Zhitong Finance App News, Shiyao Group (01093) announced that the updated overall survival (OS) results of the phase III clinical study (study number: KC/GEJA) of anitumab injection (trade name: Eniturum®) combination chemotherapy developed by the Group in cooperation with Jiangsu Kangning Jerry Biopharmaceutical Co., Ltd. to treat human epidermal growth factor receptor 2 (HER2) positive advanced gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJA)) in 2026 10 On January 23, it was selected as the latest breakthrough abstract (LBA) at the 2026 European Society of Medical Oncology (ESMO) annual meeting and presented in the form of a quick oral report.
The KC-WISE study is a randomized, double-blind, controlled, multi-center phase III clinical study (NCT05427383) with Professor Xu Jianming of the Chinese People's Liberation Army General Hospital as the main researcher and sponsored by the Group to compare the efficacy and safety of anituzumab combined chemotherapy and standard treatment head-to-head in HER2-positive GC/GEJA patients who failed trastuzumab treatment. A total of 246 participants were randomly enrolled in the study, including 125 in the anitumab group and 121 in the control group. According to the data released this time, as of July 15, 2026, the median follow-up time for the two groups reached 228 months and 223 months, respectively.
Efficacy: A total of 157 deaths occurred in both groups, including 66 cases (528%) in the anitumab group and 91 cases (752%) in the control group. The median overall survival (MoS) of the antizumab group reached 196 months, significantly superior to 96 months (risk ratio (HR) =039; 95% confidence interval (CI): 028-054; P<00001), which significantly reduced the risk of death by 61% compared to standard treatment. Subgroup analysis showed that OS benefits were consistent across all pre-set subgroups. As assessed by the Independent Review Committee (IRC), the median progression-free survival (mPFs) of the antizumab group and the control group was 71 months and 27 months (HR=035; 95% CI: 026-048; P<00001); the PFS results obtained by the investigators were similar to those of the IRC assessment, further verifying that the scheme can significantly delay disease progression.
Safety: The most common grade 3 adverse events (TEAE) in the antizumab group and control group included neutropenia (331% vs. 248%), leukopenia (274% vs. 256%), and anemia (258% vs. 140%). There were no treatment-related deaths in the anitumab group, while 5 treatment-related deaths were reported in the control group. Overall, the safety characteristics of the aniturumab group are good and the risk is manageable.
OS update data released at the 2026 ESMO annual conference further confirmed that anitumab combined with chemotherapy for second-line treatment of HER2-positive advanced GC/GEJA patients has significant benefits in short-term tumor shrinkage and long-term survival, and overall safety is controllable, which is expected to reshape the clinical treatment pattern of HER2-positive advanced GC/GEJA.
Anituzumab is a HER2 bispecific antibody that targets two non-overlapping epitopes of HER2. It can simultaneously bind to the two non-overlapping epitopes of HER2 to block the HER2 signaling pathway; through antibody-induced receptor aggregation, it enhances antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) effects, and also promotes HER2 receptor absorption and regulation of HER2 receptors on the cell surface.
Based on the groundbreaking mid-term PFS analysis results from the KC-WISE study, anitumab injection (Eniturum®) was approved for marketing by the National Drug Administration (NMPA) of the People's Republic of China in May 2026, and used in combination with chemotherapy for second-line and above treatment of patients with advanced HER2 positive GC/GEJA.
The Group is the only pharmaceutical marketing license holder (MAH) for which anitumab injection (Enitum®) has been approved for indications in mainland China, and is also the sole holder of the Enitumab® trademark. As an independent sponsor, the Group fully dominates the clinical development design and full process management of anitumab injections (Eniturum®). Relying on a mature incubation ecosystem, efficient clinical operation capabilities, comprehensive resource coordination mechanisms, and a perfect commercialization system, the Group is expected to rapidly integrate the advantages of the entire chain and bring products to market.