Targeting Taiwan’s Emerging Stock Market Listing and U.S. IND Submission
Taipei, Taiwan, Aug. 26, 2025 – OBIGEN PHARMA, Inc. (“OBIGEN”) today announced positive results from the first Phase 2 clinical trial (OBI-858-002) for its novel botulinum toxin, OBI-858, in participants with moderate to severe glabellar lines. The drugs (10U and 20U) in comparison with placebo met the primary efficacy endpoint on Day 29 with statistical significance. In addition to being highly efficacious in both doses (10U and 20U) tested, OBI-858 demonstrated a well-tolerated safety profile. Importantly, durable responses were observed in over half of participants as early as Day 3 and lasted beyond 6 months for both doses. Based on the data, OBI-858 20U was chosen as the dose to enter into Phase 3 studies.
Following the Taiwan FDA approval of 2 pivotal Phase 3 study protocols for OBI-858 on August 22, 2025, OBIGEN plans a fundraising campaign in Q4, 2025 to expand into the global markets. The company aims to file for a listing on Taiwan’s emerging stock market by late 2025 and submits a Phase 2 Investigational New Drug (IND) application to the U.S. FDA in the near future, marking its entry into a promising botulinum toxin market.
“The success of our Phase 2 trial provides patients potentially with a differentiated option to current therapies. OBI-858’s long-lasting efficacy offers patients benefits of fewer treatment sessions, reduced costs, and consistent symptom controls," said Patricia Chou, CEO of OBIGEN. “This achievement also creates an opportunity for Taiwan to enter the global botulinum toxin market for the first time with a product developed from a native Taiwanese bacterial strain. We are confident in the performance of our upcoming Phase 3 studies. As the demand for aesthetic and medical treatments grows at a rapid pace, OBIGEN is well-positioned to tap into the needs of the global market.”
Key Highlights from the Phase 2 Clinical Trials
l The OBI-858-002 Phase 2 clinical trial’s primary and several key secondary endpoints demonstrated both clinical meaningfulness and statistical significance.
l On Day 29, the percentages of participants achieving a concurrent >=2-grade improvement of glabellar lines severity at maximum frown by both the investigator’s and the subject’s live assessments were higher in the 10U (58.7%) and 20U (74.4%) groups compared to the placebo group (0.0%), reaching statistical significance (10U, p < 0.001 ; 20U, p < 0.001).
l The final results showcased OBI-858’s differentiated profile in efficacy, safety and tolerability, and immunogenicity with fast onset, long durability, and a well-tolerated safety profile.
l An ongoing repeat-dose safety extension study (OBI-858-003) with 200 participants is currently being conducted with one-year monitoring.
Halal Certification and Patent Protection
OBI-858 is the world's first botulinum toxin product with a 760 kDa molecular structure, which has demonstrated a favorable safety and tolerability profile. The Phase 2 trial highlighted its fast onset, long-lasting efficacy, high patient satisfaction, and improvement in glabellar lines. Thanks to its animal-free and alcohol-free high-purification manufacturing process, OBIGEN is one of the few companies globally to obtain Halal certification. This certification provides a key competitive advantage and a pathway for sustainable growth, particularly with the increasing demand for aesthetic products in Muslim countries.
The 760 kDa molecular structure of OBI-858 constitutes a patentable advancement that effectively mitigates the risk of infringement. Patents covering the invention have been granted in 11 key jurisdictions, including the U.S., Taiwan, Japan, South Korea, New Zealand, Australia, Saudi Arabia, Indonesia, Malaysia, Singapore, and Russia.
Expanding into Therapeutic Uses with In-House PIC/S GMP Production
Beyond its initial cosmetic use, OBI-858's mechanism of action— cleaves SNAP 25 protein to block the release of the neurotransmitter acetylcholine, and resulting in the temporary paralysis of muscles – enables a broad range of therapeutic applications. These include treatments for chronic migraine, cervical dystonia, post-stroke spasticity, facial spasms, and overactive bladders. To accelerate growth, OBIGEN is actively seeking collaborations with international partners for both aesthetic and therapeutic indications via licensing and distribution.
Botulinum toxin, a highly potent neurotoxin, requires a complicated manufacturing process in a specially designed facility to protect the safety of production operators and ensure the quality of sterile injectable drugs. Both the active pharmaceutical ingredient (API) and the drug product of OBI-858 are produced in the company's own PIC/S GMP compliant factories.
Taiwan FDA’s Approval to Proceed Phase 3 Trials
After securing approvals from Taiwan FDA on Aug. 22, 2025, OBIGEN plans to initiate two pivotal Phase 3 clinical trials. The plan is to enroll 600 participants in the monotherapy, multi-center, single dose studies. The trials are expected to be completed by end of 2026, targeting a BLA submission by early 2027 and a potential launch in Taiwan by 2028.
According to* Precedence Research, the global botulinum toxin market is projected to grow from $9.48 billion in 2025 to $21.57 billion by 2034, at a CAGR of 9.57%. OBIGEN is ready to capitalize on this trend by continuing to innovate and expand its proprietary portfolio with a mission to help people pursue health and beauty.
About OBIGEN
OBIGEN PHARMA, Inc. is Taiwan’s only fully integrated 760 kDa botulinum toxin developer and manufacturer, with patent-protected strains and formulations, and advanced production technologies. OBIGEN is committed to providing the high quality and differentiated toxin solutions across aesthetics and therapeutics to help people pursue health and beauty.
* Source: https://www.precedenceresearch.com/botulinum-toxin-market
Contact Information:
Contact: Sheila Chuang, Deputy Spokesperson
Phone: +886 2786 1217 EXT.160
Email: sheilachuang@obigenpharma.com