The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted approval to the investigational new drug (IND) application of InnoCare Pharma to initiate a trial of ICP-B794, a B7-H3 targeted antibody-drug conjugate (ADC).
This marks a step forward in the development of targeted therapies for solid tumours, including oesophageal, nasopharyngeal, lung, and prostate cancers, as well as head and neck squamous cell carcinomas, among others.
The ADC is designed to deliver a potent payload through a protease-cleavable linker. This targeting mechanism is expected to decrease off-target effects and improve treatment outcomes for patients with solid tumours.
According to InnoCare Pharma, there are currently no B7-H3-targeted therapies that have received marketing approval.
This type I transmembrane protein is expressed highly in various solid tumours and is observed as a potential anti-tumour target.
InnoCare Pharma CEO, chairwoman and co-founder Dr Jasmine Cui said: "ICP-B794 is developed from the company's proprietary ADC platform. The platform is designed to deliver ADCs with strong tumour-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."
InnoCare is focused on developing a drug portfolio targeting a wide range of solid tumour indications.
The company's research and development (R&D) team discovers and develops platforms to address solid tumours. Their approach includes leveraging technologies to detect and progress potential drug candidates that could provide clinical advantages.
Its ADC technology platform is complemented by precision medicine candidates like the tropomyosin receptor kinase (TRK) inhibitor zurletrectinib (ICP-723).
In February 2025, the NMPA approved a Phase III trial of InnoCare Pharma’s ICP-248 (Mesutoclax) with orelabrutinib as a first-line therapy for chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL).
