Announcement • Jul 17
Sichuan Biokin Pharmaceutical Co., Ltd. Announces Second Approval of Iza-Bren in China for the Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma SystImmune announced that its parent company, Sichuan Biokin Pharmaceutical Co. Ltd., has received regulatory approval from China's National Medical Products Administration (NMPA) for iza-bren (izalontamab brengitecan) for the treatment of adult patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) whose disease has progressed following prior platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. This marks the second approved indication for iza-bren in China following its recent approval for recurrent or metastatic nasopharyngeal carcinoma (NPC), further establishing iza-bren as a first-in-class EGFR × HER3 bispecific antibody-drug conjugate (ADC) with broad clinical potential across multiple solid tumors. The approval is supported by results from the pivotal PANKU-Esophagus01 (BL-B01D1-305) study. The study met both dual primary endpoints of progression-free survival (PFS) and overall survival (OS), demonstrating statistically significant and clinically meaningful improvements versus chemotherapy, while maintaining a manageable safety profile. The results were previously presented during an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Key results from the PANKU-Esophagus01 study included: Median overall survival of 9.8 months with iza-bren versus 7.2 months with chemotherapy (HR=0.64, 95% CI: 0.49–0.83; p=0.0004). Median progression-free survival by BICR of 4.2 months with iza-bren versus 2.0 months with chemotherapy (HR:0.50; 95% CI: 0.40-0.63; pAbout PANKU-Esophagus01. PANKU-Esophagus01 (BL-B01D1-305) is a randomized, open-label, multicenter phase 3 clinical trial evaluating iza-bren versus investigator's choice chemotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma who experienced disease progression following platinum-based chemotherapy plus PD-1/PD-L1 inhibitor therapy. A total of 497 patients were randomized across 80 study centers in China. The study met both dual primary endpoints of progression-free survival and overall survival at the pre-specified interim analysis. Esophageal cancer is the seventh most commonly diagnosed cancer and the sixth leading cause of cancer-related death worldwide. Esophageal squamous cell carcinoma (ESCC) is the predominant histologic subtype globally and accounts for approximately 90% of esophageal cancer cases in China. Despite advances in first-line treatment with platinum-based chemotherapy combined with PD-1/PD-L1 inhibitors, most patients with recurrent or metastatic ESCC ultimately experience disease progression and have historically faced limited treatment options in the second-line setting, with poor response rates and a median overall survival of less than one year. SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren's dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren's therapeutic novel Topo1i payload is released causing cytotoxic stress that leads to cancer cell death. Announcement • Jun 30
Sichuan Biokin Pharmaceutical Co.,Ltd. to Report First Half, 2026 Results on Aug 27, 2026 Sichuan Biokin Pharmaceutical Co.,Ltd. announced that they will report first half, 2026 results on Aug 27, 2026 Announcement • Jun 23
SystImmune Announces First Approval Of Iza-Bren For The Treatment Of Recurrent Or Metastatic Nasopharyngeal Carcinoma In China SystImmune Inc. announced that its parent company, Sichuan Biokin Pharmaceutical Co. Ltd. has received regulatory approval from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for iza-bren (BL-B01D1) for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have progressed following prior platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. This approval marks the first regulatory approval for iza-bren and represents a significant milestone in the development of SystImmune's proprietary bispecific antibody-drug conjugate platform. The approval is based on results from the pivotal Phase III BL-B01D1-303 study (NCT06118333). In this study, Iza-bren demonstrated a BICR-assessed confirmed ORR of 54.6% vs. 27.0% for chemotherapy (Odds Ratio 3.3; 95% confidence interval 1.9-5.8; p<0.0001). Median duration of response (DoR) was 8.5 months for iza-bren versus 4.8 months for physician's choice of chemotherapy (Hazard ratio 0.43; 95% CI 0.22 to 0.83). Furthermore, median progression-free survival (PFS) was 8.38 months for iza-bren compared to 4.34 months for chemotherapy (hazard ratio of 0.44; 95% confidence interval 0.32-0.62). At the time of this analysis, the overall survival (OS) data were immature. BL-B01D1-303 is a phase III, randomized, open-label, multicenter study in China to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic nasopharyngeal carcinoma who have failed PD-1/PD-L1 monoclonal antibody and at least two lines chemotherapy (one line must contain platinum-based chemotherapy). Nasopharyngeal carcinoma (NPC) is a cancer that arises from the nasopharynx, the upper part of the throat located behind the nose. Although uncommon globally, NPC is endemic in southern China, Southeast Asia, and certain regions of North Africa. Epstein-Barr virus (EBV) infection is strongly associated with the development of NPC. Patients with recurrent or metastatic disease who have progressed after standard therapies continue to face poor outcomes, with 5-year overall survival rate generally less than 10%, representing a significant unmet medical need. SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren's dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren's therapeutic novel Topo1i payload is released causing cytotoxic stress that leads to cancer cell death. 
