Kangfang Bio-PD-1/CTLA-4 dual antibody listing application accepted

On September 24, Kangfang Bio-Bio announced that the National Medical Products Administration (NMPA) of China has officially accepted its "first-in-class" PD-1/CTLA-4 bispecific antibody candonilimab (candonilimab, R & D code: AK104) for the treatment of recurrent or metastatic cervical cancer marketing application, and received priority review

According to the press release, this means that Kadenizumab has become the world's first PD-1 based bispecific antibody drug to be submitted for marketing

Kaidenigumab is a new PD-1/CTLA-4 bispecific tumor immunotherapy backbone drug under development by Kangfang Biological.

Specific to the indications of cervical cancer, clinical research data shows that kaidenizumab is effective in treating patients with relapsed or metastatic cervical cancer who have failed platinum-containing chemotherapy, and has good safety

In July 2021, the Phase 3 clinical trial of Kaidenigumab combined with chemotherapy for the first-line treatment of advanced cervical cancer was officially launched;

In February 2021, the U.

In July 2020, the FDA granted fast-track qualification for Kadenizumab to treat relapsed or metastatic cervical cancer that has failed platinum-containing chemotherapy;

In October 2020, Kaidenigumab for recurrent or metastatic cervical squamous cell carcinoma after standard treatment was included in the list of breakthrough treatment varieties in China

Professor Wu Xiaohua, director of the Department of Oncology and Gynecology of Fudan University Cancer Hospital, said that although anti-PD-1 monoclonal antibodies for the treatment of cervical cancer indications have been approved for marketing worldwide, clinical research results show that they are only positive for PD-L1 above the second line.

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