04/13 Taiwan BIO Weekly
2026-04-13 |
| Taiwan BIO Weekly |
| StemCyte International to list on public stock market with price set at NT$21 9 April, 2026 StemCyte International (TW: 4178), a cell therapy company, plans to list in Taiwan in late April at a tentative underwriting price of NT$21 per share. The company is advancing a three-pronged strategy covering cell services, cell supply, and cell-based new drugs, and has recently partnered with insurers to launch a public bank protection service, while also pursuing multiple licensing deals starting this year. Its flagship product REGENECYTE has received US FDA approval for treating nearly 80 hematopoietic and immune disorders, and the company plans to expand regional licensing in China and broaden indications. A Phase III clinical trial for long COVID is expected to begin enrollment soon with about 60 patients, with results anticipated in 2028, alongside additional international licensing opportunities during the trial phase. More... (in Chinese) |
| Gongwin Biopharm's PTS-302 lung cancer drug to file Malaysia, Philippines approvals in Q3 9 April, 2026 Gongwin Biopharm (TW: 6617) is accelerating global regulatory expansion for its lung cancer drug PTS-302, and is expected to file New Drug Application (NDA) submissions in Malaysia and the Philippines in the third quarter of this year. PTS-302 is an innovative minimally invasive targeted tumor ablation therapy (MITTA) for central airway obstruction (MAO), one of the most severe and high-mortality complications of advanced lung cancer. With existing approval in mainland China, completed regional licensing in Malaysia, and manufacturing upgraded to PIC/S GMP international standards, the company aims to enhance approval efficiency and establish a foothold in Southeast Asian markets. More... (in Chinese) |
| Lotus Pharmaceuticals' immunotherapy combination therapy approved as first-line maintenance for ES-SCLC 9 April, 2026 Lotus Pharmaceuticals (TW: 1795) announced on 8th April that its cancer drug Zepzelca (lurbinectedin) has been approved by Taiwan's Food and Drug Administration (TFDA) for use in combination with the PD-L1 inhibitor atezolizumab as a combination immunotherapy for first-line maintenance treatment of adult extensive-stage small cell lung cancer (ES-SCLC). The company also plans to actively pursue National Health Insurance reimbursement in Taiwan to improve patient access to high-quality treatment. More... (in Chinese) |
| LaunXP Biomedical expected to submit US FDA IND application for metabolic drug by year-end 9 April, 2026 LaunXP Biomedical (TW: 6876) announced that it has updated its latest research on its metabolic disease candidate LXP103. In obese rat models, LXP103 demonstrated regulation of adipocyte metabolism with both overall weight reduction and localized fat loss effects. The compound showed potential for long-term efficacy, did not affect appetite, and showed no signs of inflammation or toxicity, strengthening confidence in its development for obesity and metabolic disease treatment. The company is continuing additional animal studies focused on whole-body fat reduction and anti-weight-regain effects, with plans to submit an Investigational New Drug (IND) application to the US FDA by year-end. More... (in Chinese) |
| TCM Biotech International lists on Taiwan stock market, drug and diagnostics pipeline advances 8 April, 2026 TCM Biotech International (TW: 4169) officially listed in Taiwan on 8th April at NT$102 per share, highlighting its dual-track model of leveraging distribution sales to fund new drug development and maintain stable cash flow. The company has built broad market coverage across Taiwan's medical centers and most regional hospitals, while sustaining profitability since 2015 despite ongoing R&D investment. Its key pipeline assets--including U101 for preventing recurrent urinary tract infections and the CatCHimera liver cancer post-surgery detection platform--are entering the commercialization stage, with additional competitive advantages from in-house API development, cost control, and patent supporting future growth. More... (in Chinese) |
| PharmaEssentia sets new revenue highs for March and Q1 7 April, 2026 PharmaEssentia (TW: 6446) reported record-breaking March and first-quarter revenues, driven by strong global sales growth of its core drug Ropeg, while also securing U.S. orphan drug designation across all three indications--polycythemia vera, essential thrombocythemia, and myelofibrosis--granting tariff exemptions. At the same time, the company is expanding its global manufacturing footprint with a new facility in Puerto Rico, advancing its dual Taiwan-US production strategy to enhance supply chain resilience and align with US policy incentives. More... (in Chinese) |
| TaiMed Biologics's new HIV drug qualifies for zero-tariff sales in the US 7 April, 2026 TaiMed Biologics (TW: 4147), whose HIV drug sales are primarily in the US, today issued a statement regarding the latest US trade policy. TaiMed noted that its HIV drug Trogarzo qualifies for zero-tariff treatment due to its 2014 orphan drug designation and a friendly offshore supply chain structure. More... (in Chinese) |
| Easywell Biomedicals March revenue tops NT$100M for first time, up 70% MoM and 30% YoY 7 April, 2026 Easywell Biomedicals (TW: 1799) reported record revenue for March, surpassing NT$100 million for the first time at NT$100.12 million, a 70% increase month-on-month and 30% year-on-year. The company attributed the growth to expanding sales in the US and China, revenue-sharing from co-developed drugs, and three main growth drivers lifting overall performance. Looking ahead, analysts expect Easywell Biomedicals' new diabetes insipidus drug to contribute additional growth from Q2, with potential new royalty income in Q3, suggesting quarterly revenue could continue improving throughout the year. More... (in Chinese) |
| Foresee Pharmaceuticals new formulation prostate cancer drug CAMCEVI receives authorization in Canada 6 April, 2026 Foresee Pharmaceuticals (TW: 6576) noted that with an increasingly aging population, the number of prostate cancer patients continues to rise. According to Verified Market Reports (VMR), the global market revenue for Leuprolide (all indications) was approximately US$2.5 billion in 2024 and is expected to reach US$4.1 billion by 2033, representing a compound annual growth rate of 6.0% from 2026 to 2033. Foresee Pharmaceuticals' CAMCEVI ETM is a prefilled, 3-month sustained-release injection for prostate cancer developed using the company's proprietary extended-release injection platform, and addresses the inconvenience and potential usage errors associated with leuprolide injections. More... (in Chinese) |
| Alar Pharmaceuticals announces US Phase I clinical trial results for ALA-3000 4 April, 2026 Alar Pharmaceuticals (TW: 6785) reported that its US Phase I trial of ALA-3000 for treatment-resistant depression successfully met its primary endpoint, demonstrating favorable safety and tolerability with only mild-to-moderate, transient adverse events and no serious concerns, while secondary results showed the drug achieved sustained-release pharmacokinetics after subcutaneous injection, featuring delayed peak concentration, stable and continuous drug release without burst effect or dose dumping, and gradual blood concentration changes. More... (in Chinese) |
| Taipei Medical University partners with Cambridge on digestive disease research 2 April, 2026 Taipei Medical University has partnered with the University of Cambridge to research treatments for digestive diseases, explore new drug-testing methods, and develop a research platform, CNA reported. More... |
| Taiwan to buy record 7.05 million flu vaccines for free annual program 31 March, 2026 Taiwan plans to buy a record 7.05 million influenza jabs for its annual publicly-funded vaccination campaign, including 200,000 enhanced vaccines for seniors in residential care facilities, the Centers for Disease Control (CDC) said Tuesday. Speaking at a weekly press conference, CDC Director-General Lo Yi-chun said Taiwan saw high demand for flu vaccines last year, when it purchased a total of 6.865 million doses. More... |
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