On January 13, 2020 Innovent Biologics, Inc. ("Innovent" or the "Company") (HKEX: 01801), a biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported that the Company has entered into an out-license agreement with Coherus BioSciences, Inc. ("Coherus",Nasdaq: CHRS), a leading biosimilar company that develops and commercializes its own high-quality therapeutics as well as those of others seeking capable access to the United States market, to commercialize Innovent’s biosimilar candidate to Avastin (bevacizumab) (IBI305) in the United States and Canada (Press release, Innovent Biologics, JAN 13, 2020, View Source [SID1234553122]).
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Coherus plans to file a Biologics License Application ("BLA") with the U.S. Food and Drug Administration ("FDA") in late 2020 or early 2021 depending on FDA interaction timing, and to launch directly upon approval. IBI305 successfully completed a large Phase 3 safety and efficacy study in China, and the application was filed for approval and was accepted by the National Medical Products Administration ("NMPA") in China in January 2019, and subsequently granted priority review status. Also, under the terms of the agreement, Coherus has a non-exclusive option to license Innovent’s biosimilar to Rituxan (rituximab) (IBI301) for development and commercialization in the United States and Canada. IBI301 was filed for approval and accepted by the NMPA in China in June 2019 with priority review status.
"The clinical efficacy and safety results of IBI305 compared with bevacizumab in advanced, first-line, non-squamous NSCLC patients were presented at the 55th Annual Meeting of the ASCO (Free ASCO Whitepaper) in 2019. With the encouraging results, IBI305 is expected to be high-quality and effective therapy for patients with solid tumors," said Michael Yu, Ph.D., Founder, Chairman and CEO of Innovent. "UDENYCA, has been the most successful biosimilar launch in the United States, and made Coherus the obvious partner of choice. Coherus and Innovent share a very similar mission, vision and set of values. We are pleased to be working together to expand the products’ presence in the U.S. and benefit more patients globally."
"We are excited to enter into a strategic collaboration with one of the premier Chinese biologics companies," said Denny Lanfear, Chairman and CEO of Coherus. "Innovent is an impressive fully-integrated organization delivering substantial benefits to the healthcare system and patients in China with their first approved and successfully commercialized PD-1. Its oncology therapeutics complement UDENYCA and advance our core mission to expand choice, improve patient access and lower healthcare costs in the United States."
According to the terms of the agreement, Coherus will pay up to US$45 million for upfront and milestones payments for IBI305. In addition, Coherus will also pay double-digit percent of royalty payments based on future sales of IBI305. Financial terms for IBI301 will be the same when optioned.