Qilu Pharmaceutical Submits China's First Apalutamide Generic NDA

On September 19, the CDE website showed that the marketing application of Apalutamide Tablets from Qilu Pharmaceutical Co., Ltd. has been accepted. This is the first generic Apalutamide to be submitted for marketing in China.

Apalutamide, the original product developed by Johnson & Johnson, is a new generation oral androgen receptor inhibitor. According to the PharmaCube database, the compound patent for apalutamide will expire in 2027.

In February 2018, Apalutamide was approved for marketing by the FDA, becoming the world's first drug for the treatment of non-metastatic castration-resistant prostate cancer.

In September 2019, Apalutamide was approved for marketing in China for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (NM-CRPC) at high risk of metastasis. In August 2020, Apalutamide was approved in China for a new indication for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).

In 2022, the global sales of Apalutamide reached 1.881 billion US dollars, increasing by 45.7% year-on-year. In the first half of 2023, Apalutamide maintained strong growth with sales amounting to 1.109 billion US dollars, marking a year-on-year increase of 30.4%.

Prostate cancer is one of the most common malignant tumors in men. According to data released by the World Health Organization (WHO) Cancer Today, there were 1,414,259 new cases of prostate cancer among men worldwide in 2020, accounting for 14.1% of all malignant tumors. Its incidence rate was second only to lung cancer, with a mortality rate of 6.8%, ranking fifth. The incidence of prostate cancer in China is also increasing year by year.

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