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BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

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.

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BeiGene announced that the China National Medical Products Administration has granted conditional approval for its anti-PD-1 antibody, tislelizumab, to treat adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors.

This approval adds to the existing six indications in China for tislelizumab, enhancing its access among patients with limited treatment options. The approval is based on a Phase 2 trial with a total of 80 patients, demonstrating consistent treatment efficacy.

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BeiGene announces that BRUKINSA (zanubrutinib) has received approval from Health Canada for treating adult patients with marginal zone lymphoma (MZL) who have undergone at least one prior anti-CD20 therapy. This approval marks the third indication for BRUKINSA in Canada, following its approvals for mantle cell lymphoma and Waldenström’s macroglobulinemia. BRUKINSA demonstrated an overall response rate of 68% in clinical trials, with manageable safety profiles despite serious adverse events reported in some patients.

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BeiGene (NASDAQ: BGNE) will participate in the Cowen 42nd Annual Health Care Conference on March 7, 2022, at 9:50 a.m. ET. The event will be accessible via a live webcast on BeiGene's investor website, with an archived replay available for 90 days post-event.

As a global biotechnology company, BeiGene focuses on developing innovative and affordable medicines, aiming to improve patient access and treatment outcomes worldwide. The company is committed to enhancing access to medicines for two billion people by 2030.

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BeiGene reported significant financial results for Q4 and full year 2021, with product revenue of $196.8 million and $634.0 million, marking increases of 96.6% and 105.3%, respectively. Key drivers included sales of BRUKINSA, which rose by 378% in Q4, and tislelizumab sales of $54.4 million. Despite a net loss of $585.7 million for Q4, BeiGene's cash position improved to $6.62 billion. The company anticipates continued revenue growth due to regulatory approvals and expanding product reach, particularly in the U.S. and China.

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BeiGene announced the FDA's acceptance of its supplemental new drug application for BRUKINSA (zanubrutinib) to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The PDUFA target action date is October 22, 2022. The filing includes data from two pivotal Phase 3 trials—ALPINE and SEQUOIA—demonstrating BRUKINSA's superior efficacy over ibrutinib and chemoimmunotherapy. This milestone could enhance treatment options for patients with CLL, addressing unmet medical needs.

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BeiGene (NASDAQ: BGNE) has announced the acceptance of two new indication applications for BRUKINSA (zanubrutinib) by the European Medicines Agency (EMA) for chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL). This follows BRUKINSA’s previous approval for Waldenström’s macroglobulinemia in November 2021. The applications are supported by data from extensive Phase 3 trials showing improved overall response rates and better cardiac safety compared to other treatments. The company aims to enhance patient access to innovative therapies across the EU.

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BeiGene (NASDAQ: BGNE) has announced that its BTK inhibitor BRUKINSA (zanubrutinib) has received approval from Swissmedic for treating adult patients with Waldenström’s macroglobulinemia in Switzerland. This approval adds to its existing registrations in 44 markets worldwide. The decision is supported by data from a Phase 3 clinical trial, though the primary endpoint of statistical superiority over ibrutinib was not met. BRUKINSA is now available as a treatment option for patients who have undergone prior therapies or are not suitable for standard treatment.

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BeiGene, a global biotechnology company, announces its participation in the Guggenheim Healthcare Talks, 2022 Oncology Conference on February 10, 2022, at 9:00 a.m. ET. Investors can access a live webcast via BeiGene’s [investor website](http://ir.beigene.com) or [HKEX](http://hkexir.beigene.com). An archived replay will be available for 90 days post-event. BeiGene is dedicated to developing innovative medicines to enhance patient treatment outcomes worldwide, with a commitment to improving access for two billion more people by 2030.

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BeiGene, a biotechnology company, announced the appointments of Dr. Margaret Dugan and Dr. Alessandro Riva to its Board of Directors. Dr. Dugan will contribute to the scientific advisory committee, while Dr. Riva will join both the nominating and scientific advisory committees. Dr. Jing-Shyh Su is stepping down after four years on the board. Dr. Dugan brings over 20 years of oncology experience, having held senior roles at Novartis, while Dr. Riva has extensive experience in gene and cell therapy, previously leading teams at Gilead Sciences and Novartis.

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BeiGene announced that the China National Medical Products Administration has accepted a supplemental new drug application for its BTK inhibitor BRUKINSA (zanubrutinib) to treat adults with chronic lymphocytic leukemia (CLL). This marks the first breakthrough therapy designation for BRUKINSA in treatment-naïve CLL, supported by promising results from the global Phase 3 SEQUOIA trial. The trial demonstrated a 24-month progression-free survival of 85.5%, outperforming traditional chemoimmunotherapy. BRUKINSA is also under assessment for expanded use in treating blood cancers in China.

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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 $177.7 as of December 23, 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 18.9B.

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

18.87B
87.65M
19.46%
47.93%
0.94%
Biotechnology
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