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Hutchmed (China) Ltd - Hong-Kong-based pharmaceutical company - Says China's National Medical Products Administration has granted conditional approval to Hutchmed and AstraZeneca PLC's MET inhibitor savolitinib.
The drug is used as a treatment for non-small cell lung cancer patients who have progressed on systemic therapy, are unable to receive chemotherapy, and harbor MET exon 14 skipping alterations in tumours. 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, it adds.
Chief Executive Officer Christian Hogg 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 tumours."
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By Arvind Bhunjun; arvindbhunjun@alliancenews.com
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