 2376-1,46916695230 Jun 2371-96717297931 Mar 231,068-29317694031 Dec 221,06636016791930 Sep 221,0691,13116885430 Jun 221,07967915279131 Mar 2275-13213373931 Dec 2166-40311780630 Sep 2152-1,09910579130 Jun 2130-90110369531 Mar 21496410772731 Dec 2042-24210858930 Sep 203915610851830 Jun 20427510048131 Mar 2013-4818033531 Dec 1913-3227023930 Sep 1916-2024517030 Jun 1915-2554013431 Mar 1916-2094210831 Dec 1819-235469430 Sep 1815-230706830 Jun 1812-151735531 Mar 1810-171765831 Dec 173-155756530 Sep 173-149707030 Jun 174-34637031 Mar 175-21587131 Dec 166-14536330 Sep 166-5535730 Jun 165-106485531 Mar 169-103465331 Dec 158-93475430 Sep 157-275467양질의 수익: ONEA 은(는) 현재 수익성이 없습니다.이익 마진 증가: ONEA는 현재 수익성이 없습니다.잉여현금흐름 대비 순이익 분석과거 순이익 성장 분석수익추이: ONEA은 수익성이 없으며 지난 5년 동안 손실이 연평균 30.9% 증가했습니다.성장 가속화: 현재 수익성이 없어 지난 1년간 ONEA의 수익 성장률을 5년 평균과 비교할 수 없습니다.수익 대 산업: ONEA은 수익성이 없어 지난 해 수익 성장률을 Pharmaceuticals 업계(14.5%)와 비교하기 어렵습니다.자기자본이익률높은 ROE: ONEA는 현재 수익성이 없으므로 자본 수익률이 음수(-10.24%)입니다.총자산이익률투하자본수익률우수한 과거 실적 기업을 찾아보세요7D1Y7D1Y7D1YPharmaceuticals-biotech 산업에서 과거 실적이 우수한 기업.View Financial Health기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2026/08/12 01:13종가2026/08/12 00:00수익2026/03/31연간 수익2025/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델의 세부 정보는 당사의 GitHub 페이지에서 확인하실 수 있습니다. 또한 보고서 사용 방법에 대한 가이드와 YouTube 튜토리얼도 제공하고 있습니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스Oneness Biotech Co., Ltd.는 3명의 분석가가 다루고 있습니다. 이 중 0명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관null nullKGI Securities Co. Ltd.Hsuan ChenKGI Securities Co. Ltd.Evana ChenMasterlink Securities Investment Advisory
공고 • 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
공고 • 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
공고 • 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
공고 • 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)
공고 • 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
공고 • 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.
공고 • 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.
공고 • 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.
공고 • 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
공고 • 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.
공고 • 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.
공고 • 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.
공고 • 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
공고 • 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
공고 • 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).
공고 • 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
공고 • 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.
공고 • 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.
공고 • 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
공고 • 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.
공고 • 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.
공고 • 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.
공고 • 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.
공고 • 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.
공고 • 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.