已进入或已申请临床产品简介




Product Overview

AffecizxTM(Anti-VEGF mAb, 

STW-hPV19) 阿伐珠单抗

Affecizx (Anti-VEGF mAb, hPV19) is a humanized monoclonal antibody (mAb) that binds with high affinity to human vascular endothelial growth factor (VEGF). The antigen binding site (epitope) of Affecizx (hPV19) is different from that of Bevacizumab (Avastin, Roche/Genentech), the world 1st and so-far still the only therapeutic anti-VEGF mAb approved by the US Food and Drug Administration, FDA.  In-vitro and in-vivo dada demonstrated that the bio-activity of Affecizx (hPV19) is more than 6-8 fold stronger than that of Bevacizumab (Avastin). 

In a phase 1a clinical trial in patients with advanced solid tumors refractory to standard therapy, Affecizx (hPV19) was found to be safe and well-tolerated (no dose-limiting toxicity was detectedmaximum tolerated dose was not reached), and more importantly, demonstrated a very promising single-agent anti-tumor activity in these heavily pre-treated patients.

A phase 1b clinical trial to evaluate the safety and efficacy of Affecizx (hPV19) in combination with standard chemotherapy in patients with advanced solid tumor is ongoing.


AffecizxhPV19)阿伐珠单抗是一种特异与人血管内皮生长因子(VEGF)高亲和力结合的人源化单克隆抗体。AffecizxhPV19)结合VEGF的抗原位点(表位)不同于目前市售的抗VEGF单抗药物Bevacizumab(商品名Avastin Roche/ Genentech公司产品)。体内外研究结果表明,Affecizx (hPV19) 的生物学活性比BevacizumabAvastin6-8倍。

AffecizxhPV19单独给药治疗难治性晚期实体瘤患者的临床1a期研究中,AffecizxhPV19表现有良好的安全性和耐受性(未出现DLT,也未达到MTD),并业已呈现出令人鼓舞的单药抗肿瘤活性。AffecizxhPV19联合化疗治疗晚期实体瘤的安全性/有效性的临床1b期研究目前正在进行中。


SOLOT-EyeTM(Anti-VEGF mAb, 

ophthalmic injection) 苏洛晍眼用注射液

SOLOT-Eye苏洛晍眼用注射液(hPV19单抗眼用注射液)是公司在其已进入临床研究的广谱治疗恶性肿瘤的抗VEGF单抗静脉注射液基础上,通过成品处方及剂型优化,新成功开发出的眼用注射剂药物。

该药物的拟用眼科适应症包括老年性黄斑变性(age-related macular   degeneration,AMD)、糖尿病性黄斑水肿(diabetic macular edema, DME)等与新生血管相关的眼底疾病。苏洛晍眼用注射液(hPV19单抗眼用注射液)结合VEGF抗原的表位不同于目前国内外市场上唯一在售的抗VEGF单抗药物贝伐单抗Beavacizumab(商品名Avastin,   Roche/Genentech公司产品)及其孪生姐妹Avastin-Fab片段药物Ranibizumab雷珠单抗(商品名Lucentis诺适得,Novartis   /Genentech公司产品)。 体外系列研究结果显示hPV19单抗的生物活性及与VEGF抗原的结合能力是   Avastin或Ranibizumab的6-8倍。在激光诱导的食蟹猴脉络膜新生血管形成(CNV)疾病测试模型中:苏洛晍眼用注射液(hPV19单抗眼用注射液)疗效优于Ranibizumab雷珠单抗(眼内给予仅1/10至1/3   剂量的hPV19单抗注射液(0.05mg/眼或0.15mg/眼)即可达到剂量为0.5mg/眼的Ranibizumab对照药相近疗效)。

ARMOZX (Anti-PD-1 mAb ) 

阿沐珠(人源化单抗hAB21 or STW204 单抗注射液)

ARMOZX阿沐珠(抗PD-1人源化单抗hAB21 or STW204 单抗注射液)是思坦维公司自主研发的、具全球自主知识产权的(已申请国际PCT专利)、全新的抗PD-1单抗(人源化IgG4/kappa型, 抗体代号:hAB21)。 ARMOZX阿沐珠(hAB21单抗)特异与人PD-1蛋白的胞外区高亲和力结合,并阻断PD-1与其配体(PD-L1,PD-L2)的结合。体外研究表明ARMOZX阿沐珠(hAB21单抗)结合PD-1抗原的位点既不同于Nivolumab   (商品名Opdivo,美国Bristol-Myers Squibb公司的抗PD-1 单抗药物),也不同于Pembrolizumab (商品名Keytruda,美国Merck公司的抗PD-1 单抗药物)。ARMOZX阿沐珠(hAB21单抗)体外可完全阻断Nivolumab或Pembrolizumab与PD-1的结合;而Nivolumab或Pembrolizumab只可部分阻断hAB21单抗与PD-1的结合。hAB21 单抗结合PD-1的表位或区域更为广范,其结合位点覆盖过Nivolumab或Pembrolizumab的结合位点。在人源PD-1 knock-in小鼠皮下肿瘤模型测试中,ARMOZX阿沐珠(hAb21单抗)显示出不亚于Nivolumab的抗肿瘤活性。

ARMOZX阿沐珠注射液(STW204 单抗注射液)单药及与化疗药物或抗-VEGF单抗联合治疗晚期恶性实体肿瘤的临床研究批件申请已于2018年初递交至CFDA,目前正在CDE技术审评中。