08/10 Taiwan BIO Weekly
2026-08-10 |
| Taiwan BIO Weekly |
| CCSB's Shift Toward APIs and CDMO Proves Successful, Reports half year EPS of NT$2.39 6 August, 2026 Chunghwa Chemical Synthesis & Biotech (CCSB, TW: 1762) reported first-half 2026 revenue of NT$666 million, up 24% year over year, with operating profit of NT$115 million and EPS of NT$2.39. Following the completion of inventory processing related to a fish oil project, the company has completed its resource restructuring and is now focused on high-tech APIs and CDMO services, with growth driven by core business expansion, product mix optimization, and improved operating efficiency. The company is also advancing digital transformation through SAP ERP, LIMS, and QMS systems to strengthen operations and quality management. More... (in Chinese) |
| Energenesis Biomedical and Taiwan Tanabe Seiyaku Enter Joint Development Agreement for ENERGI-F703DFU Press release 6 August, 2026 Energenesis Biomedical Co., Ltd. (TW: 6657) today announced that it has entered into a joint development agreement with Taiwan Tanabe Seiyaku Co., Ltd. (Taiwan Tanabe), the wholly owned subsidiary of Tanabe Pharma Corporation, for ENERGI-F703DFU, Energenesis' investigational topical drug for diabetic foot ulcers (DFU). More... |
| PharmaEssentia's July Revenue Hits Another High, US and Japan ET Approvals Expected Soon 5 August, 2026 PharmaEssentia (TW: 6446) reported record-high July revenue of NT$2.51 billion, up 7.5% month over month and 92.6% year over year, driven by continued global growth of its core polycythemia vera treatment, Ropeginterferon alfa-2b (Ropeg). Revenue for the first seven months reached NT$14.48 billion, an increase of more than 70% YoY, reflecting sustained strong momentum. The company also highlighted the US launch of the newly approved Ropeg prefilled injection pen in July, which is expected to improve patient convenience and treatment adherence, attract additional patients, expand market penetration, and further support future growth. More... (in Chinese) |
| Biweekly GLP-1 Drug Clears First Human Test via Dual Fatty Acid Engineering 5 August, 2026 A Taiwanese clinical-stage biotech [Immunwork] published first-in-human Phase 1/2a data for TE-8105 on August 4, 2026, confirming a mean plasma half-life of approximately 120 hours -- roughly five days -- using a molecular engineering approach no approved or advanced-stage GLP-1 drug has previously tested in humans. The results, published in the Journal of Clinical Pharmacology (DOI: 10.1002/jcph.70224) and presented at the 20th World Congress of Basic and Clinical Pharmacology (WCP2026) in Melbourne in July 2026, position Immunwork as the second company -- alongside Pfizer with its berobenatide program -- to demonstrate a human half-life capable of supporting biweekly or less frequent GLP-1 dosing, but via a structurally distinct chemistry. More... |
| Original BioMedicals' OBM-B01 Approved by TFDA for Phase I Trial, Targeting Smoke Inhalation Market 4 August, 2026 Original BioMedicals (TW: 6483) announced that its innovative upper respiratory tract delivery therapy OBM-B01 has received TFDA approval to proceed with a Phase I human clinical trial (IND) review. Following completion of the trial and successful non-human primate efficacy studies, the company may directly file a New Drug Application (NDA) if regulatory requirements are met. OBM-B01 is a preventive treatment for fire-related smoke inhalation injuries, combining FDA-approved hydroxocobalamin and deferoxamine with a buffer solution and delivered via nebulization to protect the upper respiratory tract and lungs, targeting firefighters exposed to hazardous smoke. More... (in Chinese) |
| Medigen Vaccine Biologics Begins Enterovirus Vaccine Export to Vietnam 4 August, 2026 Medigen Vaccine Biologics (TW: 6547) announced that the first batch of its self-developed enterovirus 71 (EV71) vaccine has arrived in Vietnam and is expected to be administered after completion of local government inspection procedures. The vaccine is expected to begin contributing to revenue in August. Vietnam represents the first overseas market for Medigen's EV71 vaccine, with additional shipments planned throughout the year, subject to batch releases by Taiwan's Food and Drug Administration (TFDA). More... (in Chinese) |
| AI Drug Purification Clears GMP Test at Taiwan CDMO: 11 Percent Recovery Gain From Five Experiments 4 August, 2026 A Taiwanese contract drug manufacturer has produced what appears to be the first publicly documented proof that an AI-driven, physics-based digital twin can clear full GMP validation in a commercial biologic purification operation -- lifting product recovery by 11% from a starting point so low the drug's commercial future was in doubt. The result, achieved by Mycenax Biotech using Cytiva's GoSilico AI platform in GMP operations, arrived on July 3, 2026, at a Taipei seminar, precisely as the BIOSECURE Act -- signed into law December 2025 -- is forcing American pharmaceutical companies to identify manufacturing alternatives to Chinese contract organizations they can no longer legally use with federal funding. More... |
