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
The company fully deploys 2018 work
On January 27, the group company held a business analysis meeting to review and summarize the work in 2017, arrange and deploy the work for the new year, and put forward work requirements. At the meeting, various professional companies and directly affiliated enterprises reported on the overall work situation in 2017, focusing on analyzing the existing problems and deficiencies, and proposing corresponding solutions and work plans for 2018. Xiang Chongping, deputy general manager of the group company, systematically combed 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 "three reductions and three improvements" and the safety and environmental protection work in 2017. 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 2017, compared and analyzed the main economic indicators of various industrial sectors, and pointed out that looking for new investment and development projects around strategic objectives, promoting the optimization of organizational structure and post setting, significantly improving the level of information management, improving the ability of fund management and tax planning, achieving certain results in scientific and technological innovation and technological transformation, and strengthening marketing management and market expansion, safety and environmental protection work is basically up to standard, training and talent development have achieved new results and other work highlights; at the same time, it summarizes and reflects on the shortcomings in strategic decision-making, management innovation, performance appraisal, market operation, and talent team building. After analyzing the current macroeconomic situation and the future trends of various related industries, Yu Jianhong informed
2020
07-31
Peak Pharmaceutical Invests in Shanghai North Carolina to Build API R & D and Production Base
News from our newspaper On January 19, the group company held the second meeting of the tenth board of directors and reviewed and approved the "Proposal on Foreign Investment of Subsidiary Jianfeng Pharmaceutical." On the same day, Jianfeng Pharmaceutical signed an agreement to invest in Shanghai North Carolina Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Shanghai North Carolina") by acquiring shares and increasing capital. Shanghai Beika is a high-tech enterprise in Shanghai. It has an academician expert workstation and a number of Shanghai high-tech achievements transformation projects. It has won the title of "second prize for scientific and technological progress" in Songjiang District, Shanghai, "patent pilot enterprise" and "enterprise technology center" in Songjiang District, Shanghai. The company has strong research and development capabilities and has obtained 14 patents. At present, its main business is to provide products and customized services for domestic and foreign pharmaceutical companies. The products mainly include Tinib, alkaloids, carbohydrates and other anti-tumor drug intermediates. The customized services are mainly CDMO (contract development and manufacturing) of new drugs and intermediates. Shanghai North Carolina has two wholly-owned subsidiaries, Anhui Changtai Chemical Co., Ltd. (hereinafter referred to as "Changtai Chemical") and Anhui North Carolina Pharmaceutical Co., Ltd. (hereinafter referred to as "Anhui North Carolina"). Changtai Chemical is a pesticide manufacturer designated by the Ministry of Industry and Information Technology. It was established in July 2007. It now has three chemical synthesis workshops and a pesticide preparation compounding workshop, with 10 product approvals and 13 patents. Anhui North Carolina was established in December 2016. Its business scope includes the customization, production and sales of chemical raw materials and pharmaceutical intermediates, and the wholesale and retail of chemical raw materials and products (except hazardous chemicals
2020
07-30
Peak Pharmaceutical Invests in Shanghai North Carolina to Build API R & D and Production Base
News from our newspaper On January 19, the group company held the second meeting of the tenth board of directors and reviewed and approved the "Proposal on Foreign Investment of Subsidiary Jianfeng Pharmaceutical." On the same day, Jianfeng Pharmaceutical signed an agreement to invest in Shanghai North Carolina Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Shanghai North Carolina") by acquiring shares and increasing capital. Shanghai Beika is a high-tech enterprise in Shanghai. It has an academician expert workstation and a number of Shanghai high-tech achievements transformation projects. It has won the title of "second prize for scientific and technological progress" in Songjiang District, Shanghai, "patent pilot enterprise" and "enterprise technology center" in Songjiang District, Shanghai. The company has strong research and development capabilities and has obtained 14 patents. At present, its main business is to provide products and customized services for domestic and foreign pharmaceutical companies. The products mainly include Tinib, alkaloids, carbohydrates and other anti-tumor drug intermediates. The customized services are mainly CDMO (contract development and manufacturing) of new drugs and intermediates. Shanghai North Carolina has two wholly-owned subsidiaries, Anhui Changtai Chemical Co., Ltd. (hereinafter referred to as "Changtai Chemical") and Anhui North Carolina Pharmaceutical Co., Ltd. (hereinafter referred to as "Anhui North Carolina"). Changtai Chemical is a pesticide manufacturer designated by the Ministry of Industry and Information Technology. It was established in July 2007. It now has three chemical synthesis workshops and a pesticide preparation compounding workshop, with 10 product approvals and 13 patents. Anhui North Carolina was established in December 2016. Its business scope includes the customization, production and sales of chemical raw materials and pharmaceutical intermediates, and the wholesale and retail of chemical raw materials and products (except hazardous chemicals
2020
07-31
