BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

BeiGene announced that the China NMPA accepted a supplemental new drug application (sNDA) for BRUKINSA (zanubrutinib) to treat adult patients with Waldenström’s macroglobulinemia (WM). This follows the drug's recent NMPA approval for relapsed or refractory WM patients. The sNDA is supported by the Phase 3 ASPEN trial results, which suggest BRUKINSA may offer improved efficacy and safety compared to ibrutinib. There are approximately 1,000 new WM patients diagnosed annually in China, indicating a substantial market potential.

BeiGene, Ltd. (NASDAQ: BGNE) will participate in the J.P. Morgan 40th Annual Healthcare Conference on January 11, 2022, at 5:15 p.m. ET. The event will be accessible via a live webcast on BeiGene's investor website. An archived version will be available for 90 days post-event. As a global biotechnology company, BeiGene focuses on developing innovative medicines aimed at improving global health outcomes, with a goal of enhancing access for two billion people by 2030.

BeiGene has received approval from the China National Medical Products Administration for its anti-PD-1 antibody tislelizumab as a second- or third-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC). This marks the third lung cancer indication for tislelizumab in China and the approval is based on successful results from the global Phase 3 trial RATIONALE 303 which showed a significant increase in overall survival compared to docetaxel. With six approved indications, BeiGene aims to expand access to tislelizumab for patients in need.

BeiGene has announced a strategic collaboration with Novartis for the development of its investigational TIGIT inhibitor, ociperlimab. This includes Novartis funding additional global clinical studies alongside marketing rights for five Novartis oncology products in China. BeiGene will receive an upfront cash payment of $300 million, with potential milestone payments up to $745 million for regulatory approvals and $1.15 billion for sales milestones. The agreement is expected to enhance BeiGene's market presence and expedite access to critical therapies.

BeiGene launches the Bioisland Innovation Center (BIC) in Guangzhou, China, aimed at fostering biotechnology startups and early-stage medical innovations. This facility features advanced research infrastructure and support for entrepreneurs, aligning with BeiGene's vision to enhance patient care globally. With over 40 clinical candidates in its pipeline, BeiGene underscores its commitment to impactful medicines, aspiring to improve access for billions by 2030. The BIC represents a strategic move to cultivate new ideas and drive growth within the burgeoning Greater Bay Area biotech hub.

BeiGene has received marketing authorization from the UK Medicines and Healthcare products Regulatory Agency for BRUKINSA (zanubrutinib) to treat Waldenström's macroglobulinemia in eligible patients. This authorization follows the Phase 3 ASPEN trial, which showed BRUKINSA had a VGPR rate of 28% compared to 19% for ibrutinib. Furthermore, BRUKINSA demonstrated higher patient retention rates and fewer adverse events than its competitor, ibrutinib. The company aims to improve access to this treatment for patients in Great Britain.

BeiGene has successfully completed its STAR Offering on the Science and Technology Innovation Board, marking a significant milestone as the first triple-listed biotech firm on NASDAQ, HKEX, and STAR Market. The offering involved 115,055,260 RMB Shares, generating approximately RMB22.2 billion (US$3.5 billion) in gross proceeds. The shares began trading under the code '688235' on December 15, 2021. BeiGene aims to utilize the funds for research, clinical development, and expansion of its sales and marketing efforts in China.

BeiGene has announced a collaboration with Nanjing Leads Biolabs, granting BeiGene global rights to research and commercialize LBL-007, an investigational antibody targeting the LAG-3 pathway, outside of China. The deal includes a $30 million upfront payment and potential total payments up to $742 million, along with tiered royalties on sales. This partnership aims to enhance BeiGene's immuno-oncology portfolio, particularly in combination with its anti-PD-1 inhibitor, tislelizumab. LBL-007 is currently in Phase 1b/2 clinical trials in China.

BeiGene announced promising results from the interim analysis of the Phase 3 SEQUOIA trial for BRUKINSA in treatment-naïve chronic lymphocytic leukemia (CLL), showing superior progression-free survival (PFS) compared to bendamustine plus rituximab. The 24-month PFS rate for BRUKINSA was 85.5%, significantly higher than 69.5% for the control group. Consistent safety results were noted, with lower rates of adverse events like atrial fibrillation. Preliminary data for BRUKINSA combined with venetoclax in high-risk CLL patients also showed high efficacy and safety.