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BeiGene Ltd (NASDAQ: BGNE) is a global biotechnology leader pioneering innovative oncology therapies through its integrated research and clinical trial model. This page serves as the definitive source for verified company developments, offering stakeholders timely access to essential updates.
Find comprehensive coverage of BeiGene's progress in cancer treatment innovation, including clinical trial milestones, regulatory submissions, and strategic collaborations. The curated news collection enables efficient tracking of the company's pipeline advancements in checkpoint inhibitors and targeted small molecule therapies.
Key updates include quarterly financial results, manufacturing expansions, and peer-reviewed research publications. All content undergoes rigorous verification to ensure accuracy in reporting scientific developments and corporate announcements.
Bookmark this page for direct access to BeiGene's latest press releases and analysis of their unique CRO-free clinical development approach, a strategic differentiator in global biopharmaceutical operations.
BeiGene reported strong Q1 2021 results with a 104% increase in global product revenue to $106.1 million. Total revenue surged to $605.9 million, driven by a $650 million upfront payment from Novartis and positive outcomes from the ALPINE trial for BRUKINSA. The company achieved significant growth in China following NRDL inclusion for tislelizumab, BRUKINSA, and XGEVA. Net income stood at $66.5 million, a turnaround from last year's loss of $363.7 million. Cash and short-term investments totaled $4.8 billion.
BeiGene (NASDAQ: BGNE) reported positive interim results from the Phase 3 ALPINE trial, comparing BRUKINSA® (zanubrutinib) with ibrutinib in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). BRUKINSA met the primary endpoint, showing non-inferiority in objective response rate (ORR) (p < 0.0001), and a statistically significant superior ORR compared to ibrutinib (p = 0.0006). Safety analysis indicated a lower risk of atrial fibrillation with BRUKINSA. The trial is ongoing with future assessments planned for progression-free survival.
BeiGene (NASDAQ: BGNE) has announced promising results from the interim analysis of its Phase 3 RATIONALE 303 trial, comparing the efficacy of its anti-PD-1 antibody, tislelizumab, to docetaxel in patients with advanced or metastatic non-small cell lung cancer (NSCLC). The trial showed an overall survival (OS) median of 17.2 months for tislelizumab versus 11.9 months for docetaxel, with significant improvements across various metrics. These findings support a supplemental biologics application currently under regulatory review in China.
BeiGene (NASDAQ: BGNE) presented clinical data on its anti-PD-1 antibody, tislelizumab, combined with the investigational sitravatinib at the AACR Annual Meeting 2021. The Phase 1b trial focused on patients with unresectable/metastatic melanoma resistant to PD-1/L1 inhibitors and advanced platinum-resistant ovarian cancer.
The combination showed promising results, with a 24% objective response rate and an 88% disease control rate in melanoma patients. Adverse events were reported, with 100% of patients experiencing treatment-emergent adverse events.
BeiGene officially launched BRUKINSA (zanubrutinib) in Canada for treating adult patients with Waldenström’s macroglobulinemia (WM). Authorized on March 1, 2021, BRUKINSA aims to enhance patient access through the myBeiGene support program, offering financial assistance and education. The product's approval is based on the Phase 3 ASPEN trial, which, despite showing a favorable safety profile, did not meet the primary endpoint of statistical superiority over ibrutinib. The recommended daily dose is 320mg, as BeiGene expands its distribution efforts across Canada.
BeiGene, Ltd. (NASDAQ: BGNE) announced that its Phase 2 trial of BRUKINSA® (zanubrutinib) for hospitalized COVID-19 patients did not achieve co-primary endpoints, specifically for respiratory failure-free survival and reduction in oxygen days compared to placebo. No new safety signals for zanubrutinib were identified. The trial included 67 patients who required supplemental oxygen or mechanical ventilation. Results will be submitted for future scientific presentation. Despite this setback, the firm aims to continue exploring zanubrutinib's efficacy against COVID-19-related respiratory distress.
BeiGene, Ltd. (NASDAQ: BGNE) has received approval from the NMPA to manufacture tislelizumab at its new biologics facility in Guangzhou, China. This facility, spanning over 1 million square feet, will start producing tislelizumab for the local market and expand its capacity to 64,000 liters by the end of 2022. Tislelizumab is approved for various cancer treatments in China and is under review for additional uses. The plant adheres to cGMP standards and incorporates advanced technologies for enhanced manufacturing efficiency.
BeiGene, Ltd. (NASDAQ: BGNE) has appointed Julia Wang as its new Chief Financial Officer, effective June 30, 2021. She succeeds Howard Liang, who is retiring after a significant tenure. Julia previously served as Senior Vice President and Deputy CFO at BeiGene, bringing extensive finance experience from the biotech and pharmaceutical sectors. The transition aims to strengthen BeiGene's financial leadership as it expands globally. CEO John Oyler praised Wang's contributions, noting her strategic role in enhancing resource allocation and value creation within the company.
BeiGene (NASDAQ: BGNE) is set to present multiple studies at the AACR Annual Meeting 2021, including three oral presentations on the anti-PD-1 antibody tislelizumab and its combination with the investigational sitravatinib for treating various cancers. Key presentations include:
- RATIONALE 303: Phase 3 study results of tislelizumab in NSCLC, presented on April 12.
- Sitravatinib plus tislelizumab: Safety and preliminary activity in ovarian cancer, on April 11.
- Melanoma study: Safety and tolerability results, also on April 11.
These findings may impact the company's future drug development and market strategies.
BeiGene, Ltd. (NASDAQ: BGNE) has announced the initiation of a Phase 1 clinical trial for BGB-15025, an investigational HPK1 inhibitor aimed at enhancing T cell activation in cancer treatment. The trial will evaluate the safety, pharmacokinetics, and early antitumor activity of BGB-15025, both as a monotherapy and in combination with tislelizumab, BeiGene's anti-PD-1 antibody. This study marks a significant step in BeiGene's research into immuno-oncology therapies, potentially offering new treatment avenues for patients with advanced solid tumors.
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