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
The Sixth Plenary Session of the 18th Central Committee of the Communist Party of China was held in Beijing from October 24 to 27. It reviewed and approved the "Several Guidelines on Political Life within the Party under the New Situation" and the "Regulations on Inner-Party Supervision of the Communist Party of China. On November 22, the party committee of the group company successively held party committee and branch secretary meetings to learn the spirit of the sixth Plenary session of the 18th CPC Central Committee and put forward requirements for organizational construction and party member management. At the branch secretary meeting, Jiang Xiaomeng, secretary of the party committee of the group company, preached the main contents of "some guidelines on Inner-Party political Life under the New situation" and "regulations on Inner-Party Supervision of the Communist Party of China. He pointed out that seeking truth from facts, integrating theory with practice, keeping close ties with the masses, criticizing and self-criticism, democratic centralism, and strict party discipline are the basic norms and working principles of inner-party political life accumulated by the Communist Party of China for several generations. In the new social environment, some party members and cadres have bred some unhealthy atmosphere, which has damaged the image and interests of the party, the Sixth Plenary Session of the 18th Central Committee of the Communist Party of China proposed to strengthen and standardize the political life within the party, take the party constitution as the foundation, adhere to the party's political line, ideological line, organizational line and mass line, strive to enhance the political, contemporary, principled and fighting nature of the party's political life, and strive to enhance the party's ability of self purification, self improvement, self innovation and self improvement, Efforts should be made to improve the party's leadership and governance level, efforts should be made to safeguard the authority of the Party Central Committee, ensure the unity and unity of the party, maintain the advanced nature and purity of the party, and strive to form a centralized, democratic and disciplined party in the whole party
2020
07-31
Jinxi plant environmental protection facilities through the completion of acceptance
On November 1, Jianfeng Pharmaceutical Jinxi Pharmaceutical Factory successfully obtained the approval from Zhejiang Environmental Protection Department that the environmental protection facilities of the project passed the completion acceptance, and a key work of Jianfeng Pharmaceutical in 2016 came to an end. Jianfeng Pharmaceutical's annual output of 35 tons of cephalosporins, anti-tumor drugs and other raw material production lines and various preparation production lines technological transformation projects started construction in Jinxi Development Zone in October 2012 and were almost completed in September 2015. The construction of the project strictly abided by the "three simultaneous" system of environmental protection, conscientiously implemented the requirements in the environmental impact assessment report and its approval documents, and invested 19.34 million yuan in environmental protection facilities. The plant has basically realized the separation of clean and sewage. A new wastewater treatment system with a daily treatment capacity of 700 cubic meters and a "physical, chemical and biochemical" treatment process has been built, and an online monitoring device networked with the environmental protection department has been installed. All kinds of production wastewater, public works wastewater and domestic sewage are treated by the wastewater station and sent to Jinxi Sewage Treatment Plant for centralized treatment; there is an RTO regenerative incineration device of 10000 cubic meters per hour and a centralized treatment device of 4000 cubic meters per hour for chlorine-containing organic waste gas. All kinds of waste gas are discharged after collection and treatment. In October 2015, with the approval of Jinhua Economic and Technological Development Zone Branch of Jinhua Environmental Protection Bureau, the trial production of Jinxi project was carried out. After more than half a year of operation, in early July 2016, Zhejiang Environmental Monitoring Center Station carried out completion acceptance monitoring of environmental protection treatment facilities such as waste water and waste gas of Jinxi Pharmaceutical Factory, and issued a completion acceptance monitoring report of environmental protection facilities at the end of August.
2020
07-31
Jinxi plant environmental protection facilities through the completion of acceptance
On November 1, Jianfeng Pharmaceutical Jinxi Pharmaceutical Factory successfully obtained the approval from Zhejiang Environmental Protection Department that the environmental protection facilities of the project passed the completion acceptance, and a key work of Jianfeng Pharmaceutical in 2016 came to an end. Jianfeng Pharmaceutical's annual output of 35 tons of cephalosporins, anti-tumor drugs and other raw material production lines and various preparation production lines technological transformation projects started construction in Jinxi Development Zone in October 2012 and were almost completed in September 2015. The construction of the project strictly abided by the "three simultaneous" system of environmental protection, conscientiously implemented the requirements in the environmental impact assessment report and its approval documents, and invested 19.34 million yuan in environmental protection facilities. The plant has basically realized the separation of clean and sewage. A new wastewater treatment system with a daily treatment capacity of 700 cubic meters and a "physical, chemical and biochemical" treatment process has been built, and an online monitoring device networked with the environmental protection department has been installed. All kinds of production wastewater, public works wastewater and domestic sewage are treated by the wastewater station and sent to Jinxi Sewage Treatment Plant for centralized treatment; there is an RTO regenerative incineration device of 10000 cubic meters per hour and a centralized treatment device of 4000 cubic meters per hour for chlorine-containing organic waste gas. All kinds of waste gas are discharged after collection and treatment. In October 2015, with the approval of Jinhua Economic and Technological Development Zone Branch of Jinhua Environmental Protection Bureau, the trial production of Jinxi project was carried out. After more than half a year of operation, in early July 2016, Zhejiang Environmental Monitoring Center Station carried out completion acceptance monitoring of environmental protection treatment facilities such as waste water and waste gas of Jinxi Pharmaceutical Factory, and issued a completion acceptance monitoring report of environmental protection facilities at the end of August.
