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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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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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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…
