Qilu Pharmaceutical Secures China's First Generic Approval for Apalutamide, a $2.4 Billion Anti-Prostate Cancer Drug

From November 25 to December 1, a total of 225 varieties passed/were considered to have passed the consistency evaluation. During the same period, 79 varieties applied for the consistency evaluation.

Qilu Pharmaceutical:
Apalutamide Tablets

According to the NMPA official website, Qilu Pharmaceutical's Apalutamide Tablets obtained the drug marketing approval on December 1st, as the first generic version of this drug.

Image Source: NMPA Official Website

Apalutamide is a new generation of oral androgen receptor inhibitor, mainly used for the treatment of non-metastatic castration-resistant prostate cancer. According to publicly available data, this drug can effectively prevent androgens from binding to receptors, block the transfer of AR to the nucleus of tumor cells, and play a role in "inhibiting androgens from promoting the growth of tumor cells."

Apalutamide was approved for marketing in the United States in February 2018 as the world's first drug approved for the treatment of non-metastatic castration-resistant prostate cancer. In 2019, apalutamide was approved for marketing in China for the treatment of non-metastatic castration-resistant prostate cancer with a high risk of metastasis. Later, in 2020, it was approved to treat adult patients with metastatic endocrine therapy-sensitive prostate cancer. In 2021, apalutamide successfully entered the Class B National Medical Insurance Drug Catalogue through national medical insurance negotiations, and its sales revenue in China has continued to grow. According to Johnson & Johnson's 2023 financial report, the annual sales of apalutamide reached 2.387 billion US dollars (approximately 17 billion yuan).

Source of the image: YAOZHI Data Enterprise Edition - Hospital Sales Data Mining System Database

As of now, multiple companies in China have laid out plans for the generic version of Adapamide Tablets. Qilu Pharmaceutical's Adapamide Tablets, as the first generic version of this drug, are expected to bring new options for patients.

Source of the image: Pharma Data Enterprise Edition - Consistency Evaluation Progress Database

Status of Consistency Evaluation Approval

From November 25 to December 1, a total of 225 varieties passed/were considered to have passed the consistency evaluation.

The specific situation is as follows:

Source: YAOZHI Data Enterprise Edition - Generic Drug Consistency Evaluation Analysis System Database

Source: YAOZHI Data Enterprise Edition - Generic Drug Consistency Evaluation Analysis System Database

Acceptance Status of Consistency Evaluation

From November 25 to December 1, a total of 79 varieties applied for consistency evaluation, with specific details as follows:

Source: Yaoke Data Enterprise Edition - Generic Drug Consistency Evaluation Analysis System Database

Editor: Muyan

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