InnoCare Secures IND Approval in China for B7-H3-Targeted ADC ICP-B794 to Advance Solid Tumor Therapies
InnoCare Pharma a leading biopharmaceutical company dedicated to developing innovative treatments for cancer and autoimmune diseases, announced the recent approval of its Investigational New Drug (IND) application by the Center for Drug Evaluation (CDE) under the China National Medical Products Administration (NMPA). The IND approval allows the company to begin clinical trials of ICP-B794, a novel antibody-drug conjugate (ADC) designed to target B7-H3-expressing tumors.
ICP-B794 represents a significant addition to InnoCare’s growing pipeline of precision oncology therapies. This innovative ADC is composed of a humanized anti-B7-H3 monoclonal antibody linked to a proprietary, highly potent cytotoxic payload developed in-house by InnoCare. The payload is connected via a protease-cleavable linker, a key feature that enables selective drug release within tumor cells while limiting toxicity to healthy tissues. This targeted mechanism of action is designed to improve efficacy while reducing systemic side effects, a persistent challenge in conventional chemotherapy and some immunotherapies.
B7-H3, a type I transmembrane protein belonging to the B7 family, has garnered increasing interest in oncology research due to its high expression in a broad range of solid tumors and limited presence in normal tissues. The overexpression of B7-H3 has been observed in lung cancer, esophageal cancer, nasopharyngeal carcinoma, head and neck squamous cell carcinoma (HNSCC), prostate cancer, and other difficult-to-treat solid tumors. Currently, no B7-H3-targeted therapy has received marketing approval anywhere in the world, underscoring the unmet need and untapped potential of targeting this protein.
ICP-B794’s development aims to address this therapeutic gap. The investigational therapy is positioned as a potentially transformative treatment option for patients with B7-H3-positive cancers, especially those who have limited responses to existing therapies. The ADC’s design enables precise tumor targeting and controlled payload delivery, potentially enhancing tumor cell killing while preserving a manageable safety profile.
Dr. Jasmine Cui, Co-founder, Chairwoman, and Chief Executive Officer of InnoCare, emphasized the strategic importance of this development:
“ICP-B794 is a testament to the strength of our proprietary ADC platform, which is engineered to produce antibody-drug conjugates with robust anti-tumor activity and an optimal therapeutic window. Our goal is to significantly expand treatment options for patients with solid tumors, many of whom currently face limited therapeutic choices. As our ADC platform evolves, we are well-positioned to bring forward a pipeline of differentiated candidates that can advance the frontier of precision oncology.”
InnoCare’s ADC platform reflects the company’s broader commitment to innovation in the oncology space. The platform is tailored to generate next-generation ADCs by optimizing antibody specificity, linker stability, and payload potency. By leveraging internal R&D capabilities, InnoCare is able to maintain full control over its drug development process—from target identification to clinical validation.
The development of ICP-B794 aligns with InnoCare’s long-term strategy of building a comprehensive and competitive portfolio for solid tumor treatment. The company is investing heavily in research and development efforts that incorporate immune-oncology, targeted therapies, and advanced modalities like ADCs. These technologies are synergistic and provide a multi-pronged approach to tackling the complexity of cancer biology.
In addition to ICP-B794, InnoCare is progressing other candidates within its solid tumor portfolio, including zurletrectinib (ICP-723), a precision therapy targeting tropomyosin receptor kinase (TRK) fusion-positive cancers. ICP-723 has shown promise in early studies and represents another pillar in the company’s precision medicine strategy.
InnoCare’s focus on innovation, scientific rigor, and unmet clinical needs reflects its mission to become a global leader in cancer treatment. The IND approval for ICP-B794 marks an important step toward that vision, potentially paving the way for new hope in the treatment of aggressive and resistant solid tumors.
As clinical development begins, the company plans to enroll patients across multiple solid tumor types with confirmed B7-H3 expression, laying the foundation for a broader evaluation of ICP-B794’s safety and therapeutic potential.
