Jiangsu Hengrui Pharmaceuticals (01276) has received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration for HRS-6209 capsules and HRS-4508 tablets.

Jiangsu Hengrui Pharmaceuticals (01276) announced that it has recently received the approval notification for clinical trials from the National Medical Products Administration regarding HRS-6209 capsules and HRS-4508 tablets, which will commence clinical trials in the near future. HRS-6209 is a novel selective CDK4 inhibitor that effectively inhibits cyclin-dependent kinase 4 (CDK4), suppressing downstream Rb phosphorylation and inducing tumor cell arrest in the G1 phase, thereby exerting anti-tumor effects. It is intended for clinical use in the treatment of advanced malignant solid tumors. Compared to CDK4/6 inhibitors, it enhances selectivity for CDK6, which may improve the blood toxicity associated with CDK4/6 inhibitors. The project is conducting multiple clinical trials for combination therapies in breast cancer and has entered the Phase II clinical stage. According to inquiries, there are currently no similar products that have been approved for marketing domestically or internationally. As of now, the cumulative R&D investment for HRS-6209 related projects is approximately 161 million yuan (unaudited). HRS-4508 tablets are a novel, highly efficient, and selective tyrosine kinase inhibitor that exerts anti-tumor effects by inhibiting tumor cell proliferation. According to inquiries, similar products that have been launched abroad include Zongertinib (, trade name: Hernexeos) and Tucatinib (, trade name: Tukysa), with Zongertinib having already been approved for marketing in China. According to the EvaluatePharma database, the global sales for Tucatinib are projected to be approximately 463 million USD in 2025. As of now, the cumulative R&D investment for HRS-4508 related projects is approximately 96.7 million yuan (unaudited).