Hutchmed Limited

🇨🇳China
Ownership
-
Employees
-
Market Cap
$2.9B
Website
investing.com
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GSK's Jemperli gets FDA breakthrough status for rectal cancer

GSK received FDA Breakthrough Therapy Designation for Jemperli (dostarlimab) to treat locally advanced dMMR/MSI-H rectal cancer, based on a phase II study showing a 100% clinical complete response rate in 42 patients. GSK's financial health score is 'GREAT', suggesting strong R&D investment potential. Dostarlimab aims to avoid standard treatment's long-term adverse effects, with ongoing studies to confirm findings and establish a new standard of care.
tradingview.com
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HUTCHMED to Receive Milestone Payment from Takeda following First European

HUTCHMED to receive US$10M milestone payment from Takeda following European approval and Spain's first national reimbursement for FRUZAQLA® (fruquintinib), a novel oral targeted therapy for metastatic colorectal cancer.
stocktitan.net
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HUTCHMED Secures First EU Reimbursement for FRUZAQLA®, Unlocks $10M Milestone Payment

HUTCHMED to receive $10 million milestone payment from Takeda following Spain's first national reimbursement for FRUZAQLA® (fruquintinib) in Dec 2024, marking the first European reimbursement for previously treated metastatic colorectal cancer. FRUZAQLA® received EU approval in June 2024 as the first novel oral targeted therapy for metastatic CRC regardless of biomarker status in over a decade.
onclive.com
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China's NMPA Grants Breakthrough Therapy Designation to Savolitinib Plus Osimertinib in EGFR-mutant, MET-amplified NSCLC Post-EGFR Inhibitor Therapy

China's NMPA granted breakthrough therapy designation to savolitinib and osimertinib for EGFR-mutant, MET-amplified NSCLC post-EGFR inhibitor therapy. The combination is being evaluated in the phase 3 SACHI trial vs platinum-doublet chemotherapy. Eligibility includes EGFR sensitizing mutations, MET amplification, and measurable lesions. The primary endpoint is investigator-assessed PFS, with secondary endpoints including overall survival and safety. The FDA also granted fast track designation to the combination in 2023.
globenewswire.com
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HUTCHMED Announces Breakthrough Therapy Designation

HUTCHMED announces NMPA's Breakthrough Therapy Designation for ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) combo in EGFR mutation-positive NSCLC with MET amplification. The treatment is being evaluated in China's Phase III SACHI trial, comparing its efficacy and safety to standard platinum-based chemotherapy. NMPA grants BTD to therapies addressing life-threatening diseases with significant advantages over existing treatments, potentially expediting development and review.
pharmabiz.com
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Imfinzi receives US FDA approval to treat patients with limited-stage small cell lung cancer

AstraZeneca's Imfinzi approved in the US for limited-stage small cell lung cancer (LS-SCLC) after chemotherapy and radiation, based on ADRIATIC trial results showing improved survival and reduced risk of death and disease progression.
drugs.com
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Imfinzi Approved in the US as First and Only Immunotherapy Regimen for Patients with Limited-Stage Small Cell Lung Cancer

Imfinzi (durvalumab) is a PD-L1 inhibitor used in various cancer treatments, including NSCLC, SCLC, biliary tract cancer, and endometrial cancer. AstraZeneca, a global biopharmaceutical company, focuses on oncology, rare diseases, and bio-pharmaceuticals, aiming to redefine cancer care and eliminate it as a cause of death.
bioworld.com
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NMPA clears drugs from Innovent/Hutchmed, Hengrui, Henlius, Luye

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