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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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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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3D Medicines’ 3D185 Receives Orphan Drug Designation for Gastric Cancer
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China-based oncology specialist 3D Medicines (HKG: 1244) has announced receiving orphan drug designation (ODD) status from the US Food and Drug Administration (FDA) for its pipeline drug candidate 3D185. The designation was granted for the drug’s potential use in treating gastric cancer and gastroesophageal junction carcinoma (GC/GEJ). This marks the…
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China Medical System Licenses Opzelura from Incyte for Greater China and Southeast Asia
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China Medical System Holdings (CMS; HKG: 0867) announced the establishment of a licensing agreement with US-based Incyte Pharmaceuticals Inc., (NASDAQ: INCY) focused on Incyte’s Opzelura (ruxolitinib) cream. As per the agreement, which will initially last 10 years, the Chinese firm will take exclusive research and development (R&D), regulatory filing, and…
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Innovent’s Parsaclisib Filed for Marketing Approval in China
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China’s Center for Drug Evaluation (CDE) has received a marketing approval application for Innovent Biologics Inc’s (HKG: 1801) PI3Kδ inhibitor parsaclisib. The product candidate has been granted priority review status. The targeted indication is relapsed or refractory follicular lymphoma (r/r FL) in patients who have previously received at least two…
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Innovent Biologics’ Pemazyre Becomes First FGFR2 Inhibitor Approved in China
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China-based Innovent Biologics Inc. (HKG: 1801) announced that the first prescription has been filled in China for Pemazyre (pemigatinib), the world’s first targeted therapy for cholangiocarcinoma (bile duct cancer). The drug, an FGFR2-targeted protein kinase inhibitor, was originally discovered by US biotech Incyte Therapeutics and licensed to Innovent for Greater…
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Global Cord Blood Corp’s Cellenkos Gets FDA Nod for Myelofibrosis Trial
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Global Cord Blood Corporation (GCBC; NYSE: CO) announced receiving Investigational New Drug (IND) approval from the US FDA for its subsidiary Cellenkos’ pipeline candidate CM0804. The FDA clearance allows Cellenkos to initiate a Phase Ib, open-label study for CM0804 as an add-on therapy to ruxolitinib in patients with myelofibrosis who…
