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10/16 Taiwan Life Sciences Biweekly Newsletter

2023-10-16

 
Taiwan Life Sciences Biweekly
 
TaiGen Enters Exclusive License Agreement with YSP
12 October, 2023
TaiGen Biopharmaceuticals Holdings Ltd. has announced that TaiGen Biotechnology, a subsidiary company of TaiGen, has signed an exclusive licensing agreement with Y.S.P. Industries (M) Sdn. Bhd. to develop and commercialize TaiGen's new drug in Malaysia and Singapore. More...
 
India and Taiwan partners to create next-generation health tech
11 October, 2023
India and Taiwan have embarked on a new collaboration to develop and promote innovative solutions for the health tech sector. The International Trade Administration, Government of Taiwan and Commerce Development Research Institute (CDRI) as executing arm of the Taiwan Government have partnered with EMPI Institutions and its Atal Incubation Centre-EMPI as India partner to organize a series of B2B meets and strategic partnerships between Indian and Taiwanese health tech companies. The first round of such meetings was held in Mumbai on October 6, 2023. The Taiwan Government supports the program under the WoW! Taiwan Project. More...
 
2nd Global Biotech Taiwan CEO Awards takes place in Taipei
10 October, 2023
The race was on among young biotech Chief Executive Officers (CEOs) for top position in 2023 Best Bio CEO awards organized by Global Bio and Investment media in Taipei, Taiwan recently. All the 30 young CEOs participating in the final roadshow made a three minute presentation before the panel of judges to win the top position. More...
 
Q&A: The promotion and sale of pharmaceuticals and medical devices in Taiwan
10 October, 2023
A Q&A on the marketing and sale of pharmaceuticals and medical devices in Taiwan, compiled by Taiwan's Formosa Transnational Attorneys at Law. More...
 
Taiwan Bio Industry Organization Annual Conference Focuses on AI and Mergers and Acquisitions
3 October, 2023
The Taiwan Bio Industry Organization (Taiwan BIO) and PwC Taiwan jointly held the 17th Annual General Meeting of Taiwan BIO - Forum on the Road to Innovative Biotechnology today, discussing two main themes: "Practical Applications of AI Big Data in the Biotechnology Industry,", and "Prospects for Mergers and Acquisitions, Licensing, and Investment in Taiwan's Biotechnology Sector."

Chairman of Taiwan BIO, Wu Chung-hsiun, pointed out that the association is celebrating its 34th year since its establishment. Since that time it has organized one of the region's largest biotech gatherings - BIO Asia-Taiwan, expanded international exchanges, established the Bio Industry Academy (BIA) to nurture talent, and has invited government leaders to engage in dialogue and collaboration with the industry, serving as a driving force for industry growth. More... (in Chinese)
 
Taiwan's MET and Japan's MEJ Collaborate to Promote Smart Healthcare in Southeast Asia
3 October, 2023
Smart healthcare is not only a standard feature of modern hospitals but also a powerful tool for advancing international healthcare under Taiwan's 'New Southbound Policy' directive. The Medical Excellence Taiwan (MET) Foundation led a delegation of 10 hospitals and over 20 experts to Japan for a healthcare cooperation workshop with the Medical Excellence Japan (MEJ) Association. The focus of their collaboration was on the application and development of smart healthcare. More... (in Chinese
 
Taiwan's medtech startup Flat Medical secures funding for global market expansion
3 October, 2023
Flat Medical, a Taiwan-based medtech company specializing in innovative safety solutions for anesthesia, pain medicine, critical care and emergency medicine, has recently announced the successful closing of its Series C funding round. More...
 
New Cream Could Be Valuable Addition to Diabetic Foot Ulcer Treatment
3 October, 2023
A novel treatment for healing diabetic foot ulcers (DFU) could be on the horizon for people with diabetes in the US. Approved by the Taiwan Food and Drug Administration in 2021, ON101 cream (brand name Fespixon) [developed by Taiwan's Oneness Biotech] is used for topical treatment of DFUs. Clinical trials have found the wound-healing cream to have significant benefits for DFUs, with study participants experiencing a 60 percent complete healing rate over 16 weeks compared to 35 percent healing with an absorbent wound dressing. More...
 
