Shots:
The Chinese NMPA has accepted the marketing application for its secukinumab injection, a biosimilar version of Cosentyx, submitted as a Class 3.3 therapeutic biologic
The marketing authorization application is supported by a P-I PK similarity study in healthy volunteers and a P-III equivalence study in psoriasis pts, demonstrating that the product is highly similar to Cosentyx in efficacy, safety, PK, and immunogenicity. Detailed results will be…
Shots:
The Chinese NMPA has accepted the sNDA of gumokimab for the treatment of active ankylosing spondylitis (AS)
sNDA was backed by the P-III (AK111-303) trial in AS, which met all efficacy endpoints, with 1EP (ASAS20 response rate) showing consistent improvements across subgroups, along with 2EP (ASAS40 response rate) & gumokimab delivering rapid symptom relief…

