China Biopharmaceutical (01177): Coumoxil capsules approved for marketing

Zhitong Finance App News, China Biopharmaceutical (01177) announced that Moxil capsules (trade name: Xitaxin®), a national class 1 innovative drug developed independently by the Group, have obtained marketing approval from the China National Drug Administration (NMPA) to be used in combination with fluvizil to treat patients with hormone receptor (HR) -positive and human epidermal growth factor receptor 2 (HER2) -negative patients with locally advanced or metastatic breast cancer whose disease progresses after previous endocrine treatment.

Coumosil is the world's first triple inhibitor that simultaneously targets CDK2/4/6. It has varying degrees of inhibitory effect on CDK2, CDK4, and CDK6 kinases, and has a strong selective inhibitory ability against CDK4 kinase. Based on its unique mechanism of action, coumoxil not only helps delay resistance to CDK4/6 inhibitors in clinical practice, but also reduces the risk of bone marrow suppression.

In a key phase III clinical trial (TQB3616-III-01), the coumoxil combined with fluvizil regimen showed encouraging efficacy. The study results showed that the median progression-free survival (mPFs) was 16.62 months, which was significantly longer than the flunovir group (7.46 months) by 9.16 months, and the risk of disease progression or death was reduced by 64% (HR = 0.36, p<0.0001). Objective response rate (ORR) increased significantly (40.21% vs. 12.12%, p<0.0001). In terms of safety, most common treatment-related adverse events (TREs) are grade 1-2, which are easy to manage; hematologic toxicity such as grade 3 or greater myelosuppression is low; no TREs leading to termination of treatment or death have occurred, and are generally safe and tolerable.

In addition to the second-line treatment indications approved this time, the first-line HR+/HER2- breast cancer indications for coumosilide were submitted to the NMPA in July 2025. The Phase III clinical trial for adjuvant treatment indications has completed enrolling all patients, and it is expected that it will gradually be approved for marketing in the next two years.