Apalutamide

Prostate cancer is a high-incidence malignant tumor in the male genitourinary system. Among its subtypes, metastatic hormone-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer are the key stages in clinical diagnosis and treatment. Traditional endocrine therapy has limited benefits, and the prognosis of patients is poor. Apalutamide is a second-generation non-steroidal androgen receptor inhibitor, which can competitively block the binding of androgen to the receptor, inhibit the nuclear transport of the receptor and its interaction with DNA, thereby blocking the proliferation signal of tumor cells. It has now been approved for two major indications: non-metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer, providing eligible adult patients with a core treatment option to delay disease progression and prolong survival.

The global apalutamide market size had exceeded USD 2 billion in 2022, and is expected to maintain a compound annual growth rate of approximately 8% from 2023 to 2028. The growth momentum mainly comes from the increased penetration of early prostate cancer screening, the expansion of the indication population, and the improvement of drug accessibility in emerging markets. In terms of the Chinese market, with apalutamide being included in the National Reimbursement Drug List, the out-of-pocket proportion for patients has been greatly reduced. The sales volume of apalutamide at domestic public hospital terminals exceeded RMB 1.8 billion in 2023. At present, 4 domestic enterprises have obtained approval for the marketing of generic apalutamide, and the market competition between the originator drug and generic drugs has gradually entered a normalized stage.

The originator enterprise of apalutamide is Johnson & Johnson, and the brand name of the originator drug is "Erleada". Its core compound patent will expire in 2027 in the United States, and the compound patent in China will expire in 2026. The main dosage form of the originator drug approved is tablet, with the specification including 60mg. It has been included in the *Catalogue of Chemical Reference Preparations* of China, and is also a reference preparation recognized by the FDA. Up to now, more than 30 enterprises in China have submitted registration applications for apalutamide active pharmaceutical ingredients (APIs), among which more than 10 have a registration status of A (approved for use in marketed preparations). Both the originator drug and multiple generic preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of apalutamide impurity reference standards, covering all impurity types involved in the synthesis process and degradation pathways. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most of the products are in stock. For in-stock orders placed before 16:00, delivery can be made on the same day, which can fully meet the various needs of API R&D, quality research and generic drug consistency evaluation.