China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted priority review for InnoCare Pharma’s zurletrectinib (ICP-723) for advanced solid tumours harbouring neurotrophic tyrosine receptor kinase (NTRK) fusion genes.
Previously, the CDE had accepted the new drug application (NDA) for the pan-tropomyosin receptor kinase (TRK) inhibitor, which demonstrated better safety and efficacy in a registration clinical trial.
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InnoCare Pharma CEO, chairman, and co-founder Dr Jisong Cui said: “I am very pleased that zurletrectinib has been included in the priority review. As a new broad-spectrum anticancer drug, zurletrectinib has demonstrated outstanding efficacy and safety.
“We look forward to bringing better treatment options to patients with solid tumours as soon as possible.”
In January last year, the company dosed the first paediatric subject with zurletrectinib at the Sun Yat-sen University Cancer Center in China, launching clinical research for children aged 2 to 12 years.
This milestone followed good efficacy and safety results in adults and adolescents aged 12 to 18 years.
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By GlobalDataLast month, the NMPA approved the company’s Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib as a first-line treatment for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
The therapy is now approved for three indications: relapsed and refractory (R/R) CLL/SLL, R/R marginal zone lymphoma (R/R MZL) and R/R mantle cell lymphoma (R/R MCL).
The company’s portfolio includes various new drug products at clinical, preclinical research and development, and commercialisation stages.
It operates out of branches in China, Hong Kong, and the US.
