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
2020
07-31
Daye Peak Declared 4 Invention Patents Last Year
In 2019, Daye Jianfeng Cement Company changed its thinking, actively explored and tested the use of new materials, and summarized the research results in a timely manner, and successively declared 4 invention patents. In the production process of low-alkali cement, Daye Peak changed the traditional scheme of using high-grade sandstone ingredients alone to replace part of the sandstone and part of the iron correction material with iron ore waste soil, which not only controlled the alkali content in the clinker, but also increased the Al2O3 content in the clinker, ensuring the easy burnability and high early strength of the clinker. Innovation has also been made in the raw material batching scheme, breaking the original high-grade and low-grade sandstones used together and changing them to separate batching of high-grade and low-grade sandstones respectively, thus avoiding the disadvantage of easy material segregation in the process of high-grade and low-grade sandstones used together. At the same time, the original four-component batching is changed to five-component batching, so that low-alkali clinker can be freely switched, which is convenient for production organization and production cost. On the basis of a series of innovative achievements, Daye Peak declared four invention patents in 2019: "a technology for producing clinker from gas sludge and dust collection in steel mills", "a method for treating sludge in machine-made sand mills", "an improvement in raw material batching method" and "a technology for producing low cement from iron ore mining waste soil", all of which have high practical value. (Fan Liangwu)
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On January 14, the Party Committee of the Group Company held a summary meeting on the theme of "Do not forget your initiative mind, Keeping in mind the mission" to comprehensively summarize the progress and effectiveness of the theme education work, and on this basis further put forward the requirements for strengthening Party building. At this point, the theme education of "Do not forget your initiative mind, Keeping in Mind Mission" has been successfully concluded. Although according to the arrangement of the central government, the theme education of "Do not forget your initiative mind, Keeping in mind the mission" will start in September 2019, since the central government issued the relevant documents on the theme education of "Do not forget your initiative mind, Keeping in mind the mission", the Party committee of the group company has started to prepare in advance and organized and studied the spirit of General Secretary Xi Jinping's important speech on "Do not forget your initiative mind, Keeping in mind. Party organizations at all levels plan ahead and make full use of the "Peak News", publicity boards, party-mass activity rooms, WeChat public accounts and other media to carry out various forms of publicity to guide the majority of party members and cadres to deeply understand the important content and significance of the theme education. On June 29, the Party committee of the group company and the Party branch of Jiangbei sub branch of China Merchants Bank jointly organized party members and cadres to visit the old revolutionary base area of yinkeng village, Shafan Township, Jinhua. By reviewing the revolutionary history of the ancestors, studying the party history, reviewing the oath of joining the party, and strengthening the belief of striving for the party for the whole life, Further deeply understand the original intention and mission of seeking happiness for the Chinese people and rejuvenation of the Chinese nation. After the second batch of "Do not forget your initiative mind, Keeping in Mind Mission" thematic education officially started in September, the Party Committee of the Group Company held a thematic education arrangement meeting in a timely manner and set up a thematic education leader composed of Party Secretary Jiang Xiaomeng as the team leader and all Party committee members.