HanchorBio Announces First Patient Dosed in the Phase 1 Multi-Regional Clinical Trial of HCB101
3 October, 2023
HanchorBio Inc., a global clinical-stage biotechnology company focusing on the discovery and development of innovative immuno-biomedicines to treat a wide variety of patients suffering from different solid tumors or hematological malignancies with significant unmet medical needs, today announced that the first patient has been dosed in a Phase 1, multi-regional, multi-center clinical trial (ClinicalTrials.gov ID: NCT05892718). The trial aims to evaluate the safety, tolerability, pharmacodynamics, and anti-tumor activity of HCB101 in patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma. More...
 
PharmaEssentia Enters Into Exclusive Global License Agreement With WuXi Biologics for a Myeloid Immune Checkpoint Antibody Candidate
Press release
3 October, 2023
PharmaEssentia Corporation, (TPEx: 6446), a global biopharmaceutical innovator headquartered in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced it has entered into a license agreement with WuXi Biologics Ireland Limited to obtain the global exclusive rights to research, develop, manufacture and commercialize a myeloid immune checkpoint antibody candidate. PharmaEssentia will take over responsibility for the subsequent preclinical and clinical development efforts. More...
 
UBI Pharma contracts EirGenix for producing its biosimilar UB-851 Erythropoietin (EPO)
2 October, 2023
UBI Pharma Inc. announced that it has recently signed a production agreement with EirGenix for its biosimilar UB-851 Erythropoietin (EPO). UB-851 is mainly used for the treatment of renal anaemia, and has completed Phase III clinical trials. All clinical indicators are in line with expectations, and is currently undergoing a Rolling Review, and will subsequently apply to Taiwan's Food and Drug Administration (TFDA) for marketing approval. More...
 
TFBS Bioscience Builds Presence in Japan, Joining Emerging Regenerative Medicine Industry Cluster
2 October, 2023
TFBS Bioscience (TW: 6939) has officially established its subsidiary in the life science business park of Kashiwa-no-ha Smart City in Japan. In the initial phase, TFBS Bioscience will set up a production process laboratory and a business office in Kashiwa-no-ha, providing virus vector development services for research purposes. They will also establish close connections with local academic and research institutions, offering virus vector process development services. Simultaneously, they will promote end-to-end services for cell and gene therapy, covering research and development through to commercial production, expanding TFBS's manufacturing and testing operations in Japan. More... (in Chinese)
 
CDMO National Team Gets Moving
28 September, 2023
Taiwan's Contract Development and Manufacturing Organization (CDMO) national effort is officially underway. The Taiwan Biopharmaceutical Manufacturing Company (TBMC), led by the Ministry of Economic Affairs, is gradually assembling the operational team for this new entity. Chairman Michel Chu confirmed that experts from the Industrial Technology Research Institute and the Development Center for Biotechnology (DCB), numbering in the forties and fifties, will join the company in batches. Starting next year, TBMC will establish messenger RNA (mRNA) vaccine production facilities in Taipei and Hsinchu.

TBMC was registered in May of this year with a total registered capital of NTD 6 billion, of which NTD 2.3 billion has been paid up. With more private sector investment in the future, the capital scale will continue to expand. More... (in Chinese)
 
Medeon Biodesign's large-bore vascular closure device approved in the US
23 September, 2023
Medeon Biodesign announced on 27 September that the Cross-Seal, a large-bore vascular closure device developed in collaboration with its authorized partner, Terumo, has been notified by the US FDA of its PMA Approval, making Medeon the first company in Taiwan with PMA for Class III medical devices, and will be able to recognize a milestone payment of US$1 million. More...
 
Ever Fortune.AI medical software nets one more approval for the US market
27 September, 2023
Ever Fortune.AI announced on 26 September that its “EFAI RT Suite CT HCAP-Segmentation System” has been greenlighted by FDA. Currently, Ever Fortune has obtained 11 approvals from Taiwan’s FDA and 7 from the US.

