Securities code: Hunan Warrant Pharmaceutical Co.Ltd(688799) securities abbreviation: Hunan Warrant Pharmaceutical Co.Ltd(688799) Announcement No.: 2022004 Hunan Warrant Pharmaceutical Co.Ltd(688799)
Voluntary disclosure on the quality and efficacy of drugs through generic drugs
Announcement of conformity evaluation
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 bear legal liabilities for the authenticity, accuracy and integrity of its contents according to law.
Recently, Hunan Warrant Pharmaceutical Co.Ltd(688799) (hereinafter referred to as “the company”) received the notice of approval of supplementary drug application for mycophenolate mofetil capsules approved and issued by the State Drug Administration. The relevant information is hereby announced as follows:
1、 Basic information of drugs
1. Drug name: mycophenolate mofetil capsule
2. Dosage form: capsule
3. Specification: 0.25g
4. Registration category: Chemicals
5. Original drug approval No.: gyzz h20080016
6. Approval conclusion: This product has passed the consistency evaluation of quality and efficacy of generic drugs.
2、 Drug profile
The application of mycophenolate mofetil capsule together with corticosteroids, cyclosporine or tacrolimus is suitable for the treatment of patients receiving allogeneic kidney transplantation and liver transplantation, the prevention of organ rejection, and the induction and maintenance treatment of patients with type III-V adult lupus nephritis.
3、 Impact on the company and risk tips
According to relevant national policies, drug varieties that pass the conformity evaluation of generic drugs will receive greater support in the fields of medical insurance payment and medical institution procurement. The company has accumulated valuable experience in evaluating the efficacy of generic capsules and generic products in the future market, which will be conducive to the consistency of generic products in the market.
Because pharmaceutical products have the characteristics of high technology, high risk and high added value, the sales of drugs may be affected by national policies, changes in market environment and other factors, which are uncertain. Please make careful decisions and pay attention to preventing investment risks.
It is hereby announced.
Hunan Warrant Pharmaceutical Co.Ltd(688799) board of directors March 14, 2022