{"id":18546,"date":"2023-05-23T00:07:00","date_gmt":"2023-05-22T16:07:00","guid":{"rendered":"https:\/\/flcube.com\/?p=18546"},"modified":"2024-12-18T00:12:06","modified_gmt":"2024-12-17T16:12:06","slug":"sinomab-biosciences-sm17-ind-accepted-by-nmpa-for-potential-global-first-in-class-monoclonal-antibody","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=18546","title":{"rendered":"SinoMab BioScience’s SM17 IND Accepted by NMPA for Potential Global First-in-Class Monoclonal Antibody"},"content":{"rendered":"\n

Hong Kong-based biotech SinoMab BioScience Ltd (HKG: 3681<\/a>) has announced that the National Medical Products Administration (NMPA) has accepted for review an investigational new drug (IND) filing for SM17, a potential global first-in-class monoclonal antibody. Developed in-house by SinoMab, SM17 is the world\u2019s first humanized IgG4-\u03ba monoclonal antibody targeting IL-17RB, an immunoregulatory protein with potential as a treatment for asthma, atopic dermatitis, idiopathic pulmonary fibrosis, and other immunological disorders.<\/p>\n\n\n\n

SM17’s Mechanism of Action and Potential Applications<\/strong>
SM17 is capable of suppressing Th2 immune responses by binding to IL-17RB on Type 2 Innate Lymphoid cells (ILC2s), thereby blocking a cascade of responses induced by interleukin-25 (IL-25). IL-25, a critical cytokine classified as an “alarmin,” has been implicated in the pathogenesis of airway viral responses and allergic diseases, such as asthma.<\/p>\n\n\n\n

IND Filing and Clinical Development Progress<\/strong>
The IND filing signifies that SinoMab is set to begin China-based development of SM17, which has already entered a first-in-human Phase I study in the United States in June 2022 for assessment as a treatment for asthma. The China Phase I study will serve as a bridging study to the US trial and provide data specific to the Chinese ethnic group. The progress of the US Phase I study is reportedly strongly positive, with no serious adverse events in patients, and the trial is expected to be completed six months ahead of schedule by the end of 2023.<\/p>\n\n\n\n

SinoMab’s Pipeline and Clinical Candidates<\/strong>
SM17 is SinoMab\u2019s third pipeline candidate product to enter the clinic, following lead candidate SM03 (suciraslimab), a CD22-targeted antibody that achieved primary endpoints in a Phase III study for rheumatoid arthritis last month, and SN101, a Bruton’s tyrosine kinase (BTK) inhibitor currently in Phase II trials in China and the US.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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