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Luye Pharma’s Shandong Boan Bio Reports 17.5% Revenue Growth in 2024
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary Shandong Boan Biotechnology Co., Ltd (HKG: 6955) released its 2024 financial report, showing revenues growing 17.5% year-on-year (YOY) to RMB726.3 million (USD100 million). This growth was primarily driven by BA1101, a biosimilar of Roche’s Avastin (bevacizumab), and BA6101, a version of Amgen’s…
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AstraZeneca and Amgen’s Tezspire Shows Positive Results in Phase III Study
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AstraZeneca (NASDAQ: AZN) and Amgen (NASDAQ: AMGN) have jointly announced positive results from the Phase III WAYPOINT study for their co-developed drug Tezspire (tezepelumab). Tezspire is a thymic stromal lymphopoietin (TSLP) – targeted monoclonal antibody (mAb) that has been approved for severe asthma in over 60 countries worldwide. Study ResultsThe…
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Samsung Bioepis’ Ospomyv and Xbryk Gain FDA Approval for RANKL Inhibitor Biosimilars
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South Korea-based Samsung Bioepis Co., Ltd. announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Ospomyv (denosumab-dssb; SB16; 60 mg pre-filled syringe) and Xbryk (denosumab-dssb; SB16; 120 mg vial), biosimilars of US major Amgen’s RANKL inhibitors Prolia and Xgeva, respectively. Additionally, the…
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Amgen Reports Strong Q4 and Full-Year 2024 Sales Growth
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Amgen (NASDAQ: AMGN) released its Q4 2024 financial results this week, reporting USD 33.42 billion in annual sales after a robust 19% year-on-year (YOY) increase. Sales during Q4 reached USD 9.09 billion, up 11% YOY. The strong performance was driven by growth across key product lines and the impact of…
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FDA Clears Amgen’s Lumakras and Vectibix Combo for KRAS G12C-mutated mCRC
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US-based Amgen (NASDAQ: AMGN) has announced receiving clearance from the US Food and Drug Administration (FDA) for its Lumakras (sotorasib) combined with Vectibix (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC). This approval is for patients whose cancer has been identified through an FDA-approved…
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GlycoNex Licenses SPD8 Biosimilar to Undisclosed Company for Osteoporosis Treatment
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Taiwan-based GlycoNex, Inc. (TPEx: 4168) has announced a licensing agreement with an undisclosed company for its SPD8, a biosimilar version of Amgen’s (NASDAQ: AMGN) Prolia and Xgeva (denosumab). The agreement involves an undisclosed amount of development and commercialization milestone payments, granting the licensee rights to develop, secure regulatory approval for,…
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Amgen’s Imdylltra Gains Conditional Approval in UK for Extensive-Stage Small Cell Lung Cancer
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US biotech company Amgen (NASDAQ: AMGN) has received conditional approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its drug Imdylltra (tarlatamab). The approval is for use in adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression after at least two prior…
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Kexing Pharmaceutical Partners with Shandong Boan for Biosimilar Commercialization in Hong Kong and Macau
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China-based Kexing Pharmaceutical (SHA: 688136) has entered into a commercialization cooperation agreement with fellow Chinese firm Shandong Boan Biotechnology Co., Ltd (HKG: 6955). The partnership aims to promote the marketing and sales of Shandong Boan’s biosimilars BA6101 and BA1102 in Hong Kong and Macau. BA6101 is a biosimilar version of…
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Mabwell Bioscience Secures Licensing Deal with TABUK Pharmaceutical for MENA Region
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China-based Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has inked a licensing deal with TABUK Pharmaceutical Manufacturing Company, granting the Saudi Arabian company the regulatory filing and commercialization rights to two of Mabwell’s biosimilars in the Middle East and North Africa (MENA) region. The financial details of the agreement were…
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Amgen’s Blincyto Meets Primary Endpoint in Phase III AALL1731 Study for Pediatric B-ALL
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US-based biotechnology company Amgen (NASDAQ: AMGN) has published the results from the Phase III study (AALL1731) for its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) at the 66th American Society of Hematology (ASH) annual meeting. The study assessed the potential of adding Blincyto to chemotherapy to improve disease-free survival (DFS) in…
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Amgen Expands Biomanufacturing Footprint in North Carolina with Second Facility
