Pirtobrutinib (Jaypirca)
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FDA Greenlights Eli Lilly Drug, Glencore Revives Copper Mine as Geopolitical Headwinds Mount
Stock Market News· 2025-12-03 18:08
Group 1: Eli Lilly and Company - Eli Lilly has received full FDA approval for pirtobrutinib (Jaypirca) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously been treated with a covalent BTK inhibitor [2] - The approval expands the drug's label to include patients earlier in their treatment course and converts a December 2023 accelerated approval to a traditional approval [2] - Jaypirca is the first and only FDA-approved non-covalent BTK inhibitor, with the expanded indication based on results from the Phase 3 BRUIN CLL-321 trial [2] Group 2: Glencore - Glencore plans to restart operations at its Alumbrera copper mine in Argentina by late 2026, with initial production expected in the first half of 2028 [3] - The company aims to significantly increase copper output to 1 million tons annually by the end of 2028 and approximately 1.6 million tons by 2035 [3] - The Alumbrera mine is projected to produce around 75,000 tonnes of copper, 317,000 ounces of gold, and 1,000 tonnes of molybdenum over four years [3] - Glencore has adjusted its 2026 copper production guidance downwards to 810,000–870,000 tonnes from a previous target of 930,000 tonnes due to setbacks at its Collahuasi mine in Chile [3] Group 3: Geopolitical Developments - Belgium has expressed significant reservations regarding the EU's plan to use frozen Russian central bank assets as collateral for a loan to Ukraine, citing unaddressed economic, financial, and legal risks [4] - The Belgian government fears being asked to bear the risks of this operation alone, particularly as most of the estimated €190-200 billion in Russian assets are held by Euroclear, a Brussels-based financial clearinghouse [4] Group 4: U.S. Political Landscape - U.S. Secretary of War Pete Hegseth is under scrutiny for endangering troops by using the Signal app to discuss classified military strike plans [5] - A watchdog investigation found that classified information was shared in an unclassified group chat that included a journalist, despite denials from Hegseth and the Pentagon [5] - House Speaker Mike Johnson faces increasing pressure from within his party, with prominent Trump ally Elise Stefanik criticizing his leadership and control over House Republicans [6]
Head-to-Head Against Pembrolizumab: Innovent Announces First Patient Dosed in the First Pivotal Study of IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Melanoma
Prnewswire· 2025-03-03 00:00
Core Viewpoint - Innovent Biologics has initiated a pivotal study for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, aimed at treating unresectable locally advanced or metastatic mucosal or acral melanoma, marking a significant advancement in immuno-oncology therapy in China [1][4][8]. Group 1: Study Details - The study is a randomized, multicenter trial comparing IBI363 monotherapy to pembrolizumab (Keytruda®) in patients who have not received prior systemic therapy [1]. - The primary endpoint of the study is progression-free survival (PFS), evaluated by an Independent Radiology Review Committee (IRRC) using RECIST v1.1 criteria [1]. Group 2: Efficacy and Safety - IBI363 has shown promising efficacy signals in earlier clinical trials, with an overall objective response rate (ORR) of 61.5% and a disease control rate (DCR) of 84.6%, indicating its potential superiority over current immunotherapy standards [2][6]. - The safety profile of IBI363 is manageable, with common treatment-related adverse events including arthralgia, anemia, thyroid dysfunction, and rash, all of which are manageable with routine clinical care [3]. Group 3: Clinical Need and Market Context - Melanoma has a high mortality rate in China, with a median PFS of only around three months for IO-naïve melanoma patients, highlighting a significant unmet clinical need [4]. - Non-cutaneous subtypes like mucosal melanoma are particularly resistant to existing immunotherapies, underscoring the importance of developing new treatment options like IBI363 [4][9]. Group 4: Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer, and has launched 14 products to date [10]. - The company is actively pursuing global development for IBI363 across multiple tumor types, aiming to extend the benefits of its innovations to patients worldwide [4][10].