9/2 Taiwan Life Sciences Biweekly Newsletter
2024-09-02 |
| Taiwan Life Sciences Biweekly |
| Taiwan promotes biotechnology industry development 27 August, 2024 Premier Cho Jung-tai said Aug. 26 that the government is committed to raising Taiwan's global biotechnology profile via comprehensive policies and regulations, increased funding, resource integration and talent cultivation, according to the Executive Yuan. Cho made the remarks at the opening ceremony of the 2024 Bio Taiwan Committee in Taipei City. The event, attended by around 200 experts, officials and business representatives, focused on biomedical sustainability, smart innovations and steps to ensure a healthy Taiwan. More... |
| Bio Taiwan Committee conference opens with discussions on digital health and insurance payments 27 August, 2024 The Bio Taiwan Committee (BTC) conference has opened with discussions on digital health-related insurance payments and the evaluation of AI-assisted diagnostic tools as a reference for making insurance payment decisions. Shih Chung-Liang, the Director General of the National Health Insurance Administration (NHIA), acknowledged that digital health presents numerous challenges for insurance coverage, including questions about whether products should be classified as medical devices or medical services, how to assess clinical benefits and economic analysis, their correlation with clinical outcomes, and whether to implement bundled or fee-for-service payments. More... (in Chinese) |
| Taiwania Capital and Axil Capital jointly establish new biotech fund 27 August, 2024 Taiwania Capital announced that it has formed an international joint venture with Tokyo-based Axil Capital to establish the TaiAx Life Science Fund L.P. The fund has a target size of US$200 million (approximately NT$6.38 billion) and will focus on deepening its international presence in biotech investments. Prominent investors in the TaiAx fund include Taiwan's National Development Fund, Mizuho Securities Co., Ltd., and Mega International Commercial Bank. Axil Capital, a venture capital firm established in 2017 as a spinoff from Mizuho Securities and headquartered in Tokyo, specializes in investments in the biotech and healthcare technology sectors. More... (in Chinese) |
| Bora Pharmaceuticals and Tanvex BioPharma announce stock swap to form CDMO team 27 August, 2024 Bora Pharmaceuticals (TW: 6472) announced on the 27th that its board of directors has approved a strategic alliance with Tanvex BioPharma (TW: 6541). As part of the deal, Tanvex will issue new common shares to acquire the equity of Bora Biotech, which is responsible for Bora's large molecule CDMO business. The exchange ratio will be one share of Tanvex common stock for every one share of Bora Biotech common stock. Bora Pharmaceuticals will hold approximately 30.5 percent of Tanvex's equity, becoming the largest corporate shareholder of Tanvex. The alliance aims to efficiently integrate the strengths of both companies, positioning them to capitalize on surging local manufacturing and outsourcing opportunities. More... |
| SciVision Biotech and Bio Preventive Medicine to enter Brazilian market 27 August, 2024 SciVision Biotech (TW: 1786) announced that its adhesion prevention products for gynecological and surgical applications have received sales approval from Brazil's Anvisa and are set to contribute to revenue starting next year, marking their entry into the South American market. Similarly, Bio Preventive Medicine (TW: 6810) also announced that its self-developed innovative diagnostic reagent DNlite-IVD103 has received market approval from Brazil's National Health Surveillance Agency (ANVISA). More... (in Chinese) |
| Ever Supreme Bio Technology's CAR-T new drug to begin Phase I clinical trials 27 August, 2024 Ever Supreme Bio Technology (TW: 6712) announced that its cell therapy drug CAR001, targeting HLA-G for the treatment of solid tumors, is the fourth allogeneic CAR-T therapy for solid tumors globally. The company plans to start recruiting patients for Phase I clinical trials starting in September at China Medical University Hospital in Taichung, Taiwan. CAR001 is the world's first allogeneic HLA-G-CAR-BiTE cell therapy to enter human clinical trials. Following the completion of Phase I trials in Taiwan, Phase II trials will be conducted abroad, with Phase III potentially taking place in the United States. More... (in Chinese) |
