BeiGene Ltd.
🇨🇳China
- Country
- 🇨🇳China
- Ownership
- Public
- Established
- 2010-01-01
- Employees
- 10K
- Market Cap
- $22.1B
- Website
- http://www.beigene.com
Pfizer Enters $6 Billion Licensing Deal with China's 3SBio for Novel Cancer Drug
• Pfizer has secured global rights (excluding China) to 3SBio's experimental cancer drug SSGJ-707 for $1.25 billion upfront, with potential additional payments of up to $4.8 billion based on developmental milestones.
• SSGJ-707 is currently being evaluated for multiple cancer types including non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors, with Phase III trials in China planned to begin this year.
• The deal includes a $100 million equity investment in 3SBio by Pfizer, with manufacturing planned at Pfizer's facilities in North Carolina and Kansas following FDA clearance of the Investigational New Drug application.
Gustave Roussy Launches UMBRELLA Trial: Using Blood-Based Tumor DNA to Revolutionize Cancer Follow-Up Care
• Gustave Roussy has initiated UMBRELLA, a groundbreaking phase III trial that personalizes post-treatment cancer monitoring based on minimal residual disease (MRD) detected through blood-based circulating tumor DNA analysis.
• The trial will evaluate two strategies: pre-emptive immunotherapy (tislelizumab) for MRD-positive patients and reduced follow-up schedules for MRD-negative patients with non-metastatic lung, colorectal, pancreatic, and soft tissue sarcomas.
• UMBRELLA represents the first French multi-cancer trial using MRD status for therapeutic stratification, aiming to enroll over 700 patients across 10-11 centers in a collaborative effort involving Veracyte, IntegraGen, and BeiGene.
BeiGene to Present Extensive Hematology Data at EHA 2025, Showcasing BRUKINSA and Next-Generation Therapies
• BeiGene will present 31 abstracts at the European Hematology Association Congress in Milan, highlighting data from its BTK inhibitor BRUKINSA and investigational pipeline assets sonrotoclax and BGB-16673.
• The company's next-generation pipeline assets have demonstrated promising clinical activity and safety profiles across multiple B-cell malignancies, with over 2,500 patients enrolled globally in clinical trials.
• Four oral presentations will feature updated results from clinical studies of BGB-16673 in CLL/SLL and WM, as well as sonrotoclax in combination with BRUKINSA in R/R CLL/SLL and R/R MCL.
GSK and iTeos Terminate TIGIT Cancer Drug Development After Phase 2 Failure
• GSK and iTeos Therapeutics have discontinued development of belrestotug, their TIGIT-targeting immunotherapy, after it failed to significantly delay tumor progression in non-small cell lung cancer patients.
• The companies are terminating all ongoing trials, including a Phase 3 study, ending their four-year collaboration that began with GSK's $625 million upfront payment and potential $1.45 billion in milestone payments.
• iTeos is now conducting a strategic review to preserve capital, as the failure eliminates its most advanced drug candidate and represents another setback for TIGIT-targeting therapies in oncology.
Phase 3 ECOG-ACRIN EA4151 Trial Evaluates Necessity of Auto-HCT in Modern MCL Treatment
• The phase 3 ECOG-ACRIN EA4151 trial is investigating whether autologous hematopoietic cell transplantation (auto-HCT) still benefits mantle cell lymphoma patients in the era of improved first-line therapies.
• The study enrolled 650 patients across four treatment arms, comparing auto-HCT plus rituximab versus rituximab alone in patients achieving MRD-negative complete remission after frontline therapy.
• This research follows the phase 3 TRIANGLE trial, which previously showed auto-HCT provided no added benefit when combined with rituximab, ibrutinib, and high-dose cytarabine regimens in MCL patients.
SystImmune to Present Promising Data on Iza-bren for HER2-Negative Breast Cancer at ESMO Breast 2025
• SystImmune will present updated safety and efficacy data for izalontamab brengitecan (iza-bren), an EGFRxHER3 bispecific antibody-drug conjugate, in locally advanced or metastatic breast cancer at ESMO Breast 2025 on May 16.
• Early clinical results show encouraging efficacy across all HER2 levels in HER2-negative breast cancer patients, including HER2 0 patients, suggesting potential therapeutic benefits for patients with limited treatment options.
