Xian Janssen Submits Second Indication NDA for Apalutamide in China

Text | Zhang Hongli

Today (December 5), the Center for Drug Evaluation (CDE) of the National Medical Products Administration accepted the application for apalutamide tablets (English brand name: Erleada), a next-generation androgen receptor inhibitor under Xian Janssen.^®, Chinese Brand Name: Ansenke^®) for the second indication, with 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 is now 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. In 2009, exclusive development rights were licensed to Aragon Pharmaceuticals, Inc. in the United States. In August 2013, Johnson & Johnson acquired Aragon, with its subsidiary Xian Janssen responsible for further development, regulatory approval for market launch, production, and sales.

In the United States, on February 14, 2018, apalutamide was approved for the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC), becoming the first drug globally to treat NM-CRPC and the first novel anticancer agent to gain market approval based on the clinical endpoint of metastasis-free survival. On September 17, 2019, Xian Janssen announced that the FDA had 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, 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 during the same month. 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 in China for NM-CRPC patients, effectively addressing the gap in domestic clinical treatment for prostate cancer.

Two months after the approval of apalutamide tablets, another blockbuster drug for prostate cancer was subsequently approved in China. On November 20, Xtandi (enzalutamide), developed by Astellas and Pfizer, received marketing approval from the National Medical Products Administration (NMPA) for the treatment of patients with metastatic hormone-sensitive prostate cancer. As one of the major drugs in the field of prostate cancer, enzalutamide reached the Chinese market more than seven years later than its launch in the United States.

Enzalutamide, an androgen receptor inhibitor co-developed by Astellas and Medivation, was first approved by the FDA in August 2012 for the treatment of advanced castration-resistant prostate cancer (CRPC). In August 2016, Pfizer acquired Medivation for $14 billion, thereby bringing this drug into its portfolio. In July and November 2018, Xtandi received approval from the U.S. FDA and the European Union, respectively, for the treatment of adult patients with non-metastatic CRPC at high risk of metastasis. This approval made Xtandi the first oral medication indicated for both metastatic and non-metastatic castration-resistant prostate cancer. The expansion of indications has provided a guarantee for the steady growth of Xtandi’s sales. According to EvaluatePharma forecasts, global sales of Xtandi are expected to reach $4.467 billion in 2024, making it a “blockbuster” in the field of prostate cancer.

With its first-mover advantage in non-metastatic castration-resistant prostate cancer (nmCRPC), along with new indications for metastatic castration-sensitive prostate cancer (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 Xtandi. The current application in China to expand the indications for apalutamide tablets will not only provide new treatment options for domestic patients with prostate cancer but also serve as a catalyst for the rapid realization of its commercial value.