On May 20, Patricia Chou, CEO of OBIGEN Pharma, a subsidiary of OBI Pharma, stated that the company’s independently developed 760 kDa high-purity botulinum toxin has demonstrated outstanding performance in three key indicators during the lead-in phase of its Phase II clinical trial. Final results are expected in August, at which point OBIGEN hopes to begin discussions with major international pharmaceutical companies for potential licensing opportunities.
During its shareholders' meeting held on the same day, OBIGEN announced plans to complete preparations for public offering and registration on the Taipei Exchange Emerging Stock Board by the end of this year, marking a significant step toward entering the capital market.
According to Chou, global market research firm Precedence Research estimates that the botulinum toxin market is currently valued at around USD 9 billion and is projected to grow rapidly at a compound annual growth rate (CAGR) of 9.57%, reaching USD 21.57 billion by 2034. Botulinum toxin works by blocking the transmission of signals between nerves and muscles, resulting in muscle relaxation. While widely used in aesthetic medicine for wrinkle reduction and anti-aging, it also has well-established therapeutic uses in treating post-stroke spasticity, overactive bladder, and cervical dystonia.
OBIGEN’s largest shareholder is OBI Pharma, which holds approximately 51% of the company. Ruentex Group is the second-largest shareholder with less than a 10% stake. Additionally, around 20 domestic institutional investors participate in OBIGEN’s funding, collectively holding over 20% of shares.
OBIGEN’s 760 kDa high-purity botulinum toxin demonstrated promising safety and tolerability in Phase I trials, along with significant improvement in glabellar lines (frown lines). In the lead-in phase of the Phase II trial, it continued to show excellent results in three critical areas: time to onset, duration of effect, and user satisfaction—highlighting its strong potential for dynamic wrinkle correction. The company expects to announce full Phase II results in August and will subsequently seek regulatory approval in Taiwan to initiate a Phase III clinical trial.
In addition, OBIGEN is planning to enter the U.S. market and aims to file an Investigational New Drug (IND) application with the FDA by the end of this year, covering both aesthetic and therapeutic indications. Chou noted that while about 70% to 80% of botulinum toxin use in Taiwan is for aesthetic purposes, it is primarily used for medical indications overseas.
OBIGEN currently holds approximately NT$700 million in cash, with total funding reaching NT$1 billion—sufficient to support ongoing clinical trials in Taiwan. However, if U.S. market development is launched in parallel, the company may consider raising additional capital. Strategic planning for the next phase and preparations for a Biologics License Application (BLA) are expected to begin following the unblinding of Taiwan’s Phase II trial results at the end of August.
Resource: 浩鼎小金雞鼎晉肉毒感菌素8月臨床結果出爐 拚國際授權
