1/19 Taiwan BIO Weekly
2026-01-19 |
| Taiwan BIO Weekly |
| Taiwan's CDMO Alliance takes shape; JPM 2026 Taiwan Night rally launched 15 January, 2026 At the recently concluded annual J.P. Morgan Healthcare Conference (JPM) in San Francisco, Taiwan's biotechnology and pharmaceutical sector formally launched the Taiwan CDMO Alliance (TCA) during Taiwan Night, bringing together nearly 100 industry and investment professionals from Taiwan and overseas. Convened by ScinoPharm Taiwan founder Jo Shen, the event marked the alliance's debut as a national team aimed at promoting Taiwan’s integrated CDMO value chain--from drug development to manufacturing--on the global stage. The gathering underscored growing international attention to Taiwan’s biopharma capabilities and positioned TCA as a unified platform to compete in the global CDMO market. The TCA is a collective of 16 Taiwanese pharmaceutical companies. These are EirGenix, ScinoPharm Taiwan, Formosa Laboratories, Bora Pharmaceuticals, Yung Shin Pharmaceutical, Orient EuroPharma, Everlight Chemical, Sunny Pharmtech, SCI Pharmtech, UBI Pharma, KriSan Biotech, Taimed Biologics, Yung Zip Chemical, Syn-Tech Chem. & Pharm., Amaran Biotech, and Swiss Pharmaceutical. These companies aim to offer one-stop CDMO services across biologics, small molecules, APIs, and finished dosage forms. Collectively, the alliance has executed over 800 projects, completed more than 100 GMP programs, and filed hundreds of DMFs, with a strong FDA inspection track record. with CDMO demand surging, TCA aims to leverage Taiwan's agility, technical depth, and collaborative approach to build a Taiwan CDMO brand worldwide. More... (in Chinese) |
| U-Neuron Biomedical's UA002 erectile dysfunction drug receives dual fast-track clearance from Taiwan's TFDA 15 January, 2026 U-Neuron Biomedical (TW: 6973) announced that its novel amniotic stem cell-based drug UA002 for erectile dysfunction has received dual fast-track recognition from Taiwan's TFDA and CDE under the upcoming regenerative medicine regulatory framework. UA002 has been approved as a Pharmaceutical Special Consultation Case by TFDA and recognized as a Key Indicator Case by CDE, allowing it to benefit from one-stop regulatory guidance covering clinical trial design, manufacturing, quality control, and marketing authorization. This dual fast-track mechanism is expected to accelerate development and review processes while reducing costs, effectively giving UA002 early access to the regenerative medicine market. UA002, developed in-house by U-Neuron Biomedical, leverages stem cell regenerative capabilities to treat patients unresponsive to oral erectile dysfunction medications. Phase I trials have been completed, confirming safety and preliminary efficacy, and Phase IIa trials are ongoing with stable enrollment. With guidance from TFDA and CDE, the company can focus resources on accelerating development and market entry. Given the projected global erectile dysfunction drug market CAGR of 9.2% from 2025 and a potential size of US$7 billion by 2034, UA002 represents a promising innovation for patients and positions Taiwan as a growing hub for regenerative medicine in Asia. More... (in Chinese) |
| Pharmosa Biopharm's begins patient enrollment in L606 Phase III clinical trial with partner Liquidia 15 January, 2026 Pharmosa Biopharm (TW: 6875) announced that its US-based partner, Liquidia, has officially begun patient recruitment for the global, multi-country, multi-center Phase III clinical trial of its new drug L606 at the recently-concluded J.P. Morgan Healthcare Conference. The trial targets patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) and plans to enroll approximately 350 participants across more than 100 clinical sites in over 20 countries. This milestone marks a new stage in expanding L606's global development for the PH-ILD indication. L606 utilizes Liquidia's proprietary liposomal technology, offering a long-acting sustained-release profile that maintains stable blood concentrations for 24 hours while significantly reducing daily dosing frequency. This design aims to minimize side effects, improve patient adherence, and enhance clinical trial participation. As no long-acting inhaled therapies for PH-ILD currently exist, L606 has the potential to provide patients worldwide with a more effective, convenient, and stable treatment option, while Liquidia plans to further explore additional indications such as COPD-associated pulmonary hypertension, pulmonary fibrosis, and systemic sclerosis. More... (in Chinese) |
| Handa Pharmaceuticals grants exclusive Taiwan sales rights for leukemia drug to TSPC (Taiwan Specialty Pharma Corp.) 14 January, 2026 Handa Pharmaceuticals (TW: 6620) has granted TSPC (Taiwan Specialty Pharma Corp.) exclusive rights in Taiwan for the registration and sales of PHYRAGO, a drug for treating Ph+ CML and Ph+ ALL type leukemia. Under the agreement, Handa Pharmaceuticals will receive licensing fees and sales royalties, targeting a domestic market worth over NT$700 million annually. PHYRAGO is a 505(b)(2) product, launched in the US in October 2025, with clinical advantages in maintaining efficacy even when co-administered with acid-reducing agents, unlike other drugs of the same ingredient. More... (in Chinese) |
