10/29 Taiwan Life Sciences Biweekly Newsletter
2024-10-29 |
| Taiwan Life Sciences Biweekly |
| Raising NT$10 billion: 17 biotech companies to IPO this year 21 October, 2024 Amidst the reduction in biotech IPO fundraising in such places as the US and Hong Kong, Taiwan's biotech sector is rising against the trend. It is estimated that around 17 companies will go public this year, raising over NT$10 billion, setting a new annual high. William Lu, Chairman of Microbio group, believes that Taiwan's biotech industry has undergone a significant transformation, and as international connections deepen, the biotech "grand performance" is just beginning. More... (in Chinese) |
| Nucleate Taiwan Unites Academia and Industry to Explore Healthcare Innovations Through AI 22 October, 2024 On October 17, 2024, Nucleate Taiwan hosted the highly anticipated "AI in Biotech: Applications in Healthcare" event, drawing over 100 attendees from academia and industry. Generously sponsored by Acer Medical, the Life Sciences Research Promotion Center (LSRPC), and the National Science and Technology Council (NSTC), this event has brought together great talks about AI-driven advancements in medical diagnostics, drug discovery, and healthcare. More... |
| Chang Gung Memorial Hospital Unveils Cellular Therapy: A Beacon of Hope for Cancer Treatment Press release 21 October, 2024 Cellular therapy, a revolutionary approach where cells are manipulated outside the body and then reintroduced to treat or prevent diseases, has been recognized in recent years as a highly promising treatment in the medical field. Chang Gung Memorial Hospital in Taiwan has been at the forefront of this innovation since 2018, when it established a Good Tissue Practice (GTP) laboratory with six cell processing labs adhering to international PICS/GMP cleanliness standards. The hospital actively supports clinical trials for various immune cells and regenerative medicine, with its Department of Laboratory Medicine certified by the College of American Pathologists (CAP) and responsible for issuing quality control reports for cell production processes. More... |
| Arce Therapeutics' CAR-T cell therapy approved by US FDA for Phase I/II clinical trial 21 October, 2024 Arce Therapeutics, a subsidiary of Compal (TW: 2324), announced that its new CAR-T cell therapy drug, ARD103, designed to treat the rare disease acute myeloid leukemia (AML), has been approved by the US FDA for a Phase I/II clinical trial through IND review. The clinical trial is expected to begin in the first quarter of next year, with patient recruitment underway. Arce Therapeutics is actively developing next-generation CAR immune cell therapies and has established three proprietary platforms: DashCAR, MaxCAR, and OneCAR, for developing Chimeric Antigen Receptor T cells (CAR-T) and Chimeric Antigen Receptor Natural Killer cells (CAR-NK). More... (in Chinese) |
| Foresee Pharmaceuticals announces results of Phase I clinical trials of new drug for asthma and inflammatory bowel disease 21 October, 2024 Foresee Pharmaceuticals (TW: 6576) announced the results of its Phase I Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) clinical trials for its new MMP-12 inhibitor drug, linvemastat (FP-020), aimed at treating asthma and inflammatory bowel disease. The trial aimed to assess the safety, tolerability, and pharmacokinetics of orally administered linvemastat in healthy volunteers. More... (in Chinese) |
| Grape King Bio wins three major awards at World Congress of Food Science and Technology 21 October, 2024 Grape King Bio (TW: 1707) has won three major awards at the World Congress of Food Science and Technology this year for its innovative products that enhance athletic performance using probiotics and fungal protein. Organized every two years by the International Union of Food Science and Technology (IUFoST), this meeting is regarded as the most authoritative and representative event in the food science community, with over 60 years of history. The 22nd edition was held in Italy, attracting over 1,200 scholars from 74 countries in the food field, including a team of about 30 professors and scholars from the Taiwan Association of Food Science and Technology. More... (in Chinese) |
| REGiMMUNE, Kiji merge to create Treg 'super company' ahead of IPO 18 October, 2024 Taiwan’s REGiMMUNE and Europe-based Kiji Therapeutics are merging to create a globally minded regulatory T-cell biotech that already has its eyes set on an IPO. REGiMMUNE’s lead therapy, dubbed RGI-2001, is designed to activate regulatory T cells (Tregs) through a novel mechanism that the company has claimed could also have applications for the treatment of other autoimmune and chronic inflammatory diseases. The candidate has been shown to prevent graft-versus-host disease (GvHD) after stem cell transplants in a phase 2 study, and the biotech has been gearing up for a late-stage trial. More... |
