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和黃醫藥：和黃醫藥宣佈武田獲得歐洲藥品管理局人用藥品委員會 (CHMP) 積極意見支持呋喹替尼 (fruquintinib) 用於治療經治轉移性結直腸癌

HUTCHMED: HUTCHMED Announces Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer Received by Takeda

Hong Kong Stock Exchange ·  Apr 26 08:30
Summary by Moomoo AI
和黃醫藥（HUTCHMED）宣布其合作夥伴武田藥品工業獲得歐洲藥品管理局人用藥品委員會（CHMP）的積極意見，支持呋喹替尼用於治療經治的成人轉移性結直腸癌。這一積極意見將被歐盟委員會（EC）在決定是否在歐盟、挪威、列支敦斯登和冰島批准呋喹替尼的上市許可時考慮。若獲批准，呋喹替尼將成為歐盟首個也是唯一一個針對所有三種血管內皮生長因子受體（VEGFR）的選擇性抑制劑。該藥物在中國、香港和澳門以外的全球獨家許可權由武田擁有。CHMP的積極意見主要基於FRESCO-2 III期臨床研究結果，該研究顯示呋喹替尼在總生存期（OS）和無進展生存期（PFS）方面均顯示出具有統計學意義和臨床意義的顯著改善。和黃醫藥首席執行官兼首席科學官蘇慰國博士對此進展表示樂觀，期待呋喹替尼能為歐洲患者帶來顯著的生存獲益。呋喹替尼已於2023年6月獲EMA確認及受理上市許可申請。
和黃醫藥（HUTCHMED）宣布其合作夥伴武田藥品工業獲得歐洲藥品管理局人用藥品委員會（CHMP）的積極意見，支持呋喹替尼用於治療經治的成人轉移性結直腸癌。這一積極意見將被歐盟委員會（EC）在決定是否在歐盟、挪威、列支敦斯登和冰島批准呋喹替尼的上市許可時考慮。若獲批准，呋喹替尼將成為歐盟首個也是唯一一個針對所有三種血管內皮生長因子受體（VEGFR）的選擇性抑制劑。該藥物在中國、香港和澳門以外的全球獨家許可權由武田擁有。CHMP的積極意見主要基於FRESCO-2 III期臨床研究結果，該研究顯示呋喹替尼在總生存期（OS）和無進展生存期（PFS）方面均顯示出具有統計學意義和臨床意義的顯著改善。和黃醫藥首席執行官兼首席科學官蘇慰國博士對此進展表示樂觀，期待呋喹替尼能為歐洲患者帶來顯著的生存獲益。呋喹替尼已於2023年6月獲EMA確認及受理上市許可申請。
HUTCHMED ANNOUNCED THAT ITS PARTNER TAKEDA PHARMACEUTICALS INDUSTRY RECEIVED POSITIVE FEEDBACK FROM THE EUROPEAN MEDICINES AGENCY'S COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) IN SUPPORT OF FURUQUITINE FOR THE TREATMENT OF ADULT TRANSIENT COLORECTAL CANCER. This positive opinion will be taken into account by the European Commission (EC) when deciding whether to approve a listing licence for furquintin in the EU, Norway, Liechtenstein and Iceland. If approved, Furuquintin would be the EU's first and only selective inhibitor against all three vascular endothelial growth factor (VEGFR) receptors. The drug is licensed exclusively worldwide outside China, Hong Kong and Macau by Takeda. The positive opinion of the CHMP is mainly based on the results of the FRESCO-2 III clinical...Show More
HUTCHMED ANNOUNCED THAT ITS PARTNER TAKEDA PHARMACEUTICALS INDUSTRY RECEIVED POSITIVE FEEDBACK FROM THE EUROPEAN MEDICINES AGENCY'S COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) IN SUPPORT OF FURUQUITINE FOR THE TREATMENT OF ADULT TRANSIENT COLORECTAL CANCER. This positive opinion will be taken into account by the European Commission (EC) when deciding whether to approve a listing licence for furquintin in the EU, Norway, Liechtenstein and Iceland. If approved, Furuquintin would be the EU's first and only selective inhibitor against all three vascular endothelial growth factor (VEGFR) receptors. The drug is licensed exclusively worldwide outside China, Hong Kong and Macau by Takeda. The positive opinion of the CHMP is mainly based on the results of the FRESCO-2 III clinical study, which showed that furoquinetine showed significant improvements in both total survival (OS) and progression-free survival (PFS). Dr. Su Ju-guo, CEO and Chief Scientific Officer of Wah Wong Pharmaceuticals, is optimistic about this progress and expects that furoquinetine will bring significant survival benefits to patients in Europe. Furuquinetine was approved by EMA in June 2023 and accepted for a listing license.

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