HongKong:3681

SinoMab's IND Application of SM17 has once again Received Approval from NAMP

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星期二, 九月 12, 2023
Asthma, T helper cell, Therapy, Prevalence, Infection, Quality of life, Atopic dermatitis, Research, Innate lymphoid cell, Investigational New Drug, Patient, FIC, ILC2, National Medical Products Administration, Cytokine, Mortality, AD, IND, NMPA, Autoimmunity, Skin, Conditional sentence, Pharmaceutical industry

Current approved therapies for AD, including biologics, can significantly improve eczema area and severity index and patient's quality of life.

Key Points: 
  • Current approved therapies for AD, including biologics, can significantly improve eczema area and severity index and patient's quality of life.
  • The Company actively promoted the indication research of SM17, laying a foundation for subsequent proof of concept and commercialization.
  • The IND application of SM17 for AD has been approved by the NMPA, which fully reflects the recognition of the differentiated advantages of SM17 in the field of AD and has a bright future.
  • Currently, SM17 has obtained IND approvals from the NMPA for the treatment of asthma and AD, while our Phase I study for SM17 conducted in the US is near completion.

SinoMab Announces that IND Application of SM17 for the Treatment of Asthma was Approved by NAMP

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星期一, 八月 14, 2023
Idiopathic disease, Asthma, Idiopathic pulmonary fibrosis, Therapy, Lincoln Hospital (Bronx), Clinical trial, Quality of life, Atopic dermatitis, Research, Innate lymphoid cell, Frost, Investigational New Drug, Patient, Risk, Health, FIC, Disease, ILC2, National Medical Products Administration, FIH, Mortality, Cytokine, FDA, IPF, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, NMPA, Social Problems, Food, T helper cell, Safety, Pharmaceutical industry, Vaccine

IL-25 is a critical cytokine classified as "alarmin", which has shown to be implicated in the pathogenesis of multiple airway viral responses and allergic diseases, such as asthma.

Key Points: 
  • IL-25 is a critical cytokine classified as "alarmin", which has shown to be implicated in the pathogenesis of multiple airway viral responses and allergic diseases, such as asthma.
  • Meanwhile, the Company is also advancing the Phase I clinical study of SM17 in the U.S. at full speed.
  • The potential first-in-target antibody of SM17 has demonstrated the potential efficacy for multiple indications, including asthma and IPF (Idiopathic Pulmonary Fibrosis).
  • Compared with other currently approved therapeutic antibody drugs targeting ILC2s downstream pathway, SM17 has a differentiated advantage at the source.

SinoMab Announces IND Application of SM17 for the Treatment of Asthma was Accepted by NMPA CDE

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星期一, 五月 22, 2023
Drug development, T helper cell, Therapy, Lincoln Hospital (Bronx), Clinical trial, Quality of life, Atopic dermatitis, Research, Innate lymphoid cell, Trial of the century, Frost, Investigational New Drug, Patient, Risk, Health, Allergy, ILC2, National Medical Products Administration, FIH, Center for Drug Evaluation and Research, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Idiopathic pulmonary fibrosis, Food, NMPA, Safety, Pharmaceutical industry, Vaccine, Asthma

The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of asthma.

Key Points: 
  • The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of asthma.
  • Current approved therapies for severe asthma, including biologics, can reduce asthma annual exacerbations to a certain extent.
  • The Company believes SM17 may have great potential to satisfy unmet medical needs in asthma treatment.
  • It is expected that this new treatment option will benefit more Chinese patients in the future and bring a promising treatment for severe asthma patients.

SM17

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星期一, 五月 22, 2023

SM17

Retrieved on: 
星期一, 五月 22, 2023

SinoMab Annouces IND Application of SM17 for the Treatment of Asthma was Accepted by NMPA CDE

Retrieved on: 
星期一, 五月 22, 2023
Drug development, T helper cell, Therapy, Lincoln Hospital (Bronx), Clinical trial, Quality of life, Atopic dermatitis, Research, Innate lymphoid cell, Trial of the century, Frost, Investigational New Drug, Patient, Risk, Health, Allergy, ILC2, National Medical Products Administration, FIH, Center for Drug Evaluation and Research, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Idiopathic pulmonary fibrosis, Food, NMPA, Safety, Pharmaceutical industry, Vaccine, Asthma

The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of asthma.

Key Points: 
  • The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of asthma.
  • Current approved therapies for severe asthma, including biologics, can reduce asthma annual exacerbations to a certain extent.
  • The Company believes SM17 may have great potential to satisfy unmet medical needs in asthma treatment.
  • It is expected that this new treatment option will benefit more Chinese patients in the future and bring a promising treatment for severe asthma patients.