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
Spike New Drug Approved for Registration
On April 16, Jianfeng Pharmaceutical Company received the approval and issuance of Olopatadine Hydrochloride Eye Drops "Drug Registration Approval" (approval number: 2019S00296) approved by the State Drug Administration. Olopatadine hydrochloride eye drops is mainly used to treat the signs and symptoms of allergic conjunctivitis. It is a mast cell stabilizer and a relatively selective histamine H1-receptor antagonist. It can inhibit type I immediate allergic reactions in vivo and in vitro experiments. At present, the product has been included in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2017 Edition)" and classified as Class B. According to the relevant data of IMS database, in 2018, the global sales of olopatadine hydrochloride eye drops were about 0.37 billion US dollars, and the sales in China were about 10.232 million US dollars. Spike Pharmaceuticals already has the corresponding production line, this time to obtain the registration approval, marking Spike Pharmaceuticals has the qualification to carry out the production and sales of olopatadine hydrochloride eye drops, will further enrich the product line of Spike Pharmaceuticals, help to enhance the competitiveness of the company's pharmaceutical business. (Xia Yingpin)
2020
07-22
Peak International Trade was rated as "excellent delivery warehouse" by the big business"
On April 12, the 2019 Dalian Commodity Exchange Industrial Products Delivery Work Summary Meeting was held in Dalian. Jianfeng International Trading Company was rated as "2018 (Industrial Products) Excellent Delivery Warehouse" and Ruan Weihang, an employee of the International Trading Company, was rated as "2018 (Industrial Products) Excellent Futures Specialist in Designated Delivery Warehouse". The delivery link is the bridge link between the futures and cash markets, an important area of risk prevention and control in the futures market, and a strong guarantee for the smooth operation and function of the market. Since obtaining the qualification of PVC delivery warehouse in 2009, the chemical warehousing and logistics business of international trading company has developed steadily. In terms of management, the international trading company strictly follows the various systems of the Dalian Commodity Exchange to implement warehouse-in and warehouse-in management. The management level has been improved year by year. Broken packages have been handled on the spot, and the loss of goods has been greatly reduced. The management goal of daily clearing has been achieved, and standardized operations have been achieved; in terms of business marketing, the futures business has driven the gradual development and growth of the spot business, futures varieties have developed from a single PVC variety to four varieties of PVC, PP, PE and plywood. The business volume has increased year by year and has exceeded 500000 tons. The operation volume can exceed 2500 tons/day; In terms of customer service, from zero experience in futures business to now, customer reputation has increased year by year, and customer complaints have gradually decreased. The annual excellent delivery warehouse of the judges is the full affirmation of Dalian Commodity Exchange on the functions of international trading companies, market satisfaction, futures management level and standardization of warehouse daily management. Lou Chunming, general manager of the international trading company, said that the international trading company will implement
2020
07-31
Spike New Drug Approved for Registration
On April 16, Jianfeng Pharmaceutical Company received the approval and issuance of Olopatadine Hydrochloride Eye Drops "Drug Registration Approval" (approval number: 2019S00296) approved by the State Drug Administration. Olopatadine hydrochloride eye drops is mainly used to treat the signs and symptoms of allergic conjunctivitis. It is a mast cell stabilizer and a relatively selective histamine H1-receptor antagonist. It can inhibit type I immediate allergic reactions in vivo and in vitro experiments. At present, the product has been included in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2017 Edition)" and classified as Class B. According to the relevant data of IMS database, in 2018, the global sales of olopatadine hydrochloride eye drops were about 0.37 billion US dollars, and the sales in China were about 10.232 million US dollars. Spike Pharmaceuticals already has the corresponding production line, this time to obtain the registration approval, marking Spike Pharmaceuticals has the qualification to carry out the production and sales of olopatadine hydrochloride eye drops, will further enrich the product line of Spike Pharmaceuticals, help to enhance the competitiveness of the company's pharmaceutical business. (Xia Yingpin)
2020
07-30
Peak Cement Won the Bid for National Key Project Daye Peak Becomes Huang-Huang Railway Supplier
