Kelun Pharma wins approval for China's first generic enzalutamide tablets, entering $8.3B market
Kelun
Innovative Pharmaceutical R&D Company
On November 10, according to the official website of the National Medical Products Administration (NMPA), the generic drug Enzalutamide Tablets, filed under a Category 3 registration by Kelun Pharmaceutical, has been approved for market and is considered to have passed the consistency evaluation. This makes Kelun the first pharmaceutical company in China to have a generic version of Enzalutamide Tablets approved.
Enzalzutamide was originally developed by Astellas Pharma in collaboration with Pfizer as an androgen receptor (AR) inhibitor. It is available in two formulations: soft capsules and tablets. The soft capsule formulation received FDA approval in August 2012, followed by the tablet formulation in August 2020. Both are indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The soft capsule was approved in China in November 2019. According to data from BCPM, Enzalutamide generated global sales exceeding $8.3 billion in 2024, representing a significant year-on-year growth of 35.94%.
Focusing on the Chinese market, Enzalutamide was included in China's National Reimbursement Drug List (NRDL) in 2020. In 2024, the total sales of Enzalutamide Capsules across all terminal hospitals in China exceeded RMB 500 million. The sales momentum continued into the first half of 2025, reaching a new high of RMB 370 million—a significant year-on-year increase of 58.92%—indicating a rapidly expanding market.
As a preferred treatment for prostate cancer, only the Enzalutamide soft capsule formulation is currently commercially available in the Chinese market, with production approvals held by 10 pharmaceutical companies. Regarding the generic drug landscape, four companies, including Qilu Pharmaceutical and Kelun Pharmaceutical, have submitted applications for the Enzalutamide Tablets formulation under the Category 3 generic classification. With this recent approval, Kelun has successfully secured the status of being the first in China to both launch a generic version and pass the consistency evaluation for this product.
Kelun Pharmaceutical has achieved significant success in the generic drug sector. Since the beginning of this year, Kelun Pharma (including its subsidiaries) has secured approval and passed consistency evaluation for over 60 generic products. Among these, five are recognized as the first generic approvals in China, including Rotigotine Transdermal Patch, Enzalutamide Tablets, Imipenem and Cilastatin Sodium/ Sodium Chloride Injection, Biapenem for Injection/ Sodium Chloride Injection, and Lusutrombopag Tablets.