Circularly Permuted TRAIL

Two prospective, multicenter studies delivered as oral presentations extend the clinical exploration of the DR4/DR5 agonist from hematologic malignancies into solid tumors WUHAN, China, September 2026 – Wuhan Hiteck Biological Pharma Co., Ltd. (300683.SZ) announced that results from two prospective, multicenter clinical studies of Aponermin for Injection (SunHiTrail®), its independently developed Class 1 innovative biologic and the world's first approved DR4/DR5 agonist, were delivered as oral presentations at the Bone and Soft Tissue Tumor Session and the Multiple Myeloma Session, respectively, of the 29th Annual Meeting of the Chinese Society of Clinical Oncology (CSCO), held September 17–19, 2026 in Jinan, China. The first study reports preliminary efficacy and safety data for Aponermin monotherapy in advanced chondrosarcoma, a refractory solid tumor. The second provides updated Phase II data for Aponermin combined with bispecific antibodies in relapsed/refractory multiple myeloma (RRMM). Developed to address unmet clinical needs, the two studies provide new and robust evidence for clinical practice and drew considerable attention and strong recognition from experts at the meeting. Themed "Upholding Standardization, Empowering Innovation with Digital Intelligence," this year's CSCO Annual Meeting focused on standardized clinical oncology practice, clinical translation of novel drugs, and multidisciplinary collaboration. The meeting featured 85 academic sessions and brought together more than 20 academicians and over 30 international experts, providing a high-level platform for exchange among clinicians, researchers, and the biopharmaceutical industry across China. Presentation Overview • Congress: 29th CSCO Annual Meeting, September 17–19, 2026, Jinan, China • Presentation 1: Efficacy and Safety of DR4/DR5 Agonist Aponermin Monotherapy in Advanced Chondrosarcoma: Preliminary Report from a Prospective, Multicenter Study – Session: Bone and Soft Tissue Tumor Session (oral presentation) – Presenter: Professor Zhuqing Liu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine • Presentation 2: Aponermin Combined with Bispecific Antibodies in Relapsed/Refractory Multiple Myeloma: Updated Results from a Phase II Clinical Study – Session: Multiple Myeloma Session (oral presentation) – Presenter: Professor Aijun Liu, Beijing Chaoyang Hospital, Capital Medical University Key Findings: Aponermin Monotherapy in Advanced Chondrosarcoma Chondrosarcoma is among the most common primary malignant bone tumors in adults and is widely regarded as resistant to conventional chemotherapy and radiotherapy, leaving few effective systemic options once the disease becomes unresectable or metastatic. This multicenter, single-arm exploratory study enrolled 21 patients with advanced chondrosarcoma, 15 of whom had conventional chondrosarcoma. Twenty patients were evaluable for efficacy. Aponermin monotherapy demonstrated a degree of disease control in chondrosarcoma. • Overall population: disease control rate (DCR) of 80.0%; median progression-free survival (PFS) of 4.2 months; 4-month PFS rate of 53.9% • Conventional chondrosarcoma: DCR of 85.7% and median PFS of 7.2 months • Durability: 7 patients maintained stable disease (SD) for more than 7 months, suggesting that a subset of patients may achieve durable disease control Professor Jing Chen of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, spoke highly of the study, affirming the therapeutic value and application prospects of Aponermin in chondrosarcoma. With its unique mechanism of action, Aponermin has shown potential anti-tumor activity in chondrosarcoma. By reporting preliminary efficacy and safety data for single-agent Aponermin in advanced chondrosarcoma, this prospective, multicenter study opens a new direction for drug therapy in this refractory solid tumor and demonstrates that the potential of Aponermin is not limited to hematologic malignancies, supporting its value for clinical exploration across tumor types. Key Findings: Aponermin plus Bispecific Antibodies in RRMM In the Multiple Myeloma Session, Professor Aijun Liu presented updated Phase II data evaluating Aponermin in combination with bispecific antibodies. • Accumulated clinical data on Aponermin combined with bispecific antibodies confirm a significant synergistic anti-tumor effect between the two. • The combination showed rapid and substantial clinical activity with manageable toxicity in heavily pretreated patients with high-risk RRMM. • Activity was observed across difficult-to-treat populations, including patients with extramedullary disease, triple-class exposure, high-risk cytogenetic abnormalities, and severe renal impairment. • Clinical practice to date has fully validated that the weekly dosing schedule offers excellent efficacy and a good safety profile, with potential for further exploration. Mechanism of Action Aponermin for Injection is a circularly permuted form of human tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) and the world's first approved DR4/DR5 agonist. By binding to death receptor 4 (DR4) and/or death receptor 5 (DR5) on the tumor cell surface, it activates the extrinsic apoptotic pathway and triggers a caspase cascade, inducing p53-independent apoptosis, with potent anti-myeloma activity and low toxicity. Future Development The two oral presentations at this year's CSCO Annual Meeting span hematologic malignancies and bone and soft tissue solid tumors. The accumulation of clinical experience and the growing body of evidence are the result of the dedicated work of multicenter clinical investigators across China. Together, these findings further demonstrate the anti-tumor potential of Aponermin, extend its exploration into broader disease areas, and seek new treatment options for more cancer patients. Going forward, Hiteck will remain focused on unmet clinical needs, continuing to build its innovation portfolio across hematologic malignancies, solid tumors, neurological disorders, and other areas, and bringing more treatment regimens into clinical use. The company will also deepen its collaboration with clinical experts and academic institutions across China to explore the clinical potential of Aponermin in hematologic malignancies, bone and soft tissue tumors, and other indications, refining treatment approaches through technological innovation and accumulated clinical evidence, helping to raise the standard of cancer care, and bringing more treatment options and hope to patients. Aponermin for Injection is approved in China for relapsed or refractory multiple myeloma. Its use in chondrosarcoma and in combination with bispecific antibodies is investigational, and its safety and efficacy in these settings have not been established. About Hiteck Wuhan Hiteck Biological Pharma Co., Ltd. was founded in 1992 at the Medical School of Wuhan University and is a publicly listed biopharmaceutical company on the Shenzhen Stock Exchange (stock code: 300683). Guided by its mission of "Innovating for Life," Hiteck focuses on oncology, neurology, and immunology, with a continued commitment to the development of innovative biologics and small molecule therapeutics. In oncology, Hiteck developed Aponermin, the world's first approved DR4 and DR5 agonist, which received regulatory approval in 2023 and was rapidly included in the national reimbursement program, introducing a novel therapeutic target for patients with relapsed or refractory multiple myeloma. Hiteck is now extending the clinical exploration of Aponermin into additional hematologic malignancies and solid tumors, including bone and soft tissue sarcomas. In neurology, the company translated Nobel Prize winning discoveries into clinical practice with Jinlujie, the world's first approved nerve growth factor (NGF) therapy, which has benefited millions of patients. Leveraging the HiSMART™ platform, Hiteck is advancing multiple innovative small molecule programs in parallel, supported by GMP compliant manufacturing facilities and integrated value chain capabilities, with the aim of delivering sustained innovation and meaningful benefits to patients worldwide. Media Contact Company: Wuhan Hiteck Biological Pharma Co., Ltd. Website: Hiteckpharma.com Email: bd@hiteck.com.cn Address: Hiteck Science and Technology Park, Wuhan Economic and Technological Development Zone, Wuhan, Hubei Province, 430056, China.