[Edaily Reporter Kim Hyung-il ] Global aesthetic company JETEMA Co.,Ltd.(216080)announced on the 10th that it has applied to China’s National Medical Products Administration (NMPA) for marketing authorization for its botulinum toxin product “JETEMA Co.,Ltd. DerToxin Injection 100 Units (JTM201).” The indicated condition is severe glabellar wrinkles.

This marketing authorization application was based on the results of a Phase 3 clinical trial conducted in China. The trial compared the efficacy and safety of JTM201 with Botox in Chinese patients requiring treatment for moderate to severe glabellar wrinkles.

The trial included 506 participants. A comparison between the JTM201 group and the Botox group confirmed that JTM201 was non-inferior to Botox in terms of the improvement rate of glabellar wrinkles, as assessed by the investigator on-site four weeks after administration. Evaluations up to 16 weeks post-administration also showed that the efficacy of the two products was at a similar level.

Safety profiles were also found to be comparable to those of Botox. According to JETEMA Co.,Ltd., the incidence of adverse events and drug-related adverse events for JTM201 was similar to that of Botox, and no drug-related serious adverse events, events leading to trial discontinuation, or acute adverse events were observed after administration.

This application for marketing authorization in China is also linked to the fulfillment of a previously signed large-scale supply contract. JETEMA Co.,Ltd. had previously signed an exclusive sales agreement for botulinum toxin with China’s Huadong Aesthetics for the China, Hong Kong, and Macau regions. At the time of signing, the estimated contract value was $459 million, equivalent to approximately 552 billion won. The contract term is 10 years, starting from the date product registration is completed in the relevant regions.

However, simply filing for product approval does not guarantee revenue. Actual sales will only materialize after the NMPA review process is completed, product approval and registration are granted, and local orders are placed. In this disclosure, JETEMA Co.,Ltd. also stated that the submission of the application does not guarantee a final approval decision, and that commercialization plans may change depending on the review results.

JETEMA Co.,Ltd. is also expanding its botulinum toxin business in overseas markets outside of China. Last June, it obtained marketing authorization for JTM201 from the Thai Food and Drug Administration (TFDA) and signed a five-year supply contract worth $32 million with a local partner.

Starting with this marketing authorization application in China, JETEMA Co.,Ltd. plans to continue expanding its regulatory submissions in other countries based on the clinical data it has secured.