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
More information
Company fully deploys 2019 work
On January 28, the group company held a business analysis meeting to review and summarize the work situation in 2018, arrange and deploy the work for the new year, and put forward work requirements. At the meeting, various professional companies and directly affiliated enterprises made reports on the overall work situation in 2018, focusing on analyzing the existing problems and deficiencies, and proposing corresponding solutions and work plans for 2019. Xiang Chongping, deputy general manager of the group company, made a systematic review of the current human resources efficiency and human resources development of the company. Chen Tianci, chairman of the board of supervisors, made a report and analysis on the internal control, safety and environmental protection work in 2018. Lan Xiaolong, head of finance, analyzed the risks and challenges currently faced by the company according to the operating data and financial situation of its subordinate enterprises. The functional departments and offices of the headquarters also made a brief report on their annual work. Yu Jianhong, general manager of the group company, made a comprehensive review of the company's operation in 2018 and made a comparative analysis of the main economic indicators of each industrial sector. In 2018, the operating indicators of the company's various industrial sectors have improved significantly year-on-year, and the group company has also created the best operating performance in history. All units have completed the formulation of the second round of "three-year business plan", which points out the direction for the next three years of business work; the group company has also completed the first draft of the new "five-year strategic development plan", which is being revised and enriched. In addition, the two main businesses have also made substantial progress in investment expansion and industrial integration around strategic objectives, and the operating costs of major enterprises have decreased to varying degrees; the optimization of organizational structure and post setting has achieved new results, and management efficiency and people
2020
07-22
Company fully deploys 2019 work
On January 28, the group company held a business analysis meeting to review and summarize the work situation in 2018, arrange and deploy the work for the new year, and put forward work requirements. At the meeting, various professional companies and directly affiliated enterprises made reports on the overall work situation in 2018, focusing on analyzing the existing problems and deficiencies, and proposing corresponding solutions and work plans for 2019. Xiang Chongping, deputy general manager of the group company, made a systematic review of the current human resources efficiency and human resources development of the company. Chen Tianci, chairman of the board of supervisors, made a report and analysis on the internal control, safety and environmental protection work in 2018. Lan Xiaolong, head of finance, analyzed the risks and challenges currently faced by the company according to the operating data and financial situation of its subordinate enterprises. The functional departments and offices of the headquarters also made a brief report on their annual work. Yu Jianhong, general manager of the group company, made a comprehensive review of the company's operation in 2018 and made a comparative analysis of the main economic indicators of each industrial sector. In 2018, the operating indicators of the company's various industrial sectors have improved significantly year-on-year, and the group company has also created the best operating performance in history. All units have completed the formulation of the second round of "three-year business plan", which points out the direction for the next three years of business work; the group company has also completed the first draft of the new "five-year strategic development plan", which is being revised and enriched. In addition, the two main businesses have also made substantial progress in investment expansion and industrial integration around strategic objectives, and the operating costs of major enterprises have decreased to varying degrees; the optimization of organizational structure and post setting has achieved new results, and management efficiency and people
2020
07-31
The truth about private equity investments you need to know.
China Securities Regulatory Commission Zhejiang Regulatory Bureau and China Securities Investor Protection Fund Co., Ltd. jointly launched the "those private equity fund investment truth you need to know" investment education products. With the outbreak of private equity investment, the proportion of individual investors has further increased, and there are more and more "rich myth" scams. But the things behind "private placement" may not be as simple as you think, and risk prevention knowledge needs to be known early.
2020
07-31
The truth about private equity investments you need to know.
China Securities Regulatory Commission Zhejiang Regulatory Bureau and China Securities Investor Protection Fund Co., Ltd. jointly launched the "those private equity fund investment truth you need to know" investment education products. With the outbreak of private equity investment, the proportion of individual investors has further increased, and there are more and more "rich myth" scams. But the things behind "private placement" may not be as simple as you think, and risk prevention knowledge needs to be known early.
2020
07-30
The truth about private equity investments you need to know.
China Securities Regulatory Commission Zhejiang Regulatory Bureau and China Securities Investor Protection Fund Co., Ltd. jointly launched the "those private equity fund investment truth you need to know" investment education products. With the outbreak of private equity investment, the proportion of individual investors has further increased, and there are more and more "rich myth" scams. But the things behind "private placement" may not be as simple as you think, and risk prevention knowledge needs to be known early.
2020
07-31
Chairman Jiang Xiaomeng Directs Work in Yunnan Peak
On December 16, Jiang Xiaomeng, Secretary of the Party committee and chairman of the group company, went to Yunnan Jianfeng cement company to investigate and guide the work. On the morning of the same day, accompanied by the Yunnan peak management team, Jiang Xiaomeng went deep into the front line and successively went to the central control room of the production and manufacturing department, the raw material clay yard, the lignite yard and other areas for field investigation and investigation to understand the problems existing in the production and operation process. Subsequently, a business analysis meeting was held to make a comparative analysis of the various business indicators of Yunnan Jianfeng from January to November this year, and put forward two requirements to the management team: further strengthen internal management and improve execution; strengthen the coordination of external relations, and improve The ability and level of enterprise resource acquisition. At the Yunnan Jianfeng middle-level cadre meeting held on the afternoon of the 16th, Jiang Xiaomeng first fully affirmed Yunnan Jianfeng's highest output and best benefits since it was put into production in 2018, and expressed his gratitude to all cadres and employees of Yunnan Jianfeng for their hard work. After that, Jiang Xiaomeng made a detailed analysis of the cement industry and the regional market environment in Yunnan, and combined with the current production and operation situation of Yunnan Jianfeng, put forward the focus of the next step: 1. should fully attach importance to and mobilize the initiative and responsibility of employees at all levels to improve the overall execution of the team; 2. raw material mines are an important factor restricting the future development of cement enterprises, which should be paid full attention to and formulate clear strategies and methods, set out a timetable to obtain future production resources as much as possible; 3. continuously advocate and promote technological innovation, keep pace with the times, continuously improve production management, equipment management, production technology level, and maintain the competitive advantage of the industry; 4. further strengthen production
2020
07-31
Contact Us
No. 88 Wujiang East Road, Jinhua City, Zhejiang Province, China
Tel: +86-579-82326868
Fax : +86-579-82324666
©2023 Zhejiang Jianfeng Group Co., Ltd. Powered by: www.300.cn SEO Business License
SAF Coolest v1.2 设置面板 SHJSS-AHDB-FSSQE-ZSW
无数据提示
Sorry, the current column has no content !
You can view other columns or return to Home Page