Announcement on Subsidiary Company Obtaining Drug Registration Certificate
Release time:
2021-05-20
Securities Code: 600668 Securities Abbreviation: Jianfeng Group No.: Lin 2020-023
Zhejiang Jianfeng Group Co., Ltd.
Announcement on Subsidiaries Obtaining Drug Registration Certificate
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 assume individual and joint responsibility for the truthfulness, accuracy and completeness of its contents.
Important Content Note:
- Obtaining the Drug Registration Certificate of esomeprazole sodium for injection this time indicates that Jianfeng Pharmaceutical is qualified to produce and sell the drug, which will further enrich Jianfeng Pharmaceutical's product line and help enhance the competitiveness of the company's pharmaceutical business.
- Risk Warning: Because pharmaceutical products have the characteristics of high technology, high risk, and high added value, not only the pre-research and development of drugs, the period from approval to production is long, the investment is large, and there are many links, and the drug has obtained the registration The production and sales after the certificate are also easily affected by factors such as national policies and market environment. Investors are requested to pay attention to investment risks.
Recently, Zhejiang Jianfeng Pharmaceutical Co., Ltd. (hereinafter referred to as "the Company"), a holding subsidiary of Zhejiang Jianfeng Group Co., Ltd. (hereinafter referred to as "the Company"), received the Drug Registration Certificate of esomeprazole sodium for injection (Certificate No.: 2020S00572) approved and issued by the State Drug Administration. The relevant information is hereby announced as follows: basic Information of
1. Drugs
Drug Name: Esomeprazole Sodium for Injection
Dosage Form: Injection
Specification: 40mg (calculated by C 17 H 19 N 3 O 3 S)
Application Items: drug Registration (Domestic Production)
Registration Classification: Original Chemical Drug Category 6
Applicant: Zhejiang Jianfeng Pharmaceutical Co., Ltd.
acceptance number: CYHS1301863 Zhejiang
Certificate No.: 2020S00572
Drug Registration Standard No.: YBH03162020
Drug Validity Period: 12 Months
Drug Approval Number: the validity period of the drug approval document number of the national drug standard H20203449
is until August 25, 2025
approval conclusion: according to the the People's Republic of China drug administration law and relevant regulations, after examination, this product meets the relevant requirements for drug registration, is approved for registration, and a drug registration certificate is issued. The production process, quality standards, instructions and labels shall be in accordance with the attached.
2. Drug Development and Related Conditions
This product is used to treat:
1. as an alternative therapy for GERD when oral therapy is not applicable.
2. Use in low-risk patients with acute gastric or duodenal ulcer bleeding for whom oral therapy is not applicable (gastroscopic Forrest grading IIc-III).
Esomeprazole sodium for injection has been listed in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List (2017 Edition)" and classified as Class B; it is not included in the "National Essential Drugs List (2018 Edition)". At present, 30 enterprises, including AstraZeneca Pharmaceutical Co., Ltd., Zhengda Tianqing Pharmaceutical Group Co., Ltd., Qilu Pharmaceutical Co., Ltd., and Shandong Luoxin Pharmaceutical Group Co., Ltd., have been approved for listing in China. According to the data of the intranet, the domestic sales in 2019 (including urban and county-level public hospitals, community and township health centers) are about 3.317 billion yuan.
Peak Pharmaceutical submitted an application for registration of the drug to the State Food and Drug Administration on November 28, 2013 and was accepted. Up to now, the research and development investment of esomeprazole sodium for injection project of Jianfeng Pharmaceutical Co., Ltd. is about 14.9128 million yuan. The impact of
3. on the company and its risks suggest that
Jianfeng Pharmaceutical already has a corresponding production line. The acquisition of the Drug Registration Certificate of esomeprazole sodium for injection this time indicates that Jianfeng Pharmaceutical has the qualification to produce and sell the drug, which will further enrich the product line of Jianfeng Pharmaceutical and help to enhance the competitiveness of the company's pharmaceutical business. Due to the characteristics of high technology, high risk and high added value of pharmaceutical products, not only the period from the preliminary research and development, approval to production is long, the investment is large and there are many links, but also the production and sales of drugs after obtaining the registration certificate are easily affected by national policies, market environment and other factors. Please pay attention to the investment risk.
This is to announce
Zhejiang Jianfeng Group Co., Ltd.
Board of Directors
September 5, 2020
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