Tislelizumab

BeiGene Reports First Quarter 2024 Financial Results and Business Updates

Retrieved on: 
Wednesday, May 8, 2024
Oncology, Health, Other Health, General Health, Pharmaceutical, Biotechnology, FDA, Obinutuzumab, Acalabrutinib, NMPA, Food, Sustainability, European Commission, Progression-free survival, Fulvestrant, MTA, ASCEND, ESCC, Patent, PDUFA, ADC, CLL, Patient, CDK4, Symantec Endpoint Protection, Chronic lymphocytic leukemia, HPK1, Tislelizumab, BLA, Anticipation, EGFR, NSCLC, CDK2, GAAP, Food and Drug Administration, Growth, Lung cancer, Pharmaceutical industry

Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.

Key Points: 
  • Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.
  • The increase in product revenue was attributable to increased sales of our internally developed products, BRUKINSA and tislelizumab.
  • Gross Margin as a percentage of global product revenue for the first quarter of 2024 was 83%, compared to 80% in the prior-year period.
  • The gross margin percentage increased primarily due to proportionally higher sales mix of global BRUKINSA compared to other products in the portfolio.

BeiGene Demonstrates Global Progress in 2023 Responsible Business & Sustainability Report

Retrieved on: 
Friday, April 26, 2024
Environmental, Social and Governance (ESG), Green Technology, Climate Change, Sustainability, Pharmaceutical, Business, Oncology, Professional Services, General Health, Environment, Science, Biotechnology, Other Science, Health, Research, Responsibility, Cancer, Health equity, Woman, BGNE, Entrepreneurship, Patient, Global Health, Chronic lymphocytic leukemia, Tislelizumab, Carbon accounting, BTK

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, released its 2023 Responsible Business & Sustainability Report highlighting the Company’s strategy, the progress it has made towards existing goals, and how it intends to achieve its bold new targets.

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, released its 2023 Responsible Business & Sustainability Report highlighting the Company’s strategy, the progress it has made towards existing goals, and how it intends to achieve its bold new targets.
  • BeiGene’s Responsible Business & Sustainability Report highlights key achievements from 2023, including:
    Improved the percentage of women holding positions of Vice President and higher from 33% to 38% year over year.
  • “We are proud of the progress we’ve made on our priority areas in just a few short years,” said Christine Riley Miller, Global Head of Responsible Business & Sustainability at BeiGene.
  • We look forward to continuing our journey.”
    For more information about BeiGene’s Responsible Business & Sustainability strategy, achievements, and goals, please download a copy of the report here .

Global Oncology Innovator BeiGene Highlights New Data across Hematology and Solid Tumor Portfolio at 2024 ASCO Annual Meeting

Retrieved on: 
Wednesday, April 24, 2024
Biotechnology, General Health, Health, Pharmaceutical, Oncology, Information, Acalabrutinib, Colorectal cancer, BCL2, Follicular lymphoma, Patient, Comparison, TIS, HPK1, Tislelizumab, Lymphoid leukemia, Pharmaceutical industry

Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis

Key Points: 
  • Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis
    Real-world evaluation of treatment pattern, time to next treatment (TTNT), healthcare resource utilization (HCRU), and cost of care in follicular lymphoma (FL)
    BGB-11417-203, an ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia
    Session Type and Title: Poster Session – Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
    Preoperative (neoadjuvant) therapy with tislelizumab for locally advanced colorectal cancer with high microsatellite instability or deficient mismatch repair: an open-label, single-arm, multicenter phase II study
    Tislelizumab First-Line (1L) Gastric/Gastroesophageal Junction Cancer (G/GEJ) Treatment Efficacy on PRO-Based Symptom Endpoints Adjusting for Informative Missing Data Bias: Results from RATIONALE 305
    A first‑in‑human phase 1a dose‑escalation study of BGB‑15025 (HPK1 inhibitor) as monotherapy and in combination with tislelizumab (TIS; anti‑PD‑1 antibody) in patients (pts) with advanced solid tumors
    Long-term pooled safety analysis of tislelizumab as monotherapy or in combination with chemotherapy in patients with advanced cancers.

BeiGene Receives European Commission Approval for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

Retrieved on: 
Tuesday, April 23, 2024
Biotechnology, Pharmaceutical, Health, Oncology, PFS, Patient, Paclitaxel, Hospital, Food, European Commission, Neutropenia, JAMA Oncology, Survival, BGNE, Tislelizumab, Docetaxel, ESCC, European, Disease, Journal, Pemetrexed, Leukopenia, Neoplasm, Civil service commission, Carboplatin, ALK, EGFR, NSCLC, European Medicines Agency, Overalls, Lung cancer, Pharmaceutical industry

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use.

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use.
  • “Today’s EC authorization marks the second in the region for tislelizumab, with both NSCLC and locally advanced or metastatic esophageal squamous cell carcinoma now approved in the European Union.
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.
  • Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.

PureTech Receives FDA Fast Track Designation for LYT-200 in Head and Neck Cancers

Retrieved on: 
Thursday, April 11, 2024
Oncology, Health, FDA, Clinical Trials, Research, Science, Biotechnology, Cancer, Fast Track, Venetoclax, Food, Prognosis, Survival, AML, Bone marrow, Patient, Tislelizumab, Acute myeloid leukemia, PRTC, Head, Clinical trial, BeiGene, Pharmaceutical industry

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation for LYT-200 in combination with anti-PD1 therapy for the treatment of recurrent/metastatic head and neck squamous cell carcinomas (“head and neck cancers”).

