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和黃醫藥：自願性公告 - 和黃醫藥啟動索樂匹尼布 (sovleplenib) 治療溫抗體型自身免疫性溶血性貧血的ESLIM-02中國II/ III期研究的註冊階段

HUTCHMED: VOLUNTARY ANNOUNCEMENT - HUTCHMED Initiates Registration Stage of the ESLIM-02 Phase II/III Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia in China

香港交易所 ·  Mar 21 20:00
Summary by Moomoo AI
和黃醫藥宣布在中國啟動索樂匹尼布治療溫抗體型自身免疫性溶血性貧血的ESLIM-02 II/III期研究註冊階段。此研究旨在確認藥物的安全性與療效，主要終點為第24週時達到整體血紅蛋白應答的患者比例。II期概念驗證階段已獲積極數據，並與國家藥監局溝通，若III期研究結果積極，將支持未來新藥上市申請。首名受試者於2024年3月20日接受治療，計劃在註冊階段納入約90名患者。索樂匹尼布為口服小分子脾酪氨酸激酶抑製劑，和黃醫藥保留全球所有權利。該藥物亦進行免疫性血小板減少症的研究，並已達到ESLIM-01中國III期研究所有終點，國家藥監局已受理新藥上市申請並納入優先審評。和黃醫藥為一家專注於癌症和免疫性疾病治療藥物的生物醫藥公司，旗下三款藥物在中國上市，其中一款亦在美國上市。
和黃醫藥宣布在中國啟動索樂匹尼布治療溫抗體型自身免疫性溶血性貧血的ESLIM-02 II/III期研究註冊階段。此研究旨在確認藥物的安全性與療效，主要終點為第24週時達到整體血紅蛋白應答的患者比例。II期概念驗證階段已獲積極數據，並與國家藥監局溝通，若III期研究結果積極，將支持未來新藥上市申請。首名受試者於2024年3月20日接受治療，計劃在註冊階段納入約90名患者。索樂匹尼布為口服小分子脾酪氨酸激酶抑製劑，和黃醫藥保留全球所有權利。該藥物亦進行免疫性血小板減少症的研究，並已達到ESLIM-01中國III期研究所有終點，國家藥監局已受理新藥上市申請並納入優先審評。和黃醫藥為一家專注於癌症和免疫性疾病治療藥物的生物醫藥公司，旗下三款藥物在中國上市，其中一款亦在美國上市。
HUANG PHARMACEUTICALS ANNOUNCED THE REGISTRATION PHASE OF ESLIM-02 II/III STUDY OF SOLOPINIB FOR THE TREATMENT OF THERMAL ANTIBODY TYPE AUTOIMMUNE HEMOLYTIC ANEMIA IN CHINA. This study was designed to confirm the safety and efficacy of the drug, with the primary endpoint being the proportion of patients who achieved total hemoglobin response at week 24. The Phase II concept verification phase has received positive data and communication with the National Drug Administration. If the results of the Phase III study are positive, future applications for new drugs will be supported. The first participant received treatment on March 20, 2024, and it is planned to include approximately 90 patients at the registration phase. Solepinib is an oral small molecule splenic kinase inhibitor, and Yellow Medicine...Show More
HUANG PHARMACEUTICALS ANNOUNCED THE REGISTRATION PHASE OF ESLIM-02 II/III STUDY OF SOLOPINIB FOR THE TREATMENT OF THERMAL ANTIBODY TYPE AUTOIMMUNE HEMOLYTIC ANEMIA IN CHINA. This study was designed to confirm the safety and efficacy of the drug, with the primary endpoint being the proportion of patients who achieved total hemoglobin response at week 24. The Phase II concept verification phase has received positive data and communication with the National Drug Administration. If the results of the Phase III study are positive, future applications for new drugs will be supported. The first participant received treatment on March 20, 2024, and it is planned to include approximately 90 patients at the registration phase. Solepinib is an oral small molecule splenic kinase inhibitor, and Yellow Medicine reserves worldwide rights. The drug is also being studied in immunothrombocytopenia and has reached all the endpoints of the ESLIM-01 China Phase III study. The National Drug Administration has accepted the new drug's listing application and included in the priority review. He Wong Pharmaceuticals is a biopharmaceutical company focused on medicines for the treatment of cancer and immune diseases. Three drugs are listed in China, including one in the United States.

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