复宏汉霖创新抗PD-L1×TIGIT双抗 在澳大利亚完成首例患者用药
T神经血癌症細胞免疫力检测性性球球淀粉酶和ITIM设备构造域（T cell immunoglobulin and ITIM domain，TIGIT）是种缓和性淀粉酶激酶，在淋巴腺神经血癌症細胞中表达方法，也收录很自然破坏（NK）神经血癌症細胞、碱化的CD8+ T和CD4+ T神经血癌症細胞并且 Treg（调低性T神经血癌症細胞）等。当做免疫力检测性性查看点球淀粉酶，TIGIT可确认多样不同角色措施缓和自身和适应能力很性免疫力检测性性，在癌症免疫力检测性性缓和中的“踩后刹”角色和PD-1/PD-L1类式。药学前研发结果显示证明，评测抗PD-L1单抗、抗TIGIT单抗并且 四种单抗的整合保健法，HLX301可人与PD-L1和TIGIT特异形根据并一同阻绝PD-1/PD-L1和TIGIT/PVR负向的信号信号通路，缓和癌症神经血癌症細胞的生长的，且受性、安全的性非常好，彻底的衡量了双抗保健法的协作加强调节作用，有希望广泛用于多样不同到晚期癌症的方法，也收录非小神经血癌症細胞癌症、头颈子鳞状神经血癌症細胞癌、食管鳞癌等。目前为止，全球排名标准内未有之类靶点疗法PD-1/L1和TIGIT的双特异形免疫抗原获准出现，且HLX301在之类靶点疗法PD-L1×TIGIT双特异形免疫抗原中先一步完成任务第一例受试者施药，有希望变成 first-in-class抗PD-L1×TIGIT双抗。
复宏汉霖反复精耕未提供的临床上供需，近几年已制作出多种化的自主全新发展药得票率食品线管，在PD-1/L1、LAG-3、TIGIT、BRAF等自主全新发展靶点逐步选址，并关键深入开展双特喜欢的人抗原、抗原偶联药物剂量（ADC）等食品的开发技术。复宏汉霖正关键快速向自主全新发展型Biopharma繁衍，增加自主全新发展吸收率，进一步加强质优自主全新发展债务的扶植和的合作，“上下兼修”，为世界上用户带去优性能、可额外负担的自主全新发展手术治疗方式。
关于该HLX301 I期临床研究
本探析一项在自始规范标准改善失效、不受或无适当规范标准改善的轮廓骨转入或转入性实体化瘤病患中积极开展的，广泛宣传评诂HLX301的健康可靠性高稳定、受性、药代推热学及逐项抗癌肿较果的打开、多基地、标准容量科学探索、初次女性身体I期医学药理可靠性试验报告。合格证的受试者将接手每半个月静脉血管输注单药HLX301的改善。Ia期为标准容量逐渐增加时段.，关键结束为评诂HLX301的健康可靠性高稳定、标准容量局限毒副作用（DLT），并确实最大的受标准容量（MTD）；其次是结束包扩药代推热学、药性推热学和免疫抗体原性。Ib期为标准容量户外拓展培训时段.，关键结束为II期医学药理可靠性试验报告推见标准容量（RP2D）；其次是结束包扩主客观缓和率（ORR）、疾病症状保持率（DCR）和延续缓和時间（DOR）。
关于复宏汉霖
复宏汉霖（2696.HK）都是家亚洲地区化的去信息化怪物生态学体药业公司，立足于于为亚洲地区患儿提高可财政负担的高品性怪物药，物品履盖恶性肿瘤、企业自身天然免疫疫情、皮肤科疫情等科技领域，已在中香港发行4款物品，在欧洲联盟香港发行1款物品，3个香港发行申请办理注册申请办理提升了中医药监督管理方法局审批。自20十年注册成立来党，复宏汉霖已完工分立式化怪物生态学体医药化工工作平台，极有效率及去信息化的随时升级核心理念效果环绕产量研制开发、产量及商业服务营销全文化制造链。公司已创立落实极有效率的亚洲地区产量研制开发中心点，依照亚洲地区医药产量的质理管理方法规定（GMP）准则对其进行产量和的质理管理，最靠近广州徐汇的产量基底已提升了中和欧洲联盟GMP身份验证。
复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖20多种创新单克隆抗体，并全面推进基于自有抗PD-1单抗斯鲁利单抗的肿瘤免疫联合疗法。继国内首个生物类似药汉利康®（利妥昔单抗）、中国首个自主研发的中欧双批单抗药物汉曲优®（曲妥珠单抗，欧盟商品名：Zercepac®）、汉达远®（阿达木单抗）和汉贝泰®（贝伐珠单抗）相继获批上市，创新产品斯鲁利单抗MSI-H实体瘤的上市注册申请已纳入优先审评审批程序，HLX01利妥昔单抗类风湿关节炎新适应症、斯鲁利单抗鳞状非小细胞肺癌适应症的上市注册申请也正在审评中。公司亦同步就12个产品、9个免疫联合治疗方案在全球范围内开展20多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。
First Subject Dosed in the Australia Phase 1 Trial of Henlius' Potential First-In-Class Anti PD-L1×TIGIT Bispecific Antibody
Shanghai, China, Feburary 14th, 2022-Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the first patient has been dosed in Australia in the Phase 1 clinical trial of HLX301, a recombinant humanized anti-PD-L1 and anti-TIGIT bispecific antibody (BsAb), for the treatment of locally advanced or metastatic solid tumours.
