12/15 Taiwan BIO Weekly
2025-12-15 |
| Taiwan BIO Weekly |
| TSH Biopharm's four major growth engines aim to double annual revenue and drug approvals 12 December, 2025 TSH Biopharm (TW: 8432) plans to drive its five-year strategy (2026–2030) using four core growth engines: developing niche products in ophthalmology and rare CNS diseases to optimize its portfolio; strengthening domestic channels by increasing self-paid product sales and improving cost structure; expanding overseas markets, leveraging existing approvals with first orders expected from Malaysia and Macau; and pursuing inorganic growth through subsidiary expansion and strategic collaborations. With these initiatives, the company aims to double revenue and increase drug approvals from 10 to 20, supported by upcoming launches including its generic smoking cessation drug Varenate and a first-in-class drug for dry eye disease. More... (in Chinese) |
| Senhwa Biosciences partners with BeOne Medicines on clinical collaboration for new immuno-oncology treatment 11 December, 2025 Senhwa Biosciences (TW: 6492) announced that it has launched a clinical collaboration with multinational pharmaceutical company BeOne Medicines to jointly advance a global, multi-center clinical trial for Pidnarulex (CX-5461) into the field of immuno-oncology treatment. Senhwa stated that the trial will evaluate the safety and therapeutic potential of combining Senhwa's CX-5461 with BeOne Medicines' already marketed PD-1 inhibitor tislelizumab in treating various advanced solid tumors, including pancreatic cancer and PD-1 inhibitor–resistant melanoma. More... (in Chinese) |
| Adimmune aims to turn profitable next year via CDMO exports and enterovirus vaccine market expansion 10 December, 2025 At an investor conference Adimmune (TW: 4142) chair Steve Chan said that momentum next year will come from increased volume and product variety from overseas CDMO partners, as well as continued expansion of the company's enterovirus vaccine into Southeast Asian markets. He added that the company's influenza vaccine plant passed Brazil's GMP inspection this year, but revenue contribution will only begin after obtaining regulatory approval. Still, the door to the Southern Hemisphere market has been opened, and the company is aiming to return to profitability next year. At today's investor conference, Chan noted that Adimmune's domestic revenue currently accounts for only one-third of total sales, with the remaining two-thirds coming from overseas markets. Through multiple international manufacturing collaborations that have moved into commercial-scale production, along with its new technology platform entering tech-transfer stages, the company expects to see increased international orders in the future. More... (in Chinese) |
| Bora Pharmaceuticals and Corealis Pharma Forge Strategic Alliance to Deliver Seamless, End-to-End Oral Solid Dose Development Press release 9 December, 2025 Bora Pharmaceuticals Co., Ltd. (TW: 6472), a global leader in pharmaceutical manufacturing, and Corealis Pharma Inc., a leading early-phase Contract Development Manufacturing Organization (CDMO), have entered into a strategic alliance to provide end-to-end services for oral solid dose (OSD) development and manufacturing. The collaboration will simplify drug development and provide a more scalable pathway to commercialization. More... |
| Alliance aims to boost clinical trials 9 December, 2025 An alliance of 32 healthcare facilities and medical research institutes was yesterday founded to bolster the nation’s clinical trial capabilities. Taiwan's medical techniques are among the best in the world, but its clinical trials lag behind in scale, the Taiwan Alliance of Clinical Trial Centers said. More... |
| Lifesaving Science: Interview with TaiMed Biologics CEO, Jimmy Chang 9 December, 2025 Established in Taiwan, TaiMed Biologics is home to groundbreaking work that stretches beyond the traditional boundaries of medicine. Over the course of its 18-year history, the company has firmly established itself as a pioneering biopharmaceutical developer and manufacturer -- with the results to back it up. More... |
| TAHO Pharmaceuticals provides updates on anticoagulant oral film TAH3311 9 December, 2025 TAHO Pharmaceuticals (TW: 6467) provided an update on its anticoagulant oral film TAH3311 (BEQIA), with Europe's EMA having accepted the marketing authorization application and approval targeted for the second half of next year. In the US, after receiving an Incomplete Response Letter for the NDA, the company plans to resubmit by April or May next year. Licensing efforts will first focus on the Middle East and New Zealand/Australia, followed by the EU--where companies in Germany, France, and Italy are competing for rights--before finally pursuing the US market. More... (in Chinese) |
