HENGRUI PHARMA(01276.HK): SHR‑A2009 for Injection Combined with Adebrelimab Obtains NMPA Clinical Trial Approval for Non‑Small‑Cell Lung Cancer
NewTimeSpace News: Jiangsu Hengrui Pharmaceuticals Co., Ltd. (01276.HK) released an overseas regulatory announcement on 4 August 2026. Its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Pharmaceutical Co., Ltd., have obtained theDrug Clinical Trial Approval Noticefrom NMPA for SHR‑A2009 for Injection and adebrelimab injection. Approval is granted for Phase II clinical studies of SHR‑A2009 for Injection combined with adebrelimab, or combined with third‑generation EGFR TKI, in patients with non‑small‑cell lung cancer.
SHR‑A2009 for Injection is a HER3‑targeted antibody‑drug conjugate (ADC). It specifically binds to HER3 on the surface of tumour cells and is internalised to release free toxin for tumour‑cell killing. The Marketing Authorisation Application for monotherapy of SHR‑A2009 in non‑small‑cell lung cancer has been accepted. No HER3‑targeted ADC has been approved worldwide for NSCLC treatment as of the announcement date. Cumulative R&D expenditure for this project stands at approximately RMB329.50 million.
Adebrelimab injection is the Group’s in‑house‑developed humanised anti‑PD‑L1 monoclonal antibody with two approved indications. In 2025, combined global sales of comparable products including Atezolizumab, Avelumab and Durvalumab reached approximately USD11.054 billion. Cumulative R&D investment for this project totals roughly RMB1,251.90 million.
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