- HUTCHMED (China) Limited
- 02 January 2025 15:30:03
Source: Sharecast
The AIM-traded company revealed that its new drug application (NDA) for the combination of ‘Orpathys’, or savolitinib, and ‘Tagrisso’, or osimertinib, had been accepted by China’s National Medical Products Administration (NMPA) and granted priority review status.
It said the combination therapy targets patients with locally-advanced or metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC) exhibiting MET amplification, particularly after progression on first-line EGFR inhibitor therapy.
The NDA was supported by phase three trial data demonstrating the therapy’s superiority in progression-free survival compared to standard chemotherapy.
Hutchmed noted that the therapy previously received breakthrough therapy designation from the NMPA in December.
“This marks the first regulatory filing for the Orpathys and Tagriss combination,” said Dr Michael Shi, Hutchmed’s head of research and development and chief medical officer.
“The combination has demonstrated clear evidence to address MET-driven EGFR-inhibitor resistance and offers a continued path for oral treatment.”
Dr Shi said that with Hutchmed’s biomarker-specific approach, the company was “hopeful” to enhance treatment continuity and quality of life for NSCLC patients navigating the “challenging” journey.
“We and our partner AstraZeneca have been exploring this combination globally, through an array of late-stage clinical trials including the TATTON, SAVANNAH, SAFFRON and ORCHARD studies, and we hope to bring this all-oral, chemotherapy-free treatment option to patients with MET-driven lung cancer in the near future.”
In a separate announcement, Hutchmed disclosed plans to divest a 45% equity interest in its joint venture, Shanghai Hutchison Pharmaceuticals Limited (SHPL), for $608m.
The buyers include GP Health Service Capital and Shanghai Pharmaceuticals Holding.
Hutchmed said the move aligned with Hutchmed’s strategy to concentrate on its core oncology and immunology businesses.
The proceeds would fund advancements in its innovative pipeline, including its proprietary antibody-targeted therapy conjugate platform, with clinical trials expected to begin in late 2025.
SHPL, primarily focused on cardiovascular medications in China, contributed $47.4m in net income to Hutchmed in 2023.
Following the transaction, Hutchmed said it would retain a 5% equity stake in SHPL.
The deal, which requires shareholder and regulatory approvals, was anticipated to close by the end of the first quarter of 2025.
“This transaction to divest most of our holding in SHPL is another example of Hutchmed delivering on the strategy outlined in 2022, accelerating our path to profitability and focusing on core operations,” said Hutchmed chairman and non-executive director Dr Dan Eldar.
“SHPL is a well-established business, having delivered over $370m in dividends to Hutchmed throughout the years, and we are confident that it continues to have promising future growth prospects.
“We are focused on capitalising on our two decades of deep research into oncogenic drivers of disease and discovering and developing highly optimized therapies, through our unique ATTC platform.”
At 1503 GMT, shares in Hutchmed China were up 4.66% at 245.96p.
Reporting by Josh White for Sharecast.com.