According to Ever Fortune.AI, this breakthrough medical software is based on a closed-loop artificial intelligence algorithm module that automatically delineates 17 types of head-and-neck organs-at-risk on CT images, and transmits the result to the Treatment Planning System (TPS) for healthcare professionals to view, edit, and make manual corrections as necessary. More...
 
National Yang-Ming Chiao Tung University in Industry-Academia Research Partnership to Develop New Head and Neck Cancer Drug
27 September, 2023
A research team from National Yang-Ming Chiao Tung University has collaborated with an immunotherapy company to develop a fusion protein new drug for head and neck cancer. Through animal experiments, it has been confirmed that the drug can effectively shrink tumors, demonstrating its potential for cancer treatment. The research findings have been published in an international journal. More... (in Chinese)
 
Medigen Biotechnology's New Antiviral Drug Enters Phase II Clinical Trials
26 September, 2023
Medigen Biotechnology (TW: 3176) and the Japanese company Oncolys BioPharma are jointly conducting Phase II clinical trials in the United States for their oncolytic virus new drug OBP-301 (Telomelysin), in combination with immune checkpoint inhibitors (ICIs). The trial is expected to begin dosing patients in 2024. Medigen Biotechnology stated that the clinical trial is targeting patients with gastric cancer and gastroesophageal junction cancer who have shown resistance to ICIs. The goal is to provide second-line treatment, with each collaborating company supplying OBP-301 and ICIs as part of the clinical drug regimen. More... (in Chinese)

Adimmune's Subsidiary Enimmune Signs Sales Contract with Vietnam for its Enterovirus Vaccine
26 September, 2023
Adimmune (TW: 4142) subsidiary Enimmune (TW: 6564) announced that it has signed a distribution agreement for the Enterovirus 71 vaccine (EnVAX-A71) with Vabiotech, Vietnam's largest state-owned vaccine company. This marks the first step for the company in entering the Southeast Asian market.

Enimmune's Enterovirus vaccine has completed Phase III clinical trials in Vietnam, a region where Enterovirus Type 71 is prevalent, creating a strong demand for the vaccine. Enimmune aims to target the market of over one million newborns in Vietnam annually and plans to launch the vaccine in Vietnam by 2025. More... (in Chinese)

TTY Biopharm Continues Sales Momentum in Domestic and International Markets, Aims for Revenue and Profit Margin Growth Next Year
26 September, 2023
TTY Biopharmaceuticals (TW: 4105) held a conference to discuss its outlook. Looking ahead, general manager Sara Hou foresees the introduction of new products into the domestic market and increased sales in the US for their generic drug Lipo-AB, which is a lipid-based formulation of amphotericin B. This positive momentum is expected to continue into next year. Analysts estimate that the company's revenue growth for next year is likely to remain at around 10 percent, with a gross profit margin around 60 percent, which is considered a reasonable target. More... (in Chinese)

FaceHeart's Smart Image-Based Heart Rate Measurement Software Receives US FDA Approval
25 September, 2023
FaceHeart officially announced today that its heart rate measurement software, FaceHeart Vitals SDK, received Class II SaMD (Software as a Medical Device) certification from the US FDA on September 1, 2023. It is the world's first product to use a regular camera to measure heart rate and obtain US FDA certification. The system collects physiological information using just the front camera of a standard smartphone or tablet, enabling the rapid implementation of telemedicine, smart elderly care, remote patient monitoring, and other scenarios, ultimately realizing the vision of widespread smart healthcare. More... (in Chinese)


 
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Taiwan Bio Industry Organization (Taiwan BIO)
Contact: Daisy Tsai
Tel: +886 2 27836028 ext 14 FAX : +886 2 27836027
Mobile: +886 933-139647 | Line ID : daisy222
Email: daisy@taiwanbio.org.tw

BIO Asia-Taiwan July 24-28, 2024

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Taiwan Bio Industry Organization (TBIO)
Room C229, Bldg. C, No.99, Ln. 130, Sec. 1, Academia Rd.,
Nangang Dist., Taipei, Taiwan (11571)
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