132025-02

China Medical System is Included in the S&P Global Sustainability Yearbook 2025

China Medical System Obtained Class 1 Innovative Drug Long-acting Anti-IL-4Rα Monoclonal Antibody MG-K10

2025-01-24

China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that on 24 January 2025, the Group through subsidiaries of the Company entered into a Collaboration Agreement with Hunan Mabgeek Biotechnology Co., Ltd. (“Mabgeek Biotechnology”) and its subsidiary for Class 1 innovative drug anti-IL-4Rα humanized monoclonal antibody injection MG-K10 (“MG-K10” or the “Product”). The Group has obtained the co-development right as specifically agreed upon in the Agreement and exclusive commercialization right to the Product in Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, Taiwan Region and Singapore (the “Territory”); Mabgeek Biotechnology will support the commercialization activities and is responsible for the sale and supply of the Product. The collaboration term is perpetual.   IL-4Rα is considered a key target for the treatment of type 2 inflammatory diseases, such as atopic dermatitis (AD), asthma, prurigo nodularis, etc. Anti-IL-4Rα monoclonal […]

CMS Donated About RMB2.5 Million Worth of Special Fund and Supplies to Aid the Earthquake-stricken Area in Shigatse, Tibet

2025-01-13

On 7 January 2025, a magnitude 6.8 earthquake, which struck at a depth of 10 km, hit Tingri County, Shigatse City in Tibet, causing heavy casualties and house damages. Caring about the disaster, China Medical System Holdings Limited (“CMS”) has made proactive disaster relief efforts through its wholly-owned subsidiary, Tibet Kangzhe Pharmaceutical Development Co., Ltd. On January 9th, it donated relief supplies worth nearly RMB 0.5 million to the earthquake-stricken area through Tibet Development Philanthropic Foundation, including disinfectant, military coats, cotton quilts, and cotton jackets, etc. Moreover, on January 13th, it donated a special fund of RMB2 million to Tibet Charity Federation for post-disaster resettlement and reconstruction, to further help the disaster area to overcome the difficulties sooner.   Join hands to fight the disaster, and pray for peace and safety. CMS wishes the earthquake-stricken area in Shigatse, Tibet rebuild their homes as earlier as possible.  
【Can-Fite BioPharma-Product CF102】CAN-FITE: FDA GRANTS IND CLEARANCE FOR NAMODENOSON TO TREAT MASH PATIENTS IN A PHASE IIB STUDY

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

2024-05-21

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 […]

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

2024-05-09

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

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

2024-02-07

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 […]

【Acticor Biotech-Product ACT017】Acticor Biotech has just and timely completed patient recruitment of its phase 2/3 study in stroke

2023-11-21

 438 patients with stroke have been randomized in ACTISAVE study evaluating glenzocimab, in the United-States, Europe, Israel and United Kingdom Confirmation of clinical results communication for the second quarter 2024 Acticor Biotech (ISIN: FR0014005OJ5 – ALACT), a clinical stage biopharmaceutical company developing glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, announced the timely completion of enrollment in the ACTISAVE Phase 2/3 clinical trial in patients with acute ischemic stroke (AIS) on November 7, 2023. Gilles Avenard, General Manager of Acticor Biotech, declares: “We are pleased with the completion of the enrollment of our clinical study evaluating the efficacy of glenzocimab in 438 stroke patients exactly on schedule. We eagerly anticipate sharing the outcomes of this world-class study in the second quarter of 2024. This achievement bolsters our commitment to delivering an innovative drug for the treatment of cardiovascular emergencies, that is strengthened, moving forward at every milestone of […]
【Blueberry Therapeutics-Product BB2603】Blueberry Therapeutics Meets Primary and Secondary Endpoints in Phase 2b Trial in Onychomycosis

【Blueberry Therapeutics-Product BB2603】Blueberry Therapeutics Meets Primary and Secondary Endpoints in Phase 2b Trial in Onychomycosis