Key Points: 
  • PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation for LYT-200 in combination with anti-PD1 therapy for the treatment of recurrent/metastatic head and neck squamous cell carcinomas (“head and neck cancers”).
  • It is being evaluated in two ongoing clinical trials:
    a Phase 1/2 adaptive design trial in advanced/metastatic solid tumors, including head and neck cancers.
  • “By granting Fast Track designation to LYT-200 for head and neck cancers, the FDA continues to highlight areas of critical need within oncology as well as the potential for LYT-200,” said Aleksandra Filipovic, M.D., Ph.D., Head of Oncology at PureTech.
  • The FDA has also granted orphan drug designation to LYT-200 for the treatment of AML .

BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy

Retrieved on: 
Thursday, March 14, 2024
Cardiology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Civil service commission, Glucose, Survival, ALT, DSM-IV codes, Associate, Blas, Medicine, Patient, Esophageal cancer, Committee, Sodium, Alkaline phosphatase, University, Cancer, EMA, BGNE, Quality of life, Tislelizumab, Lung cancer, Section, European Medicines Agency, Lymphocyte, ITT, European Commission, Anemia, Division, ESCC, Fatigue, University of Southern California, BLA, Food, Pharmaceutical industry

TEVIMBRA will be available in the U.S. in the second half of 2024.

Key Points: 
  • TEVIMBRA will be available in the U.S. in the second half of 2024.
  • The FDA is also reviewing Biologics License Applications (BLAs) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
  • BeiGene has launched more than 17 potentially registration-enabling trials with TEVIMBRA, of which 11 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts.
  • More than 900,000 patients have been prescribed TEVIMBRA globally to date.

BeiGene to Present Clinical and Preclinical Data from Broad Portfolio and Pipeline at AACR Annual Meeting 2024

Retrieved on: 
Wednesday, March 6, 2024
Science, Other Science, Biotechnology, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Therapy, Macrophage, Tislelizumab, Marketing, Form 10-K, Annual report, Safety, TIS, Patient, Intellectual property, Immunoglobulin G, Cancer, Pharmaceutical industry

It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

Key Points: 
  • It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
  • BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide.
  • With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations.
  • We are committed to radically improving access to medicines for far more patients who need them.

BeiGene’s Biologics License Application for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA

Retrieved on: 
Tuesday, February 27, 2024
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Incidence, Progression-free survival, European Commission, Tislelizumab, Anemia, Quality of life, Food, File, ESCC, BLA, Nausea, Vomiting, BGNE, Platelet, Safety, Stomach, Civil service commission, Death, Patient, Survival, Biologics license application, Appetite, Cancer, Pharmaceutical industry

“In clinical trials, TEVIMBRA has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer.

Key Points: 
  • “In clinical trials, TEVIMBRA has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer.
  • Median progression-free survival for TEVIMBRA plus chemotherapy was 6.9 months vs. 6.2 months respectively; (HR: 0.78 [95% CI: 0.67, 0.90]).
  • The safety profile for TEVIMBRA in combination with chemotherapy was manageable and in line with the known safety profile of anti-PD-1 antibodies.
  • A BLA for the treatment of patients with advanced or metastatic ESCC after prior chemotherapy is also under review by the FDA.

BeiGene Receives Positive CHMP Opinion for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

Retrieved on: 
Monday, February 26, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, NSCLC, Carboplatin, European Commission, EMA, JAMA Oncology, EGFR, Committee, Tislelizumab, MAA, Neoplasm, FDA, Quality of life, Cancer, Food, ESCC, Pemetrexed, BGNE, European, Lung cancer, Civil service commission, CHMP, European Medicines Agency, Paclitaxel, Patient, Journal, Survival, ALK, Pharmaceutical industry

As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.

Key Points: 
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.
  • Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.
  • Tislelizumab is also under review by the FDA as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.
  • BeiGene has launched more than 17 potentially registration-enabling trials with tislelizumab with over 13,000 patients enrolled to-date, of which 15 have already reported positive readouts.

Enhancing Leadership in Gynecology, Asieris Pharmaceuticals Appoints Sophia Cao to Lead the Newly-Established Women's Health Business Unit, Accelerating Strategic Expansion

Retrieved on: 
Tuesday, January 9, 2024
Action plan, E pluribus unum, Woman, Bladder cancer, Marketing, Health, Elimination, Society, Cancer, Cervical cancer, Infection, World Health Organization, Diagnosis, NMIBC, Comparison, Cervical weakness, Multimedia, Death, ASCO, Breast cancer, Eli Lilly, Tislelizumab, Prevalence, MIBC, Neoadjuvant therapy, HPV, Human papillomavirus infection, LSIL, New Drug Application, NMPA, National Health Commission, Central China, Kidney cancer, Women's health, National Cancer Center, PD-1, WHO, Mortality, HSIL, Conditional sentence, Internet, Weak topology, Patient, Senior, State Council, NDA, Incidence, Head, National Medical Products Administration, Miscarriage

This strategic move is designed to enhance the company's focus on genitourinary diseases and strengthen its position in women's health.

Key Points: 
  • This strategic move is designed to enhance the company's focus on genitourinary diseases and strengthen its position in women's health.
  • Asieris Pharmaceuticals will leverage both in-house discoveries and external partnerships to enrich its gynecological portfolio, thereby reinforcing its leadership in women's health.
  • In November 2020, the World Health Organization (WHO) released a Global Strategy to Accelerate the Elimination of Cervical Cancer.
  • To further deliver its strategic vision and commitment in the realm of women's health, Asieris Pharmaceuticals has announced the establishment of the Women's Health Business Unit.