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根据新的指南,制药企业在提交糖尿病药物新药申请时,不仅要提供研究数据证明药物的降糖疗效,也要证明该药对心脏病患者以及动脉粥样硬化等心血管高风险患者的安全性。
According to the new guidelines, pharmaceutical companies submitting new drug applications for diabetes drugs should not only provide research data to prove the anti-diabetic effect of the drug, but also demonstrate the safety of the drug in patients with heart disease and at high risk of cardiovascular diseases such as atherosclerosis .