U.S. FDA accepts Junshi Bio-Treplimumab's application for the treatment of nasopharyngeal carcinoma

Shanghai, November 1, 2021/PRNewswire/ - On October 31, 2021 Beijing time, Junshi Bio (1877.
HK, 688180.
SH) announced that the U.
S.
Food and Drug Administration (FDA) has accepted Terry Pritimumab combined with gemcitabine/cisplatin is used as a first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma and a single agent for second-line and above two indications after platinum-containing treatment for recurrent or metastatic nasopharyngeal carcinoma Product License Application (BLA)
.

Dr.
Patricia Keegan, Chief Medical Officer of Junshi Biotech, said: “Treplimumab’s first listing application outside of China has made continuous progress, and we are excited about this
.

Denny Lanfear, CEO of Coherus, said: "We are very pleased that the BLA of Treprizumab has been accepted, and look forward to working together with our partner Junshi Biologics during the rest of the review process
.

This time, the BLA of Teriplizumab was granted priority review, shortening the 10-month standard review time to 6 months
.

In September 2020, teriprizumab was approved as a breakthrough therapy by the FDA for second-line and above treatment after platinum-containing treatment for relapsed or metastatic nasopharyngeal carcinoma
.

The above BLA is mainly based on the data results of the POLARIS-02 study (NCT02915432) and the JUPITER-02 study (NCT03581786)
.

Nasopharyngeal carcinoma is a malignant tumor that occurs in the mucosal epithelium of the nasopharyngeal area and is one of the common malignant tumors of the head and neck
.

In February 2021, Teriplizumab was approved by the National Medical Products Administration for the treatment of patients with relapsed/metastatic nasopharyngeal carcinoma who had previously failed second-line and above systemic treatments, becoming the first approved in the world Immune checkpoint inhibitor for the treatment of nasopharyngeal carcinoma
.

[1] https://gco.
iarc.
fr/today/data/factsheets/cancers/4-Nasopharynx-fact-sheet.
pdf.

[2] https://ascopubs.
org/doi/abs/10.
1200/JCO.
2020.
38.
15_suppl.
6521.

About Teriprolizumab Injection (Tuoyi®) 

As the first domestically-made monoclonal antibody drug targeting PD-1 that was approved for marketing in China, Teriprizumab Injection (Tuoyi®) has won the support of a major national science and technology project
.
The first indication approved for this product is the treatment of unresectable or metastatic melanoma that has previously failed systemic treatment
.
In December 2020, Teriplimumab successfully passed the national medical insurance negotiations and was included in the new version of the catalog
.
In February 2021, Teriplizumab was approved by the National Medical Products Administration (NMPA) for the treatment of patients with recurrent/metastatic nasopharyngeal carcinoma who had previously failed second-line and above systemic treatments
.
In April 2021, Teriplizumab was approved by the NMPA for the treatment of locally advanced or metastatic urothelial cancer that has failed platinum-containing chemotherapy, including neoadjuvant or adjuvant chemotherapy, which has progressed within 12 months
.
In addition, teriplizumab has also been awarded the "Chinese Society of Clinical Oncology (CSCO) Melanoma Diagnosis and Treatment Guidelines", "CSCO Head and Neck Tumor Diagnosis and Treatment Guidelines", "CSCO Nasopharyngeal Carcinoma Diagnosis and Treatment Guidelines", and "CSCO Urothelial Cancer Guidelines" Recommendations in the “Guidelines for Diagnosis and Treatment” and “Guidelines for Clinical Application of CSCO Immune Checkpoint Inhibitors”
.

In February 2021, the marketing application for new indications for the first-line treatment of teriprizumab combined with cisplatin and gemcitabine for patients with locally recurring or metastatic nasopharyngeal carcinoma was accepted by the NMPA
.
In March 2021, teriprizumab for the first-line treatment of advanced mucosal melanoma was included in the breakthrough therapy program by the State Food and Drug Administration
.
In July 2021, the new indication for the first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma with teriprizumab combined with platinum-containing chemotherapy was accepted by the NMPA
.
In terms of international deployment, the first marketing application (BLA) of teriplizumab in the U.
S.
Food and Drug Administration (FDA) has been accepted and has been granted priority review.
FDA submitted BLA domestic anti-PD-1 monoclonal antibody
.
At present, teriprizumab has been granted 2 breakthrough therapy designations, 1 fast track designation, 1 priority review designation, and 3 orphan drug designations by the FDA in the fields of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.

.

Tripriximab began clinical research and development in early 2016, and has carried out more than 30 clinical studies covering more than 15 indications around the world, actively exploring the use of this product in melanoma, nasopharyngeal cancer, urothelial cancer, and lung cancer.
, Gastric cancer, esophageal cancer, liver cancer, cholangiocarcinoma, breast cancer, kidney cancer and other indications of the efficacy and safety, and the joint therapy cooperation with leading domestic and foreign innovative pharmaceutical companies are also in progress, looking forward to more China and other countries The patient has received international advanced level of tumor immunotherapy
.

About Junshi Bio

Junshi Bio (688180.
SH, 1877.
HK) was established in December 2012.
It is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies
.
The company has a rich R&D pipeline consisting of 44 products under research, covering five major therapeutic areas, including malignant tumors, autoimmune system diseases, chronic metabolic diseases, neurological diseases and infectious diseases
.

Relying on the protein engineering core platform technology, Junshi Bio is at the forefront of international macromolecular drug research and development, and has obtained the first domestic anti-PD-1 monoclonal antibody NMPA approval, the domestic anti-PCSK9 monoclonal antibody NMPA clinical application approval, and the world's first treatment The tumor anti-BTLA blocking antibody was approved by the Chinese NMPA and the US FDA for clinical application, and the phase I clinical study was conducted in China and the United States
.
In 2020, Junshi Biotech also joined hands with domestic scientific research institutions to fight the epidemic.
The jointly developed JS016 has entered clinical trials as the first anti-neovirus monoclonal neutralizing antibody in China, and has obtained emergency use authorization in 15 countries and regions around the world.
Use local innovation to contribute to disease prevention and control in China and the world
.
At present, Junshi Bio has more than 2,500 employees worldwide, distributed in San Francisco and Maryland, Shanghai, Suzhou, Beijing and Guangzhou in China
.