Hugel Completes China Review... "Expecting Mid-Year Approval with Factory Inspection Exemption"

[Asia Economy Reporter Hyunseok Yoo] Hugel's botulinum toxin product 'Botulax' has recently completed the approval review process in China. In particular, it was exempted from the factory inspection, raising expectations that there will be no difficulties in obtaining market approval.

According to the financial investment industry on the 22nd, Hugel completed the Phase 3 clinical trial of the botulinum product in China in 2018, applied for approval to China's NMPA (National Medical Products Administration) in April last year, and completed the review on the 9th of this month.

Goo Wan-seong, a researcher at NH Investment & Securities, said, "After the document supplementation work, final approval is expected around June to July," adding, "Exports to China are expected to accelerate in the second half of the year, and Wellage, which also succeeded in obtaining Chinese sanitary approval, is expected to see high growth in exports to China after COVID-19."

According to the industry, the document supplementation process is a routine procedure and can be seen as approvable by the US FDA. In particular, the request for supplementary documents indicated that the factory inspection was exempted. Due to the exemption from the inspection, the possibility of delays or postponements in terms of timing has decreased. This increases the likelihood that Hugel will receive market approval by mid-year.

A company official explained, "Since there is no mention of factory inspection in the supplementary letter, it is understood that the factory inspection has been exempted," and added, "After submitting the documents, final review will be conducted, and approval is expected around mid-year."

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