Takeda’s EXKIVITY (mobocertinib) Receives Approval from the NMPA of China, Becoming the First and Only Therapy Available for Patients with EGFR Exon20 Insertion+ NSCLC

Takeda (TSE:4502/NYSE:TAK) today announced that EXKIVITY (mobocertinib) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. EXKIVITY has shown clinically meaningful and durable responses in patients with locally advanced or metastatic EGFR Exon20 insertion+ NSCLC and is now the first and only treatment available for this patient population in China. EXKIVITY, an oral tyrosine kinase inhibitor designed to target Exon20 insertions, was reviewed as part of the NMPA’s Breakthrough Therapy program. Full approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

“The approval of EXKIVITY in China for patients with locally advanced or metastatic EGFR Exon20 insertion+ NSCLC was only possible through dedicated collaboration and support from the NMPA and the Chinese government,” said Awny Farajallah, Head, Global Medical Affairs Oncology, Takeda. “Lung cancer is a devastating disease, and we know the discovery and delivery of precision medicines like EXKIVITY to target cancer types that are hard-to-treat have the potential to improve patient outcomes. We are thrilled to introduce EXKIVITY in China as the second lung cancer therapy from Takeda and remain committed to research and development to meet the needs of this patient community.”

Lung cancer is the most commonly diagnosed cancer in China, and NSCLC accounts for approximately 85% of all lung cancer cases in the country.¹ Of those patients diagnosed with EGFR-mutated NSCLC in China, up to 10% harbor Exon20 insertions.^2-7 Despite this prevalence, patients in China have lacked a targeted treatment option designed to address cancers driven by these mutations.

“Since the discovery of EGFR mutations nearly twenty years ago, patients with Exon20 insertions have been waiting for a targeted therapy to treat their disease,” said Sean Shan, President of Takeda China. “The approval of EXKIVITY in China is a remarkable breakthrough, demonstrating the strong commitment of the Chinese government to encourage and accelerate the introduction of innovative therapies. EXKIVITY offers a targeted, oral therapy to a population that has been historically underserved, and this approval brings us one step closer to defeating this complex and heterogeneous disease for patients in this region.”