Kangfang Bio PD-1/CTLA-4 dual resistance is eligible for FDA fast-track approval.

On August 12, Kangfang Bio announced that its core self-developed, world-first new cancer immunotherapy dual-specific antibody drug PD-1/CTLA-4 (AK104) for the treatment of advanced cervical cancer has been granted fast-track FDA approval (FTD).
this is another significant development following the FDA's approval of a registered clinical study in April 2020 of AK104 monodrative clinical studies for second-line treatment of relapsed or metastatic cervical cancer.
FDA's Fast Track program is designed to accelerate or facilitate the review process for new drugs that treat serious or life-threatening diseases or conditions that currently do not have an effective treatment and demonstrate the potential to meet the current unsealed medical needs of the disease.
Candidates who qualify for fast-track approval channels are eligible for more frequent communication with the FDA, priority review (if relevant standards are met), and rolling review of new drug applications (DAs) to accelerate the development and marketability of the drug.
AK104 is a new, potential next-generation, pioneering PD-1/CTLA-4 dual-specific tumor immunotherapy core drug developed by Kangfang Bio, designed to achieve priority binding to tumor-soaked lymphocytes (TIL) rather than normal exoglomerate lymphocytes.
AK104 targets two proven immuno-checkpoint molecules simultaneously: procedural cell death protein 1 (PD-1) and cytotoxic T lymphocyte-related protein 4 (CTLA-4), thus demonstrating the clinical efficacy of PD-1 and CTLA-4 monoclonal antibody combination therapy and the good safety that PD-1 and CTLA-4 monoclonal antibody combination therapy cannot provide.
kangfang biological official website shows that AK104 is still a number of clinical development, its single drug for stomach cancer, non-small cell lung cancer, melanoma, liver cancer, esophageal scale cancer and other indications have progressed to Phase 2.
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