09/08 Taiwan BIO Weekly
2025-09-08 |
| Taiwan BIO Weekly |
| Orient Pharma generic aims for US market launch 5 September, 2025 Orient EuroPharma Group's subsidiary Orient Pharma (TW: 4166) announced that it has independently developed a multi-layered release technology platform to produce the generic drug Tofacitinib. After submitting a paragraph IV patent challenge to the US FDA, Orient Pharma received a no-contest letter from the original developer, Pfizer, yesterday. Once approved by the FDA, the drug could be launched in the US as early as June next year. Orient Pharma noted that the number of patients with rheumatoid arthritis is continuously rising worldwide, increasing treatment demand. According to statistics, the US market for Tofacitinib alone reached about NT$75 billion, while Taiwan's market reached NT$700 million in 2023. More... (in Chinese) |
| TSH Biopharm’s smoking cessation generic drug approved for market launch 5 September, 2025 TSH Biopharm (TW: 8432) announced that its subsidiary Chuang-Yi Biotech's smoking cessation tablet VA23 has received approval from the Taiwan Food and Drug Administration (TFDA), making it the country's first generic smoking cessation drug. It is expected to meet clinical demand and provide more treatment options for smoking cessation in Taiwan. VA23 is a generic of Pfizer's Champix. VA23 was approved by the US FDA three years ago through Chuang-Yi's international partner and has been widely used there. Now as Taiwan's first generic smoking cessation drug, it is expected to build on international clinical results and offer a promising new option for domestic treatment. More... (in Chinese) |
| OBI Pharma partners with AP Biosciences to create new opportunities for next-generation bispecific ADCs 4 September, 2025 OBI Pharma (TW: 4174) announced that it has signed a Material Transfer and Technology Development Agreement (MTA) with AP Biosciences (TW: 6945). The two companies will jointly develop next-generation bispecific antibody-drug conjugates (ADCs). According to the agreement, AP Biosciences will provide bispecific antibodies (BsAbs), while OBI Pharma will leverage its proprietary GlycOBI glycan-linking platform, combined with EndoSymeOBI bifunctional enzyme and HYPrOBI highly hydrophilic linker technology, to develop novel bispecific ADCs. These will then be delivered to AP Biosciences for evaluation of further development potential, with the possibility of pursuing a technology licensing partnership. More... (in Chinese) |
| Taiwan and Japan join forces to tap into the new blue ocean of regenerative medicine 4 September, 2025 The Foundation of Medical Professionals Alliance in Taiwan recently held an industry exchange forum together with the Industrial Development Bureau and the Development Center for Biotechnology (DCB), focusing on CAR-T cell therapy, 3D bioprinting, and new regulatory trends for accelerated review. Experts predict that in vivo CAR-T therapies and new 3D bioprinting technologies currently coming out of Japan will become disruptive breakthroughs in the industry, driving opportunities in cancer treatment and tissue repair. More... (in Chinese) |
| Acer Medical advances smart healthcare onto the global stage 3 September, 2025 Acer (TW: 2353) continues to pursue opportunities beyond PCs and in AI applications. Following last year's launch of generative AI software for the gaming industry at the IFA trade show, this year the company is bringing its AI healthcare technology to Berlin, where its subsidiary Acer Medical unveiled "aiMed Smart Healthcare", an AI service platform specifically designed for medical settings that can instantly convert healthcare staff's speech or text into structured medical records. The launch marks Acer Medical's expansion from Asia to the global market. More... (in Chinese) |
| BRIM Biotech acquires 42 percent stake in Compass Bioinformatics 3 September, 2025 BRIM Biotech (TW: 6885) announced that to continue advancing the comprehensive development of innovative drugs its board approved a NT$150 million investment in Compass Bioinformatics, acquiring approximately 42 percent of the company and becoming its largest shareholder. The investment will be included in BRIM Biotech's consolidated financial statements in Q3 this year, marking the company's first step into the precision medicine market. BRIM Biotech has also partnered with ACRO Biomedical to jointly enter the regenerative medicine sector. In addition, BRIM Biotech's new drugs for dry eye disease and neurotrophic keratitis are currently in licensing discussions with international pharmaceutical companies, aiming to secure the first global licensing deal by the end of this year. More... (in Chinese) |
| Maywufa Group expands across three business segments 3 September, 2025 Maywufa Group (TW: 1731) in a recent investor conference announced that it continues to strengthen its position as a leader in daily consumer products while introducing smart factory operations. The new drug subsidiary, PhytoHealth, emphasized its international expansion through its two flagship drugs, PG2 Lyo. Injection and Oraphine 60mg Soft Capsule. The smart medical subsidiary, AmCad BioMed, is entering the global market with AI medical devices and handheld ultrasound (POCUS) solutions. More... (in Chinese) |
| AP Biosciences' CD137 bispecific therapy receives approval for Phase I clinical trial in Australia 2 September, 2025 AP Biosciences (TW: 6945) announced through its subsidiary APBIO PTY LTD that its investigational anticancer drug AP601, a bispecific antibody targeting CD73 and CD137, has received approval from the Australian Human Research Ethics Committee to proceed with a Phase I clinical trial. AP Biosciences' CEO Jeng Her stated that AP601 is the company's third bispecific antibody therapy to enter clinical trials in the past three years, developed based on its CD137 T-cell engager platform. More... (in Chinese) |
