SUZHOU, China, Jan. 13, 2020 /PRNewswire/ -- 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, today announced 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.
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 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.
About Innovent
Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of oncology, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.
Since it was founded, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 21 innovative assets in the fields of oncology, autoimmune, metabolic diseases and other major therapeutic areas, with sixteen in clinical development, five in Phase 3 clinical trials, three NDAs under review by NMPA with priority review status, while Tyvyt®, officially approved for marketing in China in 2018, has been the only PD-1 inhibitor included in the NRDL since 2019.
Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com.
About Coherus BioSciences, Inc.
Coherus is 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. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales and marketing and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus commercializes UDENYCA® (pegfilgrastim-cbqv) in the U.S. and has received regulatory approval for UDENYCA® in the European Union. Coherus is advancing late-stage clinical products CHS-1420 (adalimumab biosimilar), Bioeq's Lucentis (ranibizumab) biosimilar and Innovent's Avastin (bevacizumab) biosimilar towards commercialization, and early-stage clinical products, CHS-2020, an Eylea (aflibercept biosimilar), and CHS-131, a small molecule for nonalcoholic steatohepatitis (NASH) and multiple sclerosis. For additional information, please visit www.coherus.com.
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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.
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"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 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.
About Innovent
Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of oncology, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.
Since it was founded, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 21 innovative assets in the fields of oncology, autoimmune, metabolic diseases and other major therapeutic areas, with sixteen in clinical development, five in Phase 3 clinical trials, three NDAs under review by NMPA with priority review status, while Tyvyt®, officially approved for marketing in China in 2018, has been the only PD-1 inhibitor included in the NRDL since 2019.
Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com.
About Coherus BioSciences, Inc.
Coherus is 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. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales and marketing and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus commercializes UDENYCA® (pegfilgrastim-cbqv) in the U.S. and has received regulatory approval for UDENYCA® in the European Union. Coherus is advancing late-stage clinical products CHS-1420 (adalimumab biosimilar), Bioeq's Lucentis (ranibizumab) biosimilar and Innovent's Avastin (bevacizumab) biosimilar towards commercialization, and early-stage clinical products, CHS-2020, an Eylea (aflibercept biosimilar), and CHS-131, a small molecule for nonalcoholic steatohepatitis (NASH) and multiple sclerosis. For additional information, please visit www.coherus.com.
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SOURCE Innovent Biologics, Inc.
