InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct the clinical trial of a novel B7-H3 targeted ADC ICP-B794.

ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated to potent in-house developed payload via a protease-cleavable linker. This combination ensures precise targeting of tumor cells while minimizing off-target effects, offering a promising treatment for solid tumors such as lung cancer, esophageal cancer, nasopharyngeal cancer, head and neck squamous cell carcinomas, prostate cancer, and others.

Currently, there are no B7-H3 targeted therapies approved for marketing globally. B7-H3 is a type I transmembrane protein that is highly expressed in a variety of solid tumors. Due to its specific expression in tumor cells, it is considered a highly promising anti-tumor target.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "ICP-B794 is developed from the Company's proprietary ADC platform. The platform is designed to deliver ADCs with strong tumor-killing efficacy and an adequate therapeutic window, thereby broadening treatment options for cancer patients and improving their clinical outcomes. As the platform continues to evolve, the Company is poised to expand its portfolio with multiple differentiated ADC candidates, further advancing precision medicine in oncology."

With ongoing efforts to address the growing needs in solid tumors, InnoCare is committed to building a competitive drug portfolio aimed at treating a broad range of solid tumor indications. The Company is expanding the scope of its pipeline through a combination of targeted therapies, immune-oncology approaches, and cutting-edge ADC technology. The R&D team is focused on discovering and developing novel platforms that target various solid tumors, utilizing innovative technologies to identify and advance potential drug candidates that offer significant clinical benefits. InnoCare’s proprietary ADC technology platform, alongside promising precision medicine candidates like TRK inhibitor zurletrectinib (ICP-723), positions the Company to establish a strong presence in the field of solid tumor treatment.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-looking Statements

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ICP-B794 is developed from InnoCare's proprietary ADC platform. The platform is designed to deliver ADCs with strong tumor-killing efficacy and an adequate therapeutic window, thereby broadening treatment options for cancer patients.