Welcome to our dedicated page for BeiGene, Ltd. American Depositary Shares news (Ticker: BGNE), a resource for investors and traders seeking the latest updates and insights on BeiGene, Ltd. American Depositary Shares stock.
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 significant business highlights and financial results for Q4 and full year 2020. Notable achievements include product revenues of $100 million for Q4 and $309 million for the year, marking increases of 76% and 39% year-over-year, respectively. The company announced successful Phase 3 trial results for its drug tislelizumab and a collaboration with Novartis for its development in North America and Europe. Despite these advancements, BeiGene recorded a net loss of $472.75 million for Q4 and $1.60 billion for the year, reflecting ongoing R&D expenses.
BeiGene (NASDAQ: BGNE) has entered into an option and license agreement with Boston Immune Technologies and Therapeutics (BITT) to develop TNFR2 antagonist antibodies, aimed at cancer treatment. BITT's lead candidate, BITR2101, will undergo Phase 1 clinical trials alongside BeiGene's tislelizumab. The agreement includes an upfront payment and milestone payments totaling $16.6 million, with potential additional payments up to $105 million. This collaboration is seen as a validation of BITT's antibody platform and has the potential to improve treatment options for cancer patients.
BeiGene, Ltd. (NASDAQ: BGNE) announced FDA acceptance of a supplemental new drug application for BRUKINSA® (zanubrutinib) to treat Waldenström’s Macroglobulinemia (WM) in adults. The PDUFA target action date is October 18, 2021. The sNDA is based on data from 351 patients, primarily from the Phase 3 ASPEN trial, comparing zanubrutinib's safety and efficacy against ibrutinib. BRUKINSA is under regulatory review in multiple countries, with over 20 marketing applications submitted globally. The drug is currently approved for mantle cell lymphoma in the US and China.
BeiGene, Ltd. (NASDAQ: BGNE) announced positive results from its global Phase 3 RATIONALE 302 trial for tislelizumab in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma. The trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) compared to chemotherapy. The safety profile was consistent with known risks, with no new safety signals. This marks BeiGene's fourth positive Phase 3 readout for tislelizumab, reinforcing its potential as a treatment option for patients with advanced esophageal cancer.
BeiGene, Ltd. (NASDAQ: BGNE) announced that its anti-PD-1 antibody, tislelizumab, received approval from the China National Medical Products Administration (NMPA) for use in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (NSCLC). This marks the third approval in China for tislelizumab and its first for lung cancer. The approval follows positive interim results from the RATIONALE 303 trial, demonstrating significant benefits in overall survival.
BeiGene, Ltd. (NASDAQ: BGNE) announced a collaboration with Novartis Pharma AG to develop and commercialize its anti-PD-1 antibody, tislelizumab, in the U.S., Canada, and several European and Asian countries. Novartis will oversee regulatory submissions and commercialization. BeiGene will receive $650 million upfront and could earn up to $1.3 billion in regulatory milestones, alongside royalties on future sales. Tislelizumab is already approved in China for specific cancer treatments, with ongoing clinical trials aimed at expanding its indications.
Strand Therapeutics and BeiGene (NASDAQ: BGNE) have entered into a licensing agreement for the development of multi-functional mRNA treatments targeting solid tumors. BeiGene gains options for exclusive licenses to two immuno-oncology programs in Asia (excluding Japan), Australia, and New Zealand. Strand will receive an upfront payment of $5 million, with potential additional payments totaling up to $28 million, and a total deal value of up to $277 million, including royalties on product sales. This collaboration aims to enhance patient access to innovative therapies.
BeiGene, Ltd. (NASDAQ: BGNE) announced its participation in the J.P. Morgan 39th Annual Healthcare Conference on January 14, 2021, at 5:20 p.m. ET. Investors can access a live webcast through BeiGene's website, with an archived replay available for 90 days post-event. As a global biotechnology company, BeiGene focuses on developing innovative medicines, particularly in oncology, with products like BRUKINSA and tislelizumab currently marketed. The company employs over 5,000 staff across multiple regions, committed to improving patient outcomes.
BeiGene announced the inclusion of three of its oncology drugs in China's updated National Reimbursement Drug List (NRDL): tislelizumab, BRUKINSA (zanubrutinib), and XGEVA (denosumab). This change, confirmed by the China National Healthcare Security Administration, aims to enhance patient access and reduce financial burdens on cancer patients in China. The company plans to collaborate with NHSA for further NRDL inclusion of expanded indications for these therapies. BeiGene will also hold a conference call on December 28 to discuss these developments.
BeiGene, Ltd. announced that the China National Medical Products Administration has approved BLINCYTO for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. This marks the first approval of BLINCYTO in China and BeiGene's first product licensed from Amgen to receive approval. BLINCYTO, a bispecific immunotherapy, has shown superiority in overall survival compared to chemotherapy, reportedly doubling patient survival rates. The approval is based on a Phase 3 trial that demonstrated a 47.8% efficacy rate in Chinese subjects.
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