Primary endpoint (negative culture and/or clear nail growth) met with 83.3% response rate Secondary endpoints met at Week 52 after 9-months off treatment   On 13 November, Blueberry Therapeutics Limited (“Blueberry” or “the Company”), a pharmaceutical company focused on developing innovative, topical nanomedicines to treat dermatological conditions, announced that BB2603, a novel topical terbinafine antifungal product, has met the primary endpoint in the Phase 2b trial (BBTAF202) in patients with onychomycosis, showing superiority over placebo (vehicle) with a high level of statistical significance.   BBTAF202 was a European trial conducted in 111 subjects with mild to moderate distal subungual onychomycosis (DSO) of the toenail, recruited from sites in Germany, Poland and the Czech Republic. This trial assessed the efficacy, safety and pharmacokinetics of 3 months twice-daily treatment of BB2603-10 versus vehicle, along with 2 lower formulation strengths of BB2603-3 and BB2603-1. A 3‑month treatment duration is considerably shorter than for […]

【Sun Pharma-Product CEQUA®】CEQUA® (cyclosporine ophthalmic solution) 0.09% Phase 4 Data Showed Sustained Improvement in Dry Eye Disease Signs and Symptoms in Patients Switched From Restasis® (cyclosporine ophthalmic emulsion) 0.05%

2023-11-03

Presentation at the American Academy of Optometry (AAOPT) 2023 showed significant improvements with CEQUA®for topical ophthalmic use in both corneal fluorescein staining (CFS) and symptom questionnaire scores starting at 4 weeks and continuing to 12 weeks Study design mirrors real-world experience with dry eye disease, including allowing use of artificial tears and measurement of CFS in all five corneal zones Mumbai, India & Princeton, NJ, October 12, 2023 – Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced the presentation of Phase 4 data showing that CEQUA® (cyclosporine ophthalmic solution) 0.09% induces sustained improvement in the signs and symptoms of dry eye disease (DED). CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). In a presentation at the American Academy of Optometry (AAOPT) 2023 annual […]
Publication of new data for XF-73

Publication of new data for XF-73

2023-08-03

Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development and commercialisation of novel medicines to prevent and treat life threatening infections, today announces the publication of new data in the journal Infection & Drug Resistance from a study evaluating the potency of Destiny Pharma’s antibacterial drug, XF-73, against methicillin-resistant Staphylococcus aureus (MRSA) in two, industry-standard, skin infection models and comparing its efficacy against mupirocin, a leading topical antibiotic. The publication, entitled, “Efficacy of a Novel Antibacterial Agent Exeporfinium Chloride, (XF‑73), against Antibiotic-Resistant Bacteria in Superficial Skin Infection Models” concluded that: Destiny Pharma’s partner, China Medical System Holdings Limited (CMS) is developing the XF-73 dermal formulation as a treatment for superficial skin infections through its relationship with Tianjin Medical University. The global acute bacterial skin and skin structure infections market is estimated to be valued at US$ 3,466 million in 2022 and is expected to exhibit a CAGR of 6.0% over the forecast period (2022-2030).1 Destiny Pharma has […]

【Can-Fite BioPharma-Product CF102】Can-Fite: Granted Breakthrough Abstract Award for Namodenoson in Treatment of Advanced Liver Cancer by ASCO Conquer Cancer Foundation

2023-07-17

– Can-Fite’s novel approach for the treatment of advanced liver cancer will be presented at the American Society of Clinical Oncology (ASCO) Breakthrough Meeting in Japan on August 4th 2023 – Namodenoson is in pivotal Phase 3 study for the treatment ofadvanced hepatocellular carcinoma (HCC) – A patient from the prior Phase 2b study is cancer-free >6 years following initial treatment with Namodenoson Can-Fite announced its abstract titled “A novel approach for the treatment of advanced hepatocellular carcinoma (HCC)” is one of the highest scoring abstracts and has won the prestigious Breakthrough Abstract Award from Conquer Cancer®, the ASCO Foundation, and the 2023 ASCO Breakthrough Program Committee. Can-Fite’s Chief Scientific Officer, Founder, and Executive Chairman, Dr. Pnina Fishman, will present the poster at the ASCO Breakthrough Meeting which will take place August 3 – 5, 2023 in Yokohama, Japan. Namodenoson has received significant acknowledgment in the scientific and medical community, as evidenced […]
【Acticor Biotech-Product ACT017】Participation of Acticor Biotech in ESOC 2023, first European Forum for Stroke Research

【Acticor Biotech-Product ACT017】Participation of Acticor Biotech in ESOC 2023, first European Forum for Stroke Research

