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
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