Acalabrutinib

中国香港、上海和美国新泽西州：2026年3月23日，星期一：和黄医药(中国)有限公司 (简称 "和黄医药" 或 "HUTCHMED") (纳斯达克/伦敦证交所: HCM; 香港交易所: 13) 今日宣布在中国启动HMPL-760联合R‑GemOx方案 (利妥昔单抗、吉西他滨和奥沙利铂) 用于治疗复发/难治性弥漫性大B细胞淋巴瘤 (DLBCL) 患者的注册性III期临床试验。首名患者已于2026年3月20日接受首次给药治疗。 弥漫性大B细胞淋巴瘤是全球最常见的侵袭性非霍奇金淋巴瘤 (NHL)，约占中国所有非霍奇金淋巴瘤病例的40%。[1] 据估计，2022年中国新增非霍奇金淋巴瘤病例约81,000例。[2] 布鲁顿酪氨酸激酶 ("BTK") 被认为是治疗某些血液癌症已验证的药物靶点。HMPL-760是一种可长时间结合靶点的高效、选择性和可逆性的BTK (包括野生型和C481S突变型BTK) 抑制剂。 该研究是一项随机、双盲、阳性对照的III期临床研究，旨在评估HMPL-760联合R-GemOx方案对比安慰剂联合R-GemOx方案用于治疗既往接受过一线系统化疗、免疫治疗或免疫化疗联合治疗后复发或难治性且不适合移植的弥漫性大B细胞淋巴瘤患者的疗效、安全性和药代动力学。研究的主要终点指标包括研究者评估的无进展生存期 ("PFS") 和总生存期 ("OS")。次要终点指标包括独立审查委员会 ("IRC") 评估的PFS、IRC和研究者评估的客观缓解率 ("ORR") 、完全缓解率 ("CRR") 、缓解持续时间 (DoR) 、临床获益率 (CBR) 、到达疾病缓解的时间 (TTR)、安全性和药代动力学特征。该项研究的其他详情可登录ClinicalTrials.gov，检索注册号NCT07409428查看。 该注册性临床试验计划纳入约240名患者，主要研究者为上海交通大学医学院附属瑞金医院副院长、上海血液学研究所所长赵维莅教授。 关于HMPL-760 HMPL-760是一种研究性、非共价的第三代BTK抑制剂。HMPL-760是一种可长时间结合靶点的高效、选择性和可逆性的BTK (包括野生型和C481S突变型BTK) 抑制剂。BTK的C481S突变在对某些BTK抑制剂产生耐药性中扮演着重要角色。[3],[4] 一项评估HMPL-760联合R-GemOx用于治疗复发/难治性弥漫性大B细胞淋巴瘤患者的随机、双盲II期研究 (NCT06601504) 结果显示，与单用R-GemOx相比，HMPL-760联合R-GemOx在ORR、CRR、PFS和OS方面均展示出令人鼓舞的改善，并显示出可控的安全性，未观察到非预期的安全信号。这些令人鼓舞的结果支持了启动该项注册性III期临床试验。 和黄医药目前拥有HMPL-760在全球范围内的所有权利。 参考资料： [1] Li XQ, Li GD, Gao ZF, et al. Distribution pattern of lymphoma subtypes in China: A nationwide multicenter study of 10002 cases. J Diagn Concepts Pract. 2012; 11(02):111-115. [2] The Global Cancer Observatory, China fact sheet. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Accessed December3, 2025. [3] Woyach JA, Ruppert AS, Guinn D, et al. BTKC481S-Mediated Resistance to Ibrutinib in Chronic Lymphocytic Leukemia. J Clin Oncol. 2017;35(13):1437-1443. doi:10.1200/JCO.2016.70.2282. [4] Woyach JA, Huang Y, Rogers K, et al.  Resistance to Acalabrutinib in CLL is Mediated Primarily by BTK Mutations. Blood.  2019;134 (Supplement_1): 504.  doi:10.1182/blood-2019-127674. 前瞻性陈述本新闻稿包含1995年《美国私人证券诉讼改革法案》"安全港" 条款中定义的前瞻性陈述。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对HMPL-760用于治疗弥漫性大B细胞淋巴瘤的治疗潜力的预期，以及HMPL-760在此适应症及其他适应症中进一步临床研究计划的预期。前瞻性陈述涉及风险和不确定性。此类风险和不确定性包括下列假设：对研究时间和结果发布的预期、支持HMPL-760于中国或其他地区获批用于治疗弥漫性大B细胞淋巴瘤或其他适应症的新药上市申请的数据充足性、获得监管部门快速审批或审批的潜力、HMPL‑760的疗效及安全性、和黄医药为HMPL-760进一步临床开发计划及商业化提供资金并实现及完成的能力，以及此类事件发生的时间等。此外，由于部分研究可能依赖于与其他药物 (例如R-GemOx方案) 联合使用，因此此类风险和不确定性包括有关这些治疗药物的安全性、疗效、供应和监管批准的假设。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本新闻稿发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会、香港联合交易所有限公司以及AIM提交的文件。无论是否出现新讯息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含讯息的义务。 和黄医药（纳斯达克/伦敦证交所：HCM；香港交易所：13）是一家处于商业化阶段的创新型生物医药公司，致力于发现、全球开发和商业化治疗癌症和免疫性疾病的靶向药物和免疫疗法。自成立以来，和黄医药致力于将自主发现的候选药物带向全球患者，首三个药物现已在中国上市，其中首个药物亦于美国、欧洲和日本等全球各地获批。欲了解更多详情，请访问：www.hutch-med.com/sc。

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 23, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that it has initiated a registrational Phase III clinical trial of HMPL-760 in combination with R-GemOx (rituximab, gemcitabine and oxaliplatin) in patients with relapsed/refractory diffuse large B-cell lymphoma (“DLBCL”) in China. The first patient received the first dose on March 20, 2026. DLBCL is the most common form of aggressive non-Hodgkin lymphoma (“NHL”) worldwide, accounting for approximately 40% of all NHL cases in China. 1 In 2022, approximately 81,000 new cases of NHL are estimated to have been diagnosed in China. 