By Fineline Cube Shouyao Holdings (Beijing) Co., Ltd. (SHA: 688197) announced that the National Medical Products Administration (NMPA) has approved a clinical study for SY-9453 in patients with locally advanced or metastatic solid tumors harboring homozygous deletion of methylthioadenosine phosphorylase (MTAP). The small‑molecule MAT2A inhibitor leverages synthetic lethality to target ~15% of human cancers with MTAP deficiency.
Regulatory Milestone & Drug Profile
| Item | Detail |
|---|---|
| Company | Shouyao Holdings (Beijing) Co., Ltd. (688197.SH) |
| Drug | SY-9453 |
| Mechanism | Highly potent and selective MAT2A inhibitor |
| Indication | Locally advanced or metastatic solid tumors with MTAP homozygous deletion |
| Approval | NMPA clinical study authorization |
| Clinical Need | MTAP deletion occurs in ~15% of cancers; creates dependency on MAT2A for tumor growth |
| Innovation | Synthetic lethality approach; first MAT2A inhibitor for MTAP-deficient tumors in China |
Mechanism of Action & Preclinical Data
- Synthetic Lethality: MTAP deletion leads to accumulation of 5’‑methylthioadenosine (MTA) and restricts methionine salvage synthesis, making tumor cells dependent on methionine adenosyltransferase 2A (MAT2A)
- Selective Killing: SY-9453 inhibits MAT2A, selectively killing MTAP‑deficient tumor cells while sparing normal cells
- Preclinical Efficacy: Demonstrated strong growth inhibitory effects across various MTAP‑deleted tumor models with a manageable safety profile
- Market Opportunity: Addresses lung cancer, breast cancer, and other solid tumors with MTAP deficiency; represents a precision therapeutic approach
Market Impact & Commercial Outlook
- China Oncology Market: MTAP‑deleted tumors represent ~15% : of the ¥200 billion (~US$28 billion) solid tumor market
- Precision Oncology Trend: Synthetic lethality approaches are gaining traction; SY-9453 positions Shouyao at the forefront of targeted therapy for MTAP‑deficient cancers
- Revenue Potential: Analysts project ¥2–3 billion (US$280–420 million) peak annual sales if approved, based on specialty oncology pricing and companion diagnostic development
- Competitive Landscape: Competes with Tango Therapeutics and IDEAYA Biosciences MAT2A programs; SY-9453’s China‑first status offers regulatory and market advantage
- Next Steps: Phase I/II trial initiation expected Q2 2026; companion diagnostic development to be pursued in parallel
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and revenue projections for SY-9453. Actual results may differ due to clinical trial outcomes, competitive dynamics, and NMPA review processes.-Fineline Info & Tech