| Sinew Pharma's new drug for fatty liver disease shows positive clinical results 4 October, 2024 Sinew Pharma (TW: 6634) announced that its new drug SNP-610, developed for the treatment of fatty liver disease, has shown positive results in an open-label Phase II preclinical trial. In October, the results were accepted for publication in the Journal of Translational Medicine. More... (in Chinese) |
| Formosa Biomedical's Ivy Life Sciences immune cell therapy shows impressive clinical results 17 October, 2024 On the 17th, Formosa Biomedical announced that its subsidiary, Ivy Life Sciences, in collaboration with Taipei Veterans General Hospital and Tri-Service General Hospital, successfully completed Taiwan's first Phase II clinical trial using immune cell therapy for stage IV non-small cell lung cancer. The results showed a median progression-free survival of 5.6 months, a 100 percent disease control rate, and a one-year survival rate of 85.7 percent. The findings were recently published in the prestigious journal Scientific Reports, by Nature Publishing Group, highlighting significant prospects for future medical applications. More... (in Chinese) |
| World-first NTUH cancer screening test featured in medical journal 16 October, 2024 The success of National Taiwan University Hospital's (NTUH) two-in-one screening model in getting people to be tested for colorectal and gastric cancer markers has been highlighted in the Journal of the American Medical Association (JAMA). The findings of the decade-long "large-scale pragmatic randomized clinical trial" on the two-in-one screening model in Changhua County were published in JAMA, a peer-reviewed international medical journal, on Oct. 1, according to the hospital. More... |
| Taiwan BIO members meeting: National Development Council hopes AI technology will boost biotech industry in Taiwan 16 October, 2024 The Taiwan Bio Industry Organization (Taiwan BIO) held its members' meeting today. In his speech, National Development Council Deputy Minister Jan Fang-guan emphasized that the biotechnology industry is a major focus within government policy priorities. In recent years, with the support of AI technology, biotech has made groundbreaking advancements, potentially reducing R&D time by a hundredfold, he said. Additionally, the innovative technologies in regenerative medicine are thriving and will become a driving force for the growth of the biotech industry. More... (in Chinese) |
| EverFortune.AI's pleural effusion detection system receives approval from Malaysia 16 October, 2024 EverFortune.AI (TW: 6841) announced that its pleural effusion detection system had received an approval letter for medical devices from Malaysia. To date, EverFortune.AI has obtained 41 domestic and international medical device licenses, including 15 from Taiwan's TFDA, 11 from the US FDA, and 15 from other countries. The pleural effusion detection system utilizes AI deep learning technology to automatically analyze chest X-ray images of adult patients aged 18 and above to detect pleural effusion features. The analysis results can be transmitted to PACS/workstations for prioritization or classification of worklists. When pleural effusion features are detected, the software sends an alert through PACS/RIS workstations, allowing radiologists to identify patients with pleural effusion characteristics earlier than standard clinical procedures, enabling timely medical intervention. More... (in Chinese) |
| With new plant nearing completion, Locus Cell confident in expanding international CDMO business 16 October, 2024 Locus Cell (TW: 6891) reported that its new factory in Zhubei is set to be completed next year, and that it will serve nearby Asian countries reducing transportation costs and risks. The company remarked that the Taiwan government's recent passage of two regenerative medicine laws will significantly impact the cell therapy industry. These regulations require production sites for cell therapy products to be certified by relevant authorities (GMP certification, etc.), accelerate product launches, and increase investment in research and technological advancements. Locus Cell offers CDMO services that meet GMP certification, catering to the market's demand for high-quality cell products, and according to the company the future Zhubei plant will also comply with international standards. More... (in Chinese) |
