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BeiGene, Ltd. (NASDAQ: BGNE) is a global biotechnology company specializing in the development and commercialization of innovative cancer treatments. With a robust portfolio focused on molecularly targeted and immuno-oncology drugs, BeiGene addresses crucial oncology targets such as Bruton's tyrosine kinase (BTK) and the immune checkpoint protein PD-1. The company’s notable products include tislelizumab, a PD-1 inhibitor, and zanubrutinib, a BTK inhibitor, which have shown promising results in treating various cancers. BeiGene’s latest achievements include FDA and European regulatory approvals, significant clinical trial successes, and partnerships aimed at expanding the reach of their therapies globally. The company operates across major markets, including China, the United States, and internationally, striving to make high-quality cancer treatments more accessible. BeiGene’s commitment to advancing global health equity is evident in its innovative drug pipeline and strategic collaborations.
BeiGene reported Q4 2022 revenue of $380.1 million and a full year total of $1.4 billion, up 77.7% year-over-year. Product revenue was $339.0 million in Q4 and $1.3 billion for the year, with BRUKINSA® achieving 101% and 159% growth, while tislelizumab revenue rose 88% and 66%.
Net loss decreased to $445.3 million in Q4 from $590.7 million a year prior. Total cash and equivalents stood at $4.5 billion as of December 31, 2022. The company expects continued revenue growth amid regulatory approvals and market expansion.
BeiGene, a global biotechnology company, will participate in Cowen’s 43rd Annual Healthcare Conference on March 6, 2023. The event will feature a fireside chat at 11:10 am ET. Interested parties can access live webcasts on the investors section of BeiGene’s website, with archived replays available for 90 days post-event.
BeiGene aims to enhance patient access to innovative oncology medicines globally. Their diverse therapeutic pipeline is developed through extensive internal capabilities and collaborations, supported by a team of over 9,000 employees across multiple countries.
BeiGene has received approval from the China National Medical Products Administration (NMPA) for its PD-1 inhibitor, tislelizumab, in combination with chemotherapy for first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression. This approval is based on interim analysis data from the RATIONALE 305 trial, where tislelizumab plus chemotherapy showed a median overall survival of 17.2 months compared to 12.6 months for placebo plus chemotherapy. The treatment addresses a significant medical need, as gastric cancer is the third most common cancer in China, with many patients diagnosed at advanced stages.
BeiGene, a leading global biotechnology company, has announced its participation in two significant investor conferences. The Guggenheim Oncology Conference is scheduled for February 8, 2023, at 9:35 a.m. ET, followed by the SVB Securities Global Biopharma Conference on February 15, 2023, at 1:40 p.m. ET. Investors can access live webcasts and archived replays through the investors section of BeiGene’s website. The company aims to improve treatment access through innovative oncology medicines and has a diverse pipeline of therapeutics. With over 9,000 employees worldwide, BeiGene is committed to enhancing patient outcomes globally.
BeiGene has received FDA approval for BRUKINSA (zanubrutinib) as a treatment for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Two global Phase 3 trials showed superior efficacy of BRUKINSA compared to IMBRUVICA (ibrutinib) and bendamustine plus rituximab. In the SEQUOIA trial, BRUKINSA demonstrated a significant progression-free survival (PFS) benefit (HR 0.42, P<0.0001), while in the ALPINE trial, it achieved an overall response rate (ORR) of 80.4% compared to 72.9% for ibrutinib (P=0.0264). The approval strengthens BRUKINSA's position as a leading BTK inhibitor in the market.
BeiGene has received marketing authorization from the MHRA for its drug BRUKINSA, allowing it to treat adult patients with chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL) in Great Britain. BRUKINSA, a selective BTK inhibitor, offers a new treatment option for MZL patients, as no targeted therapies exist beyond chemoimmunotherapy. The authorization for CLL is based on two Phase 3 trials and supports BRUKINSA's role in improving clinical outcomes. Earlier this year, NICE recommended the drug for Waldenström's macroglobulinemia treatment. BRUKINSA is now authorized in over 60 markets globally.
BeiGene announced that four new indications for its PD-1 inhibitor tislelizumab have been added to China’s National Reimbursement Drug List (NRDL). This update, effective March 1, 2023, also includes the first-time listing of KYPROLIS (carfilzomib) and a successful renewal for XGEVA (denosumab). The new indications for tislelizumab cater to advanced stages of non-small cell lung cancer, advanced solid tumors, esophageal cancer, and nasopharyngeal cancer. These changes enhance patient access to these therapies, reflecting BeiGene's commitment to improving global health.
BeiGene presented positive interim results for tislelizumab in its phase 3 RATIONALE 305 trial at the 2023 ASCO Gastrointestinal Cancers Symposium. The trial showed a significant improvement in overall survival for patients with gastric or gastroesophageal junction cancer expressing PD-L1 when treated with tislelizumab and chemotherapy. This reflects a substantial market opportunity with over one million gastric cancer cases reported in 2020. BeiGene plans to continue sharing results from its global clinical program, which has enrolled over 11,500 subjects across various trials, with regulatory applications under review in the U.S. and EU.
BeiGene (NASDAQ: BGNE) announced its participation in the J.P. Morgan 41st Annual Healthcare Conference, scheduled for January 9, 2023, at 1:30 p.m. PT. A live webcast will be available on the investors section of BeiGene's website, with an archived replay accessible for 90 days post-event. The company is a global biotechnology firm focused on developing innovative oncology treatments to improve accessibility and outcomes for patients worldwide. With over 9,000 employees globally, BeiGene aims to enhance treatment access for numerous patients.
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.
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