Shanghai Junshi Biosciences has submitted a marketing authorization application (MAA) for its toripalimab to the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK.
The application has been submitted for the combination of toripalimab, cisplatin and gemcitabine as the first-line treatment for locally recurrent or metastatic nasopharyngeal carcinoma (NPC) patients.
The company is also seeking MAA for toripalimab along with paclitaxel and cisplatin for the first-line treatment for unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC) patients.
In the middle of this month, Junshi Biosciences has also submitted a MAA for toripalimab to the European Medicines Agency (EMA) for the same indications.
Junshi/TopAlliance Biosciences chief medical officer Dr Patricia Keegan said: “Within a single month, we were able to submit marketing authorisation applications for toripalimab to two major European regulatory agencies.
“This is emblematic of our determination and corporate efficiency in bringing innovative drugs to patients worldwide.
“In the coming days, we will work closely with the MHRA to promote the clinical development and application of emerging therapies in the UK.”
Junshi stated that the submission of MAA is based on the data obtained from the JUPITER-02 and JUPITER-06 trials.
The randomised, double-blinded, placebo-controlled, global JUPITER-02 Phase III trial evaluated the efficacy and safety of toripalimab in combination with gemcitabine/cisplatin to treat NPC.
The multi-centre, placebo-controlled, double-blinded, randomised JUPITER-06 Phase III trial has compared the effectiveness and safety of toripalimab in combination with paclitaxel and cisplatin in ESCC patients.
Last year, the China National Medical Products Administration (NMPA) approved toripalimab to treat NPC.
Toripalimab has also received two Breakthrough Therapy Designations and one Orphan Drug Designation from the US Food and Drug Administration (FDA) for the treatment of NPC.