JeteMa Botulinum Toxin JTM201: Application for Product Registration in China

Jetema (216080) announced that it has officially applied to the National Medical Products Administration (NMPA) of China for approval of its botulinum toxin type A product, "Jetema Derotoxin 100 Units (JTM201)," on August 10, 2026. The intended use is for moderate to severe glabellar wrinkles (frown lines). This application is the result of a clinical development process that spanned approximately four years, starting with the submission of a Phase 1/2 clinical trial plan in China in October 2022, followed by approval in January 2023, a pre-meeting application for the initiation of Phase 3 in November of the same year, Phase 3 initiation approval in March 2024, and the announcement of the Phase 3 Stage 1 results in May 2026. The clinical trial registration number is CTR20243520. Phase 3 is a multi-center, randomized, double-blind, non-inferiority parallel-group study involving 506 Chinese adults (253 in each group) to compare the efficacy and safety of JTM201 20U with Botox®. The primary endpoint for efficacy evaluation was the proportion of patients who showed an improvement of 2 points or more from baseline on the IGA-FWS and PFWS assessments at 4 weeks after administration. According to the Phase 3 Stage 1 results, JTM201 demonstrated non-inferiority compared to Botox®, and its efficacy in improving glabellar wrinkles within 16 weeks after administration was also found to be similar. In terms of safety, the incidence of adverse events and drug-related adverse events was similar to that of Botox®, and no serious drug-related adverse events, adverse events that caused discontinuation of the study, or acute adverse events occurred. Jetema stated that it plans to continue submitting additional approval applications on a country-by-country basis, building on the completion of this Chinese approval application. The Chinese cosmetic pharmaceutical market is a major market with high demand for botulinum toxin, and obtaining approval is expected to provide a foundation for commercialization and growth. However, the company's announcement also stated that the approval application does not guarantee final approval from the NMPA, and that there is a possibility of modifying or abandoning the commercialization plan if the results of the review process do not meet expectations. Investors are advised to fully consider the investment risks, including the uncertainty surrounding the approval process.