04/28 Taiwan BIO Weekly
2026-04-27 |
| Taiwan BIO Weekly |
| EverFortune.AI diagnostic system receives US FDA market approval 24 April, 2026 EverFortune.AI (TW: 6841) announced that its AI medical device software for appendicitis detection has received US FDA 510(k) clearance, adding a new growth driver for the company. The system uses deep learning to analyze contrast-enhanced abdominal CT scans and alerts clinicians when signs of appendicitis are detected, helping accelerate diagnosis of this common emergency condition and reduce risks of complications such as perforation or peritonitis. The company has now accumulated 55 medical device approvals across multiple markets, including 15 from the US FDA, and its AI solutions are used by over 70 customers worldwide. More... (in Chinese) |
| OBI Pharma's HYProtecan receives US FDA DMF acceptance, advancing ADC strategy 24 April, 2026 OBI Pharma (TW: 4174) announced that it has received confirmation from the US FDA that its HYProtecan Type II Drug Master File (DMF) has been successfully registered, accepted, and included in the US FDA public DMF list. HYProtecan is a key linker and payload component of the company's antibody-drug conjugate (ADC) platform. The technology features an exatecan-derived payload with a highly hydrophilic linker design, improving solubility and enhancing flexibility in ADC development, and serves as a core element supporting the company’s next-generation ADC pipeline. More... (in Chinese) |
| U-Neuron Biomedical's novel drug active ingredients registered in US FDA DMF 24 April, 2026 U-Neuron Biomedical (TW: 6973) announced that two active pharmaceutical ingredients derived from its amniotic fluid stem cells and exosomes have been registered in the US FDA Drug Master File (DMF), indicating preliminary FDA recognition of the submitted active components and manufacturing process data. The company is advancing UA002, an amniotic stem cell-based therapy in Phase IIa clinical trials for patients with erectile dysfunction unresponsive to oral drugs; and UB003, an exosome-based candidate in preclinical development with potential immunomodulatory, regenerative, and anti-inflammatory effects. More... (in Chinese) |
| Taiwan unveils breakthrough targeted exosome platform for non-invasive spinal cord injury repair 24 April, 2026 Taiwan-based China Medical University Hospital (CMUH), in collaboration with Ever Supreme International Biotechnology and Shine Out Bio Technology, has unveiled a targeted gene-engineered exosome platform for acute spinal cord injury (SCI) that enables intravenous, lesion-targeted delivery of brain-derived neurotrophic factor (BDNF) mRNA. More... |
| HCmed Innovations' Pulmogine receives EU MDR certification 23 April, 2026 HCmed Innovations (TW: 6934) announced that its vibrating mesh nebulizer Pulmogine has officially obtained EU Medical Device Regulation (MDR) certification, upgrading from the previous Medical Device Directive (MDD 93/42/EEC). Positioned as a long-term strategic partner to international pharmaceutical companies, HCmed Innovations has focused on R&D, quality control, and clinical safety under pharma-grade standards. With a solid regulatory foundation, the company successfully navigated the transition from MDD to the more stringent MDR framework, demonstrating strong capabilities in regulatory compliance and technical excellence. More... (in Chinese) |
| TaiRx's CVM-1118 set for China clinical trial, targets first-line liver cancer treatment in immunotherapy collaboration 23 April, 2026 TaiRx (TW: 6580) announced that its investigational liver cancer drug CVM-1118 has completed the initiation meeting for its clinical trial in China and has begun patient enrollment, with approximately 40 patients expected to be recruited. The study will evaluate combination therapy with the PD-1 antibody drug sintilimab (marketed as TYVYT), developed by Innovent Biologics and Eli Lilly. The global liver cancer treatment market, valued at about USD 4.58 billion in 2024, is projected to reach USD 12.88 billion by 2033 at an 11.4% CAGR, highlighting strong growth potential. The collaboration also reflects a mutually beneficial strategy, potentially expanding the future clinical use of both CVM-1118 and sintilimab. More... (in Chinese) |
| MOEA Leads Taiwan Pharma Pavilion at CPHI Japan and ITRI Partners with iPark Institute to Target the Asia-Pacific Pharmaceutical Market 22 April, 2026 CPHI Japan, a leading global pharmaceutical exhibition, opened on April 21. Led by the Department of Industrial Technology (DoIT) under the Ministry of Economic Affairs (MOEA), 16 leading biomedical companies formed the Taiwan Pharma Pavilion to expand their presence in the Asia-Pacific market. More... |
