Ankündigung • Mar 23
Oneness 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) Ankündigung • Jan 14
Oneness Biotech Co., Ltd., Annual General Meeting, May 20, 2026 Oneness Biotech Co., Ltd., Annual General Meeting, May 20, 2026. Location: 8 floor no,11, chung shan s. rd., jhongjheng district, taipei city Taiwan Ankündigung • Jan 06
Oneness Biotech Co., Ltd. Receives Medical Device Marketing Authorization Approval for All Indications in Wounds by EDA Egypt Oneness 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. Ankündigung • Dec 20
Oneness Biotech Co., Ltd. Receives Medical Device Import License for All Indications in Wound Dressing for India Oneness 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. Ankündigung • May 18
Oneness Biotech Co., Ltd. and Microbio (Shanghai) Co., Ltd. Selects Sns812 for Oral Presentation At the 2025 American Thoracic Society International Conference The 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. Ankündigung • May 03
Oneness Biotech Co., Ltd. to Report Q1, 2025 Results on May 12, 2025 Oneness Biotech Co., Ltd. announced that they will report Q1, 2025 results on May 12, 2025 Ankündigung • Apr 24
Oneness Biotech Co., Ltd. Announces EDA Accepts Medical Device Registration Application of Bonvadis for All Indications in Wounds in Egypt Oneness 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. Ankündigung • Apr 17
Oneness Biotech Co., Ltd. Announces the Medical Device Registration Application of Bonvadis for All Indications of Wound Dressing Oneness 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. Ankündigung • Mar 19
Oneness Biotech Co., Ltd. Announces Medical Device Registration Application of Bonvadis for All Indications in Wounds Has Been Accepted by UAE MOHAP Date 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. Ankündigung • Mar 03
Oneness Biotech Co., Ltd., Annual General Meeting, May 22, 2025 Oneness Biotech Co., Ltd., Annual General Meeting, May 22, 2025. Location: 8 floor no,11, chung shan s. rd., jhongjheng district, taipei city Taiwan Ankündigung • Feb 20
Oneness Biotech Co., Ltd. to Report Fiscal Year 2024 Results on Feb 27, 2025 Oneness Biotech Co., Ltd. announced that they will report fiscal year 2024 results on Feb 27, 2025 Ankündigung • Jan 10
Oneness Biotech Co., Ltd. Receives GMP Compliance Assessment of Foreign Pharmaceutical Manufacturers Reviewed by the Drug Administration of Vietnam Oneness 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). Ankündigung • Aug 04
Oneness Biotech Co., Ltd. to Report Q2, 2024 Results on Aug 12, 2024 Oneness Biotech Co., Ltd. announced that they will report Q2, 2024 results on Aug 12, 2024 Ankündigung • May 18
Oneness Biotech Co., Ltd. Agrees to Withdraw the 510(K) for Bonvadis Chronic Wound and Resubmit After the Supplementing Animal Study Data Oneness 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. Ankündigung • May 10
US 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 Dermatitis Oneness 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. Ankündigung • Mar 01
Oneness 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 Ankündigung • Jan 31
Oneness Biotech Co., Ltd. Announces Submission of A Phase II Clinical Trial Protocol Forsubcutaneous Injection Formulation of FB825 in Patientswith Moderate-To-Severe Atopic Dermatitis Oneness 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. Ankündigung • Jan 21
Oneness Biotech Co., Ltd. Obtains Import License in Thailand from Thai Food and Drug Administration Oneness 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. Ankündigung • Nov 10
Oneness Biotech Co., Ltd. Announces Approval of FESPIXON Oneness 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. Ankündigung • Sep 01
Oneness 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 Bonvadis Oneness 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. Ankündigung • Aug 05
Oneness 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. Ankündigung • Aug 03
US 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.