Junshi "Terripley single resistance": the first FDA breakthrough therapy identified as the domestic PD-1.

Today, Junshi Bio announced that its "Ripley single anti-injection" for the treatment of nasopharyngeal cancer has been recognized by the FDA breakthrough therapy, Ripley monoantigen became the first FDA breakthrough therapy recognized as the domestic anti-PD-1 monoantigen, which is after the Terriple single anti-treatment of nasopharyngeal cancer in May 2020 after the FDA orphan drug identification of another important registration progress.
announcement, the Terripri single-drug treatment for nasopharyngeal cancer has been recognized by the FDA as a breakthrough therapy that significantly supports and accelerates the drug's commercial development program in the United States.
Breakthrough Therapy, derived from the provisions of the Food and Drug Administration's Safety and Innovation Act (FDASIA), applies to drugs that treat serious or life-threatening diseases and have preliminary clinical evidence showing significant superiority over existing therapies, and is intended to accelerate the development and review process of the drug, and is another important fda drug review channel following fast track, accelerated approval, and priority review.
the drug development process, which is recognized as a breakthrough drug therapy, will receive closer guidance and multiple forms of support, including from senior FDA officials, to ensure that new treatment options are available to patients in the shortest possible time.
PD-1 monoantial not only has good efficacy in the use of single drugs, but also with a variety of products, treatment methods to use jointly, the broad commercial prospects so that many pharmaceutical companies have layout.
analysis by Frost Sullivan, the global market for anti-PD-1/PD-L1 inhibitors will reach $16.3 billion in 2018 and is expected to reach $63.9 billion in 2023.
Terripley single-dose injection is the first domestic monoantigen drug to be approved for sale in China with PD-1 as its target.
since the beginning of 2016 clinical research and development, Ripley monoanti has been in China, the United States and other countries to carry out more than 30 clinical studies covering more than 10 tumor species.
December 2018, Ripley monoantigen injections were conditionly approved by the National Drug Administration for the treatment of local progression or metastasis melanoma after previous standard treatment failures.
April 2020, a new adaptation application for the treatment of relapsed pyrethroid nasopharyngeal cancer that had previously failed to receive second-line and above system treatment was accepted by the National Drug Administration.
the first new drug to fight PD-1 single anti-recurrence/metastatic nasopharyngeal cancer.
addition, the Phase III clinical study JUPITER-02 study (NCT03581786) of Thetripri single anti-injection combination chemotherapy as a first-line treatment plan for patients with relapsed or metastatic nasopharyngeal cancer was completed.
May 2020, a new adaptation application for the treatment of local progressions or metastatic urethrial skin cancers that have been systematically treated in the past was accepted by the National Drug Administration.
March 2020, Ripley's monoantigeno-anti-axithinib treatment for mucosal melanoma was eligible for FDA orphan drugs.
present, in addition to the core product of Ripley monoclonal resistance, Regeneration Also has injection recombinant humanized anti-PCSK9 monoclonal antibody JS002, anti-BLyS monoclonal antibody UDP1213, as well as the world's first anti-BTLA monoclonal antibody TAB004/JS004.
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