Hsinchu, Taiwan – January 7, 2026 – OBIGEN PHARMA INC. (Ticker: 7876.TWO), Taiwan’s first botulinum toxin innovator, announced a major milestone in its global commercialization strategy. The company has officially initiated its Phase III clinical trial for OBI-858, the world’s first 760 kDa next-generation botulinum toxin, following regulatory approval by the Taiwan Food and Drug Administration (TFDA) in August 2025. The first participant for the glabellar lines indication has been enrolled, marking the start of a pivotal study that will support future market entry and international licensing opportunities.
The Phase III trial will enroll 600 participants across 16 leading hospitals and medical centers, including National Taiwan University Hospital, Taipei Veterans General Hospital, and Chang Gung Memorial Hospital, and many others. OBIGEN is targeted to complete the trial and achieve data readout by the end of 2026, positioning OBI-858 for future regulatory submissions in Taiwan and other major markets. The data are also important for advanced global partnership discussions.
OBI-858: A Breakthrough in Botulinum Toxin Innovation
OBI-858 is a differentiated and Halal-certified botulinum toxin candidate worldwide, and the first-ever product with a 760 kDa molecular structure, compared to conventional 900 kDa products currently dominating the market. Using advanced analytical techniques such as multi-angle light scattering (MALS) and transmission electron microscopy (TEM), OBIGEN has validated OBI-858’s unique molecular architecture, which exhibits a distinctive “flower-like” trimeric structure. This innovation translates into faster onset, longer lasting of effect, diffusion control, and improved safety profile, while leveraging a differentiated molecular architecture designed to reduce overlap with existing intellectual property landscapes. OBI-858 is protected by 13 granted patents across major markets including the U.S., Japan, Korea, Southeast Asia, Latin America, and the Middle East, with 7 additional patents pending, creating a robust IP portfolio that strengthens OBIGEN’s competitive moat and licensing potential.
Clinical Evidence and Market Opportunity
Phase II results demonstrated that OBI-858 delivers visible improvement in glabellar lines within 3 days, with over 60% of participants maintaining results for more than 6 months. These findings have been published in the peer-reviewed journal Dermatology and Therapy and presented at leading dermatology and plastic surgery conferences, garnering strong interest from clinicians and industry stakeholders.
OBI-858 is Halal-certified. The entire manufacturing process is free from animal-derived materials and alcohol, ensuring compliance with Islamic and vegan requirements. This certification positions OBI-858 as a trusted and innovative option for Muslim-majority and vegan markets, addressing growing demand for safe, ethical, and environmentally friendly solutions.
According to third-party market research, the global botulinum toxin market is projected to grow from $9.5 billion in 2025 to over $21.5 billion by 2034, driven by aging demographics and rising demand for fast-onset, long-lasting aesthetic and medical solutions. Long-acting formulations are expected to become the new standard, creating a significant opportunity for OBI-858 to capture market share through strategic partnerships.
Why Partner with OBIGEN?
OBIGEN is evaluating global and regional partnership structures, including development, commercialization, and strategic licensing collaborations, to accelerate worldwide access to OBI-858. OBIGEN has engaged KYBORA, a global healthcare advisory firm and investment bank, to support its global partnering process, including partner identification, outreach, process management, and transaction negotiations.
For partnership inquiries, please contact:
Patricia Chou
OBIGEN PHARMA INC.
Chief Executive Officer
Email: patriciachou@obigenpharma.com
Website: https://www.obigenpharma.com
Additional partnering contact:
Dr. Jean Chatellier, PhD
KYBORA (Global Partnering Advisor)
Partner, Executive Vice President & Senior Managing Director
Email: jean@kybora.com
Website: https://kybora.com
About OBIGEN PHARMA INC. – OBIGEN PHARMA INC. is Taiwan’s first biotechnology company dedicated to the research, development, and manufacturing of botulinum toxin products. Leveraging proprietary strain selection, advanced fermentation, and high-purity protein isolation technologies, OBIGEN has built a fully integrated value chain from API production to sterile injectable formulation. Our flagship product, OBI-858, is a next-generation, long-acting botulinum toxin with a unique 760 kDa molecular structure, designed to deliver faster onset, longer duration, and improved safety. Supported by a robust global IP portfolio, Halal certification, and PIC/S GMP-compliant facilities, OBIGEN is positioned to expand across Asia, the Middle East, the U.S., Latin America, and Europe through strategic partnerships and licensing opportunities.
About KYBORA – KYBORA is a global advisory firm and investment bank whose mission is to guide transformative healthcare companies to enduring success globally. We provide M&A, licensing, fundraising, and strategic advisory services to the global healthcare industry, creating value for our clients worldwide. With offices in the US, Switzerland, and China, and a direct presence in all key biopharma markets around the world, KYBORA offers unparalleled global reach and local knowledge.