Announcement on Subsidiary Obtaining Notice of Approval for Drug Clinical Trials
Release time:
2021-05-20
Securities Code: 600668 Securities Abbreviation: Jianfeng Group No: pro 2021-001
Zhejiang Jianfeng Group Co., Ltd.
Announcement on Subsidiaries Obtaining Drug Clinical Trial Approval Notice
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 .
Important Note:
- Company's approval notice for drug clinical trials will not have a significant impact on the company's recent operating results.
- Risk Warning: Due to the particularity of drug research and development, the pre-development of drugs and the long cycle and many links of products from development, clinical trials to production are susceptible to some uncertain factors, clinical trial progress, There are many uncertainties in the results and the future product market competition situation.
1. Summary
Recently, Zhejiang Erying Pharmaceutical Co., Ltd. (hereinafter referred to as "Erying Company") and , the controlling subsidiary of Zhejiang Jianfeng Pharmaceutical Co., Ltd., the controlling subsidiary of the Company, received the Notice of Approval for Clinical Trials of Drugs approved and issued by the State Drug Administration. The relevant details are hereby announced as follows:
2. drug basic information content
drug name: acetaminophen suppository
English name: Paracetamol Suppositories
dosage form: suppository
application classification: generic drug application
specification: 75mg , 125mg
registration classification: chemical drugs category 3
applicant: Zhejiang erying drug co., ltd.
approval conclusion: "according to the the People's Republic of China drug administration law and relevant regulations, after examination, the acetaminophen suppository accepted on 2020 5 February 13 meets the relevant requirements for drug registration, it is recommended that the bioequivalence study of this product be carried out in healthy adults with a single fasting dose, and that the study of BE be exempted under different specifications to meet pharmaceutical requirements."
3. Drug Research and Development and Investment
Acetaminophen Suppository is an antipyretic analgesic developed by Erying Company. Its registered classification belongs to chemical drug 3 . Acetaminophen Suppository is indicated for fever caused by common cold or influenza in children, and is also used for relieving mild to moderate pain such as headache, arthralgia, migraine, toothache, myalgia and neuralgia. As of the date of this announcement, the accumulated research and development expenses and technical investment of the project totaled about RMB ,788.09 . Market Situation of
4. Similar Drugs
Acetaminophen Suppository was first developed by German Bene Company and listed in Germany in 1960 . In 2019 , the dosage of German acetaminophen Suppository was about 1.08 .6 billion tablets (data source: IMS ). At present, paracetamol suppositories of infant specifications have been listed in many countries in the world. At present, paracetamol suppositories of 125 mg , 150 mg , 300 mg and 600 mg have been listed in China, of which 125 mg and 150 mg are used for fever caused by common cold or influenza in children aged 1-6 , no paracetamol suppositories exist for infants and young children aged 0-1 years. Acetaminophen suppository (75 mg ) developed by Erying Company is suitable for antipyretic and analgesic treatment for infants aged 0-1 years old in China. Acetaminophen suppository (125 mg ) is suitable for infants aged 6 months to 2 years old (administered according to age and weight). Scientifically administered acetaminophen suppository will be provided for infants aged 0-2-2-116 years old. Approval Procedures to Be Performed for Listing of 5. Products
Er Ying Company will conduct clinical trials (bioequivalence studies) according to the requirements of the Notice of Approval of Drug Clinical Trials. After the clinical trials are completed, it will apply for production. After passing the review and approval of the State Food and Drug Administration and obtaining the approval documents for drug production, it can produce
products and go on sale. 6. Impact on Listed Companies and Risk Tips
The company's approval notice for drug clinical trials will not have a significant impact on the company's recent operating results. Due to the particularity of drug research and development, the pre-development of drugs and the long cycle and many links from development, clinical trials to production of products are easily affected by some uncertain factors. There are many uncertainties in the progress and results of clinical trials and the future product market competition situation. The company will be based on the progress of research and development in a timely manner to fulfill the obligations of information disclosure, so that the majority of investors pay attention to investment risks.
