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
"We were also praised by the traffic police." On September 26, when talking about the civilized travel volunteer activities a few days ago, Li Xuegen of the big pharmacy smiled and was very happy that his work was recognized. Starting from May this year, during the rush hour on the 5th and 20th of each month (weekends and holidays are postponed), there will be a group of volunteers wearing red vests and hats, holding signs with the words "courtesy of zebra crossing, civilized crossing of the road" to divert traffic at many intersections in the city. This is a civilized travel volunteer service activity carried out by Jinhua City to further promote civilized travel and persuade uncivilized behavior. As a civilized unit at the municipal level in Jinhua, Jianfeng Group's duty junction is at the intersection of Bayi North Street and Zhongshan West Road. Before the activity was carried out, as the organizer of the group company, the group office had deep concerns. The activity took a long time and required a lot of manpower. As an enterprise, under the condition of ensuring normal production, it was completed by employees in their spare time. Can it be continued? To this end, Xiang Chongping, the leader in charge of the group company, specially organized a meeting of the directors of the subordinate enterprise offices to mobilize and deploy the matter. The group office also specially established the QQ group of "Peak Civilized Travel Volunteer Service" to release the contents and arrangements of the activities, update the duty situation, and praise the small partners on duty. At the beginning of the activity, colleagues in the headquarters building took the lead in taking up their posts. The first class was Li Hong, Li Xia, Yang Liu and Lei Yuan of the finance department of the group company. Employees of the group office, the peak health experience hall, Qiubin Factory and the international trading company also took up their posts one after another. Other enterprises also took part in an orderly manner according to the duty schedule.
2020
07-31
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2020
07-30
The company's two projects received financial subsidies for the integration of the two.
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2020
07-31
Daye peak won the title of "best integrity enterprise"
On September 4, daye city held a grand commendation meeting, daye peak cement company as the "best integrity enterprise" was commended. This is also the first time that Daye City has selected and commended the "Best Integrity Enterprise". In order to commend the advanced, promote righteousness, establish models, give full play to the role of demonstration and leadership, further encourage and stimulate the enthusiasm of enterprises and employees, unswervingly strengthen the construction of spiritual civilization and credit system in Daye City, and promote the economy of local enterprises. Good and fast development. The Daye City Federation of Trade Unions and the Office of the Spiritual Civilization Construction Committee initiated the selection and recognition of the best honest enterprises, the best honest teams, and the most beautiful honest employees throughout the city. After recommendation, review, evaluation, and publicity procedures, a total of 10 "best integrity enterprises", 10 "best integrity teams", and 20 "most beautiful integrity employees" in Daye City were selected. At the commendation meeting on September 4, Xu Yilong, member of the standing Committee of the Daye Municipal CPC Committee, minister of the United Front work, and chairman of the Municipal Federation of Trade unions, spoke highly of the scientific management and honest operation of Daye Jianfeng cement Company in recent years. I hope Daye Jianfeng can cherish the honor, give full play to its exemplary and leading role, forge ahead, and achieve better results. Xu Yilong also asked the city's enterprises, teams and employees to follow the example of award-winning units and individuals, further emancipate their minds, change their production and management concepts, establish a career with integrity, be honest, and make new contributions to serving the economic development of Daye City. (Zhu Yong)
2020
07-30
Daye peak won the title of "best integrity enterprise"
On September 4, daye city held a grand commendation meeting, daye peak cement company as the "best integrity enterprise" was commended. This is also the first time that Daye City has selected and commended the "Best Integrity Enterprise". In order to commend the advanced, promote righteousness, establish models, give full play to the role of demonstration and leadership, further encourage and stimulate the enthusiasm of enterprises and employees, unswervingly strengthen the construction of spiritual civilization and credit system in Daye City, and promote the economy of local enterprises. Good and fast development. The Daye City Federation of Trade Unions and the Office of the Spiritual Civilization Construction Committee initiated the selection and recognition of the best honest enterprises, the best honest teams, and the most beautiful honest employees throughout the city. After recommendation, review, evaluation, and publicity procedures, a total of 10 "best integrity enterprises", 10 "best integrity teams", and 20 "most beautiful integrity employees" in Daye City were selected. At the commendation meeting on September 4, Xu Yilong, member of the standing Committee of the Daye Municipal CPC Committee, minister of the United Front work, and chairman of the Municipal Federation of Trade unions, spoke highly of the scientific management and honest operation of Daye Jianfeng cement Company in recent years. I hope Daye Jianfeng can cherish the honor, give full play to its exemplary and leading role, forge ahead, and achieve better results. Xu Yilong also asked the city's enterprises, teams and employees to follow the example of award-winning units and individuals, further emancipate their minds, change their production and management concepts, establish a career with integrity, be honest, and make new contributions to serving the economic development of Daye City. (Zhu Yong)
2020
07-31
Daye peak won the title of "best integrity enterprise"
On September 4, daye city held a grand commendation meeting, daye peak cement company as the "best integrity enterprise" was commended. This is also the first time that Daye City has selected and commended the "Best Integrity Enterprise". In order to commend the advanced, promote righteousness, establish models, give full play to the role of demonstration and leadership, further encourage and stimulate the enthusiasm of enterprises and employees, unswervingly strengthen the construction of spiritual civilization and credit system in Daye City, and promote the economy of local enterprises. Good and fast development. The Daye City Federation of Trade Unions and the Office of the Spiritual Civilization Construction Committee initiated the selection and recognition of the best honest enterprises, the best honest teams, and the most beautiful honest employees throughout the city. After recommendation, review, evaluation, and publicity procedures, a total of 10 "best integrity enterprises", 10 "best integrity teams", and 20 "most beautiful integrity employees" in Daye City were selected. At the commendation meeting on September 4, Xu Yilong, member of the standing Committee of the Daye Municipal CPC Committee, minister of the United Front work, and chairman of the Municipal Federation of Trade unions, spoke highly of the scientific management and honest operation of Daye Jianfeng cement Company in recent years. I hope Daye Jianfeng can cherish the honor, give full play to its exemplary and leading role, forge ahead, and achieve better results. Xu Yilong also asked the city's enterprises, teams and employees to follow the example of award-winning units and individuals, further emancipate their minds, change their production and management concepts, establish a career with integrity, be honest, and make new contributions to serving the economic development of Daye City. (Zhu Yong)
2020
07-31