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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 (NASDAQ: BGNE) has entered into a global licensing agreement with CSPC for SYH2039, a novel MAT2A-inhibitor targeting solid tumors with MTAP deletion mutation. This mutation occurs in approximately 15% of all cancer types, particularly in glioblastoma, pancreatic cancer, and non-small cell lung cancer.
Under the agreement, BeiGene gains exclusive worldwide rights to develop, manufacture, and commercialize SYH2039. CSPC will receive $150 million in upfront and time-based payments, plus potential milestone payments and tiered royalties. BeiGene plans to explore SYH2039's potential in combination with their PRMT5 inhibitor, BGB-58067, which is expected to enter clinical trials by year-end.
BeiGene (NASDAQ: BGNE) presented new clinical data at ASH 2024, highlighting significant achievements in chronic lymphocytic leukemia (CLL) treatment. The 5-year SEQUOIA study showed BRUKINSA reduced progression/death risk by 71% compared to bendamustine-rituximab in treatment-naïve CLL patients.
Key findings include promising results from sonrotoclax combined with BRUKINSA, showing no progression in treatment-naïve CLL patients at 1.5 years median follow-up, with a 99% overall response rate and 92% best uMRD rate. The BTK degrader BGB-16673 demonstrated potential in treatment-resistant CLL, achieving a 94% overall response rate at 200mg dose.
BRUKINSA's safety profile remained consistent with previous studies, with notable efficacy in patients with unmutated IGHV, reducing progression/death risk by 79%.
BeiGene (NASDAQ: BGNE) has partnered with CLL Society to launch the Test Before Treat™ campaign, focusing on promoting biomarker testing for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients. The initiative emphasizes the importance of testing before initial treatment and retesting at subsequent treatments to ensure optimal therapy selection.
About 50% of CLL/SLL patients have high-risk molecular features that may limit treatment effectiveness. Approximately 10% have high-risk del(17p) and/or TP53 mutation before starting treatment, while 40% develop these mutations after relapsing. The campaign highlights that genetic profiles can change over time and promotes blood testing to identify mutations for better treatment guidance.
BeiGene (NASDAQ: BGNE) has announced an upcoming investor webcast scheduled for December 16, 2024 at 8:30 am EST. The company's R&D leadership team will present updates on their innovative portfolio and pipeline, specifically highlighting key presentations from the American Society of Hematology Meeting (ASH) and the San Antonio Breast Cancer Symposium. The webcast will be accessible through BeiGene's investor relations websites, with a replay available for 90 days after the event. The company also noted its intended name change to BeOne Medicines.
BeiGene's TEVIMBRA received European Commission approval for first-line treatment of advanced esophageal squamous cell carcinoma (ESCC) and gastric/gastroesophageal junction cancer in combination with chemotherapy. The approval is based on two Phase 3 studies showing significant survival benefits. In the RATIONALE-306 study for ESCC, median overall survival was 17.2 months for TEVIMBRA with chemotherapy versus 10.6 months for placebo. In the RATIONALE-305 study for G/GEJ cancer, median overall survival was 15.0 months for TEVIMBRA combination versus 12.9 months for placebo, showing a 20% reduction in death risk.
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company planning to rebrand as BeOne Medicines, has announced its participation in two upcoming investor conferences. The company will engage in fireside chats at the Citizens JMP Hematology and Oncology Summit on December 2 at 1:00 p.m. ET and Citi's Global Healthcare Conference on December 5 at 9:30 a.m. ET. Live webcasts will be available on BeiGene's investor relations websites, with recordings accessible for 90 days after the events.
Labcorp (NYSE: LH) announced that Executive Vice President and CFO Glenn Eisenberg will retire, with Julia Wang appointed as the new CFO effective December 2, 2024. Eisenberg will remain as Special Advisor to the CEO through April 2025. During Eisenberg's 10-year tenure, Labcorp doubled its revenues, completed approximately 100 acquisitions worth $11 billion, and returned over $6 billion to shareholders through repurchases and dividends. Wang joins from BeiGene, where she served as CFO and was key in driving business transformations through growth acceleration and operational efficiency.
BeiGene has settled patent litigation with MSN Pharmaceuticals regarding their attempt to market a generic version of BRUKINSA (zanubrutinib) in the U.S. Under the agreement, MSN cannot sell a generic version before June 15, 2037. The composition patent for BRUKINSA, expiring in April 2034, wasn't challenged by MSN. BRUKINSA, a BTK inhibitor approved in over 70 markets for B-cell malignancies, has the broadest label in its class globally. The settlement resolves all patent litigation against companies seeking to market generic versions of BRUKINSA, including a previous dismissal with Sandoz Inc.
BeiGene announced its plan to change its name to BeOne Medicines and its Nasdaq ticker to ONC, reflecting its commitment to fight cancer through global collaboration. The company aims to develop innovative medicines and improve treatment accessibility while addressing barriers to access. BeiGene has already helped over 1.4 million patients and plans to introduce more than 10 new potential medicines into clinical trials this year.
BeiGene reported strong Q3 2024 financial results with $1 billion in quarterly revenue, marking significant growth. BRUKINSA global revenue reached $690 million, with U.S. sales of $504 million (87% growth) and European sales of $97 million (217% growth). The company expanded its oncology pipeline with four new molecular entities entering clinical trials this quarter. Product revenue grew 67% to $993 million, with gross margin at 83%. While operating loss decreased 10%, the company achieved positive non-GAAP operating income of $66 million and generated $188 million in operating cash flow.
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