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BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

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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.

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BeiGene has announced that the FDA has accepted its Biologics License Application (BLA) for tislelizumab, an anti-PD-1 antibody aimed at treating unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior therapy. This marks a significant step in their strategy to expand treatment options globally, having previously secured approval for tislelizumab in five indications in China. The PDUFA target action date is July 12, 2022, and the submission is backed by positive results from the global Phase 3 RATIONALE 302 trial.

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BeiGene, Ltd. (NASDAQ: BGNE) announced the presentation of clinical results from its lung cancer program at the ESMO Congress 2021. The company is focused on enhancing its immuno-oncology portfolio, particularly through the combination of tislelizumab with investigational agents like ociperlimab and sitravatinib. Various Phase 3 trials are currently in progress, addressing non-small cell lung cancer (NSCLC). Subgroup analyses reveal consistent survival benefits with tislelizumab, regardless of patient characteristics. BeiGene aims to improve outcomes for NSCLC patients worldwide.

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BeiGene announced FDA approval for BRUKINSA (zanubrutinib) as a treatment for adult patients with Waldenström's macroglobulinemia. This marks the second indication for BRUKINSA in the U.S. and its third globally. The approval follows the Phase 3 ASPEN trial, which demonstrated improved efficacy and tolerability compared to ibrutinib. Key results showed a VGPR rate of 28% for BRUKINSA versus 19% for ibrutinib. The company continues to expand its global clinical program, solidifying its commitment to innovate in B-cell malignancies.

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BeiGene announces that the China National Medical Products Administration (NMPA) has accepted a supplemental Biologics License Application (sBLA) for tislelizumab in combination with chemotherapy as a first-line treatment for recurrent or metastatic nasopharyngeal cancer (NPC). This milestone, supported by positive results from the RATIONALE 309 trial, highlights the need for effective treatment options in a cancer type that predominantly affects patients in China. Tislelizumab has received multiple approvals in China across various indications, showcasing its expanding therapeutic potential.

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BeiGene has received conditional approval from the China National Medical Products Administration (NMPA) for QARZIBA® (dinutuximab beta) to treat high-risk neuroblastoma in children aged 12 months and older. This therapy is indicated for those who've undergone chemotherapy and myeloablative treatment. Clinical trials showed significant efficacy, with a five-year event-free survival rate of 57% compared to 42% of historical controls. Despite the approval, common adverse reactions include fever and pain, raising considerations regarding patient management.

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BeiGene, Ltd. (NASDAQ: BGNE) announced an investor conference call on August 25, 2021, at 9:30 a.m. ET to discuss its early development pipeline and research initiatives. The event will be accessible via a live webcast on BeiGene’s investor website, with an archived replay available for 90 days post-event. BeiGene is committed to innovative and affordable medicines aimed at enhancing patient access, with a portfolio of over 40 clinical candidates and a goal of improving access for two billion people by 2030. The company has a global team of around 7,000 employees.

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BeiGene reported strong advancements in its oncology drug portfolio, showcasing significant growth in product sales, particularly for BRUKINSA, which generated $42.4 million, up from $7.0 million YoY. Their second quarter revenue reached $150 million, a substantial increase from $65.6 million in 2020. The company highlighted positive interim results from key trials, including SEQUOIA and ALPINE, and secured conditional approvals for treatments in multiple markets. However, a net loss of $480.3 million was noted, a wider loss per share of $0.40 compared to $0.33 in Q2 2020.

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BeiGene has announced plans to establish a new R&D and manufacturing campus at the Princeton West Innovation Campus in Hopewell, NJ. The company has entered a purchase agreement for a 42-acre site, aiming to develop over one million square feet for biologic pharmaceutical manufacturing and clinical R&D. This facility is expected to enhance BeiGene's supply chain capabilities and create hundreds of jobs in the region. Construction completion is anticipated in mid-2023, with interim leasing of nearby space to commence hiring immediately.

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BeiGene announced positive topline results from the interim analysis of the Phase 3 SEQUOIA trial for BRUKINSA (zanubrutinib) in treatment-naïve chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). With a median follow-up of 25.8 months, BRUKINSA significantly improved progression-free survival (PFS) compared to bendamustine and rituximab (B+R). The trial showed strong outcomes consistent with BRUKINSA's safety profile. BeiGene plans to consult with regulatory authorities regarding next steps and aims to present data at major medical conferences.

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BeiGene, Ltd. (NASDAQ: BGNE) announced that Health Canada has approved BRUKINSA (zanubrutinib) for treating mantle cell lymphoma (MCL) in adults with at least one prior therapy. This marks the second approval for BRUKINSA in Canada. The therapy showed an overall response rate of 84% in clinical trials. Approximately 13.6% of patients discontinued treatment due to adverse events, with pneumonia being the most common. The drug offers a new option for patients with MCL, which often has a poor prognosis and is typically diagnosed at a late stage.

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FAQ

What is the current stock price of BeiGene, Ltd. American Depositary Shares (BGNE)?

The current stock price of BeiGene, Ltd. American Depositary Shares (BGNE) is $176.5 as of December 20, 2024.

What is the market cap of BeiGene, Ltd. American Depositary Shares (BGNE)?

The market cap of BeiGene, Ltd. American Depositary Shares (BGNE) is approximately 19.0B.

What type of company is BeiGene, Ltd.?

BeiGene, Ltd. is a global biotechnology company focused on developing and commercializing innovative cancer treatments.

What are some of BeiGene’s notable products?

Some of BeiGene’s notable products include tislelizumab, a PD-1 inhibitor, and zanubrutinib, a BTK inhibitor.

What markets does BeiGene operate in?

BeiGene operates in major markets including China, the United States, and internationally.

What recent achievements has BeiGene accomplished?

Recent achievements include the FDA and European regulatory approvals for its cancer treatments, significant clinical trial successes, and strategic partnerships.

What are BeiGene’s primary focus areas in oncology?

BeiGene focuses on molecularly targeted and immuno-oncology drugs, addressing targets like BTK and the immune checkpoint protein PD-1.

How does BeiGene contribute to global health equity?

BeiGene contributes to global health equity by developing innovative cancer treatments and forming strategic collaborations to make these therapies more accessible.

What are the financial highlights for BeiGene's latest quarter?

For the latest quarter, BeiGene reported total revenues of $752 million with significant growth in BRUKINSA product sales in the U.S. and Europe.

What is the significance of BeiGene's drug zanubrutinib?

Zanubrutinib is a BTK inhibitor that has shown promising results in treating various cancers, leading to increased market share and regulatory approvals.

What strategic initiatives is BeiGene currently pursuing?

BeiGene is focusing on expanding its global presence, advancing its innovative drug pipeline, and enhancing collaborations to broaden the accessibility of its cancer treatments.

What impact has BeiGene made on cancer treatment accessibility?

BeiGene has made significant strides in making high-quality cancer treatments more accessible globally through innovative drug development and strategic partnerships.

BeiGene, Ltd. American Depositary Shares

Nasdaq:BGNE

BGNE Rankings

BGNE Stock Data

18.99B
87.65M
19.46%
47.93%
0.94%
Biotechnology
Pharmaceutical Preparations
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United States of America
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