09/07 Taiwan BIO Weekly
2026-09-07 |
| Taiwan BIO Weekly |
| HanchorBio's Second Trispecific Immunotherapy, HCB303, Enters Clinical Trial Application Process with the US FDA 4 September, 2026 HanchorBio (TW: 7827) has submitted a US FDA IND application for HCB303, its second trispecific immunotherapy to enter clinical development. Developed using the company's proprietary FBDB platform, HCB303 is a humanized trispecific fusion protein designed to coordinate macrophage, T-cell, and NK-cell activity to overcome complex tumor immune resistance mechanisms. HCB303 is the company's second trispecific immunotherapy to enter clinical development, following HCB301. More... (in Chinese) |
| Handa Pharmaceuticals' HND-039 Receives Final US FDA Approval 4 September, 2026 Handa Pharmaceuticals (TW: 6620) announced on the 4th of September that its wholly owned subsidiary, Handa Oncology, received notification from the US FDA that its independently developed 505(b)(2) cancer drug HND-039 (Omcazio capsules), in 11.5 mg, 23 mg, and 34.5 mg strengths, had successfully completed the US FDA's review and received final approval for marketing. More... (in Chinese) |
| Zillion Fine Chemicals International Focuses on Liposomal Drug Development 4 September, 2026 At BIO Asia-Taiwan 2026 held in Taipei in July, Japan's Nippon Fine Chemical and its Taiwan-based subsidiary Zillion Fine Chemicals International showcased their CRO and CDMO services for liposomal drug development, alongside CRODA Pharma, which promoted its Super Refined Polysorbates excipients for stabilizing sensitive drugs and biologics. The companies also hosted a six-session seminar at the conference on liposomal technologies featuring experts from Taiwan and Japan, including Taipei Medical University and Realinn Life Science. More... (in Chinese) |
| AnnJi Pharmaceutical's AJ201 Targets US Phase III Trial and US$2.5B SBMA Market 3 September, 2026 AnnJi Pharmaceutical (TW: 7754) has completed the Phase III protocol for AJ201 (Rosolutamide) and submitted an application to the US FDA for a pivotal Phase III trial in spinal and bulbar muscular atrophy (SBMA), or Kennedy's disease. If the FDA raises no issues during the review period, the trial can proceed in the US, with approximately 200 patients planned globally. AJ201 is currently the only known SBMA drug candidate advancing toward Phase III, positioning AnnJi to expand global development and strengthen its negotiating position for potential international licensing. More... (in Chinese) |
| CH Biotech R&D Partners with Academia and Industry to Advance Plant Biostimulant R&D and Validation 3 September, 2026 The Taiwan Biostimulant Society and National Chung Hsing University's Academy of Circular Economy, together with CH Biotech R&D (TW: 6534), held a seminar today on R&D, regulation, and scientific validation technologies for plant biostimulants. The event brought together representatives from industry, government, academia, and research institutions for discussion and exchange. Plant biostimulants can help crops maintain growth and improve stress resilience by regulating plant physiology and nutrient utilization, making them an important area of development in climate-smart agriculture. More... (in Chinese) |
| Lin BioScience's Belite Bio Rare Eye Disease Drug Nears Regulatory Approval 2 September, 2026 Lin BioScience's (TW: 6696) subsidiary Belite Bio's rare eye disease drug Tinlarebant is entering the final countdown toward regulatory approval. According to the US FDA, the PDUFA target action date is February 12, 2027, and the market expects a regulatory decision no later than that date. Attention is now shifting toward the company's commercialization strategy following approval. More... (in Chinese) |
| Wellell and NTU Hospital Partner to Advance Taiwan's Medical Device Clinical Evidence in Critical Care 2 September, 2026 Wellell (TW: 4106), a major manufacturer of medical air mattresses, announced on the 2nd of September that it is partnering with National Taiwan University Hospital (NTUH) to conduct a clinical study on automated patient turning in intensive care units (ICUs). The company has donated 20 Optima Turn automated patient-turning systems to NTUH for use in the study. Apex Medical said its next step is to expand collaborations with medical centers across Taiwan based on clinical evidence and seek to have automated turning air mattresses included as standard hospital procurement items. More... (in Chinese) |
| Ever Supreme Bio Technology's Three Core Businesses Advance as August Revenue Hits NT$110 Million 1 September, 2026 Ever Supreme Bio Technology (TW: 6712) announced on the 1st of September that August revenue reached NT$110 million, up 10.47% month-over-month and 21.1% year-over-year, marking a new high for the year. The company attributed the growth to steady progress across its three core businesses: cell storage, cell preparation services, and CDMO services. More... (in Chinese) |
| Medeon Biodesign's New Medical Device to Launch in the US in Q4 31 August, 2026 Medeon Biodesign (TW: 6499) plans to launch its Urocross Expander System, a minimally invasive device for treating benign prostatic hyperplasia (BPH), in the US in the fourth quarter of this year after receiving FDA 510(k) clearance in March. The company has also applied for marketing approval in Taiwan, targeting approval by year-end. Designed to improve urinary obstruction and lower urinary tract symptoms, Urocross is positioned as a first-line minimally invasive treatment option between conventional drug therapy and invasive surgery, addressing a large US BPH market affecting approximately 40 million men. More... (in Chinese) |
| Taiwanese Biotech Firms Target Global Markets as Handa Pharmaceuticals, Foresee Pharma and Others Near US and European Approvals 30 August, 2026 Taiwanese biotech and pharmaceutical companies are gearing up to expand into international markets. Following PharmaEssentia's (TW: 6446) Ropeg approval from the US FDA for the treatment of essential thrombocythemia (ET), several other companies--including Handa Pharmaceuticals (TW: 6620), Foresee Pharmaceuticals (TW: 6576), TAHO Pharmaceuticals (TW: 6467), and Lin Bioscience (TW: 6696)--are expected to obtain drug approvals in the US, Europe, and other international markets from the third quarter of this year through the first half of next year. More... (in Chinese) |
| PharmaEssentia's Ropeg Approved by US FDA for All Adult ET Indications, Estimated to Benefit 170,000 Patients 29 August, 2026 PharmaEssentia (TW: 6446) announced that the US FDA has approved Ropeginterferon alfa-2b (Ropeg, P1101) for the treatment of essential thrombocythemia (ET), with the indication covering all adult ET patients regardless of genotype or disease status, including newly diagnosed patients who have not received cytoreductive therapy. The approval, which is expected to benefit approximately 170,000 ET patients in the US, was supported by results from the global Phase 3 SURPASS-ET trial and North American EXCEED-ET trial, with SURPASS-ET showing that Ropeg achieved a significantly higher rate of durable clinical response than anagrelide in patients resistant or intolerant to hydroxyurea. More... (in Chinese) |
| Formosa Pharmaceuticals Files Clinical Trial Application for TSY-110, an Antibody-Drug Conjugate Biosimilar Targeting HER2-Positive Breast Cancers Press release 28 August, 2026 Formosa Pharmaceuticals, Inc. (TW: 6838), today announced the submission of a Clinical Trial Application (CTA) to European regulatory authorities to conduct a pivotal clinical trial for TSY-110. TSY-110 is a biosimilar candidate referencing Roche's antibody-drug conjugate (ADC) Kadcyla (ado-trastuzumab emtansine), indicated for HER2-positive metastatic and early-stage breast cancer. More... |
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