Hsinchu, Taiwan – March 16, 2026 – OBIGEN PHARMA INC. (Ticker: 7876.TWO), Taiwan’s first botulinum toxin innovator, today announced the successful completion of participant enrollment in its two pivotal Phase III clinical trials evaluating OBI-858, the world’s first 760 kDa long-acting botulinum toxin type A (BoNT-A), for the treatment of moderate-to-severe glabellar lines.
Glabellar lines are vertical frown lines that appear between the eyebrows as a result of repeated contraction of the corrugator and procerus muscles. Botulinum toxin injections are widely used to temporarily relax these muscles, reducing the appearance of moderate-to-severe glabellar lines and improving facial aesthetics.
Initiated in mid. December 2025 (1), the two double-blind, placebo-controlled pivotal studies have enrolled some 600 participants in total across 16 leading medical centers in Taiwan within 3 months. The final participant was enrolled in mid. March 2026. Each study includes 8 clinical sites, and both trials share identical protocols and operational procedures. Together, these trials are designed to serve as confirmatory studies to support future Biologics License Application (BLA) submission.
Robust Pivotal Design Aligned with Global Regulatory Standards – The Phase III program was designed based on the positive results of OBIGEN’s completed Phase II trial (2), which demonstrated rapid onset, sustained six-month efficacy, and a favorable safety profile.
Key design features of the two pivotal trials include:
• Confirmation of the selected 20U dose identified in Phase II
• Primary endpoint of ≥2-point improvement in Glabellar Line Severity (GLS) at Week 4
• Six-month safety and efficacy follow-up
• Identical randomized, double-blind, placebo-controlled structure across both studies
The Taiwan Food and Drug Administration (TFDA) applies botulinum toxin clinical requirements aligned with those of the U.S. Food and Drug Administration (FDA). The Phase III protocol, including primary endpoint definition and dose selection, reflects internationally accepted regulatory standards and is intended to support future BLA submission in Taiwan and facilitate global regulatory dialogue.
Complementary One-Year Repeat-Dose Study Underway – In parallel with the pivotal trials, OBIGEN is conducting a one-year repeat-dose treatment study involving 200 participants to further evaluate long-term
safety, immunogenicity, and durability under repeat administration conditions. Completion of the repeat-dose study monitoring is expected in Q3, 2026, and the results are targeted available in Q4, 2026.
Together, the pivotal trials and repeat-dose study are designed to provide a comprehensive clinical package supporting regulatory submissions and global partnering discussions.
Building Toward Registration and Global Expansion – OBI-858 is a differentiated 760 kDa BoNT-A complex featuring a unique trimeric molecular architecture, analytically validated through advanced characterization methods. The product is designed to deliver rapid onset, extended duration of effect, controlled diffusion, and a favorable safety and immunogenicity profile (2) (3).
Completion of enrollment in the Phase III program marks a major execution milestone for OBI‑858 and underscores OBIGEN’s progress toward BLA submission in Taiwan. Importantly, Taiwan FDA’s new drug review framework is fully aligned with U.S. FDA and EMA standards, ensuring that the Phase III data package is generated under globally recognized, rigorous regulatory expectations. With both pivotal trials fully enrolled, the late‑stage program is meaningfully de‑risked, further strengthening OBI‑858’s credibility in global partnering discussions. In parallel, OBIGEN has received U.S. FDA acceptance of its Phase II IND for OBI‑858 in aesthetic glabellar lines, reinforcing alignment between Taiwan and U.S. regulatory pathways and supporting OBIGEN’s broader global expansion strategy. (4).
With a scalable, PIC/S GMP-compliant manufacturing platform and Halal-certified, animal-origin-free formulation, OBI-858 is positioned as a differentiated global asset in a botulinum toxin market expected to experience strong growth over the coming decade, driven by increasing demand for minimally invasive aesthetic procedures and interest in longer-lasting formulations. Long-acting formulations are increasingly viewed as a valuable innovation trend within the botulinum toxin category, creating a significant opportunity for OBI-858 to capture market share through strategic partnerships.
OBI-858 also offers long-term platform optionality, with potential expansion into therapeutic indications such as spasticity and movement disorders using the same core toxin and manufacturing infrastructure.
OBIGEN, together with its global partnering advisor KYBORA, will be available to engage in strategic discussions with potential regional and global partners regarding the development and commercialization of OBI-858. The team will be present at BIO-Europe Spring (March 23–25, 2026, Lisbon) and the Aesthetic & Anti-Aging Medicine World Congress (March 26–28, 2026, Monaco).
Why Partner with OBIGEN?
• Differentiation: World’s first 760 kDa BoNT-A complex, 1:1 labeled potency vs. BOTOX®, long duration with relatively low unit dosing, scalable GMP manufacturing, and Halal-certified supply enabling broader global access.
• Clinical validation (2) (3): Phase II in moderate-to-severe glabellar lines completed successfully in Taiwan and published in a peer-reviewed journal (fast onset as early as Day 3, durable efficacy ≥6 months, clean safety and immunogenicity profile).
• Late-stage execution (1): Two confirmatory Phase III trials (~600 participants across 16 centers) and one-year repeat-dose treatment study (200 participants across 5 centers) fully enrolled; trial completion expected Q4, 2026.
• U.S. pathway underway (4): Phase II IND accepted by the U.S. FDA. Phase III clinical development plans to be consulted with U.S. FDA Q3, 2026.
• Strategic optionality: Lead aesthetic indication with a clear path to therapeutic expansion (e.g., spasticity, movement disorders) using the same CMC and tox platform.
• Global scalability: Ready for licensing and commercialization in U.S., EU, Middle East, and Asia.
Strategically, OBI-858 may be relevant for partners looking to:
• Strengthen or refresh a neurotoxin franchise with a long-acting, fast-onset differentiated biologic
• Access a clinically de-risked, late-stage asset with scalable manufacturing and global supply readiness
• Build lifecycle value beyond aesthetics, with clear expansion paths into therapeutic indications such as spasticity and movement disorders
• Leverage Halal certification as a meaningful access differentiator in MENA, Southeast Asia, and other priority regions
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 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.
(1) January 7, 2026 - OBIGEN PHARMA Inc. Launches Phase III Clinical Trial of World’s First 760 kDa Long-Acting Botulinum Toxin OBI-858 in Taiwan https://www.obigenpharma.com/en/announcements/announcements-16
(2) Yen, YH., Tsau, TW., Lee, CH. et al. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of OBI-858 for the Treatment of Moderate-to-Severe Glabellar Lines. Dermatol Ther (Heidelb) 15, 3717–3731 (2025). https://doi.org/10.1007/s13555-025-01561-5
(3) March 3, 2026 - OBIGEN PHARMA Inc. to Present Phase II Clinical Data in E-Poster Presentation of Novel Long-Acting Botulinum Toxin OBI-858 at Aesthetic & Anti-Aging Medicine World Congress (AMWC) 2026 https://www.obigenpharma.com/en/announcements/announcements-18
(4) February 9, 2026 - OBIGEN PHARMA Inc. Announces U.S. FDA Acceptance of Phase II IND for OBI-858 in Aesthetic Glabellar Lines https://www.obigenpharma.com/en/announcements/announcements-17