| BioPreventive Medicine maintains optimistic outlook 22 April, 2026 BioPreventive Medicine (TW: 6810) announced on 21st April that the company's kidney disease biomarker test DNlite has shown new clinical results confirming its ability to monitor treatment response to drugs, highlighting its potential to develop into a companion diagnostic (CDx) product. The company plans to advance three parallel strategies--reagent sales, licensing partnerships, and companion diagnostics--to build a global precision medicine platform for kidney disease. DNlite is shifting from clinical validation to commercialization. Its POCT collaboration with South Korea's Boditech has already launched diabetic nephropathy testing, with planned IVD filings in South Korea and Europe, and is expected to drive reagent sales and licensing revenue through Boditech’s global network. More... (in Chinese) |
| CH Biotech’s agrochemical R&D innovation fuels growth opportunities 22 April, 2026 Traditional agriculture is undergoing a green transformation, with a Taiwan Stock Exchange and Taiwan Institute of Economic Research report noting a shift in the agrochemical industry from conventional pesticides to high-tech, low-carbon biological products. CH Biotech R&D (TW: 6534) is highlighted as a key player in this transition through its focus on plant growth regulators and biostimulants under a "R&D in Taiwan, global marketing" model. By targeting high value-added markets with low-carbon solutions that reduce fertilizer use while maintaining or improving crop yields and resilience, the company has built strong technical barriers via extensive field trials and international registrations, successfully expanding into markets such as the US, Canada, and Australia, and emerging as a leading example of Taiwan's agricultural biotech globalization and upgrade toward advanced, sustainable technologies. More... (in Chinese) |
| Lin BioScience subsidiary Belite Bio initiates US FDA NDA submission for Stargardt Disease drug 22 April, 2026 Lin BioScience (TW: 6696) announced on 22nd April that its subsidiary Belite Bio has officially submitted a New Drug Application (NDA) to the US FDA for LBS-008 (Tinlarebant) under a rolling submission process. Tinlarebant is an innovative oral candidate drug for Stargardt disease (STGD1), a rare inherited retinal disorder caused by ABCA4 gene mutations. Leveraging the US FDA's Breakthrough Therapy designation for the condition, Belite Bio is using the rolling NDA submission pathway to accelerate the review timeline and speed up potential approval. More... (in Chinese) |
| Taiwan health research institute signs agreement with American Association for Cancer Research 21 April, 2026 Taiwan’s National Health Research Institutes signed a five-year agreement with the American Association for Cancer Research to expand global cooperation in cancer research, CNA reported Tuesday. More... |
| Pharma's top three target North America in overseas expansion push 20 April, 2026 Amid global pharmaceutical supply chain restructuring and US policies promoting local manufacturing, overseas expansion, especially into North America, has become a key competitive battleground. Taiwanese pharmaceutical firms PharmaEssentia (TW: 6446), Lotus Pharmaceuticals (TW: 1795), and Bora Pharmaceuticals (TW: 6472), are accelerating their shift from export-driven models to localized operations, including direct market presence and production capacity deployment. PharmaEssentia is strengthening its North American footprint through investments in Puerto Rico and the acquisition of Canada's FORUS, while advancing commercialization of its Ropeg new drug. Lotus Pharmaceuticals has leveraged its integration of Alvogen to expand US market access, with the region now contributing over half of its revenue. Bora Pharmaceuticals is expanding US manufacturing and CDMO capacity, including facility upgrades and reshoring production. More... (in Chinese) |
| ACT Genomics Upgrades Clinically Recognized Genomic Test to 101-Gene Panel with 7-Day Turnaround Press release 20 April, 2026 ACT Genomics today announced a significant upgrade to the ACTDrug® series, its next-generation sequencing (NGS) genomic profiling service. The updated panel now covers 101 clinically relevant genes and offers a seven-working-day turnaround time, designed to provide comprehensive genomic information to support physicians in making treatment decision for newly diagnosed patients with advanced or metastatic cancer. More... |
| President Lai addresses medical technology conference 20 April, 2026 President Lai Ching-te said the government will expand investment in smart medical technologies to stimulate biomedical innovation to counter the complex challenges of a super-aging society, climate extremes and the prevalence of chronic diseases. According to the Presidential Office, the remarks were made at the opening ceremony of the 17th Asia-Pacific Forum of Medical Laboratory Science April 18 in Taichung City. More... |
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