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
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
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
On the founding day of the party on July 1, the grass-roots party organizations under the group Party committee organized special study and review of the oath of joining the party to commemorate the 99th anniversary of the founding of the Communist Party of China. In the afternoon of the same day, Yunnan Jianfeng Party Branch organized all party members to carry out a series of activities to remember the revolutionary martyrs, study the party's constitution, and review the oath of joining the party. Zhou Jiping, the organizing member of the Yunnan Jianfeng Party Branch, conveyed to all participating party members the relevant content of the higher-level party committee's ''Implementation Plan for the Remediation and Excellence of State-owned Enterprise Party Members'', requiring party members to strengthen party spirit and improve their own quality, take responsibility and dare to act, and keep in mind The lofty mission given by the times shows the demeanor of party members in state-owned enterprises. Fang Xuhua, secretary of Yunnan Jianfeng Party Branch, led all Party members to study the Party Constitution and review the oath of joining the Party. All the participating party members participated in the theme study meeting organized by the party committee of the group company to commemorate the 99th anniversary of the founding of the Communist Party of China through the video conference system. On July 1, the party branch of Guizhou Huangping Jianfeng Cement Company held a special commemorative event for the 99th anniversary of the founding of the party to review the oath of joining the party, study the history of the party, and further understand the difficult and glorious 99 years of the Chinese Communist Party. Through study, party members are deeply aware of the hardships in the early days of the founding of the party and the importance of development. As party members, they must strictly demand themselves, continuously improve their self-cultivation level, strengthen their beliefs, and do a good job in the vanguard and exemplary role of party members. (qi jian mei tongyi)
2020
07-31
Jianfeng Pharmaceutical Party Committee Commemorates 99th Anniversary of Party Founding
In order to celebrate the 99th anniversary of the founding of the Communist Party of China, on the afternoon of June 28, the Party committee of Jianfeng pharmaceutical company held a special commemorative activity. More than 100 Party members reviewed the oath of joining the party and listened to the special party class of "why can the Communist Party of China" delivered by Professor Zhang Wecai of the Party School of Jinhua municipal Party committee. At the beginning of the activity, Jin Huazhong, secretary of the Party Committee of Jianfeng Pharmaceutical, led all the participating party members to review the oath of joining the Party. He emphasized that the oath of joining the party is a solemn promise of every party member. As a party member, you must not forget your original intention, and compare the content of the oath in your work and life, constantly review, constantly reflect, strengthen self-examination, and use practical actions to fulfill your commitment to the party. Promise. On April 17, 2019, General Secretary Xi Jinping pointed out during an inspection in Chongqing: "We must focus on major issues such as why the Communist Party of China can, why Marxism can, and why socialism with Chinese characteristics is'good. 'Ideological and public opinion guidance." In order to enable party members to have a deeper understanding and understanding of this, the party committee of Jianfeng Pharmaceutical invited Professor Zhang Wancai, member of the School Affairs Committee and dean of the Jinhua Municipal Party School, to give a special lecture entitled "Why the Communist Party of China can. Professor Zhang reviewed the glorious history and great achievements of the Communist Party of China, combining theory with examples and current affairs, and expounded from the aspects of the Communist Party of China taking the people as the center, keeping in mind the mission of seeking happiness for the people, having the courage to self revolution and having historical responsibility. The content of his lectures was profound and simple, the classroom atmosphere was serious and earnest, and Party members were deeply enlightened. After the lecture, Jin Huazhong said in his concluding speech that the purpose of holding this commemorative event is to make all party members keep their vows in mind, strengthen theoretical guidance, strengthen ideals and beliefs, consciously practice the theme education of "not forgetting the original intention and keeping in mind the mission", and enhance all party members. Self-confidence in the road, theory, system, and culture. He stressed that the successful experience of the Communist Party of China, as a great organization, is of great practical significance to the reform and development of enterprises. Party organizations at all levels of Jianfeng Pharmaceutical should further strengthen the building of party branches and party members, further give full play to the political core role of party organizations and the vanguard and exemplary role of party members, promote the production and operation of enterprises with party building, and unite the broad masses of party members, cadres and all staff. devote themselves to all kinds of work with more enthusiasm, higher morale and more pragmatic style, and strive to achieve the annual work goals of the pharmaceutical company, together to build a better peak pharmaceutical industry. (Reporter Chen Shengmu)
