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PROVENGE to benefit from State Council meeting decision

Time Published:2018-06-21Source:Author:
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PROVENGE, the only cellular immunotherapy treatment in the world proven to extend life in certain men with advanced prostate cancer, is expected to benefit from an executive meeting of the Chinese cabinet in Beijing on Wednesday that affirmed the acceleration of approval processes for new drugs from overseas markets.

 

This followed a Chinese state drug authority meeting on the same day, which said the regulator would streamline approval processes of new drugs from overseas markets, optimize approval procedures of clinical trials, and waive existing mandatory batch-by-batch inspection of overseas drugs.

 

The latest moves are set to benefit U.S.-based Dendreon, a pioneer in the development of immunotherapy.

 

After more than 15 years of R&D by Dendreon, PROVENGE was approved by the FDA in 2010. More than 30,000 men have since been prescribed PROVENGE.

 

In 2017, Chinese multinational holding company Sanpower Group acquired Dendreon for US$819 million. Dendreon now falls under the umbrella of Nanjing Cenbest, a Shanghai-listed company with Sanpower as its controlling stakeholder.

 

Nanjing Cenbest is actively planning the Chinese launch of PROVENGE.