| Pharmosa Biopharm launches Phase III trial for pulmonary hypertension drug 8 December, 2025 Pharmosa Biopharm (TW: 6875) announced that it has shipped the first batch of L606 for the global Phase III trial targeting PH-ILD (pulmonary hypertension caused by interstitial lung disease). The supply enables licensing partner Liquidia Technologies of the US to initiate the international multi-center trial, with patient enrollment expected to begin next year, marking a key milestone for commercialization. At a media briefing, the company's CEO stated that while the Phase III trial progresses, Pharmosa Biopharm and Liquidia are simultaneously preparing for commercialization. Preparations include drug manufacturing, global supply chain setup, regulatory planning in major markets, and pre-launch strategic deployment, aiming to bring L606 to the global market as quickly as possible once clinical validation is complete. More... (in Chinese) |
| PharmaEssentia announces progress on US ET drug approval, completes first FDA AOM meeting 9 December, 2025 PharmaEssentia (TW: 6446) announced that its new drug Ropeg is making progress in the US for a new indication for essential thrombocythemia (ET). The company completed its first Application Overview Meeting (AOM) with the US FDA on December 8 and aims to obtain approval in 2026. More... (in Chinese) |
| Gongwin Biopharm's new lung cancer drug passes China regulatory review 8 December, 2025 With China releasing its first version of the Commercial Insurance Innovative Drug Catalogue, Taiwan's Gongwin Biopharm (TW: 6617) announced that its self-developed lung cancer drug PTS-302 (Proxian) has passed expert review and pricing negotiations, earning a spot on the final list. Gongwin Biopharm is the first Taiwanese listed OTC company to achieve this qualification. This milestone is expected to help PTS-302 capture a high-demand market serving millions of patients annually, with sales projected to potentially double in 2026. According to Chinese brokerage research, innovative drugs included on the list typically see peak sales growth of 20–30%, with high-value clinical drugs potentially doubling short-term sales, serving as a new growth driver for China’s pharmaceutical industry. More... (in Chinese) |
| LumiSTAR Biotechnology and DCB host 2025 Regenerative Medicine Summit: Advanced Cell Therapy meet 7 December, 2025 Co-hosted by LumiSTAR Biotechnology and the Development Center for Biotechnology (DCB), with E-Da Hospital and the Taiwan Bio Industry Organization (Taiwan BIO) as co-organizers, the 2025 Regenerative Medicine Summit: Frontier Cell Therapies meeting was held, bringing together leading experts including LumiSTAR founder and CEO Chang Yu-Fen; Miguel Forte, CEO of Kiji Therapeutics and the International Society for Cell & Gene Therapy (ISCT); Seiji Hori, CTO of VC Cell Therapy and Executive Director of iPS Portal, Shin Kawamata, Senior Executive Advisor at Cyto-Facto, and Joseph Huang, Deputy Superintendent of E-Da Dachang Hospital. Spanning cutting-edge research to clinical implementation, and from process innovation to global strategy, the forum offered a comprehensive view of the industrial momentum shaping regenerative medicine. More... (in Chinese) |
| OBI Pharma receives additional US FDA Orphan Drug Designation 7 December, 2025 OBI Pharma (TW: 4174) announced that its self-developed TROP2-targeting antibody-drug conjugate (ADC) OBI-902, which previously received orphan drug designation for cholangiocarcinoma, has now again been granted US FDA orphan drug designation, this time for gastric cancer, including gastroesophageal junction adenocarcinoma. The US FDA's orphan drug designation program aims to encourage the development of drugs for rare diseases and conditions with high unmet medical needs. In the US, a rare disease is defined as one affecting fewer than 200,000 patients. Drugs granted orphan designation can benefit from incentives such as clinical trial tax credits, reduced application fees, and market exclusivity periods, which support OBI-902's future commercial potential and opportunities for international strategic collaborations. More... (in Chinese) |
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