Jianfeng Group Lin2016 -002 (Announcement on Withdrawal of Two Drug Registration Applications by Subsidiates)
Release time:
2020-08-05
Securities Code: 600668 Securities Abbreviation: Jianfeng Group Announcement No.: 2016-002
Bond Abbreviation: 13 Peak 01 Bond Code: 122227
Bond Abbreviation: 13 Peak 02 Bond Code: 122344
Zhejiang Jianfeng Group Co., Ltd.
Prompt Announcement
on Withdrawal of Two Drug Registration Applications by Subsidiaries
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 .
Recently, china food and drug administration (hereinafter referred to as "State Food and Drug Administration") issued the Announcement on Withdrawal of 199 Drug Registration Applications by 128 Enterprises (2016 21 ), zhejiang Jianfeng Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), a subsidiary of the Company, withdrew the registration application of 2 drugs. The relevant information is hereby announced as follows:
Basic Information of 1. Products
(I) Cefapirin Sodium for Injection
Drug Name |
Cefapirin Sodium for Injection |
acceptance number |
CXHS1200117 , CXHS1200118 |
Dosage Form |
Chinese Pharmacopoeia Dosage Form Injection |
Application Phase |
Production |
Specification |
0.5g , 1.0g |
Registration Classification |
Chemical Drug 3.1 Class |
Applicant |
Zhejiang Jianfeng Pharmaceutical Co., Ltd., China Pharmaceutical Group Corporation Sichuan Antibiotic Industry Research Institute |
2008 January 17, 148, the company obtained the "Drug Clinical Trial Approval" issued by State Food and Drug Administration ; 2011# On January 10, 151, the company completed the clinical trial of the drug. On May 23, 2012, the company applied for production to State Food and Drug Administration .
(II) mitiglinide calcium capsule| drug name |
mitiglinide calcium capsule |
| acceptance number |
CXHS1400304 |
| dosage form |
Chinese Pharmacopoeia Dosage Capsule |
| Application Stage |
Production |
| Specification |
10mg/ |
| Registration Classification |
Chemical 3.1 Class |
| Applicant |
Zhejiang Jianfeng Pharmaceutical Co., Ltd., China Pharmaceutical University |
December# On the 8th of 253, the company obtained the "Drug Clinical Trial Approval" issued by State Food and Drug Administration ; 2012# On April 5, 256, the company completed the clinical trial of the drug; On December 30, 2014, the company applied for production to State Food and Drug Administration . Other Relevant Situations of 2. Drugs
Cefapirin Sodium for Injection is the first generation cephalosporin, which is suitable for respiratory system infection, urinary system infection, skin and soft tissue infection, wound infection, otolaryngology infection, intracavitary infection, etc. caused by sensitive bacteria. Up to now, the company has invested about 1089 .65 million yuan in the drug research and development project.
Mitiglinide Calcium Capsules improve postprandial hyperglycemia in Ⅱ
diabetic patients by stimulating insulin secretion. Up to now, the company has invested about 549.71 million yuan in the drug research and development project. Market Status of Similar Drugs in 3.
Production Unit |
Dosage Form |
Specification |
|
Yantai Zhengfang Pharmaceutical Co., Ltd. |
Capsule | 10mg |
|
Liaoning Huarui United Pharmaceutical Co., Ltd. |
Tablet | 5mg | , 10mg
|
Zhengda Qingchunbao Pharmaceutical Co., Ltd. |
Tablet | 5mg | , 10mg
|
Jiangsu Zhengda Tianqing Pharmaceutical Co., Ltd. |
Tablet | 5mg | , 10mg
|
Jiangsu Haosen Pharmaceutical Co., Ltd. |
Tablet | 10mg |
|
Beijing Sihuan Kebao Pharmaceutical Co., Ltd. |
Tablet | 5mg |
|
Up to now, there is no domestic manufacturer of cefapirin sodium for injection listed.
