GSK announced that the European Commission (EC) has approved a new prefilled syringe presentation for Shingrix (Recombinant Zoster Vaccine, Adjuvanted; RZV), a key advancement designed to streamline vaccine administration. Previously, Shingrix required reconstitution by mixing a lyophilised powder antigen vial with a liquid adjuvant suspension. The new ready-to-use prefilled syringe eliminates this step, offering healthcare professionals a more convenient option without altering the vaccine’s composition, efficacy, safety profile, indication, or two-dose regimen.
GSK announced on January 7, 2026, positive topline results from the two pivotal Phase III trials, B-Well 1 (NCT05630807) and B-Well 2 (NCT05630820), evaluating bepirovirsen, an investigational triple-action antisense oligonucleotide (ASO), as a potential first-in-class finite treatment for chronic hepatitis B (CHB). The randomized, double-blind trials enrolled over 1,800 virologically suppressed patients from 29 countries with CHB on stable nucleos(t)ide analogue (NA) therapy and baseline hepatitis B surface antigen (HBsAg) levels ≤3000 IU/mL. Participants received a six-month course of bepirovirsen added to ongoing NA therapy or continued NA alone.
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.
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).
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.
