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BeiGene BeiGene Reports Third Quarter 2021 Financial Results Exhibit 99.1 • Recorded product revenue of $ 192.5 million for the third quarter , representing a 111 % increase from $ 91.1 million in the prior year period Received approvals for BRUKINSA® in two new indications in the U.S. and approvals in six other markets Submitted first biologics license application ( BLA ) in the U.S. for tislelizumab in collaboration with Novartis for patients with advanced or metastatic esophageal squamous cell carcinoma following prior systemic therapy CAMBRIDGE , Mass . and BEIJING , China , November 4 , 2021 -- BeiGene , Ltd. ( NASDAQ : BGNE ; HKEX : 06160 ) , a global biotechnology company focused on developing and commercializing innovative medicines worldwide , today reported recent business highlights , anticipated upcoming milestones , and financial results for the third quarter and nine months ended September 30 , 2021 . " We remain focused on translating science into highly impactful medicines and making these medicines more affordable and accessible to many more people with cancer around the world , " said John V. Oyler , Co - Founder , Chairman and Chief Executive Officer of BeiGene . " In the third quarter we had two new indications approved for BRUKINSA in the United States , and recent BRUKINSA approvals in Australia , Singapore , Brazil , Russia , and Chile as well as a positive CHMP opinion for our first BRUKINSA filing in Europe . Tislelizumab's BLA for esophageal squamous cell carcinoma ( ESCC ) has been accepted for review by the FDA , which is the first filing for our internally developed anti - PD - 1 medicine outside of China and an important achievement in our collaboration with Novartis . This is one of many global tislelizumab studies that comprise a comprehensive PD - 1 program that has enrolled over 5,600 patients in more than 30 countries and regions and includes over 1,700 patients from outside of China . We also continued to expand and strengthen our strategic competitive advantages that we feel are critical to transform the industry and bring innovative and accessible medicines to billions more people around the world . These include research , predominantly CRO - free global clinical development , global commercial infrastructure , and internal manufacturing capabilities . " Recent Business Highlights and Upcoming Milestones Commercial Operations • • • Product sales increased 111 % in the third quarter of 2021 compared to the prior year period , primarily due to increased sales of our internally developed products and in - licensed products from Amgen ; Global sales of BRUKINSA totaled $ 65.8 million in the third quarter , representing a 320 % increase compared to the prior year period ; U.S. sales of BRUKINSA totaled $ 33.7 million in the third quarter compared to $ 5.7 million in the comparable prior year period . U.S. sales continued to accelerate in the quarter , driven by continued uptake in mantle cell lymphoma ( MCL ) and the recent FDA approvals in Waldenström's macroglobulinemia ( WM ) and marginal zone lymphoma ( MZL ) . BRUKINSA sales in China totaled $ 32.1 million in the third quarter , representing growth of 223 % compared to the prior year period , driven by a significant increase in all approved indications , including chronic lymphocytic leukemia ( CLL ) ; Sales of tislelizumab in China totaled $ 77.0 million in the third quarter , representing a 54 % increase compared to the prior year period . In the third quarter , new patient demand from broader reimbursement and further expansion of our salesforce and hospital listings continued to drive increased market penetration and market share for tislelizumab ; The commercial organization in China continued to demonstrate its ability to bring new products to market , launching the second product from the Amgen collaboration , BLINCYTO® ( blinatumomab ) , which contributed $ 5.0 million of sales in the third quarter . Two additional new products are expected to be approved or launched by the end of the year ; and We are preparing for the upcoming National Reimbursement Drug List ( NRDL ) negotiation in China for our eligible medicines , including tislelizumab in first - line non - squamous non - small cell lung cancer ( NSCLC ) , first - line squamous NSCLC and second- or third - line hepatocellular carcinoma ( HCC ) , BRUKINSA in WM , and pamiparib in germline BRCA ( gBRCA ) mutation - associated recurrent advanced ovarian , fallopian tube , or primary peritoneal cancer who have been treated with two or more lines of chemotherapy . The NRDL negotiations are anticipated to be completed in the fourth quarter of 2021 .