U.S. regulators have given a breakthrough therapy designation to an immunotherapy drug for cancers under development by a company in China.

Shanghai-based Junshi Biosciences said Thursday night that it had received the BTD from the Food and Drug Administration for toripalimab as a treatment for nasopharyngeal carcinoma, making it the first PD-1 checkpoint inhibitor from a Chinese company to receive the designation. Nasopharyngeal carcinoma, or NPC, is a rare cancer of the mucosal epithelium of the nasopharynx, of which there were 129,000 cases worldwide in 2018. Regulators in China approved toripalimab for metastatic melanoma in December 2018 and accepted an approval application for the drug in NPC in April of this year.

A BTD allows for expedited development of a drug that is seen as having potential benefit in a disease without sufficient treatments available, though it does not indicate whether the drug is likelier to succeed in clinical trials or win approval.

“Junshi prioritizes cancer types with high prevalence in China such as nasopharyngeal carcinoma, lung and liver cancer, but we found that great unmet medical needs also exist in other countries where patients are endangered by this deadly disease,” Junshi CEO Ning Li said in a statement. “The BTD will allow us to work with the FDA closely to bring the therapy to patients worldwide expeditiously.”

The company said that the 280-patient Phase III JUPITER-02 study comparing toripalimab and chemotherapy against placebo and chemotherapy had completed enrollment. The trial includes 34 sites in mainland China, Taiwan and Singapore. Junshi is also running a Phase I trial of the drug in several solid tumor indications, including NPC, at 17 sites in the U.S.

The BTD makes Junshi the latest Chinese biotech company to make significant headway in the U.S. market in recent years. In November of last year, the FDA granted accelerated approval for Beijing-based BeiGene’s BTK inhibitor Brukinsa (zanubrutinib) for mantle cell lymphoma patients who have received at least one prior therapy. And Johnson & Johnson’s Janssen unit has been advancing the BCMA-targeting CAR-T JNJ-4528 – derived from Nanjing-based Legend Biotech’s technology – for multiple myeloma. Legend itself went public earlier this year.

Photo: FDA, via Flickr (free of all copyright protection)



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