BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

BeiGene announced that the CHMP of the European Medicines Agency has issued a positive opinion recommending approval of BRUKINSA (zanubrutinib) for adult patients with chronic lymphocytic leukemia (CLL). This makes BRUKINSA the only BTK inhibitor to demonstrate superior efficacy in head-to-head trials against standard care. Notably, it has lower rates of atrial fibrillation compared to traditional treatments. Following the CHMP's endorsement, the European Commission's final decision on marketing approval is anticipated within 67 days, potentially expanding access across the EU.

BeiGene announced that BRUKINSA (zanubrutinib) demonstrated superior Progression-Free Survival (PFS) compared to IMBRUVICA (ibrutinib) in the final analysis of the Phase 3 ALPINE trial. The trial, with 652 patients globally, revealed that BRUKINSA is generally well tolerated, with safety findings consistent with previous reports. The FDA is reviewing BeiGene’s supplemental New Drug Application for BRUKINSA to treat Chronic Lymphocytic Leukemia (CLL), with a target action date of January 20, 2023. This adds to the evidence supporting BRUKINSA's efficacy against CLL.

BRUKINSA (zanubrutinib), developed by BeiGene, has received a positive recommendation from the National Institute for Health and Care Excellence (NICE) for treating Waldenström’s Macroglobulinemia (WM) in adults. This marks it as the first and only BTK inhibitor endorsed for routine use in England and Wales. NICE determined BRUKINSA to be cost-effective, with a threshold of £20,000-30,000 per quality-adjusted life year (QALY). The drug's approval addresses high unmet needs, offering an alternative to existing therapies that may cause severe side effects.

BeiGene has received a positive opinion from the European Medicines Agency (EMA) for its drug BRUKINSA (zanubrutinib), the first Bruton’s Tyrosine Kinase (BTK) inhibitor for treating relapsed or refractory marginal zone lymphoma (MZL) in Europe. The recommendation follows successful Phase 2 trial results showing a 68% overall response rate among patients. If approved, BRUKINSA will offer a chemotherapy-free treatment option for MZL patients, addressing a significant unmet need in this rare blood cancer category.

BeiGene shared significant updates on tislelizumab at ESMO 2022. The Phase 3 RATIONALE 301 trial showed non-inferiority for overall survival (OS) against sorafenib, with median OS of 15.9 months for tislelizumab versus 14.1 months for sorafenib. Tislelizumab also exhibited a higher objective response rate (ORR) of 14.3% compared to 5.4% for sorafenib. Its safety profile proved favorable, with significantly lower rates of grade >3 adverse events (48.2% vs 65.4%). Additional studies with tislelizumab underscore its potential across various tumor types.

BeiGene (NASDAQ: BGNE) will participate in the Morgan Stanley 20th Annual Global Healthcare Conference on September 14, 2022, at 9:10 a.m. ET. The event will feature a fireside chat and will be accessible via a live webcast on BeiGene's investor website. An archived replay will be available for 90 days post-event. BeiGene is dedicated to developing innovative and affordable oncology medicines to enhance treatment outcomes globally, employing a team of over 8,500 across key locations in Beijing, Cambridge, and Basel.

BeiGene announced the acceptance of a supplemental biologics license application (sBLA) for tislelizumab in combination with chemotherapy as a first-line treatment for advanced esophageal squamous cell carcinoma (ESCC) by China's National Medical Products Administration (NMPA). This application is based on positive interim data from the RATIONALE 306 trial, which involved 649 participants across several regions. Tislelizumab is already approved in China for other indications and supports BeiGene's commitment to improving oncology treatment globally.

BeiGene has entered a strategic partnership with Ontada, a McKesson company, aimed at enhancing patient access to oncology medicines through real-world evidence (RWE). The collaboration will focus on developing RWE data and insights to support community oncology care, improving education on financial impacts and therapeutic differentiation of oncology treatments. BeiGene aims to bring 10 new molecules to clinical trials annually starting in 2023. This partnership is expected to enhance patient outcomes and affordability in cancer care.

BeiGene announced that its global Phase 3 RATIONALE 301 trial for tislelizumab met its primary endpoint of non-inferior overall survival compared to sorafenib in treating unresectable hepatocellular carcinoma (HCC). The trial involved over 600 patients from the U.S., Europe, and Asia. Tislelizumab's safety profile remained consistent with previous studies, showing no new safety signals. This marks the eighth positive Phase 3 trial outcome for tislelizumab across various cancer types. Full safety and efficacy results will be presented at an upcoming medical conference.