Fosun Pharmaceutical (02196): The drug registration application for venlafaxine hydrochloride extended-release tablets was accepted by the China Drug Administration

According to Zhitong Finance App, Fosun Pharmaceutical (02196) announced that the drug registration application for venlafaxine hydrochloride extended-release tablets (hereinafter referred to as “this new drug”) from Fosun Pharmaceutical (Xuzhou) Co., Ltd., the holding subsidiary of the company was recently accepted by the China Drug Administration.

The new drug is a chemical developed independently by the Group (that is, the Company and its holding subsidiaries/units, the same below) and is intended to treat depression (including depression accompanied by anxiety) and generalized anxiety disorder.

As of September 2024, the Group's cumulative R&D investment for this new drug at this stage is approximately RMB 6.17 million (unaudited).

According to the latest IQVIA CHPA data, in 2023, sales of venlafaxine hydrochloride-related formulations approved for marketing in China (excluding Hong Kong, Macao and Taiwan regions) were approximately RMB 678 million.

Before commercial production of the new drug is carried out, it is still necessary (which mainly includes) to pass GMP compliance checks and obtain drug registration approval. The acceptance of the drug registration application will not have a significant impact on the Group's performance at this stage.