我國食藥監局批准肺癌新藥泰瑞沙

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.

倫敦證交所上市公司阿斯利康日前宣佈，中國國家食品藥品監督管理總局已批准其肺癌片劑泰瑞沙在中國銷售。

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

泰瑞沙(奧希替尼)是治療發生特定基因突變的肺癌成年患者的藥物。

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

這是阿斯利康經中國國家食藥監總局優先審批制度獲批的首款藥物，該制度縮短了創新藥的審批時限。

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."

阿斯利康執行副總裁、全球藥物研發兼首席醫學官肖恩·博恩稱：“這對泰瑞沙來說是向前邁進的重要一步，也是將一款突破性的藥物帶給中國非小細胞肺癌患者的重要機會；中國是全球表皮生長因子受體突變率最高的國家之一。”

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.

據該公司表示，審查和批准工作的迅速完成，表明中國迫切需要這種新的靶向治療。此療法對那些高發病率、重要卻未滿足醫療需求的特定類型的癌症，具有一定的治療潛力。