CFDA Accepts Athenex's IND Filing for Oral Paclitaxel
publication date: Jul 5, 2017
Athenex announced the CFDA accepted its IND filing to start China clinical trials of Oraxol, an oral formulation of the chemotherapy paclitaxel. Athenex, headquartered in Buffalo, New York, also has operations in Chongqing. The company has been conducting a US Phase III trial of Oraxol in patients with metastatic breast cancer since 2015, with initial data analysis expected later this year. To facilitate uptake of the oral drug, Athenex administers Oraxol along with a P-gp pump inhibitor (HM30181A), which the company in-licensed from South Korea's Hanmi Pharma. More details....
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