KangaBio's Novel Drug KGX105 Obtains IND Approval from CDE

KangaBio's KGX105 Secures Another CDE Clinical Trial Approval; Dual IND Clearances in China and the US Pave the Way for Global Clinical Development

KangaBio Inc. recently announced that KGX105, its self-developed core pipeline EGFR×CD3 bispecific T-cell engager (TCE) prodrug, has been granted the Investigational New Drug (IND) application approval by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), with the acceptance number CXSL2600408. Previously, KGX105 obtained the US FDA IND clearance on February 25, 2026 (IND No. 179701). This dual IND approval in China and the US marks KGX105 as the company's second innovative drug with simultaneous clinical development layouts in domestic and overseas markets.

Phase I clinical data of KGX101, the company's first pipeline asset, was presented at the 2026 AACR Annual Meeting, disclosing for the first time its safety profile and preliminary anti-tumor efficacy in melanoma treatment, continuously validating the differentiated strengths of the company's tumor-specific activatable prodrug technology platform.

I. Prior FDA Clinical Clearance Followed by a Major Breakthrough in Domestic IND Approval

The domestically approved clinical trial is a Phase I study (Trial No. KGX105ST102) designed to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of monotherapy with KGX105 in participants with locally advanced or metastatic solid tumors. The trial plans to enroll patients with locally advanced or metastatic solid tumors who have failed standard therapies and have limited remaining treatment options, bringing a novel immunotherapy modality for late-stage tumor patients in China.

II. KGX105 Addresses Unmet Clinical Needs in Solid Tumors; Prodrug Technology Mitigates Toxicity Limitations of Conventional TCEs

EGFR is a well-validated oncogenic driver overexpressed or mutated across a broad spectrum of epithelial solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, nasopharyngeal carcinoma, and pancreatic cancer. While EGFR-targeted tyrosine kinase inhibitors and monoclonal antibodies deliver therapeutic benefits, patients frequently develop acquired drug resistance, leaving scarce treatment alternatives upon disease progression.

T-cell engager bispecific antibodies represent potent immunotherapeutic agents capable of redirecting T-cell cytotoxicity toward tumor cells in an MHC-independent manner, exerting anti-tumor activity even in immune-refractory malignancies. Nevertheless, their clinical application in solid tumors is substantially constrained by on-target off-tumor toxicity and systemic T-cell activation, which may trigger severe or life-threatening adverse events.

KGX105 developed in-house by KangaBio is an innovative EGFR×CD3 bispecific TCE prodrug equipped with masked EGFR and CD3 binding domains. This design prevents non-specific binding to normal tissues and peripheral circulating T cells, thereby reducing systemic immune activation and off-target toxicities. The prodrug is selectively activated by specific proteases exclusively within the tumor microenvironment to precisely eliminate EGFR-positive tumor cells. Additionally, an albumin-binding domain is incorporated to effectively extend the drug's half-life, prolong therapeutic exposure and improve overall anti-tumor efficacy.

III. Dual IND Approvals in China and the US Mark a Key Milestone for Global R&D Strategy

Dr. Weidong Jiang, Founder and Chief Executive Officer of KangaBio, commented:

"The dual IND approvals of KGX105 from the FDA and CDE constitute a landmark milestone in the company's global R&D strategy, affirming the world-leading differentiated competitiveness of our proprietary prodrug technology platform.

The toxicity bottleneck of conventional TCEs has long hindered the advancement of solid tumor immunotherapy, and the innovative prodrug design of KGX105 precisely addresses this core industry challenge. Leveraging clinical trial approvals in both China and the US, we will rapidly advance Phase I clinical programs to efficiently validate the safety and efficacy of the candidate. We also express our sincere gratitude to our investors for consistent trust and our R&D team for persistent research breakthroughs. We will accelerate clinical trial execution to deliver a safer and more accessible novel therapeutic option for late-stage solid tumor patients worldwide."

About KangaBio Inc.

Founded by Dr. Weidong Jiang, KangaBio assembles a core team of senior experts with extensive experience in macromolecular antibody engineering, clinical development, and biopharmaceutical industrialization. Driven by the mission to address unmet medical needs in oncology, the company focuses on developing innovative prodrug molecules including immune agonists and multispecific antibodies. Supported by its differentiated tumor-specific activatable prodrug technology platform, KangaBio conducts precise molecular modification of targeted agents to reduce adverse effects of immunotherapies and enhance anti-tumor efficacy, developing a new generation of safe and potent immunotherapeutic drugs for solid tumor patients globally.