By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for trastuzumab rezetecan injection (SHR‑A1811) and granted it Priority Review status. The new indication targets adult patients with locally advanced or metastatic HER2‑positive breast cancer who have already received one or more anti‑HER2 therapies.
What Is Trastuzumab Rezetecan?
- Self‑developed anti‑HER2 antibody‑drug conjugate (ADC) that binds HER2‑expressing tumor cells and is internalized.
- Inside the lysosome, a protease cleaves the conjugate, liberating a potent payload that induces cell‑cycle arrest and drives apoptosis.
- The payload’s high membrane permeability results in a “bystander‑killing” effect, attacking neighboring tumor cells and amplifying anti‑tumor activity.
Regulatory Milestones
| Milestone | Date | Status |
|---|---|---|
| NDA acceptance for HER2‑positive breast cancer | 17 Sep 2025 | Priority Review |
| First domestic ADC approval for HER2‑mutated NSCLC | 1 May 2025 | Breakthrough Therapy |
| Total indications with Breakthrough Designation | – | 9 |
Trastuzumab rezetecan was first approved in May 2025 for unresectable locally advanced or metastatic NSCLC with HER2 (ERBB2) activating mutations after at least one prior systemic therapy. The current approval broadens its reach to a heavily pre‑treated breast cancer population, marking a significant expansion of its therapeutic portfolio.
Market Significance
- HER2‑positive breast cancer remains a high‑need area; patients progressing after first‑line anti‑HER2 therapy lack robust options.
- The bystander‑killing mechanism may overcome tumor heterogeneity, addressing residual disease that conventional ADCs may miss.
- With Priority Review and Breakthrough Therapy designations, Hengrui is positioned for accelerated market entry, potentially capturing a sizable share of the global HER2‑targeted oncology market.
Next Steps
Hengrui plans to submit detailed clinical data for the breast cancer indication in the coming months, with a target for NMPA approval by Q3 2026. Concurrently, the company is exploring international regulatory pathways to extend availability to the U.S. and EU markets.-Fineline Info & Tech