| Enimmune's Enterovirus 71 vaccine receives regulatory approval in Vietnam 14 January, 2026 Enimmune (TW: 6564), a subsidiary of Adimmune (TW: 4142), announced that its Enterovirus 71 (EV71) vaccine, EnVAX-A71, manufactured at Adimmune's cell culture facility, has received GMP certification from Vietnam's drug regulatory agency. The approval marks the second overseas GMP recognition for the facility following Thailand, and represents a key regulatory milestone toward market entry in ASEAN countries, where GMP compliance is a prerequisite for product registration. Enimmune noted that mastery of advanced bioreactor-based manufacturing has been critical to securing multi-country GMP approvals and ensuring stable vaccine quality and supply. The EV71 vaccine has already completed a Phase III multicenter clinical trial in Vietnam, demonstrating a vaccine efficacy of 99.21%. With drug registration applications submitted in Vietnam, Macau, and Thailand, Enimmune expects tangible regulatory progress within the year, while continuing to seek partners in Indonesia, Malaysia, and other Southeast Asian markets to accelerate regional commercialization and disease awareness efforts. More... (in Chinese) |
| Steminent Biotherapeutics signs production MoU with Japan’s Cyto-Facto to support cell therapy launch 14 January, 2026 Steminent Biotherapeutics (TW: 7729) announced it has signed a Letter of Intent (LOI) with Japanese regenerative medicine company Cyto-Facto to explore contract manufacturing collaboration for its stem cell therapy, Stemchymal. This partnership prepares for future market supply in Japan after regulatory approval and strengthens Taiwan-Japan collaboration in regenerative medicine. Stemchymal targets spinocerebellar ataxia and has completed Phase II clinical trials in both Taiwan and Japan, with Japanese licensee REPROCELL actively consulting with the PMDA ahead of submission for market approval. Cyto-Facto is a leading GMP manufacturer in Japan for regenerative and cell therapies, originally part of the Research & Development Center for Cell Therapy (RDC) under the Foundation for Biomedical Research and Innovation at Kobe (FBRI), and has extensive experience in CAR-T cell therapy production. The LOI focuses on Stemchymal cell preparation and contract manufacturing, including process technology, quality management, and production capacity. More... (in Chinese) |
| ASUS Smart Healthcare's handheld ultrasound series receives US FDA clearance 14 January, 2026 ASUS Smart Healthcare, a division of ASUSTek Computer (TW: 2357) announced that its handheld wireless ultrasound LU800 series received US FDA 510(k) clearance as a Class II medical device. The company emphasized that the recognition validates its long-term investment in smart healthcare R&D and encourages the team to continue developing solutions that integrate AI algorithms, wireless communication, medical imaging processing, and system integration to enhance diagnostic efficiency and care quality. The company's smart healthcare product line continues to expand, covering wearables, medical imaging devices, and mobile medical equipment. Through system platforms, ASUS Smart Healthcare integrates AI data processing and imaging analysis to optimize clinical workflows, turning complex datasets into actionable clinical insights. Key developments include AI-guided ultrasound scanning to provide real-time guidance, lowering operational barriers so even non-specialists can acquire clinically interpretable images. Looking forward, Asus aims to expand into ecosystem services, clinical decision support, mobile healthcare, and cross-system integration, leveraging AI to reshape traditional healthcare delivery. More... (in Chinese) |
| Yoda Pharmaceuticals new drug YA-101 granted Orphan Drug designation by Europe's EMA 14 January, 2026 Yoda Pharmaceuticals (TW: 7829) announced that it had received Orphan Drug designation from the European Medicines Agency (EMA) for YA-101, developed to treat multiple system atrophy (MSA). This recognition is expected to accelerate clinical development and benefit the company's future operations. EU orphan drug status provides incentives such as clinical trial tax credits, reduced regulatory fees, and up to 10 years of market exclusivity if the drug is the first approved treatment or shows significant clinical advantage. YA-101 has approval to conduct Phase II trials in the US (FDA), Taiwan (TFDA), and Japan (PMDA), with studies underway. MSA is a rare, rapidly progressing neurodegenerative disorder with no treatments to slow symptom progression. YA-101 also holds Orphan Drug designation and Fast Track status in the US, and Orphan Drug recognition in Japan, underscoring its potential to address a major unmet medical need, though development remains high-risk. More... (in Chinese) |
