1/12 Taiwan BIO Weekly
2026-01-12 |
| Taiwan BIO Weekly |
| Bora Pharmaceuticals become first pharmaceutical company in Taiwan to trade on OTCQX 8 January, 2026 On January 8, 2026, OTC Markets Group Inc. (OTCQX: OTCM) announced that Bora Pharmaceuticals Co., Ltd. (TW: 6472; OTCQX: BORAY) has qualified to trade on the OTCQX Best Market. Bora began trading on January 8 under the symbol "BORAY," according to the company's release distributed via ADR Web. OTC Markets said US investors can access Bora's current financial disclosure and real-time Level 2 quotes through its website. More... |
| OBIGEN Pharma advances into US aesthetics market, submits US FDA IND for OBI-858 Phase II trial 8 January, 2026 OBIGEN Pharma (TW: 7876) announced that it has submitted a Phase II IND to the US FDA for its innovative long-acting botulinum toxin OBI-858 for aesthetic indications. The US FDA submission signals OBIGEN's expansion beyond regional markets into the global aesthetics landscape. OBI-858, a 760 kDa long-acting botulinum toxin developed by OBIGEN Pharma, targets glabellar lines as its initial indication. Unlike traditional products, it offers faster onset (around 3 days) and longer duration (around 6 months) without increasing dosage, based on its unique molecular structure and high activity retention. The US Phase II trial will enroll approximately 105 participants in a multicenter design with a six-month follow-up and interim analysis, supporting accelerated clinical development. OBIGEN plans to integrate data from Taiwan and the US to advance global market entry. More... (in Chinese) |
| Foresee Pharmaceuticals announces Global Licensing Agreement for MMP-12 Inhibitors with Primevera Therapeutics LLC Press release 8 January, 2026 Foresee Pharmaceuticals (TW: 6576), today announced, following approval at its 2025 Extraordinary General Shareholders' Meeting, that Foresee Pharmaceuticals USA Inc., the Company's fully-owned US subsidiary, has officially signed an exclusive global licensing agreement with Primevera Therapeutics, LLC for its MMP-12 inhibitor programs. The agreement includes FP-025, FP-020 and third-generation MMP-12 inhibitors currently in the drug discovery stage. More... |
| Abnova's RNA automated production platform expands into the US 8 January, 2026 Abnova (TW: 4133) announced that its world-first integrated mRNA automated production platform, RNAutomation, launched in Q4 last year, has attracted strong interest from international CDMOs, major reagent suppliers, and pharmaceutical companies. Discussions on system specifications and orders are underway, with revenue expected from 2026. Abnova plans to enter the US market in Q1 2026 and will attend the SLAS 2026 International Conference & Exhibition in Boston to boost its global visibility in mRNA process automation. RNAutomation features a Vacuum Manifold Module that eliminates centrifugation, integrates cellulose purification to remove double-stranded RNA impurities, and incorporates a Magnetic Block Module to streamline magnetic bead washing without lithium chloride. With pre-validated RNA kits, preset software, and robotic systems, the platform enables one-stop IVT, capping, and purification, reducing human variability, shortening process time, and improving batch consistency. More... (in Chinese) |
| Andros Pharmaceuticals' APC101 wins Australian approval to launch Phase IIb/III clinical trial 7 January, 2026 Andros Pharmaceuticals (TW: 6917) announced that its spray-formulation drug APC101 for postherpetic neuralgia (PHN) has received approval from Australia's HREC to begin a global Phase IIb/III trial, also filed with Australia's TGA. The randomized, double-blind, placebo-controlled study will enroll 333 patients across multiple countries, with a US IND submitted to accelerate progress, marking a key milestone toward commercialization. Developed using Andros' proprietary S4 (Superior Skin Sorption System) transdermal platform, APC101 enables efficient skin penetration, sustained release, high local concentration, and reduced systemic toxicity. Compared with 5% lidocaine patches, it lowers skin irritation, improves comfort, and can be applied to sensitive areas above the neck. More... (in Chinese) |
| TaiGen Biotechnology posts milestone-reaching revenue, December 2025 sales jump 64-fold YoY 7 January, 2026 TaiGen Biotechnology (TW: 4157) reported December 2025 revenue of NT$220 million, up 6,482.79% year-on-year, with full-year revenue reaching NT$250 million, a 72.24% increase over 2024. The December surge was mainly driven by milestone payments from the approval of its influenza antiviral Pixavir marboxil (TG-1000) in China and income from multiple overseas commercial collaborations. Pixavir marboxil's development reached a key milestone as its capsule formulation received China marketing approval in December. Additional licensing deals in Vietnam, India, and collaborations on TG-4318 strengthened TaiGen Biotechnology's financial structure and demonstrated the market value of its pipeline. Looking ahead, the company plans to expand global licensing efforts, including in Europe, the US, and other Asian markets, while milestone and royalty revenues are expected to continue supporting operations. More... (in Chinese) |
