Tislelizumab

China NMPA Approves Tislelizumab as Second- or Third-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, January 6, 2022
Biotechnology, Health, Genetics, Pharmaceutical, Oncology, Non-Small Cell Lung Cancer, Tislelizumab, the Tislelizumab Clinical Program, BeiGene, NON-SMALL CELL LUNG CANCER, TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

A supplemental biologics license application for tislelizumab in this indication was previously accepted for review by the China NMPA in March 2021.

Key Points: 
  • A supplemental biologics license application for tislelizumab in this indication was previously accepted for review by the China NMPA in March 2021.
  • This latest approval for tislelizumab demonstrates BeiGenes commitment to bringing innovative, impactful treatments to patients in need.
  • As its third approved lung cancer indication in China, todays approval represents an important milestone, with tislelizumab now available in both front-line and second- or third-line care of NSCLC.
  • The NMPAs approval of tislelizumab is welcoming news to the lung cancer community in China, and we hope this immunotherapy will help address the unmet needs in second- or third-line treatment of NSCLC.

Asieris Announces the World's First Patient Dose Administered in Combination of Asieris'APL-1202 and BeiGene's Tislelizumab as Neoadjuvant Therapy for MIBC Patients

Retrieved on: 
Tuesday, January 4, 2022
Safety, UC, FCR, Diagnosis, COVID-19, Neoadjuvant therapy, Disease, Neoplasm, Hepatocellular carcinoma, Doctor of Philosophy, National Medical Products Administration, NMPA, Health, CHL, CDE, Tislelizumab, Center, Cancer, IND, MD, Macrophage, Therapy, METAP2, HCC, Patient, Hodgkin lymphoma, Immunoglobulin G, NSCLC, NMIBC, Pharmaceutical industry, BeiGene, MIBC

This is an open-label, multi-center Phase I/II clinical study with the following objectives: to evaluate the safety in MIBC patients; to determine the recommended Phase 2 dose (RP2D), and to assess efficacy as neoadjuvant therapy for MIBC.

Key Points: 
  • This is an open-label, multi-center Phase I/II clinical study with the following objectives: to evaluate the safety in MIBC patients; to determine the recommended Phase 2 dose (RP2D), and to assess efficacy as neoadjuvant therapy for MIBC.
  • "APL-1202 in combination with tislelizumab as neoadjuvant therapy has the potential to be the best treatment option for MIBC patients, we are very pleased that the first patient has administrated in U.S.," said Dr. Xue Yong, MD, PhD, Chief Medical Officer at Asieris.
  • APL-1202 is an orallyavailable reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment.
  • We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.

Nanjing Leads Biolabs and BeiGene Announce Worldwide License and Collaboration Agreement for LBL-007 Anti-LAG-3 Antibody; BeiGene Granted Exclusive Commercialization Rights Outside of China

Retrieved on: 
Tuesday, December 14, 2021
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, U.S. Securities and Exchange Commission, Intellectual property, Company, Cell, Global health, Private Securities Litigation Reform Act, ASCO, MHC II, IND, COVID-19, NASDAQ, Doctor of Philosophy, LAG-3, CEO, Research, Marketing, Goal, Safety, Novartis, Patient, Therapy, Tislelizumab, PARP, BTK, Bristol Myers Squibb, Jazz Pharmaceuticals, American Society of Clinical Oncology, Ligand, MHC, Technology, Society, Pharmaceutical industry, Cleveland BioLabs, Amgen, BeiGene, EU

BeiGene is the ideal partner for Leads Biolabs given its extensive experience in the development of oncology medicines worldwide and the compelling immuno-oncology combination opportunity in its pipeline.

Key Points: 
  • BeiGene is the ideal partner for Leads Biolabs given its extensive experience in the development of oncology medicines worldwide and the compelling immuno-oncology combination opportunity in its pipeline.
  • By collaborating with BeiGene, Leads Biolabs expects to significantly accelerate the development and commercialization of LBL-007.
  • BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.
  • Nanjing Leads Biolabs (Leads Biolabs) is a clinical-stage US-Sino joint venture company, focusing on development and commercialization of second-generation immuno-oncology therapeutics.

BeiGene Presents Results from Phase 3 Trial of Tislelizumab in Nasopharyngeal Cancer at ESMO Immuno-Oncology Congress 2021

Retrieved on: 
Friday, December 10, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Nasopharyngeal Cancer, Tislelizumab, the Tislelizumab Clinical Program, BeiGene, NASOPHARYNGEAL CANCER, TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

A filing based on these results is currently under review in China, where NPC as an endemic disease remains a significant unmet medical need.

Key Points: 
  • A filing based on these results is currently under review in China, where NPC as an endemic disease remains a significant unmet medical need.
  • Safety results in both arms remained similar to known risks and no new safety signals were identified.
  • The safety profile of tislelizumab and chemotherapy combination was manageable, consistent with known risks of each treatment agent.
  • BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials.