• Iza-bren, being jointly developed by SystImmune and Bristol Myers Squibb, works by blocking EGFR and HER3 signals to cancer cells while delivering a therapeutic payload that induces cancer cell death.
Pharma Leadership Shuffle: Key Executive Moves in Early 2025 Reshape Industry Landscape
• The pharmaceutical industry has experienced significant leadership changes in early 2025, with major transitions at companies including Pfizer, Boehringer Ingelheim, and Takeda.
• Former FDA CDER Director Patricia Cavazzoni's move to Pfizer as Chief Medical Officer has sparked "revolving door" criticisms, highlighting ongoing concerns about regulatory-industry transitions.
• Several biotechnology firms have strengthened their executive teams with specialized expertise in clinical development, particularly in areas like stroke treatment, antibody-drug conjugates, and neuropsychiatric therapies.
Lupus Nephritis Market Expected to Grow as Novel Therapies Enter Clinical Trials
• The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions.
• Several innovative therapies are advancing through clinical trials, including CAR-T cell treatments from companies like Allogene Therapeutics, Adicet Bio, and Caribou Biosciences, which received FDA Fast Track designations.
• Key pharmaceutical players including Aurinia Pharmaceuticals, AstraZeneca, and Roche are developing treatments such as voclosporin, anifrolumab, and obinutuzumab to address the significant unmet needs in lupus nephritis management.
Summit Therapeutics' Ivonescimab Shows Promising Results in Phase 3 NSCLC Trial
• Summit Therapeutics reported statistically significant improvement in progression-free survival for ivonescimab plus chemotherapy versus BeiGene's Tevimbra combination in advanced squamous non-small cell lung cancer.
• The bispecific antibody ivonescimab, licensed from Chinese biotech Akeso, is already approved in China but still undergoing multiple clinical trials globally for various cancer indications.
• Despite mixed results against Merck's Keytruda in a separate NSCLC trial, ivonescimab's potential as a "pipeline in a drug" positions it for possible blockbuster status in the lucrative lung cancer market.
Promising Pipeline for Mantle Cell Lymphoma Treatment: 22+ Therapies Under Development by 20+ Companies
• DelveInsight's latest report reveals a robust pipeline with 20+ companies developing 22+ therapies for mantle cell lymphoma, highlighting significant advancement in treatment options for this rare blood cancer.
• Recent approvals include AstraZeneca's CALQUENCE® (acalabrutinib) combination therapy for previously untreated MCL patients ineligible for stem cell transplantation, marking an important treatment milestone.
• Key emerging therapies include Venetoclax (AbbVie), ADI-001 (Adicet Bio), and BGB-11417 (BeiGene), with multiple compounds targeting novel mechanisms of action across various clinical development stages.
Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate
• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests.
• The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods.
• The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.
BeiGene Discontinues Ociperlimab Development After Failed Phase III Lung Cancer Trial
• BeiGene has terminated development of its anti-TIGIT antibody ociperlimab following a futility analysis showing the drug was unlikely to meet overall survival endpoints in non-small cell lung cancer.
• The decision comes after Novartis ended its $300 million licensing partnership with BeiGene in July 2023, forcing the biotech to reevaluate the drug's development pathway.
• This setback adds to mounting challenges in the TIGIT inhibitor space, following Merck's recent discontinuation of two Phase III trials of its anti-TIGIT candidate vibostolimab due to safety and efficacy concerns.
B-Cell Lymphoma Pipeline Expands with 300+ Therapies in Development for 2025
• DelveInsight's latest report reveals a robust B-cell lymphoma pipeline with over 295 companies developing 300+ therapies, highlighting significant industry investment in this area.
• Several major pharmaceutical companies including BeiGene, Celgene, Hoffmann-La Roche, and Allogene Therapeutics have initiated pivotal late-stage clinical trials for novel B-cell lymphoma treatments in March 2025.
• Emerging therapies include CAR-T cell approaches, bispecific antibodies, and novel targeted agents, with many incorporating dual-targeting mechanisms to overcome resistance seen with single-target therapies.
