HUTCHMED announces savolitinib approved in China for patients with lung cancer with MET exon 14 skipping alterations

– First selective MET inhibitor approval in China in this setting –

– First regulatory approval for the oral, potent and selective MET tyrosine kinase inhibitor –

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., June 22, 2021 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) today announces that AstraZeneca PLC (“AstraZeneca”) and HUTCHMED’s savolitinib has been granted conditional approval in China for the treatment of patients with non-small cell lung cancer (“NSCLC”) with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. This approval follows a priority review designation by China’s National Medical Products Administration (“NMPA”) and marks the first regulatory approval globally for this oral, potent and selective MET tyrosine kinase inhibitor (“TKI”).

Approximately 2-3% of newly diagnosed NSCLC patients have MET exon skipping 14 alterations, a specific genetic mutation.

The approval by the NMPA was based on positive results from a Phase II trial conducted in China in patients with NSCLC with this mutation, including patients with the more aggressive pulmonary sarcomatoid carcinoma subtype. Savolitinib demonstrated effective anti-tumor activity based on an independent review of objective response rate (“ORR”) and disease control rate (“DCR”). The approval is conditional upon successful completion of a confirmatory study in this patient population.

Christian Hogg, Chief Executive Officer of HUTCHMED, said: “It is with great pleasure that today we announce the first regulatory approval of savolitinib globally, HUTCHMED’s third self-discovered oncology drug to be commercialized. Our collaboration with AstraZeneca in 2011 has been an important driver in the development of this novel targeted oncology drug, involving both a China-based biotech and a global pharma company. This approval is a testament to the perseverance and scientific ingenuity of this long-standing alliance, and we are hopeful that this is only the beginning of the progress we can achieve for patients with MET-altered tumors.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit of AstraZeneca, said: “This approval makes savolitinib the only targeted medicine approved for these biomarker-selected patients in China, and it adds another novel medicine to our already diverse lung cancer portfolio. We are proud that this first-ever regulatory approval of savolitinib is in China, where we have a long-standing commitment to improving patient outcomes and working with the right partners to achieve that goal. Alongside HUTCHMED, we look forward to the continued development of this medicine across a range of cancers where MET alterations and amplification are drivers of tumor growth and treatment resistance.”