Five antibody products targeting the programmed death receptor 1 (PD-1) or the programmed death-ligand 1 (PD-L1) have been approved. Combined sales of the four checkpoint inhibitors marketed in the year 2017 exceeded US$ 10 bln with double and triple digit growth rates, respectively, compared with sales of the previous year. The enormous clinical and commercial success is attracting many biopharmaceutical companies, not only from countries with regulated pharmaceutical markets (USA; Europe, Japan), but also from countries with less regulated markets, especially China.
Analysis of the PD-1 and PD-L1 checkpoint inhibitor pipeline revealed 41 unique molecules in clinical development by pharmaceutical companies, of which 12% are bispecific molecules and 27% are only developed so far in less regulated countries. Further 15 unique molecules are undergoing IND-enabling studies or have already applied for clinical trial of which 40% are bispecific molecules. Most of the molecules are recombinant antibodies or antibody fusion proteins, but some other treatment modalities, such as small molecules, are also appearing in the pipeline.
Projects were identified by search in La Merie’s proprietary R&D drug database as well in national and international clinical trial databases. All findings were verified by company website visits. Additional secondary search tools include, but are not limited to, company press releases, SEC filings, corporate presentations and scientific abstracts.
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SOURCE: La Merie Publishing