Jianfeng Group Lin2016 -028 (Announcement on Acceptance Notice of Drug Clinical Trial Application of Subsidiary Company)
Release time:
2020-08-05
Securities Code: 600668 Securities Abbreviation: Jianfeng Group No.: Lin 2016-028
Bond Abbreviation: 13 Peak 01 Bond Code: 122227
Bond Abbreviation: 13 Peak 02 Bond Code: 122344
Zhejiang Jianfeng Group Co., Ltd.
Announcement on Acceptance Notice of Subsidiary Drug Clinical Trial Application
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 controlling subsidiary of the Company, received the Notice of Acceptance of Drug Registration Application (Acceptance No.: CXHL1600201 Zhejiang) and (Acceptance No.: CXHL1600202 Zhejiang) issued by Zhejiang Food and Drug Administration. The clinical research application of deoxypodophyllotoxin for injection (acceptance number: CXHL1600202 Zhejiang) and its bulk drug (acceptance number: CXHL1600201 Zhejiang) (hereinafter collectively referred to as "DPT") developed by Jianfeng Pharmaceutical and China Pharmaceutical University has been accepted by Zhejiang Food and Drug Administration.
2. drug basic information content
(I) deoxypodophyllotoxin
drug name: deoxypodophyllotoxin
dosage form: non-preparation: bulk drug
packing specification: 2Kg
per bag application item: chemical drug: class 1
Application Stage: Clinical
Applicant: Zhejiang Jianfeng Pharmaceutical Co., Ltd., China Pharmaceutical University
Application Acceptance Number: CXHL1600201 Zhejiang
Conclusion: After formal examination, the application materials basically meet the requirements of the "Measures for the Administration of Drug Registration" and other relevant regulations and are accepted. Approval is subject to review.
(II) Deoxypodophyllotoxin for Injection
Drug Name: Deoxypodophyllotoxin for Injection
Dosage Form: Preparation: Chinese Pharmacopoeia Dosage Form Injection
Specification: 100mg Package Specification: 1 bottle per box
Application Item: Chemical Drug: 1 Class
Application Stage: clinical
Applicant: Zhejiang Jianfeng Pharmaceutical Co., Ltd. and China Pharmaceutical University
Application Acceptance Number: CXHL1600202 Zhejiang
Conclusion: After formal examination, the application materials basically meet the requirements of the "Measures for the Administration of Drug Registration" and other relevant regulations and are accepted. Approval is subject to review.
3. Drug Research and Development and Registration
DPT Project is a new anti-tumor drug developed by Jianfeng Pharmaceutical in cooperation with China Pharmaceutical University in March 112. Domestic and foreign listed alkaloids of similar drugs include: paclitaxel, vinorelbine. DPT indication/ function indication is tentatively designated as first-line and second-line treatment of lung cancer, breast cancer and gastric cancer; Especially for the treatment of the above tumors resistant to paclitaxel and vinorelbine.
DPT is currently in the stage of applying for clinical trial approval. After the clinical application of is accepted, the clinical research work can only be carried out after passing the review and approval of the State Food and Drug Administration (CFDA) and obtaining the clinical trial approval document. After the clinical trial is completed, the production can be applied, after passing the review and approval of CFDA and obtaining the drug production approval, can be produced and marketed.
Up to now, the accumulated research and development investment and other related expenditures of DPT project of Jianfeng Pharmaceutical Co., Ltd. are about 33 million yuan. The impact of
4. on listed companies and risk tips
DPT clinical application filed by the company has been accepted and will not have a significant impact on the company's recent operating results. After the clinical application of
is accepted, the clinical research work can only be carried out after passing the review and approval of CFDA and obtaining the clinical trial approval document. The results and time of the inspection, review and approval during the period are uncertain. Due to the long cycle and high risk of new drug research and development, the company will timely fulfill the obligation of information disclosure according to the progress of research and development. Please pay attention to the investment risk.
hereby announce
Zhejiang Jianfeng Group Co., Ltd. Board of Directors
August 25, 2016
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