| TBMC's Chang highlights advantages for rare disease research in Taiwan 26 August, 2024 At the recent 2024 Bio Taiwan Committee (BTC) meeting, David Chang, CEO of Taiwan Biopharmaceutical Manufacturing Company (TBMC), highlighted Taiwan's advantages in high-level medical talent and its robust ICT sector, which provide cost and R&D benefits. He urged local biotech firms to capitalize on the opportunity to develop cell and gene therapies (CGT) for rare diseases, given the international retreat from this area. Chang projected that the global CGT market will reach US$40.6 billion by 2027, growing at 27.2 percent annually, with cell therapy leading the market. More... (in Chinese) |
| Bionet targets obstetrics and gynecology exosome opportunities 26 August, 2024 At a presentation this week Bionet (TW: 1784) CEO Michael Kang announced that the company plans to expand its collaboration with nearly 500 long-term partners in obstetrics and gynecology through its next-generation exosome products, aiming for new growth in regenerative medicine. Kang reported that in the first half of the year, Bionet's new business model for exosome global R&D outsourcing (Exosome Foundry) has expanded into 11 sectors, including healthcare, cosmetics, traditional Chinese medicine, pharmaceuticals, and aromatherapy, with over a hundred clients. More... (in Chinese) |
| Inventec Appliances' Chiline SmartMed Infusion System positions itself in the Thai market 26 August, 2024 Inventec (TW: 2356) announced that its subsidiary, Inventec Appliances, has successfully introduced its Chiline SmartMed Infusion System into the international medical market. The system has been implemented in Thailand's Muang Samut Paknam Private Hospital and Somdech Phra Pinklao Naval Hospital for clinical infusion verification, marking a significant step in expanding the system internationally. The Chiline SmartMed Infusion System, which includes infusion pumps, connection system software, and infusion sets, enhances patient safety and improves nursing efficiency. More... (in Chinese) |
| TSH Biopharm's liquid biopsy technology makes new breakthrough 26 August, 2024 TSH Biopharm (TW: 8432) announced that it had made significant progress with its next-generation sequencing (NGS) technology, particularly in liquid biopsy using AlphaLiquid 100 for pleural effusion in diagnosing non-small cell lung cancer (NSCLC). This technology, which has been highlighted in the international journal Molecular Diagnosis & Therapy, shows a substantial improvement in precision, identifying over 92 percent of lung cancer driver gene mutations, including both common and rare ones. This marks a notable advancement over traditional cell block testing, which detects only about 51 percent of mutations. More... (in Chinese) |
| Taiwan eyes more collaboration between high tech, health care sectors 24 August, 2024 Taiwan's high tech and health care sectors should pursue greater integration to position the country as a global leader in the field, government officials said at an annual biotech meeting in Taipei on Monday. Wu Cheng-wen, head of the National Science and Technology Council (NSTC), said the two sectors are both among the best in the world, but they have developed independently with little integration in the past. More... |
| TTY Biopharm receives drug approval for combination oral capsule cancer treatment 23 August, 2024 TTY Biopharm (TW: 4105) has received Taiwan FDA approval for its 5-Fu class, compound oral capsule cancer drug to treat breast cancer, adding to its previous approvals for gastric, pancreatic, colorectal, advanced non-small cell lung, and bile duct cancers. This marks the drug's sixth approved indication and completes TTY Biopharm's breast cancer treatment product line. The new indication is for adjuvant chemotherapy in early-stage breast cancer with high recurrence risk, HR-positive, and HER2-negative patients. TTY Biopharm now offers 8 cancer treatment drugs across four categories, strengthening its position as Taiwan's leading cancer drug brand. More... (in Chinese) |
| Health Minister advocates for enhanced global health security at biomedical forum 23 August, 2024 Taiwan's Health Minister Chiu Tai-yuan called for collective efforts to strengthen global health security on Friday while attending a biomedical forum. Chiu also emphasized the importance of expanding biomedical cooperation within the Pacific region. The Biomedical Strategic Collaborative Forum in Asia Pacific was co-hosted by the Taiwan Vietnam Medical Biotech Association, the Vietnam Health Economics Association, and the Canadian Trade Office in Taipei. More... |