Zymeworks Announces Expansion of Zanidatamab Pivotal Trial in Asia in Collaboration with BeiGene and Associated Milestone Payment

Retrieved on: 
Thursday, December 9, 2021
Biotechnology, Pharmaceutical, Health, Clinical Trials, Accelerated approval (FDA), Engineering, NYSE, Twitter, Trastuzumab, Forward-looking statement, Research, Inc., White Light Rock & Roll Review, Phagocytosis, Biliary tract, CAPOX, Safety, Progression-free survival, Drug development, PD-1, Private Securities Litigation Reform Act, Compte rendu, Patient, Breakthrough therapy, Priority review, FP, Zymeworks, Epitope, RECIST, BeiGene, European Medicines Agency, Breast, FDA, HER2, Orphan drug, Conjugation, Tislelizumab, Pharmaceutical industry, the HERIZON-GEA-01 Clinical Trial, the Zymeworks-BeiGene Collaboration, Zanidatamab, Zymeworks Inc., THE HERIZON-GEA-01 CLINICAL TRIAL, THE ZYMEWORKS-BEIGENE COLLABORATION, ZANIDATAMAB, ZYMEWORKS INC.

As a result of this development milestone, Zymeworks will receive a US$8 million payment under its zanidatamab collaboration agreement with BeiGene.

Key Points: 
  • As a result of this development milestone, Zymeworks will receive a US$8 million payment under its zanidatamab collaboration agreement with BeiGene.
  • Zymeworks and BeiGene continue to work to expedite the opening of approximately 300 clinical trial sites across 38 countries in support of the global Phase 3 pivotal trial.
  • Zymeworks collaborator, BeiGene, will oversee trial sites in Asia (excluding Japan), Australia and New Zealand, and Zymeworks will oversee trial sites in the rest of the world, including North and South America, Japan, Europe, Middle East and Africa.
  • Zanidatamab is a bispecific antibody, based on Zymeworks Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding.

BeiGene Announces Inclusion in the China National Reimbursement Drug List (NRDL) of Tislelizumab in Three New Indications, BRUKINSA® (Zanubrutinib) in One New Indication, and the First Listing for Pamiparib

Retrieved on: 
Friday, December 3, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Tislelizumab, BRUKINSA® (zanubrutinib), Pamiparib, TISLELIZUMAB, BRUKINSA® (ZANUBRUTINIB), PAMIPARIB

Since its establishment, the NHSA has accelerated the frequency of adjustment to the NRDL, forming a dynamic mechanism for annual updates.

Key Points: 
  • Since its establishment, the NHSA has accelerated the frequency of adjustment to the NRDL, forming a dynamic mechanism for annual updates.
  • We look forward to working with the NHSA to fulfill the demand for these treatments across China as soon as possible.
  • Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcR on macrophages.
  • Discovered by BeiGene scientists, pamiparib was the first PARP inhibitor approved in both platinum-sensitive and platinum-resistant relapsed ovarian cancer in China.

BeiGene and EUSA Pharma Announce NMPA Approval of SYLVANT® (Siltuximab for Injection) in China for Idiopathic Multicentric Castleman Disease

Retrieved on: 
Friday, December 3, 2021
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, PARP, Overalls, Company, NMPA, Siltuximab, Bristol Myers Squibb, Medication package insert, Effectiveness, Idiopathic multicentric Castleman disease, EU, Neoplasm, Diarrhea, Jazz Pharmaceuticals, Marketing, Global health, Tislelizumab, MCD, HIV, Private Securities Litigation Reform Act, Approved, Product, Anaphylaxis, Lymphoma, General manager, Research, Arthralgia, Itch, Respiratory tract, Review, Infection, Rash, EUSA, Therapy, Goal, U.S. Securities and Exchange Commission, Intellectual property, BTK, Twitter, Adult, NASDAQ, Lymph, FDA, Multimedia, HHV-8, Patient, Tissue, National Medical Products Administration, Safety, Technology, Novartis, IL-6, Degenerative disease, Thoracic duct, COVID-19, EMA, Union, Disease, Vaccine, Pharmaceutical industry, SYLVANT® (siltuximab for injection), EUSA Pharma, BeiGene, SYLVANT® (SILTUXIMAB FOR INJECTION), EUSA PHARMA, BEIGENE

Siltuximab is a monoclonal antibody approved in the United States, European Union, and other countries and regions around the world.

Key Points: 
  • Siltuximab is a monoclonal antibody approved in the United States, European Union, and other countries and regions around the world.
  • This approval is our second product in our collaboration with EUSA, highlighting the combined expertise of our companies as we work together on behalf of patients.
  • Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease.
  • We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera.

