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BeiGene Reaches Patent Settlement with MSN Pharmaceuticals for Brukinsa
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China-based BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), which is in the process of changing its name to BeOne Medicines Ltd, has announced a patent settlement agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories Private Ltd. concerning its oncology drug Brukinsa (zanubrutinib). The agreement stipulates that MSN’s generic version…
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BeiGene Ltd to Become BeOne Medicines Ltd, Emphasizing Global Oncology Commitment
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China-based biotechnology company BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced a proposed change of its English name to BeOne Medicines Ltd. This rebranding underscores the company’s dedication to developing innovative medicines aimed at eliminating cancer and its intention to partner with the global community to serve a…
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BeiGene to Rebrand as BeOne Medicines, Emphasizing Global Commitment to Cancer Care
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BeiGene Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading global innovator in oncology treatments, announced its intention to adopt a new English name: BeOne Medicines Ltd. The rebranding reflects the company’s mission to unite global efforts in the fight against cancer and underscores its transformative approach to fostering cross-sector…
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Shanghai Pharmaceutical Co., Ltd Secures Multiple Partnerships at CIIE
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At the 7th China International Import Expo (CIIE), China-based Shanghai Pharmaceutical Co., Ltd (SPH, SHA: 601607, HKG: 2607) announced a series of partnerships with prominent pharmaceutical companies, spanning domestic and international entities. Expanding Collaborations in Pharmaceutical InnovationFrance’s Sanofi (NASDAQ: SNY) has agreed to deepen its existing partnership with SPH, initially…
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AstraZeneca’s China President Leon Wang Confirmed to Assist in Investigation Amid Fraud Allegations
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On October 29, 2024, just hours after celebrating a business school anniversary on social media, AstraZeneca’s (AZ, NASDAQ: AZN) Global Executive Vice President and China President, Leon Wang, was confirmed to be cooperating with an investigation. The announcement came less than 48 hours later via AstraZeneca China’s official website. On…
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BeiGene CCO Yin Min Detained Amid Investigation; Company Affirms Compliance Standards
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On October 25, Yin Min, Chief Commercial Officer of BeiGene (NASDAQ: BGNE) Greater China, was taken into custody by regulatory authorities for cooperation with an ongoing investigation. Yin Min joined BeiGene in January 2022 after spending 15 years at AstraZeneca (AZ, NASDAQ: AZN), where she held several key positions, including…
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BeiGene’s PD-1 Inhibitor Tevimbra Scores First US Prescription, Offers More Affordable Option
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BeiGene Ltd, a leading China-based biotechnology company (NASDAQ: BGNE; HKG: 6160; SHA: 688235), has announced the first prescription of its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab), in the United States. This marks a significant milestone for the company as it expands its global reach. Tislelizumab received approval in the US…
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Guangzhou Releases First Batch of Innovative Drugs and Medical Devices List, Featuring Local Companies
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The Guangzhou Municipal Industry and Information Technology Bureau has unveiled the first batch of innovative drugs and medical devices included in the city’s list, with 24 products making the shortlist. This initiative is aimed at promoting local innovation and development within the pharmaceutical and medical device sectors. Among the notable…
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BeiGene’s Tevimbra Approved in China for NSCLC Patients as Neoadjuvant and Adjuvant Therapy
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading China-based biotechnology company, has announced that it has received market approval in China for its programmed death-1 (PD-1) inhibitor Tevimbra (tislelizumab). The National Medical Products Administration (NMPA) has granted approval for tislelizumab in combination with platinum-containing chemotherapy as both neoadjuvant…
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BeiGene Prices TEVIMBRA 10% Below Competitors Following FDA Approval for Esophageal Cancer Treatment
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the commercial availability of TEVIMBRA (Tislelizumab) in the United States following its approval by the FDA for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy. The drug received FDA approval in March…
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BeiGene’s FGFR2b ADC BG-C137 Enters Phase I Clinical Trial for Advanced Solid Tumors
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On October 3, 2024, BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) registered a Phase I clinical trial for BG-C137, an antibody-drug conjugate (ADC) for the treatment of advanced solid tumors, on ClinicalTrials.gov. The trial plans to enroll 68 patients with advanced solid tumors and is expected to be completed by…
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BeiGene’s Tislelizumab Receives Israeli Nod for Oesophageal Cancer Treatment
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China-based biotech firm BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has been granted market approval in Israel for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). The Israeli Ministry of Health has approved Tevimbra for use as a monotherapy second-line treatment for adult patients with unresectable or metastatic oesophageal squamous…
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AbbVie Accuses BeiGene of Trade Secret Theft in BTK Degrader Dispute
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AbbVie Sues BeiGene Over Alleged Trade Secret Theft in BTK Degrader ProgramU.S. pharmaceutical titan AbbVie Inc. (ABBV) has initiated legal proceedings against BeiGene Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235), accusing the Chinese biotech firm of pilfering trade secrets vital to its Bruton’s tyrosine kinase (BTK) degrader program. According to…
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BeiGene Positions for Global Growth with Strong Half-Year Results and R&D Investment
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) reported robust second-quarter 2024 results, highlighting significant corporate advancements that position the company for future global expansion. For the first half of 2024, BeiGene achieved total operating revenue of USD 1.6808 billion, reflecting a 61.1% year-on-year (YOY) increase. Product revenue surged by 73.0%…
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BeiGene Advances R/R CLL/SLL Treatment with FDA Fast-Tracked BGB-16673 in Phase I/II Clinical Trial
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its novel compound BGB-16673. This investigational Bruton’s tyrosine kinase (BTK) targeting chimeric degradation activation compound (CDAC), known as a proteolysis-targeting chimera (PROTAC) product, represents…
