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 the eastern corner of the production area of Jianfeng Health Technology Company, there is a very inconspicuous building. From below, only a few pipes of uneven thickness can be seen on the top and the slogan "Focus on Environmental Protection and Promote Sustainable Development" with red letters on the yellow background on the stainless steel guardrail. Walking up, you can only see several closed pools and a small room with stacks of documents, test tubes, glass bottles and other testing tools on the table. This is the peak and healthy sewage treatment station. The production sewage of the whole factory area is concentrated here. After adjustment (PH adjustment), pre-acidification, anaerobic, anoxic, aerobic (aeration), precipitation and other links, it is discharged into the pipe network after reaching the special discharge standard. Yin Zhiwu, executive deputy general manager of Jianfeng Health, said that because the sewage treatment station in Wucheng District has not yet been built, Jianfeng Health has not yet been able to achieve pipe discharge, and the relevant national laws have strict requirements on the discharge of water pollutants from the extraction pharmaceutical industry. Sewage discharge must reach a special discharge limit, that is, chemical oxygen demand (COD) must be less than 50 mg/L. Enterprise development and environmental protection are both the concept of peak health since its establishment. In March this year, on the basis of the original environmental protection facilities, Jianfeng Health carried out technical renovation of waste gas collection and treatment facilities, and at the same time installed a sealing cover on the sewage treatment station to realize the closed collection of waste gas. Since the trial operation of this facility in mid-May, the overall effect has been obvious. The original treatment tank would emit an unpleasant smell during work, but now the smell has been significantly reduced. Compared with the young enterprise of peak health, the relatively "older" peak pharmaceutical has more experience in sewage treatment and environmental protection. Akihama
2020
07-31
2016 Annual General Meeting of Shareholders
News from our newspaper On May 19, the on-site meeting of Jianfeng Group's 2016 Annual General Meeting of Shareholders was held in Conference Room 314 of Jianfeng Building to deliberate and pass the "2016 Annual Report on the Work of the Board of Directors" and other proposals. The meeting was convened by the board of directors of Jianfeng Group and chaired by Chairman Jiang Xiaomeng. A total of 6 shareholders and proxies attended the meeting, and the total number of voting shares held by them was 55,604,815, accounting for 16.16 of the total voting shares of the company. Some directors, supervisors and secretary of the board of directors of the company attended the meeting, and some senior managers attended the meeting as nonvoting delegates. The meeting was held and voted on by a combination of on-site voting and online voting, it deliberated and passed nine proposals, including the 2016 Work Report of the Board of Directors, the 2016 Work Report of the Board of Supervisors, the 2016 Financial Final Accounts Report, the 2016 Profit Distribution Proposal, the Proposal to Hire the Company's 2017 Audit Institution, the Proposal to Provide Guarantee to Holding Subsidiaries, the 2016 Annual Report and its Summary, the Election of Mr. Huang Sujian as Director of the Company and the Election of Mr. Chen Tianci as Supervisor of the Company. (Zhou Hengbin)
2020
07-31
2016 Annual General Meeting of Shareholders
News from our newspaper On May 19, the on-site meeting of Jianfeng Group's 2016 Annual General Meeting of Shareholders was held in Conference Room 314 of Jianfeng Building to deliberate and pass the "2016 Annual Report on the Work of the Board of Directors" and other proposals. The meeting was convened by the board of directors of Jianfeng Group and chaired by Chairman Jiang Xiaomeng. A total of 6 shareholders and proxies attended the meeting, and the total number of voting shares held by them was 55,604,815, accounting for 16.16 of the total voting shares of the company. Some directors, supervisors and secretary of the board of directors of the company attended the meeting, and some senior managers attended the meeting as nonvoting delegates. The meeting was held and voted on by a combination of on-site voting and online voting, it deliberated and passed nine proposals, including the 2016 Work Report of the Board of Directors, the 2016 Work Report of the Board of Supervisors, the 2016 Financial Final Accounts Report, the 2016 Profit Distribution Proposal, the Proposal to Hire the Company's 2017 Audit Institution, the Proposal to Provide Guarantee to Holding Subsidiaries, the 2016 Annual Report and its Summary, the Election of Mr. Huang Sujian as Director of the Company and the Election of Mr. Chen Tianci as Supervisor of the Company. (Zhou Hengbin)
