HENGRUI PHARMA (01276.HK): HER3 ADC Ruzaltatug Rezetecan granted breakthrough therapy designation

NewTimeSpace News: On 11 September 2026, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (stock code: 01276; A-share stock code: 600276) announced that Ruzaltatug Rezetecan for Injection (SHR-A2009 for Injection) of its subsidiary Suzhou Suncadia Biopharmaceuticals Co., Ltd. has recently been included in the breakthrough therapy designation list by the Center for Drug Evaluation of the National Medical Products Administration.

On the basic information of the drug, the drug is named Ruzaltatug Rezetecan for Injection, with acceptance number CXSL2300598; it is a therapeutic biological product under Class 1 registration, with an application date of 15 July 2026. The proposed indication is for use in combination with bevacizumab for the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have failed prior treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). Upon review, the application complies with the requirements of the Provisions for Drug Registration and the announcement of the National Medical Products Administration on the release of three documents including the Working Procedures for the Review of Breakthrough Therapeutic Drugs (Trial) (2020 No. 82), and the drug has been accepted into the breakthrough therapeutic drug procedure.

The announcement stated that lung cancer is the second most common cancer worldwide and the leading cause of cancer-related deaths, with approximately 1.176 million new cases and approximately 743,300 deaths in China in 2024, ranking first among all cancers in both incidence and mortality. Ruzaltatug Rezetecan for Injection is an antibody-drug conjugate targeting HER3 that specifically binds to HER3 on the surface of tumour cells, is internalised into the cells and transported to lysosomes, where it hydrolyses to release free toxins that kill tumour cells. HER3 expression is found in various solid tumours, with HER3 expression in NSCLC accounting for approximately 82.7%, and HER3 expression is up-regulated after EGFR TKI treatment. The marketing application for the drug as a monotherapy in clinical trials for NSCLC has been accepted, and no HER3-targeting ADC for the treatment of NSCLC has been approved globally. As at the date of the announcement, the cumulative research and development investment in the project relating to Ruzaltatug Rezetecan for Injection was approximately RMB 354.70 million (unaudited).

The Company also noted that the Center for Drug Evaluation gives priority allocation of resources for communication and exchanges to drugs included in the breakthrough therapeutic drug procedure and strengthens guidance to facilitate drug development; drug development is susceptible to various factors including technology, approval and policy, and there are many uncertain risks in the review policies and future market competition. The Company will actively advance the research and development project in accordance with the relevant state regulations and will timely perform its information disclosure obligations on subsequent progress.

View announcement.

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.