Jianfeng Group Lin2016 -002 (Announcement on Withdrawal of Two Drug Registration Applications by Subsidiates)
Release time:
2020-08-05
Securities Code: 600668 Securities Abbreviation: Jianfeng Group Announcement No.: 2016-002
Bond Abbreviation: 13 Peak 01 Bond Code: 122227
Bond Abbreviation: 13 Peak 02 Bond Code: 122344
Zhejiang Jianfeng Group Co., Ltd.
Prompt Announcement
on Withdrawal of Two Drug Registration Applications by Subsidiaries
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, china food and drug administration (hereinafter referred to as "State Food and Drug Administration") issued the Announcement on Withdrawal of 199 Drug Registration Applications by 128 Enterprises (2016 21 ), zhejiang Jianfeng Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), a subsidiary of the Company, withdrew the registration application of 2 drugs. The relevant information is hereby announced as follows:
Basic Information of 1. Products
(I) Cefapirin Sodium for Injection
Drug Name |
Cefapirin Sodium for Injection |
acceptance number |
CXHS1200117 , CXHS1200118 |
Dosage Form |
Chinese Pharmacopoeia Dosage Form Injection |
Application Phase |
Production |
Specification |
0.5g , 1.0g |
Registration Classification |
Chemical Drug 3.1 Class |
Applicant |
Zhejiang Jianfeng Pharmaceutical Co., Ltd., China Pharmaceutical Group Corporation Sichuan Antibiotic Industry Research Institute |
2008 January 17, 148, the company obtained the "Drug Clinical Trial Approval" issued by State Food and Drug Administration ; 2011# On January 10, 151, the company completed the clinical trial of the drug. On May 23, 2012, the company applied for production to State Food and Drug Administration .
(II) mitiglinide calcium capsule| drug name |
mitiglinide calcium capsule |
| acceptance number |
CXHS1400304 |
| dosage form |
Chinese Pharmacopoeia Dosage Capsule |
| Application Stage |
Production |
| Specification |
10mg/ |
| Registration Classification |
Chemical 3.1 Class |
| Applicant |
Zhejiang Jianfeng Pharmaceutical Co., Ltd., China Pharmaceutical University |
December# On the 8th of 253, the company obtained the "Drug Clinical Trial Approval" issued by State Food and Drug Administration ; 2012# On April 5, 256, the company completed the clinical trial of the drug; On December 30, 2014, the company applied for production to State Food and Drug Administration . Other Relevant Situations of 2. Drugs
Cefapirin Sodium for Injection is the first generation cephalosporin, which is suitable for respiratory system infection, urinary system infection, skin and soft tissue infection, wound infection, otolaryngology infection, intracavitary infection, etc. caused by sensitive bacteria. Up to now, the company has invested about 1089 .65 million yuan in the drug research and development project.
Mitiglinide Calcium Capsules improve postprandial hyperglycemia in Ⅱ
diabetic patients by stimulating insulin secretion. Up to now, the company has invested about 549.71 million yuan in the drug research and development project. Market Status of Similar Drugs in 3.
Production Unit |
Dosage Form |
Specification |
|
Yantai Zhengfang Pharmaceutical Co., Ltd. |
Capsule | 10mg |
|
Liaoning Huarui United Pharmaceutical Co., Ltd. |
Tablet | 5mg | , 10mg
|
Zhengda Qingchunbao Pharmaceutical Co., Ltd. |
Tablet | 5mg | , 10mg
|
Jiangsu Zhengda Tianqing Pharmaceutical Co., Ltd. |
Tablet | 5mg | , 10mg
|
Jiangsu Haosen Pharmaceutical Co., Ltd. |
Tablet | 10mg |
|
Beijing Sihuan Kebao Pharmaceutical Co., Ltd. |
Tablet | 5mg |
|
Up to now, there is no domestic manufacturer of cefapirin sodium for injection listed.
