Zhitong Finance App News, Hengrui Pharmaceutical (01276) issued an announcement. Recently, Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”) product SHR-4375 injection for the treatment of pancreatic cancer was certified as an orphan drug by the US Food and Drug Administration (hereinafter referred to as the “US FDA”). Orphan medicines, also known as rare disease drugs, refer to drugs used to prevent, treat, and diagnose rare diseases. This time, the company has been certified as an orphan drug by the US FDA, and will have the opportunity to enjoy US policy support in product development, registration and commercialization.
SHR-4375 injection is an antibody-drug conjugate (ADC) that targets tissue factor (TF), independently developed by the company. It can specifically bind to TF on the surface of tumor cells and be internalized to release toxins through protease cleavage in tumor cytosomes, inducing cell cycle blocking and triggering tumor cell apoptosis. According to inquiries, Tisotumab vedotin (Tivdak), a competitor with the same target, obtained accelerated approval from the FDA for marketing in 2021, and sales have not yet been confirmed. Domestic clinical trials of the company's SHR-4375 injection have advanced to phase II. Up to now, the total R&D investment for SHR-4375 injection-related projects is about 58.7 million yuan (unaudited).
After the SHR-4375 injection is certified as an orphan drug, it is expected that the progress of clinical trials and marketing registration will be accelerated. At the same time, you can enjoy certain policy support, including but not limited to tax credits for clinical trial expenses, exemption from application fees for new drugs, and 7-year market exclusivity after product approval.