Subcategory & Sub-subcategory
Product Name
Sotatercept-csrk
Specifications
- Expression System: Developed from a DMF-filed mammalian cell line optimized for consistently high titer, supporting cost-efficient large-scale manufacturing and broad media-platform adaptability
- Regulatory Status: Biosimilar of sotatercept (ACVR2A/ACTRIIA inhibitor mAb, originator Acceleron Pharma, US approval 2024-03-26), demonstrating high analytical comparability to the reference product
- Application: Targets ACTRIIA (ACVR2A) for cardiovascular, respiratory, endocrine and metabolic disorders, with pulmonary arterial hypertension (PAH) as a representative indication
- Certification Standard: Regulatory compliance ensured through a DMF-filed cell line, supporting global regulatory readiness and streamlined submissions
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