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
11-03
Jinhua Municipal Party Committee Secretary Chen Long: I wish your enterprise better and better
On the morning of October 16, Chen long, secretary of the Jinhua Municipal CPC Committee, and his entourage came to the construction site of Jianfeng Pharmaceutical's internationalization project to investigate and affirmed the good development status and clear future development ideas of Jianfeng Pharmaceutical. At the construction site, Jiang Xiaomeng, chairman of the group company and chairman of the pharmaceutical company, introduced the overall situation of the investment scale, factory layout, and production direction of the Jianfeng Pharmaceutical internationalization project to Chen Long and his entourage. Huang Jinlong, general manager of the pharmaceutical company, accompanied Chen Long and his entourage to visit the preparation workshop under construction. The construction site is neat, tidy and orderly, and the facilities and equipment are perfect and advanced, all have been unanimously affirmed by the leaders who came to investigate. When learning that the peak internationalization project has introduced international advanced equipment, built in accordance with European and American standards, and its products are oriented to the international market, Chen long said happily: "your goals are very clear and your thinking is very clear. I wish your enterprise better and better!" (this newspaper reporter)
2020
10-23
Liu Haiping, vice mayor of Pu'er City, said during the survey: "Peak is an enterprise with feelings"
On September 30, Liu Haiping, member of the standing Committee of the Pu'er Municipal CPC Committee and vice mayor of Pu'er City, Yunnan Province, and relevant responsible persons of Pu'er City and Simao District, visited the company for investigation and research, and communicated with the leaders of the group company on topics such as further strengthening cooperation between the two sides. "Yunnan Jianfeng has not only developed well in Pu'er these years, achieved good benefits and contributed considerable tax revenue, but also made great contributions to promoting the economic development of Pu'er and the stability of the southwest border region. It is our 'star enterprise' and 'baby enterprise '." Liu Haiping said so in the exchange. He said that Pu'er is an important window for the implementation of the "Belt and Road" concept. It has good conditions in natural resources, transportation, electricity, etc., and the peak is a "sentimental enterprise" and has a good foundation in the local area. Strengthen cooperation; various government departments will also earnestly "stand on the platform" and "do a good job as a shopkeeper" to serve enterprises. Chairman Jiang Xiaomeng and General Manager Yu Jianhong exchanged views with Liu Haiping and his party on the layout of peak industry and strengthening cooperation with Pu 'er. After that, accompanied by General Manager Yu Jianhong and Deputy General Manager Huang Jinlong, Liu Haiping and his party visited the Jinxi Factory of Jianfeng Pharmaceutical Factory. (this newspaper reporter)
2020
10-09
The first batch of Jianfeng Pharmaceuticals to enter Jinhua (Shanghai) Science and Technology Center
News from our newspaper On September 16, at the unveiling ceremony of the Yangtze River Delta G60 Jinhua (Shanghai) Science and Technology Innovation Center and Jinhua (Shanghai) Talent Building, Jiang Xiaomeng, chairman of the group company and chairman of the pharmaceutical company, took over from Chen Long, secretary of the Jinhua Municipal Party Committee. The golden key with big red flowers. Spike Pharmaceuticals became one of the first seven companies to enter the center. The Yangtze River Delta G60 Jinhua (Shanghai) Science and Technology Center and Jinhua (Shanghai) Talent Building are the first "Science and Technology and Talent Enclave" in Shanghai in the nine cities of the Yangtze River Delta G60 Science and Technology Corridor, and the first cross-regional industrial collaborative innovation center in the Science and Technology Corridor. The center is located in Shanghai Lingang Songjiang Science and Technology City, with a total area of nearly 10,000 square meters. It includes two parts: science and technology innovation and talent service. There are five major centers, including talent service center, science and technology innovation exhibition center, business incubation center, enterprise research and development center, and talent project roadshow center. It is a science and technology innovation platform that integrates the functions of project incubation, recruitment of institutions, and talent recruitment. Chen Long, secretary of the Jinhua Municipal Party Committee, said in his speech at the unveiling ceremony that in the future, all scientific and technological enterprises stationed in Jinhua (Shanghai) Science and Technology Center and Talent Building can equally enjoy Jinhua's local science and technology and talent policies, so as to further break the space limitation, enable talents from the two places to share the most favorable treatment and convenient services, help enterprises to develop in Shanghai and achieve industrialization in Jinhua. At the ceremony, leaders such as Chen Long, secretary of the Jinhua Municipal Party Committee, and Cheng Xiangmin, secretary of the Shanghai Songjiang District Party Committee, awarded seven companies, including Jianfeng Pharmaceutical, the golden key to symbolize their entry. At the Yangtze River Delta Integrated Talent Cooperation Project Symposium held after the ceremony, Jiang Xiaomeng spoke as a representative of Jinhua entrepreneurs. He believed that Shanghai, as an international metropolis, has an agglomeration effect on high-end intellectual resources and grasps the first-class element resources of scientific and technological innovation in China and even the world. The establishment of G60 Jinhua (Shanghai) science and technology innovation center and talent building in the Yangtze River Delta helps Jinhua enterprises to take off in scientific and technological innovation and information exchange, which will provide strong and continuous scientific and technological support and intellectual support for the long-term development of enterprises in the future, and attract more excellent domestic and foreign talents to serve Jinhua enterprises, It plays a key role in further improving scientific research ability, innovation ability and personnel training. During the event, Jiang Xiaomeng successively accepted on-site interviews with "People's Daily", "Liberation Daily", "Zhejiang Daily" and other media. He said that the establishment of science and technology innovation and talent bases in Shanghai has greatly enhanced Jinhua's attractiveness to enterprises. "With this base, we don't need to introduce talents to Jinhua, but directly recruit talents in Shanghai, and at the same time enjoy Jinhua's various talent recruitment policies, and change Shanghai talents to Jinhua's use. This is a kind of bold. The innovation has greatly solved the dilemma of attracting talents for enterprises." As a settled enterprise, it will also make full use of its own advantages to continuously inject resource vitality into the science and technology innovation center, and continue to contribute to the long-term development of Jinhua's economy. (this newspaper reporter)
2020
09-22
Spike Pharmaceutical Added New Products
On September 3, Spike Pharmaceutical Company received the approval of the State Drug Administration for the registration of esomeprazole sodium for injection (approval number: 2020S00572). Esomeprazole sodium for injection is mainly used to treat low-risk patients with gastroesophageal reflux disease and acute gastric or duodenal ulcer bleeding when oral therapy is not applicable. It has been listed in the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List (2017 Edition) ", classified as Class B. According to industry statistics, 30 companies including Zhengda Tianqing and Qilu Pharmaceutical have been approved for listing in China. In 2019, domestic sales (including urban and county-level public hospitals, community and township health centers) were about 3.317 billion yuan. Jianfeng Pharmaceutical submitted an application for registration of esomeprazole sodium for injection to the State Food and Drug Administration in November 2013 and was accepted. Up to now, Jianfeng Pharmaceutical has invested nearly 15 million yuan in research and development for the project and has a corresponding production line. This time to obtain the injection of esomeprazole sodium drug registration approval, marking the peak pharmaceutical has the drug production, sales qualification, will further enrich the peak pharmaceutical product line, help to enhance the competitiveness of the peak pharmaceutical business. (Lu Yating, Liu Yang)
2020
09-11