The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has included SHR-1826 in its list of breakthrough therapies for non-squamous non-small cell lung cancer with c-Met overexpression

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12 January 2026: The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has included SHR-1826 in its list of breakthrough therapies for non-squamous non-small cell lung cancer with c-Met overexpression

Suzhou Shengdiya Biotech, a subsidiary of Jiangsu Hengrui Medicine, announced that SHR-1826 for injection has been included in the Breakthrough Therapy Drug program by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration, marking an important regulatory milestone for the company’s oncology pipeline
The Breakthrough Therapy Designation applies to SHR-1826 as a monotherapy for adult patients with non-small cell lung cancer who have failed at least one line of systemic therapy, specifically targeting patients with locally advanced or metastatic non-squamous disease with high c-Met protein expression and no driver gene alterations
This development comes amid a significant public health burden, as lung cancer remains the leading cause of cancer-related death in China, with many patients diagnosed at an advanced stage and a five-year survival rate of only around 20%, highlighting the urgent need for more effective treatment options
SHR-1826 is an antibody drug conjugate targeting c-Met, designed to bind selectively to tumor cells, undergo internalization, and deliver its cytotoxic payload directly to cancer cells, offering a more targeted approach compared with conventional systemic therapies
With its inclusion in the Breakthrough Therapy program, SHR-1826 will receive prioritized regulatory support and guidance to accelerate development, although the company noted that drug development and commercialization remain subject to regulatory, technical, and market-related risks as clinical and review processes continue