Hong Kong-based SinoMab Bioscience Ltd (HKG: 3681) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II/III study of its tyrosine kinase (BTK) inhibitor SN1011 for neuromyelitis optica spectrum disorders (NMOSD). The trial is expected to enroll its first patient in Q1 2023.
Drug Profile
SN1011 is designed to be more selective than existing BTK inhibitors, targeting autoimmune diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), pemphigus, and multiple sclerosis. The drug has entered Phase II trials for pemphigus vulgaris and SLE, leveraging its high target selectivity and affinity.
NMOSD Context
NMOSD, an autoimmune central nervous system disease with high recurrence and disability, was listed as a rare disease in China in May 2018. Other NMOSD treatments in development include Harbour Bio’s batoclimab (HBM9161), Hengrui Medicine’s SHR1459, Ascentage’s lisaftoclax, InnoCare’s orelabrutinib, and Shanghai Pharma’s anti-CD20 monoclonal antibody. Viela Bio’s inebilizumab and Roche’s satralizumab were approved in China in March 2022 and May 2021, respectively.-Fineline Info & Tech