| Advagene Biopharma's AD17002 Completes Phase II Trial Enrollment Ahead of Schedule 4 August, 2026 Advagene Biopharma (TW: 6709) announced on the 4th of August that its proprietary asthma drug AD17002, being developed for the treatment of moderate-to-severe eosinophilic asthma, has completed enrollment of all subjects in its Phase II clinical trial ahead of schedule, achieving a key development milestone. The company will continue dosing participants and conducting safety follow-up, with topline data unblinding and analysis planned for early 2027 to accelerate further clinical development and international licensing opportunities. More... (in Chinese) |
| Oneness Biotech's New Drug Meets Endpoint After Trial Unblinding 3 August, 2026 Oneness Biotech (TW: 4743) announced that the post-marketing confirmatory trial of its diabetic foot ulcer drug ON101 (Fespixon) has been successfully unblinded, meeting the primary efficacy endpoint with statistically significant results and showing a favorable safety profile, thereby achieving the studyÕs objectives. Taiwan's TFDA has accepted the trial as a confirmatory study in place of the Phase III trial originally planned for the United States, and the company will submit the data to regulators in Taiwan and mainland China to seek expanded indications in China, discontinue further clinical trials there, and satisfy Taiwan's post-marketing requirements. More... (in Chinese) |
| GlycoNex Enrolls First Patient in Phase I Trial of Next-Generation ADC drug GNX1021 3 August, 2026 GlycoNex (TW: 4168) announced on the 3rd of August that its next-generation glycan-antigen-targeting ADC GNX1021 has enrolled the first subject in its Phase I clinical trial in Japan, marking its entry into human clinical development and a key milestone in the companyÕs global ADC strategy. The multinational, multicenter Phase I study in Japan and Taiwan will evaluate GNX1021's safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity in patients with advanced solid tumors. GlycoNex will continue dose escalation and patient enrollment to determine the recommended dose for further development. More... (in Chinese) |
| TTY Biopharm's Targeted Lung Cancer Drug Added to Taiwan's NHI Reimbursement List 3 August, 2026 TTY Biopharm (TW: 4105) announced that its targeted lung cancer drug Aumolertinib was added to Taiwan's National Health Insurance (NHI) reimbursement program in August, providing a new treatment option for patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). The drug is Taiwan's first domestically developed and manufactured third-generation EGFR-TKI oral targeted therapy for lung cancer, marking a milestone for local drug development and pharmaceutical supply resilience. Developed and produced in response to clinical needs, Aumolertinib aims to improve treatment accessibility through a locally supplied alternative to imported therapies. More... (in Chinese) |
| Taiwan's Pharmosa Biopharm Acquires 54% Stake in Taiwan's ProOptic, Building Dual Drug-Device Platform 3 August, 2026 Pharmosa Biopharm (TW: 6875), a Taiwan-based emerging-stock biotech company, announced the completion of a strategic investment in ProOptic, a Taiwan-based advanced medical device developer, acquiring a 54% stake and completing a board reshuffle. The move formally establishes Pharmosa's dual-platform strategy combining "drug formulation" with "precision drug delivery devices." More... |
| Taiwan health delegation promotes medical services in Singapore 30 July, 2026 A Taiwan healthcare industry delegation attended a business matchmaking event in Singapore on Thursday to promote the country's medical services, products, and technology. More... |
| Genovate Biotechnology Goes Private in Merger with Easywell Biomedicals, Creating Taiwan-US Pharma Platform 29 July, 2026 Easywell Biomedicals (TW: 1799) completed its share swap merger with Genovate Biotechnology (TW: 4130) on July 28, with Genovate delisting from the Taiwan stock market to become a wholly-owned subsidiary. The deal formally launches a Taiwan-US integrated pharmaceutical platform. Easywell Chairman Lin Han-fei has assumed the role of Genovate chairman, while former China Chemical & Pharmaceutical General Manager Wu Chih-yung has been recruited as Genovate's new general manager. Through its US subsidiary Tulex Pharmaceuticals, Easywell has already secured 11 US FDA drug approvals. More... |
| Taiwan biotech looks outward in next phase of growth BioWorld subscription required 27 July, 2026 Taiwan's biotechnology sector was built around domestic health needs, including vaccines and drug manufacturing, but it is increasingly looking outward -- to international partnerships, licensing, clinical development and a bigger role in the global biomedical ecosystem. More... |
| ========================================= |
| 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) ========================================= Taiwan BIO is not responsible for the accuracy of the contents of news articles linked. |