SHANGHAI, May 29, 2025 /PRNewswire/ — The National Medical Products Administration has recently granted approval for Trastuzumab rezetecan, China’s first domestically developed antibody-drug conjugate (ADC), for treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2 (ERBB2) mutations who have previously received at least one systemic therapy.
The approval of Trastuzumab rezetecan was based on the pivotal HORIZON-Lung study led by Professor Lu Shun at Shanghai Chest Hospital, which demonstrated groundbreaking efficacy in HER2-mutant locally advanced or metastatic NSCLC patients who have received prior systemic therapy. The trial achieved a median follow-up of 14.2 months, an IRC-confirmed objective response rate (ORR) of 74.5%, and a median progression-free survival (mPFS) of 11.5 months—thereby doubling the efficacy of conventional treatments. In addition, Trastuzumab rezetecan significantly reduced the toxicity risks typically associated with conventional ADCs. These results have redefined global benchmarks for ADC research and garnered significant attention from the international scientific community.
Trastuzumab rezetecan has achieved breakthroughs in both efficacy and safety through pioneering molecular design from the ground up, a milestone made possible by Hengrui Pharmaceuticals’ decade-long development of its ADC R&D platform, the Hengrui Rapid Modular ADC Platform (HRMAP). HRMAP enables end-to-end capabilities spanning molecular design, preclinical optimization, and clinical translation. To date, Hengrui has advanced over 10 differentiated ADC candidates into clinical development, including Trastuzumab rezetecan, its flagship HER2-targeted ADC therapy.
Shun Lu, MD, PhD, Director of oncology department (Shanghai Lung Tumor Clinical Medical Center)，China, and principal investigator of Horizon-Lung, said, “the HORIZON-Lung study validates Trastuzumab rezetecan as a transformative therapy for HER2-mutant NSCLC, addressing a critical unmet need for advanced HER2-driven NSCLC patients in China. Grounded in epidemiological data that accurately reflect China’s NSCLC epidemiological landscape, this therapeutic advance not only provides a novel treatment option for patients, but also heralds China’s emergence as a pioneering force in shaping the global ADC landscape for precision oncology.
Beyond its established efficacy in lung cancer, Trastuzumab rezetecan has demonstrated significant clinical advances across multiple tumor types, with eight additional indications—including breast cancer, colorectal cancer, gastric cancer, biliary tract cancer, cervical cancer, ovarian cancer, fallopian tube cancer, and primary peritoneal cancer—receiving Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA).