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China Medical System: As the First Prescription Issued, Innovative Drug Velphoro® has entered National Scale Clinical Application
2024-02-08

China Medical System: As the First Prescription Issued, Innovative Drug Velphoro® has entered National Scale Clinical Application

On 6 February, first-line phosphate-lowering Drug Velphoro® (sucroferric oxyhydroxide chewable tablets) has been issued its first prescription in the Gansu Provincial Hospital, which marks that the first iron-based, non-calcium phosphate binder (PB) approved by National Medical Products Administration (NMPA) in China[1] has officially entered clinical application. Velphoro® has become a new option of phosphorus-lowering treatment for CKD dialysis patients in China, and filled the gap of phosphorus-lowering treatment for Chinese paediatric patients aged 12 to 18 years old with CKD stages 4-5 or CKD on dialysis.   Velphoro® is a Class 5.1 imported innovative drug, which was approved through the priority review and approval procedure in China in February 2023 for the control of serum phosphorus (sP) levels in adults with chronic kidney disease (CKD) on hemodialysis (HD) or peritoneal dialysis (PD), and meanwhile, for the control of sP levels in paediatric patients 12 years of age and older with […]

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IND Approvals: Two of CMS’s Innovative Drugs Highly Selective TYK2 Inhibitor CMS-D001 and GnRH Receptor Antagonist CMS-D002 are approved for Drug Clinical Trials
2024-02-07

IND Approvals: Two of CMS’s Innovative Drugs Highly Selective TYK2 Inhibitor CMS-D001 and GnRH Receptor Antagonist CMS-D002 are approved for Drug Clinical Trials

China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that CMS-D001 tablets (“CMS-D001”) and CMS-D002 capsules (“CMS-D002”) self-developed by the Group have been granted approvals for drug clinical trials recently by National Medical Products Administration of the People’s Republic of China (“NMPA”). NMPA agrees to conduct (i) a randomized, double-blind, placebo-controlled phase I clinical study of single or multiple dose escalation and food effects (open) to evaluate the safety, tolerability, pharmacokinetics and efficacy of CMS-D001 in healthy subjects and patients with plaque psoriasis; and (ii) a randomized, double-blind, placebo-controlled phase I clinical study of single or multiple dose escalation to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CMS-D002 in healthy adult premenopausal female subjects.   CMS-D001 CMS-D001 is a highly selective TYK2 (tyrosine kinase 2) inhibitor. TYK2 is a member of the JAK kinase family, which is an important component in immune cell signaling. CMS-D001 […]

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CMS Obtained Exclusive License of a First-line Phosphate-lowering Drug Velphoro®
2024-02-02

CMS Obtained Exclusive License of a First-line Phosphate-lowering Drug Velphoro®

Obtained Velphoro®, an innovative drug (sucroferric oxyhydroxide chewable tablets) which has been newly included in the National Reimbursement Drug List. It is a new generation of iron-based, non-calcium PB and approved in China for the control of serum phosphorus (sP) levels in adults with chronic kidney disease (CKD) on hemodialysis or peritoneal dialysis, and for the control of sP levels in paediatric patients 12 years of age and older with CKD stages 4-5 (defined as glomerular filtration rate <30mL/min/1.73 m²) or CKD on dialysis.   The Product has been approved in China, and it will expand the Group’s marketed innovative product portfolio, and will synergize with the marketed products XinHuoSu (recombinant human brain natriuretic peptide for injection), Plendil (felodipine sustained-release tablets) and Desidustat tablets (intended to treat anemia in CKD patients) which is in the clinical development stage in terms of resources network. It is expected to have a positive […]

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