Jiangsu Hengrui Pharmaceuticals Co.,Ltd. (ASX: 600276) has announced that the company, along with its subsidiaries Shandong Shengdi Pharmaceutical Co., Ltd. and Guangdong Hengrui Pharmaceutical Co., Ltd., has received Drug Clinical Trial Approval Notices from the National Medical Products Administration for the capsules HRS-6209 and HRS-9813, as well as the tablet HRS-8080. Clinical trials for these drugs are scheduled to commence in the near future.

HRS-6209 is a novel selective CDK4 inhibitor. It potently inhibits cyclin-dependent kinase 4 (CDK4), blocks downstream Rb phosphorylation, and induces tumor cell arrest in the G1 phase, thereby exerting an anti-tumor effect. It is intended for clinical use in treating advanced malignant solid tumors. Compared to CDK4/6 inhibitors, it offers improved selectivity for CDK6, which may mitigate the hematological toxicity associated with CDK4/6 inhibitors. The project includes multiple clinical trials for combination therapies in breast cancer and has already advanced to Phase II clinical studies. Market inquiries indicate no similar products have been approved for marketing domestically or internationally.

HRS-8080 is a novel, potent, and selective oral Selective Estrogen Receptor Degrader (SERD). It effectively and highly selectively degrades the estrogen receptor (ER), inhibits ER activity and downstream signaling, thereby suppressing tumor cell proliferation. Multiple clinical trials for breast cancer under this project are actively underway and have progressed to Phase II/III clinical stages.

HRS-9813 is a Class 1 innovative drug independently developed by the company. Preclinical data shows that HRS-9813 can significantly improve pulmonary fibrosis in mice with a favorable safety profile. In breast cancer xenograft models, the combination of HRS-9813 with HRS-6209 demonstrated synergistic advantages with good overall animal tolerance. Current market inquiries reveal that no similar drugs have been approved for marketing either in China or abroad.