HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 24, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that it will host a R&D update in Shanghai, China, and via webcast on Tuesday, July 9, 2024. During the event, the senior management team will share insights into the Company's R&D strategy and vision. Additionally, the team will provide updates on certain programs within HUTCHMED's extensive and innovative pipeline. This will include updates on the ...

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 24, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it will host a R&D update in Shanghai, China, and via webcast on Tuesday, July 9, 2024. During the event, the senior management team will share insights into the Company’s R&D strategy and vision. Additionally, the team will provide updates on certain programs within HUTCHMED’s extensive and innovative pipeline. This will include updates on the ...

— Approval for previously treated metastatic colorectal cancer based on results from positive, global, Phase III FRESCO-2 Trial — — FRUZAQLA® (fruquintinib) is the first novel targeted therapy in the EU for metastatic colorectal cancer regardless of biomarker status in over a decade — HONG KONG, SHANGHAI and FLORHAM PARK, N.J., June 21, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that its partner Takeda (TSE:4502/​NYSE:TAK) has received notificati ...

— Approval for previously treated metastatic colorectal cancer based on results from positive, global, Phase III FRESCO-2 Trial — — FRUZAQLA® (fruquintinib) is the first novel targeted therapy in the EU for metastatic colorectal cancer regardless of biomarker status in over a decade — HONG KONG, SHANGHAI and FLORHAM PARK, N.J., June 21, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that its partner Takeda (NYSE:TAK) has received notification from th ...

— Publication shows treatment demonstrated durable response rate of 48.4% vs. 0% with placebo — — Presentations at EHA showcased subgroup analyses demonstrating consistent benefits regardless of prior lines of therapies or prior TPO/TPO-RA1 exposure — — Data supported regulatory submission in China accepted in January 2024 — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 17, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) today announces that results from ESLI ...

文章核心观点 - 公司的一项III期临床试验ESLIM-01显示,其新药sovleplenib在治疗成人原发性免疫性血小板减少症(ITP)方面具有持久的疗效,且安全性良好[1][2][3] - 公司还在中国获得了该适应症的突破性治疗指定,并已提交新药申请并获得优先审评[5] - 公司正计划在美国开展剂量探索性研究,并在中国启动了sovleplenib用于治疗温抗体自身免疫性溶血性贫血的II/III期临床试验[5][10] 根据目录分别总结 临床试验结果 - ESLIM-01是一项2:1随机、双盲、III期临床试验,入组188名既往接受过至少1种ITP治疗的成人患者[3] - 该试验达到了主要终点,sovleplenib组的持久性反应率为48.4%,而安慰剂组为0%(p<0.0001)[3] - 总反应率在0-12周和0-24周分别为68.3%和70.6%,明显高于安慰剂组的14.5%和16.1%(p<0.0001)[3] - sovleplenib组患者的中位缓解时间为8天,而安慰剂组为30天[3] - 进一步分析显示,无论既往接受过多少线治疗或是否曾使用过TPO/TPO-RA类药物,sovleplenib均能带来一致的临床获益[4] 安全性和生活质量 - sovleplenib的安全性与既往研究结果一致,大多数不良事件为轻度或中度[5] - sovleplenib还显著改善了患者的生活质量,包括身体功能和精力/疲劳方面[5] 监管进展 - 中国国家药品监督管理局(NMPA)已授予sovleplenib突破性治疗指定,并受理了优先审评的新药申请[5] - 公司正计划在美国开展剂量探索性研究,并在中国启动了sovleplenib用于治疗温抗体自身免疫性溶血性贫血的II/III期临床试验[5][10]

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated Phase I clinical trial of its menin inhibitor HMPL-506 in patients with hematological malignancies in China. The first patient received their first dose on May 31, 2024. This is a Phase I, multicenter, open-label clinical study to evaluate the safety, pharmacokinetics and efficacy of HMPL-506 in patients with hematological mali ...

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated Phase I clinical trial of its menin inhibitor HMPL-506 in patients with hematological malignancies in China. The first patient received their first dose on May 31, 2024. This is a Phase I, multicenter, open-label clinical study to evaluate the safety, pharmacokinetics and efficacy of HMPL-506 in patients with hematological mali ...

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 03, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) today announces that results from FRUTIGA, HUTCHMED's Phase III trial of fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric cancer in China, were published in Nature Medicine. Updated efficacy data in key subgroups and data on quality of life (QoL) within this publication were also presented on June 1 at the American Soc ...

文章核心观点 - 公司宣布将在即将举行的美国临床肿瘤学会(ASCO)年会上发布多项新药物的临床试验数据 [1][2][3] - 包括:富吉替尼联合辛替利单抗治疗子宫内膜癌的II期注册试验结果、富吉替尼在胃癌和结直肠癌中的III期试验更新数据、以及HMPL-295等新药的初步临床数据 [2][3] 富吉替尼联合辛替利单抗治疗子宫内膜癌 - 该联合疗法在pMMR状态的复发/转移性子宫内膜癌患者中显示出良好的疗效,无论是否接受过贝伐珠单抗治疗 [2] - 87例有效评估患者的客观缓解率为35.6%,包括2例完全缓解,疾病控制率为88.5%,中位无进展生存期为9.5个月,中位总生存期为21.3个月 [2] 富吉替尼在胃癌和结直肠癌中的临床进展 - FRUTIGA III期胃癌试验的进一步更新数据,包括关键亚组分析和生活质量数据将在本次ASCO会议上公布 [3] - FRESCO和FRESCO-2 III期结直肠癌试验、小细胞肺癌联合疗法以及HMPL-295的初步临床数据也将在会上发表 [3] 公司概况 - 华领医药是一家创新型商业化生物制药公司,专注于肿瘤和免疫疾病领域的靶向治疗和免疫治疗药物的发现、全球开发和商业化 [7] - 公司拥有约5,000名员工,其中肿瘤/免疫领域的团队约1,800人,自成立以来一直致力于将自主发现的候选药物推向全球市场 [7] - 公司已在中国上市了3款自主研发的药物,其中1款还在美国上市 [7]