Yuyan Pharmaceutical’s self-developed Retoxin® uses recombinant protein technology to preserve the active protein's molecular structure while eliminating the biosafety risks associated with traditional production methods. (Photo/Yuyan Pharmaceutical)

Chongqing - Chongqing Yuyan Pharmaceutical announced that its independently developed Retoxin® (Project Code: YY001), an innovative Recombinant Type A Botulinum Toxin for Injection, has received official marketing approval from China’s National Medical Products Administration.

This product is the world's first recombinant Type A botulinum toxin, marking a significant technological leap from natural extraction to precise genetic recombination.

Currently, all botulinum toxins available on the market are natural versions extracted directly from Clostridium botulinum. Yuyan Pharmaceutical’s self-developed Retoxin® uses recombinant protein technology to preserve the active protein's molecular structure while eliminating the biosafety risks associated with traditional production methods. 

According to the company, the resulting toxin boasts high purity and superior specific activity, demonstrating higher efficacy, enhanced safety profiles, and low immunogenicity in clinical settings.

In the medical aesthetics sector, botulinum toxin has become a staple for treating dynamic wrinkles and masseter hypertrophy, or face and shoulder slimming, thanks to its unique ability to block nerve signals and temporarily relax muscles.

According to Frost & Sullivan, China’s botulinum toxin market grew from 1.9 billion yuan (approx. 280 million U.S. dollars) in 2017 to 4.6 billion yuan in 2021, representing a compound annual growth rate of 25.6%. The market is projected to reach 390 billion yuan by 2030. Industry experts believe the launch of Retoxin® will mark a turning point for technological upgrades in this highly competitive market.

Beyond its approved indication for improving moderate-to-severe glabellar lines in adults, the product is also being explored for therapeutic applications. Clinical trials for the treatment of upper limb spasticity in adults have completed Phase II in China, with Phase III trials currently underway.

Among the seven botulinum toxin products currently approved in China, only one is domestically manufactured, with the majority of the market share held by imported brands. The approval of Retoxin® not only signifies a breakthrough for Chinese innovative drugs in this field but also serves as a vivid example of the deep integration between local fundamental research and industrial transformation.

"The successful approval of our recombinant Type A botulinum toxin is the first step in Yuyan Pharmaceutical's transition into the commercialization phase," stated Dr. Wu Yang, Chief Scientific Officer of Yuyan Pharmaceutical.

Founded in 2020, Chongqing Yuyan Pharmaceutical is a Chinese innovative biopharmaceutical company. The launch of its core product, Retoxin®, signals the end of the company’s pure investment stage, as it begins to generate revenue from sales.