Enhertu by AstraZeneca, Daiichi wins new approval in China
AstraZeneca PLC on Monday said that its antibody drug conjugate Enhertu won another approval in China. The Cambridge, England-based pharmaceutical company said that the National Medical Products Administration approved Enhertu as the first HER2-directed therapy for adult patients with HER-2 mutant metastatic non-small cell lung cancer.
The approval is based on positive results of phase 2 trials.
It is the fourth approval in China across three different tumour types for the cancer drug that is jointly developed by AstraZeneca and Tokyo-based Daiichi Sankyo Co Ltd.
"Since our initial approval of Enhertu for patients with HER2-positive metastatic breast cancer in China last year, we have remained committed to bringing this innovative antibody drug conjugate to more patients in China, especially those that have previously not been eligible for treatment with a HER2-directed therapy. Today's milestone marks the fourth approval of Enhertu in China and follows the recent approval for HER2-positive metastatic gastric cancer, reinforcing its benefit across multiple HER2-targetable tumours," said Kiminori Nagao, head of the Asia, South & Central America business unit at Daiichi Sankyo.
AstraZeneca shares were 0.7% higher at 11,844.00 pence each on Monday morning in London. Daiichi shares had closed 0.2% lower at JPY4,982.00 each on Friday in Tokyo. Japanese markets are closed on Monday for Sports Day.
