Four new drugs of the same type have been approved for clinical trials in China for the first time, from companies such as Astrazeneca PLC Sponsored ADR (AZN.US) and BEIGENE (06160).

According to the official website of China's National Medical Products Administration Center for Drug Evaluation (CDE) and public information, this week (August 12th to August 17th), 4 first-class innovative drugs have obtained the Clinical Trial Implication Permit (IND) in China for the first time. They are from LUYE PHARMA (02186), Caiskaidi, BEIGENE (06160), and Astrazeneca PLC Sponsored ADR (AZN.US). This article will introduce the relevant information of these products based on public information. LUYE PHARMA: LY01620 Mechanism of action: mRNA therapeutic vaccine Indications: HPV16-related high-grade squamous intraepithelial lesions According to a press release from LUYE PHARMA, the mRNA therapeutic vaccine LY01620 developed by its subsidiary company Jemai Bio for human papillomavirus (HPV) has been approved for clinical trials, aiming to develop a treatment for HPV16-related high-grade squamous intraepithelial lesions. LY01620 is developed based on the mRNA sequence and lipid nanoparticle (LNP) delivery system developed by Jemai Bio, utilizing mRNA to express HPV-specific antigens E6/E7, inducing the body to produce specific T-cell immunity to clear HPV-infected cervical epithelial cells, block the process of carcinogenesis, and restore normal cervical epithelial cells. Preclinical studies have shown that LY01620 can induce antigen-specific T-cell immunity in different animal species and has good immunogenicity. In addition, this is the first product from Jemai Bio to be granted IND approval. Jemai Bio is a research-based company under the LUYE PHARMA Group focusing on the development of lipid nanoparticle delivery of small molecule chemotherapeutics and nucleic acid drugs, with a product pipeline covering oncology drugs, analgesics, mRNA vaccines, novel adjuvants, nucleic acid drugs, and other areas. Caiskaidi: CS060380 tablet Mechanism of action: small molecule agonist targeting THR- Indications: Non-alcoholic fatty liver disease/non-alcoholic fatty liver disease(CS060380 is a small molecule agonist targeting thyroid hormone receptor (THR-), designed for the treatment of non-alcoholic fatty liver disease (NASH), also known as MASH. The product is highly specific and enriched in liver tissue, and has shown promising preclinical data, especially in improving NAS score and fibrosis in NASH mouse models, with low effective doses, significant efficacy, and good tolerability. The product was approved for clinical trials in the United States in May this year and received IND approval in China this time, aiming to develop treatments for non-alcoholic fatty liver disease/non-alcoholic fatty liver disease. Astrazeneca PLC Sponsored ADR: Injectable AZD7798 Mechanism of action: monoclonal antibody targeting T-cell subsets Indications: Moderate to severe Crohn's diseaseAstrazeneca PLC Sponsored ADR (AstraZeneca) has received IND approval for the 1st class new drug injectable AZD7798, intended to develop treatments for moderate to severe Crohn's disease. According to the official website and public information of Astrazeneca PLC Sponsored ADR, AZD7798 is a potential "first-in-class" humanized monoclonal antibody targeting T-cell subsets. It can eliminate CCR9-positive lymphocytes and is intended to treat Crohn's disease. Studies have shown that the interaction between CCR9/CCL25 regulates the inflammatory immune response of the intestinal mucosa by balancing different subgroups of dendritic cells, representing a potential therapeutic target for Crohn's disease (CD). AZD7798 is currently in phase 2 clinical studies internationally. BEIGENE: BGB-45035 tablet Mechanism of action: protein degrader targeting IRAK4 Indications: Atopic dermatitisBEIGENE's 1st new drug BGB-45035 tablet has been approved for clinical trials, intended for the treatment of moderate to severe atopic dermatitis. According to public information from BEIGENE, BGB-45035 tablet is a protein degrader targeting IRAK4, the second protein degrader developed by BEIGENE on its own CDAC platform. This product has the potential to induce deeper and faster degradation of IRAK4 and has stronger cytokine suppression compared to other similar drugs. IRAK4 is a key protein in the inflammation mediated by Toll-like receptors (TLRs) and IL-1 receptors. IL-1 and toll-like receptors play key roles in the immune response to pathogen invasion, and abnormalities in these signaling pathways are potential mechanisms for various inflammatory diseases, including rheumatoid arthritis, atopic dermatitis, and others. This article is reprinted from the WeChat public account "WuXi AppTec"; GMTEight editor: Liu Xuan.