Junshi Bio-Treplimumab obtained the second breakthrough therapy designation by the U.S. FDA

On August 11, 2021, Beijing time, Junshi Bio (1877.
HK, 688180.
SH) announced that the company’s self-developed anti-PD-1 monoclonal antibody drug teriprizumab combined with gemcitabine/cisplatin was used for late relapse or The first-line treatment for patients with metastatic nasopharyngeal carcinoma has been awarded Breakthrough Therapy Designation by the U.
S.
Food and Drug Administration (FDA)
.

This is also the second breakthrough therapy designation granted by the U.

The anti-PD-1 monoclonal antibody drug teriprizumab combined with gemcitabine/cisplatin was awarded Breakthrough Therapy Designation by the U.

Breakthrough therapy is suitable for the treatment of serious or life-threatening diseases and preliminary clinical evidence shows that the drug is significantly better than existing therapies , aiming to accelerate the development and review process of the drug

This breakthrough therapy designation is mainly based on an international multi-center phase III registered clinical study (JUPITER-02 study) of Teriplizumab
.

At the American Society of Clinical Oncology (ASCO) annual meeting held in June this year, the JUPITER-02 study was selected as the first local innovative drug research into the "Blockbuster Research Abstract" (No.

The JUPITER-02 study, as the first local innovative drug research, was selected as the "Blockbuster Research Abstract" (No.

Junshi Bio, the first domestically-made anti-PD-1 monoclonal antibody to be recognized as a breakthrough therapy by the FDA, is expected to complete the BLA submission for the first-line treatment of teriprizumab for recurrent or metastatic nasopharyngeal carcinoma indications within the third quarter

Dr.

The affirmation of the clinical performance of the drug is bound to accelerate the process of its overseas commercialization, and help Junshi Biologics to implement its international strategy of'basing in China and deploying globally'

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
.

According to statistics from the World Health Organization, the number of new cases of nasopharyngeal carcinoma diagnosed worldwide in 2020 will exceed 130,000[1], and nearly half of them will occur in China[2]

Data show that the average 5-year survival rate of nasopharyngeal cancer patients in China from stage I to IV has reached more than 80%, which is at a high level in the world
.

However, in clinical practice, recurrent/metastatic nasopharyngeal carcinoma brings great pain to patients

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

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

https://gco.
iarc.
fr/today/data/factsheets/populations/160-china-fact-sheets.
pdf.

https://gco.
iarc.
fr/today/data/factsheets/populations/160-china-fact-sheets.
pdf.

Chen YP, et al.
Lancet2019.
394:64-80.

Chen YP, et al.
Lancet2019.
394:64-80.

Nasopharyngeal Carcinoma Professional Committee of Chinese Anti-Cancer Association.
Chinese Journal of Radiation Oncology.
2018;27(1):7-15.

Nasopharyngeal Carcinoma Professional Committee of Chinese Anti-Cancer Association.
Chinese Journal of Radiation Oncology.
2018;27(1):7-15.

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

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, Teriplizumab Injection (Tuoyi®) has been supported by 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 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 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 layout, in March 2021, Junshi Bio-Bio announced the rolling submission of teriprizumab listing application to the U.
S.
Food and Drug Administration (FDA) and obtained rolling review
.
At present, teriprizumab has been granted 2 breakthrough therapy designations, 1 fast track designation and 3 orphan drug designations by the FDA in the fields of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma
.

Tripriximab has been clinically developed since the beginning of 2016, and has carried out more than 30 clinical studies around the world, actively exploring its use in melanoma, nasopharyngeal cancer, urothelial cancer, lung cancer, gastric cancer, esophageal cancer, and liver cancer.
The efficacy and safety of indications such as, cholangiocarcinoma, breast cancer, kidney cancer, etc.
, and joint therapy cooperation with leading innovative pharmaceutical companies at home and abroad are also underway.
We look forward to allowing more patients in China and other countries to obtain internationally advanced tumors.
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 pipeline of products under research, including 28 innovative drugs and 2 biosimilars, covering five 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 in the clinical application of China's NMPA and the US FDA, 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.
It has obtained emergency use authorization in the United States and Italy, and uses local innovations.
Contribute to disease prevention and control in China and the world
.
At present, Junshi Biotech has more than 2,000 employees worldwide, distributed in San Francisco and Maryland, Shanghai, Suzhou, Beijing and Guangzhou in China
.