Chinese biopharmaceutical company CStone Pharmaceuticals (HKEX:2616) announced on Sunday that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a new indication for sugemalimab.

This approval covers the use of sugemalimab as a monotherapy for adult patients with unresectable stage III non-small cell lung cancer (NSCLC) with PD-L1 expression on 1% or more tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations, and whose disease has not progressed following platinum-based chemoradiotherapy (CRT).

The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

Dr. Jason Yang, CEO, president of R&D, and executive director at CStone, said: "Since its initial EU approval in July 2024, sugemalimab has become one of only two PD-(L)1 antibodies approved for stage III NSCLC in Europe, providing a comprehensive treatment option spanning both locally advanced, unresectable stage III and metastatic stage IV NSCLC. Its commercial footprint has now expanded to over 60 countries and regions globally, with market access applications approved or under regulatory review in more than 10 countries. Furthermore, sugemalimab has been included in multiple national reimbursement systems -- an affirmation of its recognised clinical value and pharmacoeconomic benefit."