Global First Recombinant Botulinum Toxin Type A (YY001) Files for Market Approval in China for Glabellar Lines Treatment
MingMed
Innovative Drug Developer
On December 31, MingMed announced that its holding companyChongqing Yuyan Pharmaceutical Co., Ltd.Self-developedInjectable Recombinant Botulinum Toxin Type A YY001The listing application has been accepted by the NMPA for the temporary improvement of frown lines caused by the activity of the corrugator and/or procerus muscles in adults aged 65 and under.Moderate to Severe Glabellar LinesAccording to the press release from MingMed,This is the world's first recombinant Type A botulinum toxin in the botulinum toxin field.。
Screenshot source:MingMed Official WeChat
As a recombinant Type A botulinum toxin, YY001 avoids the biosafety risks associated with traditional production methods using Clostridium botulinum to produce botulinum toxin, without altering protein activity. Meanwhile, through an entirely innovative manufacturing process, the recombinant botulinum toxin produced by Chongqing Yuyan Pharmaceutical Co., Ltd.Characterized by high purity, high specific activity, and low immunogenicity。
November 23,Huadong Medicine has reached a cooperation with Chongqing Yuyan Pharmaceutical Co., Ltd., obtained YY001 in the medical aesthetics indications field in mainland China, Hong Kong, and Macao regions.Exclusive Commercialization Rights`, and will be responsible for YY001 in the medical aesthetics indications field in Hong Kong and Macao, China.`Exclusive Clinical Development and Regulatory SubmissionAccording to the agreement, Huadong Medicine will pay Chongqing Yuyan Pharmaceutical Co., Ltd. an upfront payment of 50 million yuan and registration milestone payments of up to 100 million yuan.
In September 2024, Chongqing Yuyan Pharmaceutical Co., Ltd. announcedYY001 Phase III Clinical Study for the Treatment of Moderate to Severe Glabellar Lines(Code Name YY001-001)Achieve SuccessData shows: YY001 demonstrated a high level of consistency with the completed Phase I/II clinical results in the large-scale population Phase III clinical trial;Its efficacy, safety, and immunogenicity have all reached the established endpoints of the clinical trial., showing excellent performance compared to the control drug.
Medical aesthetic indications outside,July 2024,YY001 for treatmentAdult Upper Limb Muscle SpasmsClinical Research(Code YY001-002)Has also entered the Phase II clinical trial stage in China.
