Recently, Junshi Biotech (1877.HK, 688180.SH) announced that the company’s self-developed anti-PD-1 monoclonal antibody drug teriprizumab for the treatment of esophageal cancer (EC) has been approved by the U.S. Food and Drug Administration ( (Orphan-drug Designation) granted by the FDA. This is the fourth orphan drug designation obtained by teriprizumab. Previously, teriprizumab has been designated as an orphan drug by the FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma and soft tissue sarcoma.

Orphan-drug, also known as rare disease drugs, refers to drugs used for the prevention, treatment, and diagnosis of rare diseases. The orphan drug designation granted by the FDA is applicable to drugs and biological agents for rare diseases with fewer than 200,000 patients in the United States. The orphan drug qualification issued by the FDA this time will help teriplimumab enjoy certain policy support in the follow-up research and development, registration and commercialization of teriplizumab in the United States, including but not limited to (1) taxation of clinical trial costs Credit; (2) Exemption of new drug application fees; (3) 7 years of market exclusivity after listing and not affected by patents. This certification will reduce the investment in new drug research and development to a certain extent, and accelerate the progress of clinical trials and marketing registration.

About Teriprolizumab Injection

As the first domestically-made monoclonal antibody drug targeting PD-1 that was approved for marketing in my country, Teriprizumab injection 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 received the "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Melanoma", "CSCO Guidelines for the Diagnosis and Treatment of Head and Neck Tumors", "CSCO Guidelines for the Diagnosis and Treatment of Nasopharyngeal Carcinoma", and "CSCO Urothelial Carcinoma 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 layout, the first marketing application (BLA) of tereprizumab 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 awarded 2 breakthrough therapy designations, 1 fast track designation, 1 priority review designation and 4 orphans by the FDA in the fields of mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma, and esophageal cancer. Identification of drug qualifications.

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.