Aesthetic device and injectable company Jeisys Medical (JETEMA) announced on the 29th that it has obtained final Clinical Study Report (CSR) approval for Phase 3, Stage 1 of its botulinum toxin formulation JTM201 in China. Based on these results, the company plans to file a Biologics License Application (BLA) in China within the first half of this year.
The Phase 3 trial enrolled 506 adult patients with moderate to severe glabellar lines, of whom 503 received treatment. At Week 4 post-injection, the proportion of patients achieving at least a 2-point improvement on the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) scale at maximum frown was 77.8% in the JTM201 group versus 77.7% in the Botox group. The company stated that JTM201 met the pre-specified non-inferiority margin, confirming efficacy. The photographic assessment improvement rate was 81.1% for JTM201, also demonstrating non-inferiority to Botox. Jeisys Medical emphasized that similar results were observed in its domestic Phase 3 and U.S. Phase 2 trials, providing consistent efficacy data across global studies.
In terms of durability and patient satisfaction, over 90% of subjects perceived improvement in glabellar lines at Week 4, and more than 60% still experienced effect at Week 16. Patient satisfaction assessment showed 85.9% of treated subjects rated the outcome as 'satisfied or better.' No serious adverse events (SAEs) or treatment discontinuations were reported, and no neutralizing antibodies were detected, indicating a favorable immunogenicity profile.
China is considered a key growth region for the global botulinum toxin market, driven by rising aesthetic demand. Industry analysts note that securing regulatory approval in China would enable access to large distribution networks and hospital/clinic channels, boosting revenue potential. Jeisys Medical already holds HA filler approvals in China, and the addition of a toxin product is expected to create synergies in its aesthetic portfolio.
A company representative stated: 'Based on this China Phase 3 CSR, we plan to submit the BLA within the first half of the year. We expect China sales from the botulinum toxin product to begin in earnest next year, alongside existing HA filler revenue.'
Source: Read the original report | Published: May 29, 2026