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
Tianjin Flemish Company Donates Anti-epidemic Materials
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.
2020
08-05
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.
2020
08-05
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.
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.
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
07-31
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