---
title: "復宏漢霖兩個產品獲歐盟委員會批准用於特定人羣骨質疏鬆症治療等適應症"
description: "復宏漢霖宣佈，BILDYOS 和 BILPREVDA 兩個產品已獲歐盟委員會批准，適用於特定人羣的骨質疏鬆症治療。此次批准涵蓋所有歐盟成員國及冰島、列支敦士登和挪威，適應症包括高風險絕經後女性及男性的骨質疏鬆症、前列腺癌男性的骨質流失、以及成人晚期骨惡性腫瘤的骨相關事件預防等。"
type: "news"
locale: "zh-HK"
url: "https://longbridge.com/zh-HK/news/258059688.md"
published_at: "2025-09-19T09:57:45.000Z"
---

# 復宏漢霖兩個產品獲歐盟委員會批准用於特定人羣骨質疏鬆症治療等適應症

> 復宏漢霖宣佈，BILDYOS 和 BILPREVDA 兩個產品已獲歐盟委員會批准，適用於特定人羣的骨質疏鬆症治療。此次批准涵蓋所有歐盟成員國及冰島、列支敦士登和挪威，適應症包括高風險絕經後女性及男性的骨質疏鬆症、前列腺癌男性的骨質流失、以及成人晚期骨惡性腫瘤的骨相關事件預防等。

復宏漢霖 (02696.HK) 公佈，近日 BILDYOS 以及 BILPREVDA 兩個產品的上市許可申請 (MAAs)，已獲歐盟委員會批准，該等商品名由 N.V. Organon 於歐盟註冊商標。此次獲批意味着兩個產品在所有歐盟成員國及冰島、列支敦士登和挪威獲得集中上市許可。

獲批適應症為 Prolia 與 XGEVA 於歐盟上市的所有適應症，具體而言：

BILDYOS 適應症為骨折高風險的絕經後婦女及男性的骨質疏鬆症治療；骨折高風險的前列腺癌男性與激素消融相關的骨質流失治療；及骨折高風險的成年患者中與長期全身糖皮質激素治療相關骨質流失的治療。

BILPREVDA 適應症包括預防成人晚期骨惡性腫瘤的骨相關事件；及不可手術切除或手術切除後可能導致嚴重功能障礙的骨鉅細胞瘤患者的治療，包括成人和骨骼發育成熟的青少年患者。

### Related Stocks

- [02696.HK - 復宏漢霖](https://longbridge.com/zh-HK/quote/02696.HK.md)

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