share_log

和黃醫藥：自願性公告 - 和黃醫藥在中國啟動HMPL-306治療伴有IDH1及/或IDH2突變的復發/難治性急性髓系白血病患者的RAPHAEL註冊性III期研究

HUTCHMED: VOLUNTARY ANNOUNCEMENT - HUTCHMED Initiates the RAPHAEL Registrational Phase III Trial of HMPL-306 for Patients with IDH1- and/or IDH2-Mutated Relapsed/Refractory Acute Myeloid Leukemia in China

Hong Kong Stock Exchange ·  May 14 08:02
Summary by Futu AI
和黄医药（HUTCHMED）宣布在中国启动了一项名为RAPHAEL的注册性III期临床试验，针对携带IDH1和/或IDH2突变的复发/难治性急性髓系白血病（AML）患者。该研究旨在评估HMPL-306，一种新型的IDH1和IDH2酶双重抑制剂的安全性和疗效。RAPHAEL研究是一项多中心、随机、开放标签的III期试验，主要终点为总存活期，次要终点包括无事件存活期和完全缓解率。首名受试者已于2024年5月11日接受首次给药治疗。公司计划招募约320名患者参与研究，由北京大学人民医院黄晓军教授领导。此前，HMPL-306在I期研究中显示出积极数据，II期临床试验推荐剂量治疗取得令人振奋的完全缓解率。和黄医药是一家专注于癌症和免疫性疾病治疗的生物医药公司，已有三个药物在中国上市，其中一个也在美国上市。
和黄医药（HUTCHMED）宣布在中国启动了一项名为RAPHAEL的注册性III期临床试验，针对携带IDH1和/或IDH2突变的复发/难治性急性髓系白血病（AML）患者。该研究旨在评估HMPL-306，一种新型的IDH1和IDH2酶双重抑制剂的安全性和疗效。RAPHAEL研究是一项多中心、随机、开放标签的III期试验，主要终点为总存活期，次要终点包括无事件存活期和完全缓解率。首名受试者已于2024年5月11日接受首次给药治疗。公司计划招募约320名患者参与研究，由北京大学人民医院黄晓军教授领导。此前，HMPL-306在I期研究中显示出积极数据，II期临床试验推荐剂量治疗取得令人振奋的完全缓解率。和黄医药是一家专注于癌症和免疫性疾病治疗的生物医药公司，已有三个药物在中国上市，其中一个也在美国上市。
HUTCHMED ANNOUNCED THE LAUNCH OF A REGISTERED PHASE III CLINICAL TRIAL CALLED RAPHAEL IN CHINA IN PATIENTS WITH RELAPSED/MALIGNANT ACUTE MYELOID LEUKEMIA (AML) WITH IDH1 AND/OR IDH2 MUTATIONS. This study was designed to evaluate the safety and efficacy of HMPL-306, a novel IDH1 and IDH2 enzyme double inhibitor. THE RAPHAEL STUDY IS A MULTICENTRALIZED, RANDOMIZED, OPEN-LABEL PHASE III EXPERIMENT WITH PRIMARY ENDPOINTS FOR OVERALL SURVIVAL, WITH SECONDARY ENDPOINTS INCLUDING EVENT-FREE SURVIVAL AND FULL MITIGATION RATES. The first patient received the first drug treatment on 11 May 2024. The company plans to recruit about 320 patients to participate in the study, led by Professor Huang Xiaojian, People's Hospital of Peking University. Previously, HMPL-306 demonstrated consistent data in a Phase I study, and a Phase II clinical trial recommended total attenuation rate of revitalizing drug therapy. Huanghuang Pharmaceuticals is a biopharmaceutical company focused on the treatment of cancer and immune diseases. Three drugs have been listed in China, including one in the United States.
HUTCHMED ANNOUNCED THE LAUNCH OF A REGISTERED PHASE III CLINICAL TRIAL CALLED RAPHAEL IN CHINA IN PATIENTS WITH RELAPSED/MALIGNANT ACUTE MYELOID LEUKEMIA (AML) WITH IDH1 AND/OR IDH2 MUTATIONS. This study was designed to evaluate the safety and efficacy of HMPL-306, a novel IDH1 and IDH2 enzyme double inhibitor. THE RAPHAEL STUDY IS A MULTICENTRALIZED, RANDOMIZED, OPEN-LABEL PHASE III EXPERIMENT WITH PRIMARY ENDPOINTS FOR OVERALL SURVIVAL, WITH SECONDARY ENDPOINTS INCLUDING EVENT-FREE SURVIVAL AND FULL MITIGATION RATES. The first patient received the first drug treatment on 11 May 2024. The company plans to recruit about 320 patients to participate in the study, led by Professor Huang Xiaojian, People's Hospital of Peking University. Previously, HMPL-306 demonstrated consistent data in a Phase I study, and a Phase II clinical trial recommended total attenuation rate of revitalizing drug therapy. Huanghuang Pharmaceuticals is a biopharmaceutical company focused on the treatment of cancer and immune diseases. Three drugs have been listed in China, including one in the United States.
Helpful
Not Helpful

This announcement is a separate document:

Doc 1     View Translation

The translation is provided by third-party software.


The information provided by Futu AI is automatically generated by third-party artificial intelligence (AI) software based on news content. It is only available to users located outside of China mainland.


The above content is for informational or educational purposes only and does not constitute any investment advice related to Futu. Although we strive to ensure the truthfulness, accuracy, and originality of all such content, we cannot guarantee it.