11/25 Taiwan Life Sciences Biweekly Newsletter
2024-11-25 |
| Taiwan Life Sciences Biweekly |
| TSH Biopharm's dry eye medication set to launch in Taiwan 19 November, 2024 TSH Biopharm (TW: 8432) announced that TYRVAYA, the worldÕs first nasal spray treatment for dry eye disease, has received a New Drug Approval notification from Taiwan's FDA (TFDA). This marks the second successful drug approval for TSH Biopharm this year. TSH Biopharm's General Manager, Yang Szu-Yuan, stated that TYRVAYA was approved by the US FDA in 2021 and has since been successfully launched. Developed by the US-based Oyster Point Pharma, this medication offers a new treatment option for Taiwanese patients with dry eye disease. Through a strategic partnership with Ji Xing Pharmaceuticals last year, TSH Biopharm rapidly initiated the registration and commercialization process for TYRVAYA in Taiwan. More... (in Chinese) |
| Taho Pharma's antithrombotic drug enters Phase III clinical trials 19 November, 2024 Taho Pharma, scheduled to list on the Taipei Exchange in late December, announced that its antithrombotic oral dissolvable film drug TAH3311 has entered Phase III clinical trials in the US, with the first group of participants completing initial dosing. Following an End of Phase I meeting with the FDA in July 2023, the agency approved a bioequivalence-based trial design comparing blood concentration levels with the original tablet formulation. The trial will involve 60 healthy participants, is expected to conclude in the first quarter of 2025, and will serve as the basis for regulatory approval applications in the US and Europe. More... (in Chinese) |
| Energenesis Biomedical's signs MOU with Taiwan Tanabe Seiyaku for commercialization of new drug Press release 19 November, 2024 Energenesis Biomedical (TW: 6657) announced that it has signed a Memorandum of Understanding (MOU) with Mitsubishi Tanabe Pharma's subsidiary, Taiwan Tanabe Seiyaku, for Taiwan and Southeast Asian commercialization rights of its new drug F703 DFU, developed for the treatment of diabetic foot ulcers. This marks one of the few collaborations between a Taiwanese biotech company and one of Japan's top 10 pharmaceutical companies for the joint sales and manufacturing of a new drug. More... (in Chinese) |
| Lukas Biomedical expands footprint in Vietnam with announcement of new sales agent 18 November, 2024 Lukas Biomedical (TW: 6814) announced that it had signed a five-year exclusive agency agreement with Vietnam-based M Pro International Enterprise to expand its presence in Vietnam's regenerative medicine sector. Under the deal, Lukas will receive USD6 million (approximately NTD195 million) in royalties. The agreement grants the partner rights to conduct medical research, negotiate technology licensing collaborations, carry out clinical trials, and develop markets for Lukas' cell therapy applications, focusing on cancer recurrence prevention and adjuvant treatments. More... (in Chinese) |
| BRIM Biotech highlights new drug BRM411 at Glaucoma Research Society meeting 18 November, 2024 BRIM Biotech (TW: 6885) announced that its consultant Dr. Lu Da-Wen, from Taipei's Tri-Service General Hospital, presented at the Glaucoma Research Society (GRS) Annual Meeting in Siem Reap, Cambodia, highlighting the superior mechanism of action of BRIMÕs new drug, BRM411. The presentation emphasized how BRM411 surpasses existing rho kinase inhibitor (ROCKi) glaucoma treatments by effectively reducing intraocular pressure while significantly minimizing red-eye side effects (hyperemia). More... (in Chinese) |
| Foresee Pharmaceuticals Receives the Second Positive Recommendation from DSMB to Continue the Casppian Study, a Phase 3 Clinical Trial of Leuprolide (FP-001) Injectable Emulsion for the Treatment of Central Precocious Puberty Press release 16 November, 2024 Foresee Pharmaceuticals (TW: 6576), today announces the second positive safety review by the independent Data and Safety Monitoring Board for its Casppian Phase 3 registration study. The DSMB recommended that Foresee Pharmaceuticals continue the trial without any modification. The Casppian Phase 3 study is an open-label, multicenter, multinational clinical trial to evaluate the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg controlled release in patients with central (Gonadotropin-Dependent) precocious puberty (CPP). ForeseeÕs leuprolide injectable emulsion, 42 mg (marketed under the brand name CAMCEVI¨), is currently approved for the treatment of adult patients with advanced prostate cancer and has demonstrated positive efficacy and safety results with statistically significant treatment effects in adult male patients with advanced prostate cancer. More... |
