By Fineline Cube 
Sichuan Huiyu Pharmaceutical Co., Ltd. (SHA: 688553) announced that the National Medical Products Administration (NMPA) has approved a clinical trial for HYP-6589, a Category 1 chemical drug, to be evaluated in combination with osimertinib for advanced non‑small cell lung cancer (NSCLC) with targetable driver genes.
Regulatory Milestone & Drug Profile
| Item | Detail |
|---|---|
| Company | Sichuan Huiyu Pharmaceutical Co., Ltd. (688553.SH) |
| Drug | HYP-6589 (small‑molecule SOS1 inhibitor) |
| Combination | Osimertinib (third‑generation EGFR inhibitor) |
| Indication | Advanced NSCLC with targetable driver genes |
| Approval | NMPA clinical trial authorization |
| Mechanism | Binds SOS1 catalytic region, inhibits KRAS‑GTP activation, blocks RAS‑RAF‑MAPK and RAS‑PI3K‑AKT‑mTOR pathways |
| Strategic Rationale | Addresses osimertinib resistance via SOS1 inhibition |
Mechanism of Action & Competitive Advantage
- SOS1 Inhibition: HYP-6589 specifically targets the SOS1 catalytic region, preventing KRAS‑GTP activation and blocking downstream oncogenic signaling
- Resistance Overcoming: SOS1 is implicated in multiple resistance pathways to third‑generation EGFR inhibitors like osimertinib; HYP-6589 may delay or overcome this resistance
- Combination Synergy: By inhibiting SOS1, the drug enhances osimertinib efficacy and provides a novel strategy for EGFR‑mutated NSCLC patients who progress on standard therapy
- Global Landscape: No approved SOS1 inhibitors for NSCLC; positions Huiyu as a first‑mover in this resistance‑targeting mechanism
Market Impact & Commercial Outlook
- China NSCLC Market: Valued at ¥45 billion : (~US$6.3 billion) in 2025, with EGFR‑mutated patients representing 40% of cases
- Osimertinib Resistance: ~30% : of osimertinib‑treated patients develop resistance within 2 years, creating a ¥10 billion addressable market for combination therapies
- Revenue Potential: Analysts project ¥2–3 billion (US$280–420 million) peak sales if HYP-6589 demonstrates efficacy in overcoming resistance
- Strategic Value: Category 1 status enables priority review; success could attract global partnership interest from osimertinib manufacturers (AstraZeneca)
- Next Steps: Phase I trial initiation expected Q2 2026; biomarker‑selected patient enrollment to begin in major oncology centers
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and revenue projections for HYP-6589. Actual results may differ due to clinical trial outcomes, competitive dynamics, and NMPA review processes.-Fineline Info & Tech