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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 presented new safety and efficacy data for BRUKINSA (zanubrutinib) at the 63rd ASH Annual Meeting. Results from a Phase 2 trial showed that 93.8% of patients maintained disease control, while 64.1% improved their response. Treatment was well-tolerated, with 59.6% of prior ibrutinib users and 70.0% of acalabrutinib users not experiencing recurrence of intolerable adverse events. BRUKINSA's design aims to optimize kinase selectivity, thus reducing off-target effects. These findings reinforce BRUKINSA's potential for B-cell malignancies patients intolerant to other BTK inhibitors.
BeiGene announced results from the RATIONALE 309 trial, where its drug tislelizumab significantly improved progression-free survival (PFS) in patients with recurrent or metastatic nasopharyngeal cancer (RM-NPC) compared to placebo and chemotherapy. The median PFS was 9.2 months for the drug combination versus 7.4 months for placebo, demonstrating a notable survival benefit across subgroups. The safety profile was consistent with known risks, and a supplemental biologics license application is under review in China for this indication.
BeiGene (NASDAQ:BGNE) has announced the addition of three of its innovative oncology medicines to China's National Reimbursement Drug List (NRDL), effective January 1, 2022. The newly included medicines are anti-PD-1 antibody tislelizumab in three new indications, the BTK inhibitor BRUKINSA in one new indication, and the PARP inhibitor pamiparib for recurrent advanced ovarian cancer. This move aims to enhance patient access to effective cancer treatments while reducing financial burdens on families.
BeiGene, Ltd. (NASDAQ: BGNE) and EUSA Pharma have announced NMPA approval for SYLVANT® (siltuximab) in treating adult patients with idiopathic multicentric Castleman disease (iMCD) in China. This approval highlights the companies' collaboration and provides a vital new treatment option for patients suffering from this rare, debilitating disease. The approval is supported by a Phase 2 trial demonstrating significant efficacy with a durable response rate of 34% versus 0% for placebo. SYLVANT® has already been approved in multiple regions, and BeiGene plans to launch it in 2022.
BeiGene (NASDAQ: BGNE) announced that results from the RATIONALE 309 trial evaluating tislelizumab with chemotherapy in nasopharyngeal cancer will be presented at the ESMO IO Congress from December 8-11, 2021. This interim analysis supports a regulatory submission in China for recurrent or metastatic nasopharyngeal cancer. Additionally, data from trials involving tislelizumab combined with the kinase inhibitor sitravatinib in melanoma and ovarian cancer will be shared, highlighting the company's commitment to developing effective immunotherapies and addressing unmet medical needs globally.
BeiGene, Ltd. announced the pricing of its initial public offering (STAR Offering) on the STAR Market of the Shanghai Stock Exchange, offering 115,055,260 ordinary shares, representing 8.62% of its outstanding shares. The shares are priced at RMB192.60 each, yielding gross proceeds of approximately RMB22.2 billion (US$3.5 billion). The funds will support research, development, and expansion in China. The shares are expected to trade on December 15, 2021. An over-allotment option for 17,258,000 additional shares could increase the offering to 132,313,260 shares.
BeiGene announced the European Commission's approval of BRUKINSA (zanubrutinib) for treating Waldenström’s macroglobulinemia (WM) patients who have undergone prior therapy or are unsuitable for chemo-immunotherapy. This approval spans all EU member states, Iceland, and Norway. The decision is based on the Phase 3 ASPEN trial, showing BRUKINSA's safety advantages over ibrutinib despite not meeting the primary endpoint for statistical superiority. BeiGene aims to expedite access to this therapy across Europe.
BeiGene, Ltd. announced its initial public offering (IPO) on the STAR Market of the Shanghai Stock Exchange, offering 115,055,260 ordinary shares, representing 8.62% of its total shares as of October 31, 2021. The STAR Offering will be conducted for investors in the People's Republic of China (PRC) with additional options for 17,258,000 shares. Proceeds will fund R&D, the construction of centers in China, and sales expansion. The offering is subject to market conditions and regulatory approvals and will not involve the U.S. market.
BeiGene has acquired a 42-acre site in Hopewell, New Jersey, to develop a new manufacturing campus focused on advanced cancer medicines. This investment aims to enhance U.S. manufacturing capabilities and diversify its global supply chain. The project includes a 400,000-square-foot facility with 16,000 liters of biologics capacity, estimated to cost several hundred million dollars. Construction is slated to begin in 2022, with completion expected in late 2023 or 2024.
BeiGene has initiated the Phase 1 clinical trial for BGB-23339, a novel allosteric TYK2 inhibitor aimed at treating inflammation and immunology disorders. This candidate has exhibited potent inhibition of inflammatory cytokines in preclinical studies and represents the first internally developed asset in this therapeutic area. The trial aims to evaluate the drug's safety, tolerability, and preliminary efficacy in up to 115 healthy volunteers across Australia and China. This development expands BeiGene’s portfolio beyond oncology.
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