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FDA Grants BeiGene’s Lymphoma Treatment Priority Review americanpharmaceuticalreview
August 23, 2019
BeiGene, Ltd. has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for zanubrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
BeiGene’s Tislelizumab Achieves Positive Phase II Results contractpharma
July 19, 2019
Investigational anti-PD-1 antibody aims to treat Chinese patients with relapsed/refractory classical Hodgkin’s lymphoma.
NMPA grants priority review to BeiGene's sNDA for tislelizumab biospectrumasia
July 08, 2019
The sNDA for tislelizumab as a potential treatment for patients with previously treated locally-advanced or metastatic UC was accepted by the NMPA in May 2019.
China’s regulator agrees to review BeiGene’s tislelizumab pharmaceutical-technology
June 05, 2019
The National Medical Products Administration (NMPA) in China has agreed to review BeiGene’s supplemental new drug application (sNDA) of tislelizumab in urothelial carcinoma (UC).
BioAtla & BeiGene Enter Development Pact contractpharma
April 15, 2019
Agreement also covers the manufacturing and commercialization of BioAtla’s investigational CAB CTLA-4 antibody (BA3071).
Ambrx, BeiGene to develop next-generation biologics biospectrumasia
March 08, 2019
Ambrx to receive an upfront payment of $10 million to apply its proprietary Expanded Genetic Code platforms to discover novel biologic drug candidates in this collaboration with BeiGene
BeiGene and Ambrx form R&D alliance for new biologics pharmaceutical-technology
March 08, 2019
China-based immuno-oncology drugs maker BeiGene and American biopharmaceutical firm Ambrx have formed a research and development (R&D) partnership to develop next-generation biologic drugs.
BeiGene gains FDA breakthrough therapy status for zanubrutinib in mantle cell lymphoma firstwordpharma
January 16, 2019
BeiGene announced that it received a breakthrough therapy designation for its investigational Bruton's tyrosine kinase (BTK) inhibitor zanubrutinib to treat adults with mantle cell lymphoma (MCL) who have received at least one prior therapy.
BeiGene Receives FDA Breakthrough Therapy Designation for Zanubrutinib americanpharmaceuticalreview
January 16, 2019
BeiGene announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for its investigational Bruton’s tyrosine kinase (BTK) inhibitor....
China’s BeiGene delays US filing for rival to Imbruvica pharmaphorum
December 05, 2018
BeiGene’s plans for an early approval for BTK inhibitor zanubrutinib in the US and to start challenging Janssen/AbbVie’s blockbuster Imbruvica have suffered a setback.

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