| Taimed Biologics begins enrollment for long-acting HIV drug, expands into autoimmune therapy 7 January, 2026 Taimed Biologics' (TW: 4147) long-acting HIV drug candidates, TMB-365/TMB-380, continue to advance in clinical development and are expected to become a key growth driver for the company. The Phase IIb trial enrolled its first patient in December 2025, with full enrollment anticipated by mid-2026. An interim analysis could be completed by late 2026 or early 2027, and the trial is expected to conclude in the second half of 2027. Positive Phase IIb results would reduce development risk and increase potential licensing value. Beyond HIV, Taimed Biologics is expanding into next-generation autoimmune disease therapies using an antibody-drug conjugate (ADC) platform derived from TMB-365. Leveraging its own GMP manufacturing facilities and CDMO partnerships, the company aims to advance multiple R&D programs while pursuing international licensing and co-development opportunities, broadening its therapeutic portfolio. More... (in Chinese) |
| Medigen Vaccine Biologics breaks ground on new facility, construction handled by Acer Group's Shine Passion Engineering 7 January, 2026 Acer Group's (TW: 2353) subsidiary Acer Synergy Tech (TW: 6751), through its engineering company Shine Passion Engineering (TW: 7849), has secured the construction contract for Medigen Vaccine Biologics' (TW: 6547) new facility in the Hsinchu Biomedical Science Park and officially broke ground today. The facility is designed as a BSL-2 production-grade vaccine manufacturing site, built according to international PIC/S GMP standards and biosafety regulations. It will house a cell-culture-based vaccine antigen production line to support Medigen Vaccine Biologics's enterovirus vaccine scale-up, process development, and mass production. Shine Passion Engineering highlighted the company's experience in high-tech cleanroom engineering, successfully applied to GMP-level biotech facilities, offering one-stop services from design to construction and validation. With domestic biotech investment expanding, Shine Passion Engineering aims to strengthen its role in the vaccine and advanced therapy manufacturing sector. More... (in Chinese) |
| YD Bio Enters into MOU to Merge with EG BioMed, Advancing DNA Methylation-Driven AI Platforms for Cancer Diagnostics and Drug Development Press release 6 January, 2026 YD Bio Limited (Nasdaq: YDES), a biotechnology company advancing DNA methylation-based cancer detection technology and ophthalmologic innovations, today announced that the Company has entered into a Memorandum of Understanding to merge with EG BioMed, a biotechnology company specializing in DNA methylation-based cancer diagnostics and AI-driven biomarker analytics. More... |
| Elixiron Immunotherapeutics to debut on the Emerging Stock Board at NT$35 6 January, 2026 Elixiron Immunotherapeutics (TW: 7871) will debut on Taiwan's Emerging Stock Board at a reference price of NT$35, bringing new momentum to the biotech sector. The company is advancing two Phase II candidates: EI-1071, a small-molecule drug for Alzheimer's disease that modulates microglia to reduce neuroinflammation, and EI-001, a fully human anti-IFN-? monoclonal antibody for vitiligo. EI-1071 is expected to complete enrollment by the end of this year, while EI-001 is scheduled to provide preliminary Phase II results in the first half of next year. Elixiron Immunotherapeutics is the first Asian biotech to receive joint funding twice from Bill Gates and the Alzheimer's Association and has attracted investments from CDIB Capital Group, Taiwania Capital, Affinity Capital, Lotte Group, Daiwa Capital, and Qisda Group. EI-001 has also received US FDA Orphan Drug Designation for HLH. Following a dual strategy of licensing and in-house development, with cumulative equity funding of US$73 million, the company aims to file its first product for regulatory approval by 2028, positioning the company to expand its global presence in innovative drug development. More... (in Chinese) |
| GlycoNex leverages advanced AI models to accelerate next-generation anti-glycan antibody development 6 January, 2026 GlycoNex (TW: 4168) is accelerating its next-generation anti-glycan antibody development by partnering with Taiwan's PrecisemAb Biotech to leverage high-performance AI computing and quantum mechanics simulations. The collaboration focuses on identifying key interaction points between antibodies and tumor glycan antigens, optimizing specificity to design novel antibodies with higher tumor selectivity for precision medicine applications. In addition, GlycoNex is exploring AI integration into drug manufacturing process development to shorten experimental timelines, improve process efficiency, and reduce production costs. The company emphasized that using advanced AI and quantum-level simulations will enhance R&D efficiency and strengthen its pipeline of next-generation antibody therapeutics for cancer treatment. More... (in Chinese) |
