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BeiGene Launches Charitable Access Program for Brukinsa in Low-Income Countries
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), the China-based biotech firm, has announced that the first patients have received doses of Brukinsa (zanubrutinib) through a charitable access initiative designed to provide the drug to patients in low- and middle-income countries (LMICs). This initiative is made possible by a partnership…
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BeiGene Launches Legal Action Against Sandoz and MSN Over Brukinsa Patent Infringement
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BeiGene Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235), the China-based biotech firm, has initiated patent infringement proceedings against two generics manufacturers: Switzerland’s Sandoz Inc. (OTCMKTS: SDZNY) and U.S.-based MSN Pharmaceuticals. This legal action follows notifications received from both companies regarding their Abbreviated New Drug Applications (ANDAs) submitted to the U.S.…
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BeiGene’s Brukinsa Receives FDA Approval for Relapsed or Refractory Follicular Lymphoma
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biotech company based in China, has announced its latest indication approval in the United States for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The US Food and Drug Administration (FDA) has granted approval for Brukinsa in combination with the…
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BeiGene Subsidiary Pi Health Cayman to be Merged in Deal Valued at $41.8 Million
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BeiGene (NASDAQ: BGNE) has announced that Delaware-based Pi Health Inc. is set to absorb and merge its wholly-owned subsidiary Pi Health Cayman at a mutually agreed valuation of USD 41.8 million. Following the merger, BeiGene will directly hold the corresponding equity in Pi Health. Concurrently, Pi Health plans to bring…
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BeiGene’s Brukinsa Outperforms Acalabrutinib in MAIC for Relapsed/Refractory CLL, Says BeiGene
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the results of a matching-adjusted indirect comparison (MAIC) between its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), and acalabrutinib in terms of efficacy. The comparison is based on data from the Phase III ALPINE and Phase III ASCEND studies, which…
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BeiGene’s Tislelizumab Receives CHMP Recommendation for Three NSCLC Indications in Europe
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BeiGene (NASDAQ: BGNE) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended its programmed death-1 (PD-1) inhibitor tislelizumab for a marketing license for three non-small cell lung cancer (NSCLC) indications. The CHMP’s positive opinion is for: Patients with EGFR or ALK mutation-positive…
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China Anti-Cancer Association Forms Consortium for Standardizing Cancer Research Ethics Reviews
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The medical ethics professional committee of the China Anti-Cancer Association (CACA) has announced the formation of the China Cancer Clinical Research Medical Ethics Review Mutual Recognition Consortium. This consortium aims to streamline and standardize the ethical review process for clinical research in cancer treatment across China. The founding members of…
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BeiGene Submits Additional Application for Tislelizumab in NSCLC in China
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BeiGene (NASDAQ: BGNE) has announced the submission of a supplementary Biologic License Application in China for its programmed death-1 (PD-1) inhibitor, tislelizumab. The company is seeking regulatory approval for a new indication in the perioperative (neoadjuvant + adjuvant) treatment of patients with resectable non-small cell lung cancer (NSCLC). The Center…
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BeiGene’s Tislelizumab Secures 12th Indication Approval in China for HCC First-Line Treatment
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BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has received approval in China for the first-line treatment of irresectable or metastatic hepatocellular carcinoma (HCC), marking the drug’s 12th indication approval in the country. The approval is supported by the RATIONALE 301 study, a randomized, open-label, global…
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Bio-Thera Secures FDA Approval for Avzivi, a Biosimilar to Roche’s Avastin
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received market approval from the U.S. Food and Drug Administration (FDA) for Avzivi (bevacizumab), a biosimilar version of Roche’s (SWX: ROG) Avastin. The approved indications for Avzivi include non-small cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), glioblastoma (GBM), renal…
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BeiGene Ltd Strikes Exclusive Global License Deal with Ensem Therapeutics for CDK2 Inhibitor
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China-based biopharmaceutical company BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced a licensing agreement with Ensem Therapeutics Inc., a biopharma company incubated by CBC Group and operating in Massachusetts, US, and Shanghai, China. According to the agreement, BeiGene will obtain an exclusive global license to Ensem’s oral cyclin-dependent…
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BeiGene’s Brukinsa Secures Additional EU Approval for Follicular Lymphoma Treatment
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has achieved its latest global approval for the Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The European Commission has approved Brukinsa in combination with obinutuzumab (Roche’s CD20-targeted Gazyva) as a third-line treatment for relapsed or refractory (R/R) follicular lymphoma (FL). This marks…
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BeiGene Ltd Opens Global Industrialization Base for Small-Molecule Drugs in Suzhou
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the inauguration of its small-molecule innovative drug global industrialization base in Suzhou, Jiangsu province. The 50,000 square meter facility is projected to produce 1 billion tablets/granules of solid preparations annually. State-of-the-Art Production Capabilities The plant is equipped with commercial-scale and…
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BeiGene Ltd Reports Q3 2023 Financial Results with 102% YOY Revenue Increase
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has released its financial results for the third quarter of 2023. The biotechnology company reported total revenues of USD 781 million, with global product sales reaching USD 595 million, marking year-on-year (YOY) increases of 102% and 70%, respectively. Net profits for the…
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CIIE 2023: Danaher, Boehringer-Ingelheim, Merck, J&J, BeiGene, and Fosun Pharma Announce China Partnerships
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The 6th China International Import Expo (CIIE) held in Shanghai this week has been a platform for multiple companies to announce their strategic partnerships in China. Among the notable participants are Danaher (NYSE: DHR), Boehringer-Ingelheim (BI), Merck Sharp & Dohme (MSD, NYSE: MRK), Johnson & Johnson (J&J, NYSE: JNJ), BeiGene…
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Zymeworks and BeiGene Terminate Licensing Agreement for ZW49 ADC
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Zymeworks Inc. (NASDAQ: ZYME), a Canada-based biotech company, has announced in its Q3 financial report that the licensing agreement with China’s BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) for the antibody drug conjugate (ADC) zanidatamab zovodotin (ZW49) has been cancelled. This development affects the HER2-targeted ADC that BeiGene had…
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BeiGene’s ZW25 on Track for Priority Review for Cholangiocarcinoma Treatment by CDE
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The Center for Drug Evaluation (CDE) website has indicated that BeiGene’s (NASDAQ: BGNE) ZW25 (zanidatamab) is set to receive priority review status for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma in patients with high HER2 expression who have previously received systemic treatment. This priority review status is a…
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Amoy Diagnostics Receives NMPA Approval for MSI Detection Kit as Companion Diagnostic for Immunotherapy
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a prominent player in the Chinese diagnostics industry, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its human microsatellite instability (MSI) detection kit. This kit, which utilizes fluorescent PCR capillary electrophoresis,…
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BeiGene’s Brukinsa Gains NICE Recommendation for CLL Treatment in the UK
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China-based biotech BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the National Institute for Health and Care Excellence (NICE) in the UK has issued a final draft guidance (FDG) recommending the company’s Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) for the treatment of eligible adult patients with…
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BeiGene’s Tislelizumab Shows Promising Results in ESMO Presentations for GC/GEJC and NSCLC
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China-based biotech BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced two late-breaking presentations of Phase III data for its programmed death-1 (PD-1) inhibitor tislelizumab at the European Society for Medical Oncology (ESMO) Congress 2023. The presentations include an oral presentation for tislelizumab in combination with chemotherapy for advanced…
