Anti-tumor Nanodrug “Sirolimus for Injection (Albumin-bound)” Obtains Clinical Trial Approval

The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that “Sirolimus for Injection (albumin-bound)” (the “Product”) developed by CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.*(石藥集團中奇製藥技術(石家莊)有限公司), a subsidiary of the Company, has obtained clinical trial approval granted by the National Medical Products Administration of the People's Republic of China to conduct clinical trials in China, being the first sirolimus preparation administered by injection obtaining clinical trial approval in China. Sirolimus, also known as rapamycin, is a macrolide antibiotic immunosuppressant and a mTOR specific inhibitor. At present, sirolimus marketed in China and overseas are all oral medications for the prevention of organ rejection in patients receiving renal transplants. The Product utilises special technology to encapsulate sirolimus into human serum albumin to overcome the shortcoming that oral formulation fails to deliver sufficient concentration of drug to target site, thus having the potential for treating a series of diseases caused by the mTOR signaling pathway. The Product has achieved administration of sirolimus by injection without hormone pretreatment and expanded the field of application of the drug. The clinical indication of this approval is for the treatment of solid tumors and hematological tumors. The preclinical study demonstrated that the Product has good anti-tumor activity in several models of solid tumors and hematological tumors, providing a promising prospect of demonstrating good anti-tumor efficacy in clinical trials. The Product is a Class 2 chemical drug under the registration system in China and currently there is no product of the same type available in the global market. The Group will endeavor to push forward the clinical trials of the Product and strive to launch the Product as soon as possible.