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BioCentury
ARTICLE | Regulation

June 10 Quick Takes: Everest wins first China approval

Plus BARDA buys additional monkeypox and smallpox vaccine from Bavarian Nordic, and updates from Fulcrum, ADC, GSK and more

June 11, 2022 1:13 AM UTC

Everest Medicines Ltd. (HKEX:1952) gained its first regulatory authorization Friday when China approved Trodelvy sacituzumab govitecan-hziy to treat triple-negative breast cancer. The company has local rights to the antibody-drug conjugate targeting TROP2 under a 2019 deal with Immunomedics Inc., which Gilead Sciences Inc. (NASDAQ:GILD) has since acquired. Trodelvy led to an overall response rate of 38.8% among 80 patients in the EVER-132-001 trial in China; much of its value to Gilead and Everest lies in its potential for label expansions, although its benefit in another breast cancer population has been modest.

The U.S. Biomedical Advanced Research and Development Authority (BARDA) ordered 500,000 additional doses of the smallpox and monkeypox vaccine Jynneos from Bavarian Nordic A/S (CSE:BAVA; Pink:BVNRY) for delivery in 2022, bringing the total U.S. inventory of liquid-frozen Jynneos to nearly 2 million doses. The Danish company amended its 2022 guidance, with revenue now expected to be DKK 1,800-2,000 million, up from DKK 1,400-1,600 million...

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