OBIGEN Pharma, a subsidiary of Taiwan-based OBI Pharma, announced on the 26th that its independently developed next-generation botulinum toxin, OBI-858, has successfully met the primary efficacy endpoint with statistical significance in its first human Phase II clinical trial (OBI-858-002). Two pivotal Phase III trials for OBI-858 have recently been approved by the Taiwan Food and Drug Administration (TFDA). To support international expansion, OBIGEN plans to launch a cash capital increase in the fourth quarter of this year and aims to apply for listing on Taiwan’s Emerging Stock Board before year-end.
The Phase II study focused on patients with moderate-to-severe glabellar lines. Results showed that both the 10U and 20U treatment groups achieved statistically significant improvement compared with placebo on Day 29, demonstrating strong efficacy and tolerability. More than half of patients showed visible effects as early as Day 3, with treatment benefits lasting over six months. Based on these results, the 20U dose was selected for Phase III trials.
On August 22, Taiwan’s FDA approved OBIGEN to initiate two pivotal Phase III trials. The company stated that to further capture global market opportunities, it will not only proceed with financing and domestic listing plans, but also prepare to file an Investigational New Drug (IND) application with the U.S. FDA for a Phase II clinical trial.
CEO Pei-Fen Chou emphasized that OBI-858’s long-acting profile could reduce the frequency of treatments, lower costs, and provide more consistent results, representing a breakthrough as the first botulinum toxin product developed from a locally derived strain in Taiwan. She expressed strong confidence in the upcoming Phase III trials, highlighting the growing global demand for botulinum toxins in both aesthetics and therapeutic settings, positioning OBIGEN as an emerging force in the market.
OBI-858 is the world’s first botulinum toxin with a 760 kDa molecular structure. Phase II results demonstrated rapid onset, durable effects, and high patient satisfaction in glabellar line treatment. Manufactured through a highly purified process free of animal-derived components and alcohol, OBI-858 has also obtained Halal certification, giving it a unique advantage in the fast-growing Muslim aesthetic medicine market.
Mechanistically, OBI-858 acts by cleaving the SNAP-25 protein to block acetylcholine release, leading to temporary muscle relaxation. Beyond aesthetic indications, OBIGEN sees potential expansion into therapeutic applications such as chronic migraine, cervical dystonia, post-stroke limb spasticity, hemifacial spasm, blepharospasm, overactive bladder, and plantar fasciitis. The company is actively seeking international partners to pursue licensing and distribution opportunities for both medical and aesthetic indications worldwide.
Given the high potency of botulinum toxin, stringent manufacturing standards are essential. OBI-858’s active pharmaceutical ingredient and lyophilized injection are both produced at OBIGEN’s in-house PIC/S GMP-certified facilities, ensuring operator safety and sterile product quality.
The TFDA-approved Phase III program will adopt a monotherapy, multicenter, single-dose design, enrolling 600 participants, with the goal of completing trials by the end of 2026. OBIGEN aims to submit a Biologics License Application (BLA) in early 2027, targeting market launch in Taiwan by 2028.
According to Precedence Research, the global botulinum toxin market is projected to grow from USD 9.48 billion in 2025 to USD 21.57 billion by 2034, with a compound annual growth rate of 9.57%. OBIGEN stated it will actively leverage this growth trend by expanding its R&D pipeline and patent portfolio to deliver innovative solutions for both aesthetic and therapeutic markets, helping people pursue health and beauty worldwide.
Resource: 浩鼎旗下鼎晉新型肉毒桿菌素醫美二期臨床告捷，預計年底登興櫃
