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
More information
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On the morning of July 13, Tianjin Jianfeng Flanders Pharmaceutical Technology Development Co., Ltd. donated materials to the Tianjin Development Zone Charity Association to help the development zone community fight the epidemic.
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In late July, leaders of the group company Jiang Xiaomeng, Yu Jianhong, Chen Tianci and Qin Xuping visited subordinate enterprises separately and sent heatstroke prevention and cooling supplies to employees working under high temperature, urging everyone to pay attention to heatstroke prevention and cooling and safe production work to ensure good physical condition.
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On July 17 and 18, the Group's work analysis meeting for the first half of 2020 was held at the Peak Building of the Group's headquarters to summarize and review the work in the first half of the year and make arrangements for the work in the second half of the year.
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The company requires to do a good job in summer safety production
The high temperature season is approaching, and the group company issued a notice a few days ago to make arrangements for safe production in summer.
2020
08-05
The company requires to do a good job in summer safety production
The high temperature season is approaching, and the group company issued a notice a few days ago to make arrangements for safe production in summer. The notice requires all subordinate units of the company to attach great importance to the work of production safety in summer, and all production and business units should hold a special meeting on production safety in summer. According to the characteristics of production in summer, they should focus on safety risk analysis for mines, outdoor operations and high-temperature posts, and implement control measures to avoid the occurrence of safety accidents such as scalding, heatstroke and electric shock. In order to further strengthen the safety production management in the high temperature season, the notice requires the main person in charge of each production and business unit to lead a team to conduct a comprehensive inspection of the production and business premises according to the characteristics of summer production; strengthen the daily safety production inspection of key posts and special posts; timely rectify the found unsafe behaviors and hidden dangers; Strengthen the management of the storage and use of flammable, explosive, dangerous chemicals and drugs; cooling measures shall be taken for the space exceeding the storage temperature limit of articles. If it is found that the electrical equipment circuit and exhaust fan circuit are aged and damaged, replace them in time and keep the grounding wire in good condition. Do a good job in checking the fire pool, pipeline water pressure and fire extinguishing equipment to ensure that the fire fighting facilities are sensitive, intact and reliable. The high temperature in summer is also a period of frequent occurrence of heatstroke and other diseases. The notice requires all units to do a good job in heatstroke prevention and cooling, implement various relevant measures, and equip necessary cooling facilities or materials such as fans, air conditioners, ice cubes and other cooling facilities or materials according to the conditions of the production site; do a good job in the distribution of heatstroke prevention drugs, supplies and cool drinks in workshops, warehouses, construction sites and other production lines; strengthen canteen management to prevent food poisoning. (this newspaper reporter)
2020
07-22
The company requires to do a good job in summer safety production
The high temperature season is approaching, and the group company issued a notice a few days ago to make arrangements for safe production in summer. The notice requires all subordinate units of the company to attach great importance to the work of production safety in summer, and all production and business units should hold a special meeting on production safety in summer. According to the characteristics of production in summer, they should focus on safety risk analysis for mines, outdoor operations and high-temperature posts, and implement control measures to avoid the occurrence of safety accidents such as scalding, heatstroke and electric shock. In order to further strengthen the safety production management in the high temperature season, the notice requires the main person in charge of each production and business unit to lead a team to conduct a comprehensive inspection of the production and business premises according to the characteristics of summer production; strengthen the daily safety production inspection of key posts and special posts; timely rectify the found unsafe behaviors and hidden dangers; Strengthen the management of the storage and use of flammable, explosive, dangerous chemicals and drugs; cooling measures shall be taken for the space exceeding the storage temperature limit of articles. If it is found that the electrical equipment circuit and exhaust fan circuit are aged and damaged, replace them in time and keep the grounding wire in good condition. Do a good job in checking the fire pool, pipeline water pressure and fire extinguishing equipment to ensure that the fire fighting facilities are sensitive, intact and reliable. The high temperature in summer is also a period of frequent occurrence of heatstroke and other diseases. The notice requires all units to do a good job in heatstroke prevention and cooling, implement various relevant measures, and equip necessary cooling facilities or materials such as fans, air conditioners, ice cubes and other cooling facilities or materials according to the conditions of the production site; do a good job in the distribution of heatstroke prevention drugs, supplies and cool drinks in workshops, warehouses, construction sites and other production lines; strengthen canteen management to prevent food poisoning. (this newspaper reporter)
2020
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