Alphamab Oncology and CSPC Pharmaceutical have announced that the anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has been granted Breakthrough Therapy Designation by the Centre for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).

康宁杰瑞与石药集团宣布，抗HER2双表位抗体药物偶联物（ADC）JSKN003已获中国国家药品监督管理局（NMPA）药品审评中心（CDE）突破性治疗药物认定。

Ovarian cancer is among the most common gynaecological malignancies in China, with an increasing incidence and the highest mortality rate among these cancers. Standard treatment involves surgery combined with platinum-based chemotherapy and maintenance therapy using targeted treatments.

卵巢癌是中国最常见的妇科恶性肿瘤之一，其发病率逐年上升，居妇科恶性肿瘤死亡率之首。标准治疗方式为手术联合含铂化疗及使用靶向治疗的维持治疗。

Around 80% of ovarian cancer cases eventually recur, progressing to platinum-resistant disease. Patients with PROC have limited treatment options, with existing therapies offering only modest benefits.

大约80%的卵巢癌病例最终会复发，并进展为铂耐药性疾病。PROC患者治疗选择有限，现有疗法仅带来轻微益处。

JSKN003 is an anti-HER2 bispecific ADC developed using Alphamab’s proprietary glycan-specific conjugation platform. It binds to HER2 on tumour cells and releases topoisomerase I inhibitors (TOPIi) through cellular endocytosis, exerting anti-tumour effects.

JSKN003 是一款利用 Alphamab 专有的糖链特异性偶联平台开发的抗 HER2 双特异性 ADC。它能够结合肿瘤细胞上的 HER2，并通过细胞内吞作用释放拓扑异构酶 I 抑制剂 (TOPIi)，从而发挥抗肿瘤作用。

Compared with other ADCs, JSKN003 has demonstrated improved serum stability and a stronger bystander effect, potentially expanding its therapeutic application.

与其他ADC相比，JSKN003展示了更好的血清稳定性和更强的旁观者效应，可能扩大其治疗应用。

The designation applies to the treatment of platinum-resistant recurrent epithelial ovarian cancer (PROC), primary peritoneal cancer, or fallopian tube cancer, regardless of HER2 expression levels.

该指定适用于治疗铂类耐药的复发性上皮性卵巢癌（PROC）、原发性腹膜癌或输卵管癌，无论HER2表达水平如何。

The Breakthrough Therapy Designation for JSKN003 is supported by pooled analysis from two clinical studies: JSKN003-101 and JSKN003-102.

JSKN003的突破性疗法认定得到了来自两项临床研究（JSKN003-101和JSKN003-102）的汇总分析的支持。

A Phase III clinical trial for JSKN003 in this indication is currently enrolling participants and progressing well. As a novel bispecific ADC, JSKN003 incorporates enzyme catalysis and click chemistry mechanisms, enhancing serum stability and bystander effects while improving therapeutic efficacy.

JSKN003在此适应症的III期临床试验目前正在招募参与者，并进展顺利。作为一种新型双特异性ADC，JSKN003结合了酶催化和点击化学机制，增强了血清稳定性和旁观者效应，同时提高了治疗效果。

The Breakthrough Therapy Designation is expected to accelerate its development, review, and approval process, potentially making the treatment available to patients with PROC more quickly.

突破性疗法指定有望加速其开发、审查和批准过程，可能使PROC患者更快地获得治疗。

Source: alphamabonc.com

来源：alphamabonc.com