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
Two Cement Enterprises Start to Implement "Big Patrol Inspection"
With the change of the competition situation in the industry, the profit space of cement production enterprises has been greatly squeezed. Reducing costs and increasing efficiency and job optimization have become the inevitable choice to improve the enterprise's own development ability and enhance the core competitiveness. In accordance with the requirements of the group company to realize the transformation from extensive management to lean management, combined with the advanced experience of peer enterprises, recently, Yunnan peak, daye peak two enterprises have implemented "big inspection" to promote the overall optimization of posts. On November 1, daye peak post inspection officially started full operation, starting from the limestone storage yard at the source of the production line to the cement storage. the original 15 posts were merged, and the best experienced mechanics, electricians and post workers were transferred to form a large inspection class, which was mainly responsible for on-site emergency disposal and post routine maintenance to ensure the normal production of the whole production line. In order to ensure the smooth implementation of the large-scale inspection, daye peak management team has repeatedly communicated and discussed with the heads of relevant workshops and departments, and held a special workshop post optimization promotion meeting in September to clarify objectives and responsibilities, formulate implementation steps, and do a lot of preparatory work. At the kick-off meeting for the implementation of the large-scale inspection on October 31, Zhang Fengliang asked daye peak employees to recognize the current situation of serious cement overcapacity and cruel market competition, understand the necessity of implementing the large-scale inspection, and asked the workshop leaders to do a good job in training and guiding the employees, shorten the transition period, normalize the operation of the large-scale inspection as soon as possible, and at the same time, managers should also change their working ideas and concepts and do a good job in full-time, strengthen the inspection, overhaul and maintenance of the regular day shift, and find and solve the problems existing in the equipment and process in time.
2020
07-31
Two Cement Enterprises Start to Implement "Big Patrol Inspection"
With the change of the competition situation in the industry, the profit space of cement production enterprises has been greatly squeezed. Reducing costs and increasing efficiency and job optimization have become the inevitable choice to improve the enterprise's own development ability and enhance the core competitiveness. In accordance with the requirements of the group company to realize the transformation from extensive management to lean management, combined with the advanced experience of peer enterprises, recently, Yunnan peak, daye peak two enterprises have implemented "big inspection" to promote the overall optimization of posts. On November 1, daye peak post inspection officially started full operation, starting from the limestone storage yard at the source of the production line to the cement storage. the original 15 posts were merged, and the best experienced mechanics, electricians and post workers were transferred to form a large inspection class, which was mainly responsible for on-site emergency disposal and post routine maintenance to ensure the normal production of the whole production line. In order to ensure the smooth implementation of the large-scale inspection, daye peak management team has repeatedly communicated and discussed with the heads of relevant workshops and departments, and held a special workshop post optimization promotion meeting in September to clarify objectives and responsibilities, formulate implementation steps, and do a lot of preparatory work. At the kick-off meeting for the implementation of the large-scale inspection on October 31, Zhang Fengliang asked daye peak employees to recognize the current situation of serious cement overcapacity and cruel market competition, understand the necessity of implementing the large-scale inspection, and asked the workshop leaders to do a good job in training and guiding the employees, shorten the transition period, normalize the operation of the large-scale inspection as soon as possible, and at the same time, managers should also change their working ideas and concepts and do a good job in full-time, strengthen the inspection, overhaul and maintenance of the regular day shift, and find and solve the problems existing in the equipment and process in time.
2020
07-31
Jiang Xiaomeng: A Centennial Enterprise with Craftsman Spirit
Editor's note: A few days ago, the United Front Work Department of the Jinhua Municipal Party Committee, the Municipal Federation of Industry and Commerce and other units jointly launched a large-scale publicity campaign of "2016 Faith and Good Commerce". On October 18, Jinhua media reporters walked into the peak and conducted a collective interview with Chairman Jiang Xiaomeng. On October 21, the front page of Jinhua Daily published an article entitled "Jiang Xiaomeng: A Centennial Enterprise with Craftsman Spirit" written by its reporter Zhang Shuai. This newspaper is reproduced. Jiang Xiaomeng: With the spirit of craftsmanship and a century-old enterprise, speaking of the 58-year development history of Jianfeng Group, Chairman Jiang Xiaomeng's face is filled with passion and confidence. As one of Jinhua's oldest established companies, Spike is more qualified than most companies to imagine a hundred years. In the past 58 years, the peak has experienced ups and downs. Every time it encounters a major turning point, generations of "peak people" have opened a new chapter with tireless efforts and simple wisdom. A set of data shows the development trend: in the first half of this year, the peak achieved operating income of 1.103 billion yuan, an increase of 4.15 percent over the same period last year, and the net profit attributable to the owners of the parent company was 0.103 billion yuan, an increase of 12.9 percent over the same period last year. These data in the current weak domestic economic development, has become more prominent. Someone once asked Jiang Xiaomeng, what is the craftsman spirit? He answered that the essence of the craftsman spirit lies in firmness, steadfastness and professionalism, which is a spirit of excellence and refinement of what you do and the quality of your products. And these are the true portrayal of the peak standing for 58 years, and it is also a model for our "wushang" group to stick to industry, operate with integrity, and serve the country with industry. Looking back on history, through the sea, the formation of cement medicine
2020
07-31