4. Sales Data, Production and Usage
Cefapirin Sodium for Injection Major foreign manufacturers are Japan Bristol Company and
Bristol-Myers Squibb(Bristol-Myers) Company; Up to now, there are no similar products on the market in China. The main foreign manufacturers of mitiglinide calcium capsules are Japan's Kissei Pharmaceutical Company (Kissei). Company has not found the specific production, sales data and usage of the above-mentioned similar products from public channels. Impact of
5. on the Company and Risk Prompt
Company voluntarily withdrew the registration application of the above 2
drugs according to the latest policy of the State Food and Drug Administration on drug review and approval, and in combination with the current situation of domestic drug clinical trials and the recommendations of clinical trial institutions and contract research organizations, the decision was made after careful consideration.The withdrawal of the registration application will not have a significant impact on the company's current operating results, but will increase the development time and uncertainties of related products. please the majority of investors rational investment, pay attention to investment risk.
hereby announce
Zhejiang Jianfeng Group Co., Ltd. Board of Directors
January 21, 2016
More information
Pharmaceutical Company Established New Drug R & D Promotion Committee
Recently, the new drug research and development promotion committee of Jianfeng pharmaceutical company was formally established, which will be responsible for promoting the new drug research and development progress of pharmaceutical companies and subordinate enterprises, and coordinating the new drug research and development work of various departments and subordinate enterprises. The New Drug Promotion Committee is headed by Huang Jinlong, deputy general manager of the group and general manager of the pharmaceutical company, and Jiang Hong, deputy general manager of the pharmaceutical company, is headed by Pang Xiong, Shi Cunyuan, Xu Lizhen, Yu Jingjing, Zheng Kunwu, Feng Lixiang, Kang Litao, Li Qian, Wu Chonggui, Zhai Tsunami, Huang Fang and Tong Xiaojun. The committee has an office, and Shi Cunyuan is also the director of the office, responsible for the supervision, communication, and coordination of the company's new drug research and development projects. The main responsibilities of the new drug promotion committee include: organizing the establishment and improvement of the R & D project management system and relevant regulations of the pharmaceutical company; organizing the formulation of the development plan of the new drug R & D project of the pharmaceutical company and supervising the implementation; making decisions on project initiation and participating in project evaluation; supervising the management of new drug R & D of the pharmaceutical company and providing guidance; Responsible for the process management of new drug R & D projects and the promotion and coordination of new drug R & D; carry out the assessment of new drug research and development projects; issue the responsibility system assessment and task statement of new drug research and development projects; be responsible for solving major technical problems in the process of new drug research and development; be responsible for the research and improvement of the management mode of research and development projects of pharmaceutical companies; be responsible for the future trend analysis of new drug research and development projects; review the major scientific research achievements of pharmaceutical companies and put forward reward suggestions. Huang Jinlong said that the research and development of new drugs is an important foundation for the healthy development of the pharmaceutical industry and is a systematic project. Jianfeng Pharmaceutical has always attached great importance to the research and development of new drugs, but there is still a certain gap between the progress of research and development and the development process of the enterprise, and the lack of coordination in the research and development process also affects the progress and quality of new drug research and development to a certain extent. The purpose of the establishment of the New Drug Research and Development Promotion Committee is to solve the progress of new drug research and development, to find and solve problems in time, to implement more targeted, and to effectively integrate enterprise resources, improve the speed and quality of new drug research and development, and make good product reserves for the healthy development of pharmaceutical companies. (Reporter Ni Yingzhen)
2020
09-11
Jianfeng Pharmaceutical ranks among the top 100 Chinese pharmaceutical industries in 2019
