August 29, Jinyao Pharmaceutical(600488) issued an announcement. Recently, the company received the " Chemical Raw Materials " certificate for difluprednate approved by the State Food and Drug Administration.Approval of the Drug Marketing Application. It is understood that difluprednate is a topical corticosteroid that can inhibit inflammatory responses caused by various irritants. Currently, the main dosage form on the market is eye drops, primarily used to treat inflammation and pain associated with eye surgery.

According to statistics from the IQVIA database, the global sales of difluprednate preparations (including single and compound preparations) in 2023 and 2024 will be US$49 million and US$41 million, respectively.

The announcement indicates that the company submitted its registration application for difluprednate API to the National Medical Products Administration (NMPA) in August 2020 and was accepted. From June to October 2022, the company completed the submission of supplementary documentation as required by the notice and recently received the " Notice of Approval of Marketing Application for Chemical

The company stated that the difluprednate API received the " Notice of Approval of Application for Marketing of Chemical APIs

As a firm practitioner of the integrated API and preparation strategy in the domestic pharmaceutical industry, Jinyao Pharmaceutical has been deeply engaged in this field for many years, extending its advantages in APIs to preparations. By integrating the upstream and downstream industrial chains, it promotes the coordinated development of the "API + preparation" integrated strategy. The approval of difluprednate eye drops and APIs demonstrates the company's advantages in integrated API and preparations.

In the future, the company will continue to take technological innovation as its core driving force, adhering to the integrated strategy of raw materials and preparations, anchoring the goal of "tackling high-value projects, optimizing the entire process system, and making collaborative breakthroughs in multiple tracks", we will continue to increase R&D investment, and continue to make efforts in R&D system construction, product pipeline layout, and R&D platform construction to promote the efficient transformation of scientific research results.

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