By Fineline Cube 
Ruijin Hospital Hainan Boao Research Hospital (Ruijin Hainan Hospital) successfully introduced Tarlatamab for Injection, making it the first medical institution in China to provide access to this global innovative DLL3‑targeted T‑cell engager (TCE) therapy for small cell lung cancer (SCLC). The introduction leverages the “pioneering trial” policies of the Lecheng Pilot Zone in Hainan.
Key Points
| Item | Detail |
|---|---|
| Drug | Tarlatamab for Injection |
| Developer | Amgen (originally); BeiGene collaboration for China |
| Mechanism | DLL3 x CD3 T‑cell engager (TCE) |
| Indication | Small cell lung cancer (SCLC) |
| Access Point | Ruijin Hainan Hospital (Hainan Boao Research Hospital) |
| Policy Leveraged | Lecheng Pilot Zone “pioneering trial” policy |
| Significance | First China accessibility for Tarlatamab |
| Global Approval | Approved in US, Japan, UK |
Drug Profile: Tarlatamab
- Innovative Design: Bispecific antibody simultaneously binding DLL3 on tumor cells and CD3 on T‑cells, activating polyclonal T‑cell response
- Clinical Value: Addresses high unmet need in relapsed/refractory SCLC where standard therapies show limited efficacy
- Administration: Intravenous infusion in hospital setting with monitoring
- Safety: Cytokine release syndrome (CRS) and neurotoxicity managed via established TCE protocols
China SCLC Market Context
| Parameter | China Data |
|---|---|
| Annual SCLC incidence | ~150,000‑180,000 new cases (2025) |
| % of all lung cancers | 13‑15% |
| 5‑year survival rate | <7% for extensive‑stage disease |
| Current 2L+ options | Topotecan, lurbinectedin (limited access) |
| Target population for Tarlatamab | ~40,000‑50,000 relapsed/refractory patients |
| Market potential | ¥3‑4 billion (US$420‑560 million) by 2028 |
Policy Advantage: Lecheng Pilot Zone
The Lecheng International Medical Tourism Pilot Zone allows expedited import of innovative drugs approved overseas but not yet available in mainland China. Key benefits include:
- Review Timeline: 3‑6 months vs. 12‑18 months standard NMPA approval
- Patient Access: Enables treatment of urgent medical needs while China NDA review is pending
- Real‑World Evidence: Data generated can support future NMPA registration
- Reimbursement: Private insurance coverage available; supports commercial preview
Global Status & China Pathway
- US Approval: May 2025 (accelerated approval for SCLC)
- Japan Approval: October 2025
- UK Approval: December 2025
- China NDA: BeiGene (partner) submitted NDA in Q3 2025; Priority Review granted
- Commercial Launch: Expected mid‑2026 in mainland China; Hainan access provides 6‑month head start
Partnership Structure
BeiGene Collaboration:
- Global Oncology Partnership with Amgen includes co‑development and commercialization of Tarlatamab in China
- BeiGene leads regulatory filing and commercialization; Ruijin Hainan Hospital serves as early access center
- Revenue Share: BeiGene retains majority of China profits; Amgen receives milestones and royalties
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Tarlatamab’s commercial trajectory, market penetration, and regulatory timeline in China. Actual results may differ due to competitive responses, reimbursement negotiations, and safety profile evolution.-Fineline Info & Tech