Securities code: 600276 securities abbreviation: Jiangsu Hengrui Medicine Co.Ltd(600276) Announcement No.: pro 2022-001 Jiangsu Hengrui Medicine Co.Ltd(600276)
Suggestive announcement on the progress of drug registration
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. Recently, the website of the State Drug Administration (hereinafter referred to as “the State Drug Administration”) was queried https://www.nmpa.gov.cn. ）It was learned that the State Food and Drug Administration approved the listing of Jiangsu Hengrui Medicine Co.Ltd(600276) (hereinafter referred to as the “company”) proline hengglijing tablets and darcilil hydroxyethanesulfonate tablets. The relevant information is hereby announced as follows: I. Basic information of the drug 1. Drug name: proline hengglijing tablets
Dosage form: tablet
Registration classification: Class 1 Chemicals
Prescription drugs / over-the-counter drugs: prescription drugs
Approved approval: This product is suitable for improving glycemic control in adults with type 2 diabetes. 2. Drug name: darcilil hydroxyethanesulfonate tablets
Dosage form: tablet
Registration classification: Class 1 Chemicals
Prescription drugs / over-the-counter drugs: prescription drugs
Intended to be approved: This product combined with fluticasone is used in the treatment of recurrent or metastatic breast cancer with hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative after endocrine therapy. 2、 Other information about drugs
1. Other conditions of proline hengglitazin tablets
Proline hengglitazin is a sodium glucose cotransporter 2 (SGLT2) inhibitor. By inhibiting SGLT2, it reduces the reabsorption of glucose filtered by renal tubules and increases urinary glucose excretion. Upon inquiry, the SGLT2 inhibitor products on the market worldwide include AstraZeneca’s dagglitazin, Johnson & Johnson’s cagglitazin, Boehringer Ingelheim’s englglitazin, MSD’s egglitazin, Sanofi’s soglitazin, AstraZeneca’s igglitazin, Sino foreign pharmaceutical’s togglitazin and Dazheng pharmaceutical’s lugglitazin. After querying the evaluatepharma database, the global sales of SGLT2 inhibitor related products in 2020 was about US $7.681 billion. Up to now, the cumulative R & D cost of proline hengliejing related projects has been about 273.53 million yuan.
2. Other conditions of darcilil hydroxyethanesulfonate tablets
In April 2021, the marketing application for the proposed approved indications of darcilil hydroxyethanesulfonate tablets was included in the priority review and approval procedure by the State Food and drug administration according to the priority review scope “(IV) drugs included in the breakthrough treatment drug procedure”.
Darcilide hydroxyethanesulfonate is a new class 1 Chemical drug independently developed by Jiangsu Hengrui Medicine Co.Ltd(600276) . It is an oral, efficient and selective small molecule CDK4 / 6 inhibitor. The world’s first CDK4/6 inhibitor, the Pfizer Inc’s Palbociclib (trade name Ibrance), was approved by the US Food and Drug Administration (HR+/HER2-) through accelerated reviews in February 2015. It is used as an initial endocrine therapy combined with letrozole in the treatment of advanced breast cancer. In February 2016, new indications and fluor group were approved for the treatment of advanced or metastatic breast cancer after HR+/HER2- endocrine therapy. At present, palbociclib has been listed in EU, Japan and other countries and regions. Palbociclib was approved in China in July 2018. It was used for the combination of aromatase inhibitors as initial endocrine therapy for HR+/HER2- locally advanced or metastatic breast cancer. Other CDK4 / 6 inhibitors that have been approved for marketing by FDA include ribociclib (trade name kisquali) developed by Novartis, abemaciclib (trade name verzenio) developed by Eli Lilly and trilaciclib (trade name cosela) developed by G1 therapeutics. At present, palbociclib of Pfizer and abemaciclib of Lilly have been approved in China.
After querying the evaluatepharma database, the global sales of similar products of dalcili hydroxyethyl sulfonate tablets in 2020 was about US $6.992 billion. Up to now, about 363.59 million yuan has been invested in research and development of dalcili hydroxyethanesulfonate related projects. 3、 Risk tips
The company has not obtained the official documents issued by the State Food and drug administration. After obtaining the official documents, the company will timely disclose the main contents of the drug registration certificate in accordance with the relevant provisions of Shanghai Stock Exchange. Please make careful decisions and pay attention to preventing investment risks.
It is hereby announced.
Jiangsu Hengrui Medicine Co.Ltd(600276) board of directors January 3, 2022
