Jiangsu Hengrui Pharmaceuticals (600276.SH) plans to include the class 1 new drug injection SHR-A2102 in breakthrough therapeutic categories.

On December 4th, the official website of the China National Medical Products Administration Drug Evaluation Center (CDE) announced that Jiangsu Hengrui Pharmaceuticals' class 1 new drug injection SHR-A2102 is proposed to be included in breakthrough therapies, indicated for the treatment of locally advanced or metastatic urothelial carcinoma that has failed prior platinum-based chemotherapy and PD-(L)1 inhibitor therapy. SHR-A2102 is an antibody-drug conjugate (ADC) targeting Nectin-4 developed by Jiangsu Hengrui Pharmaceuticals. The drug has previously been granted fast track designation by the US FDA for treating advanced urothelial carcinoma. SHR-A2102 is an ADC targeting Nectin-4 with a payload of a topoisomerase inhibitor (TOPi). Previously, the application for clinical trials of this product for treating advanced solid tumors has been approved by the FDA. Clinical trial applications for SHR-A2102 as a monotherapy or in combination with other anti-tumor therapies for advanced solid tumors have also been approved by the China NMPA and are currently in phase 2 clinical trials. The inclusion of SHR-A2102 for treating urothelial carcinoma in the breakthrough therapy category by CDE signifies a new milestone in the research progress of this product.