Recently, the NMPA released the latest drug marketing approval announcement. Aurisco's Enzalutamide Tablets have been officially approved for marketing and are deemed to have passed the consistency evaluation. This is the third company to obtain the consistency evaluation for this product after Sichuan Kelun and Qilu Pharmaceutical, indicating that competition in the significant prostate cancer generic drug market has intensified once again.

Image Source: NMPA Official Website

The original research pharmaceutical companies for Enzalutamide are Astellas and Pfizer, with the brand name "Xtandi" (Enzalutamide). As an androgen receptor (AR) inhibitor, Enzalutamide plays a pivotal role in the field of prostate cancer treatment. In August 2012, the drug received its first FDA approval in the United States for the treatment of advanced castration-resistant prostate cancer and officially entered the Chinese market in 2019, becoming an important treatment option for prostate cancer patients in China.

From a global market perspective, enzalutamide has performed remarkably well. Public data shows that in 2024, the drug's global sales reached approximately $8 billion (equivalent to about 57.7 billion RMB), representing a year-over-year increase of over 31%, firmly securing its top position in the prostate cancer drug market.

▲Enzalutamide Global Sales

Source of the image: YAOZHI Data —— Sales Data of Best-Selling Drugs Worldwide

In the Chinese market, enzalutamide is also in a period of rapid growth. In 2023, the total sales of enzalutamide capsules in all-terminal hospitals exceeded 600 million yuan, and in 2024 it surpassed 900 million yuan, with a year-on-year increase of nearly 54%.

▲Enzalutamide Capsules Total Sales in China Across All Terminals

Source of the image: Yaoke Data —— Drug Sales Analysis System for All Terminals

Prostate cancer is one of the most common malignant tumors in the male urinary and reproductive systems. With the aggravation of population aging and the increase in screening awareness, the incidence and diagnosis rates of prostate cancer in China are on the rise, indicating that this market still has significant growth potential.

Notably, there are currently two formulations of enzalutamide available in China — soft capsules and tablets. The soft capsule formulation was developed earlier, with the original developer Astellas, along with several generic pharmaceutical companies such as Hansoh Pharma, Qilu Pharmaceutical, and Zhengdatianqing, having received approval for market entry. Market competition has now reached a fever pitch.

By contrast, the tablet market is a "new battleground." In November 2025, Sichuan Kelun Pharmaceutical was the first to secure the domestic generic production of Enzalutamide tablets in China, becoming the first company to pass the evaluation for this formulation. Just one month later, Qilu Pharmaceutical Co., Ltd. followed with its approved product launch. With the addition of Aurisco, the number of companies in China with approved Enzalutamide tablets has now increased to three.

Source of the image: PharmData -- Consistency Evaluation Analysis System

From the perspective of the competitive landscape, the market potential for enzalutamide tablets remains to be tapped. Tablets have advantages such as relatively simple production processes, lower costs, and greater convenience for patients to take, showing strong substitution potential among certain patient groups. For latecomers, whether they can secure a share in the highly competitive market will test the company's marketing capabilities and channel strategies.

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Editorial Responsibility| Xiao Er

Typesetting Design | Xiao Bai

Reprint Permission| Teacher Chen 17308362010 (same WeChat)