Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK) jointly announced, that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) granted a Breakthrough Therapy designation to KN026 (HER2 bispecific antibody) combined with chemotherapy for the treatment of HER2-positive gastric cancer (including gastroesophageal junction cancer).Gastric cancer is one of the most common gastrointestinal malignancies in the world, and the number of new cases and deaths of gastric cancer in China every year is close to 42% of the world，that bring a heavy disease burden for patients, especially those with advanced or metastatic gastric cancer.

Alphamab Oncology（股票代码：9966.HK）和CSPC Pharmaceutical Group Co.，Ltd。（股票代码：1093.HK）共同宣布，中国国家医药产品监督管理局（NMPA）药物评估中心（CDE）授予KN026（HER2双特异性抗体）联合化疗突破性治疗称号，用于治疗HER2阳性胃癌（包括胃食管连接癌）。胃癌是世界上最常见的胃肠道恶性肿瘤之一，中国每年新增胃癌病例和死亡人数接近世界的42%，给患者，特别是晚期或转移性胃癌患者带来沉重的疾病负担。

Human epidermal growth factor receptor2 (HER2) is overexpressed in about 15-20% of gastric cancer patients, which is associated with tumor aggressiveness and poor prognosis. Therefore, there is a huge unmet clinical need in the treatment of patients with HER2-positive gastric cancer who progress or relapse after first-line therapy.

人表皮生长因子受体2（HER2）在约15-20%的胃癌患者中过表达，这与肿瘤侵袭性和不良预后相关。因此，在一线治疗后进展或复发的HER2阳性胃癌患者的治疗中存在巨大的未满足的临床需求。

The clinical study of KN026 in this indication has preliminarily shown a breakthrough in efficacy and good safety, which has obvious clinical advantages compared with existing treatment methods.According to the results of a Phase II clinical trial evaluating the safety and efficacy of KN026 monotherapy in patients with advanced HER2-expressing gastric Cancer or gastroesophageal junction adenocarcinoma who have failed at least one previous standard therapy, published in the European Journal of Cancer in November 2022, a total of 45 subjects received KN026 monotherapy at least once, of which 27 had high HER2 expression, 14 had low HER2 expression, and 4 had no HER2 expression.

KN026在该适应症中的临床研究初步显示出疗效和安全性的突破，与现有治疗方法相比具有明显的临床优势。根据欧洲癌症杂志2022年11月发表的一项II期临床试验结果，评估KN026单药治疗晚期HER2表达胃癌或胃食管连接腺癌患者的安全性和有效性，这些患者至少以前一种标准治疗失败，共有45名受试者至少接受过一次KN026单药治疗，其中27例HER2高表达，14例HER2低表达，4例无HER2表达。

Among the 39 patients assessed for efficacy, the HER2-high .

在评估疗效的39名患者中，HER2高。