Jianfeng Pharmaceutical was rated as a provincial trademark brand demonstration enterprise
On December 28, 2017, Zhejiang Administration for Industry and Commerce announced the list of trademark brand demonstration counties (cities, districts), demonstration towns (streets) and demonstration enterprises in Zhejiang Province in 2017. Jianfeng Pharmaceutical Company was identified as a trademark brand demonstration enterprise, and it was also the only enterprise in Jinhua City to enter the list. Peak Pharmaceutical was established in 1998 and obtained the first registered trademark in 1999. Since then, Jianfeng Pharmaceutical has been actively carrying out brand building in accordance with the requirements of the Trademark Law and other laws and regulations, and has set up an intellectual property department to carry out trademark management, rights protection and other activities; it has established a sound trademark management system, strictly in accordance with the provisions of the Trademark Law to supervise and manage the use of trademarks inside and outside the enterprise, and safeguard the legitimate rights and interests of the enterprise. Establish strategic cooperation with professional institutions, for trademark applications, renewals and other work. In recent years, Jianfeng Pharmaceutical has also explored trademark investment, creating value through intangible assets such as trademarks and brands, promoting efficiency improvement, and further expanding corporate influence; at the same time, it has continuously increased investment in new product research and development and technological transformation, and actively Declare various patents to provide strong support for brand building with technological innovation. According to incomplete statistics, Jianfeng Pharmaceutical and its subsidiaries currently have more than 120 valid trademarks, including 1 well-known trademark in China, 2 well-known trademarks in Zhejiang Province, 5 well-known trademarks in Jinhua City, and 2 overseas registered trademarks; Obtained more than 40 domestic and international patents. Trademark is an important part of intellectual property rights, in the knowledge economy, brand effect is increasingly becoming the leading force of economic development.
2020
07-31
Peak Pharmaceutical Invests in Shanghai North Carolina to Build API R & D and Production Base
News from our newspaper On January 19, the group company held the second meeting of the tenth board of directors and reviewed and approved the "Proposal on Foreign Investment of Subsidiary Jianfeng Pharmaceutical." On the same day, Jianfeng Pharmaceutical signed an agreement to invest in Shanghai North Carolina Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Shanghai North Carolina") by acquiring shares and increasing capital. Shanghai Beika is a high-tech enterprise in Shanghai. It has an academician expert workstation and a number of Shanghai high-tech achievements transformation projects. It has won the title of "second prize for scientific and technological progress" in Songjiang District, Shanghai, "patent pilot enterprise" and "enterprise technology center" in Songjiang District, Shanghai. The company has strong research and development capabilities and has obtained 14 patents. At present, its main business is to provide products and customized services for domestic and foreign pharmaceutical companies. The products mainly include Tinib, alkaloids, carbohydrates and other anti-tumor drug intermediates. The customized services are mainly CDMO (contract development and manufacturing) of new drugs and intermediates. Shanghai North Carolina has two wholly-owned subsidiaries, Anhui Changtai Chemical Co., Ltd. (hereinafter referred to as "Changtai Chemical") and Anhui North Carolina Pharmaceutical Co., Ltd. (hereinafter referred to as "Anhui North Carolina"). Changtai Chemical is a pesticide manufacturer designated by the Ministry of Industry and Information Technology. It was established in July 2007. It now has three chemical synthesis workshops and a pesticide preparation compounding workshop, with 10 product approvals and 13 patents. Anhui North Carolina was established in December 2016. Its business scope includes the customization, production and sales of chemical raw materials and pharmaceutical intermediates, and the wholesale and retail of chemical raw materials and products (except hazardous chemicals
2020
07-31
The company was rated as an advanced unit of the city's focus on talent and love talent.
News from our newspaper On December 11, the Talent Work Leading Group of the Jinhua Municipal Committee of the Communist Party of China commended the advanced units of Jinhua City that value talents and love talents. 36 units including Jianfeng Group won this honor. The selection of advanced units that value talents and love talents is a measure taken by the Jinhua Municipal Party Committee to further create a good atmosphere of focusing on talents and loving talents, fully respect and make good use of the first resource of talents, serve innovation to drive development, and implement the development strategy of strengthening the province with talents and innovation. The enterprises and institutions that have won this honorary title have always regarded talents as the fundamental driving force for development for a long time, regarded the investment of talents as the most effective investment, and integrated the love of talents into the unit culture. Remarkable achievements have been made in gathering talents, achieving talents, transforming and upgrading, and accelerating development. The Jinhua Municipal Party Committee requires the majority of employers to learn from advanced units, vigorously promote the trend of focusing on talents and loving talents, remove the obstacles to the talent development system and mechanism, and in accordance with the requirements of "walking in the forefront and jointly building Jinhua", in order to promote the construction of a modern metropolitan area and accelerate the construction of the province An important growth pole for high-quality development provides talent support and intellectual guarantee. (this newspaper reporter)
2020
07-31