By Fineline Cube 
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that China’s National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for savolitinib and granted Priority Review for the treatment of adult patients with MET‑amplified locally advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after at least two prior lines of therapy. Savolitinib, marketed in China as ORPATHYS, is the first selective MET inhibitor approved in the country.
Regulatory & Product Summary
| Item | Detail |
|---|---|
| Drug | Savolitinib (ORPATHYS®) |
| Company | HutchMed (China) Ltd (1093.HK / HCM) |
| Partner | AstraZeneca (global co‑development, China commercialization) |
| Regulatory Status | NDA accepted + Priority Review (NMPA) |
| Indication | MET‑amplified advanced gastric cancer/GEJ adenocarcinoma (post‑≥2L therapy) |
| Mechanism | Selective oral MET tyrosine kinase inhibitor (TKI) |
| Existing Approval | First selective MET inhibitor approved in China (March 2021) |
| Reimbursement | Included in National Reimbursement Drug List (NRDL) since March 2023 |
Mechanism of Action & Scientific Rationale
MET Pathway: MET is a receptor tyrosine kinase critical for normal cell development. In gastric cancer, MET amplification drives tumor growth via aberrant pathway activation.
Savolitinib’s Role: Blocks MET signaling caused by mutations (exon 14 skipping), gene amplification, or protein overexpression. In preclinical and Phase 2 studies, savolitinib demonstrated robust antitumor activity in MET‑amplified gastric cancer, a population with limited targeted therapy options.
Clinical Data: Phase 2 trial (NCT049›) showed objective response rate (ORR) of 45% and median PFS of 6.8 months in heavily pretreated MET‑amplified gastric cancer patients.
Market Opportunity: Gastric Cancer in China
Disease Burden:
- Incidence: 480,000 new gastric cancer cases annually in China (50% of global total)
- MET Amplification: 5‑8% of gastric cancers harbor MET amplification → ~35,000 eligible patients/year
- Treatment Gap: No approved MET‑targeted therapy for gastric cancer; standard care is chemotherapy + immunotherapy with limited efficacy
Market Size:
- China Gastric Cancer Market: ¥28 billion (2025), growing at 8% CAGR
- Targeted Therapy Segment: ¥3.5 billion opportunity for MET inhibitors
- Savolitinib Revenue Projection: ¥800 million‑1.2 billion peak sales by 2029 (if approved for this indication)
Competitive Landscape
| Drug | Company | Target | Stage (China) | Indication |
|---|---|---|---|---|
| Savolitinib | HutchMed/AstraZeneca | MET TKI | NDA under Priority Review | MET‑amplified gastric cancer (post‑≥2L) |
| Tepotinib | Merck KGaA | MET TKI | Phase III (ongoing) | MET‑amplified gastric cancer |
| Capmatinib | Novartis | MET TKI | Phase II | MET‑exon14‑skipping NSCLC only |
| C‑Met ADC | Various | MET ADC | Pre‑clinical | Broad MET‑positive tumors |
First‑Mover Advantage: Savolitinib is 9‑12 months ahead of tepotinib in China, with Breakthrough Therapy Designation status providing accelerated review.
Priority Review & Regulatory Pathway
NMPA Priority Review Benefits:
- Review Timeline: 130 days vs. 200 days standard
- Rolling Submission: Allows staggered data packages
- Reimbursement Fast‑Track: Eligible for 2026 NRDL negotiation if approved by Q3 2026
PDUFA‑Style Timeline:
- NDA Acceptance: Dec 2025
- Priority Review Completion: Expected May 2026
- Potential Approval: Q2‑Q3 2026
- Commercial Launch: H2 2026 (leveraging AstraZeneca’s 1,200‑person oncology sales force)
Commercial Strategy & AstraZeneca Partnership
AstraZeneca’s Role:
- Lead Commercialization: AZ responsible for all China marketing, distribution, and hospital access
- Revenue Split: HutchMed receives tiered royalties (mid‑teens to low‑twenties) on net sales + milestone payments for gastric cancer indication
- Synergy: AZ’s oncology franchise (Tagrisso, Imfinzi) creates bundling opportunities in top hospitals
Pricing Strategy: Expected ¥15,000‑18,000 per month (aligned with other targeted oncology agents); NRDL inclusion could drop price to ¥5,000‑7,000 but volume could triple.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding savolitinib’s regulatory review timeline, market penetration, revenue forecasts, and competitive positioning in MET‑amplified gastric cancer. Actual results may differ materially due to NMPA review outcomes, clinical data presentation, competitive responses, and NRDL negotiation dynamics.-Fineline Info & Tech