Biopharmaceutical company HUTCHMED (China) Limited (Nasdaq: HCM) (AIM: HCM) (HKEX: 13) announced on Wednesday that it has completed patient enrollment for SANOVO, its China Phase III trial evaluating ORPATHYS (savolitinib) in combination with TAGRISSO (osimertinib) as a first-line treatment for patients with non-small cell lung cancer (NSCLC) harbouring EGFR mutations and MET overexpression. The final patient was enrolled on 18 August 2025.
SANOVO is a blinded, randomised, controlled study comparing the efficacy and safety of the ORPATHYS plus TAGRISSO combination against TAGRISSO monotherapy, a standard-of-care option. The primary endpoint is progression-free survival, with secondary measures including overall survival, objective response rate and safety. Topline results are expected in H2 2026, with potential submission to China's National Medical Products Administration if outcomes are positive.
ORPATHYS, a selective MET tyrosine kinase inhibitor, is co-developed and commercialised in China by AstraZeneca and HUTCHMED. TAGRISSO, AstraZeneca's third-generation EGFR-TKI, is a globally established therapy across multiple stages of EGFR-mutated NSCLC.
The SANOVO trial builds on promising results from earlier studies, including TATTON and SAVANNAH, and follows recent China approval of the ORPATHYS and TAGRISSO combination in June 2025 for EGFR mutation-positive NSCLC patients with MET amplification after EGFR TKI progression.
HUTCHMED is advancing multiple late-stage oncology programmes, with three medicines already marketed in China and international approvals secured in the US, Europe and Japan.
Airiver medical receives FDA approval for central airway stenosis trial
INOVIO to begin rolling submission of BLA for INO-3107
Calluna Pharma begins Phase 2 study of CAL101 in idiopathic pulmonary fibrosis
Coya Therapeutics wins FDA clearance to advance COYA 302 into Phase 2 ALS trial
Innovent Biologics receives approval over squamous cell lung cancer study
Novocure submits FDA PMA for Tumor Treating Fields therapy in pancreatic cancer
HUTCHMED completes enrollment in Phase III SANOVO trial of ORPATHYS and TAGRISSO in China
LivaNova announces commercial launch of Essenz Perfusion System in China
Precigen's PAPZIMEOS granted US FDA approval to treat with recurrent respiratory papillomatosis
Leads Biolabs completes patient enrollment in pivotal Opamtistomig trial for EP-NEC
BioDlink's bevacizumab injection secures Colombia and Pakistan marketing authorisation
Insmed's BRINSUPRI (brensocatib) non-cystic fibrosis bronchiectasis treatment approved by US FDA
Nuformix files US Orphan Drug Designation for NXP002 in Idiopathic Pulmonary Fibrosis