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 2020-018
Zhejiang Jianfeng Group Co., Ltd.
Announcement on Subsidiaries Obtaining Notice of 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 .
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 Jianfeng Yien Biotechnology Co., Ltd. (hereinafter referred to as "Jianfeng Yien") , , a holding subsidiary of Zhejiang Jianfeng Pharmaceutical Co., Ltd., the company's holding subsidiary, received the "Drug Clinical Trial Approval Notice" approved and issued by the State Food and Drug Administration, "JFAN-1001 Capsule, Notice No: 2020LP00246 " and "JFAN-1001 Capsules, Notification No: 2020LP00247 ". The relevant details are hereby announced as follows:
2. drug basic information content
drug name: JFAN-1001 capsule
English name: JFAN-1001Capsule
dosage form: capsule
application item: clinical research application
specification: 10mg , 30mg
registration classification: chemical drugs category
applicant: Zhejiang Jianfeng yien biotechnology co., ltd
approval conclusion: "according to the the People's Republic of China drug administration law and relevant regulations, after examination, 2020 6 February 7 accepted JFAN-1001 glue capsule meets the relevant requirements of drug registration and agrees to carry out clinical trials according to the submitted plan."
3. Drug Research and Development and Registration
JFAN-1001 is a new anti-tumor drug developed by Jianfeng Yien. The registration classification belongs to chemical drug 1 . Jianfeng Yien first submitted JFAN-1001 clinical trial application and was accepted on 2020 6 January 7 (acceptance numbers: CXHL2000255 , CXHL2000256 ). JFAN-1001 is a small molecule antineoplastic agent with indications for EGFR-T790M secondary mutation-positive locally advanced or metastatic non-squamous non-small cell lung cancer. As of the date of this announcement, the accumulated research and development expenses and technical investment of the project totaled about 4676.04 .03 million yuan.
Market Situation of Similar Drugs in 4.
Currently, targeted drugs for epidermal growth factor receptor (EGFR ) inhibitors listed in China include: the first generation EGFR inhibitors include gefitinib, erlotinib and icotinib; The second generation EGFR inhibitors include afatinib and dacotinib; the third generation EGFR inhibitor includes AstraZeneca's osimertinib, which was approved for listing in the United States on November 11, 2009, , , , and approved for listing in China on March 122, , 2017, . AstraZeneca global annual sales of osimertinib in 2019, , .7 billion (source: 2019# AstraZeneca Annual Financial Statement for 129), almetinib of Jiangsu Haosen Pharmaceutical Co., Ltd. was approved to be listed in China in January , March this year. The company's JFAN-1001 is the third generation EGFR inhibitor with the same target as osimertinib, at present, similar drugs in the clinical research stage include efitinib of Shanghai Alex pharmaceutical technology co., ltd., avetinib of Hangzhou essen pharmaceutical research co., ltd., Nanjing shenghe pharmaceutical co., ltd. SH-1028 , Jiangsu osaikang pharmaceutical co., ltd. ASK120067 , Jiangsu runxin biotechnology co., ltd. RX518 and many other enterprises. Approval Procedure for 5. Products to Be Listed Jianfeng Yien will conduct clinical trials according to the requirements of the Notice of Approval of Drug Clinical Trials. After the clinical trials are completed, production will be declared. Production and marketing can only be carried out after passing the review and approval of the State Food and Drug Administration and obtaining the approval documents for drug production. 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 August 19, 2020
More information
Editor's note: During the National Day, the "Jinhua New Observation" column of Jinhua TV Station launched a series of reports on "National Day New Observation: New Development of Old Enterprises" to understand the new developments of those old enterprises that have grown up with New China in the new era. October 3 broadcast of the "peak of the 'centennial 'ideal", about the development of the peak group and the future direction of development. The "century" ideal of the peak Jinhua TV reporter Wang Dujuan Jiang Qian host: speaking of Zhejiang Jianfeng Group Co., Ltd., Jinhua people are no stranger. The older generation of Jinhua people are more familiar with, may be the predecessor of Jianfeng Group-Jinhua Cement Factory. Open the first old photo 58 years ago, surrounded by mountains and a rice field in the middle. Old Jinhua can see at a glance that this is the Wise Temple, 8 kilometers north of Jinhua City and east of the former Zhuangtou of Luodian Town. In August 1958, the first group of pioneers came here and built Jinhua's first cement factory on a desolate hillside of 16.94 mu with a pair of hands and warm blood. From the earliest cattle-drawn ball forming machine to the electric ball forming machine, from pure manual labor to machine substitution, it took 26 years of hard work. By 1983, the annual output of peak cement reached 120000 tons, the output value was 6.75 million yuan, and the profit was 2.4 million yuan. In these 26 years, the cement plant has experienced a difficult period of the country, and the ten-year catastrophe of the "Cultural Revolution" has finally ushered in a good time of reform and opening up with tenacious vitality, laying the foundation for steady development in the future. Looking at these old pictures,
