Junshi receives special FDA designation for cancer drug

Junshi Biosciences, a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced on Thursday the US Food and Drug Administration has recently granted Breakthrough Therapy designation to its cancer drug Toripalimab for the treatment of nasopharyngeal carcinoma, or cancer that occurs in the nasopharynx.

According to FDA regulations, the BTD is designed to expedite the development and review process of drugs intended to treat a serious condition when preliminary clinical evidence indicates the drug may result in substantial improvement over available therapies on a clinically significant endpoint.

Products that have obtained BTD will receive closer guidance and various forms of support, including from senior FDA officials, to ensure patients are provided with new treatment options in the shortest amount of time.

Li Ning, chief executive officer of Junshi Biosciences, said the company found great unmet medical needs exist in other countries where patients are endangered by this deadly disease, although it prioritizes cancer types with high prevalence in China such as nasopharyngeal carcinoma, lung and liver cancer.

The BTD designation will allow it to work with the FDA closely to bring therapy to patients worldwide expeditiously, he said.