Announcement on the consistency evaluation of subsidiary drugs through generic drugs.
Release time:
2021-05-20
Securities Code: 600668 Securities Abbreviation: Jianfeng Group No.: Pro 2020-002
Zhejiang Jianfeng Group Co., Ltd.
Announcement
on Compliance Evaluation of Subsidiary Drugs Passing Generic Drugs 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 assumes individual and joint responsibility for the truthfulness, accuracy and completeness of its contents .
Recently, Zhejiang Jianfeng Pharmaceutical Co., Ltd. (hereinafter referred to as "Company " ), a controlling subsidiary of Zhejiang Jianfeng Group Co., Ltd. (hereinafter referred to as "" Jianfeng Pharmaceutical "), received the" Drug Supplementary Application Approval "for paroxetine hydrochloride tablets approved and issued by the State Drug Administration (batch number: 2020B02472 ), Jianfeng Pharmaceutical Paroxetine Hydrochloride Tablets have passed the consistency evaluation of generic drug quality and curative effect (hereinafter referred to as" generic drug consistency evaluation "). The relevant information is hereby announced as follows:
1. Drug Basic Information
Drug Name: Paroxetine Hydrochloride Tablets
Dosage Form: Tablet
Specification: 20mg (calculated by C 19 H 20 FNO 3 )
Registration Classification: Chemical
Applicant: Zhejiang Jianfeng Pharmaceutical Co., Ltd.
Acceptance No.: CYHB1950106
Batch No.: 2020B02472
Approval Conclusion: according to the provisions of the the People's Republic of China Drug Administration Law, the Opinions of the State Council on Reforming the Review and Approval System for Drugs and Medical Devices (Guo Fa (2015 ) 44 ) and the Announcement on Matters Related to the Evaluation of Quality and Efficacy Consistency of Generic Drugs (2017 100 ), after examination, this product has passed the evaluation of quality and efficacy consistency of generic drugs.
OTHER CONDITIONS RELATED TO 2. MEDICINE
(I) FUNCTION INDICATIONS: This product is used to treat depression, obsessive compulsive disorder, panic disorder with or without square terrors, social phobia/ social anxiety disorder. After the curative effect is satisfied, continue to take this product can prevent the recurrence of depression, panic disorder and obsessive-compulsive disorder.
(II) The National Drug Administration received the application for consistency evaluation of the drug in January of 2019 1 .
(III) As of the date of disclosure of this report, the drug research and development investment of about 1289 yuan (unaudited).
(IV) Included in the National Medical Insurance and Basic Drug List: Paroxetine Hydrochloride Tablets have been included in the National Basic Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drug List (2019 Edition ) and classified as Class A; It has been listed in the National Essential Drug List (2018 Edition ) .
(V) the market situation of similar drugs: domestic enterprises that have passed the consistency evaluation of this drug are: Zhejiang Huahai Pharmaceutical Co., Ltd., Beijing Fuyuan Pharmaceutical Co., Ltd., and Sino-US Tianjin SmithKline Pharmaceutical Co., Ltd. In 2018 , the sales of paroxetine hydrochloride tablets in domestic hospitals were about 3.78 .8 billion yuan (data from the database of drug intelligence network). In 2018 , Jianfeng Pharmaceutical achieved a cumulative sales of paroxetine hydrochloride tablets of about 9739.49 yuan.
3. Risk Alert
According to relevant national policies, drug varieties that pass the consistency evaluation will receive greater support in the fields of medical insurance payment and medical institution procurement. If there are more than 3 manufacturers of the same variety of drugs that pass the consistency evaluation of generic drugs, the varieties that do not pass the consistency evaluation of generic drugs will no longer be selected in the centralized procurement of drugs. The Paroxetine Hydrochloride Tablets of Jianfeng Pharmaceuticals has passed the quality and efficacy consistency evaluation of generic drugs, which is conducive to expanding the market share of the drug and enhancing its market competitiveness. As drug sales are affected by national policies, market environment and other factors, there is greater uncertainty. Investors are advised to pay attention to investment risks.
is hereby announced.
Zhejiang Jianfeng Group Co., Ltd.
Board of Directors
March 11, 2020
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