InnoCare Announces the Acceptance of New Drug Application for pan-TRK Inhibitor Zurletrectinib in China

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a New Drug Application (NDA) for its new generation pan-TRK inhibitor zurletrectinib (ICP-723) for the treatment of adult and adolescent patients (12 to 18 years old) with advanced solid tumors harboring NTRK gene fusions.

In the registrational trial for adult and adolescent patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy with a good safety profile. Zurletrectinib was also shown to overcome acquired resistance to the first-generation TRK inhibitors.

Meanwhile, the Company is accelerating the registrational trial for pediatric patients (2 to 12 years old).

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, “Zurletrectinib has demonstrated outstanding efficacy and safety profile in adult, adolescent, and pediatric patients with tumors harboring NTRK fusion genes, bringing better treatment options for patients with solid tumors. The Company is expanding the scope of its solid tumor pipelines through a combination of targeted therapies, immune-oncology approaches, and cutting-edge ADC technology, looking forward to meeting the unmet needs of patients with solid tumors early.”

NTRK fusion genes occur in various types of adult and pediatric tumors. In some rare tumors, such as salivary gland carcinoma, secretory breast cancer, and infantile fibrosarcoma, the incidence of NTRK gene fusion exceeds 90%¹. It is estimated that there are about 6,500 new cases of NTRK fusion-positive solid tumors are diagnosed, in China each year. There are highly unmet clinical needs in this area due to lack of effective treatment options.

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

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

¹ Cocco, E., Scaltriti, M., and Drilon, A. (2018). NTRK fusion-positive cancers and TRK inhibitor therapy. Nature Reviews Clinical Oncology 15, 731-747.

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Zurletrectinib has demonstrated outstanding efficacy and safety profile in adult, adolescent, and pediatric patients with tumors harboring NTRK fusion genes, bringing better treatment options for patients with solid tumors.