According to the official website of the National Medical Products Administration Drug Review Center (CDE), this week, there are many clinical trials of Class 1 innovative drugs that have applied for "implemented permission" to pass. The People's Daily Health Client sorted out some products. The indications of these products include ER+/HER2-breast cancer, type 1 SMA, solid tumor and lymphoma , chronic kidney disease , hemophilia , etc.
Pfizer :ARV-471 (PF-07850327) tablet
indication: ER+/HER2-Breast cancer
Public information shows that ARV-471 (PF-07850327) tablet is a protein degradation targeted chimera targeted to degrade estrogen receptor (ER). Pfizer (Pfizer) has reached a research and development agreement with Arvinas for a amount of more than US$2 billion to jointly develop ARV-471.
Pfizer official website image
ARV-471 is a potential "best-in-class" protein degrader. Previously, in phase 1 clinical trials, ARV-471 reduced ER levels by up to 90% regardless of whether the tumor expressed wild-type ER or mutant ER. Among the 34 patients who can evaluate clinical benefits, the clinical benefit was 41%. The drug is currently conducting a Phase 2 clinical trial of the dose-extended phase of the treatment of ER+/HER2-breast cancer. The clinical indication for this drug is ER+/HER2-breast cancer.
Jinlan Gene: GC101 adeno-associated virus injection
Indications: Type 1 SMA
Jinlan Gene developed AAV gene therapy drug GC101 adeno-associated virus injection has been approved for clinical approval, and the indication is type 1 spinal muscular atrophy.
Spinal muscular atrophy (SMA) is a hereditary neuromuscular disease caused by mutations in motor neuron survival gene 1 (SMN1) resulting in defective SMN protein function. It affects neuronal function and causes neurogenic atrophy in patients' muscles. It is one of the autosomal recessive genetic diseases that cause infants and young children to die.
According to Jinlan Gene, GC101 injection is designed to treat 5q spinal muscular atrophy. It directly delivers and supplements SMN protein to the central nervous system through intrathecal administration, improving the respiratory function and motor ability of SMA patients.
GC101 injection was conducted in advance by Beijing Ruixi Rare Disease Gene Therapy Technology Research Institute. Beijing Wujiahe Gene Technology Co., Ltd. and its subsidiary Beijing Jingpudi Technology Co., Ltd. completed product production and pharmacological research. Beijing Jinlan Gene Technology Co., Ltd. completed pharmacological research, clinical plan formulation and drug registration application, and will conduct subsequent clinical research and clinical trials.
Fuhong Hanlin official website picture
Fuhong Hanlin: HLX60
Indications: solid tumors and lymphomas
According to Fuhong Hanlin's official website, HLX60 is an innovative monoclonal antibody independently developed by Fuhong Hanlin to target GARP. It can block the GARP-mediated release of TGF-β1 by specifically binding to GARP, reverse the immunosuppressive effect in TME, and improve the anti-tumor immune response.
In addition, HLX60 can clear GARP-positive tumor cells and immunosuppressive cells such as Tregs through antibody-dependent cell-mediated cytotoxicity (ADCC), thereby exerting an anti-tumor effect. Preclinical research results show that the anti-tumor effect of HLX60 combined with Hansy® is significantly better than the monotherapy effect of Hansy® or HLX60, and has good tolerance and safety, fully reflecting the synergistic anti-tumor effect of dual immunotherapy. The clinical indications approved for this drug are solid tumors and lymphomas.
AstraZeneca : AZD5718 tablets
Indications: Chronic kidney disease
According to public information of AstraZeneca, AZD5718 is a selective, reversible 5-lipoxygenase-activated protein (FLAP) inhibitor that can inhibit the production of leukotrienes.
Overseas, the drug has previously shown positive efficacy in phase 2 clinical trials for patients with proteinuria chronic kidney disease with or without 2 diabetes . The drug was approved for clinical trials in China, and the indication to be developed is chronic kidney disease.
According to literature reports, under existing treatment methods, patients with chronic kidney disease (CKD) still have the risk of renal and cardiovascular events due to residual albuminuria. In the human body, 5-lipoxygenase and its activated proteins affect the production of leukotrienes.Leukotriene is a lipid mediator that pro-inflammatory and vasoconstriction. Its biological effects include stimulating leukocyte chemotaxis, neutrophil activation, promoting vascular permeability and vasoconstriction, etc., which are related to the etiology of chronic inflammatory diseases, and chronic inflammation will lead to the aggravation and progression of CKD.
Shengsi Bio: Recombinant human coagulation factor VIIa-Fc fusion protein for injection
Indications: Hemophilia
inhibitor is a neutralizing antibiotic antibody produced by hemophilia patients after infusion of exogenous coagulation factor products (eight factors/nine factors), and is the most serious complication in replacement treatment of hemophilia. After the inhibitor is produced, the efficacy of conventional factor replacement therapy will be reduced or ineffective, resulting in an increase in the incidence of bleeding-related lesions in the patient and greatly increasing the difficulty of bleeding treatment.
At present, the first-line drug for hemostasis treatment in patients with inhibitors in China is the seven factors of activation and recombination. However, the barriers to activation of seven-factor products are extremely high, and there are few products on the market. No similar products have been launched in China. The market is monopolized by imported products and the price is high, which greatly limits the popularity of products among domestic patients.
According to Shengsi Bio, Shengsi 109 is a long-acting seven-factor product. Through its original dual-head homodimeric Fc fusion technology, it can maintain the hemostasis effect of activated seven-factor while greatly improving its half-life in the body. After this product is approved for clinical approval, Shengsi Biologics will conduct clinical research in adolescents and over 12 years old and adults with inhibitors (congenital eight-factor/nine-factor deficiency).
Source: People's Daily Health Client
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