China’s NMPA Accepts Fosun Pharma’s BLA for Innovative Botulinum Toxin Product RT002

(Shanghai, China) Recently,Shanghai Fosun Pharmaceutical (Group) Co., Ltd.(“Fosun Pharma”; stock code: 600196.SH, 02196.HK), a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China, announced that the Biologics License Application (“BLA”) for RT002 (DaxibotulinumtoxinA for injection) for the temporary improvement of moderate to severe glabellar lines caused by movements of corrugator or procerus muscles in adults, which was submitted by its holding subsidiary Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (“Fosun Pharma Industry”) through license-in, was recently accepted for review by the National Medical Products Administration (“NMPA”).

Fosun Pharma Industry entered into a license agreement with US-based Revance Therapeutics, Inc. (“Revance”) in December 2018, whereby Fosun Pharma Industry was granted the exclusive rights to use, import, sell, and otherwise commercialize (excluding manufacturing) RT002 in Mainland China, Hong Kong SAR and Macao SAR.

RT002 is a long-acting neuromodulator developed based on Revance’s proprietary peptide technology and is manufactured in the United States. RT002 doesn’t contain any human serum albumin or animal-based components and is stable at ambient temperature.

Revance’s clinical programs have investigated RT002 for aesthetic indications including glabellar lines and upper facial lines and therapeutic indications including cervical dystonia and upper limb spasticity. RT002 temporarily blocks nerve impulses causing relaxation of local muscles that is reversible, resulting in reduced appearance of facial wrinkles and lines.

Revance’s BLA for RT002 indicated to improve moderate to severe glabellar lines in adults was approved by the U.S. Food and Drug Administration (“U.S. FDA”) in September 2022. Up to now, the supplemental biologics license application (“sBLA”) for the new indication of this product to treat cervical dystonia in adults is under regulatory review by the U.S. FDA. Further, Fosun Pharma Industry has completed its Phase ? clinical trial for RT002 for cervical dystonia in China (excluding Hong Kong, Macao, and Taiwan).