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
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Spike New Drug Approved for Registration
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2020
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Spike New Drug Approved for Registration
On April 16, Jianfeng Pharmaceutical Company received the approval and issuance of Olopatadine Hydrochloride Eye Drops "Drug Registration Approval" (approval number: 2019S00296) approved by the State Drug Administration. Olopatadine hydrochloride eye drops is mainly used to treat the signs and symptoms of allergic conjunctivitis. It is a mast cell stabilizer and a relatively selective histamine H1-receptor antagonist. It can inhibit type I immediate allergic reactions in vivo and in vitro experiments. At present, the product has been included in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2017 Edition)" and classified as Class B. According to the relevant data of IMS database, in 2018, the global sales of olopatadine hydrochloride eye drops were about 0.37 billion US dollars, and the sales in China were about 10.232 million US dollars. Spike Pharmaceuticals already has the corresponding production line, this time to obtain the registration approval, marking Spike Pharmaceuticals has the qualification to carry out the production and sales of olopatadine hydrochloride eye drops, will further enrich the product line of Spike Pharmaceuticals, help to enhance the competitiveness of the company's pharmaceutical business. (Xia Yingpin)
2020
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