2026年潜在关键新药上市

As a supplement to our well-known quarterly Outlook report, Biomedtracker is pleased to present a longer-term look at some key late-stage drugs projected to hit the market in 2026. These drugs represent newdrug classes, major changes to standards of care, and/or large market opportunities across the wide rangeof indications covered by Biomedtracker and Datamonitor Healthcare. This report will enable you to: •Identify high-impact launches–Discover drugs that could achieve blockbuster potential, transformtreatment landscapes, or launch in new therapeutic classes.•Anticipate competitive shifts–Understand which therapies may change the standard of care anddisrupt existing markets.•Track key regulatory milestones–Follow critical catalysts, including PDUFA dates, pivotal trialreadouts, and first approvals.•Support strategic decisions–Leverage our expert insights to enhance portfolio planning,competitors monitoring, and drive informed planning.•Access concise analyst insights–Benefit from clear, one-page summaries for each highlighteddrug with therapy area, company details, likelihood of approval, and links to deeper analysis on BMT. More details about each drug can be viewed on Biomedtracker by clicking theicon. Methodology Scope and Objective This report highlights pharmaceutical candidates that were inPhase III or later stages ofdevelopmentas ofJuly 2025, with selectPhase IIb/II/IIIdrugs included based on the presenceofnear-term regulatory catalysts. The primary objective is to identify drugs with significant potentialformarket impact (blockbuster potential),clinical relevance, andregulatory advancement. Selection Criteria Strategic Relevance Drugs were selected based on the followingcatalysts: The report focuses on drugs that demonstrate: •Large Market Potential (Blockbuster)•Major Change to Standard of Care•Representation of Novel Drug Classes •Product Launch Catalysts•Approval Decision Catalysts•Regulatory Filing Catalysts(e.g., NDA/BLAsubmissions)•Phase III or Pivotal Trial Readouts These criteria ensure that the report capturescandidates with the highest likelihood ofinfluencing both clinical practice andcommercial landscapes. Blockbuster Potential Ablockbuster drugis defined as one generating$1 billion or more in annual revenue. While itremains uncertain whether any of the drugs listed will reach this benchmark, the report aims tospotlight those with potential to do so. Contents This report covers the following indications: Metabolic Oncology Dermatology Allergy •Duchenne Muscular Dystrophy•FamilialChylomicronemiaSyndrome•Glycogen Storage Disease•Mucopolysaccharidosis II (MPS II; HunterSyndrome)•Obesity–Cagrisema•Obesity–Orforglipron•Obesity–Rybelsus•Porphyria •Acute Lymphoblastic Leukemia |Myelodysplastic Syndrome | AcuteMyelogenous Leukemia•Bladder Cancer•Colorectal Cancer•Gastric Cancer•HER2+ Breast Cancer•Melanoma•Multiple Myeloma•Non-small Cell Lung Cancer–Datroway•Non-small Cell Lung Cancer–Zipalertinib•Ovarian Cancer•Polycythemia Vera•Prostate Cancer•Renal Cell Carcinoma•Small Cell Lung Cancer•Triple Negative Breast Cancer •Atopic Dermatitis (Eczema)–Anzupgo•Atopic Dermatitis (Eczema)–Rocatinlimab•Atopic Dermatitis (Eczema)–Zoryve •Anaphylaxis•Chronic Rhinosinusitis Autoimmune/Immunology (A/I) •Dermatomyositis•Myasthenia Gravis•Primary Biliary Cholangitis•Psoriatic Arthritis•Pulmonary Alveolar Proteinosis•Urticaria Endocrine •Achondroplasia•Cushing’s Syndrome•Diabetes Mellitus, Type II Hematology Neurology •HemophiliaA Cardiovascular (CV) •Amyotrophic Lateral Sclerosis•Huntington’s Disease•Multiple Sclerosis•Narcolepsy–AXS-12•Narcolepsy–Oveporexton•Neuropsychiatric symptoms in Alzheimer’sdisease•Parkinson’s Disease •Acute Coronary Syndrome•Cardiomyopathy-Hypertrophic•Cardiovascular Disease•Chronic Heart Failure–Preserved EjectionFraction•Chronic Heart Failure–Reduced Ejection Fraction•Chronic Heart Failure and Cardiomyopathies–Unspecified•Dyslipidemia/ Hypercholesterolemia•Hypertension (Systemic)•Peripheral Artery Disease Infectious Diseases •COVID-19 Prevention and Seasonal InfluenzaVaccines•HIV / AIDS Treatment•Urinary Tract and Reproductive Tract Infections Psychiatry •Major Depressive Disorder•Schizophrenia–Brilaroxazine•Schizophrenia–TV-44749 Respiratory•Asthma A N A P H Y L M|A Q S T|L O A:AV E R A G E|B I O M E D T R A C K E R P R O F I L E Anaphylaxis The U.S. Food and Drug Administration (FDA) has accepted Aquestive Therapeutics’ New Drug Application (NDA) for Anaphylm forthetreatment of severe allergicreactions. The Prescription Drug User Fee Act (PDUFA) target action date has been set for January 31, 2026. Anaphylm (epinephrine) represents a significantadvancement in the emergency treatment of severe allergic reactions, or anaphylaxis. The drug's most notable feature is its innovative sublingual film deliverysystem. In April 2025, Anaphylm was shown to maintain its consistentpharmacokinetic (PK)profile, as seen in adults, in pediatric patients