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BeiGene Submits Supplementary BLA for Tislelizumab in Small Cell Lung Cancer
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BeiGene (NASDAQ: BGNE) has announced that its supplementary Biologic License Application (sBLA) for the programmed death-1 (PD-1) inhibitor tislelizumab has been accepted for review by the Center for Drug Evaluation (CDE) in China. The application seeks approval for the drug to be used in combination with etoposide and chemotherapy as…
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BeiGene’s Brukinsa Receives Positive CHMP Opinion for Follicular Lymphoma Treatment
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China-based biotechnology leader BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the receipt of a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval for its BTK inhibitor Brukinsa (zanubrutinib) as a treatment for relapsed/refractory follicular lymphoma (r/r FL). This recommendation positions Brukinsa as…
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China’s NHC Expands Rare Disease List, Includes 21 Cancer Types
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The National Health Commission (NHC) of China has released an updated national list of rare diseases, doubling the number of conditions to 86, including 21 cancer types. This marks the first update to China’s orphan disease schedule since the initial list of 121 conditions was introduced in 2018. Market Access…
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BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal
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China-based biotech company BeiGene (NASDAQ: BGNE) has reached a mutual agreement with Novartis (NYSE: NVS) to terminate their licensing deal from January 2021, under which Novartis held co-development and commercial rights to the programmed death-1 (PD-1) inhibitor, tislelizumab, in North America, Japan, the EU, and six other European countries. BeiGene…
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Nona Biosciences and BeiGene Form Partnership to Advance Antibody Discovery
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Nona Biosciences, a wholly owned subsidiary of Harbour BioMed (HKG: 2142), has announced a strategic partnership with China-based BeiGene (NASDAQ: BGNE). The collaboration focuses on the field of antibody discovery, with the aim of leveraging Nona’s proprietary technology to enhance BeiGene’s research capabilities. Financial details of the agreement have not…
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Asieris Pharmaceuticals’ APL-1202 Shows Positive Interim Analysis in MIBC Trial with BeiGene’s Tislelizumab
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has revealed positive results from a Phase II interim analysis of its drug candidate APL-1202, combined with BeiGene Ltd’s (NASDAQ: BGNE; HKG: 6160) programmed death-1 (PD-1) inhibitor tislelizumab, as neoadjuvant chemotherapy (NAC) in muscular invasive bladder cancer (MIBC). The trial has demonstrated…
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Luye Pharma’s Botawei Receives NMPA Approval for Breast Cancer Treatment
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Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its injectable goserelin acetate in microsphere form, trade-named Botawei, for the treatment of breast cancer in premenopausal and perimenopausal women eligible for hormone therapy. Botawei: A Pioneering Treatment for…
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BeiGene’s Q2 2023 Financial Report Highlights 81.8% YOY Product Revenue Growth
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China-based biotech company BeiGene (SHA: 688235, HKG: 6160, NASDAQ: BGNE) has released its financial report for the second quarter of 2023, demonstrating strong year-on-year (YOY) growth of 81.8% in product revenues, reaching USD 553.7 million. Sales in China contributed USD 233.9 million, while the US market generated USD 223.5 million.…
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BeiGene and Bristol-Myers Squibb/Celgene Settle Partnership, Termination Set for 2023
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BeiGene (NASDAQ: BGNE) has announced a settlement and termination agreement with US firm Bristol-Myers Squibb/Celgene (BMS, NYSE: BMY), formally ending their previous partnership on December 31, 2023. As part of the agreement, both parties have agreed to withdraw arbitral proceedings. Bristol-Myers Squibb/Celgene will transfer 23,273,108 ordinary shares of BeiGene back…
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Hainan Boao Lecheng Partners with BeiGene to Boost Medical Tourism and Biotech Innovation
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The Hainan Boao Lecheng International Medical Tourism Pilot Zone has entered into a partnership with China-based biotech firm BeiGene (NASDAQ: BGNE). The collaboration aims to capitalize on the respective strengths of both entities to advance the translation of scientific and technological achievements, foster talent cultivation and exchange, and co-construct innovation…