2020
07-31
Jinxi plant environmental protection facilities through the completion of acceptance
On November 1, Jianfeng Pharmaceutical Jinxi Pharmaceutical Factory successfully obtained the approval from Zhejiang Environmental Protection Department that the environmental protection facilities of the project passed the completion acceptance, and a key work of Jianfeng Pharmaceutical in 2016 came to an end. Jianfeng Pharmaceutical's annual output of 35 tons of cephalosporins, anti-tumor drugs and other raw material production lines and various preparation production lines technological transformation projects started construction in Jinxi Development Zone in October 2012 and were almost completed in September 2015. The construction of the project strictly abided by the "three simultaneous" system of environmental protection, conscientiously implemented the requirements in the environmental impact assessment report and its approval documents, and invested 19.34 million yuan in environmental protection facilities. The plant has basically realized the separation of clean and sewage. A new wastewater treatment system with a daily treatment capacity of 700 cubic meters and a "physical, chemical and biochemical" treatment process has been built, and an online monitoring device networked with the environmental protection department has been installed. All kinds of production wastewater, public works wastewater and domestic sewage are treated by the wastewater station and sent to Jinxi Sewage Treatment Plant for centralized treatment; there is an RTO regenerative incineration device of 10000 cubic meters per hour and a centralized treatment device of 4000 cubic meters per hour for chlorine-containing organic waste gas. All kinds of waste gas are discharged after collection and treatment. In October 2015, with the approval of Jinhua Economic and Technological Development Zone Branch of Jinhua Environmental Protection Bureau, the trial production of Jinxi project was carried out. After more than half a year of operation, in early July 2016, Zhejiang Environmental Monitoring Center Station carried out completion acceptance monitoring of environmental protection treatment facilities such as waste water and waste gas of Jinxi Pharmaceutical Factory, and issued a completion acceptance monitoring report of environmental protection facilities at the end of August.
2020
07-30
Daye Jianfeng Safety Standard was awarded as the only award-winning enterprise in daye city in 2015.
Due to the achievements made in the establishment of secondary safety production standardization, daye peak cement company recently received a special award of 200000 yuan from daye municipal government. In order to encourage industrial and commercial enterprises in the region to improve their production safety, daye municipal government set up a special fund in 2015, stipulating that 200000 yuan will be awarded to those who pass the secondary safety standardization review before December 31, 2015. It is understood that among the industrial and commercial enterprises in daye city, there were 4 enterprises that applied for and passed the examination in 2015, but only daye peak passed the examination before December. Therefore, Daye Peak has become the only enterprise that has won the special award for the establishment of the safety standard in Daye City in 2015. (Ye Meifang)
2020
07-31
Two Cement Enterprises Start to Implement "Big Patrol Inspection"
With the change of the competition situation in the industry, the profit space of cement production enterprises has been greatly squeezed. Reducing costs and increasing efficiency and job optimization have become the inevitable choice to improve the enterprise's own development ability and enhance the core competitiveness. In accordance with the requirements of the group company to realize the transformation from extensive management to lean management, combined with the advanced experience of peer enterprises, recently, Yunnan peak, daye peak two enterprises have implemented "big inspection" to promote the overall optimization of posts. On November 1, daye peak post inspection officially started full operation, starting from the limestone storage yard at the source of the production line to the cement storage. the original 15 posts were merged, and the best experienced mechanics, electricians and post workers were transferred to form a large inspection class, which was mainly responsible for on-site emergency disposal and post routine maintenance to ensure the normal production of the whole production line. In order to ensure the smooth implementation of the large-scale inspection, daye peak management team has repeatedly communicated and discussed with the heads of relevant workshops and departments, and held a special workshop post optimization promotion meeting in September to clarify objectives and responsibilities, formulate implementation steps, and do a lot of preparatory work. At the kick-off meeting for the implementation of the large-scale inspection on October 31, Zhang Fengliang asked daye peak employees to recognize the current situation of serious cement overcapacity and cruel market competition, understand the necessity of implementing the large-scale inspection, and asked the workshop leaders to do a good job in training and guiding the employees, shorten the transition period, normalize the operation of the large-scale inspection as soon as possible, and at the same time, managers should also change their working ideas and concepts and do a good job in full-time, strengthen the inspection, overhaul and maintenance of the regular day shift, and find and solve the problems existing in the equipment and process in time.
2020
07-30