China Accepts Anke Biotech's Clinical Trial Application for Tumor Drug

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Anhui Anke Biotechnology (Group) (SHE:300009) has won approval from China's National Medical Products Administration (NMPA) to carry out clinical trials for its AK2405 drug for injection, according to a Monday filing with the Shenzhen bourse.

The injection is a HER2-targeting antibody-drug conjugate (ADC), which has an antibody component that specifically binds to the target antigen on the surface of tumor cells.

The product is classified under Registration Category 1 for therapeutic biological products and is used to treat advanced malignant solid tumors.

The company said preclinical studies showed high specificity and anti-tumor activity.

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