BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

BeiGene will present new clinical data on zanubrutinib at the ASCO Annual Meeting from June 3-7, 2022. Key insights include long-term efficacy results from the Phase 3 ASPEN trial, showing BRUKINSA's advantages over ibrutinib in treating Waldenström macroglobulinemia, with a median follow-up of 43 months. The Phase 2 ROSEWOOD trial results indicate a 68.3% overall response rate for zanubrutinib combined with obinutuzumab in relapsed follicular lymphoma. These findings support the drug's safety profile and potential in expanding treatment options for patients.

BeiGene announced the opening of a new regional office in Basel, Switzerland, signifying its expanding presence in Europe. This new office will act as a hub for the company’s European operations, which already include over 270 employees. BeiGene aims to leverage the skilled talent in Basel to enhance its growth and reach more patients globally with innovative therapies. The company is involved in more than 100 clinical trials worldwide and has received multiple approvals for its medications, including zanubrutinib for treating Waldenström's macroglobulinemia.

BeiGene announced significant clinical results at the EHA 2022 Hybrid Congress, showcasing BRUKINSA (zanubrutinib) in 20 presentations focusing on hematologic malignancies. Highlights include the ROSEWOOD trial, demonstrating zanubrutinib's efficacy in follicular lymphoma, and promising early data for the BGB-11417 BCL-2 inhibitor. With over 3,900 subjects in 35 trials globally, BRUKINSA has achieved over 20 approvals in key markets including the U.S. and China.

BeiGene reported a strong financial performance in Q1 2022, with product revenue reaching $261.6 million, a 146% increase from the previous year. Notably, BRUKINSA sales soared 372% globally, driven by substantial growth in the U.S. and China. The company also saw positive interim results from key clinical trials, including the RATIONALE-306 study, indicating a statistically significant improvement in overall survival. Despite these achievements, BeiGene faced a net loss of $434.3 million for the quarter, attributed to lower collaboration revenue. Cash reserves stand at $6.3 billion.

BeiGene announced that the China National Medical Products Administration has granted conditional approval for BLINCYTO to treat pediatric patients with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). This marks the second approval for BLINCYTO in China, following a prior approval for adult patients in December 2020. The pediatric approval is based on ex-China research data and aims to provide a new treatment option for young patients. BeiGene has a commercial team of over 3,100 in China and is expanding its portfolio of 16 approved cancer treatments.

BeiGene has announced the groundbreaking of its flagship U.S. facility in Hopewell, New Jersey, aimed at advancing cancer medicine. This facility will comprise 400,000 square feet dedicated to biologic pharmaceutical manufacturing and clinical R&D, with a capacity for up to 16,000 liters of biologics formula. The expansion is expected to create hundreds of jobs and supports BeiGene's commitment to improving access to cancer treatments globally. The location will bolster its global supply chain strategy.

BeiGene announced that its BTK inhibitor, BRUKINSA (zanubrutinib), has received approval for use in Uruguay, expanding its availability in Latin America. The drug is indicated for adult patients with previously treated mantle cell lymphoma, relapsed or refractory marginal zone lymphoma, and Waldenström’s macroglobulinemia. The commercial distribution will be handled by Adium under an exclusive agreement. This follows previous approvals in Brazil, Chile, and Ecuador, reflecting BeiGene's commitment to improving patient access to innovative treatments across the region.

BeiGene (NASDAQ: BGNE) presented new clinical data at the 2022 ASCO Annual Meeting from its oncology programs. Key highlights include a Phase 3 analysis of tislelizumab for first-line treatment of recurrent/metastatic nasopharyngeal cancer and the primary analysis of the ROSEWOOD trial with zanubrutinib in follicular lymphoma. With over 800 researchers, BeiGene aims to enhance treatment access and outcomes globally, showcasing long-term data for its therapies, including the promising update on BRUKINSA for Waldenström macroglobulinemia.

BeiGene (NASDAQ: BGNE) announced that the RATIONALE 306 Phase 3 trial of tislelizumab in combination with chemotherapy achieved a statistically significant improvement in overall survival for patients with previously untreated advanced esophageal squamous cell carcinoma (ESCC) compared to placebo. The safety profile was consistent with earlier studies, showing that no new safety issues arose. Tislelizumab is currently under review by the FDA and EMA for multiple indications, and the positive results from RATIONALE 306 advance its potential as a standard treatment for ESCC.