China-based TYK Medicines, Inc. (HKG: 2410) announced on August 26, 2025, that it has entered into a potential exclusive distribution agreement with Sichuan Huiyu Pharmaceutical Co., Ltd. (SHA: 688553) for its next‑generation tyrosine‑kinase inhibitor, asandeutertinib mesylate tablets (TY‑9591).
Deal Structure
- Exclusive distributor: Sichuan Huichenxin Pharmaceutical Co., Ltd., a wholly‑owned subsidiary of Sichuan Huiyu, will hold exclusive rights to sell TY‑9591 in mainland China (excluding Hong Kong, Macau, Taiwan, and overseas markets).
- Milestone payment: Up to RMB 150 million may be paid upon achievement of predefined commercial milestones.
- Scope: The agreement covers all phases of the product life‑cycle, including marketing, sales, and post‑marketing surveillance.
TY‑9591: A Brain‑Penetrant TKI
| Feature | Detail |
|---|---|
| Indication | EGFR‑mutated non‑small cell lung cancer (NSCLC) with brain metastases |
| Mechanism | Irreversibly binds EGFR mutations (exon 19 del, exon 21 L858R, exon 19 del/T790M, L858R/T790M) and crosses the blood‑brain barrier |
| Safety profile | Modified from osimertinib to allow higher dosing and reduce off‑target toxicity |
| Clinical milestone | Pre‑NDA submitted in China (April 2025) |
Strategic Implications
- Market access: The partnership gives TYK a dedicated, experienced distributor with established commercial channels in mainland China, accelerating time‑to‑market.
- Competitive edge: TY‑9591’s enhanced safety and brain‑penetration position it as a compelling alternative to existing EGFR‑TKIs, potentially capturing a sizable share of the growing NSCLC‑brain metastasis market.
- Revenue upside: The milestone payment structure aligns incentives and could generate significant upside as the drug gains regulatory approval and market traction.
Outlook
Analysts note that the potential nature of the agreement means regulatory, commercial, and pricing approvals remain pending. However, the strategic alignment between TYK’s innovative pipeline and Sichuan Huiyu’s distribution network could catalyze a strong launch in China’s largest oncology market.-Fineline Info & Tech