2020
07-02
Jianfeng Pharmaceutical Party Committee Commemorates 99th Anniversary of Party Founding
In order to celebrate the 99th anniversary of the founding of the Communist Party of China, on the afternoon of June 28, the Party committee of Jianfeng pharmaceutical company held a special commemorative activity. More than 100 Party members reviewed the oath of joining the party and listened to the special party class of "why can the Communist Party of China" delivered by Professor Zhang Wecai of the Party School of Jinhua municipal Party committee. At the beginning of the activity, Jin Huazhong, secretary of the Party Committee of Jianfeng Pharmaceutical, led all the participating party members to review the oath of joining the Party. He emphasized that the oath of joining the party is a solemn promise of every party member. As a party member, you must not forget your original intention, and compare the content of the oath in your work and life, constantly review, constantly reflect, strengthen self-examination, and practice with practical actions.
2020
07-02
Jianfeng Pharmaceutical Party Committee Commemorates 99th Anniversary of Party Founding
In order to celebrate the 99th anniversary of the founding of the Communist Party of China, on the afternoon of June 28, the Party committee of Jianfeng pharmaceutical company held a special commemorative activity. More than 100 Party members reviewed the oath of joining the party and listened to the special party class of "why can the Communist Party of China" delivered by Professor Zhang Wecai of the Party School of Jinhua municipal Party committee. At the beginning of the activity, Jin Huazhong, secretary of the Party Committee of Jianfeng Pharmaceutical, led all the participating party members to review the oath of joining the Party. He emphasized that the oath of joining the party is a solemn promise of every party member. As a party member, you must not forget your original intention, and compare the content of the oath in your work and life, constantly review, constantly reflect, strengthen self-examination, and use practical actions to fulfill your commitment to the party. Promise. On April 17, 2019, General Secretary Xi Jinping pointed out during an inspection in Chongqing: "We must focus on major issues such as why the Communist Party of China can, why Marxism can, and why socialism with Chinese characteristics is'good. 'Ideological and public opinion guidance." In order to enable party members to have a deeper understanding and understanding of this, the party committee of Jianfeng Pharmaceutical invited Professor Zhang Wancai, member of the School Affairs Committee and dean of the Jinhua Municipal Party School, to give a special lecture entitled "Why the Communist Party of China can. Professor Zhang reviewed the glorious history and great achievements of the Communist Party of China, combining theory with examples and current affairs, and expounded from the aspects of the Communist Party of China taking the people as the center, keeping in mind the mission of seeking happiness for the people, having the courage to self revolution and having historical responsibility. The content of his lectures was profound and simple, the classroom atmosphere was serious and earnest, and Party members were deeply enlightened. After the lecture, Jin Huazhong said in his concluding speech that the purpose of holding this commemorative event is to make all party members keep their vows in mind, strengthen theoretical guidance, strengthen ideals and beliefs, consciously practice the theme education of "not forgetting the original intention and keeping in mind the mission", and enhance all party members. Self-confidence in the road, theory, system, and culture. He stressed that the successful experience of the Communist Party of China, as a great organization, is of great practical significance to the reform and development of enterprises. Party organizations at all levels of Jianfeng Pharmaceutical should further strengthen the building of party branches and party members, further give full play to the political core role of party organizations and the vanguard and exemplary role of party members, promote the production and operation of enterprises with party building, and unite the broad masses of party members, cadres and all staff. devote themselves to all kinds of work with more enthusiasm, higher morale and more pragmatic style, and strive to achieve the annual work goals of the pharmaceutical company, together to build a better peak pharmaceutical industry. (Reporter Chen Shengmu)
2020
07-03