On January 8, 2026, AskBio Inc., a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced that the United States Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AB-1009. This investigational adeno-associated virus (AAV) gene therapy is designed for the treatment of late-onset Pompe disease (LOPD), a rare, progressive genetic metabolic disorder caused by deficiency of the enzyme acid alpha-glucosidase (GAA). Reduced or absent GAA levels lead to glycogen accumulation in muscles and tissues, resulting in progressive skeletal muscle weakness, respiratory insufficiency, and significant morbidity; without early intervention, the disease can lead to premature death.
The TOGETHER-PsA trial (NCT06588296) is a 52-week, randomized, multicenter, assessor-blinded, open-label Phase 3b study evaluating the efficacy and safety of concomitant subcutaneous ixekizumab (Taltz, an IL-17A inhibitor) and tirzepatide (Zepbound, a dual GIP/GLP-1 receptor agonist) compared to ixekizumab monotherapy in 271 adults with active psoriatic arthritis (PsA) and obesity (BMI ≥30 kg/m²) or overweight (BMI 27-29.9 kg/m² with ≥1 weight-related comorbidity). Participants had high baseline disease burden (mean DAPSA score 58.65, HAQ-DI 1.3) and mean BMI 37.6 kg/m²; over 60% had prior advanced therapy exposure. Both arms included lifestyle counseling for reduced-calorie diet and physical activity.
In a randomized crossover clinical trial (NCT05263232), Harmsen et al. investigated the metabolic effects of natural daylight exposure during office hours in individuals with type 2 diabetes (T2D). Thirteen participants with T2D, virologically suppressed on treatment, were exposed to either natural daylight (facilitated through windows) or constant artificial office lighting for 4.5 consecutive days in a controlled setting, with interventions separated by a washout period.
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).
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.
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.