hereby announce
Zhejiang Jianfeng Group Co., Ltd. Board of Directors
January 6, 2001
More information
Jiang Xiaomeng Yunnan Jianfeng Lectures on Party Lessons
In order to implement the requirements of the higher-level party committee secretary to give in-depth party lectures in enterprises, on July 4, Jiang Xiaomeng, secretary of the party committee and chairman of the group company, gave a special lecture on "two studies and one doing" for party members at Yunnan Jianfeng Cement Company. In the lecture, Jiang Xiaomeng started from the background, overall requirements, learning and education content, and main measures of the "two studies and one doing" activities. He hoped that all party members and cadres would understand "awe, gratitude, humility, and decent", and put forward "What should the current enterprise do" and "How should the enterprise go in the future" and other issues. Jiang Xiaomeng analyzed the future development trend of cement and pharmaceutical industries in detail, emphasized the importance of seizing opportunities, and pointed out that with the homogenization of cement industry becoming more and more serious, if we want to take the road of differentiated brand development, the core of competition is to strengthen self management and maximize the cost, so as to improve the competitive advantage. As far as Yunnan Jianfeng is concerned, it is necessary to continuously improve the level of process technology management and increase the hourly output by increasing inspection efforts. Starting from strengthening the control of raw material procurement, the quality and price should be controlled. By strengthening sales management, vigorously develop direct agents, and strive to maximize the profit per ton; By strengthening equipment maintenance, reduce equipment accidents and further reduce the consumption of machine materials; Make good use of people, while constantly tapping talents and cultivating new people, we will gradually control the total number of workers and improve labor productivity. According to the current situation and the company's development strategy, what should the party members of the peak do? Jiang Xiaomeng asked all the party members and cadres of Yunnan peak to play a good vanguard and exemplary role and take the lead in learning new knowledge, new technology and new experience.
2020
07-30
Yunnan Peak Starts Secondary Security Standardization Creation
On June 19, Yunnan Jianfeng cement company held a mobilization meeting to further implement the requirements of the State Council, Yunnan Province, Pu'er City and Simao District Safety Supervision Bureau on carrying out safety production standardization work, and deploy the secondary safety standardization work. At the meeting, Liu Shenghua, deputy general manager of Yunnan Jianfeng, read out the requirements and work arrangements for creating a secondary enterprise for safety production standardization. The representative of Yunnan superstar Safety Technology Service Co., Ltd., the evaluation unit of safety production standardization, explained in detail the relevant knowledge of safety production standardization consultation and evaluation for the participants, and explained the requirements, standards and other elements of safety production standardization work. Zhou Jiping, general manager of Yunnan Jianfeng, mobilized the establishment of secondary safety production standardization at the meeting, requiring all workshops and departments to prepare and report the data before the end of October, and both software and hardware meet the acceptance conditions, so as to complete the bid creation work by the end of the year. Through the mobilization meeting, the responsible persons of Yunnan Jianfeng and superstar companies and relevant personnel had in-depth exchanges, further unified their thinking, and improved Yunnan Jianfeng employees' understanding of safety production standardization. Everyone recognizes that carrying out safety production standardization work is not only to implement the spirit of a series of documents of the party and the country, but also a mandatory requirement of the government for enterprises, and it is also the need for the sustainable and healthy development of enterprises themselves. Through the development of safety production standardization, enterprises can be promoted to establish and improve the safety production responsibility system, improve the safety production management system, standardize the production operation behavior, investigate and control the hidden dangers of accidents, effectively control the sources of danger, make the production equipment and facilities meet the safety standards, and continuously improve
2020
07-31
Yunnan Peak Starts Secondary Security Standardization Creation
On June 19, Yunnan Jianfeng cement company held a mobilization meeting to further implement the requirements of the State Council, Yunnan Province, Pu'er City and Simao District Safety Supervision Bureau on carrying out safety production standardization work, and deploy the secondary safety standardization work. At the meeting, Liu Shenghua, deputy general manager of Yunnan Jianfeng, read out the requirements and work arrangements for creating a secondary enterprise for safety production standardization. The representative of Yunnan superstar Safety Technology Service Co., Ltd., the evaluation unit of safety production standardization, explained in detail the relevant knowledge of safety production standardization consultation and evaluation for the participants, and explained the requirements, standards and other elements of safety production standardization work. Zhou Jiping, general manager of Yunnan Jianfeng, mobilized the establishment of secondary safety production standardization at the meeting, requiring all workshops and departments to prepare and report the data before the end of October, and both software and hardware meet the acceptance conditions, so as to complete the bid creation work by the end of the year. Through the mobilization meeting, the responsible persons of Yunnan Jianfeng and superstar companies and relevant personnel had in-depth exchanges, further unified their thinking, and improved Yunnan Jianfeng employees' understanding of safety production standardization. Everyone recognizes that carrying out safety production standardization work is not only to implement the spirit of a series of documents of the party and the country, but also a mandatory requirement of the government for enterprises, and it is also the need for the sustainable and healthy development of enterprises themselves. Through the development of safety production standardization, enterprises can be promoted to establish and improve the safety production responsibility system, improve the safety production management system, standardize the production operation behavior, investigate and control the hidden dangers of accidents, effectively control the sources of danger, make the production equipment and facilities meet the safety standards, and continuously improve