Roche's Tiragolumab Combination Shows Inferior Outcomes in Advanced NSCLC Trial
• Roche's phase 2/3 SKYSCRAPER-06 trial reveals tiragolumab plus Tecentriq and chemotherapy performed worse than Keytruda-chemo combination in first-line advanced non-squamous NSCLC treatment.
• Both progression-free survival and overall survival endpoints showed inferior results in the tiragolumab arm, prompting Roche to reevaluate its ongoing development program.
• The setback adds to growing concerns about TIGIT inhibitors, following recent failures from other companies including MSD's vibostolimab in melanoma trials.
Global Clinical Trials for Myelodysplastic Syndrome Show Significant Industry Investment in 2025
• A comprehensive review of global Myelodysplastic Syndrome clinical trials reveals extensive research activity across G7 and E7 countries, with major pharmaceutical companies leading development efforts.
• The analysis highlights significant participation from industry leaders including Bristol-Myers Squibb, Novartis, and Sanofi, demonstrating strong commercial interest in MDS therapeutics.
• The report indicates evolving clinical trial landscapes across multiple regions, with detailed tracking of trial phases, enrollment trends, and success rates over the past five years.
Brukinsa Demonstrates Superior Safety Profile Compared to Imbruvica in CLL Treatment Study
• A new study comparing BTK inhibitors in chronic lymphocytic leukemia treatment shows Brukinsa (zanubrutinib) had fewer severe side effects than Imbruvica (ibrutinib), with 4% versus 9% incidence respectively.
• Notable findings include complete absence of neutropenia in the Brukinsa group compared to 3% in the Imbruvica group, suggesting particular benefits for older or immunocompromised patients.
• Treatment discontinuation and dose reductions were less frequent with Brukinsa, though researchers emphasize the importance of personalized treatment decisions based on individual patient characteristics.
Chinese Cancer Drug Outperforms Merck's Keytruda in Landmark Lung Cancer Trial
• A novel Chinese experimental cancer drug has demonstrated unprecedented efficacy in late-stage trials, nearly doubling progression-free survival in non-small-cell lung cancer patients compared to Keytruda.
• Merck's Keytruda, a leading cancer immunotherapy drug, has generated over $130 billion in sales since 2014, including $29.5 billion in the previous year.
• The breakthrough Chinese trial results of 11.1 months versus Keytruda's 5.8 months mark a significant advancement in cancer immunotherapy and challenge Western pharmaceutical dominance.
Phase II Trial Shows Breakthrough 63.6% Response Rate for Novel Bladder Cancer Combination Therapy
• Disitamab Vedotin combined with Toripalimab achieved a 63.6% pathological complete response rate in muscle-invasive bladder cancer patients, nearly doubling traditional chemotherapy outcomes.
• The clinical trial demonstrated strong efficacy across all HER2 expression levels, with HER2 IHC 3+ patients showing an exceptional 84.6% complete response rate.
• The treatment showed favorable safety with only 27.7% grade 3 or higher adverse events, significantly lower than conventional chemotherapy's 40-50% rate.
Akeso's Gumokimab (IL-17 mAb) Application Accepted for Psoriasis Treatment in China
• Akeso's gumokimab, an IL-17 targeting monoclonal antibody, has its NDA accepted by China's NMPA for treating moderate to severe plaque psoriasis.
• Clinical trials showed gumokimab's rapid efficacy, with PASI 75 response rates approaching 96% at week 12 and sustained improvement over 52 weeks.
• Safety profiles of gumokimab were comparable to placebo, indicating good tolerability, which addresses the need for safer psoriasis treatments.
• Akeso aims to meet diverse patient needs by combining gumokimab with other drugs like ebronucimab, enhancing their autoimmune disease product synergy.
Acalabrutinib Receives FDA Approval for Previously Untreated Mantle Cell Lymphoma
• The FDA has granted traditional approval to acalabrutinib in combination with bendamustine and rituximab for untreated MCL patients ineligible for stem cell transplant.
• The approval was based on the ECHO trial, which showed a 27% reduction in disease progression or death compared to chemoimmunotherapy alone.
• Median progression-free survival was 66.4 months with acalabrutinib versus 49.6 months with chemoimmunotherapy, demonstrating a clinically significant improvement.
• Acalabrutinib is now the first and only BTK inhibitor approved for first-line MCL treatment, offering a new option for this rare and aggressive cancer.
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