我国食药监局批准肺癌新药泰瑞沙

The London stock market listed company AstraZeneca announced that the China Food and Drug Administration (CFDA) has granted marketing authorization for its lung cancer pill Tagrisso in China.

伦敦证交所上市公司阿斯利康日前宣布，中国国家食品药品监督管理总局已批准其肺癌片剂泰瑞沙在中国销售。

Tagrisso (osimertinib) is designed for the treatment of adult lung cancer patients with certain genetic mutations,

泰瑞沙(奥希替尼)是治疗发生特定基因突变的肺癌成年患者的药物。

It is the first AstraZeneca medicine approved under the CFDA's Priority Review pathway, using an accelerated timeline for an innovative medicine.

这是阿斯利康经中国国家食药监总局优先审批制度获批的首款药物，该制度缩短了创新药的审批时限。

Sean Bohen, executive vice-president of global medicines development and chief medical officer at AstraZeneca, said: "This is an important step forward for Tagrisso and a significant opportunity to bring a breakthrough medicine to patients with non-small cell lung cancer in China, where epidermal growth factor receptor mutation rates are some of the highest in the world."

阿斯利康执行副总裁、全球药物研发兼首席医学官肖恩·博恩称：“这对泰瑞沙来说是向前迈进的重要一步，也是将一款突破性的药物带给中国非小细胞肺癌患者的重要机会；中国是全球表皮生长因子受体突变率最高的国家之一。”

According to the company, the rapid review and approval signal the urgent need for new, targeted treatments with the potential to address specific types of cancer with high incidence rate and significant unmet medical need in China.

据该公司表示，审查和批准工作的迅速完成，表明中国迫切需要这种新的靶向治疗。此疗法对那些高发病率、重要却未满足医疗需求的特定类型的癌症，具有一定的治疗潜力。