On August 25, the "2019 Top 100 Series List of China's Pharmaceutical Industry" was released in Kunming. Zhejiang Jianfeng Pharmaceutical Company was shortlisted as one of the top 100 enterprises in China's pharmaceutical industry. The product Berunning (Olopatadine Hydrochloride Eye Drops) was selected as the "Most Growing Product Brand" of China's pharmaceutical industry ". The "Top 100 Pharmaceutical Industry Series List" was evaluated and released by Guangzhou Punctuation Pharmaceutical Information Co., Ltd., a subsidiary of the Southern Institute of Pharmaceutical Economics of the State Drug Administration, and is known as the "Oscar in Chinese Pharmaceutical Industry. Southern Institute is the earliest institution in China that specializes in pharmaceutical industry policy and market economy research, pharmaceutical market research, pharmaceutical economic data analysis and research, and pharmaceutical professional media publishing. It is in the field of market information value-added services and media communication and marketing services in China's pharmaceutical and health industry., The field of professional quality improvement has extremely extensive influence. The "Top 100 Pharmaceutical Industry" is comprehensively evaluated by the company's annual pharmaceutical industry sales revenue, total profit and R & D investment results. On the same day, the "most growing product brand" of Chinese medicine selected by the Southern Institute's media "Pharmaceutical Economic News" was released simultaneously. Spike Pharmaceuticals product Beirunning (Olopatadine Hydrochloride Eye Drops) was selected. (Xu Yuting)
2020
09-01
Company Disclosure 2020 Semi-Annual Report
On August 28, the Group held the 16th meeting of the 10th Board of Directors of the Company by means of communication, and considered and adopted the "2020 Semi-Annual Report of Jianfeng Group" and the "Proposal on Changes in the Company's Accounting Policy". On August 29, the Company's 2020 semi-annual report was publicly disclosed on the Shanghai Stock Exchange and the Shanghai Securities News and China Securities News. In the first half of the year, the Group focused on the general policy of "grasping projects, making up for shortcomings, improving quality and efficiency, and constantly improving the core competitive advantage", and on the basis of doing a good job in epidemic prevention and control, the Group seized the resumption of work and production, accelerated project construction, and enhanced the core competitiveness of enterprises. In the first half of 2020, the company achieved total operating income of 1.44 billion yuan, net profit attributable to shareholders of 0.368 billion yuan, net profit per share of 1.07 yuan. As of the end of June 2020, the Company's total assets were $5.892 billion, net assets were $4.068 billion, and net assets per share were $11.82. From February to April, affected by the epidemic, the national project construction progress slowed down, cement market demand decreased; after May, the epidemic was effectively controlled, infrastructure investment continued to recover, the real estate industry continued to pick up, cement sales steadily rebounded. During the outbreak, Daye Peak completed the technical transformation projects such as the cold machine, cement mill, into the desulfurization tower anti-corrosion transformation, to ensure the efficient operation of the production equipment after the resumption of work. Yunnan peak rotary kiln production, cement production and other major technical and economic indicators of steady rise; comply with market trends, timely adjustment of marketing policies. Guizhou Jianfeng has promoted the project infrastructure construction, equipment installation and commissioning, raw material bidding and other work in an orderly manner, and through preliminary publicity to enhance the popularity of the Jianfeng brand in the local area, and make a series of preparations for the transformation from project construction to production and operation. In the first half of 2020, the reform of China's medical and health system continued to deepen, and new policies were introduced intensively. Peak Pharmaceuticals and its subsidiaries in the epidemic prevention work at the same time in the first time to achieve the resumption of production, and actively organize donations to support the fight against the epidemic, was named the annual "war epidemic star" the most socially responsible pharmaceutical enterprises. In the first half of the year, Jianfeng Pharmaceutical continued to increase the introduction and development of varieties, and JFAN-1001 applied for clinical application of new anti-tumor drugs. At present, it has obtained the notice of approval for clinical trials. Optimize the production process of API workshop and further shorten the production cycle of raw materials. Continue to improve product sales policies and strengthen market channel control. Shanghai North Carolina further straightened out the internal management structure, production and marketing convergence more smoothly, continue to promote the construction of Anhui North Carolina and Anhui Zhongwang Phase II technical transformation project, promote the peak pharmaceutical raw materials, preparations integration of industrial upgrading strategy. Other business segments of the company actively responded to the challenge of the new crown epidemic and carried out production and operation activities in a standardized