On July 29, according to the CDE website, the marketing application for injectable Ruzetatoprolol (RHR-A2009) submitted by Suzhou Shengdiya Biopharmaceutical Co., Ltd., a subsidiary of Hengrui Medicine, was accepted. Based on its clinical progress, the indication for this application is speculated to be: EGFR-mutant advanced non-small cell lung cancer.

Lung cancer is the leading cause of cancer-related deaths worldwide, with non-small cell lung cancer (NSCLC) accounting for as much as 85%. According to data from Yaozhi, the market for NSCLC treatment drugs in my country continues to expand, with total sales exceeding RMB 84.5 billion in 2025 and reaching RMB 21.445 billion in Q1 2026, representing a year-on-year increase of 8.55%, indicating huge potential in the market.

SHR-A2009, a HER3 ADC drug independently developed by Hengrui Medicine, is composed of a fully human HER3 monoclonal antibody and a DNA topoisomerase I inhibitor, precisely targeting tumor cells. In May of this year, Hengrui Medicine announced that the Phase III clinical trial (study code: SHR-A2009-301) of SHR-A2009 for the treatment of EGFR-mutant advanced non-small cell lung cancer met its primary endpoint. SHR-A2009 significantly prolonged progression-free survival (PFS) compared to platinum-based doublet chemotherapy.

Currently, the global HER3 ADC development is highly competitive, with more than ten drugs in clinical trials. Merck/Daiichi Sankyo's demaptratumumab has already been submitted for marketing approval in the United States, and SHR-A2009 follows closely behind, becoming the second HER3 ADC product globally to be submitted for marketing approval. Yilian Bio's YL202 has also advanced to Phase III clinical trials.
It's worth noting that the competitive landscape of HER3-targeted therapy isn't limited to monoclonal antibody ADCs. Rencon's EGFR×HER3 bispecific antibody ADC, Elontuzumab, developed by Baili Tianheng, was approved for marketing in China in June 2026, becoming the world's first approved EGFR×HER3 bispecific antibody ADC. This formally establishes a competitive landscape for HER3-targeted therapy, with both monoclonal antibody ADCs and bispecific antibody ADCs developing in parallel. However, globally, no monoclonal antibody ADC specifically targeting HER3 has yet been approved. If SHR-A2009 is ultimately approved, it will fill this gap, providing the first HER3 monoclonal antibody ADC treatment option for patients with EGFR-mutant advanced non-small cell lung cancer.

Overall, the marketing application for SHR-A2009 signifies a further realization of Hengrui Medicine's R&D strength in the ADC field. As the review process progresses, whether this drug can be successfully launched and subsequently reshape the landscape of advanced lung cancer treatment alongside bispecific antibody ADCs and other products using different technological approaches warrants continued attention.

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