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China Medical System’s Opzelura Approved in Hong Kong for Non-segmental Vitiligo Treatment
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China Medical System Holdings (CMS; HKG: 0867) has announced that the market filing for its Opzelura (ruxolitinib) cream has been approved in Hong Kong. This topical Janus kinase (JAK) inhibitor is now approved for use as a local treatment for non-segmental vitiligo in patients aged 12 years and above, expanding…
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China Medical System’s Opzelura Cream Filing for Vitiligo Accepted by NMPA
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China Medical System Holdings (CMS; HKG: 0867) has announced that its market filing for Opzelura (ruxolitinib) cream for the treatment of vitiligo has been accepted for review by the National Medical Products Administration (NMPA). Opzelura is a topical Janus kinase (JAK) inhibitor designed for external use. It received approval in…
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CMS’s Methotrexate Injection Gains NMPA Approval for Active Rheumatoid Arthritis Treatment
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China Medical System Holdings (CMS; HKG: 0867) has received approval from the National Medical Products Administration (NMPA) for an additional indication for its methotrexate injection. The drug is now approved for the treatment of active rheumatoid arthritis (RA) in adults. Methotrexate is internationally recognized as a first-line treatment and cornerstone…
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China Medical System’s Methylthioninium Tablets Get NMPA Green Light for Colonoscopy Use
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China Medical System Holdings (CMS; HKG: 0867) has announced that it has received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its methylthioninium enteric coated sustained-release tablets. This oral formulation is the first of its kind in China and is indicated for enhancing the visualization…
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China Medical System Secures Exclusive Rights to Baiyiyuan Biotech’s Implant in Greater China
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China Medical System Holdings (CMS; HKG: 0867) has entered into a licensing agreement with Shanghai-based Baiyiyuan Biotech, securing exclusive rights to promote, market, and commercialize Baiyiyuan’s decellularized matrix implant across Greater China, including the China mainland, Hong Kong, Macau, and Taiwan. The financial details of the agreement were not disclosed.…
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China Medical System Holdings’ Desidustat NDA Accepted for Review by China’s NMPA
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China Medical System Holdings (CMS; HKG: 0867) has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its desidustat. The oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) is under development to treat anemia in adult chronic kidney disease (CKD) patients who…
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China Medical System’s Opzelura Approved in Macau for Vitiligo Treatment
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China Medical System Holdings (CMS; HKG: 0867) has announced that it has received market approval in Macau for Opzelura (ruxolitinib) cream, a topical treatment indicated for patients aged 12 and above with non-segmental vitiligo involving the face. Opzelura, a topical Janus kinase (JAK) inhibitor, was initially approved in the U.S.…
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China Medical System Expands Portfolio with Incyte’s Povorcitinib for Autoimmune Diseases
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China Medical System Holdings (CMS; HKG: 0867) has announced a new cooperation and licensing agreement with US-based Incyte Pharmaceuticals Inc. (NSDQ: INCY), focusing on Incyte’s selective oral JAK1 inhibitor, povorcitinib. CMS has secured the exclusive rights to research, develop, file for regulatory approval, and commercialize the drug in Greater China,…
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China Medical System Gets Green Light for Phase III Clinical Trial of Opzelura in Atopic Dermatitis
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China Medical System Holdings (CMS; HKG: 0867) has received approval from the National Medical Products Administration (NMPA) to commence a Phase III clinical study for its Opzelura (ruxolitinib) cream, which is indicated for the treatment of atopic dermatitis (AD). This development marks a significant step forward for CMS in expanding…
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CMS Secures NMPA Approval for Clinical Trials of TYK2 Inhibitor CMS-D001 and GnRH Antagonist CMS-D002
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China Medical System Holdings Ltd (CMS, HKG: 0867) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for two of its drug candidates: CMS-D001 and CMS-D002. CMS-D001 is a highly selective TYK2 (tyrosine kinase 2) inhibitor aimed at treating immune inflammatory diseases, including…
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China Medical System Reclaims Rights to Velphoro from WinHealth in Greater China
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China Medical System Holdings Ltd (CMS, HKG: 0867) has announced a rights assignment agreement with fellow Chinese firm WinHealth Investment (HK) Ltd concerning Velphoro (sucroferric oxyhydroxide). Initially, CMS entered into a licensing agreement with WinHealth in June of the previous year, which granted WinHealth exclusive rights for regulatory filing, import,…
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China Medical System Holdings Secures Exclusive Rights to Promote Xihong Biopharma’s Aesthetic Fillers
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China Medical System Holdings Ltd (CMS, HKG: 0867) has announced a licensing agreement with Jiangxi Xihong Biopharma Co., Ltd, granting CMS exclusive promotion, marketing, and commercialization rights for Xihong Biopharma’s injectable polycaprolactone microspheres filler and injectable hydroxyapatite microspheres filler in China mainland, Hong Kong, Macau, and Taiwan. Both Category III…
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China Medical System Expands into Southeast Asia with Singapore Manufacturing Plant Lease
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China Medical System Holdings Ltd (CMS, HKG: 0867) has announced that its joint venture, PharmaGend Global Medical Services Pte., Ltd (PharmaGend), has entered into a lease agreement with Strides Pharma Global Pte., Ltd for a manufacturing facility in Singapore, which includes the acquisition of certain production machinery and equipment. This…
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China Medical System Gets NMPA Green Light for Phase III Vitiligo Study with Ruxolitinib Cream
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China Medical System Holdings (CMS; HKG: 0867) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for its Opzelura (ruxolitinib) cream for the treatment of non-segmental vitiligo. Opzelura, a topical Janus kinase (JAK) inhibitor, was approved in the…
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China Medical System’s Methotrexate Injection Receives NMPA Review for Rheumatoid Arthritis Indication
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China Medical System Holdings (CMS; HKG: 0867) has announced that the National Medical Products Administration (NMPA) has accepted another indication approval filing for its methotrexate injection. The company is now seeking NMPA approval for the use of the drug in treating active rheumatoid arthritis (RA) in adults. Initially approved for…
