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恒瑞医药(600276.SH):瑞维鲁胺片治疗高瘤负荷的转移性激素敏感性前列腺癌患者获批转为完全批准

Hengrui Pharmaceutical (600276.SH): Revirulamide tablets for treatment of patients with metastatic hormone-sensitive prostate cancer with a high tumor burden were approved and converted to full approval

Zhitong Finance ·  Mar 27, 2023 16:00

According to the Zhitong Finance App, Hengrui Pharmaceutical (600276.SH) announced that recently, the company received approval from the China Drug Administration (“China Drug Administration”) to issue a “Drug Supplement Application Approval Notice” for leviruramide tablets. The China Drug Administration approved the use of leviruramide tablets to “treat patients with metastatic hormone-sensitive prostate cancer (MHSPC) with high tumor load” from conditional approval to routine approval.

According to reports, reviverutamide tablets are second-generation AR inhibitors. Compared with first-generation AR inhibitors, they have a stronger AR inhibitory effect and have no agonizing effect. In June 2022, the company's levirudamide tablets were approved for conditional registration. In addition to the company's products, six nonsteroidal AR inhibitors, including bicalutamide and enzalutamide, have been marketed globally, and bicalutamide, enzalutamide, apatamide, and darotamide have been approved for marketing in China. According to inquiries, global sales of second-generation AR inhibitors enzalutamide, apatamide, and darotamide totaled about US$6.297 billion in 2021.

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