Securities code: 600196 stock abbreviation: Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) No.: pro 2022-014 bond Code: 136236 bond abbreviation: 16 Fuyao 01
Bond Code: 143020 bond abbreviation: 17 Fuyao 01
Bond Code: 143422 bond abbreviation: 18 Fuyao 01
Bond Code: 155067 bond abbreviation: 18 Fuyao 02
Bond Code: 155068 bond abbreviation: 18 Fuyao 03
Shanghai Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) (Group) Co., Ltd
Announcement on the progress of drug clinical trials of holding subsidiaries
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear individual and joint liabilities for the authenticity, accuracy and completeness of its contents.
1、 Overview
Recently, Jinzhou AoHong Pharmaceutical Co., Ltd. (hereinafter referred to as “AoHong pharmaceutical”), a holding subsidiary of Shanghai Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) (Group) Co., Ltd. (hereinafter referred to as “the company”), made a study on fcn-437c (hereinafter referred to as “the new drug”) for the treatment of hormone receptor positive (HR +) in China (excluding Hong Kong, Macao and Taiwan, the same below) Human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer was initiated in phase III clinical trial.
2、 Research status of the new drug
The new drug is an innovative small molecule CDK4/6 inhibitor which is intended for the treatment of advanced / metastatic solid tumors (including HR+ and HER2- advanced breast cancer). Chongqing fuchuang Pharmaceutical Research Co., Ltd., a holding subsidiary of the company, conducted preclinical research on the new drug, and exclusively licensed AoHong pharmaceutical to develop (including but not limited to clinical trial, listing registration, etc.) and commercialize the new drug in China.
As of the date of this announcement, the CDK4 / 6 inhibitors listed in China mainly include piperacillin capsule of Pfizer Inc. and abecilide tablets of Eli Lilly and company (approved for listing in December 2020). According to the iqvia CHPA data (provided by iqvia, iqvia is the world’s leading provider of professional information and strategic consulting services for the medical and health industry; iqvia CHPA data represents the drug sales market of hospitals with more than 100 beds in China, and the actual sales situation of different drugs may differ from iqvia CHPA data to varying degrees due to their different sales channel layout), In 2020 and the first half of 2021, the sales of CDK4 / 6 inhibitors in China were about 70.11 million yuan and 37.96 million yuan respectively.
As of December 2021, the group (i.e. the company and its holding subsidiaries / units) has invested about 153.66 million yuan (Unaudited) in the research and development of the new drug at this stage.
3、 Risk tips
According to the experience of new drug research and development, there are certain risks in new drug research and development. For example, clinical trials may be terminated due to problems such as safety and / or effectiveness.
According to the requirements of relevant Chinese laws and regulations, the new drug can only be listed after a series of clinical studies are carried out in China and approved by the national drug evaluation department.
The R & D and listing of new drugs is a long-term work, and there are many uncertain factors. Please pay attention to the investment risks.
It is hereby announced.
Board of directors of Shanghai Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) (Group) Co., Ltd. January 19, 2002