06/01 Taiwan BIO Weekly
2026-06-01 |
| Taiwan BIO Weekly |
| HeXun Biosciences builds dual-engine strategy, expects TPEx listing in June 29 May, 2026 Seeing the US$50 billion+ global regenerative medicine market as a major opportunity, HeXun Biosciences (TW: 6986) is expected to list on the Taipei Exchange in late June, with a provisional offering price of NT$52. The company is pursuing a dual-engine strategy combining novel drug development with cell therapy CDMO/CMO services. In addition to advancing the clinical development of its allogeneic stem cell drug HeXell-2020, HeXun is also expanding into cell therapy CDMO/CMO services. More... (in Chinese) |
| TTY Biopharm focusing on three core strategies to become international pharma company 29 May, 2026 TTY Biopharm (TW: 4105) held its shareholders' meeting on the 28th of May, with the message that it has adhered to three core strategies: exporting difficult-to-manufacture generic drugs, in-licensing innovative international medicines, and developing domestically produced new drugs. Looking ahead, TTY Biopharm will aim to launch two new products annually to sustain growth momentum, while steadily advancing toward its goal of becoming an international pharmaceutical company. The company highlighted the performance of its niche liposomal product Lipo-AB, which has continued to gain market share in the United States, exceeding one-third of the market last year, while also maintaining growth in South Korea and expanding into Australia, the Middle East, and Southeast Asia. Export sales now contribute more than 16% of revenue, with management aiming to increase that figure to 20%. More... (in Chinese) |
| Taiwan Bio Therapeutics secures strategic investment from Mitsui Kinzoku 28 May, 2026 Taiwan Bio Therapeutics (TW: 6892), following the recent addition of the Mayo Clinic as a strategic shareholder, announced on the 27th of May that its first private placement of common shares in 2025 has brought in Mitsui Kinzoku, under Japan s Mitsui Group, as a new shareholder. The company has acquired about a 1.5% stake, according to reports. The investment highlights Taiwan Bio Therapeutics' technological strengths in regulatory T-cell therapeutics and regenerative medicine, which have gained strong recognition from a leading global industrial player. More... (in Chinese) |
| HanchorBio to List on Taiwan Innovation Board at NT$120 per Share as HCB101 Clinical Data Support Global Partnering Discussions Press release 28 May, 2026 HanchorBio, Inc. (TW: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced that it will be officially listed on the Taiwan Innovation Board on May 29, 2026, with an underwriting price of NT$120 per share. HanchorBio is focused on developing differentiated immunotherapies targeting large unmet needs in oncology and autoimmune diseases. The company's core technology is its proprietary FBDB platform, which integrates multiple immune-modulating mechanisms into a single molecule and supports the development of multi-target, multifunctional biologic therapies. More... |
| Foresee Pharmaceuticals completes Phase III clinical trial for CPP novel drug, targets US FDA filing by year-end 27 May, 2026 Foresee Pharmaceuticals (TW: 6576) announced on the 27th of May that its Phase III clinical trial for FP-001 (42 mg Leuprolide Mesylate), a novel therapy for central precocious puberty (CPP), has successfully completed the last patient's last visit (LPLV), officially concluding patient enrollment and follow-up procedures for the study. The company said it will accelerate regulatory filing preparations and plans to submit a New Drug Application (NDA) to the US FDA by the end of 2026, while simultaneously pursuing filings in major global markets. The company said FP-001 is a long-acting sustained-release GnRH agonist administered once every six months, compared with most currently available therapies that require monthly or quarterly injections. More... (in Chinese) |
| Gongwin Biopharm targets strong operational growth in the second half of the year 27 May, 2026 Gongwin Biopharm (TW: 6617) said its lung cancer drug PTS302 (Prostacine) is entering a harvest phase in China, with management expecting a significant sales uplift in the second half of the year. The drug has been introduced to 310 hospitals in China, helping drive January-April revenue to NT$12.86 million, up 15.9% year-on-year. Beyond China, PTS302 has been licensed in Morocco, Algeria, Malaysia, and Singapore, while the company has upgraded PIC/S GMP manufacturing standards to facilitate international approvals and pipeline development. More... (in Chinese) |
