Akeso Inc. Receives Regulatory Approval from U.S. FDA, Australia's TGA, and China's NMPA to Begin Clinical Trials for First Bispecific ADC, AK146D1

Reuters
07/03
Akeso Inc. Receives Regulatory Approval from U.S. FDA, Australia's TGA, and China's NMPA to Begin Clinical Trials for First Bispecific ADC, AK146D1

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Akeso Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: CN23642) on July 03, 2025, and is solely responsible for the information contained therein.

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