甘李藥業(603087.SH)：甘精胰島素注射液(Ondibta®)上市許可申請(MAA)獲得歐盟CHMP積極意見

智通財經

11/13

智通財經APP訊，甘李藥業(603087.SH)發佈公告，公司及其歐洲全資子公司甘李藥業歐洲有限責任公司(Gan&LeePharmaceuticalsEuropeGmbH，以下簡稱「甘李歐洲」)於近日收到歐洲藥品管理局(EuropeanMedicinesAgency， EMA)的通知，甘精胰島素注射液(商品名：Ondibta®)獲得EMA人用藥品委員會(Committee for Medicinal Products for Human Use，CHMP)積極意見。CHMP 建議歐盟委員會(EuropeanCommission，EC)批准甘精胰島素注射液(商品名： Ondibta®)作為 Lantus SoloStar 的生物類似藥上市，用於治療成人、青少年和2歲及以上兒童的糖尿病。CHMP的建議將進入EC審查階段，以獲得Ondibta®在歐盟、冰島、列支敦士登和挪威的上市許可，最終決定預計將於明年初做出。

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