Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced a market approval filing to the National Medical Products Administration (NMPA) in China for its in-licensed daxibotulinumtoxin A for injection (RT002). The drug is intended for use in the temporary improvement of moderate to severe frown lines in adults, attributed to the activity of the corrugator muscle or the depressor interbrow muscle.
Licensing Deal and US Approval
In December 2018, Fosun struck a licensing deal with US-based Revance Therapeutics Inc., securing exclusive rights to use, import, and sell RT002 in mainland China, Hong Kong, and Macau. The drug received approval in the US for improving moderate to severe frown lines in September 2022. Additionally, a new indication approval filing for the treatment of adult cervical dystonia has been accepted for review in the US, with a Phase III trial for this indication also concluded in China.
Novel Characteristics of RT002
RT002 is a novel, long-acting neuromodulator and is distinguished as the first and only botulinum toxin product sourced, processed, and manufactured in the US without the use of human blood-derived products or animal-derived proteins in its formulation. The pivotal Phase III SAKURA study demonstrated that daxibotulinumtoxin A can provide observable wrinkle improvement as early as 1 day post-injection. At week 4, 74% of subjects showed improvement in their eyebrow lines, and 98% of subjects experienced a reduction in the severity of eyebrow lines. The median duration of effect is up to 6 months, with some patients maintaining improvements even after 9 months.
Market Potential and Competition
Currently, there is no product containing daxibotulinumtoxin botulinum toxin type A commercially available in mainland China. However, similar products such as Allergan’s Botox, Lanzhou Institute of Biological Products’ botulinum toxin type A for injection, Hugel, Inc.’s Letybo, and Ipsen Limited’s Dysport are available in the market. Botulinum toxin A for injection generated RMB 546 million (USD 79.2 million) in China sales in 2022, indicating a substantial market opportunity for RT002.-Fineline Info & Tech
