Securities code: 300630 securities abbreviation: Hainan Poly Pharm.Co.Ltd(300630) Announcement No.: 2022-021
Bond Code: 123099 bond abbreviation: Puli convertible bond
Hainan Poly Pharm.Co.Ltd(300630)
FDA announcement on the approval of omeprazole sodium for injection in the United States
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.
Hainan Poly Pharm.Co.Ltd(300630) (hereinafter referred to as ” Hainan Poly Pharm.Co.Ltd(300630) ” or “the company”) recently received the notice of approval for the listing of generic drugs of esmeprazole sodium for injection issued by the U.S. Food and Drug Administration (FDA). The relevant information is hereby announced as follows:
1、 Basic information of drugs
(I) drug name: esmeprazole sodium for injection
(II) dosage form: injection
(III) specification: 40 mg
(IV) indications: 1. As an alternative therapy for short-term treatment of gastroesophageal reflux disease (GERD) with erosive esophagitis (EE) in adults and children aged 1 month to 17 years when oral therapy is not applicable. 2. Reduce the risk of rebleeding after therapeutic endoscopy for acute bleeding of gastric or duodenal ulcer in adults.
2、 Approval status
(I) registration category: generic drugs
(II) anda No.: 215732
(III) listing Permit Holder: Hainan Poly Pharm.Co.Ltd(300630)
3、 Other relevant information of drugs
Esmeprazole, also known as esomeprazole, is a single L-isomer of omeprazole. Both belong to proton pump inhibitors, which can effectively inhibit gastric acid secretion. It is clinically used to treat gastroesophageal reflux disease, erosive reflux esophagitis and so on. This drug is one of the most successful examples of isomer development. Compared with the first generation omeprazole, it has stronger effect of inhibiting gastric acid and less adverse reactions. The drug was first developed by AstraZeneca. In 2000, its oral preparation was listed in Sweden with the trade name Nexium. Its injection was launched in 2003 and was approved by the U.S. Food and Drug Administration (FDA) in March 2005.
Hainan Poly Pharm.Co.Ltd(300630) was successfully developed and applied for generic drug registration in Europe, the United States and China respectively. Recently, the company received the approval notice from the U.S. Food and Drug Administration (FDA), which indicates that the company has the qualification to sell ace omeprazole sodium for injection in the United States, which will have a positive impact on the company’s expansion of the U.S. market.
4、 Risk tips
The company attaches great importance to drug research and development, and strictly controls the quality and safety of drug research and development, manufacturing and sales. Due to the characteristics of high-tech, high-risk and high added value of pharmaceutical products, not only the early research and development of drugs and the long cycle and many links of products from research and development, clinical trial approval to production, but also the production and sales of drugs after obtaining approval are vulnerable to some uncertain factors. The company will timely fulfill the obligation of information disclosure according to the follow-up progress. Please make careful decisions and pay attention to preventing investment risks.
5、 Documents for future reference
(I) supporting documents
It is hereby announced.
Hainan Poly Pharm.Co.Ltd(300630) board of directors
February 13, 2022