| Primo Biotechnology's new radiopharmaceutical plant completed 15 November, 2024 Primo Biotechnology celebrates two major achievements; on November 12 the company was recognized by Taiwan's Ministry of Economic Affairs (MoEA) Small and Medium Enterprise Administration as an outstanding startup company. Just two days later the company announced the completion of its radiopharmaceutical manufacturing plant. Primo Biotechnology expects to pass PIC/S GMP international certification process by the end of this year and enter the production phase to meet the rapidly growing demand for radiopharmaceuticals in nuclear medicine. In addition to investing in the early development of novel radioligand theranostics (RLT), Primo Biotechnology has also accelerated the approval of new drugs through the Taiwan FDA, and recently signed a licensing agreement with an international biotech firm to introduce mature and promising cancer diagnostic drugs. More... (in Chinese) |
| Focusing on ophthalmic new drugs, BRIM Biotechnology plans to go public mid-December 14 November, 2024 BRIM Biotechnology, focused on ophthalmic new drug development, plans to go public in mid-December. During a recent pre-listing performance presentation. BRIM's chairman, Andrew Lin, stated that since its establishment in 2013, the company has been dedicated to new drug translational science and currently has four ophthalmic new drugs in clinical development. Following public listing, BRIM aims to become an internationally recognized biotech pharmaceutical company. More... (in Chinese) |
| Pharmosa Biopharm's to begin Phase III clinical trial for L606 as early as end of year Press release 13 November, 2024 Pharmosa Biopharm (TW: 6875) stated at an investor conference that it had achieved its target of securing two regional licensing agreements for its drug-device combination product L606 ahead of schedule. The company will continue to advance licensing negotiations in other key markets. Additionally, another new drug, L608, is expected to submit its Phase II clinical trial application for the treatment of systemic sclerosis with digital ulcers (SSc-RP/DU) by mid-next year. L606 is a new formulation of treprostinil encapsulated in liposomes, used for treating pulmonary arterial hypertension (PAH, class I pulmonary hypertension) and pulmonary hypertension associated with interstitial lung disease (PH-ILD, class III pulmonary hypertension). Pharmosa has also developed its proprietary nebulizer, mastering the core 'drug + device' technology, which solidifies its unique position in the industry. More... (in Chinese) |
| Acepodia's allogeneic cell therapy new drug receives US FDA IND approval, partners with Pfizer to launch clinical trials 13 November, 2024 Acepodia (TW: 6976) announced that its lead candidate ACE1831 for treating IgG4-related disease (IgG4-RD), had received US FDA approval for its Investigational New Drug (IND) application. This approval marks AcepodiaÕs first clinical entry into the autoimmune disease field with allogeneic cell therapy. ACE1831 uses Acepodia's proprietary antibody-cell conjugation technology (ACC), combining CD20-targeting antibodies with gamma delta T cells to create an off-the-shelf treatment. This approach avoids the side effects of CAR-T therapies and is easier to scale for production. ACE1831 is also in a Phase I clinical trial for non-Hodgkin lymphoma (NHL). More... (in Chinese) |
| Taiwan showcases smart medicine prowess at MEDICA 2024 12 November, 2024 A delegation from Taiwan is attending this year's MEDICA, one of the world's largest medical trade fairs, running Nov. 11-14 in the German city of Dusseldorf to showcase the country's smart health care capabilities and expand global business opportunities. More... |
| Cutting-Edge Stem Cell Technology Captures the Heart of Asian King - iPSC Family Stem Cell Storage Service Press release 12 November, 2024 In a significant stride for the global regenerative medicine industry, MetaTech Inc., a leading biotechnology company in Taiwan, unveiled its groundbreaking "iPSC Family Stem Cell Storage" service. The launch event, held in Taipei, was graced by renowned Taiwanese pop icon Jay Chou's wife, Hannah Quinlivan, who serves as the service's ambassador. Quinlivan has not only donated her own peripheral blood but has also entrusted her daughter's umbilical cord blood to MetaTech for the creation and storage of iPSC (induced pluripotent stem cell). More... |
| GlycoNex Announces Manufacturing Agreement with Sterling for GNX102-ADC Clinical Trial Production Press release 12 November, 2024 GlycoNex, Inc. (TW: 4168), hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced a manufacturing agreement with Sterling Pharma Solutions, a UK-based CDMO with a specialist Antibody-Drug Conjugate (ADC) division, for clinical trial production of GNX102-ADC in preparation for a planned Phase 1 clinical program investigating the drug technology. More... |
| Cutting-Edge Stem Cell Technology Captures the Heart of Asian King - iPSC Family Stem Cell Storage Service Press release 12 November, 2024 In a significant stride for the global regenerative medicine industry, MetaTech Inc., a leading biotechnology company in Taiwan, unveiled its groundbreaking "iPSC Family Stem Cell Storage" service. The launch event, held in Taipei, was graced by renowned Taiwanese pop icon Jay Chou's wife, Hannah Quinlivan, who serves as the service's ambassador. Quinlivan has not only donated her own peripheral blood but has also entrusted her daughter's umbilical cord blood to MetaTech for the creation and storage of iPSC (induced pluripotent stem cell). More... |