On March 19, Daye Jianfeng Cement Company officially received a notice from China Railway Construction Material Collection Center that the company was shortlisted for the new Huang (Mei) Huang (Zhou) railway project in the Hubei section of the Shanghai-Chengdu high-speed railway along the Yangtze River in the second place, and obtained the right to supply the 6th package of cement. This is the first stick undertaken by Daye Jianfeng in 2019, and it is also the second time to enter the high-speed rail project after the Wu (Han) Jiu (Jiang) high-speed rail. The Huanghuang high-speed railway is a component of the "eight vertical and eight horizontal" high-speed railway network in the "National Medium and Long-term Railway Network Plan". It is a component of the Wuhan-Hangzhou and Beijing-Hong Kong-Kowloon high-speed railway network. It has a total length of 125 kilometers and a design speed of 350 kilometers per hour. It will start construction at the end of 2018. It will be opened to traffic in 2021. In addition to the characteristics of large demand for high-speed railway and highway projects, the project time span is long and the product quality requirements are high, especially the high-speed railway project has extremely strict requirements on the alkali content of cement. After participating in the bidding, Yuan Xianming, executive deputy general manager of Daye Peak, organized production, quality control, procurement and other relevant departments for many times to carry out tests on the production of low-alkali cement and adjust the proportion of raw materials. The quality control department also sent samples to the provincial professional inspection department for comparative inspection to ensure product stability. The marketing department carefully checked the details of the tender, strictly checked and repeatedly deduced the bid price. Finally, with the full cooperation of all departments, the successful bidding was passed, finalist Huang-Huang high-speed rail project. It is understood that as the country continues to increase investment in infrastructure transportation construction, daye peak adjusted its work direction at the end of 2018, requiring marketing work in 2019 to focus on key projects.
2020
07-31
Daye Peak Opens "Standard Year"
After the 2019 overhaul ended in early March, Daye Jianfeng Cement Company immediately launched the "Standard Year" activity to carry out standardized rectification in view of a series of defects and problems in the daily management process. The goal of the "Standard Year" activity is to target specific issues that affect employees' work efficiency and safe and environmentally friendly production. Through the formulation of institutionalized work standards, further standardize employees' various operations, improve operational efficiency, and improve grassroots management execution, so as to achieve The purpose of improving the company's image, reducing costs, improving efficiency, and increasing benefits. In order to ensure the smooth progress of the activities, daye peak has set up a promotion team headed by general manager Zhang fengliang to be responsible for the overall promotion of the "standard year" activities, mainly including revising the activity plan, summarizing the standardized implementation standards of various departments, implementing the plan, supervising the implementation progress, evaluating the implementation effect, collecting suggestions and opinions in the implementation process, etc. Based on the foundation, aiming at the details and solving problems is a major feature of Daye peak's "standard year" activity. For example, the "Flange Sealing Operation Standard", which is currently being tried out, not only puts forward standardization requirements for such a "trivial matter" in equipment management as flange sealing, but also attaches "model" photos to make it clear to mechanics What should be done and what should be done. However, this "small standard" aims at three problems: leakage at the production site, extensive mechanic work and waste of materials. Once it becomes the behavior habit of employees, the hygiene and cost control at the production site are bound to be improved. It is understood that Daye peak "standard year" activities plan to continue for three years to promote, activities
2020
07-22
Daye Peak Opens "Standard Year"
After the 2019 overhaul ended in early March, Daye Jianfeng Cement Company immediately launched the "Standard Year" activity to carry out standardized rectification in view of a series of defects and problems in the daily management process. The goal of the "Standard Year" activity is to target specific issues that affect employees' work efficiency and safe and environmentally friendly production. Through the formulation of institutionalized work standards, further standardize employees' various operations, improve operational efficiency, and improve grassroots management execution, so as to achieve The purpose of improving the company's image, reducing costs, improving efficiency, and increasing benefits. In order to ensure the smooth progress of the activities, daye peak has set up a promotion team headed by general manager Zhang fengliang to be responsible for the overall promotion of the "standard year" activities, mainly including revising the activity plan, summarizing the standardized implementation standards of various departments, implementing the plan, supervising the implementation progress, evaluating the implementation effect, collecting suggestions and opinions in the implementation process, etc. Based on the foundation, aiming at the details and solving problems is a major feature of Daye peak's "standard year" activity. For example, the "Flange Sealing Operation Standard", which is currently being tried out, not only puts forward standardization requirements for such a "trivial matter" in equipment management as flange sealing, but also attaches "model" photos to make it clear to mechanics What should be done and what should be done. However, this "small standard" aims at three problems: leakage at the production site, extensive mechanic work and waste of materials. Once it becomes the behavior habit of employees, the hygiene and cost control at the production site are bound to be improved. It is understood that Daye peak "standard year" activities plan to continue for three years to promote, activities
2020
07-31