2 Bruton’s tyrosine kinase (“BTK”) is considered a validated target for drugs that aim to treat certain hematological cancers. HMPL-760 is a highly potent, selective, and reversible inhibitor with long target engagement against BTK, including wild-type and C481S-mutated BTK. The trial is a randomized, double-blind, positive controlled Phase III study to evaluate the efficacy, safety, and pharmacokinetics (“PK”) of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in DLBCL patients who are relapsed or refractory after prior treatment with first-line systemic chemotherapy, immunotherapy, or immunochemotherapy regimens and ineligible for transplantation. Primary outcome measures include investigator-assessed progression-free survival (“PFS”) and overall survival (“OS”). Secondary outcome measures include independent review committee (“IRC”)-assessed PFS, IRC- and investigator-assessed objective response rate (“ORR”), complete response rate (“CRR”), duration of response (DoR), clinical benefit rate (CBR), time to response (TTR), safety and PK characteristics. Additional details may be found at clinicaltrials.gov, using identifier NCT07409428 . This registrational trial plans to enroll approximately 240 patients and is being led by principal investigator Professor Weili Zhao, Vice President of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Director of the Shanghai Institute of Hematology. About HMPL-760 HMPL-760 is an investigational, non-covalent, third generation BTK inhibitor. It is a highly potent, selective, and reversible inhibitor with long target engagement against BTK, including wild-type and C481S-mutated BTK. BTK C481S mutation plays an important role in resistance to certain BTK inhibitors . 3 , 4 A randomized, double-blind Phase II study ( NCT06601504 ) evaluating HMPL-760 in combination with R-GemOx in patients with relapsed/refractory DLBCL has demonstrated encouraging improvements in ORR, CRR, PFS and OS compared to R-GemOx alone, with a manageable safety pro no unexpected safety signal. These encouraging results supported the initiation of this registrational Phase III trial. HUTCHMED currently retains all rights to HMPL-760 worldwide. About HUTCHMED HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of HMPL-760 for the treatment of DLBCL and the further development of HMPL-760 in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support a new drug application submission of HMPL-760 for the treatment of DLBCL or other indications in China or other jurisdictions, its potential to gain approvals from regulatory authorities on an expedited basis or at all, the efficacy and safety pro HMPL-760, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for HMPL-760 and the timing of these events. In addition, as certain studies rely on the use of other drug products such as R-GemOx as combination therapeutics with HMPL-760, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com Ben Atwell / Tim Stamper +44 7771 913 902 (Mobile) / +44 7779 436 689 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Deutsche Numis Joint Broker Freddie Barnfield / Jeffrey Wong / Duncan Monteith +44 20 7260 1000 _____________________ 1 Li XQ, Li GD, Gao ZF, et al. Distribution pattern of lymphoma subtypes in China: A nationwide multicenter study of 10002 cases. J Diagn Concepts Pract . 2012; 11(02):111-115. 2 The Global Cancer Observatory, China fact sheet. . Accessed December 3, 2025. 3 Woyach JA, Ruppert AS, Guinn D, et al. BTKC 481S -Mediated Resistance to Ibrutinib in Chronic Lymphocytic Leukemia. J Clin Oncol . 2017;35(13):1437-1443. doi: 10.1200/JCO.2016.70.2282 . 4 Woyach JA, Huang Y, Rogers K, et al. Resistance to Acalabrutinib in CLL is Mediated Primarily by BTK Mutations. Blood. 2019;134 (Supplement_1): 504. doi: 10.1182/blood-2019-127674 .