The National Medical Products Administration has recently granted approval forTrastuzumabrezetecan, 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 ofTrastuzumab rezetecan was based on the pivotalHORIZON-Lung study led by Professor Lu ShunatShanghai Chest Hospital, which demonstrated groundbreaking efficacy inHER2-mutant locally advanced or metastatic NSCLC patients who have received prior systemic therapy. The trial achieved amedian follow-up of 14.2 months, anIRC-confirmed objective response rate (ORR) of 74.5%, and amedian progression-free survival (mPFS) of 11.5 months-thereby doubling the efficacy of conventional treatments. In addition, Trastuzumab rezetecansignificantly reduced the toxicity risks typically associated withconventional ADCs. These results haveredefined global benchmarks for ADC researchand garnered significant attention from the international scientific community.
Trastuzumab rezetecanhas achieved breakthroughs inboth efficacy and safety through pioneering molecular design from the ground up, a milestone made possible byHengrui Pharmaceuticals' decade-long development of its ADC R&D platform, the Hengrui Rapid Modular ADC Platform (HRMAP). HRMAPenables end-to-end capabilities spanningmolecular design, preclinical optimization, and clinical translation. To date, Hengrui has advanced over10 differentiated ADC candidatesinto clinical development, includingTrastuzumab rezetecan, its flagship HER2-targeted ADC therapy.
Shun Lu, MD, PhD, Director of oncology department (Shanghai Lung Tumor Clinical Medical Center)ï¼OEChina, 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 rezetecanhas demonstratedsignificant clinical advances across multiple tumor types, witheight additional indications-includingbreast cancer, colorectal cancer, gastric cancer, biliary tract cancer, cervical cancer, ovarian cancer, fallopian tube cancer, and primary peritoneal cancer-receivingBreakthrough Therapy Designation (BTD)from China's National Medical Products Administration (NMPA).
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SOURCE Hengrui Pharma
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