Hutchmed Limited

Imfinzi (durvalumab) is a PD-L1 inhibitor used in various cancer treatments, including NSCLC, SCLC, biliary tract cancer, and endometrial cancer. AstraZeneca is a leader in oncology, focusing on early detection and innovative treatments for lung cancer and immuno-oncology, aiming to redefine cancer care and eliminate it as a cause of death.

Innovent Biologics and HUTCHMED announce conditional approval in China for TYVYT® (sintilimab) and ELUNATE® (fruquintinib) combination therapy for advanced endometrial cancer with pMMR tumors, following priority review and breakthrough therapy designation by the NMPA.

HUTCHMED and Innovent announce China's NMPA conditional approval for ELUNATE® (fruquintinib) combined with TYVYT® (sintilimab) for advanced endometrial cancer, based on FRUSICA-1 study results showing 35.6% ORR, 88.5% DCR, 9.5 months PFS, and 21.3 months OS.

Hutchmed renews contract with China's NHSA; Orpathys (savolitinib), an oral MET TKI for NSCLC with MET exon 14 skipping alterations, remains in the NRDL until Jan 1, 2025, under current terms. Orpathys, jointly developed by Hutchmed and AstraZeneca, is the first selective MET inhibitor in China and the NRDL.

HUTCHMED announces renewal of ORPATHYS® (savolitinib) inclusion in China's National Reimbursement Drug List (NRDL) effective January 1, 2025, maintaining current terms. ORPATHYS®, an oral MET TKI, received conditional approval in China in 2021 for treating NSCLC with MET exon 14 skipping alterations. The NRDL inclusion aims to improve drug affordability, covering 95% of China's population.

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HUTCHMED announces Takeda's launch of FRUZAQLA® (fruquintinib) in Japan, the first novel oral targeted therapy for metastatic colorectal cancer in over a decade, triggering a milestone payment to HUTCHMED.

Datopotamab deruxtecan, an investigational TROP2-directed ADC, is being evaluated in multiple clinical trials for advanced NSCLC, including TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01. These trials assess efficacy and safety in patients with actionable genomic alterations and those requiring systemic therapy following prior treatment. Primary endpoints include objective response rate (ORR) and progression-free survival (PFS). AstraZeneca and Daiichi Sankyo collaborate on the development and commercialization of datopotamab deruxtecan.

Combining osimertinib with savolitinib showed a 32% objective response rate in NSCLC patients with EGFR mutations and high MET overexpression/amplification after osimertinib failure, with a 49% response rate among those with high MET expression.