BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

BeiGene reported a remarkable third quarter with product revenue reaching $192.5 million, up 111% from $91.1 million year-over-year. Key approvals for BRUKINSA in the U.S. include new indications, while the FDA accepted the first BLA for tislelizumab targeting esophageal cancer. Total revenue for the quarter was $206.4 million, with a net loss of $413.9 million. Cash and equivalents totaled $3.9 billion. The company continues to expand its global footprint, emphasizing affordability and accessibility for cancer treatments.

BeiGene announced positive results from the SEQUOIA trial, showcasing that BRUKINSA (zanubrutinib) outperforms traditional chemoimmunotherapy in patients with treatment-naïve chronic lymphocytic leukemia (CLL). Achieving significant improvements in progression-free survival, the data reflects strong efficacy with low rates of atrial fibrillation, a common side effect of other treatments. Additional findings suggest BRUKINSA's potential for patients intolerant to existing BTK inhibitors. These results will be presented at the American Society of Hematology meeting from December 11-14, 2021.

BeiGene announced that BRUKINSA (zanubrutinib) received regulatory approval in Russia for treating adult patients with mantle cell lymphoma (MCL) who have undergone at least one prior therapy. This marks the first approval of BRUKINSA in Russia, expanding its reach to ten countries globally. The drug, distributed exclusively by Nanolek, showed an overall response rate of 83.7% in clinical trials. The approval reinforces BRUKINSA's status as a competitive treatment option for patients with MCL.

BeiGene announced the approval of BRUKINSA® (zanubrutinib) in Australia for adults with mantle cell lymphoma (MCL) who have undergone at least one prior therapy. This marks the second indication for BRUKINSA in Australia, following its initial approval for Waldenström’s macroglobulinemia in October 2021. Currently, BRUKINSA is authorized in nine countries for MCL. With an overall response rate of 83.7% from clinical trials, the new indication provides patients with critical treatment options as MCL is typically hard to treat and often diagnosed late.

BeiGene has announced that BRUKINSA (zanubrutinib) has received approval in Australia for treating mantle cell lymphoma (MCL) in adult patients who have undergone at least one prior therapy. This marks the drug's second approved indication in Australia, following its initial approval for Waldenström's macroglobulinemia. To date, BRUKINSA is approved in nine countries for MCL. The drug achieved an overall response rate of 83.7% in clinical trials, reflecting its potential as a new treatment option for MCL patients in Australia.

BeiGene has announced that its drug BRUKINSA (zanubrutinib) has received approval from the Australia Therapeutic Goods Administration for treating adult patients with Waldenström’s macroglobulinemia who have undergone at least one prior therapy or are first-line treatment candidates. This follows a recent approval in Singapore for the treatment of mantle cell lymphoma. The approval is based on results from the ASPEN clinical trial, which showed BRUKINSA's higher response rates and improved tolerability compared to ibrutinib.

BeiGene has received TGA approval in Australia for its BTK inhibitor BRUKINSA (zanubrutinib), aimed at treating adult patients with Waldenström’s macroglobulinemia (WM) who have had prior therapy or are unsuitable for chemo-immunotherapy. This follows a recent approval in Singapore for treating mantle cell lymphoma patients. The approval is based on the ASPEN trial, which showed BRUKINSA's efficacy versus ibrutinib. Immediate access will be provided through a BeiGene-sponsored program.

BeiGene (NASDAQ: BGNE) has been added to several FTSE Russell indices, including the FTSE Global Equity Index Large Cap and FTSE Developed ESG Low Carbon Select Index, effective September 17, 2021. This inclusion enhances the company's visibility in the global investment community and supports its commitment to sustainability. BeiGene aims to increase access to cancer treatments globally and has a goal to radically improve access to medicines for two billion people by 2030. CEO John V. Oyler and ESG Lead Christine Riley Miller emphasized the company's dedication to innovative and equitable health solutions.

BeiGene's European commercial team is preparing to launch BRUKINSA, its first medicine submitted for EU marketing authorization, pending approval. The CHMP has recommended approval for BRUKINSA (zanubrutinib) for adult patients with Waldenström’s macroglobulinemia, based on the Phase 3 ASPEN trial results. BRUKINSA showed a higher very good partial response rate and a favorable safety profile compared to ibrutinib. The final decision by the European Commission is expected within 67 days.