By Fineline Cube Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that SHR‑7877 has received National Medical Products Administration (NMPA) approval to enter clinical trials in combination with HS‑20093 (with or without adebelisib) for the treatment of extensive‑stage small cell lung cancer (SCLC).
Regulatory Milestone & Trial Design
| Item | Detail |
|---|---|
| Company | Jiangsu Hengrui Pharmaceuticals |
| Drug | SHR‑7877 (Category 1 therapeutic biological product) |
| Combination Partner | HS‑20093 (± adebelisib) |
| Indication | Extensive‑stage small cell lung cancer |
| Approval | NMPA clinical trial authorization |
| Mechanism | SHR‑7877 induces/activates T cells; HS‑20093 is a B7‑H3‑targeting ADC |
| Status | Ready to initiate clinical studies |
Drug Profile & Innovation
- SHR‑7877: Novel T‑cell engager that induces and activates patient T cells to recognize and eliminate tumor cells
- HS‑20093: Hengrui’s internally developed antibody‑drug conjugate (ADC) targeting B7‑H3, already cleared for trials in lung cancer, sarcoma, head and neck cancer, and other solid tumors
- Synergistic Strategy: Dual immunotherapy (T‑cell activation) + targeted cytotoxic payload aims to overcome SCLC’s immunosuppressive microenvironment
- Competitive Edge: First‑in‑China combination of a T‑cell engager and B7‑H3 ADC for extensive‑stage SCLC, a setting with extremely high unmet need
Market Impact & Commercial Outlook
- China SCLC Burden: Approximately 150,000–180,000 new SCLC cases annually; extensive‑stage disease accounts for 70% of diagnoses with 5‑year survival <5%
- Standard of Care: Limited to platinum‑based chemotherapy ± immunotherapy; no approved targeted therapies exist for extensive‑stage SCLC
- Market Potential: Analysts project ¥2–3 billion (US$280–420 million) peak sales potential if SHR‑7877/HS‑20093 combo demonstrates survival benefit in Phase III
- Strategic Significance: Advances Hengrui’s leadership in ADC and immuno‑oncology; validates internal synergy between biologics and ADC platforms
- Next Steps: Phase I/II trial initiation expected Q2 2026; data may support breakthrough therapy designation and expedited NMPA review
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, market potential, and regulatory pathways for SHR‑7877 and HS‑20093. Actual results may differ due to clinical trial outcomes, competitive developments, and NMPA review processes.-Fineline Info & Tech