Akeso Inc. has announced that its first bispecific Antibody-Drug Conjugate $(ADC)$, AK146D1, has received regulatory approval to commence clinical trials from the U.S. Food and Drug Administration (FDA), Australia's Therapeutic Goods Administration $(TGA)$, and China's National Medical Products Administration (NMPA). This marks a significant milestone for Akeso, as AK146D1 targets both Trop2 and Nectin4, representing a key component of the company's "IO+ADC" 2.0 strategy aimed at advancing cancer therapies. The approval allows Akeso to proceed with its Phase Ia clinical trial, with the first patient already successfully enrolled.
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