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US biotech company Amgen (NASDAQ: AMGN) has announced plans to construct a second drug substance manufacturing facility in Holly Springs, North Carolina, raising its total biomanufacturing investment in the region to USD 1.5 billion. This new plant, costing USD 1 billion, follows Amgen’s previously announced commitment of USD 550 million…
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Mabwell Bioscience Enters Licensing Agreement for Biosimilar Denosumab in Peru
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced a licensing agreement with its partner in Peru, which will handle the marketing of Mabwell’s MAILISHU (9MW0311) and MAIWEIJIAN (9MW0321), biosimilars of denosumab in Peru. Mabwell will retain responsibility for the development, manufacturing, and commercial supply of these products. Biosimilars…
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AstraZeneca’s Tezspire Meets Phase III Co-Primary Endpoints in CRSwNP Study
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AstraZeneca Inc., (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced positive high-level results from the Phase III WAYPOINT study for Tezspire (tezepelumab) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The drug, a thymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb) co-developed with US firm Amgen (NASDAQ: AMGN),…
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Amgen’s Tavneos Receives NMPA Approval for ANCA-Associated Vasculitis Treatment in China
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US biotechnology company Amgen (NASDAQ: AMGN) has announced that it has received market approval in China for its drug Tavneos (avacopan). The National Medical Products Administration (NMPA) has approved Tavneos for use as adjuvant therapy in adults with severe and active anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis, specifically granulomatous polyangitis…
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Amgen Reports Q3 2024 Revenues of USD 8.5 Billion, Marking a 23% YOY Increase
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US biotechnology company Amgen (NASDAQ: AMGN) has announced its financial results for the third quarter of 2024, with revenues reaching USD 8.5 billion, an increase of 23% year-on-year (YOY). Product sales saw a 24% increase, with an 8% growth when excluding sales from the Horizon Therapeutics (Horizon) acquisition. In the…
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Shanghai Henlius and Organon Submit Biosimilar Application for Denosumab to FDA
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Shanghai Henlius Biotech Inc. (HKG: 2696) and its US partner Organon (NYSE: OGN) have jointly announced that the Biologic License Application (BLA) for HLX14, an investigational biosimilar of Amgen’s (NASDAQ: AMGN) Prolia/Xgeva (denosumab), has been accepted for review by the US Food and Drug Administration (FDA). Denosumab, a recombinant anti-RANKL…
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FDA Extends Review of Amgen’s Lumakras for KRAS G12C mCRC Treatment to January 2025
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On October 18, FirstWord reported that the U.S. FDA has extended the review period for Amgen (NASDAQ: AMGN)’s KRAS G12C inhibitor Lumakras (sotorasib) in combination with the anti-EGFR monoclonal antibody panitumumab for second-line treatment of KRAS G12C-mutated metastatic colorectal cancer (mCRC) by three months, pushing the decision date to January…
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MediLink Therapeutics Partners with Amgen for Clinical Trial in Small Cell Lung Cancer
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Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced a partnership with US pharmaceutical giant Amgen Inc. (NASDAQ: AMGN). The collaboration will see the two companies conduct a global clinical trial combining MediLink’s B7-H3-targeting antibody-drug conjugate (ADC) YL201 with Amgen’s DLL3- and CD3-targeting bispecific T-cell engager (BiTE) IMDELLTRA for the…
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Amgen’s Tepezza Receives Approval in Japan for Treating Thyroid Eye Disease
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Amgen (NASDAQ: AMGN), a prominent biotechnology company based in the U.S., has announced that its drug Tepezza (teprotumumab, genetical recombination) has received market approval in Japan. The country’s Ministry of Health, Labour, and Welfare (MHLW) has authorized the medication for treating active or high clinical activity score (CAS) thyroid eye…
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Amgen to Establish New Site in Hyderabad, India, with Focus on Technology and Digital Innovation
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Amgen (NASDAQ: AMGN), a leading biopharmaceutical company based in the U.S., has announced strategic plans to expand its presence in India with the establishment of a new facility in Hyderabad. The site, to be named Amgen India, is designed to accommodate up to 3,000 employees and is expected to be…
