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
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2020
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Peak natural products among the top 20 scientific and technological innovation in TEDA
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Peak pharmaceutical "enterprise information construction project" through the acceptance
The "Enterprise Informatization Construction Project" of Jianfeng Pharmaceutical Company was included in the list of key projects of "Integration of Industrialization and Industrialization" (high-level and in-depth combination of informatization and industrialization) in Jinhua City in 2015, and successfully passed the on-site acceptance of the expert group on the morning of May 18. The main contents of the "enterprise information construction project" of the pharmaceutical company include: the tank farm control system, which solves the problem of closed metering and transportation of organic solvents between the tank farm and the production area, can automatically realize the terminal metering setting, and effectively ensure the safety and environmental protection requirements of the tank farm operation; The air conditioning automatic control system realizes the control of the temperature, humidity and room pressure difference in the air conditioning area through the PLC digital-to-analog conversion of the upper computer and lower computer and the terminal actuator regulator, ensure the cleanliness requirements of the production area environment; The online particle monitoring software system automatically adjusts to the standard flow through the upper computer, vacuum system, laser sensor and isodynamic sampling probe, etc. through the flow detector device and key orifice plate inside each sensor, monitors the temperature, humidity, particles, planktonian bacteria, room pressure difference, etc., implements dynamic management, and realizes visual monitoring of the production process environment. MRP production management system, it makes it easier for the warehouse, workshop, and management personnel to obtain information about the flow of materials in the production process, the implementation of production plans, and product inventory. During the on-site acceptance on the 18th, the acceptance team composed of the Information Department of the Municipal Economic and Information Commission, the Economic and Development Bureau of the Development Zone, the Municipal Information Promotion Association and professors of Zhejiang Normal University checked the contracts of each system software, purchase and transfer records, training records, and problem records in project implementation,
2020
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Peak natural products among the top 20 scientific and technological innovation in TEDA
A few days ago, Tianjin Jianfeng Natural products Research and Development Co., Ltd. stood out among nearly 35000 enterprises in Tianjin Development Zone and won the honor of "Top 20 Scientific and technological Innovation Enterprises of 2015. The selection criteria for the top 20 scientific and technological innovation enterprises in Tianjin Economic and Technological Development Zone mainly include: they have won science and technology awards or patent awards in 2015, as well as other awards above the provincial level; they have obtained the qualification certification or approval of research and development institutions above the provincial level; in 2015, the number of invention and utility model patent applications and authorizations was large, totaling more than 15; in 2015, they were supported by national or Tianjin key science and technology plans; scientific research achievements have made significant progress and technology. According to the above standards, Jianfeng Natural Products Company has not only won the second prize of Tianjin Science and Technology Innovation Project Award for the achievements of "Tianjin Plant Waste Reutilization Technology Engineering Center Construction", but also completed the process research of grape seed extract and ginsenoside to pesticide residues, and formulated the international business standard of grape seed extract (grape seed oligomeric proanthocyanidins). In order to better carry out the pilot experiment, large-scale technical transformation was carried out on the second workshop, and the process optimization of extracting anthocyanins from blueberries has been carried out. At the same time, the main business income, operating profit, tax revenue and other economic indicators of peak natural products company in 2015 have increased significantly year-on-year. Relying on the advantages of excellent quality, good efficiency, great contribution, safety and environmental protection, and good social responsibility, Jianfeng Natural Products Company successfully passed the review and became one of the "Top 20 Scientific and Technological Innovation Enterprises in 2015" in Tianjin Development Zone. (
2020
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