|Junshi Biosciences Announces Submission of a Marketing Authorization Application for Toripalimab to the UK Medicines and Healthcare Products Regulatory Agency|
|By: GlobenewsWire - 24 Nov 2022||Back to overview list
-- 2nd MAA submission in Europe reflects toripalimab’s steady yet speedy progress towards global commercialization
SHANGHAI, China, Nov. 24, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the company has submitted a marketing authorization application (“MAA”) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) 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.
“Within a single month, we were able to submit marketing authorization applications for toripalimab to two major European regulatory agencies,” said Dr. Patricia Keegan, Chief Medical Officer of Junshi/TopAlliance Biosciences. “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.”
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 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.
About Nasopharyngeal Carcinoma
About Esophageal Cancer
More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.
In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are six approved indications for toripalimab in China:
The first three indications have been included in the National Reimbursement Drug List (“NRDL”) (2021 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for treatment of melanoma and NPC.
In the United States, the FDA is reviewing the BLA resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic NPC and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. The FDA has set a PDUFA action date for December 23, 2022. The FDA has granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer ("SCLC").
In Europe, toripalimab was also designated as an orphan medicinal product by the EU’s European Commission for the treatment of NPC. In November 2022, MAA was submitted to the EMA and MHRA for: 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC.
About Junshi Biosciences
In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. The JS016 and VV116 programs are a part of the company’s continuous innovation for disease control and prevention of the global pandemic.
Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.
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