2020
07-31
City Red Cross thanks spike help "anti-epidemic"
On February 26, Jinhua City Red Cross Party Secretary, Executive Vice President Shi Yiwei and his entourage to visit the peak, the peak in the prevention and control of the new coronary pneumonia epidemic actively contribute to love, brave social responsibility of the great love and kindness to express gratitude. Jiang Xiaomeng, chairman of the group company, Huang Jinlong, deputy general manager of the group company and general manager of the pharmaceutical company, and Xiang Chongping, deputy general manager of the group company, had a discussion with Vice President Shi Yiwei and his party. In order to solve the difficult problems for caring enterprises to resume work and production, the Municipal Red Cross Society, based on its own functional positioning and giving full play to its unique advantages, conducted a large feedback and return visit to caring enterprises, and jointly established three Red Cross volunteer service teams, including traditional Chinese medicine service, psychological assistance, and emergency rescue training, to take "eight measures" to help caring enterprises resume work and production. Vice President Shi Yiwei led the backbone of three volunteer service teams to the peak for a return visit, expressing his gratitude for the contribution made by the peak in the prevention and control of the new coronary pneumonia epidemic, and sent a letter of thanks and the "New Coronary Pneumonia Prevention and Control Enterprises Resuming Work and Resuming Production Protection Manual". Chairman Jiang Xiaomeng introduced the industrial layout, production and operation of the peak, focusing on the resumption of work and production of the peak enterprises, and put forward opinions and suggestions on the reduction and exemption of basic electricity charges for enterprises, the support policies for small and medium-sized enterprises, and the payment of "five insurance and one fund. (Reporter Ni Yingzhen)
2020
07-30
City Red Cross thanks spike help "anti-epidemic"
On February 26, Jinhua City Red Cross Party Secretary, Executive Vice President Shi Yiwei and his entourage to visit the peak, the peak in the prevention and control of the new coronary pneumonia epidemic actively contribute to love, brave social responsibility of the great love and kindness to express gratitude. Jiang Xiaomeng, chairman of the group company, Huang Jinlong, deputy general manager of the group company and general manager of the pharmaceutical company, and Xiang Chongping, deputy general manager of the group company, had a discussion with Vice President Shi Yiwei and his party. In order to solve the difficult problems for caring enterprises to resume work and production, the Municipal Red Cross Society, based on its own functional positioning and giving full play to its unique advantages, conducted a large feedback and return visit to caring enterprises, and jointly established three Red Cross volunteer service teams, including traditional Chinese medicine service, psychological assistance, and emergency rescue training, to take "eight measures" to help caring enterprises resume work and production. Vice President Shi Yiwei led the backbone of three volunteer service teams to the peak for a return visit, expressing his gratitude for the contribution made by the peak in the prevention and control of the new coronary pneumonia epidemic, and sent a letter of thanks and the "New Coronary Pneumonia Prevention and Control Enterprises Resuming Work and Resuming Production Protection Manual". Chairman Jiang Xiaomeng introduced the industrial layout, production and operation of the peak, focusing on the resumption of work and production of the peak enterprises, and put forward opinions and suggestions on the reduction and exemption of basic electricity charges for enterprises, the support policies for small and medium-sized enterprises, and the payment of "five insurance and one fund. (Reporter Ni Yingzhen)
2020
07-31
City Red Cross thanks spike help "anti-epidemic"
On February 26, Jinhua City Red Cross Party Secretary, Executive Vice President Shi Yiwei and his entourage to visit the peak, the peak in the prevention and control of the new coronary pneumonia epidemic actively contribute to love, brave social responsibility of the great love and kindness to express gratitude. Jiang Xiaomeng, chairman of the group company, Huang Jinlong, deputy general manager of the group company and general manager of the pharmaceutical company, and Xiang Chongping, deputy general manager of the group company, had a discussion with Vice President Shi Yiwei and his party. In order to solve the difficult problems for caring enterprises to resume work and production, the Municipal Red Cross Society, based on its own functional positioning and giving full play to its unique advantages, conducted a large feedback and return visit to caring enterprises, and jointly established three Red Cross volunteer service teams, including traditional Chinese medicine service, psychological assistance, and emergency rescue training, to take "eight measures" to help caring enterprises resume work and production. Vice President Shi Yiwei led the backbone of three volunteer service teams to the peak for a return visit, expressing his gratitude for the contribution made by the peak in the prevention and control of the new coronary pneumonia epidemic, and sent a letter of thanks and the "New Coronary Pneumonia Prevention and Control Enterprises Resuming Work and Resuming Production Protection Manual". Chairman Jiang Xiaomeng introduced the industrial layout, production and operation of the peak, focusing on the resumption of work and production of the peak enterprises, and put forward opinions and suggestions on the reduction and exemption of basic electricity charges for enterprises, the support policies for small and medium-sized enterprises, and the payment of "five insurance and one fund. (Reporter Ni Yingzhen)
2020
07-31