Recently, the NMPA (National Medical Products Administration) released its latest drug marketing approval announcement, officially approving the marketing of Enzalutamide tablets from Aurite Pharmaceuticals, which is considered to have passed the consistency evaluation. This makes Aurite the third company, following Sichuan Kelun and Qilu Pharmaceutical, to obtain consistency evaluation approval for this product, signifying a further escalation of competition in the market for blockbuster generic prostate cancer drugs.
Enzalutamide was originally developed by Astellas and Pfizer, and marketed under the brand name "Xtandi". As an androgen receptor (AR) inhibitor, enzalutamide plays a crucial role in the treatment of prostate cancer. In August 2012, it was first approved by the US FDA for the treatment of advanced castration-resistant prostate cancer; it officially entered the Chinese market in 2019, becoming an important treatment option for prostate cancer patients in China.
From a global market perspective, enzalutamide's performance has been remarkable. Public data shows that in 2024, the drug's global sales reached approximately $8 billion (approximately RMB 57.7 billion), representing a year-on-year increase of over 31%, firmly maintaining its leading position in the prostate cancer drug market.
In the domestic market, enzalutamide is also experiencing rapid growth. In 2023, the total sales of enzalutamide capsules in hospitals across all terminals exceeded 600 million yuan, and in 2024 it exceeded 900 million yuan, representing a year-on-year increase of nearly 54%.
Prostate cancer is one of the most common malignant tumors of the male genitourinary system. With the aging population and increased awareness of screening, the incidence and diagnosis rate of prostate cancer in China are on the rise, and this market still has considerable room for growth.
It is worth noting that enzalutamide is currently available in two dosage forms in China—soft capsules and tablets. The soft capsule dosage form was introduced earlier, and the original drug, Astellas, along with several generic drug companies such as Hansoh Pharmaceutical, Qilu Pharmaceutical, and Chia Tai Tianqing Pharmaceutical, have already obtained approval for market launch, leading to fierce market competition.
In contrast, the tablet market is a "new battleground." In November 2025, Sichuan Kelun Pharmaceutical became the first domestic manufacturer to obtain approval for a generic version of enzalutamide tablets, becoming the first company to pass the evaluation for this dosage form. Just one month later, Qilu Pharmaceutical followed suit and was approved for market launch. With the addition of Aurite Pharmaceutical, the number of domestic manufacturers with approved enzalutamide tablets has increased to three.
From a competitive perspective, the market potential for enzalutamide tablets remains largely untapped. Tablets offer advantages such as relatively simple production processes, lower costs, and greater convenience for patients, making them a strong potential substitute for certain patient groups. For latecomers, the ability to gain a foothold in this fiercely competitive market will test their marketing capabilities and channel strategy.

https://news.yaozh.com/archive/47518.html