Jiangsu Hansoh Pharmaceutical Co. Ltd. (HKG: 3692) entered into an exclusive license, collaboration, and distribution agreement with Glenmark Specialty S.A. for aumolertinib, a third‑generation EGFR‑TKI for non‑small cell lung cancer (NSCLC). Glenmark gains rights across Middle East, Africa, Southeast/South Asia, Australia, New Zealand, Russia/CIS, and Caribbean territories. Hansoh receives an upfront payment plus milestones potentially exceeding $1 billion and tiered royalties.
Transaction Overview
| Component | Details |
|---|---|
| Product | Aumolertinib (third‑generation EGFR‑TKI) |
| Licensor | Jiangsu Hansoh Pharmaceutical (3692.HK) |
| Licensee | Glenmark Specialty S.A. |
| Territories | Middle East, Africa, Southeast/South Asia, Australia, New Zealand, Russia/CIS, Caribbean |
| Financial Terms | Upfront payment + milestones >$1B + tiered royalties |
| Innovation | China’s first domestically developed third‑generation EGFR‑TKI |
Aumolertinib Regulatory Approvals
| Approval Date | Indication | Region |
|---|---|---|
| Mar 2020 | T790M‑positive locally advanced/metastatic NSCLC (post‑EGFR‑TKI) | China |
| Dec 2021 | First‑line EGFR exon 19 deletion/L858R NSCLC | China |
| Mar 2025 | Unresectable locally advanced NSCLC post chemoradiotherapy | China |
| May 2025 | Adjuvant Stage II‑IIIB NSCLC post‑resection | China |
| Jun 2025 | Aumseqa brand approved | UK (MHRA) |
Market Opportunity & Strategic Context
- Territory Size: Licensed regions cover 3+ billion people with growing NSCLC incidence
- EGFR‑TKI Market: Global market $8‑10 billion; third‑generation agents dominate first‑line in US/EU
- Aumolertinib Differentiation: First China‑developed third‑generation EGFR‑TKI; proven efficacy across four indications including adjuvant setting
- Glenmark Strategy: Strengthens oncology portfolio in emerging markets; leverages existing commercial infrastructure in licensed territories
- Peak Sales Potential: $500‑800 million annual sales in licensed territories by 2032 if approved across multiple regions
Strategic Implications
- For Hansoh: $1B+ milestone structure monetizes global rights while retaining China market; validates innovation platform; provides non‑dilutive capital for next‑generation pipeline.
- For Glenmark: Acquires proven EGFR‑TKI with best‑in‑class potential for underserved markets; accelerates entry into high‑value oncology segment; reduces R&D risk with approved product.
- For Market: Demonstrates China’s capability to develop globally competitive oncology assets; third‑generation EGFR inhibition remains cornerstone of NSCLC treatment; regional licensing model optimizes global value capture.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding milestone achievements, regulatory approvals in licensed territories, and market penetration. Actual results may differ due to regulatory feedback, competitive responses, or pricing negotiations.-Fineline Info & Tech
