Zhejiang Acea Pharmaceutical Co. Ltd. failed to obtain marketing approval from China’s NMPA for its third-generation EGFR tyrosine kinase inhibitor, abivertinib. The NDA was based on a phase II trial of abivertinib in patients with EGFR Thr790Met point mutation-positive non-small-cell lung cancer with disease progression from prior EGFR inhibitors.
Cullinan Oncology Inc.’s lead program deal with Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. brings $275 million up front and the potential for as much as $130 million in regulatory milestone payments.
Cullinan Oncology Inc.’s lead program deal with Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. brings $275 million up front and the potential for as much as $130 million in regulatory milestone payments.
Shanghai Allist Pharmaceuticals Co. Ltd.’s third-generation EGFR tyrosine kinase inhibitor, furmonertinib, met its primary endpoint in a phase III trial, demonstrating longer progression-free survival vs. first-generation EGFR TKI Iressa (gefitinib, Astrazeneca plc) as first-line therapy for locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer.
Shanghai Allist Pharmaceuticals Co. Ltd.’s third-generation EGFR tyrosine kinase inhibitor, furmonertinib, met its primary endpoint in a phase III trial, demonstrating longer progression-free survival vs. first-generation EGFR TKI Iressa (gefitinib, Astrazeneca plc) as first-line therapy for locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer.
A novel pharmacologically targetable metabolic mechanism driving resistance to epidermal growth factor receptor (EGFR)-targeting tyrosine kinase inhibitors (TKIs) has been identified in preclinical models of lung cancer in a Chinese study led by scientists at Shanghai Jiao Tong University School of Medicine.
Researchers have retrospectively divided more than 16,000 non-small-cell lung cancer (NSCLC) patients with EGFR mutations into four structure-based subgroups, and looked at how the members of each subgroup fared depending on which EGFR inhibitor they were given.
Researchers have retrospectively divided more than 16,000 non-small-cell lung cancer (NSCLC) patients with EGFR mutations into four structure-based subgroups, and looked at how the members of each subgroup fared depending on which EGFR inhibitor they were given.
Hongyun Biotech Co. Ltd. raised ¥100 million (US$15.5 million) in a series B round to move its new generation EGFR inhibitor, RC-01, to the IND stage in China and the U.S. for non-small-cell lung carcinoma (NSCLC). The plan is to finish the IND filing by the end of this year and start the trial in 2022.
Diamedica Therapeutics Inc.’s chief medical officer, Harry Alcorn, said that “due to the complexity [of diabetic kidney disease (DKD)], there's not a clear answer” as to why such patients did less well in the company’s Redux phase II trial with DM-199 (recombinant human tissue kallikrein 1 [KLK1]). “But I wouldn't say that there wasn't a response in the DKD group,” he said, citing upside in 30% of subjects.
