JETEMA(216080) has entered the approval process to enter the Chinese botulinum toxin market.
JETEMA said on the 11th that it applied to the National Medical Products Administration (NMPA) in China for marketing authorization of the botulinum toxin product "JETEMA The Toxin Injection 100 units (JTM201)." The indication is improvement of moderate to severe glabellar lines.
The application was based on the results of a phase 3 clinical trial involving 506 Chinese patients. Comparing the JTM201 arm with the Botox arm, JTM201 demonstrated noninferiority to Botox in the investigator's on-site assessment of glabellar line improvement at 4 weeks after administration. In evaluations through 16 weeks, the efficacy of the two products was similar.
There was little difference between the two products in safety as well. In the JTM201 arm, there were no drug-related serious adverse events or adverse events that led to discontinuation.
Whether China grants approval is also tied to whether JETEMA's previously signed large-scale supply contract generates actual sales.
JETEMA signed an exclusive sales contract with Huadong Aesthetics in China for JTM201 in China, Hong Kong and Macao. The expected contract amount at the time was $459 million, or about 552 billion won, and the contract period is 10 years from the time product registration is completed in those regions.
However, this approval application will not immediately translate into sales. Only after NMPA review is completed, marketing authorization and product registration are secured, and local purchase orders are placed will the supply contract translate into actual sales.
Starting with the China approval application, JETEMA plans to expand approval procedures by country. On Jun. in Thailand, it received marketing authorization from the Food and Drug Administration (TFDA) and subsequently signed a five-year supply contract worth $32 million with a local partner.