Hutchmed (China) Limited’s Orpathys (savolitinib) is now launched in China for patients with lung cancer and MET exon 14 skipping alterations that have progressed following prior systemic therapy or who are unable to receive chemotherapy. In June 2021, China became the first country globally to approve savolitinib. However, as seen with a few other China first approvals, Chinese biotech companies have started going first for domestic approval before expanding into other markets, says GlobalData, a leading data and analytics company.

The approval of savolitinib follows a priority review designation by the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) based on positive results from a single-arm Phase II trial conducted in China in patients with non-small cell lung cancer (NSCLC) with this mutation, including patients with the PSC subtype. Hutchmed has a partnership with AstraZeneca for commercialization of Orpathys in China.

GlobalData’s latest report, ‘Non-Small Cell Lung Cancer – Epidemiology Forecast Report to 2029, reveals that the diagnosed incident cases of NSCLC across Urban China are expected to increase from 0.3 million in 2019 to 0.46 million in 2029, at highest annual growth rate (AGR) of 5.32%.

Orpathys becomes the third drug globally and the first drug in China to be approved in the MET tyrosine inhibitor class.

The potential competitors include Merck KGaA’s MET inhibitor Tepmetko (tepotinib), which is the first drug from this class that received approval in MET-positive NSCLC, with Japanese approval in Mar 2020, and US FDA approval in Feb 2021. In addition, Novartis’ Tabrecta (capmatinib) becomes the second drug in this class with US FDA approval in May 2020.

Ms. Bhavani Nelavelly, Pharma Analyst at GlobalData, comments: “MET exon 14 skipping is found to be an oncogenic driver in NSCLC patients, and approval in highly selective segment of NSCLC patients targets the common yet challenging mutation where there is high unmet need. China has a huge oncology burden to manage, with the largest number of cancer patients globally. This approval is one more testimony of Chinese government policy reforms encouraging innovative oncology drug development. China has made critical progress in managing the burden with the acceleration of the innovative drug development.”

AstraZeneca already has a strong presence in the Chinese oncology market, and the commercialization of Orpathys will further boost its oncology portfolio. It further signifies AstraZeneca’s heavy focus in China market. Moreover, AstraZeneca and Hutchmed are exploring savolitinib across a range of cancers where MET alterations are drivers for tumor growth.

Ms. Nelavelly concludes: “In the past there were several agreements between a domestic company and western company, where the western company commercial capabilities were best used to boost overall market access for the drug. Orpathys is better positioned to gain from AstraZeneca’s commercial experience in China, as AstraZeneca has strong commercialization experience for its own lung cancer portfolio consisting of a wide range of drugs including Imfinzi, Iressa and Tagrisso. AstraZeneca reported 10% growth in sales in the China market for FY2020, with notable growth in Tagrisso and Imfinzi sales.”