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.
Not satisfied with the findings of a World Trade Organization (WTO) dispute panel, Turkey informed the WTO April 28 that it has initiated arbitration proceedings to review those findings, which involve an EU complaint about measures Turkey employs concerning the production, importation and marketing of prescription drugs.
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.
Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA.
Former JHL Biotech Inc. CEO Racho Jordanov and former Chief Operating Officer Rose Lin were sentenced for their respective roles in conspiring to commit trade secret theft and wire fraud exceeding $101 million. The pair last summer admitted to obtaining confidential, proprietary, and trade-secret information from Roche Holding AG’s Genentech Inc. unit and using what they stole to reduce expenses and hasten the timeline of JHL’s efforts to develop biosimilars.
Three U.S.-listed China-based biopharmas were among five companies named this week by the U.S. SEC for reportedly failing to submit necessary accounting reports under the Holding Foreign Companies Accountable Act (HFCAA).
The U.S. Securities and Exchange Commission (SEC) recently issued a provisional list of five U.S.-listed Chinese companies that reportedly failed to submit necessary accounting reports required under Holding Foreign Companies Accountable Act. The list included three biopharmas: Beigene Ltd., Hutchmed Ltd., and Zai Lab Ltd.
Chinese investment in U.S. companies is dropping, but Chinese biopharma firms are increasingly eyeing licensing deals on early stage inventions patented by U.S. universities, Lin Sun-Hoffman, founding partner at Liu, Chen & Hoffman LLP, said during a Feb. 24 U.S. Patent and Trademark Office webinar on biopharma patents in China.
Despite Reata Pharmaceuticals Inc.’s complete response letter (CRL) for bardoxolone in treating kidney function loss in those with Alport syndrome, the street treated the company well on Feb. 28.
Over the past few years, China has been quick to make promises to improve its regulatory and patent schemes for biopharmaceuticals and medical devices in keeping with its World Trade Organization (WTO) commitments, but it’s been slow to fulfill those promises – at least in the eyes of the Office of the U.S. Trade Representative (USTR).
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