| Taiwan presents smart healthcare applications at Berlin seminar 26 May, 2026 Health Minister Shih Chung-liang presented Taiwan's smart healthcare applications and AI-driven medical technologies at a seminar in Berlin hosted by the Taipei Representative Office in the Federal Republic of Germany, highlighting Taiwan s healthcare strengths and calling for deeper cooperation with Germany. More... |
| Heron Neutron Medical files new indication application for AB-BNCT targeting breast cancer 26 May, 2026 Heron Neutron Medical (TW: 7799) announced that its B10 L-BPA injection has been submitted to Taiwan's FDA for approval to begin a clinical study evaluating accelerator-based boron neutron capture therapy (AB-BNCT) in patients with recurrent, locally advanced, or metastatic triple-negative breast cancer (TNBC). If approved, the study will be conducted in collaboration with leading medical centers including Linkou Chang Gung Memorial Hospital, marking the company's expansion of its AB-BNCT platform from head and neck cancer into the treatment of aggressive breast cancer and broader solid tumor applications. More... (in Chinese) |
| Medimaging Integrated Solution secures Taiwan approval for arthroscope, aims to revive business growth 26 May, 2026 Medimaging Integrated Solution (TW: 6796) announced that its minimally invasive electronic arthroscope EJA100 has received Taiwan Class II medical device approval following earlier clearance from the US FDA through the 510(k) pathway, completing the company's platform deployment in both flexible and rigid disposable endoscopy systems for minimally invasive surgery. Despite a slight Q1 loss and weaker margins from product mix changes, the company expects recovery as its endoscopy products gain global approvals and key orders, driving improved revenue and profitability. According to market research reports, the global disposable endoscope market is expanding at a compound annual growth rate of over 20%. More... (in Chinese) |
| Lumosa Therapeutics' LT3001 exploratory clinical trial passes Taiwan FDA review 26 May, 2026 Lumosa Therapeutics (TW: 6535) announced that its new chemical entity drug LT3001, developed for acute ischemic stroke, has passed review by the Taiwan FDA for an exploratory clinical trial investigating its mechanism of action under multiple-dose administration. The company expects to complete patient enrollment for the exploratory study within one year, although the actual timeline may vary depending on execution progress. Each year, approximately 15 17 million people worldwide suffer a stroke, of which around 80% are ischemic. If LT3001 can overcome current safety limitations, it could potentially be administered within 24 hours after stroke onset, either alone or in combination with mechanical thrombectomy, with an estimated market potential of up to US$10.6 billion. More... (in Chinese) |
| PharmaEssentia's ET drug wins Taiwan approval, with US, Japan likely to follow by August 25 May, 2026 PharmaEssentia (TW: 6446) announced that clinical findings for its novel drug Ropeginterferon alfa-2b (Ropeg, also known as P1101) in essential thrombocythemia (ET) have attracted significant international attention, with multiple study papers set to be presented at the 2026 meetings of the American Society of Clinical Oncology (ASCO) and the European Hematology Association (EHA). The company said Ropeg for ET received the world's first approval letter from Taiwan s Ministry of Health and Welfare on May 12. Approvals in the US, Japan, China, and South Korea are expected later this year. Ropeg has already been approved and commercially launched in 50 countries worldwide for the treatment of polycythemia vera (PV). ET belongs to the same myeloproliferative neoplasm (MPN) disease category as PV and represents Ropeg's next targeted indication following PV. More... (in Chinese) |
| ========================================= |
| Taiwan Bio Industry Organization (Taiwan BIO) Tel: +886 2 27836028 Fax: +886 2 27836027 Email: biotaiwan@gmail.com BIO Asia-Taiwan 2026 (15-19 July, 2026) ========================================= Taiwan Bio Industry Organization (Taiwan BIO) Room C229, 2F, Bldg. C, No. 99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei, Taiwan (11571) ========================================= |