More than four decades on from the approval of the first biologic drug, the industry has reached a tipping point, and biotech drugs now outnumber small molecules in the global R&D pipeline. At the start of the biotech industry, progress was slow. Between 1983 and 1995, the U.S. FDA approved an average of two biologics each year. Now, biologics have taken the lead by the smallest of margins, accounting for 50.1% of drugs in development at the start of 2026, according to the Pharma Annual Review 2026, published by Pharmaprojects, a firm that tracks global pharma R&D.
Innovent Biologics Inc. has presented preclinical data on IBI-3055, a trispecific T-cell engager for the treatment of autoimmune diseases. This trispecific antibody targets CD19, BCMA and CD3, and features an innovative 1+1+1 T-cell engager design with CD3 masking to minimize non-specific T-cell activation.
The tumor necrosis factor (TNF)-α-induced protein 8-like 2 (TIPE2), predominantly expressed in bone marrow-derived cells or lymphoid tissues, is an essential regulator of immune homeostasis. TIPE2 acts as a key negative modulator of inflammatory signaling through the suppression of toll-like receptor (TLR) activity, with TIPE2-deficient mice exhibiting spontaneous systemic inflammation and premature death.
Invivyd Inc. has announced the discovery and advancement of VMS-063, a novel monoclonal antibody candidate for the treatment and prevention of measles.
Researchers from Singlomics Zhuhai Danxu Biopharmaceuticals Co. Ltd. presented DXP-006, a humanized antibody targeting IL1RAP, a shared co receptor required for IL 1, IL 33 and IL 36 cytokines.
More than four decades on from the approval of the first biologic drug, the industry has reached a tipping point, and biotech drugs now outnumber small molecules in the global R&D pipeline.
Cue Biopharma Inc. has reached a preclinical milestone in its collaboration and license agreement with Boehringer Ingelheim Pharma GmbH & Co. KG, following the latter’s selection of a first compound for lead optimization. The milestone triggers a $7.5 million payment to Cue.
Researchers from the University of Naples Federico II (Italy) and collaborating institutions reportedd the design of a next-generation mRNA vaccine that leverages a phylogenetically informed consensus receptor binding domain heterotrimers representing the major variant lineages.
Researchers from Hangzhou Innogate Pharma Co. Ltd. and Innorace Biopharma Co. Ltd. have identified new cyclic GMP-AMP synthase (MB21D1; cGAS) inhibitors that are potentially useful for the treatment of Aicardi-Goutieres syndrome, psoriasis, rheumatoid arthritis, systemic lupus erythematosus and more.
Simcere Pharmaceutical Group Ltd.’s monoclonal antibody, rademikibart (CBP-201), met the primary endpoint in a Chinese phase III study in adults and adolescents with moderate to severe atopic dermatitis.
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