Announcement on Subsidiary Obtaining Notice of Approval for Drug Clinical Trials
Release time:
2021-05-20
Securities Code: 600668 Securities Abbreviation: Jianfeng Group No: pro 2020-018
Zhejiang Jianfeng Group Co., Ltd.
Announcement on Subsidiaries Obtaining Notice of 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 .
Important Note:
- Company's approval notice for drug clinical trials will not have a significant impact on the company's recent operating results.
- Risk Warning: Due to the particularity of drug research and development, the pre-development of drugs and the long cycle and many links of products from development, clinical trials to production are susceptible to some uncertain factors, clinical trial progress, There are many uncertainties in the results and the future product market competition situation.
1. Summary
Recently, Zhejiang Jianfeng Yien Biotechnology Co., Ltd. (hereinafter referred to as "Jianfeng Yien") , , a holding subsidiary of Zhejiang Jianfeng Pharmaceutical Co., Ltd., the company's holding subsidiary, received the "Drug Clinical Trial Approval Notice" approved and issued by the State Food and Drug Administration, "JFAN-1001 Capsule, Notice No: 2020LP00246 " and "JFAN-1001 Capsules, Notification No: 2020LP00247 ". The relevant details are hereby announced as follows:
2. drug basic information content
drug name: JFAN-1001 capsule
English name: JFAN-1001Capsule
dosage form: capsule
application item: clinical research application
specification: 10mg , 30mg
registration classification: chemical drugs category
applicant: Zhejiang Jianfeng yien biotechnology co., ltd
approval conclusion: "according to the the People's Republic of China drug administration law and relevant regulations, after examination, 2020 6 February 7 accepted JFAN-1001 glue capsule meets the relevant requirements of drug registration and agrees to carry out clinical trials according to the submitted plan."
3. Drug Research and Development and Registration
JFAN-1001 is a new anti-tumor drug developed by Jianfeng Yien. The registration classification belongs to chemical drug 1 . Jianfeng Yien first submitted JFAN-1001 clinical trial application and was accepted on 2020 6 January 7 (acceptance numbers: CXHL2000255 , CXHL2000256 ). JFAN-1001 is a small molecule antineoplastic agent with indications for EGFR-T790M secondary mutation-positive locally advanced or metastatic non-squamous non-small cell lung cancer. As of the date of this announcement, the accumulated research and development expenses and technical investment of the project totaled about 4676.04 .03 million yuan.
Market Situation of Similar Drugs in 4.
Currently, targeted drugs for epidermal growth factor receptor (EGFR ) inhibitors listed in China include: the first generation EGFR inhibitors include gefitinib, erlotinib and icotinib; The second generation EGFR inhibitors include afatinib and dacotinib; the third generation EGFR inhibitor includes AstraZeneca's osimertinib, which was approved for listing in the United States on November 11, 2009, , , , and approved for listing in China on March 122, , 2017, . AstraZeneca global annual sales of osimertinib in 2019, , .7 billion (source: 2019# AstraZeneca Annual Financial Statement for 129), almetinib of Jiangsu Haosen Pharmaceutical Co., Ltd. was approved to be listed in China in January , March this year. The company's JFAN-1001 is the third generation EGFR inhibitor with the same target as osimertinib, at present, similar drugs in the clinical research stage include efitinib of Shanghai Alex pharmaceutical technology co., ltd., avetinib of Hangzhou essen pharmaceutical research co., ltd., Nanjing shenghe pharmaceutical co., ltd. SH-1028 , Jiangsu osaikang pharmaceutical co., ltd. ASK120067 , Jiangsu runxin biotechnology co., ltd. RX518 and many other enterprises. Approval Procedure for 5. Products to Be Listed Jianfeng Yien will conduct clinical trials according to the requirements of the Notice of Approval of Drug Clinical Trials. After the clinical trials are completed, production will be declared. Production and marketing can only be carried out after passing the review and approval of the State Food and Drug Administration and obtaining the approval documents for drug production. 6. Impact on Listed Companies and Risk Tips
The company's approval notice for drug clinical trials will not have a significant impact on the company's recent operating results. Due to the particularity of drug research and development, the pre-development of drugs and the long cycle and many links from development, clinical trials to production of products are easily affected by some uncertain factors. 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 August 19, 2020
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