CStone Pharmaceuticals: Sugemalimab Receives UK MHRA Approval for Stage III NSCLC

Key Highlights

• Sugemalimab, CStone’s innovative anti-PD-L1 monoclonal antibody, has received a new indication approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) in adults.
• The new indication covers adult patients with unresectable stage III NSCLC who have PD-L1 expression on ≥1% of tumour cells and no sensitising EGFR mutations, ALK, or ROS1 genomic aberrations, and whose disease has not progressed following platinum-based chemoradiotherapy (CRT).
• This UK approval closely follows the European Commission’s (EC) approval, marking the second indication for sugemalimab in the UK and further strengthening its presence in the European oncology market.
• The approval is based on robust data from the GEMSTONE-301 study, a multicenter, randomized, double-blind Phase III trial, which demonstrated that sugemalimab significantly improved progression-free survival (PFS) and provided a clinically meaningful prolongation of overall survival (OS) in patients with stage III NSCLC.
• CStone has established four commercialization partnerships for sugemalimab, expanding its reach to over 60 countries and regions across Europe, the Middle East and Africa, and Latin America. The global commercial rollout is actively underway.
• 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, reinforcing its competitive position in this therapeutic space.
• Sugemalimab has also been included in multiple national reimbursement systems, highlighting its recognized clinical value and cost-effectiveness.
• The company has ongoing market access applications in more than ten countries, with regulatory reviews underway.

Details for Shareholders and Potential Investors

• The MHRA’s approval represents a significant regulatory milestone and validates CStone’s global development and registration strategy. This approval could unlock further commercial opportunities and contribute to revenue growth.
• The product’s expansion in indications and geographic footprint enhances its market potential and may positively impact CStone’s share price.
• Sugemalimab is positioned as a standard-of-care option: In combination with chemotherapy, it has received the highest-level recommendation [I, A] in the first-line setting for both squamous and non-squamous NSCLC according to the European Society for Medical Oncology (ESMO) Non-Oncogene-Addicted Metastatic NSCLC Living Guideline.
• CStone is actively pursuing additional regulatory filings for sugemalimab in other cancers, including gastric cancer (GC) and esophageal squamous cell carcinoma (ESCC), which could further enhance its market profile.
• Important Risk Disclosure: The company has issued a cautionary statement warning that there is no guarantee that they will ultimately be able to develop and market sugemalimab successfully in all jurisdictions. Shareholders and potential investors are advised to exercise due care and seek professional advice if in doubt.

About Sugemalimab

Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody developed using the OmniRat^® transgenic animal platform. This approach may reduce the risk of immunogenicity and toxicity for patients.

Approval Status:

• EC and MHRA (Europe and UK):
  • Combination with platinum-based chemotherapy for first-line treatment of metastatic NSCLC with no sensitizing EGFR mutations or ALK, ROS1, or RET genomic tumor aberrations.
  • Monotherapy for adults with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumour cells and no sensitizing EGFR mutations, or ALK, ROS1 genomic aberrations, and whose disease has not progressed following platinum-based CRT.
• NMPA (China):
  • Combination with chemotherapy as first-line treatment of metastatic squamous and non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
  • Treatment of patients with unresectable stage III NSCLC whose disease has not progressed following platinum-based CRT.
  • Treatment of relapsed or refractory extranodal NK/T-cell lymphoma.
  • Combination with chemotherapy for first-line treatment of unresectable locally advanced, recurrent or metastatic ESCC.
  • Combination with chemotherapy for first-line treatment of unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 CPS ≥5.

About CStone Pharmaceuticals

Founded in late 2015 and listed on the Hong Kong Stock Exchange (HKEX: 2616), CStone is an innovation-driven biopharmaceutical company focused on oncology, autoimmune/inflammation, and other key disease areas. The company has launched 4 innovative drugs and secured approvals for 20 new drug applications across 9 indications. Its pipeline features 16 promising candidates, including potentially first-in-class or best-in-class antibody-drug conjugates, multispecific antibodies, immunotherapies, and precision medicines.

The company’s management team boasts comprehensive experience spanning preclinical research, clinical development, drug manufacturing, business development, and commercialization.

For more details, visit the official website: www.cstonepharma.com

Board Composition

As of the announcement date, the Board of CStone Pharmaceuticals comprises Dr. Wei Li (Chairman and non-executive director), Dr. Jianxin Yang (executive director), Mr. Kenneth Walton Hitchner III and Mr. Edward Hu (non-executive directors), and Mr. Kenneth Howard Jarrett, Ms. Fang Xie, and Ms. Catherine Yen (independent non-executive directors).

Potential Share Price Sensitivity

• The MHRA approval for sugemalimab’s new indication in the UK is a significant regulatory achievement that expands the company’s commercial opportunities in major markets.
• With additional market access applications underway and further indications being pursued, any future approvals could serve as further share price catalysts.
• The inclusion of sugemalimab in national reimbursement systems and top-tier clinical guidelines underscores its value proposition and may positively influence reimbursement and uptake.
• Investors should closely monitor further regulatory and commercial updates, as well as any developments in sugemalimab’s inclusion in clinical guidelines.
• Caution: There are no guarantees regarding the ultimate commercial success of sugemalimab, and shareholders should exercise caution.

Disclaimer

This article is for informational purposes only and does not constitute investment advice. The company has cautioned that there is no assurance regarding the ultimate successful development or commercialization of sugemalimab. Shareholders and potential investors are advised to exercise due care and consult their professional advisors before making investment decisions related to CStone Pharmaceuticals.

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