1/26 Taiwan BIO Weekly
2026-01-26 |
| Taiwan BIO Weekly |
| ACRO Biomedical reports surge in R&D achievements 23 January, 2026 ACRO Biomedical (TW: 6748), internationally recognized for its regenerative medicine technologies based on decellularized tissue and organs, has recently reported a surge in R&D achievements. Following the successful development of three regenerative medical devices--hemostatic dressings, hemostatic particles, and hemostatic gel--the company has also secured approval from Taiwan's Ministry of Health and Welfare for its corneal stroma medical device. In addition, its application for the use in promoting hair follicle regeneration or angiogenesis has been granted a Japanese patent. Meanwhile, its Class III implantable aesthetic medical devices are nearing regulatory approval. Once completed, ACRO Biomedical will possess the most comprehensive portfolio of Class III regenerative medical devices in the industry. More... (in Chinese) |
| Bora Pharmaceuticals secures ophthalmology drug approval, targets US$1.9B market 22 January, 2026 Bora Pharmaceuticals (TW: 6472) announced that it has obtained approval for the generic version of RESTASIS, originally developed by Allergan. This ophthalmic drug is a sterile, single-use formulation, and will be prepared for US launch by its subsidiary Upsher-Smith (USL). According to IQVIA data, the 12-month market through November last year indicates a current market size of approximately US$1.9 billion, with relatively stable competition. More... (in Chinese) |
| Ever Supreme Bio Technology and Shine Out Biotechnology advance exosome therapies for neurodegenerative diseases 21 January, 2026 Taiwan officially entered a super-aged society in 2025, with over 20% of its population, or 4.5 million people, aged 65 and above, bringing with it a growing burden of neurodegenerative diseases such as dementia, Alzheimer's, and Parkinson’s diseases. Shine Out Biotechnology (TW: 6926), a spin-off from Taiwan's China Medical University, established in 2023, is developing exosome-based therapies to address these unmet medical needs. Its lead candidate, dEV-001, uses a brain-targeting exosome platform to deliver curcumin to neurons, showing promising preclinical safety and efficacy. The company submitted a Pre-IND application to the US FDA in late 2025, aiming to start Phase I clinical trials in 2026. In Q4 2025, Ever Supreme Bio Technology (TW: 6712) acquired 100% of Shine Out Biotechnology, combining their technology platforms and advancing regenerative medicine applications under Taiwan's dual-track regulatory framework. Shine Out Biotechnology's exosome platform can deliver small molecules, nucleic acids, and proteins across the blood-brain barrier, targeting key sites in neurodegenerative diseases while minimizing toxicity and immune response. More... (in Chinese) |
| Unicocell Biomed's exosome product receives cosmetics certification in the Philippines 21 January, 2026 Unicocell Biomed (TW: 6794) announced that its exosome product has received approval from the Philippines Food and Drug Administration as a Cosmetic Product, to be officially sold in the Philippines. This marks an important step for Unicocell Biomed's exosome product expanding into Southeast Asia, following its earlier entry into the Japanese market. Unicocell Biomed stated that the Philippines, with a population of over 100 million, is a key market for medical aesthetics and cosmetics in Southeast Asia and has been experiencing continuous growth in recent years. The approval indicates that its product meets ASEAN Cosmetic Directive standards, which were jointly established by the ten ASEAN countries, laying a foundation for future expansion into other Southeast Asian markets. More... (in Chinese) |
| ScinoPharm Taiwan's multiple myeloma treatment receives Taiwan approval 21 January, 2026 ScinoPharm Taiwan (TW: 1789) announced that its multiple myeloma treatment Bortezomib, following approval by the US FDA in 2023, has now successfully obtained marketing authorization from Taiwan's Food and Drug Administration (TFDA). This marks the only domestically manufactured multiple myeloma injectable in Taiwan to receive dual approval from both the US FDA and Taiwan TFDA. More... (in Chinese) |
| Merdury Biopharmaceutical’s orally disintegrating tablets approved by Taiwan's TFDA 20 January, 2026 Merdury Biopharmaceutical (TW: 6932) announced that its 50mg orally disintegrating tablets for adult male erectile dysfunction has received TFDA approval and is entering the commercialization stage. This marks the company's first drug to obtain a marketing authorization and the second domestically approved sildenafil orally disintegrating tablet in Taiwan. Designed for convenience without water, the mint-flavored tablet offers advantages over traditional swallowable forms, enhancing patient experience and adherence, and its technology is patented. More... (in Chinese) |
| Zheng Yang Biomedical Technology invests in AventaCell BioMedical, teams up with Nan Ya Plastics to advance regenerative medicine 20 January, 2026 AventaCell BioMedical, a company invested by Zheng Yang Biomedical Technology Group, held an extraordinary shareholders' meeting and outlined its partnership with Nan Ya Plastics (TW: 1303). Nan Ya, attracted by AventaCell's cell culture medium production technology, announced on December 16 last year that its board approved an investment in AventaCell totaling up to NT$210 million. Both parties aim to leverage their strengths to seize opportunities in the regenerative medicine industry, while enhancing development and sales of medical products. More... (in Chinese) |
| PET Pharm Biotech teams up with Honeybear Biosciences 19 January, 2026 PET Pharm Biotech (TW: 7762) announced that it has signed a Memorandum of Understanding (MOU) with Honeybear Biosciences, to collaborate to advance Taiwan's first antibody-radioconjugate (ARC) new drug development, accelerate the implementation of local clinical trials, and strengthen preclinical animal studies and manufacturing capabilities, bridging the process from nonclinical to clinical stages. This partnership is seen as a key integration in Taiwan's nuclear medicine new drug development chain, laying the foundation for precision oncology and the advancement of high-barrier radiopharmaceuticals. Honeybear Biosciences, founded in 2021, is focused on antibody-drug conjugates (ADCs). In 2025, it obtained authorization from Singapore's Agency for Science, Technology and Research (A*STAR) to adopt its CoNectarR patented platform, applying it to the development of next-generation ARCs. More... (in Chinese) |
| Reprogramming the cancer messenger: A new era of tumor extracellular vesicle engineering 19 January, 2026 Researchers at National Taiwan University have developed a modular platform to reprogram tumor-derived extracellular vesicles (EVs), transforming them from oncogenic messengers into safe, customizable drug delivery vehicles through precise molecular editing. More... |
| Sunny Pharmtech starts 2026 on a high note with US FDA approval of PTD-I 18 January, 2026 Sunny Pharmtech (TW: 6676) announced that its Phytonadione Injectable Emulsion USP (PTD-I, 1 mg), developed for the treatment of vitamin K1 deficiency, was officially approved by the US FDA, with the approval publicly announced on January 12, granting the product its US marketing authorization. This marks the first product to receive approval this year among Sunny Pharmtech's recently submitted applications. The approval also represents a concrete achievement of one of the company's key strategies; continued expansion of its US market presence. More... (in Chinese) |
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