Shanghai Junshi Biosciences Co., Ltd. that the company has submitted a marketing authorization application to the United Kingdom's Medicines and Healthcare products Regulatory Agency for toripalimab. The indications requested in the MAA are: 1) Toripalimab, in combination with cisplatin and gemcitabine, for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and 2)Toripalimab, in combination with paclitaxel and cisplatin, for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (“ESCC”). Junshi Biosciences also submitted a MAA to the European Medicines Agency (“EMA”) for toripalimab for the same indications in mid-November.

The MAA submission for NPC and ESCC is based on the results from JUPITER-02 (an international randomized, placebo-controlled, double-blinded Phase III trial, NCT03581786) and JUPITER-06 (a randomized, placebo-controlled, double-blinded, multi-center Phase III trial, NCT03829969). The JUPITER-02 results were first presented in the plenary session of the American Society of Clinical Oncology (“ASCO”) 2021 annual meeting (#LBA2) and subsequently published in detail as the cover article of the September 2021 issue of Nature Medicine. According to its final progression-free survival (PFS) analysis, the toripalimab plus chemotherapy arm had a significantly longer PFS than the placebo plus chemotherapy arm as assessed by a blinded independent radiology committee (BIRC) with median PFS of 21.4 vs.

8.2 months, hazard ratio (HR)=0.52 (95% CI: 0.37-0.73), two-sided p<0.0001. In 2021, two indications for the treatment of NPC were approved by the China National Medical Products Administration (“NMPA”), thereby making toripalimab the world's first immune checkpoint inhibitor approved for the treatment of NPC. In the United States, the NPC indications of toripalimab have been granted 2 Breathrough Therapy Designations and 1 Orphan Drug Designation by the Food and Drug Administration (“FDA”), while the Biologics License Application (“BLA”) for toripalimab for the treatment of NPC is under review.

If approved, toripalimab will be the first and only drug approved for the treatment of NPC in the U.S. In Europe, toripalimab was designated as an orphan medicinal product by the European Commission (“EC”) for the treatment of NPC. The JUPITER-06 results were first presented in a mini-oral session during the 2021 European Society for Medical Oncology (“ESMO”) Congress and later published in Cancer Cell with an editorial preview. The overall survival (OS) and PFS were significantly better in the toripalimab plus chemotherapy arm than in the placebo plus chemotherapy arm, with a median OS of 17 vs.

11 months (HR=0.58, 95% CI: 0.43-0.78, P=0.0004) and PFS HR=0.58 (95% CI: 0.46-0.74), p<0.0001. In May 2022, the supplemental new drug application (“sNDA”) for toripalimab in combination with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic ESCC was approved by the NMPA in China. Additionally, US FDA has also granted an orphan drug designation to toripalimab for the treatment of patients with ESCC.