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
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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