The application for the listing of regenerant biology Terripley single anti-new anti-adhesive disease was accepted

On February 18, Junshi Bio announced that the company had received a "notice of acceptance" approved by the State Drug Administration, and that the new adaptation application for Ripley monoantithermal combination chemotherapy for advanced first-line relapsed metastatic nasopharyngeal cancer that had not received systematic treatment was accepted.
December 2020, Terripley's single-dose injection was successfully included in the new health-care list through the National Health Care Negotiations.
currently, Ripley has been awarded 1 breakthrough therapy, 1 fast track and 3 orphan drug qualifications by the FDA in the fields of mucosal melanoma, nasopharyngeal cancer, and soft tissue sarcoma.
nasopharyngeal cancer is a malignant tumor that occurs in the epithelitis of the mucous membrane of the nasopharyngeal system and is one of the most common head and neck malignancies.
, according to the World Health Organization, the number of new cases of nasopharyngeal cancer diagnosed worldwide by 2020 has reached 133,000, with nearly half occurring in China.
The Board of Directors and all directors of the Company warrant that the contents of this announcement are free of any false records, misleading statements or material omissions, and shall be legally liable for the authenticity, accuracy and completeness of its contents.
This new adaptation listing application is based on the JUPITER-02 Study (NCT03581786), a randomized, double-blind, placebo-controlled, international multi-center Phase I.I. clinical study led by Professor Xu Ruihua of Sun Yat-sen University-affiliated Oncology Hospital.
results showed that the first-line treatment of patients with relapsed or metastatic nasopharyngeal cancer in the first-line treatment of Terripri monoantigen/cisplatin significantly extended the patient's progressive survival compared to the standard first-line treatment of gisithamin/cisplatin.
As of the date of this announcement, this study is the world's largest immuno-checkpoint inhibitor combined chemotherapy first-line treatment of recurrence or metastatic nasopharyngeal cancer I.I. phase clinical study Ripley monoanti is China's first approved PD-1 target of domestic monoantigen drugs, and has so far been carried out in China, the United States and other countries covering more than 15 adaptations of more than 30 clinical studies.
December 17, 2018, Ripley monoantigen was conditionally approved by the National Drug Administration for the treatment of non-excisive or metastasis melanomas that have failed systemic treatment in the past, and was recommended by the 2019 and 2020 Guidelines for the Diagnosis and Treatment of Melanoma at the Chinese Society of Clinical Oncology (CSCO).
New adaptation application for triplethroid for third-line treatment of relapsed metastatic nasopharyngeal cancer, and triplethion for second-line treatment of metastatic urethrial skin cancer was accepted by the National Drug Administration in April 2020 and May 2020, respectively.
2020, the two new adaptation listing applications have been included in the priority review process by the State Drug Administration.
September 2020, Ripley monoantigen was recognized as a breakthrough therapy by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed metastatic nasopharyngeal cancer.
December 2020, Ripley's monoantigen injection was successfully negotiated through the National Health Care Administration and included in the new health care catalog.
currently, Ripley monoantigen has been awarded 1 breakthrough therapy, 1 fast track, and 3 orphan drug qualifications by the FDA in the areas of mucosal melanoma, nasopharyngeal cancer, and soft tissue sarcoma.