Domestic Innovative Drug Savolitinib (Orpathys) Launches Commercial Sales in China Within Three Weeks of Approval

　　【Pharmaceutical Network Product News】Recently, HUTCHMED announced that Orpathys (savolitinib), co-developed with AstraZeneca, was commercially launched in China on July 12, 2021. This is an innovative drug with independent intellectual property rights in China, indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping mutations, whose disease has progressed on or who are intolerant to standard platinum-based chemotherapy.
 

It is understood that the New Drug Application (NDA) for savolitinib was previously granted priority review status by the National Medical Products Administration (NMPA), ensuring prioritized resource allocation throughout the regulatory review and approval process. In June of this year, savolitinib received conditional approval in China for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) factor exon 14 skipping mutations, whose disease has progressed following or who are intolerant to standard platinum-based chemotherapy. In other words, this new drug produced in China took less than three weeks to transition from regulatory approval to commercial launch. This highlights the accelerating pace at which new drugs produced in China are approved and marketed, bringing new treatment options to the vast lung cancer patient population in China.
 

China has a substantial lung cancer patient population and a high incidence rate. Data indicate that over 774,000 new lung cancer cases are diagnosed annually in China, accounting for more than one-third of the global total. Of these cases, over 80% are non-small cell lung cancer (NSCLC). It is estimated that MET exon 14 skipping mutations occur in approximately 2%–3% of NSCLC patients. This alteration represents a targetable mutation in the MET gene, and patients harboring it generally exhibit a poor prognosis. To overcome this clinical bottleneck, the development of next-generation, highly efficacious drugs is urgently needed.
 

As a selective oral small-molecule MET inhibitor, savolitinib inhibits tumor growth, angiogenesis, and tumor metastasis. The approval of savolitinib by China's National Medical Products Administration (NMPA) was based on positive results from a Phase II single-arm clinical trial conducted in China, which enrolled patients with non-small cell lung cancer (NSCLC) harboring such mutations, including those with pulmonary sarcomatoid carcinoma. According to the independent review assessment of the trial's primary endpoints—objective response rate (ORR) and disease control rate (DCR)—savolitinib demonstrated favorable and durable anti-tumor activity.
 

Additionally, according to a new dataset for savolitinib published in *The Lancet Respiratory Medicine*, in the TRES cohort (61 NSCLC patients), the IRC-assessed ORR was 49.2% and the DCR was 93.4%. The median time to response was 1.4 months, and the median DOR was 8.3 months, with 7 patients (10%) achieving a duration of response of at least 12 months. The median progression-free survival (PFS) was 6.8 months, with 6- and 12-month PFS rates of 52% and 31.9%, respectively. The median overall survival (OS) was 12.5 months.
 

The product was jointly developed by HUTCHMED and AstraZeneca, and HUTCHMED entered into a collaboration and commercialization agreement with AstraZeneca for savolitinib in 2011. Under the terms of the parties' licensing and collaboration agreement, the first commercial sale of Orpathys will trigger a US$25 million non-creditable and non-refundable milestone payment. HUTCHMED is responsible for the clinical development, marketing authorization, manufacturing, and supply of Orpathys in China, while AstraZeneca is responsible for its commercialization. AstraZeneca will pay HUTCHMED a fixed royalty of 30% on all sales of Orpathys in China.