4. Sales Data, Production and Usage
Cefapirin Sodium for Injection Major foreign manufacturers are Japan Bristol Company and
Bristol-Myers Squibb(Bristol-Myers) Company; Up to now, there are no similar products on the market in China. The main foreign manufacturers of mitiglinide calcium capsules are Japan's Kissei Pharmaceutical Company (Kissei). Company has not found the specific production, sales data and usage of the above-mentioned similar products from public channels. Impact of
5. on the Company and Risk Prompt
Company voluntarily withdrew the registration application of the above 2
drugs according to the latest policy of the State Food and Drug Administration on drug review and approval, and in combination with the current situation of domestic drug clinical trials and the recommendations of clinical trial institutions and contract research organizations, the decision was made after careful consideration.The withdrawal of the registration application will not have a significant impact on the company's current operating results, but will increase the development time and uncertainties of related products. please the majority of investors rational investment, pay attention to investment risk.
hereby announce
Zhejiang Jianfeng Group Co., Ltd. Board of Directors
January 21, 2016
More information
In March, the authoritative organization of the cement industry successively released two series of lists of China's top 500 building materials enterprises in 2022 and China's top 100 cement clinker production capacity in 2022. Jianfeng Group ranked among the "top 100" in the two lists ". The list of China's top 500 building materials enterprises was officially released in early March. This series of lists was selected by the China Building Materials Enterprise Management Association. Through more than 20 years of comprehensive data research on China's building materials industry, referring to international practices, the rankings are based on the company's annual operating income., Cement products, building ceramics, waterproof materials, aluminum-plastic profiles, coatings, glass, building materials equipment manufacturing and other sub-industries related to building materials. Jianfeng Group ranks 96th among the companies on the list and 27th among the cement manufacturers on the list. On March 16, the awarding ceremony of 2022 China's top 100 cement clinker production capacity list was held in Hangzhou. This series of lists is released by China Cement Network, an authoritative organization in China's cement industry. The ranking is based on the total production capacity (excluding the production capacity of other kiln types and grinding stations) of new dry clinker production lines completed and put into operation by Chinese cement enterprises in China as of December 31, 2022. The data statistics are calculated based on the design production capacity and 310 days of annual operation. Jianfeng Group ranked 53rd with an annual design capacity of 3.627 million tons. (this newspaper reporter)
2023
03-21
Company sends off retired employees
On the morning of February 22, the trade union of the group company held a simple and warm farewell party for retired employees in 2021-2022. More than 50 retired employees gathered together to discuss and exchange with Jiang Xiaomeng and other group leaders.
2023
03-04
On the first day of the new year, group leaders went to the grassroots level.
On January 29, the first day of work after the Spring Festival holiday, the leaders of the group company made a video connection to subordinate enterprises stationed abroad, and separately visited the gold enterprises to learn about the resumption of work and put forward requirements for the implementation of the work plan for the new year.
2023
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Group Companies Commend 2022 Advanced
On the morning of January 18, the group company held the 2022 annual summary commendation meeting to review the work of the previous year, make arrangements for the work in 2023, sign the 2023 economic responsibility system with various professional companies and directly affiliated enterprises, and solemnly commend the 2022 advanced collectives and individuals.
2023
01-29
Jiang Xiaomeng re-elected chairman of the Municipal Federation of Industry and Commerce
On December 24, 2022, the Jinhua Federation of Industry and Commerce (General Chamber of Commerce) held the seventh member representative meeting. Jiang Xiaomeng, secretary of the party committee and chairman of the group company, was re-elected as the chairman of the Municipal Federation of Industry and Commerce at this meeting.
2023
01-12
Peak Pharmaceutical Donates Epidemic Prevention Materials
Since the optimization and adjustment of the new crown infection epidemic management policy, there has been an explosive growth of infected people in the country, and the pressure on the supply of related materials has increased sharply. Before and after New Year's Day, the company has twice organized epidemic prevention materials, through the Jinhua City Charity Federation, Jinhua City Economic and Technological Development Zone Charity Federation targeted donations, a total value of more than 200,000 yuan.
2023
01-12