| GlycoNex partners with Sterling Pharma Solutions to accelerate GNX102-ADC production 12 November, 2024 GlycoNex (TW: 4168) announced that it had signed a production agreement with the UK-based contract manufacturing organization, Sterling Pharma Solutions. Under this agreement, SterlingÕs antibody-drug conjugate (ADC) division will manufacture GlycoNex's ADC drug, GNX102-ADC, in preparation for upcoming Phase I human clinical trials. GNX102-ADC is a dual-function combination of GlycoNexÕs proprietary monoclonal antibody GNX102 and a chemical drug. It not only precisely targets cancer cells while minimizing harm to normal cells, but also enhances the concentration of the therapeutic drug in tumor cells, significantly improving treatment efficacy. More... (in Chinese) |
| The Limitless Potential of Repurposed Drugs 11 November, 2024 Breathing new life into drugs that were once considered unsuccessful is the driving force behind drug repurposing. This innovative approach allows researchers to re-evaluate existing medications or shelved candidates, exploring their potential for new therapeutic uses or targeting overlooked medical conditions. The result? Faster, cost-effective breakthroughs that can transform patient care and reshape the healthcare landscape. More... |
| Steminent Biotherapeutics' cell facility receives foreign manufacturer certification from Japan's MHLW 11 November, 2024 Steminent Biotherapeutics (TW: 7729) has achieved a significant milestone in its overseas expansion, with the company announcing that its cell facility had received the "Foreign Manufacturer Certification for Regenerative Medical Products" from Japan's Ministry of Health, Labour and Welfare (MHLW), making it the only Taiwanese company to date to obtain this certification. The company also achieved MHLW recognition for "regenerative medical products" in the country's foreign manufacturer category. More... (in Chinese) |
| InnoPharmax submits Phase III clinical trial application for D07001 to US FDA, targeting cholangiocarcinoma treatment opportunity 11 November, 2024 InnoPharmax (TW: 4172) announced that it had formally submitted a Phase III clinical trial application to the US FDA for D07001, an oral gemcitabine soft capsule for the treatment of cholangiocarcinoma. If the FDA does not provide any feedback within 30 days of the review period, the clinical trial can officially begin. The trial will include 195 patients with third-line cholangiocarcinoma and those unwilling to accept second-line injectable chemotherapy. In addition, the company is preparing a related clinical trial plan for pancreatic cancer and expects to apply for a Phase III clinical trial for pancreatic cancer next year. More... (in Chinese) |
| Taiwan Bio Industry Organization (Taiwan BIO)'s Johnsee Lee discusses new 'Healthy Taiwan' initiative 7 November, 2024 At a recent forum on health and biotech in Taiwan, Johnsee Lee, Honorary Chairman of Taiwan BIO, gave a presentation on the current state of Taiwan's biotech industry, including its recent rapid growth rate and emerging technologies in the fields of drug discovery, precision health, regenerative medicine, and exosomes. With the governmentÕs new 'Healthy Taiwan' initiative, Lee mentioned that there a push to shift the focus of public health from treatment to prevention. Numerous advanced testing technologies have emerged from these new innovations, which Lee believes deserve increased government attention. More... (in Chinese) |
| Abnova launches nanoCAR-T mRNA Services to enter CAR-T cell therapy applications 7 November, 2024 Abnova (TW: 4133) has launched 'nanoCAR-T mRNA Services', integrating its NanoAb nanobody technology platform, mRNA IVT vector design, and LNP delivery technology to innovate in CAR-T cell therapy applications. Nanobodies, at just one-tenth the size of conventional antibodies, offer superior tissue penetration and the ability to target previously inaccessible areas such as brain tissues and tumor microenvironments. These features enable their use in antibody-drug conjugates (ADCs), bispecific antibody drugs (BiTEs), and nanoCAR-T, highlighting their transformative potential in the field of cell therapy. More... (in Chinese) |
| AnHorn Medicines to launch Phase I clinical trial in the US for protein degrader-based male pattern baldness drug 7 November, 2024 AnHorn Medicines, a new drug development company with an AI-driven platform focused on protein degrader technology, has announced that the US FDA has approved its Investigational New Drug (IND) application for AH-001, an innovative protein degrader for treating male pattern baldness. The company plans to launch a Phase I clinical trial in the US in the fourth quarter of 2024 to evaluate the safety and tolerability of AH-001. 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) ========================================= |