133 Innovative Drug Candidates Accepted by CDE Last Month, Oncology Drugs Dominate

　　【Pharmaceutical Network Product InformationAccording to statistics, in October 2024, the CDE accepted 133 innovative drug varieties (drug registration category "1"), among which oncology drugs still accounted for the majority. These include AbbVie's ABBA-400 injectable powder, GSK's Belrestotug injection, Kangbaida (Sichuan) Biomedical Technology's BY101921 tablets, and Chipscreen Biosciences' CS231295 tablets.
 

Many varieties have shown good characteristics in clinical research. For example, Belrestotug is an anti-TIGIT monoclonal antibody that GSK introduced from iTeos Therapeutics for $2.075 billion. In the Phase II GALAXIES Lung-201 study for NSCLC, compared with the dostarlimab (anti-PD-1 monoclonal antibody) monotherapy group, the dostarlimab+belrestotug group showed clinically significant tumor regression. Based on these positive results, GSK initiated the Phase III GALAXIES Lung-301 study comparing dostarlimab+belrestotug with pembrolizumab+placebo as a first-line treatment for NSCLC patients. In addition to NSCLC, GSK also launched a Phase II study comparing dostarlimab+belrestotug with dostarlimab as a first-line treatment for head and neck squamous cell carcinoma (HNSCC).
 

BY101921 is an orally administered small-molecule inhibitor targeting PARP7. Relevant studies have shown that inhibiting PARP7 can restore the interferon signaling pathway, activate the innate immune STING pathway, upregulate phosphorylated STAT1, thereby suppressing tumor growth. In preclinical studies, BY101921 demonstrated significant anti-tumor efficacy and safety, showing potential to become a BIC (Best-in-Class) drug for the same target.
 

MicroCore Pharma's CS231295 tablet is a small-molecule multi-target protein kinase inhibitor. Preclinical studies have shown that the drug exhibits significant pharmacodynamic activity, ideal pharmacokinetic properties, and good safety.
 

Huao Tai's HB0028 injection is a bispecific antibody targeting programmed death-ligand 1 (PD-L1) and transforming growth factor-β (TGF-β). Preclinical studies have shown that the tumor inhibition rate of HB0028 is significantly higher than that of the individual parent molecules. In addition, the HB0028 project fuses the TGF-β type II receptor with the C-terminus of the anti-PD-L1 antibody, overcoming the drawback of O-glycosylation that often occurs when similar drugs fuse the TGF-β type II receptor with the N-terminus of the anti-PD-L1 antibody. This also further enhances the efficacy of HB0028.
 

Sanofi's SAR442970 injection is a bispecific antibody developed based on Nanobody technology. According to previously disclosed information from Sanofi, by linking Nanobody molecular fragments, the company’s team can create new compounds (referred to as "multivalent" nanobody molecules) capable of binding to multiple different targets simultaneously. For example, a single therapeutic nanobody molecule can bridge tumor cells and immune cells by binding to multiple sites on both tumor and immune cells, helping the body's immune system fight cancer.
 

In addition to anti-tumor drugs, other varieties with clinical applications under review include ADI-001 for the treatment of lupus nephritis and AstraZeneca's AZD6234 injection for obesity.
 

Among them, AstraZeneca's AZD6234 is a long-acting amylin receptor agonist and CALCR receptor agonist, currently under development for the treatment of obesity. AstraZeneca has stated that the future market will no longer focus on treating obesity but will shift towards long-term, sustained weight management.
 

Currently, the obesity treatment market is mainly dominated by two leading products from Eli Lilly and Novo Nordisk. Multinational pharmaceutical companies like AstraZeneca also hope to establish a foothold in the obesity drug market. On November 4 (local time), AstraZeneca presented research data on its oral small-molecule weight loss drug at the ObesityWeek conference in the United States. The report showed that in an early-stage study, AstraZeneca's once-daily oral GLP-1 receptor agonist "AZD5004/ECC5004" reduced patients' average weight by 5.8% within four weeks and demonstrated good tolerability.
 

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