Targeted drugs for advanced breast cancer, are expected to become the flagship new drug products of the Group
Sihuan Pharmaceutical Holdings Group Ltd. is pleased to announce that , Xuanzhu Biopharmaceutical Co., Ltd. ( 軒竹生物科技有限公司 ) (“Xuanzhu Biopharm”) has obtained the approval for the conduction of phase III clinical trials from the National Medical Products Administration of the People’s Republic of China in relation to its class 1 new drug Birociclib (XZP-3287, CDK4/6(cyclin-dependent kinases 4 and 6) inhibitor) (“Birociclib”), specifically: Birociclib is used in combination with Fulvestrant in those who accept endorcrine therapy but with disease progression and showed hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative(HER2-) locally advanced, recurrent or metastatic breast cancer. Xuanzhu Biopharm has held a kick-off meeting for the phase III clinical trial of Birociclib, and will commence clinical trial shortly.
The phase I clinical data demonstrate Birociclib, a novel selective CDK4/6 inhibitor, has the potential to overcome endocrine therapy resistance in hormone receptor-positive (HR+) breast cancer patients. Birociclib also exhibited efficacy in patients with hormone receptor (HR) positive, HER2-negative advanced breast cancer who have progressed following multiple lines of treatment. Pre-clinical data show Birociclib has a unique pharmacokinetic profile, which penetrates the blood-brain barrier, predicting its potential efficacy in breast cancer patients with brain metastases and brain tumors. Moreover, due to the novel targeting mechanism of CDK4/6 inhibitor, Birociclib is able to demonstrate clinical benefits and market influence through multiple novel Birociclib-based combination therapies.
Breast cancer is one of the most prevalent malignant tumors in the world, and according to the latest figures released by the International Agency for Research on Cancer (IARC), the number of new cases of breast cancer reached 2.26 million in 2020, surpassing lung cancer as the most prevalent malignant tumors in the world. It is also the most prevalent malignant tumors in women worldwide, with approximately 680,000 deaths from breast cancer. In 2020, there was about 420,000 new cases of breast cancer and 120,000 deaths in China, making it one of the most common causes of death from malignant tumors in women.
Hormone receptor-positive (HR+) breast cancer accounts for about 70% of all breast cancers, and is the most common type of breast cancer. The most popular drugs in this field are CDK4/6 inhibitors, which restore cell cycle control and block tumour cell proliferation by selectively inhibiting CDK4/6. The global market size of CDK4/6 exceed US$7 billion in 2020, and it is expected to exceed US$15 billion by 2025.
Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group said: " Class 1 New Drug Birociclib was self-developed by Xuanzhu Biopharm, has successfully obtained approval for the conduction of clinical trials from NMPA, which will further enrich the research and development pipeline for innovative drugs of the subsidiary. It is beneficial for the future market sales and competition of such drug, and will bring positive impacts to the operation results of the Group.”