Recombinant Botulinum Toxin

YY001：A potentially first-in-class recombinant botulinum toxin type A candidate

Botulinum toxin is a neurotoxic protein produced by Clostridium botulinum.  Botulinum toxin can be classified into seven types according to the particular serotypes, namely types A to G. They act through different intracellular protein targets and exhibit different durations of effect and potencies. In terms of efficacy, only type A shows a clinically important biologic activity, hence it is the most often studied and used type of botulinum toxin.

As of January 2023, YY001 was the only recombinant botulinum toxin product candidate approved by the NMPA to undergo clinical trials, and also the first and only clinical-stage recombinant botulinum toxin type A product candidate globally, according to Frost & Sullivan.

YY001 is produced from a novel manufacturing pathway of recombinant protein that is designed to solve biosafety issues of producing natural botulinum toxin from the host Clostridium botulinum. We believe that YY001 is a highly differentiated product with multiple advantages including high purity which potentially improves the safety profile, significant response rate and manufacturing scalability. We also believe that this high purity of YY001 reduces the immunogenicity risks associated with introducing exogenous proteins into the human body and could improve the overall safety and efficacy of YY001 administration.

YY001 is classified as a Class 2.4 therapeutic biologic product by the NMPA. We had completed the Phase III clinical trial and moved forward to the BLA submission. As part of our commercialization plan, we have completed the construction of a GMP-compliant manufacturing facility with a total GFA of approximately 12,000 square meters. The facility is currently designed with an annual manufacturing capacity of two million vials of YY001 in freeze-dried form, and it commenced operation in the first quarter of 2023.