China Approves Remegen's Disitamab Vedotin for HER2-Positive Advanced Breast Cancer with Liver Metastasis
• China's National Medical Products Administration (NMPA) has approved Remegen's antibody-drug conjugate disitamab vedotin (RC-48) for patients with HER2-positive advanced breast cancer with liver metastasis.
• The approval marks a significant advancement in targeted therapy options for Chinese patients with advanced breast cancer, particularly addressing the challenging subset with liver metastases.
• Disitamab vedotin joins the growing field of antibody-drug conjugates targeting HER2, offering a new treatment approach in a market where targeted therapies for metastatic breast cancer remain an area of high unmet need.
Shionogi to Acquire Japan Tobacco's Pharmaceutical Subsidiaries for $1.1 Billion
• Shionogi & Co. plans to acquire Japan Tobacco's pharmaceutical subsidiaries Torii Pharmaceutical and Akros Pharma for ¥160 billion ($1.1 billion) to strengthen its global R&D capabilities.
• The acquisition, negotiated since early 2024, will proceed through a tender offer beginning June 18 with a share price of ¥6,350 to acquire at least 11.89% of the minority stake.
• This strategic move represents significant consolidation in the Japanese pharmaceutical sector and expands Shionogi's market presence amid increasing global competition.
D-Wave and Japan Tobacco Pioneer Quantum-Enhanced AI for Drug Discovery
• D-Wave Quantum Inc. and Japan Tobacco have successfully completed a proof-of-concept project that combines quantum computing with AI to accelerate drug discovery, outperforming classical computing methods.
• The quantum-hybrid workflow enhanced large language models to generate more valid and "drug-like" molecular structures than traditional methods, potentially revolutionizing the identification of first-in-class small molecule compounds.
• This breakthrough represents the first documented case where annealing quantum computation outperformed classical results in LLM training for pharmaceutical development, according to Japan Tobacco's Chief Scientific Officer.
EMA Recommends Approval of Averoa's XOANACYL for Chronic Kidney Disease Treatment
• The European Medicines Agency's CHMP has issued a positive opinion for XOANACYL, an oral therapy for chronic kidney disease, with final European Commission approval expected by June 2025.
• XOANACYL offers a dual mechanism of action, providing ferric iron for addressing iron deficiency while controlling phosphorus absorption in CKD patients, addressing two common complications of the disease.
• Averoa, which licensed XOANACYL from Akebia Therapeutics in 2022, is actively seeking strategic commercial partnerships to bring the treatment to market across Europe following anticipated regulatory approval.
FDA Accepts LEO Pharma's Delgocitinib Cream NDA for Chronic Hand Eczema
• The FDA has accepted LEO Pharma's New Drug Application (NDA) for delgocitinib cream 2% for treating moderate to severe Chronic Hand Eczema (CHE) in adults.
• The NDA is supported by Phase 3 DELTA 1 and DELTA 2 clinical trials, which demonstrated the efficacy and safety of delgocitinib cream compared to a cream vehicle.
• Delgocitinib cream is an investigational topical pan-JAK inhibitor that addresses the unmet need for CHE patients who have inadequate responses to topical corticosteroids.
• The FDA regulatory review process is expected to conclude in the second half of 2025, potentially offering a new treatment option for this debilitating condition.
LEO Pharma's Delgocitinib Cream Receives FDA Filing Acceptance for Chronic Hand Eczema Treatment
• The FDA has accepted LEO Pharma's New Drug Application for delgocitinib cream, a potential first-in-class treatment for chronic hand eczema (CHE) in the U.S.
• Delgocitinib cream, a topical pan-JAK inhibitor, could become the first FDA-approved treatment specifically for adults with moderate to severe CHE.
• The application is supported by Phase 3 DELTA 1 and DELTA 2 trial results, demonstrating significant efficacy and safety compared to a vehicle cream.
• If approved, delgocitinib cream promises to address the high unmet need for CHE patients, offering a new option beyond traditional topical corticosteroids.
© Copyright 2025. All Rights Reserved by MedPath