China National Medical Products Administration Approves BeiGene?s Tislelizumab for Patients with Classical Hodgkin?s Lymphoma Who Have Received at Least Two Prior Therapies
- Second?BeiGene-discovered drug to receive regulatory approval, first in?China
- Tislelizumab is an anti?PD-1 antibody specifically designed to minimize binding to Fc?R on macrophages
Tislelizumab is being studied in a broad clinical program as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. Currently, 15 registration-enabling clinical trials are being conducted in?China?and globally, including 11 Phase 3 trials and four pivotal Phase 2 trials.
Tislelizumab is not approved for use outside?China. About the Tislelizumab Clinical Program Clinical trials of tislelizumab include:- Phase 2 trial in patients with locally advanced or metastatic urothelial bladder cancer (NCT04004221);
- Phase 3 trial in patient with locally advanced or metastatic urothelial carcinoma (NCT03967977);
- Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with non-small cell lung cancer (NSCLC; NCT03358875);
- Phase 3 trial of tislelizumab in combination with chemotherapy ?versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
- Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
- Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
- Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
- Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
- Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
- Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
- Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
- Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
- Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889);
- Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).
About?BeiGene
BeiGene?is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 3,000 employees in?the United States,?China,?Australia, and?Europe;?BeiGene?is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer.?BeiGene?is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. In?the United States,?BeiGene?markets and distributes BRUKINSA??(zanubrutinib) and in?China, the Company has received approval to market its anti-PD-1 antibody tislelizumab and markets ABRAXANE??(nanoparticle albumin?bound paclitaxel), REVLIMID??(lenalidomide), and VIDAZA??(azacitidine) under a license from Celgene Logistics Sarl, a?Bristol-Myers Squibb company3.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene?s plans and expectations for the commercialization of tislelizumab, the potential implications of clinical data for patients, BeiGene?s further advancement of, and anticipated clinical development, regulatory milestones and commercialization of tislelizumab. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including?BeiGene's?ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval;?BeiGene's?ability to achieve commercial success for its marketed products and drug candidates, if approved;?BeiGene's?ability to obtain and maintain protection of intellectual property for its technology and drugs;?BeiGene's?reliance on third parties to conduct drug development, manufacturing and other services; BeiGene?s limited operating history and?BeiGene's?ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled ?Risk Factors? in BeiGene?s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in?BeiGene's?subsequent filings with the?U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and?BeiGene?undertakes no duty to update such information unless required by law.
Investor Contact Craig West +1 857-302-5189 ir@beigene.com | Media Contact Liza Heapes or Vivian Ni +1 857-302-5663 or +1 857-302-7596 media@beigene.com |