Kelun Pharmaceutical Files for First-to-File Generic Enzalutamide Soft Capsules, Targeting a Blockbuster Drug with Over $4 Billion in Global Sales

On March 10, Kelun, Qilu Pharmaceutical, and Shenyang Red Flag Pharmaceutical submitted marketing applications for Enzalutamide Soft Capsules under the Class 4 generic drug pathway. To date, no first generic version of this product has been approved in China. Enzalutamide is an androgen receptor inhibitor that achieved global sales exceeding USD 4 billion in 2019.

Source: CDE Official Website

Enzalutamide is an androgen receptor inhibitor co-developed by Astellas and Medivation. It first received FDA approval for marketing in August 2012 for the treatment of advanced castration-resistant prostate cancer. In August 2016, Pfizer acquired Medivation for $14 billion, thereby adding this blockbuster drug to its portfolio.

Global Sales of Enzalutamide

Source: Menet’s Sales Database for Multinational Listed Companies

With the clinical benefit of extending survival by 5 months and the advantage of not requiring concurrent use with the glucocorticoid prednisone in clinical practice, enzalutamide rapidly captured the market after its launch. In 2019, its global sales exceeded $4 billion, significantly surpassing Johnson & Johnson’s abiraterone, thereby becoming an undisputed blockbuster drug in the prostate cancer market.

Astellas’ enzalutamide was approved for entry into the Chinese market in November 2019, with its compound patent expected to expire as early as 2026. In November 2018, Star-Tai Pharmaceutical, a subsidiary of Fosun Pharma, successfully challenged the invention patent for “diarylhydantoin compounds” (Patent No. ZL200680025545.1) associated with this product, thereby removing this patent barrier for other domestic companies intending to file for generic enzalutamide approval in China.

New Classification and Marketing Application Status of Enzalutamide

Source: Menet MED2.0 China Drug Evaluation Database

Data from Menet shows that currently, four companies in China have submitted marketing applications for enzalutamide under the new classification, including Hansoh, Kelun, Qilu Pharmaceutical, and Shenyang Red Flag Pharmaceutical Co., Ltd. Who will secure the first generic approval? Menet will continue to monitor the situation.

Source: Menet Database, CDE Official Website

Note: Data statistics are current as of March 10. Any omissions or errors are welcome to be corrected!