BeiGene and EUSA Pharma Announce NMPA Approval of SYLVANT® (Siltuximab for Injection) in China for Idiopathic Multicentric Castleman Disease

Retrieved on: 
Friday, December 3, 2021
Science, Biotechnology, Research, Pharmaceutical, Physical Therapy, Health, Infectious Diseases, Clinical Trials, PARP, Overalls, Company, NMPA, Siltuximab, Bristol Myers Squibb, Medication package insert, Effectiveness, Idiopathic multicentric Castleman disease, EU, Neoplasm, Diarrhea, Jazz Pharmaceuticals, Marketing, Global health, Tislelizumab, MCD, HIV, Private Securities Litigation Reform Act, Approved, Product, Anaphylaxis, Lymphoma, General manager, Research, Arthralgia, Itch, Respiratory tract, Review, Infection, Rash, EUSA, Therapy, Goal, U.S. Securities and Exchange Commission, Intellectual property, BTK, Twitter, Adult, NASDAQ, Lymph, FDA, HHV-8, Patient, Tissue, National Medical Products Administration, Safety, Technology, Novartis, IL-6, Degenerative disease, Thoracic duct, COVID-19, EMA, Union, Disease, Vaccine, Pharmaceutical industry

Todays approval provides a new treatment for patients in China with this rare systemic disorder, commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene.

Key Points: 
  • Todays approval provides a new treatment for patients in China with this rare systemic disorder, commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene.
  • This approval is our second product in our collaboration with EUSA, highlighting the combined expertise of our companies as we work together on behalf of patients.
  • Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease.
  • We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera.

BeiGene to Present New Clinical Data on Tislelizumab at ESMO IO Congress 2021

Retrieved on: 
Thursday, December 2, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Patient, Private Securities Litigation Reform Act, NSCLC, Ovarian cancer, Safety, PARP, Oncology, Technology, TKI, Company, Novartis, Large-cell lung carcinoma, Form 10-Q, Cancer, EGFR, Bristol Myers Squibb, Chemoradiotherapy, Squamous cell carcinoma, Therapy, COVID-19, Goal, U.S. Securities and Exchange Commission, Melanoma, BTK, Cisplatin, Nasopharyngeal carcinoma, Intellectual property, Twitter, Research, ESMO, Jazz Pharmaceuticals, Marketing, Global health, Tislelizumab, European Society for Medical Oncology, NPC, PD-1, Neoadjuvant therapy, Immunotherapy, Congress, II, NASDAQ, Standard of care, Lymphatic system, Pharmaceutical industry

To learn more about BeiGenes research and development and activities at ESMO IO, please visit https://beigenemedical.eu/ .

Key Points: 
  • To learn more about BeiGenes research and development and activities at ESMO IO, please visit https://beigenemedical.eu/ .
  • Combination strategy is considered key to overcoming primary and acquired resistance to anti-PD-1 therapy and expanding clinical benefit of immunotherapy to more patients.
  • BeiGene is investigating the potential of novel tislelizumab combinations to drive stronger and more sustained tumor responses and impede tumor immune escape.
  • BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

Zymeworks Launches Global Phase 3 Zanidatamab Trial in First-Line HER2‑Positive Gastroesophageal Adenocarcinoma (GEA)

Retrieved on: 
Tuesday, November 9, 2021
Biotechnology, Pharmaceutical, Health, Clinical Trials, Population, Progression-free survival, Cancer, European Society for Medical Oncology, COVID-19, Trastuzumab, Accelerated approval (FDA), Oncology, GEA, Mortality, Safety, DCR, MBA, Trial of the century, European Medicines Agency, HER2, Standard of care, Research, Forward-looking statement, Phagocytosis, Epitope, BTC, Patient, FDA, Breast, Private Securities Litigation Reform Act, Inc., Orphan drug, Breakthrough therapy, CEO, Disease, CAPOX, Trae tha Truth, Twitter, Interest, Corr, White Light Rock & Roll Review, RECIST, Priority review, News, Engineering, Tislelizumab, Diarrhea, Incidence, Zymeworks, Biliary tract, BeiGene, NYSE, Drug development, Pharmaceutical industry, Vaccine, Zanidatamab, the Zymeworks-BeiGene Collaboration, Zymeworks Inc., ZANIDATAMAB, THE ZYMEWORKS-BEIGENE COLLABORATION, ZYMEWORKS INC.

We are incredibly excited to launch our second pivotal, and first Phase 3 clinical trial for zanidatamab, HERIZONGEA01, said Ali Tehrani, Ph.D., Zymeworks President & CEO.

Key Points: 
  • We are incredibly excited to launch our second pivotal, and first Phase 3 clinical trial for zanidatamab, HERIZONGEA01, said Ali Tehrani, Ph.D., Zymeworks President & CEO.
  • The encouraging zanidatamab Phase 2 data support its further investigation with tislelizumab in this Phase 3 HERIZON-GEA-01 trial in first-line HER2-positive gastroesophageal adenocarcinomas, said Yong (Ben) Ben, M.D., Chief Medical Officer, Solid Tumors, at BeiGene.
  • Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2.
  • Zanidatamab is also being evaluated in several Phase 2 clinical trials for HER2-expressing gastroesophageal, colorectal, and breast cancers.