| New scanning tech improves cancer detection 22 August, 2024 Low-dose computed tomography (LDCT) scans using technology developed by National Taiwan University Hospital can increase the accuracy rate of identifying abnormalities by 25 percent when screening for lung cancer, the Health Promotion Administration (HPA) said yesterday. The scans using artificial intelligence support systems developed by the hospital are available in seven hospitals nationwide, and people in high-risk groups are eligible for the screenings, such as those with a family history of lung cancer or those with an extended history of heavy smoking, the agency said. More... |
| The New Cancer Drugs Fund: Taiwan's Lifeline for Patients 22 August, 2024 President Lai Ching-te gained widespread public interest during his election campaign last year by announcing his "Healthy Taiwan" policy focusing on disease prevention and health maintenance. The cornerstone of the plan is the establishment of a Taiwan Multi-Support Cancer Drugs Fund (CDF). Lai has dedicated NT$10 billion (around US$330 million) to the fund, which is designed to support Taiwan's cancer patients and their families in accessing necessary treatment, who often can't sustain the high out-of-pocket costs of innovative treatments not covered by National Health Insurance (NHI). More... |
| Taiwan Bio Therapeutics launches three initiatives to expand into international markets 22 August, 2024 Taiwan Bio Therapeutics (TW: 6892) is accelerating its international expansion with three key strategies: advancing cell therapy, securing global CDMO contracts, and leveraging AI automation. Taiwan's new regenerative medicine regulations offer a solid legal foundation for cell and gene therapies, while the BIOSECURE Act in the U.S. creates opportunities for expansion into the American market. The company announced its foray into immunology with TregCel (TRK-001), a regulatory T cell therapy developed with TRACT, now approved for Phase II trials by the FDA. Taiwan Bio Therapeutics has also applied for a Phase II trial in Taiwan for kidney transplant rejection. Additionally, the company is making progress in gene-edited T cell technology with Harvard University, focusing on advanced manufacturing processes. More... (in Chinese) |
| Bora Pharmaceuticals acquires first aseptic injectable manufacturing facility 22 August, 2024 Bora Pharmaceuticals (TW: 6472) has acquired a microbial injectable manufacturing plant in Canton, Maryland, from Emergent BioSolutions. This acquisition, effective immediately, enhances Bora's CDMO capabilities by adding the production of finished sterile injectable drug products to its existing expertise in raw material production. The deal strengthens Bora's competitiveness in large molecule contract manufacturing and will help clients with biotech drug development and commercial-scale production. More... (in Chinese) |
| Far Eastern Medical and Electronics and Shuang Ho Hospital Sign MOU to Collaborate on Smart Healthcare 22 August, 2024 Far Eastern Medical and Electronics Technology is partnering with Taipei Medical University's Shuang Ho Hospital to develop smart healthcare solutions, signing an MOU on August 22nd to collaborate on advancing smart healthcare, focusing initially on international medical applications. Far Eastern Medical and Electronics Technology, experienced in integrating smart healthcare services, collaborates with Microsoft and others to develop AI, automation, and data management technologies. It supports global healthcare institutions with international service platforms in regions such as Europe, the U.S., and Southeast Asia, and plans to expand to Singapore, the Middle East, and Japan. More... (in Chinese) |
| Compal Electronics expands AI program with hospital partnership 22 August, 2024 Compal is expanding its AI healthcare efforts through a strategic partnership with Shin Kong Hospital, focusing on AI medical imaging for quantitative lung fibrosis by combining Compal's AI hardware with the hospital's AI models. And in May, the Kinpo Group which includes Compal, signed an MOU with Taichung Veterans General Hospital. Compal Chairman Chen Rui-Tsung emphasized the company's ongoing commitment to smart healthcare, with successful AI applications in areas like frozen shoulder risk detection, brainwave stress analysis, and hearing tests already commercialized and showing promising growth potential. More... (in Chinese) |
