09/15 Taiwan BIO Weekly
2025-09-15 |
| Taiwan BIO Weekly |
| ITRI teams up with Taiwan Medical and Biotech Industry Association to lead 35 Taiwanese companies into Thailand 11 September, 2025 The Industrial Technology Research Institute (ITRI), together with the Taiwan Medical and Biotech Industry Association, has led a delegation of 35 smart healthcare companies to Thailand. The initiative takes Taiwan's smart healthcare supply chain from clinical validation to market implementation, directly connecting with hospitals, industries, and distribution channels within Thailand. The effort aims to help Taiwan's smart medical device sector quickly seize new healthcare opportunities in the rapidly growing ASEAN market and expand its international footprint. More... (in Chinese) |
| Bora Pharmaceuticals reports double-digit revenue growth in first eight months 11 September, 2025 Bora Pharmaceuticals (TW: 6472) posted August revenue of NT$1.37 billion, down 26.6% YoY, but cumulative January-August revenue rose 14.8% to NT$13.2 billion. CDMO revenue rebounded strongly, up 17.5% MoM and 29.7% YoY, with year-to-date growth of 59.5%. Its Maple Grove facility's transition and generic drug shipment delays weighed on August sales, but orders are expected to recover. Customer demand for US capacity is rising, with Bora's Plymouth, Minnesota site under phased divestment and attracting multiple potential buyers. More... (in Chinese) |
| Shine-On BioMedical's exosome drug licensed to Singapore's ESCO, with NT$200mil upfront plus royalties 11 September, 2025 Shine-On BioMedical (TW: 6926) announced that it has signed a licensing agreement with Singapore's ESCO Aster (EA) for its patented exosome small-molecule drug loading technology. Under the agreement, Shine-On BioMedical will receive an upfront license fee of NT$200 million plus 5% royalties on product sales. The company estimates that over the next 10–15 years, the licensing deal could generate billions of NT dollars in long-term revenue. More... (in Chinese) |
| Amaran Biotech wins CDMO excellence award 11 September, 2025 Taiwan's Amaran Biotech announced that at the 2025 Asia-Pacific Biologics CDMO Excellence Awards held in Singapore by IMAPAC, it won the Best Biologics CDMO Award: Fill-Finish, recognizing the company's strength in aseptic filling processes and showcasing Taiwan's biotech industry on the international stage. Competing alongside CDMOs from South Korea, China, Australia, and other regions, Amaran Biotech emerged as the winner through a public voting process, earning the Best Aseptic Filling Award. More... (in Chinese) |
| TWi Biotechnology submits application to China NMPA for EBS new drug Phase II/III clinical trials 11 September, 2025 TWi Biotechnology (TW: 6610) announced that it has submitted an application to China's National Medical Products Administration (NMPA) for Phase II/III clinical trials for its investigational new drug AC-203, developed to treat simplex-type hereditary epidermolysis bullosa (EBS), with completion expected within three years. AC-203 is a topical ointment designed for inflammatory skin conditions, including simplex-type hereditary epidermolysis bullosa (EBS) and bullous pemphigoid (BP). More... (in Chinese) |
| SciVision Biotech expands overseas, Russia to contribute to revenue starting Q4 11 September, 2025 SciVision Biotech (TW: 1786) announced that it had made significant progress in its overseas expansion, with promising news from the Russian market. Its hyaluronic acid dermal fillers, available in 1ml, 2ml, 5ml, and 10ml formats for facial and body (including buttock) sculpting, totaling 18 formulations, have obtained Russian sales approval. This marks the first domestically produced subcutaneous filler to be certified in Russia, with revenue contribution expected as early as Q4 this year. More... (in Chinese) |
| 3D Global Biotech's technology licensing partnership boosts YD Bio's successful Nasdaq listing 8 September, 2025 3D Global Biotech (TW: 6808) announced that its licensing partner, YD Bio, successfully listed on the US Nasdaq on August 28. At the core of YD Bio's international market appeal is 3D Global Biotech's limbal stem cell (LSC) exosome technology, which holds significant potential for developing treatments for major ocular diseases such as dry eye and glaucoma. More... (in Chinese) |
