China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its SHR-A1811 combined with SHR-9839 in advanced solid tumors. This approval is a significant step forward in the development of innovative treatments for patients with advanced cancer.
SHR-A1811: HER2-Targeted ADC
SHR-A1811 is a HER2-targeted antibody drug conjugate (ADC) designed to induce cell cycle arrest and tumor cell apoptosis. The drug works by binding to HER2-expressing tumor cells and entering the cells through endocytosis. Once inside, it releases toxins through protease cleavage in the tumor cell lysosomes. Similar products from Roche (Kadcyla), AstraZeneca/Daiichi Sankyo (Enhertu), and RemeGen (disitamab vedotin) are commercially available globally, highlighting the potential market for this class of drugs.
SHR-9839: Dual-Pathway Antibody Drug
SHR-9839 is an in-house developed antibody drug designed to treat advanced malignant tumors. It exerts anti-tumor effects by simultaneously blocking two key signaling pathways related to tumor occurrence and development. This dual-action mechanism positions SHR-9839 as a promising candidate for the treatment of advanced solid tumors. Currently, there is one similar product approved globally, underscoring the innovation and potential of Hengrui’s approach.
Strategic Implications
The clinical trial approval for the combination of SHR-A1811 and SHR-9839 by the NMPA is a strategic milestone for Jiangsu Hengrui Pharmaceuticals. It underscores the company’s commitment to advancing innovative cancer therapies and enhancing patient outcomes. By combining the strengths of a HER2-targeted ADC with a dual-pathway antibody drug, Hengrui aims to address significant unmet medical needs in the treatment of advanced solid tumors. This development is expected to enhance Hengrui’s position in the global oncology market and contribute to the advancement of personalized medicine.-Fineline Info & Tech
