Xian Janssen's Apalutamide Receives Second Indication Approval in China for Metastatic Hormone-Sensitive Prostate Cancer

On August 14, the National Medical Products Administration (NMPA) released an announcement regarding pending collection of drug approval documents, indicating that Xian Janssen’s marketing application for the second indication of its next-generation androgen receptor inhibitor apalutamide tablets (apalutamide, Erleada) in China has been officially approved (Acceptance Number: JXHS1900156).

Globally, prostate cancer is the second most common type of tumor in men. Over the past decade, the incidence of prostate cancer in China has been on the rise, and it has now become the fifth most common cancer among Chinese men. As an androgen-dependent tumor, endocrine therapy is currently one of the more mainstream clinical treatment options for prostate cancer, alongside radical surgery, radiation therapy, and chemotherapy.

Apalutamide is a second-generation potent androgen receptor (AR) inhibitor that blocks the androgen signaling pathway in prostate cancer cells, inhibiting cancer cell growth through three mechanisms, thereby delaying the onset of distant metastasis. The drug was initially developed by the University of California, which granted exclusive development rights to Aragon Pharmaceuticals in 2009. In August 2013, Johnson & Johnson acquired Aragon, with its subsidiary Xian Janssen responsible for further development, regulatory approval for market launch, manufacturing, and sales.

On February 14, 2018, apalutamide received approval from the U.S. FDA for the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC), becoming the first drug globally indicated for NM-CRPC and the first novel antineoplastic agent to be approved based on the clinical endpoint of metastasis-free survival. On September 17, 2019, the FDA approved apalutamide for the treatment of metastatic castration-sensitive prostate cancer (mCSPC).

In China, Xian Janssen submitted the marketing application for apalutamide tablets in March 2019. In May of the same year, apalutamide tablets were included in the priority review program due to their significant clinical advantages and were also listed in the second batch of overseas new drugs urgently needed for clinical use. On September 5, apalutamide tablets received approval from the NMPA for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (NM-CRPC) at high risk of metastasis. This approval also made apalutamide the first next-generation AR inhibitor used for NM-CRPC patients in China, effectively addressing the gap in the clinical treatment of prostate cancer domestically.

Leveraging its first-mover advantage in nmCRPC, along with new indications for mCSPC and potential indications such as combination therapy with abiraterone for chemotherapy-naïve metastatic CRPC, Erleada is highly regarded by the industry. EvaluatePharma predicts that global sales of Erleada will reach $2.115 billion in 2024, second only to Astellas/Pfizer’s Xtandi. The successful expansion of apalutamide tablets’ indications in China will not only provide domestic prostate cancer patients with new treatment options but also serve as a catalyst for the rapid realization of its commercial value.