Securities code: 600566 securities abbreviation: Hubei Jumpcan Pharmaceutical Co.Ltd(600566) Announcement No.: 2022-009 convertible bond Code: 110038 convertible bond abbreviation: Jichuan convertible bond
Hubei Jumpcan Pharmaceutical Co.Ltd(600566)
Announcement on subsidiary obtaining drug registration certificate
The board of directors and all members of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear individual and joint liabilities for the authenticity, accuracy and completeness of its contents.
Recently, Hubei Jumpcan Pharmaceutical Co.Ltd(600566) Group Co., Ltd., a wholly-owned subsidiary of Hubei Jumpcan Pharmaceutical Co.Ltd(600566) (hereinafter referred to as "the company"), received the drug registration certificate of concentrated magnesium sodium potassium sulfate oral solution approved and issued by the State Drug Administration (hereinafter referred to as "the State Drug Administration"), and now the relevant information is announced as follows: I. Basic information of the drug registration certificate
Drug name: concentrated solution of magnesium sodium potassium sulfate for oral use
English name / Latin name magnesium sulfate, sodium sulfate and potassium
Sulfate Concentrate Oral Solution
Main ingredients: magnesium sulfate, sodium sulfate and potassium sulfate
Specification 177ml: 1.6g magnesium sulfate (calculated as MgSO4), 17.5g sodium sulfate and 3.13g potassium sulfate
Acceptance No.: cyhs200040 8 countries
Certificate No.: 2022s00043
Dosage form oral solution
Application item drug registration (domestic production)
Registered classification: Class 3 chemicals
Drug registration standard series ybh00362022
number
The drug is valid for 24 months
Package specification: 177ml / bottle, 2 bottles / box.
Prescription drugs / over-the-counter drugs prescription drugs approval No.: gyzz h20223027
The drug approval number is until January 29, 2027
Enterprise name of valid listing Permit Holder: Hubei Jumpcan Pharmaceutical Co.Ltd(600566) Group Co., Ltd
Production address: baotawan, Daqing West Road, Taixing City
Pharmaceutical manufacturer name: Hubei Jumpcan Pharmaceutical Co.Ltd(600566) Group Co., Ltd
Production address: baotawan, Daqing West Road, Taixing City
According to the drug administration law of the people's Republic of China and relevant regulations, after examination, the product meets the relevant requirements of drug registration, the registration is approved, and the certificate of drug injection approval conclusion book is issued. The production process, quality standards, instructions and labels shall be implemented in accordance with the attached. A drug manufacturing enterprise shall meet the requirements of the standard for the quality control of drug production before it can produce and sell drugs.
2、 Relevant information of drug research
The concentrated solution of magnesium sodium potassium sulfate for oral use was developed by Braintree laboratories in the United States. It was approved by FDA on August 5, 2010. The trade name is suprep ® The bowlprepkit is 6 ounces (about 177ml) per bottle, including 17.5g sodium sulfate, 3.13g potassium sulfate and 1.6g magnesium sulfate. This product is suitable for adults. It is used for intestinal cleaning before any operation that requires intestinal cleaning.
The company's first application for registration of this product will be accepted on June 12, 2020. Up to now, the cumulative R & D expenditure of the drug is about 28 million yuan (Unaudited), which has been expensed.
The product is classified into 3 categories of chemical drugs. According to the relevant provisions of the announcement on matters related to the consistency evaluation of the quality and efficacy of generic drugs (2017 No. 100) issued by the State Food and drug administration, it is deemed to have passed the consistency evaluation after listing.
3、 Market situation of similar drugs
Up to now, the company's concentrated magnesium sodium potassium sulfate oral solution is the first imitation listed in China. Except for the company, no other manufacturers have been approved to go public in Chinese mainland.
As a new type of intestinal cleaning preparation agent, magnesium sodium potassium sulfate oral concentrated solution has the characteristics of small dosage, high patient tolerance and good intestinal cleaning effect. It is the recommended medication in the guidelines for intestinal cleaning preparation in Europe and the United States. The medicine is not only suitable for intestinal cleaning preparation before enteroscopy, but also for intestinal cleaning preparation before surgery and radiation examination.
According to the data of Intranet, in 2020, the total sales of drugs related to intestinal cleaning and preparation in urban public hospitals in China exceeded 1 billion yuan. At present, the commonly used intestinal cleaning preparations in China include compound polyethylene glycol electrolyte powder, sodium phosphate oral solution and so on.
4、 Risk tips
This time, the company obtained the drug registration certificate of magnesium sodium potassium sulfate oral concentrated solution, which is a further supplement to the company's products and enriches the company's product line. Product sales are vulnerable to China Meheco Group Co.Ltd(600056) industry policy changes, bidding and procurement, market and competitive environment changes and other factors, and there is uncertainty. Please invest rationally and pay attention to investment risks.
It is hereby announced.
Hubei Jumpcan Pharmaceutical Co.Ltd(600566) board of directors February 11, 2022