and orderly manner. Tianjin natural products company vigorously explore the international and domestic markets, sales revenue to achieve steady growth. Peak Health focuses on the basic idea of "sales orientation, burden reduction and efficiency improvement, fine-grained savings, cost reduction and efficiency enhancement" to effectively improve the operational efficiency of enterprises. Jianfeng International Trade has actively developed new storage business varieties and achieved practical results, and has become the first enterprise in Jinhua to formally obtain the qualification of "network freight. Peak cable seizes the special needs of communication cables such as subways, vigorously promotes large logarithmic cables for subways, and strives to achieve the long tail effect. On the same day, the company also held the 10th meeting of the Ninth Board of Supervisors and reviewed and approved relevant reports. (residual fruit)
2020
09-01
The company organizes new employee induction training
From August 12 to 14, in order to strengthen the training of talents in the group and improve the comprehensive quality of new employees, Jiang Xiaomeng, secretary of the party committee and chairman of the group company, Yu Jianhong, general manager, and other leaders and heads of relevant enterprises and departments conducted a three-day induction training for new employees. New employees from foreign enterprises such as Guizhou Huangping Peak, Daye Peak and Shanghai North Carolina participated simultaneously through online methods. In the course of corporate culture, General Manager Yu Jianhong started from the history of the development and struggle of the peak, divided into five stages: hard work, determined reform, diversified development, strategic adjustment, and strategic development, and introduced in detail the development process of the group company and the current industrial layout., The results achieved; from the aspects of enterprise spirit, vision, development philosophy, values, business philosophy, etc, this paper introduces the peak corporate culture rooted in 62 years of history and inherited in the blood; from the perspective of an enterprise manager and old employees, he speaks a lot of truth to the new employees and puts forward a lot of hopes and suggestions. Chairman Jiang Xiaomeng took "How New Employees Achieve Win-Win with Enterprises" as the topic, and proposed that the key to the success of an enterprise lies in how to select, retain, educate and employ people. Peak and employees complement each other. Peak can achieve today's achievements and the struggle of generations of peak people are inseparable. He also taught new employees the basic concepts that need to be understood, the basic qualities that need to be possessed and the sense of hardship in entering the new environment through 16 key words, and combined with his own experience and quoting from others, he analyzed the core elements of success, the signs of a successful career, the personal qualities that need to be possessed for success, and the importance of establishing a personal knowledge management system, it expresses the ardent hope of new employees to adjust their mentality, keep learning, clear goals, clear dreams, cultivate win-win thinking, and grow up together with the peak. The heads of the human resources department of the group company, the safety management office of the group company, and the comprehensive department of the pharmaceutical company also taught the new employees the corporate rules and regulations and the "Employee Handbook", safety knowledge and professional ethics. The new employees also visited the group exhibition hall and had a deeper understanding of the development history and enterprise achievements of the peak. After the training, the human resources department also organized an examination to test the training effect. (Reporter Chen Shengmu)
2020
08-21
According to this newspaper, through the interconnection monitoring of the transportation department in Zhejiang province, the network freight platform of peak international trading company passed the online service capability audit, interface access audit, eight capability identification and other audit procedures, and successfully obtained the road transportation business license with the qualification of "network freight" on July 2. It is understood that Jianfeng International Trade is currently the first enterprise in Jinhua and Quzhou to obtain this qualification.
2020
08-05
News from our newspaper On July 21, Xi Jinping, General Secretary of the Central Committee of the Communist Party of China, President of the State, and Chairman of the Central Military Commission hosted a symposium for entrepreneurs in Beijing and delivered an important speech. Over the past few days, the General Secretary's speech has aroused strong repercussions in all walks of life. On July 23, Jiang Xiaomeng, chairman of the group company, said in an interview with Jinhua TV that the general secretary's speech was calm and inspiring, and pointed out the direction of future work for entrepreneurs.
2020
08-05