2020
07-31
Yunnan Peak Starts Secondary Security Standardization Creation
On June 19, Yunnan Jianfeng cement company held a mobilization meeting to further implement the requirements of the State Council, Yunnan Province, Pu'er City and Simao District Safety Supervision Bureau on carrying out safety production standardization work, and deploy the secondary safety standardization work. At the meeting, Liu Shenghua, deputy general manager of Yunnan Jianfeng, read out the requirements and work arrangements for creating a secondary enterprise for safety production standardization. The representative of Yunnan superstar Safety Technology Service Co., Ltd., the evaluation unit of safety production standardization, explained in detail the relevant knowledge of safety production standardization consultation and evaluation for the participants, and explained the requirements, standards and other elements of safety production standardization work. Zhou Jiping, general manager of Yunnan Jianfeng, mobilized the establishment of secondary safety production standardization at the meeting, requiring all workshops and departments to prepare and report the data before the end of October, and both software and hardware meet the acceptance conditions, so as to complete the bid creation work by the end of the year. Through the mobilization meeting, the responsible persons of Yunnan Jianfeng and superstar companies and relevant personnel had in-depth exchanges, further unified their thinking, and improved Yunnan Jianfeng employees' understanding of safety production standardization. Everyone recognizes that carrying out safety production standardization work is not only to implement the spirit of a series of documents of the party and the country, but also a mandatory requirement of the government for enterprises, and it is also the need for the sustainable and healthy development of enterprises themselves. Through the development of safety production standardization, enterprises can be promoted to establish and improve the safety production responsibility system, improve the safety production management system, standardize the production operation behavior, investigate and control the hidden dangers of accidents, effectively control the sources of danger, make the production equipment and facilities meet the safety standards, and continuously improve
2020
07-30
The Company shall organize special operation safety management training
What kind of management process is needed for the special operation permit? How to manage the ticket of the special operation permit? What are the contents of the eight kinds of special operations?... On June 17, the safety committee of the group company organized a special lecture on safety production to conduct systematic and comprehensive training on the safety management knowledge of special operations. The trainer invited for this training is Ge Zhengliang, head of EHS (Environmental Environment, Health Health, Safety) of Zhejiang Prodbang Pharmaceutical Co., Ltd. He has many years of experience in enterprise safety production management and is also a well-known safety management expert in Jinhua region. He has participated in the enterprise safety and environmental protection inspection organized by Jinhua Safety Supervision Bureau for many times and has a certain understanding of the situation of major enterprises in the peak. In this lecture, Ge Zhengliang divided into four parts: division of special operation license scope, special operation license management process, special operation license ticket management, and eight major types of special operation contents. Combined with relevant laws and regulations and his own practical experience in safety production management, Ge Zhengliang explained in simple terms eight special operation situations such as hot work, hoisting, high place, temporary power consumption, open circuit, blind plate plugging, restricted space, etc, standardize the licensed business division, approval department, the places to be paid attention to in the approval management of each type of operation, the responsibilities of the relevant approval department, the matters needing attention in on-site operation, the approval process, ticket management and other knowledge, and make a detailed description of the relevant special operation contents according to the working characteristics of peak subordinate enterprises. In addition, he also shared the experience of special operation safety management of Plo Pharmaceutical.
2020
07-31
Yunnan Jianfeng won the honor of "key leading enterprise in Pu'er City"
Recently, Yunnan Jianfeng Cement Company was awarded the honorary title of "2016 Pu'er Key Leading Enterprise" by the Pu'er Municipal Party Committee and Municipal Government. In recent years, according to the requirements of the group company's "three reductions and three improvements", Yunnan Jianfeng has focused on internal management and external market expansion, tried every means to reduce costs in production, timely controlled market trends in sales, and constantly refreshed various business indicators. While striving to create its own brand value, Yunnan Jianfeng always regards giving back to the society and serving local development as its own responsibility and obligation. Since the establishment of the company, Yunnan Jianfeng has actively responded to the government's call to support the construction of poor border areas and provide free cement to some poor people. Support the education construction in border areas and donate funds for students in need. At the same time, it has paid various taxes and fees on time in accordance with the law and has become a major profit and tax producer in Pu'er City for years. It has gradually grown from a new cement enterprise in Pu'er area to a leading enterprise in the cement industry. The honor of "key leading enterprises in Pu'er City in 2016" is the affirmation and recognition of Yunnan Jianfeng's work over the past few years by the local government and society. During the "Thirteenth Five-Year Plan" period, southwestern Yunnan is about to usher in an explosive stage of development. The construction of international railway projects, the construction of border expressway projects, the construction of airport projects and the construction of people's livelihood projects will all start this year. The acquisition of the honorary title of "Key Leading Enterprise in Pu'er City in 2016" will also provide strong support for Yunnan Jianfeng to strive for the right to supply these projects. (Li Yun)
2020
07-31