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. New Risk • Jun 10
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.7% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 0.7% per year for the foreseeable future. Minor Risk Share price has been volatile over the past 3 months (8.6% average weekly change). 
