Securities code: China Meheco Group Co.Ltd(600056) securities abbreviation: China Meheco Group Co.Ltd(600056) Announcement No.: Lin 2022017 China Meheco Group Co.Ltd(600056)
Announcement on subsidiary obtaining drug registration certificate
The company and all members of the board of directors guarantee that there are no false records, misleading statements or major omissions in the contents of the announcement, and bear individual and joint liabilities for the authenticity, accuracy and completeness of the contents.
Recently, Tianfang Pharmaceutical Co., Ltd. (hereinafter referred to as Tianfang Co., Ltd.), a wholly-owned subsidiary of China Meheco Group Co.Ltd(600056) (hereinafter referred to as “the company”), received two drug registration certificates of rosuvastatin calcium tablets (hereinafter referred to as “the drug”) approved and issued by the State Drug Administration (hereinafter referred to as “the drug”). The relevant information is hereby announced as follows:
1、 Basic information of registration certificate
Drug name: rosuvastatin calcium tablets
Acceptance No.: cyhs2000730, cyhs2 Sichuan Meifeng Chemical Industry Co.Ltd(000731)
Approval No.: 2022s00227, 2022s00228
Dosage form: tablet
Specification: 5mg, 10mg
Registration classification: chemical drugs category 4
Listing Permit Holder: Tianfang Pharmaceutical Co., Ltd
Drug manufacturer: Tianfang Pharmaceutical Co., Ltd
Drug approval No.: gyzz h20223159, gyzz h20223160
Approval conclusion: according to the drug administration law of the people’s Republic of China and relevant regulations, after examination, this product meets the relevant requirements of drug registration. The registration is approved and a drug registration certificate is issued.
2、 Other relevant information of drugs
(I) Tianfang Co., Ltd. submitted the drug registration application to the State Food and Drug Administration in October 2020 and was accepted.
(II) as of the disclosure date of this announcement, the cumulative R & D investment of Tianfang Co., Ltd. in the drug API and tablet project is about 16.32 million yuan (Unaudited), and the drug API has passed the technical review of the drug evaluation center of the State Drug Administration.
(III) drug introduction
The drug was developed by Japan’s yanye pharmaceutical company in the late 1980s. The worldwide development, listing and sales interests of some Asian countries except Japan were transferred to AstraZeneca in 1998. It was listed in the Netherlands in 2002 and officially approved in the United States in 2003. The trade name is Crestor. It was approved to be imported and listed in China in December 2006. The trade name is determinable, and the specifications are 5mg, 10mg and 20mg.
This product is applicable to primary hypercholesterolemia (type IIA, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIB) that can not properly control dyslipidemia after diet control and other non drug treatment (such as exercise therapy and weight loss); This product is also suitable for patients with homozygous familial hypercholesterolemia as an adjuvant treatment of dietary control and other lipid-lowering measures (such as LDL removal therapy), or when these methods are not applicable.
(IV) introduction to drug market
According to the data query on the website of the State Food and drug administration, as of the disclosure date of this announcement, except Tianfang Co., Ltd., the enterprises that have passed / deemed to have passed the consistency evaluation of this drug in China include Zhejiang Jingxin Pharmaceutical Co.Ltd(002020) , Hefei Yingtai Pharmaceutical Co., Ltd., lunanbeite Pharmaceutical Co., Ltd., Zhejiang Hisun Pharmaceutical Co.Ltd(600267) etc., with specifications of 5mg, 10mg and 20mg.
According to the query of the third-party database PDB, the sales volume of the drug in China’s sample hospitals in 2021 was about 377 million yuan.
3、 Impact on listed companies and risk tips
This time, rosuvastatin calcium tablets of Tianfang Co., Ltd. obtained the drug registration certificate according to the new registration classification method of chemical drugs, which is conducive to improving the company’s market competitiveness in the drug field and accumulating valuable experience for the company’s subsequent generic drug development.
The company attaches great importance to drug research and development, and strictly controls the quality and safety of drug research and development, manufacturing and sales. Due to the characteristics of high-tech, high-risk and high added value of pharmaceutical products, not only the early research and development of drugs and the long cycle and many links of products from development and clinical trial approval to production, but also the listing and sales of drugs after obtaining approval are vulnerable to some uncertain factors. Please pay attention to the investment risk. It is hereby announced.
Board of directors
