Announcement on Subsidiary Companies Obtaining Drug Registration Approval
Release time:
2020-08-05
Securities Code: 600668 Securities Abbreviation: Sharp Group No.: Pro 2019-007
Bond Abbreviation: 13 Spike 02 Bond Code: 122344
Zhejiang Jianfeng Group Co., Ltd.
Announcement on Subsidiaries Obtaining Drug Registration Approval
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 shall bear individual and joint liability for the authenticity, accuracy and completeness of its contents.
Recently, Zhejiang Jianfeng Pharmaceutical Co., Ltd. (hereinafter referred to as "Jianfeng Pharmaceutical"), a holding subsidiary of Zhejiang Jianfeng Group Co., Ltd. (hereinafter referred to as "the Company"), received the "Drug Registration Approval Document" (Approval No.: 2019S00296) of olopatadine hydrochloride eye drops approved and issued by the State Drug Administration. The relevant information is hereby announced as follows: basic Information of
1. Drugs
Drug Name: Olopatadine Hydrochloride Eye Drops
Dosage Form: Ophthalmic Preparation
Specification: 0.1 (5ml:5mg, based on C 21 H 23 NO 3 )
Application Items: Domestic Drug Registration
Registration Classification: Chemical Drug Class 4
Applicant: Zhejiang Jianfeng Pharmaceutical Co., Ltd.
Acceptance Number: CYHS1600042 Zhejiang
batch number: 2019S00296
drug standard number: YBH00792019
drug validity period: 36 months
drug approval number: national drug H20193095
drug approval number validity period: until April 02, 2024
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 of drug registration, approves the registration, and issues the drug approval number.
Other relevant conditions of 2. drug
This drug is used to treat the signs and symptoms of allergic conjunctivitis. It is a mast cell stabilizer and a relatively selective histamine H1- receptor antagonist. It can inhibit type I immediate allergic reactions in vivo and in vitro experiments.
Olopatadine Hydrochloride Eye Drops has been included 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, Novartis Europharm Limited, towering pharmaceutical (China) co., ltd., Jiangsu hanchen pharmaceutical co., ltd., Jiangxi kelun pharmaceutical co., ltd., Guangdong hongying technology co., ltd., Qilu pharmaceutical co., ltd. and Shenyang xingqi ophthalmic co., ltd. olopatadine hydrochloride eye drops have been approved for listing in China. After querying the IMS database, global sales of olopatadine hydrochloride eye drops in 2018 were approximately US $0.37 billion and China sales were approximately US $10.232 million.
Up to now, the research and development investment of spiking pharmaceutical olopatadine hydrochloride eye drops project is about 660 yuan. The impact of
3. on the company
Jianfeng Pharmaceutical already has a corresponding production line. This time, it has obtained the Drug Registration Approval Document of olopatadine hydrochloride eye drops, which indicates that Jianfeng Pharmaceutical has the qualification to produce and sell the drug. It will further enrich the product line of Jianfeng Pharmaceutical and help to enhance the competitiveness of the company's pharmaceutical business.
4. Risk Warning
Company attaches great importance to the quality and safety of drug research and development, manufacturing and sales. However, due to the characteristics of high technology, high risk and high added value of pharmaceutical products, not only the early stage of drug research and development, approval to production has a long cycle, large investment and many links, moreover, the production and sales of drugs after obtaining approval are also vulnerable to national policies, market environment and other factors. Please the majority of investors cautious decision-making, pay attention to prevent investment risk.
Zhejiang Jianfeng Group Co., Ltd.
Board of Directors
April 17, 2019
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