| Vice President Hsiao: Biotechnology to play a crucial role in Taiwan and the world 15 October, 2024 Taiwan Vice President Hsiao Bi-khim met with the winners of the 2024 Taiwan BIO Awards today and stated that the government has supported the biotechnology industry through various policies over recent years, with the hope that the industry will play a more crucial role both in Taiwan and abroad. She expressed her hope that everyone will work together to continue driving industry development, becoming a vital force in promoting public health. More... (in Chinese) |
| Bionet and Dalin Tzu Chi Hospital report positive news in regenerative medicine 15 October, 2024 Bionet (TW: 1784) and Dr. Lyu Shaw-Ruey from Dalin Tzu Chi Hospital jointly presented treatment results for degenerative osteoarthritis today. Bionet highlighted that this was the first nationwide presentation of results with a complete one-year follow-up and statistical significance since the implementation of the "Regulations Governing the Application or Use of Specific Medical Techniques or Examinations, or Medical Devices". Dr. Lyu stated that over the past two years, 78 patients with degenerative osteoarthritis underwent Autologous Cartilage Regeneration Facilitation Procedure (ACRFP) using autologous adipose-derived stem cell therapy, representing 51 percent of all cases in Taiwan treated with adipose-derived stem cells across various indications. The treatment showed an 88 percent cartilage regeneration rate. More... (in Chinese) |
| Tanvex approves merger with Bora Pharmaceuticals to build international CDMO team 15 October, 2024 Tanvex (TW: 6541) held an extraordinary shareholders' meeting today and approved the merger with Bora Pharmaceuticals' subsidiary, Bora Biotech. This decision marks a significant step for Tanvex towards a strategic alliance with Bora Pharmaceuticals, aiming to collaboratively establish an international CDMO team. More... (in Chinese) |
| OBI Pharma's Chinese partner's Phase II trial interim analysis of new anti-cancer drug wins CSCO outstanding paper award 14 October, 2024 Taiwan's OBI Pharma (TW: 4174) announced that its partner in China, Ascentawits Pharmaceuticals, had presented the interim analysis results of the Phase II clinical efficacy and safety study of its new anti-cancer drug AST-3424 (also known as OBI-3424, for which OBI Pharma holds global development rights outside of certain Asian countries) at the 2024 Annual Meeting of the Chinese Society of Clinical Oncology (CSCO). The study was awarded the outstanding paper award by the conference. More... (in Chinese) |
| Lukas Biomedical engages with Pham Ngoc Thach University of Medicine to enter Vietnam's regenerative medicine market 14 October, 2024 Lukas Biomedical (TW: 6814) announced that it had successfully entered the Vietnamese regenerative medicine market. Invited by Pham Ngoc Thach University of Medicine, one of Vietnam's top five public medical universities, the company shared its accumulated research and development achievements, clinical trial data, and future development directions in the field of innovative cell therapy through a special presentation. The company will also engage in discussions with the university's president, deans, director of the oncology department, attending physician in oncology, director of the biomedical research center, and the chairman of the Ho Chi Minh City Stem Cell Association. More... (in Chinese) |
| US NCI sponsors Senhwa Biosciences' new anti-cancer drug program, first clinical trial approved by FDA 14 October, 2024 Senhwa Biosciences (TW: 6492) announced that its drug Pidnarulex (CX-5461), has been selected as an experimental drug for the US National Cancer Institute's (NCI) NExT anti-cancer program, with a five-year sponsorship. The first clinical trial under this program has been approved by the US FDA. The trial will evaluate the drug's ability to induce a Rad51 response in patients with or without homologous recombination deficiency (HRD) gene mutations in advanced solid tumors. The study aims to identify biomarkers beyond BRCA1/2 and PALB2 that could achieve synthetic lethality with CX-5461, potentially broadening the drug's indications and accelerating its approval to benefit patients. More... (in Chinese) |
| BioGend Therapeutics signs distribution agreement with Japanese company 14 October, 2024 BioGend Therapeutics (TW: 6733) has signed a product distribution agreement with Japan's HOYA Technosurgical Corporation. In the future, the company will proceed with product registration with the Ministry of Health and Welfare according to regulations and begin hospital sales. 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 2025 (23-27 July, 2025) ========================================= Taiwan Bio Industry Organization (TBIO) Room C229, Bldg. C, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei, Taiwan (11571) ========================================= |