The Prescription Drug User Fee Act (PDUFA) target action date is OctoĪdvanced BRUKINSA in new markets, with more than 20 marketing authorization applications submitted outside of the United States and China, covering more than 40 countries and regions, including by BeiGene in the European Union (EU), Canada, Australia, South Korea, Singapore, and Taiwan, and with support from our five distribution partners: Adium Pharma S.A. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). Product revenue consisted of sales in China of tislelizumab and sales of BRUKINSA in China and the United States, as well as sales in China of in-licensed products from our collaborations with Amgen and Bristol Myers Squibb (BMS) andĪnnounced inclusion of tislelizumab, BRUKINSA ® (zanubrutinib) and XGEVA ® (120-mg denosumab) in five indications in the updated National Reimbursement Drug List (NRDL) in China.īRUKINSA ® (zanubrutinib), a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects, approved in the United States and China in selected indications and under development for additional approvals globally.Īnnounced that the U.S. Generated $100.10 million and $308.87 million in product revenue in the three and twelve months ended December 31, 2020, respectively.
Recent Business Highlights and Upcoming Milestones With the recent inclusion of our products on the National Reimbursement Drug List in China we are working to expand access to our oncology treatments across China and drive further revenue growth.” “Our commercial teams continue to execute, with product revenue of $100 million for the fourth quarter and $309 million for the year, representing increases of 76% and 39%, respectively, over the prior year periods. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. “We made significant progress in the fourth quarter of 2020 and more recently with our collaboration agreement with Novartis to develop and commercialize tislelizumab in North America, Europe, and Japan, two positive Phase 3 readouts for tislelizumab demonstrating overall survival benefits over standard of care chemotherapy, and the expansion of our commercial portfolio, including the recent approval of tislelizumab in China in first-line squamous non-small cell lung cancer,” said John V.
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(NASDAQ: BGNE HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today reported recent business highlights, anticipated upcoming milestones, and financial results for the fourth quarter and full year of 2020.
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