Announcement of Jianfeng Group Lin2017 -005 on Subsidiary Obtaining Drug Clinical Trial Approval
Release time:
2020-08-05
Securities Code: 600668 Securities Abbreviations: Jianfeng Group Number: Pro 2017-005
Bond Abbreviations: 13 Peak 01 Bond Code: 122227
Bond Abbreviations: 13 Peak 02 Bond Code: 122344
Zhejiang Jianfeng Group Co., Ltd.
Announcement on Subsidiaries Obtaining Approval for Drug Clinical Trials
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 subsidiary of the Company, received the "Drug Clinical Trial Approval Document" (Deoxypodophyllotoxin for Injection, Approval Document No.: 2017L01082 ) and (Deoxypodophyllotoxin, Approval Document No: 2017L01083)(hereinafter collectively referred to as "DPT"). The relevant details are hereby announced as follows:
2. drug basic information content
(I) deoxypodophyllotoxin
drug name: deoxypodophyllotoxin
English name: Deoxypodophyllotoxin
dosage form: bulk drug
application items: domestic Drug Registration
Registration Classification: Chemical Drug Class 1
Applicant: Zhejiang Jianfeng Pharmaceutical Co., Ltd. and China Pharmaceutical University
Approval Conclusion: "According to the the People's Republic of China Drug Administration Law and relevant regulations, after examination, this product meets the relevant requirements of drug registration and agrees to conduct clinical trials of this product preparation."
(II) deoxypodophyllotoxin for injection
drug name: deoxypodophyllotoxin for injection
English name: Deoxypodophyllotoxin for Injection
dosage form: injection
application items: domestic drug registration
specification: 100mg
registration classification: chemical drugs category 1
applicant: Zhejiang Jianfeng pharmaceutical co., ltd. and China pharmaceutical university
approval conclusion: "according to the the People's Republic of China drug administration law and relevant regulations, after examination, this product meets the relevant requirements of drug registration and agrees to carry out clinical trials."
Research and Development and Registration of 3. Drugs
DPT Project was established in March 104 by 2012. Jianfeng Pharmaceutical Co., Ltd. is a new anti-tumor drug developed in cooperation with China Pharmaceutical University. The registration classification belongs to Class 1 of chemical drugs. The first DPT clinical trial application submitted by Jianfeng Pharmaceutical was accepted on July 27, 2016 (acceptance numbers: CXHL1600201 Zhejiang, CXHL1600202 Zhejiang). DPT is an alkaloid antineoplastic drug with tentative indications for lung cancer, breast cancer and gastric cancer, which will be finalized based on clinical trial results. As of the date of this announcement, the accumulated research and development investment and other related expenditures of the DPT project of Jianfeng Pharmaceutical Co., Ltd. totaled about 34.12 million yuan.
Market Situation of Similar Drugs in 4.
Currently, the same alkaloid anti-tumor drugs listed in China mainly include paclitaxel, vinorelbine and docetaxel. The main manufacturers of paclitaxel injection include Yangzijiang Pharmaceutical Group Co., Ltd., Beijing Shuanglu Pharmaceutical Co., Ltd., Haizheng Pfizer Pharmaceutical Co., Ltd., etc, the main manufacturers of Vinorelbine include Jiangsu Haosen Pharmaceutical Group Co., Ltd., Jiangsu Hengrui Pharmaceutical Co., Ltd., Haizheng Pfizer Pharmaceutical Co., Ltd., etc., and the main manufacturers of docetaxel injection include Jiangsu Hengrui Pharmaceutical Co., Ltd., Yangtze River Pharmaceutical Group Co., Ltd.
According to IMS database statistics, the global sales of the above three drugs in 2015 were 16.46, 1.07 and 0.669 billion US dollars respectively, totaling 2.422 billion US dollars.
5. products still need to go on the market.
DPT is currently in the approved clinical trial stage. Jianfeng Pharmaceutical will complete the clinical trial according to the requirements of the "Drug Clinical Trial Approval". After the clinical trial is completed, it will declare for production. It can only produce and market after passing the review and approval of CFDA and obtaining the drug production approval.
Impact of 6. on Listed Companies and Risk Tips
The company has obtained the "Drug Clinical Trial Approval" this time, which will not have a significant impact on the company's recent operating results.
Due to the particularity of drug research and development, there are unpredictable risks such as long cycle and many links from clinical trials to commissioning. 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
March 22, 2017
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