Hengrui, SHR‑4298, RAS: China Approves Two Novel Anti‑Tumor Drugs for Clinical Trials

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA) has granted approval to commence clinical trials for two of its next‑generation anti‑tumor candidates: SHR‑4298 Injection for advanced solid tumours and HRS‑2329 Tablets for patients whose tumours harbour RAS mutations or amplifications.

SHR‑4298 Injection – A Category 1 Therapeutic Biological

• Mechanism – A novel antibody‑drug conjugate (ADC) engineered to target solid‑tumour antigens with high specificity.
• Pre‑clinical data – Demonstrated robust tumour‑growth inhibition in multiple xenograft models, with a favourable safety profile.
• Clinical intent – Designed for patients with advanced or metastatic solid tumours, irrespective of histology.

HRS‑2329 Tablets – Targeting RAS‑Driven Tumours

• Mechanism – A small‑molecule inhibitor that disrupts downstream signalling in RAS‑mutated or RAS‑amplified tumours.
• Pre‑clinical data – Showed potent anti‑tumour activity in cell‑line and patient‑derived xenograft models with RAS alterations.
• Clinical intent – Aimed at patients with advanced solid tumours whose tumours carry RAS mutations or amplifications, a currently underserved cohort.

Regulatory Context

• NMPA clearance removes a major regulatory hurdle, allowing Hengrui to initiate phase I/II investigations in China and to explore international expansion.
• The approvals align with China’s “Made in China 2025” initiative to accelerate the development of innovative biologics and targeted therapies.

Market Implications

• Hengrui’s pipeline now includes the first dual‑mechanism ADC and a targeted RAS inhibitor approved for clinical testing in China, positioning the company as a leader in precision oncology.
• Positive trial outcomes could unlock global regulatory submissions (e.g., EMA, FDA) and attract strategic partnerships or licensing agreements.
• The absence of comparable treatments in the market underscores the potential for a strong commercial foothold once efficacy is proven.-Fineline Info & Tech