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On April 21, Eastern Time, Revance Therapeutics announced that its Biologics License Application (BLA) for DaxibotulinumtoxinA for injection in the treatment of moderate to severe frown lines has been accepted by the U.
Moderate to severe glabellar lines This is a long-acting neuromodulator for aesthetic and multiple potential therapeutic indications Long-acting neuromodulator
DaxibotulinumtoxinA (RT002) is a novel, next-generation, long-acting neuromodulator based on Revance's proprietary technology platform.
A novel, next-generation, long-acting neuromodulator based on Revance's proprietary technology platform,
Research has shown that RT002 can be used for cosmetic and treatment of symptoms including glabellar lines, cervical dystonia and plantar fasciitis
The product works by blocking nerve impulses, temporarily inhibiting muscle movements that cause wrinkles, resulting in smoother, refreshed skin.
According to data published in 2021 in the Official Journal of the American Society for Dermatologic Surgery (ASDS) , subjects experienced rapid and sustained improvement in the severity of static glabellar lines after repeated treatment with RT002
After repeated treatment with RT002, subjects experienced rapid and sustained improvement in the severity of static glabellar lines
In China, Fosun Pharma's holding subsidiary Fosun Pharma Industry signed a license agreement with Revance in December 2018 to introduce RT002 for exclusive use, import, sales and other commercialization (excluding manufacturing) in mainland China, Hong Kong and Macau.
Authorized application areas include cosmetic and therapeutic indications
Screenshot source: Official website of China Drug Clinical Trial Registration and Information Publicity Platform
According to the official website of the China Drug Clinical Trial Registration and Information Publicity Platform, RT002 is conducting two international multi-center Phase 3 studies in China, namely: 1) To evaluate the efficacy and Safety: A randomized, double-blind, placebo-controlled, parallel, international multicenter Phase 3 study in China Extension Study (ASPEN-1-CN); 2) To evaluate the efficacy and safety of RT002 in the treatment of moderate to severe glabellar lines : A multicenter, randomized, double-blind, placebo-controlled phase 3 clinical study
China Extension Study of International Multicenter Phase 3 Study
It is hoped that RT002 will progress smoothly in clinical development and registration application, and bring long-acting therapy to patients as soon as possible
References:
References:[1] Revance Receives FDA Acceptance of BLA Resubmission for DaxibotulinumtoxinA for Injection for Glabellar Lines .
[3] Revance Announces Publication of Results on Static Glabellar Lines With Repeated Treatment of DaxibotulinumtoxinA for Injection From the SAKURA Clinical Program in Dermatologic Surgery .
[4] Fu Rui Medical Technology (1696.
HK) entered into a sublicense agreement with Fosun Industrial on the long-acting botulinum toxin product RT002.
Retrieved Jul 15, 2021, from https://mp.
weixin.
qq.
com/s/StHq29UDGmHPBFTEhNG8Ew
