By Fineline Cube 
China‑based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced today that the National Medical Products Administration (NMPA) has granted approval for a Phase III clinical trial of its antibody‑drug conjugate (ADC) Trastuzumab rezetecan. The study will compare Trastuzumab rezetecan monotherapy with the standard neoadjuvant regimen of docetaxel + carboplatin + trastuzumab + pertuzumab in patients with previously untreated, early or locally advanced HER2‑positive breast cancer.
Product Overview
- Mechanism of Action – Trastuzumab rezetecan targets HER2‑expressing tumor cells, internalizes via receptor‑mediated endocytosis, and releases a potent toxin from a protease‑cleavable linker inside lysosomes. The released agent induces cell‑cycle arrest and apoptosis, offering a highly specific therapeutic profile.
- Development – Independently developed by Hengrui, the ADC has already achieved regulatory clearance in China (May 2025) for the treatment of adult patients with HER2‑activating mutant non‑small cell lung cancer (NSCLC) who have progressed after at least one systemic therapy.
Trial Design
- Population – Adults with early or locally advanced HER2‑positive breast cancer who have not received prior systemic therapy.
- Arms
- Trastuzumab rezetecan monotherapy
- Standard neoadjuvant therapy: docetaxel + carboplatin + trastuzumab + pertuzumab
- Endpoints – Pathological complete response (pCR) rate, event‑free survival, overall survival, and safety profile.
- Timeline – Enrollment to begin Q4‑2025 with first results expected in 2027.
Strategic Implications
- Portfolio Expansion – Positions Hengrui as a key player in HER2‑targeted oncology, complementing its existing NSCLC indication.
- Regulatory Momentum – NMPA approval underscores China’s commitment to advancing innovative ADCs and may accelerate global regulatory interest.
- Commercial Opportunity – Successful trial outcomes could unlock significant market potential across China and beyond, targeting the growing demand for next‑generation HER2 therapies.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech