Junshi Ripley single resistance was approved for Phase III clinical overlay by fda fast track eligibility overlay

Recently, the first-line treatment of PD-1 monoanti-Terripri monoantigen for mucosal melanoma adaptation was awarded fast-track qualification by the FDA, and the application for Phase III clinical trial of this combination therapy for first-line treatment in patients with mucosal melanoma was also approved by the FDA.
The first approved domestic PD-1 single anti-2018 December 2018, Junshi biotrepri single anti-injection in china obtained the conditional approval of NMPA listing, the commodity named Tuyi, approved adaptive disorder for the past to accept the systemic system treatment failure of the non-excisive or metastasis melanoma treatment.
this drug is China's first approved listing of PD-1 single anti-drug, access to major national science and technology projects support.
2019, the new edition of the Chinese Society of Clinical Oncology (CSCO) Melanoma Guidelines lists Regency Biologics' Ripley monoanti as the recommended drug.
Since the beginning of 2016, the company has conducted more than 30 clinical studies around the world, actively exploring a variety of adaptations including nasopharyngeal cancer, urethra skin cancer, lung cancer, stomach cancer, esophageal cancer, liver cancer, breast cancer, kidney cancer, etc.
following the first approved adaptive melanoma, Ripley single resistance has been approved in China nasopharyngeal cancer, urethra skin cancer two new adaptive disorders.
At the end of December 2020, Therpley's monoantigen injections were included in the new National Health Insurance Directory, the only PD-1 monoantigen in the new National Health Insurance Directory for melanoma treatment and included in the National Health Insurance Directory.
set FDA multiple qualifications in one of the domestic PD-1 single resistance as a domestic PD-1 single resistance, Regency biology Terripley single resistance set FDA multiple qualifications in one.
before the fast-track qualification, Tripley Monoanti had obtained three FDA-granted orphan drug qualifications, one breakthrough therapy, and three adaptations.
Currently, the three adaptive melanomas, nasopharyngeal cancers, and soft tissue sarcoma of Regency BioTripley have all been certified as orphan drugs issued by the FDA, and will then receive a clinical trial fee tax credit, waiver of new drug application fees, and a seven-year market exclusive right and no patent-free benefits, which will help Ripley single resistance to the above three adaptations in the United States follow-up research and development, registration and commercialization.
Tripley's mono-anti-nasopharyngeal cancer adaptation has been awarded a breakthrough FDA-awarded drug therapy that, accordingly, will receive closer guidance and multiple forms of support in the development process in the United States, including senior FDA officials, to ensure that new treatment options are available to patients in the shortest possible time.
this time, tripley's treatment for melanoma has been approved by the FDA as a fast track, and development in the U.S. will receive multiple forms of accelerated review treatment that will significantly accelerate the drug's development and launch in the U.S.
common types of melanoma that do not meet the unseeded clinical needs of mucosal melanoma include limb end type, mucous membrane type, chronic daylight damage type and non-chronic daylight injury type.
Currently, treatment options are very limited for patients with metastasis mucosal melanoma, a high incidence of malignant tumors in Asia that are insensitive to traditional chemotherapy and immunotherapy, with a total survival of less than a year and clinical treatment needs not yet met.
Tripley monoantigen for mucosal melanoma Phase III. Phase III clinical trials Junshi Bio is the first in the world to explore the use of Terriple monoantigen anti-angiogenesis VEGFR inhibitors in mucosal melanoma, is the field of mucosal melanoma treatment of Chinese characteristics.
this time, in addition to obtaining fast-track eligibility, tripley monoantigenic acetinine's Phase III clinical trial application for first-line treatment in patients with mucosal melanoma was approved by the FDA to conduct the study directly.
is known to be an international multi-center, randomized, open-label Phase III clinical trial designed to assess the effectiveness and safety of the Terripri monoantigen-combined acytinine-K drug Paboli-pearl monoantigen therapy in patients with non-removable, local progression or metastasis mucosal melanoma.
220 patients in a 1-to-1 scale.
the main study endpoints were patients' progress-free survival (PFS), and secondary studies end with patients' objective remission rate (ORR), total lifetime (OS), remission duration (DOR), safety and tolerance.
It is worth noting that in the current globally approved PD-1/PD-L1 monoantigen, the K drug Paboliju monoantigen has achieved landmark results in clinical studies of KEYNOTE-001 and KEYNOTE-006, becoming a PD-1/PD-L1 immunosuppressant for long-term survival benefits in patients with advanced melanoma.
Chinese the incidence of melanomas in these groups is different from that in Western countries, and mucosal melanomas are found in Chinese patients.
K drug Paboliju monotherapy for mucosal melanoma is slightly less effective than other subtypes, JunshiTripri single anti-combination axithinib combination can be regarded as a characteristic treatment for Patients with Mucosal melanoma in China, looking forward to the clinical results of this comparison study with K drug Paboli jumbo.