2024-05-21

【Can-Fite BioPharma-Product CF102】CAN-FITE: FDA GRANTS IND CLEARANCE FOR NAMODENOSON TO TREAT MASH PATIENTS IN A PHASE IIB STUDY

9th May 2024 – Can-Fite BioPharma issued a press release, which is summarized as follows: Can-Fite BioPharma Ltd announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for Namodenoson, for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), for the Company’s ongoing Phase IIb clinical study. Namodenoson is a small molecule orally bioavailable drug, targeting the A3 adenosine receptor, over-expressed on the surface of liver pathological cells in MASH but not normal cells. This potentially makes Namodenoson an ideal specific candidate for the treatment of MASH. Indeed, in a Phase IIa clinical study Namodenoson, has been shown to reduce hepatic steatosis, inflammation and fibrosis, with an excellent safety profile. Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and the IND approval by FDA will allow for the recruitment […]

2024-05-13

CMS’s 32nd Anniversary | Embracing “New Rise” with “New CMS”

When the development of a Pharma resonates with the trend of the industry, it is not hard to imagine how fast it will accelerate.   Through 32 years of development, CMS has transferred through three stages to continuously build a new CMS for adapting to the external environment. From “selling” drugs when starting up a business, to “owning” drugs by purchasing products’ rights, and now to “creating” drugs via its innovation platform, every step taken by CMS is consistent with industrial development sooner or later.   On its 32nd Birthday, with the landings of differentiated innovation fruits, CMS has successfully embarked on the commercialization era of innovative products, continuously building sustainable growth momentum.     Persistent innovation investment and transformation bring us the great confidence to embrace “New Future, New Rise”!

2024-05-10

“Kangzhe” Brand was Awarded the 21st “Shenzhen Top Brand (Bay Area Top Brand)”

On 9th May, the 21st Shenzhen Top Brand and Bay Area Top Brand Event was held grandly, and unveiled series of award lists. The “Kangzhe” brand was awarded the “Shenzhen Top Brand” and “Bay Area Top Brand.”   Since 2003, the Shenzhen Top Brand event has been spearheaded by the Shenzhen Industry Association, in collaboration with relevant departments, industry associations, professional institutions, and media organizations to form an evaluation committee. It has fostered a group of Chinese brands with distinct advantages by motivating enterprises in Shenzhen to cultivate and establish esteemed brands.   The “Kangzhe” brand participated in the evaluation for the first time. Leveraging its distinctive and professional brand image as well as outstanding innovation achievements,  “Kangzhe” brand stood out among 428 applicants and has been awarded as “Shenzhen Top Brand (Bay Area Top Brand)” with high scores in various dimensions, including market position, industry reputation, brand value, and […]

2024-05-09

【Neurelis-Product Diazepam Nasal Spray】NEURELIS ANNOUNCES TWO POSTER PRESENTATIONS AT THE 76TH ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY

San Diego, CA – [April 11, 2024] – Neurelis, Inc. will present a poster on VALTOCO® (diazepam nasal spray) for the treatment of episodes of frequent seizure activity (i.e., seizure clusters) in patients with epilepsy ages 6 to 65 years, describing the time to treatment across different subpopulations.  A second presentation will provide insight into characterization of a repeat-dosing model for preclinical diazepam studies. These findings will be showcased through posters at the 76th Annual Meeting of the American Academy of Neurology (AAN) in Denver from April 13 to 18, offering both in-person attendance and live online participation in a hybrid format. “These studies represent our continued commitment to improving outcomes for patients with epilepsy,” said Adrian L. Rabinowicz, M.D., Chief Medical Officer. “Our persistent research highlights the efficacy of VALTOCO, and we are delighted to disseminate these additional findings to patients, physicians, and healthcare organizations attending AAN, an event […]

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 […]

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) […]

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 […]

2024-03-19

China Medical System: Approval to Conduct a Phase 3 Clinical Trial Investigating Ruxolitinib Cream in Atopic Dermatitis in China

NMPA has approved the application to conduct a clinical trial evaluating the safety and efficacy of ruxolitinib cream for the treatment of mild to moderate atopic dermatitis (AD) in China. Ruxolitinib cream, a novel cream formulation of Incyte’s (NASDAQ:INCY) selective JAK1/JAK2 inhibitor ruxolitinib, 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) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.   China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that the National Medical Products Administration (NMPA) of the People’s Republic of China has […]

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 […]

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 […]

【Acticor Biotech – Product ACT017】Publication of ACTIMIS clinical study results in the Lancet Neurology Journal

Achievement of ACTIMIS primary endpoint, confirming the safety of glenzocimab in acute ischemic stroke patients Reduction in the rate and severity of intracranial hemorrhages and of mortality in glenzocimab-treated patients Acticor Biotech (FR0014005OJ5 – ALACT), a clinicalstage biotechnology company focused on the development of glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, focusing stroke, announces the publication of phase 1b/2a clinical results of ACTIMIS study in The Lancet Neurology Journal on 23rd, January. The manuscript is entitled: Safety and efficacy of platelet glycoprotein VI inhibition in acute ischaemic stroke (ACTIMIS): a phase 1b/2a randomized, placebo-controlled, trial The ACTIMIS clinical trial evaluated glenzocimab in combination with the reference treatment (thrombolysis with or without thrombectomy) in patients presenting with an Acute Ischemic Stroke(AIS). This publication displays the full analysis of ACTIMIS results. The key results presented in the manuscript are: – Achievement of ACTIMIS primary endpoint, confirming the safety of […]