Beigene Ltd Stock Price, News & Analysis

BeiGene announced that the Center for Drug Evaluation of China has accepted a supplemental biologics license application for tislelizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC). The sBLA is underpinned by data from the RATIONALE 301 clinical trial, which involved 674 participants across Asia, Europe, and the US. HCC has a poor prognosis, particularly in China, where survival rates are low. Tislelizumab is already approved in China for other indications and aims to expand treatment access for HCC patients.

BeiGene announced the final results of the ALPINE trial, demonstrating that BRUKINSA has superior progression-free survival (PFS) compared to IMBRUVICA in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The trial involved 652 patients globally; BRUKINSA achieved a PFS rate of 78.4% at 24 months versus 65.9% for IMBRUVICA. Additionally, BRUKINSA exhibited a favorable cardiac safety profile, with fewer cardiac events leading to treatment discontinuation. The FDA is currently reviewing the supplemental New Drug Application (sNDA) for BRUKINSA, with a decision expected by January 20, 2023.

Phanes Therapeutics has entered a clinical supply agreement with BeiGene (NASDAQ: BGNE) to study PT199, an anti-CD73 monoclonal antibody, in combination with BeiGene's tislelizumab for advanced solid tumors. The Phase I clinical trial (NCT05431270) will assess the safety and efficacy of this combination in patients who have not responded to standard treatments. PT199 is designed to inhibit immunosuppressive environments in tumors and aims to enhance antitumor immune responses.

BeiGene announced the final progression-free survival (PFS) results from the ALPINE trial, comparing BRUKINSA (zanubrutinib) with IMBRUVICA (ibrutinib) in relapsed/refractory CLL and SLL patients. The findings, to be presented at the American Society of Hematology (ASH) Annual Meeting on December 13, 2022, showed superior PFS for BRUKINSA (HR: 0.65). With nearly 30 months of follow-up, BRUKINSA demonstrated a favorable safety profile and lower discontinuation rates compared to ibrutinib. Investor events will be held in New Orleans and via webcast.

BeiGene has received European Commission approval for BRUKINSA (zanubrutinib) to treat adult patients with chronic lymphocytic leukemia (CLL), expanding its treatment options for both treatment-naïve and relapsed/refractory cases. BRUKINSA demonstrated superior efficacy compared to IMBRUVICA in clinical trials, achieving an overall response rate of 80.4% versus 72.9%. The drug also has a favorable safety profile with lower rates of atrial fibrillation. This approval opens up significant growth opportunities for BeiGene in the European market.

BeiGene (NASDAQ: BGNE) has received approval in Brazil for BRUKINSA (zanubrutinib) to treat adult patients with Waldenström’s macroglobulinemia (WM) and relapsed/refractory marginal zone lymphoma (MZL). This follows its previous approval for mantle cell lymphoma (MCL). BRUKINSA is designed for targeted BTK inhibition and supports a broad clinical program, with over 4,700 subjects in 35 trials globally. It is now approved in 58 markets, enhancing access to innovative cancer treatments worldwide.

BeiGene reported strong financial results for Q3 2022, with product revenue of $349.5 million, an 82% increase from the prior year. Key products, BRUKINSA and tislelizumab, generated revenues of $155.5 million and $128.2 million, respectively. BRUKINSA demonstrated superior Progression-Free Survival compared to IMBRUVICA in its Phase 3 ALPINE trial. Despite a net loss of $557.6 million, the company maintains a robust cash position of $5.1 billion for future investments and growth.

BeiGene has announced its participation in two investor conferences: the 6th Annual Cowen IO Next Virtual Conference on November 11 at 9:40 a.m. ET and the 13th Annual Jefferies Global Healthcare Conference on November 16 at 11:25 a.m. ET. A live webcast will be available on BeiGene's investor website, with an archived replay accessible for 90 days post-event. BeiGene is dedicated to developing affordable oncology medicines and operates globally with over 9,000 employees across multiple locations including Beijing, Cambridge, and Basel.

BeiGene, a global biotechnology company, announced the acceptance of 15 abstracts for the upcoming American Society of Hematology (ASH) Annual Meeting from December 10-14, 2022, in New Orleans. Among the highlights are three oral presentations focusing on BRUKINSA (zanubrutinib) and the novel Bcl-2 inhibitor BGB-11417. These findings showcase significant progress in developing treatments for B-cell malignancies. An investor event is scheduled for December 11, at 8:00 PM CST to discuss the data presented.