$2 Billion Psoriasis Oral Drug Battle Heats Up: Qilu, Zhengda Qingjiang Vie for First Generic

On November 17, the CDE official website showed that the apremilast tablets submitted by Jiangsu Zhengda Qingjiang Pharmaceutical Co., Ltd. for marketing application as a Category 4 generic drug have been accepted. Data from Menet shows that the global sales of apremilast tablets exceeded 2 billion US dollars in 2020. Currently, no generic drug companies in China have been approved for this product. Qilu Pharmaceutical Co., Ltd., CSPC Ouyi Pharmaceutical Co., Ltd., Jiangxi Qingfeng Pharmaceutical Industry Co., Ltd., and other eight companies have submitted marketing applications under the new classification and are under review.

Data shows that Apremilast Tablets (formerly known as Aprest Tablets), a small molecule inhibitor of phosphodiesterase-4 (PDE-4) developed by Celgene, was launched in the United States in 2014 and approved for marketing in China in August 2021 for the treatment of psoriasis.

Source: MiNei Network Multinational Listed Companies Sales Database

In 2019, Amgen announced the acquisition of Apremilast for $13.4 billion. In 2020, the global sales of this product exceeded $2 billion. It is reported that Apremilast is the first oral drug approved for psoriasis in 20 years, naturally drawing significant attention from pharmaceutical companies in China.

Source: MiNei Network One-Click Search

Data from Menet shows that currently, eight companies, including Qilu Pharmaceutical, CSPC Ouyi Pharmaceutical, Jiangxi Qingfeng Pharmaceutical, and China Resources Double-Crane Pharmaceutical | Nanjing Haijing Pharmaceutical, have submitted new classification-based applications for the marketing approval of Apremilast Tablets. These involve 27 acceptance numbers, and the competition for the first generic has entered a white-hot stage.

Source: CDE official website, MiNeiNet database