Securities code: Hybio Pharmaceutical Co.Ltd(300199) securities abbreviation: Hybio Pharmaceutical Co.Ltd(300199) Announcement No.: 2022031 Hybio Pharmaceutical Co.Ltd(300199)
Suggestive announcement on the approval of terlipressin for injection in Brazil
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
Hybio Pharmaceutical Co.Ltd(300199) (hereinafter referred to as "the company" or " Hybio Pharmaceutical Co.Ltd(300199) ") recently learned through the official website of the Brazilian health supervision agency (Anvisa) that volpharma, the agent seller of terlipressin preparation for injection of the company, has obtained the listing approval of the product in Brazil. The relevant information is as follows:
1、 Basic information of approved products
Drug name: terlipressin for injection
Listing license No.: 253518692422021-02
Active ingredient: terlipressin acetate
Dosage form: powder injection
Product specification: 1mg each (including terlipressin 0.86mg)
Manufacturer: Hybio Pharmaceutical Co.Ltd(300199)
Applicant: Vol Pharma
Authorization period: 5 years after the commercial sale of the product
Drug category: prescription drugs
Date of approval: March 21, 2022
2、 Other information about drugs
Terlipressin is a synthetic vasopressin analogue, which belongs to vasoconstrictor among vasoactive drugs. It is mainly used for hemostasis of variceal bleeding in liver cirrhosis. Now it is widely used in the treatment of hepatorenal syndrome, cirrhotic ascites, septic shock, burns, acute liver failure, cardiac arrest and so on.
3、 Impact on the company
This time, the sales agent Vol company has obtained the listing approval from the Brazilian Health Supervision Bureau, which indicates that the company will further expand its international market business, play a positive role in promoting the progress of internationalization, facilitate the development of the company's export business and enhance the company's international competitiveness.
4、 Risk tips
Due to the characteristics of high technology, high risk and high added value of pharmaceutical products, the sales of drugs after approval will be affected by uncertain factors such as market and environmental changes, and there is a risk that the sales will not meet the expectations. The sales method of this product is exclusive authorization, and the sales situation is uncertain after the end of the authorization period. Please make careful decisions and pay attention to investment risks.
It is hereby announced.
Hybio Pharmaceutical Co.Ltd(300199) board of directors March 24, 2022
