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February 4, 2023

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Accutar Biotechnology Receives NMPA Clearance of IND Application for AC0682 in ER-Positive Breast Cancer

BROOKLYN, N.Y. & SHANGHAI–(BUSINESS WIRE/AETOSWire)– Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, announces that the China National Medical Products Administration (NMPA) has cleared the company’s investigational new drug application (IND) for AC0682 for the treatment of patients with estrogen receptor (ER)-positive breast cancers. AC0682 is an orally bioavailable chimeric degrader molecule designed to target ERα protein with high potency and selectivity.

Accutar Biotechnology Receives NMPA Clearance of IND Application for AC0682 in ER-Positive Breast Cancer

“Breast cancer is the most common cancer among women in China. We are excited about the IND clearance of AC0682 in China, after its IND clearance and initiation of a Phase 1 study in the US late last year,” said Jie Fan, Ph.D., Chief Executive Officer, Accutar Biotechnology, Inc. “We look forward to accelerating the development of AC0682 and furthering our commitment to bringing innovative medicines to patients worldwide.”

The Phase 1 study in China will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0682 treatment in Chinese patients with ER-positive breast cancer. Accutar expects to begin enrollment of this study in the second half of this year.

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