Hugel "Botulinum Toxin, China Approval Waiting Number 2... Market Authorization Imminent"

[Asia Economy Reporter Yoo Hyun-seok] Hugel's botulinum toxin product 'Botulex,' which is awaiting approval in China, is nearing the point of receiving marketing authorization.

According to industry sources on the 17th, Hugel successfully completed Phase 3 clinical trials of its botulinum product in China in 2018. Subsequently, in the first half of last year, the company applied for marketing approval of the botulinum toxin product to the China Food and Drug Administration (CFDA).

In particular, the waiting number has rapidly decreased since the application, indicating that marketing approval is imminent. A company official stated, "The waiting number was 9 on December 27 last year," adding, "Despite the rapid spread of COVID-19 in China, the number dropped to 6 on January 27 this year, 5 on the 24th of last month, and as of the day before yesterday, it went down to 2."

Hugel expects to obtain marketing approval in China around mid-year. The company official said, "Currently, Hugel is the only domestic botulinum toxin company to have received marketing approval in Taiwan," and added, "If approval is obtained in China this year, it will be the first domestic toxin company to enter the Greater China market encompassing both Taiwan and mainland China, so expectations for this Chinese approval are high."

This content was produced with the assistance of AI translation services.