| Grape King Signs MOU with Thailand Food Institute 21 August, 2024 Grape King (TW: 1707) is expanding into the ASEAN market with the August 20 signing of an MOU with the Thailand Food Institute to collaborate on biotechnology R&D and establish a presence in Thailand. Additionally, their subsidiary, Pro-Partner, will enter Malaysia in the first half of next year as its first overseas market. Grape King is also advancing through a joint venture with All Cosmos Bio-Tech (TW: 4148), while Pro-Partner is focusing on direct selling. To cater to the Muslim population in the ASEAN region, Grape King's Zhongli plant features a halal-certified production line. More... (in Chinese) |
| Meet Daniel Villegas of Amgen Taiwan Promotional interview 20 August, 2024 Amgen Taiwan's General Manager Daniel Villegas began his career in the fast-moving consumer goods space before transitioning into biopharmaceuticals. His professional journey has spanned four continents and covered various therapeutic areas, from rare diseases to immunology. More... |
| In clinical trials collaboration, Chang Gung Memorial Hospital Partners with Amgen Taiwan 20 August, 2024 Chang Gung Medical Foundation has signed a letter of intent with Taiwan Amgen to deepen their collaboration in clinical trials, focusing on hematologic oncology, cardiovascular diseases, immunology, and renal diseases. By combining Chang Gung's vast clinical experience with Amgen's biotechnology expertise, the partnership aims to provide better treatment options for patients and improve healthcare quality. This collaboration builds on a strong foundation, as the two organizations have already conducted over 50 clinical trials together in the past 14 years. Chang Gung diagnoses around 20,000 new cancer cases annually, representing 18% of Taiwan's total, and initiates 300 clinical trials each year, with 74% related to new drug research. Additionally, it handles 200 company-commissioned clinical trials annually, underscoring its leading position in the field. The partnership with Amgen aims to further enhance these efforts, leveraging their combined strengths to drive innovation in medical technology and clinical development. More... (in Chinese) |
| BioGend Therapeutics' bone growth factor to enter Phase III clinical trials in Taiwan and Japan 20 August, 2024 BioGend Therapeutics (TW: 6733) plans to discuss a Phase III clinical trial for its bone growth factor (OIF) with Japan's PMDA by year-end, and if approved for a small-scale trial, BioGend aims to conduct Phase III trials in both Taiwan and Japan. The product has shown effectiveness in Japan’s non-union bone fracture trials, and Phase II results from Taiwan and the US are expected soon. Additionally, a joint venture in China aims to start Phase III trials next year. The company noted that Medtronic’s Infuse is the only FDA-approved bone regeneration product, dominating the market for over 20 years. Despite its infection risks and annual sales of USD500-600 million, no competitors have emerged. BioGend’s bone growth factor aims to replace Infuse by avoiding animal-derived risks and offering cost-effective production, targeting a significant share of the global market. More... (in Chinese) |
| GlycoNex completes Phase I clinical trial of biosimilar SPD8 19 August, 2024 GlycoNex (TW: 4168) announced on the 16th that its SPD8, a biosimilar to Denosumab developed with Mitsubishi Gas Chemical Company (MGC), has successfully completed Phase I clinical trials in Japan. The drug has shown comparable safety and bioequivalence to the original Denosumab in trials with healthy postmenopausal women. Following these results, GlycoNex plans to initiate Phase III trials in the fourth quarter of 2024 to conduct larger-scale studies on osteoporosis patients, evaluating SPD8's efficacy, safety, and immunogenicity. Denosumab, marketed as Prolia and Xgeva, generated global sales of $6.1 billion in 2023. With increasing awareness of osteoporosis risks, the market is expanding, and GlycoNex is advancing its global development plans to offer diverse treatment options beyond Japan. The progress of SPD8 represents a significant step for GlycoNex, demonstrating its expertise in monoclonal antibody engineering and its commitment to making advanced biologic therapies more accessible. More... (in Chinese) |
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