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2020
07-31
Peak Cement Successfully Enters Lancang Airport Project
News from our newspaper On September 26, the first batch of airport runway cement produced by Yunnan Jianfeng Cement Company was successfully delivered to the Lancang Airport site, which marked another important step in the expansion of Jianfeng Cement in the southwest Yunnan market. Lancang Airport is located in Donghi Town, Lancang Lahu Autonomous County, Pu'er City. It is the center of the "three counties" and "Pu'er Green Triangle" tourist areas of Lancang, Menglian and Ximeng, with a wide range of radiation and obvious location advantages. The project is a national "Twelfth Five-Year Plan" construction project and a key construction project in Yunnan Province. It was approved by the State Council and the Central Military Commission in January 2013. It started construction at the end of November 2014 and is expected to be completed in April 2017. The current project of Lancang Airport is designed to meet the target of 250000 passenger throughput and 750 tons of cargo throughput by 2020, including the construction of a 2600-meter-long and 45-meter-wide runway, the construction of a new 3000-square-meter terminal building and 4 apron parking spaces, including communication, navigation, lighting, meteorology and other supporting projects. The total investment of the project is 1.533 billion yuan. Upon completion, it can be used for Boeing 737 series, Airbus A319 and A320 series, MA-60 and other passenger aircraft take off and land. Since the start of the Lancang Airport project, Yunnan Peak has listed it as an important goal to strive. Compared with ordinary cement, special cement for airport runways has the characteristics of small shrinkage, strong wear resistance, good frost resistance and low alkali content in addition to the requirements of ordinary 42.5 Portland cement. To this end, Yunnan peak in the project to strive for at the same time, the collection of technical forces to tackle the problem, in the clinker composition to determine, cooked.
2020
07-31
Peak Cement Successfully Enters Lancang Airport Project
News from our newspaper On September 26, the first batch of airport runway cement produced by Yunnan Jianfeng Cement Company was successfully delivered to the Lancang Airport site, which marked another important step in the expansion of Jianfeng Cement in the southwest Yunnan market. Lancang Airport is located in Donghi Town, Lancang Lahu Autonomous County, Pu'er City. It is the center of the "three counties" and "Pu'er Green Triangle" tourist areas of Lancang, Menglian and Ximeng, with a wide range of radiation and obvious location advantages. The project is a national "Twelfth Five-Year Plan" construction project and a key construction project in Yunnan Province. It was approved by the State Council and the Central Military Commission in January 2013. It started construction at the end of November 2014 and is expected to be completed in April 2017. The current project of Lancang Airport is designed to meet the target of 250000 passenger throughput and 750 tons of cargo throughput by 2020, including the construction of a 2600-meter-long and 45-meter-wide runway, the construction of a new 3000-square-meter terminal building and 4 apron parking spaces, including communication, navigation, lighting, meteorology and other supporting projects. The total investment of the project is 1.533 billion yuan. Upon completion, it can be used for Boeing 737 series, Airbus A319 and A320 series, MA-60 and other passenger aircraft take off and land. Since the start of the Lancang Airport project, Yunnan Peak has listed it as an important goal to strive. Compared with ordinary cement, special cement for airport runways has the characteristics of small shrinkage, strong wear resistance, good frost resistance and low alkali content in addition to the requirements of ordinary 42.5 Portland cement. To this end, Yunnan peak in the project to strive for at the same time, the collection of technical forces to tackle the problem, in the clinker composition to determine, cooked.
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