Kangfang Bio-Kaidening PD-1/CTLA-4 dual antibody treatment of cervical cancer marketing application accepted

Hong Kong, September 24, 2021/PRNewswire/ - Kangfang Bio (9926.

This means that Kangfang Bio's independently developed and industrialized kadenimumab has become the world's first PD-1 based bispecific antibody drug to submit a marketing application, and it has also become the first bispecific independently developed by China.

Kadninimab was the first to submit for listing and was accepted in the world, marking that China's biopharmaceutical level is rapidly leading the world.

For Kangfang Biologics, kaidenimumab is the second independently developed and innovative antibody drug of Kangfang Biologics to submit a marketing application, and it is the fifth new drug marketing application submitted by Kangfang Biologics in China and the United States

Clinical research data shows that Kadenizumab is effective in treating patients with relapsed or metastatic cervical cancer who have failed platinum-containing chemotherapy and has good safety

Professor Wu Xiaohua, director of the Department of Oncology and Gynecology of the Cancer Hospital of Fudan University, said that although PD-1 monoclonal antibody for the treatment of cervical cancer has been approved for marketing worldwide, clinical research results show that it is only in PD-L1 positive patients above the second line.

Professor Kong Beihua from the Gynecological Oncology Branch of the Chinese Medical Association and Professor Kong Beihua from the Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, said that cervical cancer is the highest incidence of gynecological malignancies in China.

Dr.

Major milestones related to the treatment of Cervical Cancer with Kadenizumab:

In July 2021, the Phase III 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 approval for Kadenizumab to treat relapsed or metastatic cervical cancer that has failed platinum-containing chemotherapy.

In October 2020, the use of Kaidenigumab for recurrent or metastatic cervical squamous cell carcinoma after standard treatment was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration to be included in the list of "breakthrough treatment varieties"

At present, the main indications for the deployment of Kaidenin monoclonal antibody also include gastric cancer, lung cancer, liver cancer, esophageal squamous cell carcinoma and nasopharyngeal carcinoma

About Kaidenigumab (PD-1/CTLA-4 double antibody)

Kaidenizumab (AK104) is a new and pioneering PD-1/CTLA-4 bispecific tumor immunotherapy backbone drug independently developed by Kangfang Biological.

About Kangfang Bio

Kangfang Bio (HKEx stock code: 9926.

Source: Kangfang Bio