In order to continue to thoroughly implement the spirit of General Secretary Xi Jinping's important speech and promote the healthy growth of people in the non-public sector of the economy and the healthy development of the non-public sector of the economy in Jinhua, the United Front work Department of the Jinhua Municipal CPC Committee, the Municipal Federation of Industry and Commerce and other units jointly carried out a large-scale publicity campaign of "2016 faith, righteousness and good business. On October 18, reporters from Jinhua TV and Jinhua Daily walked into the peak to fully understand the development process and business philosophy of the peak. Launched a series of reports on "Xinyi Good Wushang", aiming to vigorously promote the deeds of Jinhua's local outstanding enterprises, strengthen the construction of integrity in the non-public economy under the new situation, promote traditional virtues, establish new social fashions, actively practice the core values of socialism, and guide people in the industrial and commercial circles. Be a model of patriotism, dedication, law-abiding management, entrepreneurial innovation, and repaying the society; at the same time, through the required course, improve the internal governance structure and practice internal skills to make "patriotism, dedication, integrity, law-abiding, innovation, and contribution" become the new normal of the enterprise and the enterprise, thereby enhancing the corporate brand. In the face of the collective interview of Jinhua media reporters, Jiang Xiaomeng, chairman of the group company, introduced the arduous course of the development of peak entrepreneurship and the future development ideas of cement, medicine and health industries, and focused on the transformation and upgrading of enterprises, innovation and development, social welfare and other aspects. A series of work done. He said that Jianfeng has a history of 58 years since it started its business. It has always adhered to industry, integrity management, and industry to serve the country. In addition to actively assuming social responsibilities and advocating cadres and employees to participate in social welfare activities, it also strives to protect the natural environment and ecological resources in the process of production and operation,
2020
07-31
In order to continue to thoroughly implement the spirit of General Secretary Xi Jinping's important speech and promote the healthy growth of people in the non-public sector of the economy and the healthy development of the non-public sector of the economy in Jinhua, the United Front work Department of the Jinhua Municipal CPC Committee, the Municipal Federation of Industry and Commerce and other units jointly carried out a large-scale publicity campaign of "2016 faith, righteousness and good business. On October 18, reporters from Jinhua TV and Jinhua Daily walked into the peak to fully understand the development process and business philosophy of the peak. Launched a series of reports on "Xinyi Good Wushang", aiming to vigorously promote the deeds of Jinhua's local outstanding enterprises, strengthen the construction of integrity in the non-public economy under the new situation, promote traditional virtues, establish new social fashions, actively practice the core values of socialism, and guide people in the industrial and commercial circles. Be a model of patriotism, dedication, law-abiding management, entrepreneurial innovation, and repaying the society; at the same time, through the required course, improve the internal governance structure and practice internal skills to make "patriotism, dedication, integrity, law-abiding, innovation, and contribution" become the new normal of the enterprise and the enterprise, thereby enhancing the corporate brand. In the face of the collective interview of Jinhua media reporters, Jiang Xiaomeng, chairman of the group company, introduced the arduous course of the development of peak entrepreneurship and the future development ideas of cement, medicine and health industries, and focused on the transformation and upgrading of enterprises, innovation and development, social welfare and other aspects. A series of work done. He said that Jianfeng has a history of 58 years since it started its business. It has always adhered to industry, integrity management, and industry to serve the country. In addition to actively assuming social responsibilities and advocating cadres and employees to participate in social welfare activities, it also strives to protect the natural environment and ecological resources in the process of production and operation,
2020
07-31
In order to continue to thoroughly implement the spirit of General Secretary Xi Jinping's important speech and promote the healthy growth of people in the non-public sector of the economy and the healthy development of the non-public sector of the economy in Jinhua, the United Front work Department of the Jinhua Municipal CPC Committee, the Municipal Federation of Industry and Commerce and other units jointly carried out a large-scale publicity campaign of "2016 faith, righteousness and good business. On October 18, reporters from Jinhua TV and Jinhua Daily walked into the peak to fully understand the development process and business philosophy of the peak. Launched a series of reports on "Xinyi Good Wushang", aiming to vigorously promote the deeds of Jinhua's local outstanding enterprises, strengthen the construction of integrity in the non-public economy under the new situation, promote traditional virtues, establish new social fashions, actively practice the core values of socialism, and guide people in the industrial and commercial circles. Be a model of patriotism, dedication, law-abiding management, entrepreneurial innovation, and repaying the society; at the same time, through the required course, improve the internal governance structure and practice internal skills to make "patriotism, dedication, integrity, law-abiding, innovation, and contribution" become the new normal of the enterprise and the enterprise, thereby enhancing the corporate brand. In the face of the collective interview of Jinhua media reporters, Jiang Xiaomeng, chairman of the group company, introduced the arduous course of the development of peak entrepreneurship and the future development ideas of cement, medicine and health industries, and focused on the transformation and upgrading of enterprises, innovation and development, social welfare and other aspects. A series of work done. He said that Jianfeng has a history of 58 years since it started its business. It has always adhered to industry, integrity management, and industry to serve the country. In addition to actively assuming social responsibilities and advocating cadres and employees to participate in social welfare activities, it also strives to protect the natural environment and ecological resources in the process of production and operation,
2020
07-30