HENGRUI PHARMA (01276.HK): Clinical trials approved for HRS-6209 capsules and HRS-4508 tablets in advanced breast cancer and solid tumors

NewTimeSpace News: On 7 September 2026, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (stock code: 01276) announced that it had received Clinical Trial Approval Notices from the NMPA for HRS-6209 capsules and HRS-4508 tablets, with clinical trials to commence shortly. The applications were accepted on 29 May 2026 (acceptance nos. CXHL2600632 and CXHL2600633) and approved for an open-label, multicenter Phase Ib/II clinical study evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of HRS-6209 in combination with other anti-tumor therapies in patients with advanced unresectable or metastatic breast cancer, or of HRS-9813 in patients with advanced solid tumors.

The announcement showed that HRS-6209 is a novel selective CDK4 inhibitor that potently inhibits cyclin-dependent kinase 4 (CDK4), suppresses downstream Rb phosphorylation and induces G1 arrest in tumor cells, offering improved CDK6 selectivity over CDK4/6 inhibitors and potentially alleviating related hematological toxicity. The project has advanced into Phase II with multiple combination trials in breast cancer under development, and no similar product has yet been approved in China or overseas, with cumulative R&D investment of approximately RMB 160.9 million (unaudited). HRS-4508 tablets are a novel, potent and selective tyrosine kinase inhibitor; similar products already approved overseas include Zongertinib (Hernexeos) and Tucatinib (Tukysa), of which Zongertinib has also been approved in China, and global sales of Tucatinib in 2025 were approximately USD 463 million per EvaluatePharma, with cumulative R&D investment of approximately RMB 96.7 million (unaudited) in the HRS-4508 project.

The company reminded that the drugs still need to undergo clinical trials and NMPA evaluation and approval before they can be manufactured and marketed.

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