Qilu Pharmaceutical Submits First Domestic Application for Enzalutamide Tablets

On August 31, the CDE website showed that the marketing application for Qilu Pharmaceutical's generic drug Enzalutamide Tablets had been accepted.

Enzalutamide, originally developed by Astellas and Medivation as an androgen receptor inhibitor, was first approved by the FDA in August 2012 for the treatment of advanced castration-resistant prostate cancer. In August 2016, Pfizer acquired Medivation for $14 billion, bringing this drug into its portfolio.

In November 2019, the original Enzalutamide was approved for marketing in China. The approved indications in China include: 1) For metastatic castration-resistant prostate cancer patients who have failed androgen deprivation therapy and have not previously received chemotherapy, with no symptoms or only mild symptoms; 2) For the treatment of adult male patients with non-metastatic castration-resistant prostate cancer.

According to the PharmaCube database, three generic versions of enzalutamide soft capsules have been approved by the NMPA, with Hansoh Pharma securing the first approval. Qilu Pharmaceutical Co., Ltd.'s enzalutamide soft capsule was also approved this year.No Enzalutamide Tablets have been approved yet.

Prostate cancer is the second most common type of tumor in men globally, with approximately 1.3 million new cases diagnosed worldwide in 2018. In China, prostate cancer is the most common cancer of the male urinary and reproductive systems, with an incidence rate of approximately 9.8 per 100,000 people.

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