JETEMA said on the 2nd that it received approval for the clinical study report (CSR) of phase 3 for its botulinum toxin product JTM201 conducted recently in China, confirming its efficacy and safety.
According to the company, in the phase 3 trial in China involving 506 participants, JTM201 showed a frown line improvement effect equivalent to Botox. It met the primary endpoint of noninferiority.
At 4 weeks after dosing, the investigator-assessed improvement rate for frown lines was 77.8%. At 16 weeks, more than 60% of patients maintained the effect. No neutralizing antibody formation was observed during the trial period, confirming safety.
JETEMA plans to submit a biologics license application (BLA) to the National Medical Products Administration (NMPA) in China based on these clinical results. The company said that if the approval process proceeds smoothly, it aims to launch the product in China in the second half of 2027.
The company is also proceeding with commercialization preparations. JETEMA signed a long-term supply contract worth a total of 550 billion won over 10 years with Huadong Aesthetics, a Chinese aesthetics specialist corporations.
The company expects that whether JTM201 is approved in China will be an important turning point for JETEMA's overseas business expansion. China is considered a market with high entry barriers because there are few approved botulinum toxin products. The Chinese botulinum toxin market is expected to grow to about 5 trillion won by 2030.
Nam Jeong-seon, CEO of JETEMA, said, "The competitiveness based on the original strain introduced from Europe has been verified through global clinical trials," adding, "We plan to strengthen our push into the Chinese aesthetics market by expanding our portfolio to botulinum toxin following the hyaluronic acid (HA) filler "Epitique," which is being sold in China."