Shanghai Henlius Biotech has made an announcement indicating that their investigational new drug (IND), which is known as HLX17 and is a biosimilar version of pembrolizumab, has been approved by the National Medical Products Administration (NMPA).Henlius has developed HLX17 independently and plans to carry out clinical trials for multiple indications including melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, biliary tract cancer, triple-negative breast cancer as well as microsatellite instability-high or mismatch repair-deficient cancers and gastric cancer.According to NMPA biosimilar guidelines HLX17 was developed while taking into consideration various standards from EMA and FDA.

上海恒流生物技术有限公司（Shanghai Henlius Biotech）宣布，他们的研究新药（IND）已获得国家医药产品管理局（NMPA）的批准，该新药被称为HLX17，是pembrolizumab的生物仿制药。Henlius独立开发了HLX17，并计划针对多种适应症进行临床试验，包括黑色素瘤，非小细胞肺癌，食道癌，头颈部鳞状细胞癌，结直肠癌，肝细胞癌，胆道癌，三阴性乳腺癌以及微卫星不稳定性高或错配修复缺陷型癌症和胃癌。根据NMPA生物仿制药指南，HLX17的开发同时考虑了EMA和FDA的各种标准。

Studies have shown that HLX17 is comparable to reference pembrolizumab in terms of pharmacology, pharmacodynamics, pharmacokinetics and immunogenicity.As checkpoint inhibitors of immunity gain more and more significance to immunotherapy, HLX17 becomes a promising option in management of cancers. This monoclonal antibody targets PD-1 receptor on T cells thereby preventing interaction with PD-L1 and PD-L2 molecules.

研究表明，HLX17在药理学，药效学，药代动力学和免疫原性方面与参考pembrolizumab相当。随着免疫检查点抑制剂对免疫治疗的重要性越来越大，HLX17成为治疗癌症的有希望的选择。该单克隆抗体靶向T细胞上的PD-1受体，从而阻止与PD-L1和PD-L2分子的相互作用。

In this way, it releases the inhibition of immune response by PD-1pathway enabling T-cells to better identify and attack tumour cells.On its part, Henlius has made great strides in immunotherapy development with a portfolio that includes a diverse range of potential immune checkpoints like PD-1/L1, CTLA-4, LAG-3 and TIGIT.

通过这种方式，它通过PD-1途径释放对免疫应答的抑制，使T细胞能够更好地识别和攻击肿瘤细胞。就其而言，Henlius在免疫疗法开发方面取得了长足的进步，其投资组合包括多种潜在的免疫检查点，如PD-1/L1，CTLA-4，LAG-3和TIGIT。

The company anticipates that these therapies will be effective across various indications as well as complementing its other in-house products and innovative treatments.Moving forward Henlius intends to focus on addressing unmet medical needs while expanding their disease a.

。展望未来，Henlius打算专注于解决未满足的医疗需求，同时扩大其疾病a。