KDIGO 2026 Guideline: Anemia Management in CKD

KDIGO 2026 Guideline: Anemia Management in CKD

The Kidney Disease: Improving Global Outcomes (KDIGO) 2026 Clinical Practice Guideline for the Management of Anemia in Chronic Kidney Disease (CKD) provides a comprehensive update to the 2012 guideline, incorporating over a decade of new evidence on anemia pathophysiology, diagnosis, and treatment. Anemia remains a prevalent complication in CKD, associated with reduced quality of life, increased cardiovascular risk, higher hospitalization rates, and greater need for transfusions. This guideline targets healthcare providers, patients, and stakeholders involved in caring for adults and children with CKD-associated anemia, including those not on dialysis, on hemodialysis or peritoneal dialysis, or post-kidney transplantation.

Eisai and Biogen Announce NMPA Acceptance of BLA for Subcutaneous LEQEMBI in Early Alzheimer’s Disease

Eisai and Biogen Announce NMPA Acceptance of BLA for Subcutaneous LEQEMBI in Early Alzheimer’s Disease

On January 5, 2026, Eisai Co., Ltd. and Biogen Inc. announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for the subcutaneous autoinjector (SC-AI) formulation of LEQEMBI® (lecanemab; brand name in China: “乐意保®”), a humanized IgG1 monoclonal antibody targeting soluble aggregated amyloid-beta protofibrils for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s and mild Alzheimer’s dementia).

Ascletis Advances Oral Small Molecule GLP-1 ASC30 into U.S. Phase II for Diabetes Treatment

Ascletis Advances Oral Small Molecule GLP-1 ASC30 into U.S. Phase II for Diabetes Treatment

On January 4, 2026, Ascletis Pharma Inc. (HKEX: 1672), a Hong Kong-listed biotechnology company specializing in metabolic diseases, announced U.S. FDA clearance of its Investigational New Drug (IND) application for a Phase II clinical trial of ASC30 in type 2 diabetes mellitus (T2DM). ASC30 is an in-house discovered oral small molecule glucagon-like peptide-1 receptor (GLP-1R) fully biased agonist, designed for once-daily oral administration or once-monthly to once-quarterly subcutaneous dosing, targeting obesity, diabetes, and related conditions.

Eisai and Biogen Announce NMPA Acceptance of BLA for Subcutaneous LEQEMBI in Early Alzheimer’s Disease

ScinoPharm Gains U.S. FDA Approval for Generic Glatiramer Acetate Injection in Multiple Sclerosis Treatmen

On January 5, 2026, ScinoPharm Taiwan Ltd. (TWSE: 1789), based in Tainan, announced a significant milestone: U.S. Food and Drug Administration (FDA) approval for its Glatiramer Acetate Injection, a therapeutic equivalent to Teva’s Copaxone® for the treatment of relapsing forms of multiple sclerosis (MS). This approval positions ScinoPharm as the only Taiwanese pharmaceutical company to successfully navigate the stringent regulatory pathway for this product, underscoring Taiwan’s emerging role in the global complex generics sector.

FDA Approves Mitapivat (AQVESME) for Anemia in Alpha- or Beta-Thalassemia

FDA Approves Mitapivat (AQVESME) for Anemia in Alpha- or Beta-Thalassemia

Alpha- and beta-thalassemia are inherited hemoglobinopathies causing chronic hemolytic anemia, ineffective erythropoiesis, iron overload, and complications including fatigue and organ damage. Management has relied on supportive care such as transfusions and chelation, with no prior disease-modifying oral therapies approved for all subtypes. Mitapivat, a first-in-class oral pyruvate kinase activator, targets underlying red blood cell energy deficits to improve survival and function.