share_log

康方生物(09926.HK):国家药监局受理开坦尼(卡度尼利,PD-1/CTLA-4)用于一线治疗宫颈癌的新适应症上市申请

Kangfang Biology (09926.HK): The State Drug Administration accepted the marketing application for new indications of chetanil (cardonil, PD-1/CTLA-4) for first-line treatment of cervical cancer

Gelonghui Finance ·  Apr 23 20:19

Gelonghui, April 24 | Kang Fang Biotech (09926.HK) issued an announcement. The China Drug Administration (“NMPA”) has recently officially accepted the world's first bispecific antibody Ketanil independently developed by the company(cardonil, PD-1/CTLA-4) marketing application for a new indication (“SnDA”) for first-line treatment of persistent, recurrent, or metastatic cervical cancer with or without platinum-containing chemotherapy with or without bevacizumab.

KaitaniIt was approved by the NMPA in June 2022 to treat patients with recurrent or metastatic second-/third-tier cervical cancer who have previously failed platinum-containing chemotherapy. This SNDA is based on the AK104-303 study, which shows that KetaniPatients in the entire population (regardless of PD-L1 expression level) benefit significantly. This time SNDa means Open TaneyIt will advance to the field of first-line treatment of cervical cancer, bringing broad benefits to all patients with advanced cervical cancer.

This is KaitaniApplication for marketing of the third indication. In January 2024, KaitaniCombined chemotherapy was accepted by NMPA for first-line treatment of gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, which will bring more effective and safe treatment options to all patients with gastric cancer (regardless of PD-L1 expression level).

Disclaimer: This content is for informational and educational purposes only and does not constitute a recommendation or endorsement of any specific investment or investment strategy. Read more
    Write a comment