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
Tianjin Flemish Company Donates Anti-epidemic Materials
On the morning of July 13, Tianjin Jianfeng Flanders Pharmaceutical Technology Development Co., Ltd. donated materials to the Tianjin Development Zone Charity Association to help the development zone community fight the epidemic.
2020
08-05
In late July, leaders of the group company Jiang Xiaomeng, Yu Jianhong, Chen Tianci and Qin Xuping visited subordinate enterprises separately and sent heatstroke prevention and cooling supplies to employees working under high temperature, urging everyone to pay attention to heatstroke prevention and cooling and safe production work to ensure good physical condition.
2020
08-05
On July 17 and 18, the Group's work analysis meeting for the first half of 2020 was held at the Peak Building of the Group's headquarters to summarize and review the work in the first half of the year and make arrangements for the work in the second half of the year.
2020
08-05
The company requires to do a good job in summer safety production
The high temperature season is approaching, and the group company issued a notice a few days ago to make arrangements for safe production in summer.
2020
08-05
The company requires to do a good job in summer safety production
The high temperature season is approaching, and the group company issued a notice a few days ago to make arrangements for safe production in summer. The notice requires all subordinate units of the company to attach great importance to the work of production safety in summer, and all production and business units should hold a special meeting on production safety in summer. According to the characteristics of production in summer, they should focus on safety risk analysis for mines, outdoor operations and high-temperature posts, and implement control measures to avoid the occurrence of safety accidents such as scalding, heatstroke and electric shock. In order to further strengthen the safety production management in the high temperature season, the notice requires the main person in charge of each production and business unit to lead a team to conduct a comprehensive inspection of the production and business premises according to the characteristics of summer production; strengthen the daily safety production inspection of key posts and special posts; timely rectify the found unsafe behaviors and hidden dangers; Strengthen the management of the storage and use of flammable, explosive, dangerous chemicals and drugs; cooling measures shall be taken for the space exceeding the storage temperature limit of articles. If it is found that the electrical equipment circuit and exhaust fan circuit are aged and damaged, replace them in time and keep the grounding wire in good condition. Do a good job in checking the fire pool, pipeline water pressure and fire extinguishing equipment to ensure that the fire fighting facilities are sensitive, intact and reliable. The high temperature in summer is also a period of frequent occurrence of heatstroke and other diseases. The notice requires all units to do a good job in heatstroke prevention and cooling, implement various relevant measures, and equip necessary cooling facilities or materials such as fans, air conditioners, ice cubes and other cooling facilities or materials according to the conditions of the production site; do a good job in the distribution of heatstroke prevention drugs, supplies and cool drinks in workshops, warehouses, construction sites and other production lines; strengthen canteen management to prevent food poisoning. (this newspaper reporter)
2020
07-22
The company requires to do a good job in summer safety production
The high temperature season is approaching, and the group company issued a notice a few days ago to make arrangements for safe production in summer. The notice requires all subordinate units of the company to attach great importance to the work of production safety in summer, and all production and business units should hold a special meeting on production safety in summer. According to the characteristics of production in summer, they should focus on safety risk analysis for mines, outdoor operations and high-temperature posts, and implement control measures to avoid the occurrence of safety accidents such as scalding, heatstroke and electric shock. In order to further strengthen the safety production management in the high temperature season, the notice requires the main person in charge of each production and business unit to lead a team to conduct a comprehensive inspection of the production and business premises according to the characteristics of summer production; strengthen the daily safety production inspection of key posts and special posts; timely rectify the found unsafe behaviors and hidden dangers; Strengthen the management of the storage and use of flammable, explosive, dangerous chemicals and drugs; cooling measures shall be taken for the space exceeding the storage temperature limit of articles. If it is found that the electrical equipment circuit and exhaust fan circuit are aged and damaged, replace them in time and keep the grounding wire in good condition. Do a good job in checking the fire pool, pipeline water pressure and fire extinguishing equipment to ensure that the fire fighting facilities are sensitive, intact and reliable. The high temperature in summer is also a period of frequent occurrence of heatstroke and other diseases. The notice requires all units to do a good job in heatstroke prevention and cooling, implement various relevant measures, and equip necessary cooling facilities or materials such as fans, air conditioners, ice cubes and other cooling facilities or materials according to the conditions of the production site; do a good job in the distribution of heatstroke prevention drugs, supplies and cool drinks in workshops, warehouses, construction sites and other production lines; strengthen canteen management to prevent food poisoning. (this newspaper reporter)
2020
07-31
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