By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced an exclusive licensing agreement with Glenmark Specialty S.A. (GSSA), a wholly‑owned subsidiary of Glenmark Pharmaceuticals, to develop and commercialize trastuzumab rezetan (SHR‑A1811) outside China.
Product Snapshot
- Trastuzumab rezetan is a next‑generation antibody‑drug conjugate (ADC) that couples the HER2‑specific monoclonal antibody trastuzumab to a potent anti‑cancer payload via a cleavable linker.
- The ADC was granted approval in China in May 2025 for adult patients with unresectable, locally advanced or metastatic non‑small‑cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations who have received at least one prior systemic therapy.
Licensing Deal Highlights
| Element | Detail |
|---|---|
| Territory | Glenmark receives exclusive rights to develop and commercialize the drug outside China, the U.S., Canada, Europe, Japan, Russia, and 13 Central Asian republics. |
| Financials | Hengrui Pharma will receive an upfront payment of USD 18 million, with milestone payments up to USD 1.093 billion tied to regulatory approvals and sales, plus sales‑royalties. |
| Strategic Fit | The partnership leverages Glenmark’s global commercial network and Hengrui’s proven pipeline in oncology, positioning the ADC for rapid entry into key international markets. |
Market & Competitive Landscape
- The global HER2‑positive NSCLC market is projected to reach $4 billion by 2030, driven by expanding indications for HER2‑targeted therapies.
- Trastuzumab rezetan’s oral‑ready ADC platform differentiates it from existing antibody‑based therapies such as pertuzumab and lapatinib by delivering cytotoxic payloads directly to tumor cells while sparing healthy tissue.
- Glenmark’s prior success with ADCs in hematology and solid tumors (e.g., belantamab mafodotin) positions it well to accelerate the commercial rollout of SHR‑A1811.
Forward‑Looking Statements
- Hengrui Pharma anticipates that the partnership will shorten time‑to‑market for trastuzumab rezetan in regions where regulatory pathways are more streamlined.
- Glenmark plans to initiate phase‑III global trials in late 2026, aiming for regulatory submissions in the U.S. and EU by 2028.-Fineline Info & Tech