| Adimmune's strong international collaborations drive dual track of vaccines and biosimilars 8 September, 2025 Adimmune announced that after completing production of seasonal flu vaccines for domestic pandemic needs this year, its production lines continue to operate due to strong international demand. In response to Sanofi's vaccine volume expansion plan, the company is conducting trial production on its second sterile injectable filling line. In addition, Adimmune's collaboration with a Korean partner to produce biosimilars for overseas markets is approaching launch. Commercial batch production has begun, and partner personnel are on-site. Preparatory work for Q3 and Q4 has progressed smoothly, positioning the company to convert these efforts into tangible revenue next year. More... (in Chinese) |
| ANXO Pharma's files for US Phase I clinical trial for its new schizophrenia drug 8 September, 2025 ANXO Pharmaceutical (TW: 6677) has submitted a Phase I clinical trial application (IND) to the US FDA for its new schizophrenia drug AX251. Under the US "silence approval" approach, if the FDA raises no additional questions within 30 days of accepting the IND, the trial may proceed immediately. Approval would mark ANXO's successful entry into the new drug arena, with its first candidate targeting a rapidly growing, common modern disease and tapping into a global market worth over US$10 billion. AX251 is a 505(b)(2) drug, reformulating an existing oral medication into a next-generation, long-acting injectable using ANXO's proprietary NanoCIP nanocrystal injection platform. This new formulation significantly improves bioavailability while reducing side effects. More... (in Chinese) |
| Strong testing demand pushes Applied BioCode toward quarterly profitability 8 September, 2025 As the fall-winter flu season approaches, Applied BioCode (TW: 6598) is seeing strong demand for its testing products. The company announced it has secured major orders from two key clients for RPP tests (20-target respiratory multiplex assays), while other customers have begun validating GPP tests (17-target gastrointestinal multiplex assays). With growth also continuing in animal testing applications, Applied BioCode aims not only to narrow losses in the second half of the year but also to achieve quarterly profitability. From January to July, Applied BioCode reported revenue of NT$276 million, up 24.2% year-on-year, and a first-half EPS loss of NT$1, reflecting a narrowing of its losses. More... (in Chinese) |
| Pharmacy's Next Chapter: Education, Genomics, AI, and Pharmacovigilance From Classroom to Clinic 8 September, 2025 Healthcare systems worldwide are navigating rising costs, aging populations, and rapid scientific advances. Pharmacy, once primarily associated with dispensing medicines, is increasingly positioned at the center of solutions. The International Pharmacy Conference at Taipei Medical University (TMU) brought together experts from Asia, the United States, and Europe to explore how education reform, genetics, artificial intelligence (AI), and pharmacovigilance are redefining the profession. More... |
| Doctor AI? Taiwan's tech giants make a push into smart healthcare 8 September, 2025 Imagine having to undergo an electrocardiogram (ECG) test for 14 days, but instead of wearing a Holter monitor, you simply attach a small device to your chest with a disposable body patch. Or maybe imagine a doctor using artificial intelligence (AI) assisted diagnostic software that can scan images of your eyes and quickly detect signs of damage. These are some of the next-generation, patient-friendly and AI-integrated healthcare innovations developed by Taiwan's top tech companies Quanta Computer and Acer Medical. More... |
