拜耳公司宣布，诺倍戈（达罗他胺）联合雄激素剥夺疗法（ADT）治疗转移性激素敏感性前列腺癌（mHSPC）成年患者的新适应症申请已获国家药品监督管理局（NMPA）药品审评中心（CDE）受理。诺倍戈是口服新一代雄激素受体抑制剂（ARi），已先后获批用于治疗有高危转移风险的非转移性去势抵抗性前列腺癌（NM-CRPC）成年患者，和联 ...

Orion's collaboration partner Bayer has submitted an application to the Center of Drug Evaluation (CDE) of China's National ...

Bayer seeks China NMPA marketing authorization for ARi darolutamide in combo with ADT in patients with metastatic hormone-sensitive prostate cancer: Berlin Wednesday, January 8, 2 ...

达罗他胺 首次于 2019 年在美国获批上市，用于 去势抵抗性前列腺癌的一线治疗 ，2021 年同适应症在中国获批上市， 2023 年在中国获批新适应症， 与 ADT 和多西他赛联合使用 ，用于 激素依赖性前列腺癌的一线治疗 。

丨 2025年1月8日 星期三 丨 NO.1 以岭药业撤回G201-Na胶囊药物临床试验申请 ...

A growing array of pharmaceutical options has investigators trying to figure out which drugs and drug combinations are the ...

1 月 7 日，拜耳宣布已向 CDE 提交口服雄激素受体抑制剂（ARi）达罗他胺的上市申请，与雄激素剥夺疗法（ADT）联合用药，用于治疗转移性激素敏感性前列腺癌（mHSPC）患者。这是该药在中国申报的第 3 ...

EET Orion's collaboration partner Bayer submits application in China for third indication of darolutamide Orion's collaboration ...

EET Orion’s collaboration partner Bayer submits application in China for third indication of darolutamide Orion’s collaboration partner Bayer has submitted an application to the Center of Drug ...

Evan Y. Yu, MD, discusses how individualized first-line systemic therapy selection for metastatic hormone-sensitive prostate ...

Evan Y. Yu, MD, discusses how systemic therapy options for newly diagnosed metastatic hormone-sensitive prostate cancer ...

Its pipeline includes LAE001 to treat metastatic hormone-sensitive prostate cancer (mHSPC); and other drug candidates for cancer treatments. Laekna is also developing a pipeline product range that ...