2020
07-31
2016 Annual General Meeting of Shareholders
News from our newspaper On May 19, the on-site meeting of Jianfeng Group's 2016 Annual General Meeting of Shareholders was held in Conference Room 314 of Jianfeng Building to deliberate and pass the "2016 Annual Report on the Work of the Board of Directors" and other proposals. The meeting was convened by the board of directors of Jianfeng Group and chaired by Chairman Jiang Xiaomeng. A total of 6 shareholders and proxies attended the meeting, and the total number of voting shares held by them was 55,604,815, accounting for 16.16 of the total voting shares of the company. Some directors, supervisors and secretary of the board of directors of the company attended the meeting, and some senior managers attended the meeting as nonvoting delegates. The meeting was held and voted on by a combination of on-site voting and online voting, it deliberated and passed nine proposals, including the 2016 Work Report of the Board of Directors, the 2016 Work Report of the Board of Supervisors, the 2016 Financial Final Accounts Report, the 2016 Profit Distribution Proposal, the Proposal to Hire the Company's 2017 Audit Institution, the Proposal to Provide Guarantee to Holding Subsidiaries, the 2016 Annual Report and its Summary, the Election of Mr. Huang Sujian as Director of the Company and the Election of Mr. Chen Tianci as Supervisor of the Company. (Zhou Hengbin)
2020
07-30
Jianfeng Pharmaceutical Won Advanced Collective of Municipal Red Cross Humanitarian Promotion Award
On April 24, the Red Cross Society of Jinhua issued a circular commending the advanced units and individuals of the 2016 Red Cross Humanitarian Promotion Award. Peak Pharmaceutical Company won the Red Cross Humanitarian Promotion Award for Advanced Collective. The Red Cross is a social relief organization engaged in humanitarian work, with the purpose of carrying forward the spirit of humanity, fraternity and dedication, protecting human life and health, and promoting the cause of peace and progress of mankind. As a socially responsible enterprise, Jianfeng Pharmaceutical has always attached importance to public welfare and charity work, vigorously promoted the spirit of the Red Cross, and vigorously supported the work of the Red Cross with practical actions. In September 2016, at the theme publicity activity of "World First Aid Day" and the opening ceremony of the municipal Red Cross emergency rescue station (point), Huang Jinlong, deputy general manager of the group company and general manager of the pharmaceutical company, donated 6 AEDs known as "life-saving artifact" to the Red Cross on behalf of Jianfeng Pharmaceutical, it is equipped with six Red Cross emergency rescue service stations (points), namely, Jinhua high-speed railway station, sports center, cultural center, Shuanglong scenic spot, Siping village scenic spot and Suoyuan village scenic spot. The configuration of AED equipment has played a very good role in improving the emergency rescue capacity of Jinhua's key locations, and has been affirmed by the Red Cross and related units. (Spike Pharmaceuticals)
2020
07-31
Jingmai Airport Test Flight Successfully Runway Cement Spike Manufacturing
On April 7, a Boeing 737-700 aircraft of China Eastern Airlines Yunnan took off from Kunming. After completing two flight test subjects, it landed safely at Lancang Jingmai Airport. This not only marked the basic completion of the airport flight area, The official start of the test flight also marked that the "Peak" brand airport runway cement passed the first "final exam". Lancang Jingmai Airport is a major project with milestone significance in the history of Pu'er transportation construction. Since then, an air corridor connecting southwest Yunnan and Southeast Asia has been added between Kunming and Pu'er, which will greatly promote the development and utilization of tourism resources in Lancang, Menglian and Ximeng "Pu'er Green Triangle" area, and promote the sustainable development of local economy and society; it is of great significance to strengthen the city's national defense construction, maintain border stability, promote national unity, improve emergency rescue capabilities, and promote Pu'er's integration into the country's "Belt and Road" construction. Since the start of the construction of the airport, Yunnan Jianfeng has been paying close attention to it, organizing technical research and repeated tests, and finally produced high-quality airport runway special cement, and with excellent product quality, superior product performance and high-quality service, it has become a runway for Lancang Airport. Cement manufacturer. This not only fills the gap of "peak" airport special cement, but also is of great significance to promote the "peak" brand and improve the market influence of enterprises. It is understood that Jingmai Airport is initially confirmed to be officially opened to traffic at the end of May. (Li Liangping)
2020
07-31