Domestically-developed cancer drug approved in US

A totally domestically-developed and produced cancer drug has become China's first innovative medicine to be approved by the US Food and Drug Administration.

Shanghai Junshi Biosciences Co., Ltd. announced the approval of its LOQTORZI (toripalimab-tpzi) for the treatment of recurrent or metastatic Nasopharyngeal Carcinoma (NPC).

LOQTORZI is a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody enabling the immune system to activate and kill tumors.

NPC is an aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of skull, and is a common cancer in the head and neck part.

According to the World Health Organization, there are more than 130,000 new NPC cancer cases in the world each year.

Due to the location of the primary tumor, surgery is rarely an option, and patients are usually treated primarily by radiation and chemotherapy. LOQTORZI is the first FDA-approved medicine for NPC patients in the US. Market applications in Europe and UK have been issued and are under evaluation, Junshi Biosciences said.

This approval was based on results of the JUPITER-02 study and the POLARIS-02 study. Both clinical trials were positive.

Dr Xu Ruihua, from Sun Yat-sen University Cancer Center, and the principal investigator of JUPITER-02 and POLARIS-02, said the success of the medicine was achieved thanks to decades of in-depth research and dedication by Chinese oncology experts and research teams.

"We hope that this promising therapy will bring hopes to NPC patients in the world and solve their difficulty in lacking effective therapy," he said.

Li Ning, CEO of Junshi Biosciences, said this approval is an international recognition of Chinese research and manufacturing ability. It will boost the company's establishment of its global commercialization network to introduce innovative and high-quality drugs from China to more patients overseas.