NEW YORK – Hutchmed said Thursday that the new drug application (NDA) for its c-MET inhibitor Orpathys (savolitinib) with AstraZeneca's Tagrisso (osimertinib) as a second-line treatment for patients with locally advanced or metastatic EGFR-positive non-small cell lung cancer with MET amplification was accepted by China's National Medical Products Administration (NMPA).
The company separately announced it was divesting most of its equity interest in Shanghai Hutchison Pharmaceuticals and would use the proceeds from the transaction to advance its pipeline.
China's NMPA granted priority review to the Orpathys-Tagrisso NDA. The NDA was based on data from the Phase III SACHI trial, which compared the Orpathys-Tagrisso combination to platinum-based doublet-chemotherapy, the standard-of-care treatment in this setting. The results from the SACHI trial have not yet been reported, but Hutchmed said the study has met is predefined primary endpoint of progression-free survival in a planned interim analysis.
Researchers will present data from SACHI at an upcoming medical meeting.
"The [Orpathys-Tagrisso] combination has demonstrated clear evidence to address MET-driven EGFR-inhibitor resistance and offers a continued path for oral treatment," Hutchmed Chief Medical Officer Michael Shi said in a statement. "With our biomarker-specific approach, we are hopeful to enhance treatment continuity and quality of life for NSCLC patients navigating this challenging journey."
The acceptance of the NDA also triggered a milestone payment to Hutchmed from AstraZeneca, the amount of which was not disclosed.
In 2021, Orpathys was approved in China for the treatment of NSCLC patients with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
Also on Thursday, Hutchmed said it was divesting 45 percent of its equity interest in Shanghai Hutchison Pharmaceuticals to GP Health Service Capital and Shanghai Pharmaceuticals Holding for $608 million in cash. Hutchmed previously held 50 percent equity interest in Shanghai Hutchison Pharmaceuticals, with Shanghai Pharma holding the other 50 percent.
Under the two agreements, GP Health Service Capital has agreed to acquire a 35 percent equity interest in Shanghai Hutchison Pharmaceuticals from Hutchmed for approximately $473 million in cash, while Shanghai Pharma has agreed to acquire a 10 percent equity interest from Hutchmed for approximately $135 million in cash. After the transactions, Shanghai Pharma will hold a total of 60 percent equity interest in Shanghai Hutchison Pharmaceuticals. Hutchmed will retain a 5 percent equity interest in the company.
In addition to using the proceeds to advance its pipeline, Hutchmed also plans to use the funds to enable the development of antibody-targeted therapy conjugates, a type of drug similar to an antibody-drug conjugate that instead combines antibodies with targeted therapies instead of cytotoxic payloads.