On February 22, 2026 CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas, reported that the UK MHRA has granted a new indication for sugemalimab as a monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemoradiotherapy (CRT).
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Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated, "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 ten countries. Furthermore, sugemalimab has been included in multiple national reimbursement systems—an affirmation of its recognized clinical value and pharmacoeconomic benefit."
Dr. Qingmei Shi, Chief Medical Officer of CStone, added, "The MHRA’s approval of sugemalimab for Stage III NSCLC represents another significant endorsement from a major international regulatory agency and will further unlock its global commercial potential. We are proud of CStone’s clinical development and regulatory affairs teams for their’ effective execution, invaluable experience in global registration, and ability to navigate mature regulatory frameworks in Europe and the UK. Sugemalimab in combination with chemotherapy treating stage IV NSCLC has received the highest-level recommendation [I, A] in the first-line setting for both squamous and non-squamous NSCLC in the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Non-Oncogene-Addicted Metastatic NSCLC Living Guideline. We look forward to the potential inclusion of this newly approved stage III NSCLC indication in this authoritative guideline in the near future. CStone will continue to advance regulatory filings for sugemalimab in additional indications, including gastric cancer (GC) and esophageal squamous cell carcinoma (ESCC)."
About Sugemalimab
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.
The EC and MHRA have approved sugemalimab for two indications:
In combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations; and
Monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based CRT.
The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications:
In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and metastatic squamous NSCLC;
For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based CRT;
For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and
In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression CPS ≥5.
(Press release, CStone Pharmaceauticals, FEB 22, 2026, View Source [SID1234662833])