Hansoh Pharmaceutical announced that its in-house developed antibody-drug conjugate (ADC) HS-20093 has been granted Breakthrough Therapy Designation by China’s National Medical Products Administration (NMPA).HS-20093 is a novel ADC targeting B7-H3, consisting of a fully-humanised monoclonal antibody linked to a topoisomerase inhibitor (TOPOi) payload. Lung cancer is among the most widespread cancers globally.

汉寿制药宣布，其内部开发的抗体-药物偶联物（ADC）HS-20093已被中国国家医药产品管理局（NMPA）授予突破性治疗指定。HS-20093是一种靶向B7-H3的新型ADC，由与拓扑异构酶抑制剂（TOPOi）有效载荷连接的完全人源化单克隆抗体组成。肺癌是全球最广泛的癌症之一。

Approximately 70% of small-cell lung cancer cases are diagnosed at an extensive stage, meaning the disease has spread beyond the lungs to other parts of the body. ES-SCLC is notably challenging to treat, with a five-year survival rate of around 3%. This designation recognises HS-20093’s potential as a treatment for extensive-stage small-cell lung cancer (ES-SCLC) in patients who have undergone standard first-line therapy, including platinum-based chemotherapy with immunotherapy.Most ES-SCLC patients experience a relapse post-initial treatment, and the median survival for relapsed cases remains low at approximately 5-6 months with current standard treatments.The drug is currently in Phase III trials in China for small-cell lung cancer and in earlier stages of study (Phases I and II) for sarcoma, head and neck cancers, oesophageal squamous cell carcinoma, and other solid tumours.Hansoh Pharma entered a license agreement with GlaxoSmithKline (GSK) in December 2023, granting GSK exclusive rights outside of the Chinese Mainland, Hong Kong, Macau, and Taiwan to develop, manufacture, and commercialise HS-20093 (also known as GSK5764227). GSK is currently conducting a global Phase I clinical trial for the drug and received a Breakthrough Therapy Designation from the US FDA in August 2024 for treating relapsed or refractory ES-SCLC patients.Source: hspharm.com.

大约70%的小细胞肺癌病例是在广泛的阶段被诊断出来的，这意味着该疾病已经扩散到肺部以外的身体其他部位。ES-SCLC的治疗极具挑战性，五年生存率约为3%。该名称认识到HS-20093在接受标准一线治疗（包括铂类化疗和免疫治疗）的患者中治疗广泛期小细胞肺癌（ES-SCLC）的潜力。大多数ES-SCLC患者在初始治疗后会复发，并且使用当前的标准治疗，复发病例的中位生存期仍然较低，约为5-6个月。该药物目前正在中国进行小细胞肺癌的III期临床试验，并处于肉瘤，头颈癌，食管鳞状细胞癌和其他实体瘤的早期研究阶段（I期和II期）。。葛兰素史克目前正在进行该药物的全球I期临床试验，并于2024年8月获得美国FDA的突破性治疗指定，用于治疗复发或难治性ES-SCLC患者。来源：hspharm.com。