By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS‑4642, a home‑developed KRAS G12D inhibitor formulated as a liposome, has received NMPA approval to launch a Phase 1b/2 clinical trial in patients with KRAS G12D‑mutated solid tumors.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | HRS‑4642 injection |
| Company | Jiangsu Hengrui Pharmaceuticals |
| Agency | NMPA (China) |
| Approval Type | Phase 1b/2 trial nod |
| Target | KRAS G12D mutation |
| Indication | Solid tumors (KRAS G12D‑mutated) |
| Next Step | Dosing of first patient expected Q1 2026 |
Drug Profile
- Class: KRAS G12D inhibitor, liposome formulation
- Mechanism: Specifically binds to KRAS G12D, inhibiting downstream MEK and ERK phosphorylation to exert anti‑tumor effects
- Innovation: Home‑developed by Hengrui; liposomal delivery aims to improve tumor targeting and tolerability
- Pipeline Status: First KRAS G12D asset from a Chinese biopharma to reach late‑stage development |
Clinical Trial Design
| Parameter | Detail |
|---|---|
| Study Phase | Phase 1b/2 (dose‑expansion and signal‑finding) |
| Primary Objectives | Safety, tolerability, efficacy (ORR, DCR, PFS) |
| Patient Population | KRAS G12D‑mutated solid tumor patients |
| Combination Arms | SHR‑1701 (PD‑L1/TGF‑βRII), SHR‑7367 (FAP/CD40), SHR‑8068 (CTLA‑4), adebrelimab (PD‑L1), bevacizumab (VEGF) |
| Endpoints | ORR, DCR, PFS, OS, safety profile |
Market Impact & Outlook
- KRAS G12D Landscape: KRAS G12D mutations occur in ~10‑12% of pancreatic, ~3‑4% of colorectal, and ~1‑2% of lung cancers in China, representing an addressable market of >80,000 patients annually.
- Competitive Position: First KRAS G12D inhibitor from a Chinese company to enter Phase 1b/2; global competitors include Mirati’s MRTX1133 (preclinical) and Revolution’s RMC‑9805 (Phase 1).
- Revenue Potential: Analysts project China peak sales potential of ¥1.5‑2.0 billion (~US$200‑270 million) if approved, assuming 30% market share of KRAS G12D‑positive patients by 2035.
- Strategic Value: Multi‑drug combo strategy leverages Hengrui’s extensive immuno‑oncology pipeline, potentially creating synergistic regimens that could differentiate HRS‑4642 from monotherapy approaches.
- Next Catalysts: Initial safety and efficacy data expected at a major oncology conference in late 2026; dosing of first patient triggers a US$5 million milestone payment from Hengrui’s R&D partnership fund.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding HRS‑4642’s clinical development, regulatory pathway, and commercial potential. Actual results may differ materially due to risks including clinical trial outcomes, safety profiles, and competitive dynamics in the KRAS inhibitor market.-Fineline Info & Tech