The FDA granted Kangfang BioPD-1/CTLA-4 dual anti-new drug (AK104) rapid approval for treatment of advanced cervical cancer.

Introduction: AK104 is a new, potential next-generation pioneer PD-1/CTLA-4 dual-specific tumor immunotherapy backbone drug independently developed by Kangfang Bio.
August 12, Kangfang Bio announced that its core independently developed, the world's 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 approval channel (FTD) by the U.S. Food and Drug Administration (FDA).
this is another significant development following the FDA's approval of a registered clinical study in April 2020 on AK104 monodrative clinical studies for second-line treatment of recurrence or metastatic cervical cancer.
FDA's Fast Track Program is designed to accelerate or facilitate the review process for new drugs that are used to treat serious or life-threatening diseases or conditions that currently do not have an effective treatment and demonstrate the potential to meet the current unseeded medical needs of the disease.
Drug candidates with fast-track eligibility 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 marketization of related drugs.
AK104 is a new, potential next-generation, pioneering PD-1/CTLA-4 dual-specific tumor immunotherapy backbone drug developed by Kangfang Bio, which aims to achieve priority binding to tumor-soaked lymphocytes (TIL) rather than normal exoglomerate lymphocytes.
AK104 targets two proven immuno-checkpoint molecules simultaneously: program 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 therapies and the good safety that PD-1 and CTLA-4 monoclonal antibody combination therapies cannot provide.
AK104 Project is the 2017 National Health and Health Commission and the Ministry of Science and Technology 13th Five-Year "Major New Drug Creation" science and technology major special support project, 2017 Guangdong Province "Pearl River Talent Program" to introduce innovation and entrepreneurship team support project.
was jointly named one of the "Top 10 Advances in Chinese Pharmaceutical Biotechnology 2017" by the China Pharmaceutical Biotechnology Association and the China Pharmaceutical Biotechnology magazine.
.