TIGIT (T cell immunoreceptor with immunoglobulin and ITIM domains) is an inhibitory receptor, mainly expressed on natural killer (NK) cells and activated CD8+ T cells, CD4+ T cells, and T regulatory cells. As an inhibitory receptor, TIGIT can inhibit innate and adaptive responses in various mechanisms of action and act as a “brake” like PD-1/PD-L1 does to stop T cells from attacking tumours. Pre-clinical studies reported that HLX301 can simultaneously block both PD-1/PD-L1 and TIGIT/PVR pathways, restore TCR signaling, inhibit tumour growth, and has good tolerance and safety, paving the way for further clinical development to against a variety of advanced cancers, including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, etc. At present, no BsAb targeting PD-1/PD-L1 and TIGIT has been approved for marketing globally. As the first to be dosed in the subject, HLX301 is expected to be a first-in-class anti-PD-L1×TIGIT BsAb.
Underpinned by the patient-centric strategy, Henlius has built an innovative product pipeline with many emerging targets, including PD-1/L1, LAG-3, TIGIT, BRAF, etc. and has been developing a forward-looking presence in bispecific antibodies and the antibody-drug conjugates (ADC). Looking forward, Henlius is actively accelerating the evolution to an innovative Biopharma and improving efficiency through innovations, and will continue its momentum for innovation, further strengthening the in-licensing and collaboration on external innovative assets, and bringing more high-quality and affordable therapies to patients worldwide.
About HLX301 Phase 1 Trial
This open-label, multicentre, dose-finding, first-in-human phase 1 study aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumour efficacy of HLX301 in locally advanced or metastatic solid tumour patients who have failed prior standard treatment and are intolerant or ineligible to standard therapy. Eligible patients will receive intravenous infusion of HLX301 as a single agent every- two-week. Phase 1a is a dose escalation study. The primary endpoints are to evaluate the safety, dose limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) of HLX301. Secondary endpoints include pharmacokinetic, pharmacodynamic and immunogenicity. Phase 1b is a dose expansion study. The primary endpoint is to determine the recommended phase 2 dose (RP2D). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), and duration of response (DOR).
About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 4 products have been launched in China, 1 in the European Union (EU), 3 New Drug Applications (NDAs) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has established global R&D centres and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (GMP).
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary serplulimab (anti-PD-1 mAb) as backbone. Apart from the launched products 汉利康® (rituximab), the first China-developed biosimilar, 汉曲优® (trastuzumab, Zercepac in the EU), the first China-developed mAb biosimilar approved both in China and in the EU, 汉达远® (adalimumab) and 汉贝泰® (bevacizumab), the NDA of innovative product serplulimab indicated for MSI-H solid tumors has been granted priority review, and the NDAs of HLX01 (rituximab) for the treatment of rheumatoid arthritis and serplulimab for the treatment of squamous non-small cell lung cancer are also under review. What's more, Henlius has conducted over 20 clinical studies for 12 products and 9 combination therapies worldwide, expanding its presence in major market as well as emerging market.
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