| AmCad BioMed's thyroid cancer detection enters health insurance sandbox, potential for coverage by year-end 2 September, 2025 AmCad BioMed (TW: 4188) announced that AmCad Thyroid has officially entered this year’s health insurance sandbox program and could be covered by National Health Insurance by year-end. The company also plans to expand hospital penetration of AmCad Lung in Taiwan and initiate insurance code reimbursement in the US, while establishing a demonstration site in the Middle East. Its AI-powered handheld ultrasound (POCUS) has already been procured by the Jordanian government. AmCad BioMed has now built six major product lines: AmCad Thyroid, AmCad Lung, CellDetect, BreastDetect, ColorUS, and the Acoustic Scattering Tissue Imaging Platform, four of which have obtained US FDA 510(k) clearance. More... (in Chinese) |
| Biotech startups spark funding boom with eight success stories 1 September, 2025 Biotech startups in Taiwan are experiencing a strong fundraising surge, with eight companies collectively raising over NT$4 billion. The primary driver has been strong backing from major shareholders, and the funding is focused on new drug development, precision diagnostics, AI-driven drug discovery, and digital health. Among these eight, Libo Pharma and Elixiron Immunotherapeutics are preparing to list on the Taipei Exchange later this year, while AnBogen Therapeutics is advancing clinical trials in Taiwan. HanchorBio, Libo Pharma, Primo Biotechnology, T-E Meds, Taiwan Universe BioMedicine, and Syncell are all developing innovative therapies, ranging from immune-modulating drugs and ADCs to radioligand treatments and novel protein-based therapies. Digital health and AI-focused startups such as Wecome Energy and TherapiAI are also expanding, highlighting AI and digital platforms as emerging drivers in pharmaceutical R&D and CDMO services. More... (in Chinese) |
| Taiwan's big three telecoms push into telemedicine 31 August, 2025 One year after updated regulations took effect, Taiwan's three major telecoms--Chunghwa Telecom, FarEasTone, and Taiwan Mobile--are aggressively expanding into telemedicine. With the Ministry of Health and Welfare extending home-based critical care, remote urgent outpatient services, and home hemodialysis, telecom companies are integrating AI applications such as symptom analysis, care record management, and early warning systems to enhance remote healthcare delivery. Chunghwa Telecom has developed its SynDr. telemedicine platform and Remote Patient Monitoring (RPM) system, enabling real-time video consultations and AIoT-based physiological monitoring for home care. The company has also formed cross-industry alliances to build nationwide telemedicine networks. FarEasTone has launched a 5G remote consultation platform based on its Big Data, AI, and IoT technologies, connecting hospitals across urban and rural areas and enabling continuous care. It is also expanding internationally to markets like Palau and Indonesia. FarEasTone supports home urgent care and provides cloud-based medical information systems to improve physician efficiency. Taiwan Mobile leverages its enterprise communications and AI capabilities to offer smart medical communication solutions, enhancing cross-department collaboration, doctor-patient interaction, and digital recordkeeping, while promoting digital transformation in healthcare communications. More... (in Chinese) |
| JelloX Biotech's 3D pathology solution enters US market, targeting cancer companion diagnostics 22 July, 2025 JelloX Biotech has developed the world's first 3D pathology solution by combining its patented tissue-clearing reagent with AI-assisted analysis technology, overcoming the limitations of traditional 2D pathology in identifying spatial structures. The company is currently promoting self-pay clinical testing, giving patients in Taiwan early access to the innovation. The technology has already completed clinical data validation in indications such as colorectal polyps, breast cancer, lung cancer, and tumor biomarkers (PD-L1, HER2), and is now moving forward with self-pay clinical testing. Among these, the 3D pathology test for colorectal polyps has shown the ability to improve adenoma detection rate (ADR) and is expected to obtain Taiwan's medical clearance in the second half of this year, paving the way for formal integration into clinical diagnostic workflows. More... (in Chinese) |
| Synbio Tech's world-first TWK10 probiotic strain for muscle gain and fat reduction advances on multiple clinical fronts 22 July, 2025 Synbio Tech (TW: 1295) has specialized in lactic acid bacteria research for over 25 years. Since its early days, the company has focused on building branded and internationalized probiotic strains and offers vertically integrated CDMO services to help clients create differentiated products, making it one of the few major probiotic companies in Taiwan with both advantages. Currently, it is advancing multiple clinical trials, including studies on the TWK10 sports probiotic for weight management, LP28 probiotic for immune enhancement, and LDL557 postbiotic for joint health, all expected to be completed this year. In addition, Synbio Tech's new plant will begin operations in September, moving toward its goal of doubling fermentation capacity by 2026. More... (in Chinese) |
| HanchorBio's multifunctional fusion protein biopharmaceutical emerges as a rising star, with a NT$5.9 billion licensing deal highlighting its long-acting anticancer potential 22 July, 2025 HanchorBio-KY (TW: 7827) is one of the few biotech companies worldwide mastering tri-functional biopharmaceutical technology. Its lead drug, HCB101, has entered Phase Ib/IIa clinical trials and, at the end of June, was licensed to Shanghai Henlius for up to USD 202 million (around NT$5.9 billion). Upon future commercialization, HanchorBio will receive 6–12 percent in sales royalties under the agreement. HanchorBio's founder and chairman, Liu Shi-Gao, was also the founder of Shanghai Henlius, where he achieved the milestone of developing the first Taiwan-originated PD-1 monoclonal antibody approved for marketing in both China and the EU. He emphasized that by founding HanchorBio in Taiwan after leaving Henlius, his mission is to continuously develop First-in-Class drugs and accelerate Taiwan’s rise as a world-class biopharmaceutical powerhouse. More... (in Chinese) |
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