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) to conduct the clinical trial of ICP-189, a novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor, in combination with furmonertinib, a highly brain-penetrant, broadly active mutation-selective EGFR (epidermal growth factor receptor) inhibitor, in China.

In mid-July, InnoCare and ArriVent announced the clinical development collaboration to evaluate the anti-tumor activity and safety of ICP-189 combined with furmonertinib in patients with advanced non-small cell lung cancer (NSCLC).

Furmonertinib is being advanced by ArriVent in global studies in patients with advanced or metastatic NSCLC with EGFR or HER2 mutations, including exon 20 insertion mutations and other uncommon EGFR mutations. It is approved in China as a first-line treatment for adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations, where it is being further developed for additional indications with Shanghai Allist Pharmaceuticals Co., Ltd, (SSE: 688578) who discovered furmonertinib.

ICP-189 is a potent and selective oral allosteric inhibitor of SHP2, developed by InnoCare for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents. In the dose escalation study, the dosage has been escalated up to 120 mg with no DLT observed and a favorable PK and safety profile has been demonstrated. Preliminary efficacy was observed in ICP-189 monotherapy. One patient with cervical cancer in the 20 mg dose cohort achieved confirmed partial response.

Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said: “SHP2 inhibitor is an ideal partner for combination with multiple targeted and immune-oncology therapies in the field of solid tumor. ICP-189 has demonstrated significant anti-tumor effect in tumor models driven by KRAS^G12C mutation and EGFR over-expression. We will work with ArriVent to accelerate clinical development of the combination of ICP-189 and furmonertinib, so that this innovative therapy can benefit patients with advanced NSCLC earlier."

NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases.

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 cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. For more information, please visit: http://www.innocarepharma.com.

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