Beigene Ltd Stock Price, News & Analysis

BeiGene has received its second regulatory approval for BRUKINSA (zanubrutinib) in Israel, targeting adult patients with Waldenström’s Macroglobulinemia (WM). This approval comes after the initial sanction for mantle cell lymphoma in 2021. BRUKINSA is now nationally reimbursed for patients in second or third-line treatment for WM. The drug has over 20 approvals globally, with more than 40 regulatory submissions currently under review.

BeiGene announced that the China National Medical Products Administration has granted conditional approval for its anti-PD-1 antibody, tislelizumab, to treat adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors.

This approval adds to the existing six indications in China for tislelizumab, enhancing its access among patients with limited treatment options. The approval is based on a Phase 2 trial with a total of 80 patients, demonstrating consistent treatment efficacy.

BeiGene announces that BRUKINSA (zanubrutinib) has received approval from Health Canada for treating adult patients with marginal zone lymphoma (MZL) who have undergone at least one prior anti-CD20 therapy. This approval marks the third indication for BRUKINSA in Canada, following its approvals for mantle cell lymphoma and Waldenström’s macroglobulinemia. BRUKINSA demonstrated an overall response rate of 68% in clinical trials, with manageable safety profiles despite serious adverse events reported in some patients.

BeiGene (NASDAQ: BGNE) will participate in the Cowen 42nd Annual Health Care Conference on March 7, 2022, at 9:50 a.m. ET. The event will be accessible via a live webcast on BeiGene's investor website, with an archived replay available for 90 days post-event.

As a global biotechnology company, BeiGene focuses on developing innovative and affordable medicines, aiming to improve patient access and treatment outcomes worldwide. The company is committed to enhancing access to medicines for two billion people by 2030.

BeiGene reported significant financial results for Q4 and full year 2021, with product revenue of $196.8 million and $634.0 million, marking increases of 96.6% and 105.3%, respectively. Key drivers included sales of BRUKINSA, which rose by 378% in Q4, and tislelizumab sales of $54.4 million. Despite a net loss of $585.7 million for Q4, BeiGene's cash position improved to $6.62 billion. The company anticipates continued revenue growth due to regulatory approvals and expanding product reach, particularly in the U.S. and China.

BeiGene announced the FDA's acceptance of its supplemental new drug application for BRUKINSA (zanubrutinib) to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The PDUFA target action date is October 22, 2022. The filing includes data from two pivotal Phase 3 trials—ALPINE and SEQUOIA—demonstrating BRUKINSA's superior efficacy over ibrutinib and chemoimmunotherapy. This milestone could enhance treatment options for patients with CLL, addressing unmet medical needs.

BeiGene (NASDAQ: BGNE) has announced the acceptance of two new indication applications for BRUKINSA (zanubrutinib) by the European Medicines Agency (EMA) for chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL). This follows BRUKINSA’s previous approval for Waldenström’s macroglobulinemia in November 2021. The applications are supported by data from extensive Phase 3 trials showing improved overall response rates and better cardiac safety compared to other treatments. The company aims to enhance patient access to innovative therapies across the EU.

BeiGene (NASDAQ: BGNE) has announced that its BTK inhibitor BRUKINSA (zanubrutinib) has received approval from Swissmedic for treating adult patients with Waldenström’s macroglobulinemia in Switzerland. This approval adds to its existing registrations in 44 markets worldwide. The decision is supported by data from a Phase 3 clinical trial, though the primary endpoint of statistical superiority over ibrutinib was not met. BRUKINSA is now available as a treatment option for patients who have undergone prior therapies or are not suitable for standard treatment.

BeiGene, a global biotechnology company, announces its participation in the Guggenheim Healthcare Talks, 2022 Oncology Conference on February 10, 2022, at 9:00 a.m. ET. Investors can access a live webcast via BeiGene’s [investor website](http://ir.beigene.com) or [HKEX](http://hkexir.beigene.com). An archived replay will be available for 90 days post-event. BeiGene is dedicated to developing innovative medicines to enhance patient treatment outcomes worldwide, with a commitment to improving access for two billion more people by 2030.