Top-line phase III results showing Hutchmed Ltd.’s targeted therapy fruquintinib reduced the risks of death and disease progression by 34% and 68%, respectively, for patients with metastatic colorectal cancer could “lay a solid foundation for Hutchmed to initiate discussions with regulatory authorities worldwide,” a spokesperson of Hutchmed, told BioWorld.
Top-line phase III results showing Hutchmed Ltd.’s targeted therapy fruquintinib reduced the risks of death and disease progression by 34% and 68%, respectively, for patients with metastatic colorectal cancer could “lay a solid foundation for Hutchmed to initiate discussions with regulatory authorities worldwide,” a spokesperson of Hutchmed, told BioWorld.
Beigene Ltd.’s tislelizumab met its primary endpoint of noninferior overall survival vs. sorafenib as a first-line treatment in hepatocellular carcinoma (HCC), marking the eighth positive phase III trial readout for the anti-PD-1 drug across multiple cancer types and lines of therapy.
Beigene Ltd.’s tislelizumab met its primary endpoint of noninferior overall survival vs. sorafenib as a first-line treatment in hepatocellular carcinoma (HCC), marking the eighth positive phase III trial readout for the anti-PD-1 drug across multiple cancer types and lines of therapy.
It’s an august August for Hutchmed Ltd. as it reported positive business results and a number of trial developments, including results from its pivotal global phase III FRESCO-2 trial evaluating the investigational use of fruquintinib in patients with advanced, refractory metastatic colorectal cancer, which met its primary endpoint of overall survival.
About $1.7 trillion in securities of China-based issuers listed on U.S. exchanges could face trading prohibitions in as little as two years, Y.J. Fischer, director of the U.S. SEC’s Office of International Affairs, warned during remarks at the May 24 annual meeting of the International Council of Securities Associations.
About $1.7 trillion in securities of China-based issuers listed on U.S. exchanges could face trading prohibitions in as little as two years, Y.J. Fischer, director of the U.S. SEC’s Office of International Affairs, warned during remarks at the May 24 annual meeting of the International Council of Securities Associations.
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
The China Securities Regulatory Commission has issued draft rules to permit U.S. auditors to examine U.S.-listed Chinese companies on April 2, 2022, following a provisional list by the U.S. SEC. The draft rules specified the requirement for the overseas-listed companies and relevant securities service providers to disclose confidential materials in overseas offerings and listing.