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BeiGene’s Tislelizumab Receives Positive CHMP Opinion for Esophageal Cancer Treatment
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BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending a first market approval. The regulatory decision on whether to approve tislelizumab monotherapy for unresectable, locally…
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BeiGene’s Brukinsa Receives US FDA Review for Relapsed/Refractory Follicular Lymphoma sNDA
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China-based biotechnology company BeiGene (NASDAQ: BGNE) has announced that the US Food and Drug Administration (FDA) has accepted for review a new supplemental new drug application (sNDA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The application seeks to add a new indication for the treatment of adults with…
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Novartis Terminates TIGIT-Targeted Antibody Deal with BeiGene, Retains Rights to Ociperlimab
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Swiss pharmaceutical giant Novartis AG (NYSE: NVS) has decided to terminate an option and license deal with China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235), which was focused on the development of BeiGene’s TIGIT-targeted antibody drug, ociperlimab. The initial deal, signed in December 2021, included a USD 300 million upfront…
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BeiGene Secures Exclusive Licensing Deal with Duality Biotherapeutics for Novel Drug Development
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China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced an exclusive option and licensing agreement with Duality Biotherapeutics, a novel modality drug developer with operations in both the United States and China. This strategic partnership aims to leverage Duality’s expertise in developing innovative therapies. Financial Terms and MilestonesAccording to…
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Chime Biologics, Leads Biolabs, and BeiGene Form Strategic Partnership for LAG-3 mAb LBL-007
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Wuhan-based Contract Development and Manufacturing Organization (CDMO) Chime Biologics has signed a strategic cooperation agreement with Nanjing-based Leads Biolabs and Beijing firm BeiGene Inc., (NASDAQ: BGNE, HKG: 6160). The cooperation focuses on the development and global manufacturing of LBL-007, a LAG-3 monoclonal antibody (mAb). BeiGene’s Acquisition and Global Rights to…
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Luye Pharma’s Goserelin Acetate Microspheres Approved by NMPA for Prostate Cancer Treatment
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Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its injectable goserelin acetate in microsphere form, a treatment for prostate cancer requiring androgen castration therapy. This innovative formulation is designed to provide a smoother drug release during the…
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BeiGene Initiates First-in-Human Trial for Next-Generation BCL-2 Inhibitor BGB-21447
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China-based BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the first patient dosing in a first-in-human trial for its pipeline candidate, BGB-21447, a next-generation BCL-2 inhibitor. The trial, which is potentially superior to venetoclax based on preclinical activity, is being conducted at Shandong Hospital. Phase I Study Design and…
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BeiGene to Showcase Brukinsa Data at ICML, Highlighting Efficacy in Relapsed Follicular Lymphoma
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China-based biopharmaceutical company BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it will present data on its Bruton’s tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) at the 17th International Conference on Malignant Lymphoma (ICML). The data highlights the potential of Brukinsa in combination with obinutuzumab for the treatment of…
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AbbVie Inc. Files Lawsuit Against BeiGene Over BTK Inhibitor Brukinsa
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US-based AbbVie Inc., (NYSE: ABBV), the company behind the first-in-class Bruton’s tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib), has taken legal action against BeiGene’s (NASDAQ: BGNE) BTK inhibitor Brukinsa (zanubrutinib). The lawsuit was filed by AbbVie subsidiary Pharmacyclics in the Delaware District Court on the day it was awarded a new…
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CDE Indicates Priority Review for Overland ADCT’s Zynlonta and BeiGene’s Brukinsa
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The Center for Drug Evaluation (CDE) in China has indicated that Overland ADCT BioPharma (CY) Ltd’s Zynlonta (loncastuximab tesirine), an antibody-drug conjugate (ADC) targeting CD19, and BeiGene Ltd’s (NASDAQ: BGNE, HKG: 6160, SHA: 688235) Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) are on track to receive priority review statuses. Both…