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BeiGene’s Q2 2024 Revenues Surge 56% YOY, Highlighted by Strong U.S. Market Performance
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has reported its financial results for the second quarter of 2024, with total revenues hitting USD 929 million, representing a robust 56% increase year-on-year (YOY). Product sales accounted for USD 921 million of this total, marking a 66% YOY uptick. Operating losses, according…
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BeiGene Launches Flagship US Facility in New Jersey to Expand Oncology R&D and Manufacturing
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a global biotechnology company, has announced the inauguration of its flagship facility in Hopewell, New Jersey, located within the Princeton West Innovation Campus. The establishment of BeiGene’s USD 800 million plant represents the successful conclusion of a three-year expansion initiative aimed at enhancing…
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BeiGene Receives NMPA Greenlight for BG-C9074 Clinical Trial in Advanced Solid Tumors
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the National Medical Products Administration (NMPA) in China has approved its clinical filing for the Category 1 pipeline candidate BG-C9074. The antibody drug conjugate (ADC) is set to be initially assessed for the treatment of general advanced solid tumors, marking…
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BeiGene’s Tislelizumab Approved by China’s NMPA for First-Line Extensive Stage Small Cell Lung Cancer
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a biopharmaceutical company, has announced that its programmed-death (PD)-1 monoclonal antibody (mAb), tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China. The drug is now approved to be used in combination with chemotherapy for the treatment of patients with…
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BeiGene to Terminate Partnership with NewBridge Pharmaceuticals for MENA Region
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company based in China, has announced the cancellation of its partnership with NewBridge Pharmaceuticals. The partnership was focused on the sales, distribution, and commercialization of Brukinsa (zanubrutinib) in the Middle East and North Africa (MENA) region. The mutual decision to…
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Zymeworks and BeiGene Submit BLA in China for Zanidatamab as Second-Line HER2-Positive BTC Treatment”
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Zymeworks Inc. (NASDAQ: ZYME), a Canadian biotech company, in partnership with BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), has submitted a Biologics License Application (BLA) to Chinese regulators for zanidatamab, a bispecific antibody for the treatment of HER2-positive biliary tract cancer (BTC) as a second-line therapy. Zymeworks’ zanidatamab is designed…
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BeiGene’s Brukinsa Secures Conditional Approval in China for R/R Follicular Lymphoma
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company based in China, has received conditional approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The approval is for the use of Brukinsa in combination with the CD20-targeted obinutuzumab for…
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BeiGene’s Q1 2024 Revenue Jumps 68% YOY on Strength of Brukinsa and Tislelizumab Sales
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BeiGene, Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has released its financial results for the first quarter of 2024, revealing a total revenue of USD 752 million, marking a 68% year-on-year (YOY) increase. Product revenue specifically soared 82% YOY to USD 747 million. Notably, US sales experienced a significant surge,…
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BeiGene’s Anti-PD-1 Therapy Tislelizumab Expands Indication for Gastric Cancer in China
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that its anti-PD-1 therapy, tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China for the first-line treatment of locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (G/GEJ) in combination with fluorouracil and platinum-based…
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BeiGene’s Tislelizumab Secures EC Approval for Three NSCLC Indications
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the European Committee (EC) has granted approval for its programmed death-1 (PD-1) inhibitor, tislelizumab, for three distinct non-small cell lung cancer (NSCLC) indications. The approvals allow for the use of tislelizumab in the following scenarios: The approvals were supported by…
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ImmuneOnco Receives NMPA Approval for Phase III Clinical Trial of CD47 Inhibitor TIMDARPACEPT
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its investigational drug timdarpacept (IMM01). This drug is the first SIRPαFc fusion protein targeting CD47 to be designed in China.…
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BeiGene Launches Guangzhou ADC Production Park to Strengthen Manufacturing Muscle
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company, has announced the operational launch of its antibody drug conjugate (ADC) production park in Guangzhou, a strategic move to bolster the company’s clinical and commercial manufacturing capabilities. The new facility is expected to significantly enhance the production of BeiGene’s…
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Mabwell Bioscience Receives NMPA Approval for Biosimilar Version of Amgen’s Xgeva
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its biosimilar product 9MW0321, a version of Amgen’s Xgeva (denosumab). This makes Mabwell the first company to gain approval for a biosimilar version of the drug in…
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BeiGene and GenFleet Join Forces for DLBCL Trial Combining Brukinsa and GFH009
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a China-based biotechnology company, has entered into a clinical research and drug supply cooperation agreement with fellow Chinese firm GenFleet Therapeutics. The partnership will kick off a Phase Ib/II clinical trial to evaluate the safety and efficacy of a combination regimen featuring…
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BeiGene Terminates Partnership with Shoreline Therapeutics for NK Cell Therapies
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A close examination of BeiGene’s (NASDAQ: BGNE; HKG: 6160; SHA: 688235) recent annual report has revealed that the company has terminated its earlier partnership with US biotech firm Shoreline Therapeutics Inc. The agreement, which was set to be effective from the first quarter of 2024, did not provide a specific…
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BeiGene’s Tislelizumab Receives FDA Approval for Esophageal Squamous Cell Carcinoma
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BeiGene (NASDAQ: BGNE) has announced that the US Food and Drug Administration (FDA) has granted approval for its programmed death-1 (PD-1) inhibitor, tislelizumab, as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC). The approval is for patients who have been previously treated…
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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…
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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…
