By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that its self-developed Category 1 drug, Retlirafusp α Injection, has received marketing approval from China’s National Medical Products Administration (NMPA). The drug is indicated for first‑line treatment of locally advanced unresectable, recurrent, or metastatic gastric and gastroesophageal junction adenocarcinoma (GC/GEJC) that is PD‑L1 positive (CPS ≥ 1), representing the world’s first approved anti‑PD‑L1/TGF‑βRII bispecific antibody fusion protein.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | Retlirafusp α Injection |
| Company | Jiangsu Hengrui Pharmaceuticals (600276.SH/1276.HK) |
| Regulatory Status | NMPA marketing approval |
| Indication | First‑line PD‑L1+ (CPS ≥ 1) advanced GC/GEJC |
| Mechanism | Anti‑PD‑L1/TGF‑βRII bispecific antibody fusion protein |
| Trial Basis | RELIGHT (SHR-1701-Ⅲ-307) Phase 3 study |
| Significance | First‑in‑world bispecific PD‑L1/TGF‑βRII approval |
Clinical Evidence: RELIGHT Phase 3 Study
Study Design: Randomized, double‑blind, multicenter Phase 3 trial comparing Retlirafusp α + chemotherapy vs. placebo + chemotherapy in first‑line advanced GC/GEJC.
Efficacy Results:
| Population | Median OS | Death Risk Reduction | Key Finding |
|---|---|---|---|
| ITT | 15.8 months | 34% | Statistically significant survival benefit |
| PD‑L1 CPS ≥ 1 | 16.7 months | 43% | Enhanced benefit in biomarker‑selected group |
| Liver Metastases | 16.8 months | 54% | Strong activity in poor‑prognosis subgroup |
Safety Profile:
- Favorable safety vs. placebo + chemo
- Improved myelosuppression, suggesting potential myeloprotective effects
- Manageable immune‑related adverse events
Market Opportunity: Gastric Cancer in China
Disease Burden:
- Incidence: 480,000 new GC cases annually in China (50% of global total)
- PD‑L1+ (CPS ≥ 1): ~55% of patients → ~264,000 eligible
- Market Size: China GC drug market ¥25 billion (2025), growing at 8% CAGR
- Unmet Need: First‑line standard of care (chemo ± PD‑1) yields mOS ≈ 12 months; significant room for improvement
Retlirafusp α Peak Sales Projection: ¥3.5‑4.5 billion (US$490‑630 million) by 2030, assuming 12‑15% market share in first‑line PD‑L1+ GC.
Competitive Landscape
| Drug | Company | Mechanism | Stage (China) | ITT mOS (1L GC) |
|---|---|---|---|---|
| Retlirafusp α | Hengrui | PD‑L1/TGF‑βRII bispecific + chemo | Approved | 15.8 months |
| Nivolumab + chemo | BMS | PD‑1 + chemo | Marketed | 13.8 months |
| Pembrolizumab + chemo | MSD | PD‑1 + chemo | Marketed | 13.9 months |
| Tislelizumab + chemo | BeiGene | PD‑1 + chemo | Marketed | 13.9 months |
| Zanidatamab + chemo | Zymeworks | HER2 bispecific + chemo | Phase III | Not yet reported |
Differentiation: Retlirafusp α’s dual PD‑L1 blockade + TGF‑β inhibition offers superior survival benefit and myeloprotective advantage, positioning it as potential new standard of care in PD‑L1+ GC.
Commercial Strategy & Manufacturing
Launch Timeline: Q1 2026 commercial rollout via Hengrui’s 4,000‑person oncology sales force covering 1,500+ tertiary hospitals.
Pricing: Expected ¥18,000‑22,000 per treatment cycle (vs. PD‑1 inhibitors at ¥15,000‑20,000), justified by superior OS data and myeloprotective benefit.
Manufacturing: Changzhou biologics facility (capacity: 10,000 L) already GMP‑certified for bispecific antibody production.
Reimbursement: Targeting NRDL inclusion in 2026 via breakthrough therapy and rare disease pathways (gastric cancer qualifies for priority review).
Financial Impact & Valuation
Near‑Term Revenue: ¥800 million‑1.2 billion in 2026 (partial year launch), accelerating to ¥3 billion in 2027.
Peak Valuation: Retlirafusp α alone could contribute ¥15‑18 per share to Hengrui’s DCF, representing 15‑18% upside from current trading price.
Pipeline Synergy: Success validates Hengrui’s bispecific platform, supporting 6‑8 additional candidates in PD‑L1 combos for lung, liver, and pancreatic cancers.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Retlirafusp α’s commercial launch, market penetration, revenue forecasts, and competitive positioning. Actual results may differ materially due to clinical adoption rates, pricing negotiations, competitive responses, and NRDL inclusion decisions.-Fineline Info & Tech