Announcement of Jianfeng Group Lin2017 -005 on Subsidiary Obtaining Drug Clinical Trial Approval
Release time:
2020-08-05
Securities Code: 600668 Securities Abbreviations: Jianfeng Group Number: Pro 2017-005
Bond Abbreviations: 13 Peak 01 Bond Code: 122227
Bond Abbreviations: 13 Peak 02 Bond Code: 122344
Zhejiang Jianfeng Group Co., Ltd.
Announcement on Subsidiaries Obtaining Approval for Drug Clinical Trials
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 .
1. Summary
Recently, Zhejiang Jianfeng Pharmaceutical Co., Ltd. (hereinafter referred to as "Jianfeng Pharmaceutical"), a subsidiary of the Company, received the "Drug Clinical Trial Approval Document" (Deoxypodophyllotoxin for Injection, Approval Document No.: 2017L01082 ) and (Deoxypodophyllotoxin, Approval Document No: 2017L01083)(hereinafter collectively referred to as "DPT"). The relevant details are hereby announced as follows:
2. drug basic information content
(I) deoxypodophyllotoxin
drug name: deoxypodophyllotoxin
English name: Deoxypodophyllotoxin
dosage form: bulk drug
application items: domestic Drug Registration
Registration Classification: Chemical Drug Class 1
Applicant: Zhejiang Jianfeng Pharmaceutical Co., Ltd. and China Pharmaceutical University
Approval Conclusion: "According to the the People's Republic of China Drug Administration Law and relevant regulations, after examination, this product meets the relevant requirements of drug registration and agrees to conduct clinical trials of this product preparation."
(II) deoxypodophyllotoxin for injection
drug name: deoxypodophyllotoxin for injection
English name: Deoxypodophyllotoxin for Injection
dosage form: injection
application items: domestic drug registration
specification: 100mg
registration classification: chemical drugs category 1
applicant: Zhejiang Jianfeng pharmaceutical co., ltd. and China pharmaceutical university
approval conclusion: "according to the the People's Republic of China drug administration law and relevant regulations, after examination, this product meets the relevant requirements of drug registration and agrees to carry out clinical trials."
Research and Development and Registration of 3. Drugs
DPT Project was established in March 104 by 2012. Jianfeng Pharmaceutical Co., Ltd. is a new anti-tumor drug developed in cooperation with China Pharmaceutical University. The registration classification belongs to Class 1 of chemical drugs. The first DPT clinical trial application submitted by Jianfeng Pharmaceutical was accepted on July 27, 2016 (acceptance numbers: CXHL1600201 Zhejiang, CXHL1600202 Zhejiang). DPT is an alkaloid antineoplastic drug with tentative indications for lung cancer, breast cancer and gastric cancer, which will be finalized based on clinical trial results. As of the date of this announcement, the accumulated research and development investment and other related expenditures of the DPT project of Jianfeng Pharmaceutical Co., Ltd. totaled about 34.12 million yuan.
Market Situation of Similar Drugs in 4.
Currently, the same alkaloid anti-tumor drugs listed in China mainly include paclitaxel, vinorelbine and docetaxel. The main manufacturers of paclitaxel injection include Yangzijiang Pharmaceutical Group Co., Ltd., Beijing Shuanglu Pharmaceutical Co., Ltd., Haizheng Pfizer Pharmaceutical Co., Ltd., etc, the main manufacturers of Vinorelbine include Jiangsu Haosen Pharmaceutical Group Co., Ltd., Jiangsu Hengrui Pharmaceutical Co., Ltd., Haizheng Pfizer Pharmaceutical Co., Ltd., etc., and the main manufacturers of docetaxel injection include Jiangsu Hengrui Pharmaceutical Co., Ltd., Yangtze River Pharmaceutical Group Co., Ltd.
According to IMS database statistics, the global sales of the above three drugs in 2015 were 16.46, 1.07 and 0.669 billion US dollars respectively, totaling 2.422 billion US dollars.
5. products still need to go on the market.
DPT is currently in the approved clinical trial stage. Jianfeng Pharmaceutical will complete the clinical trial according to the requirements of the "Drug Clinical Trial Approval". After the clinical trial is completed, it will declare for production. It can only produce and market after passing the review and approval of CFDA and obtaining the drug production approval.
Impact of 6. on Listed Companies and Risk Tips
The company has obtained the "Drug Clinical Trial Approval" this time, which will not have a significant impact on the company's recent operating results.
Due to the particularity of drug research and development, there are unpredictable risks such as long cycle and many links from clinical trials to commissioning. There are many uncertainties in the progress and results of clinical trials and the future product market competition situation. The company will be based on the progress of research and development in a timely manner to fulfill the obligations of information disclosure, so that the majority of investors pay attention to investment risks.
hereby announce
Zhejiang Jianfeng Group Co., Ltd. Board of Directors
March 22, 2017
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
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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)
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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)
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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)
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