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China Medical System: New Drug Application of Desidustat Tablets Accepted in China
2024-04-23

China Medical System: New Drug Application of Desidustat Tablets Accepted in China

Desidustat Tablets are novel, oral HIF-PHI for treating anaemia in non-dialysis adultchronic kidney disease patients. The Product is administrated orally, thus expecting to improve the treatment compliance of patients and to meet the unmet treatment needs in the field of CKD anaemia, including both dialysis and non-dialysis patients. China Phase III trial of the Product has demonstrated positive results.The primary endpoint has indicated that Desidustat is more effective than placebo in increasing Hb level. Currently, 4 innovative drugs of CMS have entered intocommercialization  Meanwhile, continuous advance of products’ clinical development and registration process such as Desidustat Tablets is expected to enrich the Group’s marketed innovative product portfolio, and generate new driving force to the Group’s sustainable and healthy development.   China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that on 22 April 2024, the New Drug Application (NDA) of Desidustat Tablets  (“Desidustat Tablets” or the “Product”) has been accepted by the National Medical Products […]

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China Medical System: New Drug Application of Ruxolitinib Cream Approved in Macau
2024-04-16

China Medical System: New Drug Application of Ruxolitinib Cream Approved in Macau

China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region of the People’s Republic of China (“Macau”) has approved the new drug application of Ruxolitinib Cream (the “Product”) on 11 April 2024. The drug registration certificate was obtained on 16 April 2024. The Product is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.   Ruxolitinib cream, a novel cream formulation of Incyte’s (NASDAQ:INCY) selective JAK1/JAK2 inhibitor ruxolitinib[1], is the first and only topical JAK inhibitor approved for use in the United States. Ruxolitinib cream is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older and for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) […]

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CMS and Incyte Announce Collaboration and License Agreement for Povorcitinib, an Oral JAK1 Inhibitor, in mainland China, Hong Kong, Macau, Taiwan and Southeast Asia
2024-04-01

CMS and Incyte Announce Collaboration and License Agreement for Povorcitinib, an Oral JAK1 Inhibitor, in mainland China, Hong Kong, Macau, Taiwan and Southeast Asia

Povorcitinib, a selective oral JAK1 inhibitor discovered by Incyte, is an investigational medicine being evaluated for the treatment of non-segmental vitiligo, hidradenitis suppurativa (HS), prurigo nodularis (PN), asthma and chronic spontaneous urticaria.   HONG KONG, China and WILMINGTON, Del. –1 April, 2024 –China Medical System Holdings Limited (“CMS” or the “Group”) and Incyte (Nasdaq:INCY) (“Incyte”) are pleased to announce that on 31 March 2024, that the Group, through a wholly-owned dermatology medical aesthetic subsidiary of the Company (“CMS Skinhealth”), and Incyte entered into a Collaboration and License Agreement for the development and commercialization of povorcitinib (the “Product”), a selective oral JAK1 inhibitor, to research, develop, register and commercialize the Product in Mainland China, Hong Kong, Macao, Taiwan Region and eleven Southeast Asian countries (the “Territory”) and a non-exclusive license to manufacture the Product in CMS’ Territory.   Under the terms of the agreement, CMS will make an upfront payment to […]

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