| Diversification and overseas market support boosts Genomics Biotech's 2026 outlook 14 January, 2026 Genomics Biotech (TW: 4195) saw December 2025 revenue hit NT$111 million, up 81.5% year-on-year, with full-year revenue of NT$708 million, up 36.9%, setting new company records. The company highlighted that orders from academic, biotech, and semiconductor clients, alongside completed instrument installations and NGS projects, are driving continued growth. The company also added nine new Laboratory Developed Test (LDT) certifications, bringing the total to ten, strengthening its leadership in WGS/WES clinical applications and expanding its clinical testing segment. Overseas, Genomics Biotech is growing its presence in the Philippines, Australia, Malaysia, Thailand, and Indonesia, leveraging distributors and partnerships with Illumina to promote gene sequencing and multi-omics services across the Asia-Pacific. The company's multi-pronged strategy of domestic diversification and international expansion positions it to significantly boost revenue contribution from both instruments and clinical services in 2026. More... (in Chinese) |
| US FDA sets target for completion of PharmaEssentia's ET drug review 13 January, 2026 PharmaEssentia announced that its new drug Ropeg has made solid progress in its US application for a new indication, essential thrombocythemia (ET). The US FDA has set a target review completion date of August 30, 2026, potentially providing a new growth driver for the company's 2026 operations. PharmaEssentia submitted the ET application on October 30, 2025, entered substantive review on December 29, and responded on time to key FDA information requests covering statistical and clinical issues by January 5, 2026. CEO KC Lin noted that no new ET therapies have been approved by the FDA in nearly 30 years, highlighting the unmet medical need. PharmaEssentia added that 2025 revenue surpassed NT$15.6 billion, up more than 60% year-on-year, and the company will continue strengthening its global myeloproliferative neoplasm (MPN) market presence while preparing US commercial, medical, and market access strategies for the ET indication. More... (in Chinese) |
| OBI Pharma and TegMine Therapeutics Sign Exclusive Global License Agreement for Glycan-Targeting ADC Press release 12 January, 2026 OBI Pharma (TW: 4174) announced that it has entered into a commercial license agreement with TegMine Therapeutics, Inc. (TegMine), a San Francisco-based biopharma focused on developing antibodies targeting cancer-associated glycans and glycoproteins, for a glycan-targeting ADC. Under the terms of the agreement, OBI is eligible to receive an upfront payment as well as development and commercial milestones. Following product launch, OBI will also receive royalties based on a tiered percentage of annual net sales. While the detailed financial terms are not disclosed in accordance with the confidentiality provisions, the overall deal economics are broadly comparable to those of recent similar licensing transactions in the market. TegMine will obtain the exclusive global rights to develop and commercialize the ADC under the license agreement. More... |
| Lai touts Taiwan's smart healthcare 12 January, 2026 The "Healthy Taiwan Sprout Project" launched last year has approved funding worth NT$2.94 billion (US$93.05 million) for 197 smart healthcare projects, President William Lai said yesterday, adding that he hoped to see healthcare and technology integration become the next "divine mountains" maintaining Taiwan's international competitiveness. He made the remark at the opening ceremony of the 19th Nobel Health Care Forum in Taipei. More... |
| Formosa Pharmaceuticals Announces Licensing Agreement with Samil Pharmaceuticals, Co., Ltd, for Commercialization of Clobetasol Propionate Ophthalmic Suspension for the Treatment of Inflammation and Pain Following Ocular Surgery Press release 12 January, 2026 Taiwan-based Formosa Pharmaceuticals (TW: 6838) announced today that the company has entered into an exclusive licensing agreement with Samil Pharmaceuticals, Co., Ltd (KS: 000520), for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a patented innovative medicine for the treatment of inflammation and pain following ocular surgery in South Korea. Samil, established in 1947, is one of the most prominent Korean manufacturers of pharmaceutical products across multiple therapeutic areas, with a core specialization and focus on ophthalmic medicines, and having long-standing partnerships with global players such as Samsung, Abbvie, Nicox, and Thea. The licensing agreement includes upfront payment, sales milestones, and royalties, throughout the term of the agreement. More... |
| Taichung hospital develops new medicine delivery system to treat brain disorder 12 January, 2026 China Medical University Hospital has developed a new medicine delivery system designed to carry curcumin directly to damaged brain cells to help treat disorders such as Parkinson's disease. The condition occurs when dopamine-producing nerve cells in the brain begin to degenerate. Dopamine shortages affect the brain's control of movement, causing tremors, muscle stiffness and slowed motion. Around 60% of people with the condition may develop dementia in later stages. More... |
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