| Lotus Pharmaceuticals secures first Southeast Asia approval as cardiovascular drug receives Singapore market authorization 6 January, 2026 Lotus Pharmaceuticals (TW: 1795) announced that its cardiovascular drug VAZKEPA (Icosapent Ethyl) has been approved by the Health Sciences Authority (HSA) of Singapore, marking its first entry into the Southeast Asian market. VAZKEPA is authorized as an adjunct therapy to be used alongside patients' maximum tolerated statin dose to reduce cardiovascular risk. It is indicated for adults on statin therapy who are at high cardiovascular risk, with elevated triglyceride levels and either have established cardiovascular disease or are diabetic with two or more additional cardiovascular risk factors. VAZKEPA is the first prescription drug composed solely of the active ingredient icosapent ethyl, a highly purified form of EPA, for reducing cardiovascular events in high-risk populations. Cardiovascular disease remains a major health concern in Singapore, with roughly one in three deaths related to heart disease or stroke and about one-third of the population affected by high cholesterol and/or hypertension, highlighting the importance of therapies like VAZKEPA in reducing cardiovascular risk. More... (in Chinese) |
| Taiwan's protein drug research takes a major leap forward with Nuclera protein expression screening system installations 5 January, 2026 To accelerate the front end of Taiwan's new drug R&D and address key protein research bottlenecks, Ho Shou-chuan, Chairman of YFY Academy, has donated Nuclera's eProtein Discovery high-throughput protein expression screening system to National Cheng Kung University and National Taiwan University. The platform completes protein expression, screening, and preliminary purification within 48 hours, cutting processes that traditionally take weeks, and marks the introduction of world-leading protein expression technology into Asia's higher education system, helping align Taiwan's research capabilities with top global institutions. Developed by Cambridge, UK-based startup Nuclera, the eProtein Discovery System replaces traditional cell-based methods with a fully automated, cell-free approach that directly converts DNA into active, soluble proteins. By integrating digital microfluidics technology, the system enables up to 192 high-throughput screening conditions and rapidly generates key data on protein yield and quality. Nuclera CEO Michael Chen noted that Taiwan is the first region in Asia to formally adopt the system; since its 2024 launch, it has been installed at more than 60 sites worldwide, with further expansions planned for early-stage drug discovery applications. More... (in Chinese) |
| Taiwan's ScinoPharm secures US FDA approval of Glatiramer Acetate Injection for MS treatment 5 January, 2026 ScinoPharm Taiwan (TW: 1789) has announced a landmark achievement in the global pharmaceutical landscape, securing US Food and Drug Administration (FDA) approval for Glatiramer Acetate Injection, a treatment for Multiple Sclerosis (MS), making it the only pharmaceutical company in Taiwan to achieve this historic milestone. More... |
| PharmaEssentia posts NT$1.92B revenue in December, sets new records for monthly, quarterly, and annual sales 5 January, 2026 PharmaEssentia (TW: 6446) announced that its December 2025 consolidated revenue reached NT$1.92 billion, up 23.84% month-on-month and 69.93% year-on-year, driving record-breaking revenue for the month, Q4, and the full year. In Q4 2025, revenue totaled NT$4.88 billion, a 25.4% quarterly increase, marking the 11th consecutive quarter of record highs. Full-year revenue reached NT$15.63 billion, up 60.61% year-on-year, highlighting the strong market potential of its rare blood cancer drug Ropeginterferon alfa-2b (Ropeg, P1101). Expansion of the US and Japan sales teams by 65% and 45% respectively in 2025 has already begun contributing significantly, supporting expectations for substantial operational growth in 2026. PharmaEssentia is preparing for the launch of Ropeg in essential thrombocythemia (ET) following the US FDA submission for the new indication on October 30, 2025, which entered substantive review on December 29. The company has responded to clinical and statistical information requests on schedule. If the review proceeds smoothly, US approval for ET could arrive in the first half of 2026, forming a key driver for the company's second growth curve while consolidating its position in the existing polycythemia vera (PV) market. More... (in Chinese) |
| BioGend Therapeutics' RevoCart approved by US Patent and Trademark office 5 January, 2026 BioGend Therapeutics (TW: 6733) announced that its RevoCart product has received US patent approval for "Implants for Cartilage and Related Devices and Methods". Notified by its patent firm, PROCOPIO, CORY, HARGREAVES & SAVITCH LLP, the patent--US Patent No. 12,521,468--carries a 20-year term, securing intellectual property protection for the company’s cartilage implant technology in the US market. More... (in Chinese) |
| AI detects stomach cancer risk in remote communities from upper endoscopic images 2 January, 2026 Researchers at National Taiwan University Hospital and the Department of Computer Science & Information Engineering at National Taiwan University developed an AI system made up of several models working together to read stomach images. Trained using doctors' expertise and pathology results, the system learns how specialists recognize stomach disease. It automatically selects clear images, focuses on the correct areas of the stomach, and highlights important surface and vascular details. More... |
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