| PharmaEssentia's files for Taiwan ET drug approval of Ropeg 7 September, 2025 PharmaEssentia (TW: 6446) announced that it has submitted an application to Taiwan’s TFDA for a new indication of its drug Ropeginterferon alfa-2b (P1101), or Ropeg, targeting essential thrombocythemia (ET). According to TFDA's timeline, the review period is approximately 180 days (excluding any additional information requests). In July, PharmaEssentia also applied to the US National Comprehensive Cancer Network (NCCN) to include Ropeg in the ET treatment guidelines, with formal recommendation expected as early as this year. The NCCN guidelines are globally recognized clinical standards for cancer treatment, regularly updated based on the latest clinical data, and widely followed by the medical community. Inclusion in the NCCN guidelines can support special reimbursement, off-label use, or hospital adoption even before FDA approval, which would positively impact Ropeg's insurance coverage and reimbursement strategy in the ET market. More... (in Chinese) |
| Taiwan advances robotic spinal surgery 6 September, 2025 Taiwan is taking steps toward a future of faster, safer, and more precise spinal surgeries through robotics, as Point Robotics MedTech, a leader in spinal surgery navigation, forms a strategic partnership with industrial robotics firm Techman Robot. More... |
| From Innovation to Implementation: Canada and Taiwan's Cross-Border Path from Research to Market 5 September, 2025 Digital health revolutions and aging populations define this era, and countries race to future-proof healthcare while protecting economic resilience. Solving cross-border challenges requires more than innovation; it demands meaningful collaboration. Canada increasingly turns to Taiwan for that collaboration, recognizing a partner that shares democratic values and complementary industrial strengths. More... |
| Latest update on ITRI's innovative dual-target glaucoma drug licensed to BRIM Biotech 22 July, 2025 Glaucoma is one of the leading causes of vision loss worldwide, but current treatments still face issues such as high side effects and insufficient efficacy. Taiwan's Industrial Technology Research Institute (ITRI), through its Biomedical Technology and Device Research Laboratories, leveraged years of experience in small-molecule drug development and tyrosine kinase inhibitor (TKI) research to develop a novel dual-target glaucoma drug that successfully overcomes the red-eye side effect seen with first-generation therapies. The drug won the 2023 R&D 100 Award and the 2024 Edison Gold Award, and in 2024 was licensed to BRIM Biotech (TW: 6885) to accelerate international clinical trials. More... (in Chinese) |
| Fecula Biotech's 'banana-resistant starch' oral cancer vaccine aims for clinical trials in 2026 22 July, 2025 Fecula Biotech (TW: 7627) is leveraging its core technology of embedding banana-resistant starch to develop both cancer vaccine drug candidates and health supplements. Its oral cancer vaccine candidate FBFGP57 is expected to enter Phase I clinical trials as early as the end of 2026, with preparations underway to apply for Orphan Drug Designation (ODD) from the US FDA, targeting eventual licensing to international pharmaceutical companies. In addition, the company is applying its resistant starch technology to repurpose waste from Taiwan’s local specialty agricultural products into sustainable health supplements, which are already being sold on domestic and overseas e-commerce platforms. Since moving into the Southern Taiwan Science Park Incubation Center in February 2019, Fecula Biotech has received angel investment from the National Development Fund and, in 2022, was listed on the Taipei Exchange's Pioneer Stock Board. Fecula uses exosomes derived from gut microbiota as carriers for cancer vaccines, encapsulated with 'banana-resistant starch' to create an oral formulation capable of withstanding stomach acid. The company emphasized that resistant starch not only serves as a protective capsule but also acts as a prebiotic in the intestines, enhancing colonization of beneficial gut bacteria. More... (in Chinese) |
| StemCyte Biotech's public cord blood bank advances cell therapy, REGENECYTE wins FDA approval 22 July, 2025 StemCyte Biotech (TW: 4178), founded in the United States, is the only company in Taiwan and one of just two in the US with access to an allogeneic public cord blood bank. Its cord blood-derived new drug REGENECYTE received Biologics License Application (BLA) approval from the US FDA in November 2024, making it the world's first cell therapy company to obtain a cord blood drug license, and marking a major milestone for Taiwan's cell therapy sector with FDA approval of a new drug. More... (in Chinese) |
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