Five Aponermin Studies Presented at the 23rd IMS Annual Meeting, Spanning Frail Newly Diagnosed and Hard-to-Treat Relapsed/Refractory Multiple Myeloma

WUHAN, China, September 2026 – Wuhan Hiteck Biological Pharma Co., Ltd. (300683.SZ) announced that five basic and clinical studies of Aponermin for Injection (SunHiTrail®), the world's first approved DR4/DR5 agonist, were accepted for poster presentation at the 23rd International Myeloma Society (IMS) Annual Meeting & Exposition, held September 23–26, 2026 at the Scottish Event Campus (SEC) in Glasgow, United Kingdom. The studies were presented by investigators from Beijing Chaoyang Hospital of Capital Medical University, The First Affiliated Hospital of Zhejiang University School of Medicine, and The First Affiliated Hospital of Sun Yat-sen University, and include exploratory analyses of efficacy biomarkers for Aponermin-based regimens, as well as efficacy and safety evaluations of Aponermin combined with proteasome inhibitors, immunomodulatory drugs, cytotoxic agents, XPO-1 inhibitors, and BCL-2 inhibitors.

The studies involve frail patients with newly diagnosed multiple myeloma (NDMM) who are not candidates for intensive chemotherapy, and patients with relapsed/refractory multiple myeloma (RRMM) facing major treatment challenges, including relapse after immunotherapy, bulky extramedullary disease, and multi-drug exposure.

Presentation Overview

All five studies were presented in poster format.

Study Highlights

•     Ultra-frail newly diagnosed patients (PA-093): This study evaluates the clinical efficacy and safety of Aponermin combined with selinexor (CPT+S) in ultra-frail patients with NDMM.

•     Relapse after immunotherapy (PA-036): This subgroup analysis of a prospective, single-arm, multicenter trial evaluates Aponermin combined with carfilzomib, pomalidomide, and dexamethasone in patients with RRMM relapsing after CAR-T or BiTE therapy.

•     Carfilzomib-based regimens (PA-164): A single-center retrospective analysis assesses the efficacy and safety of Aponermin combined with carfilzomib and dexamethasone (Kd)-based regimens in RRMM.

•     Extramedullary disease (PA-037): This study evaluates Aponermin plus KT-DECP as a bridging regimen for RRMM with extramedullary disease.

•     Combination with a BCL-2 inhibitor (PA-524): This basic research study examines the synergy between venetoclax and circularly permuted TRAIL in multiple myeloma through DR5 upregulation and BID-dependent crosstalk.

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. It binds to death receptor 4 (DR4) and/or death receptor 5 (DR5) on the tumor cell surface, activating the extrinsic apoptotic pathway and triggering a caspase cascade that induces p53-independent apoptosis. Multiple studies have also shown that DR4/DR5 agonists exert immunomodulatory effects, suppressing regulatory T cells, tumor-associated macrophages, myeloid-derived suppressor cells, and other immunosuppressive cells in the tumor microenvironment, thereby helping to improve the tumor immune microenvironment.

Scientific Context

The IMS Annual Meeting is one of the most authoritative scientific gatherings in the global myeloma field, covering basic research, translational medicine, and clinical practice in multiple myeloma and other plasma cell disorders. This year's meeting featured 635 research abstracts, including poster presentations, and 35 late-breaking abstracts, together with multiple special sessions on basic biology, immunotherapy, disease monitoring, and other topics. In addition, the International Myeloma Working Group (IMWG) released an important new work, Defining Cure in Multiple Myeloma, during the meeting.

In recent years, basic research, real-world case analyses, and early and interim data from investigator-initiated trials (IITs) of Aponermin for Injection have been successively presented at top-tier international congresses, including the IMS Annual Meeting. Ranging from study design to in-depth analysis of the target mechanism of action, this body of work fully reflects the recognition of DR4/DR5 agonists for the treatment of hematologic malignancies within the international hematology community, as well as a continuously deepening understanding of their mechanism.

Future Development

Hiteck will accelerate its ongoing research on Aponermin, with the goal of bringing additional safe, effective, and innovative treatment options to patients as early as possible.

FAQ

What is Aponermin?

Aponermin for Injection (SunHiTrail®) is a Class 1 innovative biologic developed by Hiteck. It is a circularly permuted form of human TRAIL and the world's first approved DR4/DR5 agonist, approved in China in 2023 for relapsed or refractory multiple myeloma.

What was presented at the 23rd IMS Annual Meeting?

Five posters: four clinical studies of Aponermin-based combination regimens in newly diagnosed and relapsed/refractory multiple myeloma, and one basic research study on the mechanism of synergy between Aponermin and venetoclax.

Which patients do these studies focus on?

Frail patients with newly diagnosed multiple myeloma, and patients with RRMM facing major treatment challenges, including relapse after CAR-T or bispecific therapy, extramedullary disease, and extensive prior drug exposure.

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 continues to build the clinical evidence for Aponermin-based combination regimens across newly diagnosed and difficult-to-treat relapsed myeloma populations. 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.

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