Shanghai First People's Hospital

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.

Changchun GeneScience Pharmaceutical Co., Ltd. (GenSci) has registered a Phase I clinical trial of GenSci148, a multispecific fusion protein targeting VEGF-A, VEGF-C, VEGF-D, and angiopoietin-2 (Ang-2), in patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). The trial is listed as not yet recruiting, with an estimated start date of September 2026 at Shanghai General Hospital. The open-label, dose-escalation study (NCT07817615) is structured in two parts and plans to enroll up to 60 participants. Part 1 evaluates single ascending intravitreal doses — 1 mg, 3 mg, 7 mg, and 10 mg per eye — in nAMD patients. Part 2 moves to multiple ascending doses across all three indications, with dose levels described as low, medium, and high. Participants meeting retreatment criteria during follow-up may receive additional injections. The primary completion date is listed as June 2028, with full study completion expected by October 2028. GenSci148 is designed to simultaneously block three VEGF isoforms (VEGF-A, VEGF-C, VEGF-D) and Ang-2, a combination that, according to a GenSci press release, is intended to suppress pathological angiogenesis, reduce vascular permeability, and improve vascular stability. The molecule's broader target profile distinguishes it from faricimab (Vabysmo), Roche's approved dual VEGF-A/Ang-2 bispecific antibody, which does not address VEGF-C or VEGF-D. Whether the broader VEGF blockade translates into clinically meaningful differences in durability or anatomical outcomes remains to be established in human studies. The molecule's development involved an AI-guided protein engineering collaboration with Shanghai Matwings Technology Co., Ltd. (Matwings). According to a Matwings press release, four iterative AI–wet lab cycles evaluated 222 protein variants, with reported preclinical improvements including up to approximately 10-fold improved VEGF-A binding affinity, up to approximately 3-fold improved VEGF-A/C/D functional blockade, and inhibitory activity maintained 84 days after dosing in an evaluated nonclinical retinal model. Under the specific experimental conditions tested, the optimized molecule also showed greater inhibition than aflibercept and faricimab. Matwings explicitly noted these findings are preclinical and do not establish comparative clinical efficacy or safety. GenSci said it received clinical trial clearance from China's National Medical Products Administration (NMPA) in August 2026. Faricimab, approved by the US FDA in January 2022 for nAMD and DME, demonstrated non-inferior visual acuity gains versus aflibercept and achieved up to 16-week dosing intervals in Phase III trials. China-based Kexing Biopharm's GB10, a bispecific antibody employing a structurally distinct VEGF-Trap fused to an anti-Ang-2 single-domain VHH antibody, dosed its first subject in a Phase I trial in China in mid-2026. GenSci148 is differentiated by its explicit simultaneous targeting of VEGF-A, VEGF-C, VEGF-D, and Ang-2, although whether broader VEGF blockade translates into greater durability or clinical efficacy remains unproven. GenSci, a subsidiary of Changchun High-Tech Industries (Group) and headquartered in Changchun, China, has been expanding its ophthalmology pipeline alongside partnerships in other therapeutic areas, including a USD 1.365 billion global ex-China licensing deal for its anti-TSHR antibody GS-098 announced in December 2025. GenSci148 represents the company's ophthalmology lead program and, according to its pipeline page, is listed under the Evomab multispecific antibody platform. Safety, tolerability, pharmacokinetics, and pharmacodynamics data from Part 1 are expected to inform dose selection for Part 2. The key question for progression will be whether the Phase I safety profile supports the dosing intervals GenSci has proposed, and whether preliminary efficacy signals in Part 2 — across nAMD, DME, and RVO — justify the broader development investment that would be required to compete against established agents in each indication. Spot something wrong? Report an issue with this article

Shanghai, June 2, 2026 — Beyang Therapeutics Co., Ltd. today announced the initiation meeting for the Phase Ib clinical trial of its self-developed innovative small-molecule ophthalmic solution, BT01001, was successfully held recently at Shanghai General Hospital. The meeting brought together Principal Investigators (PIs) Dr. Kun Liu and Dr. Xueying Ding, along with core members from both ophthalmology research teams, to conduct an in-depth discussion and deployment regarding the trial protocol, execution details, and quality control standards. The newly initiated Phase Ib clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BT01001 eye drops in patients with Diabetic Macular Edema (DME). The study features a 12-week treatment period and aims to assess the safety, tolerability, and preliminary efficacy of BT01001 in the treatment of DME through rigorous clinical design. About BT01001 BT01001 is a proprietary small-molecule ophthalmic solution formulated to achieve high posterior eye tissue exposure via the trans-scleral vascular pathway. As a potent dual-inhibitor of VEGFR and FGFR kinases, BT01001 aims to provide a non-invasive, effective treatment for DR, potentially improving patient compliance and reducing the risks associated with intravitreal injections. About Beyang Beyang Therapeutics is an AI-driven innovative drug R&D company, aiming to become the "DreamWorks" in the field of innovative Drug Discovery. The company focuses on the development of drugs with clear mechanisms of action (MOA) and high potential for clinical translation, in the areas with unmet medical needs. Based on its proprietary ExCEED platform (molecular design, druggability assessment, and biological research), Beyang boasts industry-leading preclinical pipeline conversion rates. The core team comprises experienced scientists from leading pharmaceutical companies such as Pfizer, Merck, and Hengrui. They have participated in the R&D of three globally-launched small molecule drugs and successfully advanced over 10 projects into clinical trials. With strict target selection standards and an "AI + experience-driven" model, the company is actively deploying in high-potential fields, accelerating the development of effective drugs to address unmet patient needs while maximizing commercial value. Contact： Minghui Tong, PhD Tel：+86-13265738517 Email：tongmh@beyangtx.com Website：Beyang Therapeutics Co., Ltd.