BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

Biocytogen Pharmaceuticals has partnered with BeiGene to license its RenMab™ and RenLite™ mice platforms for the development of fully human monoclonal antibodies. These advanced mouse models, which have been developed over five years, enable high-affinity, specific antibody generation essential for innovative drug development. BeiGene aims to enhance its drug discovery capabilities and improve patient access to affordable medicines. Biocytogen, with a robust pipeline of 12 core products, is committed to advancing antibody-based therapies.

BeiGene (NASDAQ: BGNE) has announced a new grant to Crossroads4Hope, a New Jersey-based cancer support organization, aimed at expanding their psychosocial support programs. This partnership aligns with BeiGene's commitment to enhancing cancer treatment accessibility, particularly as they establish a new clinical R&D and manufacturing site in Hopewell, N.J. Crossroads4Hope has assisted over 17,350 individuals since its inception, providing no-cost services to those affected by cancer. This initiative showcases BeiGene's dedication to community involvement and improving patient outcomes.

BeiGene reported updated results from the Phase 3 RATIONALE-309 trial of tislelizumab combined with chemotherapy for recurrent/metastatic nasopharyngeal cancer. At a median follow-up of 15.5 months, the combination showed a significant progression-free survival (PFS) benefit of 9.6 months compared to 7.4 months for the control group. The trial’s findings suggest that tislelizumab may become a standard first-line treatment. The safety profile remained manageable. The drug’s regulatory pathway is supported by planned filings in the U.S. and Europe for first-line treatment.

BeiGene has received approval from the China National Medical Products Administration (NMPA) for tislelizumab, its anti-PD-1 antibody, as a treatment for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who experience disease progression or are intolerant to first-line chemotherapy. This marks the eighth approved indication for tislelizumab in China. The approval is based on positive results from the global Phase 3 trial, RATIONALE 302, which demonstrated significant improvements in overall survival. Tislelizumab is also under review by the FDA and EMA.

BeiGene announced final results from the Phase 3 ALPINE trial, confirming that its BTK inhibitor, BRUKINSA, shows superior efficacy compared to ibrutinib in treating relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). In the trial, BRUKINSA achieved an overall response rate (ORR) of 80.4% versus 72.9% for ibrutinib (p=0.0264). Additionally, BRUKINSA demonstrated a lower incidence of atrial fibrillation (4.6% vs. 12.0%) and fewer treatment discontinuations due to adverse events (13.0% vs. 17.6%). The next planned analysis will focus on progression-free survival.

BeiGene has announced upcoming presentations at the AACR Annual Meeting 2022, highlighting results from subanalyses of the Phase 3 studies RATIONALE-303 and RATIONALE-304 regarding tislelizumab for treating non-small cell lung cancer (NSCLC). These presentations aim to elucidate patient characteristics that may enhance treatment responses. Currently, BeiGene is involved in extensive clinical trials, with 17 Phase 3 and 4 pivotal Phase 2 trials underway, showcasing tislelizumab's potential in solid tumors and enhancing treatment outcomes globally.

BeiGene announced that marketing authorization applications (MAA) for tislelizumab, an anti-PD-1 antibody, have been validated for review by the European Medicines Agency (EMA). These applications, submitted by Novartis, target patients with advanced esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer (NSCLC). Clinical trials demonstrated significant improvements in overall and progression-free survival. The MAA submission for NSCLC is based on results from three trials involving 1,499 patients and supports continuous collaboration with Novartis.

858 Therapeutics has announced key leadership changes to enhance its growth trajectory. Jane Huang, M.D., joins as an independent director, bringing extensive oncology experience from BeiGene. Sanjay Trehan is appointed as SVP of Business Development, having held significant roles at Genentech and Sanofi. Gretchen Bain, Ph.D., is promoted to SVP of Biology, recognizing her contributions since the company’s inception. These changes are aimed at advancing its oncology-focused therapeutic portfolio.

BeiGene has received its second regulatory approval for BRUKINSA (zanubrutinib) in Israel, targeting adult patients with Waldenström’s Macroglobulinemia (WM). This approval comes after the initial sanction for mantle cell lymphoma in 2021. BRUKINSA is now nationally reimbursed for patients in second or third-line treatment for WM. The drug has over 20 approvals globally, with more than 40 regulatory submissions currently under review.