China-based Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate AFN0328. This investigational mRNA drug targets tumors associated with human papillomavirus (HPV), particularly HPV16 and/or HPV18 in the cervix, which are linked to high-grade squamous intraepithelial lesions (HSIL). HSIL is a precancerous condition that can progress to cervical cancer if left untreated.
AFN0328 is being co-developed by Hefei Afana Biotechnology Co., Ltd and is expected to induce a robust immune response by stimulating the production of high levels of neutralizing antibodies and cellular immune responses against the HPV virus. Preclinical pharmacological results suggest that AFN0328 could be effective in treating patients with HSIL related to HPV16 and/or HPV18. Notably, AFN0328 is the first drug candidate targeting CD228 to be approved for clinical trials in China, and there are no similar products currently available on the global market.- Flcube.com
