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白皮书

Apalutamide API – an attractive NCE-1 opportunity for generic pharma companies

Prostate cancer accounts for 7.3% of all incident cases of cancer globally, as per estimates released by Globocan 2020. The 5-year prevalence of prostate cancer is estimated at ~ 5 million worldwide, making it the second most common cancer among men.

Apalutamide is an oral second-generation, nonsteroidal androgen receptor inhibitor and became the first FDA-approved drug for non-metastatic castration-resistant prostate cancer patients. It received additional approval in 2019 for metastatic hormone-sensitive prostate cancer and is in phase 3 trials for metastatic hormone-refractory prostate cancer.

Our API allows formulators to choose an IP-compliant market entry that meets the regulatory requirements. The key aspects of our offering are: 

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