2023-05-26

ACTICOR BIOTECH (FR0014005OJ5 – ALACT), a clinicalstage biotechnology company focused on the development of innovative drugs for the treatment of cardiovascular emergencies, in particular stroke, announces today that it will participate in the European Stroke Organization Conference (ESOC) 2023 on May 24, 25 and 26, 2023 in Munich, Germany. At this conference, the Company presented three posters on the clinical development of glenzocimab: 1) Design of the ACTISAVE study (Abstract N°2314 – Poster n° P0511- session of May 25, 2023) Authors: Y. Pletan et al. This poster presents the methodology of the ACTISAVE study and the mapping of its global launch. 2) Sub-analysis of the ACTIMIS study – Glenzocimab Tolerance in association with antithrombotics (Abstract N°2314 – Poster n° P0507 – session of May 25, 2023) Authors: A. Peeters et al. This poster presents the results of a subgroup analysis of the ACTIMIS study in patients who received antithrombotic therapy […]

【Can-Fite BioPharma-Product CF101】EMA Gives Green Light for Piclidenoson Pivotal Phase III Clinical Trial for Psoriasis Treatment-The Pivotal Study is Aimed to Support a Marketing Authorization Application

2023-04-10

Can-Fite announced that it received a positive opinion from the Committee for Medicinal Products for Human Use(CHMP) of the European Medicines Agency (EMA) with respect to the submission of a registration plan for a pivotal Phase III clinical trial for the treatment of moderate to severe psoriasis. The pivotal Phase III study and the safety of the 3 mg twice daily dose of Piclidenoson are accepted by the agency. The Company intends to initiate a prospective double-blind, placebo-controlled and randomized clinical trial with its lead product Piclidenoson aimed at demonstrating clinical safety and efficacy for the treatment of moderate to severe psoriasis sufficient to support a marketing authorization application. The agency also commented on the registration plan submitted by the Company relating to the chemistry, manufacturing, and controls (CMC), nonclinical data, and clinical pharmacology data. Can-Fite is currently submitting a comparable data package to the US Food and Drug Administration. Can-Fite recently reported topline results from its Phase III COMFORT™ study […]
【Can-Fite BioPharma-Product CF102】Namodenoson Significantly Inhibits Pancreatic Cancer in Preclinical Studies—A Patent Has Been Filed

【Can-Fite BioPharma-Product CF102】Namodenoson Significantly Inhibits Pancreatic Cancer in Preclinical Studies—A Patent Has Been Filed

2023-01-24

– Data show significant anti-cancer effect in pancreatic carcinoma as a monotherapy and an additive effect when combined with gemcitabine, the standard-of-care chemotherapy for pancreatic cancer – Namodenoson’s excellent safety profile and its ability to directly inhibit the growth of pancreatic tumors present its potential as an effective drug for the treatment of this devastating disease which has a 5-year survival rate of only 11% in the U.S. – Can-Fite has filed a patent application that covers the use of Namodenoson for the treatment of pancreatic cancer Can-Fite announced that its anti-cancer drug Namodenoson significantly inhibits the growth of pancreatic carcinoma as a stand-alone treatment. In combination with the leading chemotherapy used in pancreatic cancer, gemcitabine, Namodenoson demonstrated a significant additive effect. These pre-clinical studies were conducted on advanced pancreatic carcinoma patient cells. Namodenoson’s molecular mechanism of action in pancreatic cancer involves the regulation of the NF-κB/IκB/STAT3-mediated pathway. Namodenoson is […]

【Can-Fite BioPharma-Product CF101】Can-Fite Submits Market Registration Plan to European Medicines Agency for Piclidenoson in The Treatment of Psoriasis; FDA Submission to Follow

2023-01-10

Can-Fite announced today it has submitted a market registration plan to the European Medicines Agency (EMA) for its lead drug candidate Piclidenoson in the treatment of moderate to severe psoriasis. A submission to the U.S. Food and Drug Administration (FDA) will follow. Registration plans for both the EMA and FDA include final efficacy and safety results from Can-Fite’s successful COMFORT™ Phase III study and the protocol for the Company’s upcoming Phase III pivotal trial together with a request for registration advice from the regulators. Current chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data are also included. Can-Fite recently reported topline results from its Phase III COMFORT™ study which met its primary endpoint with statistically significant improvement over placebo in psoriasis patients and an excellent safety profile for Piclidenoson. The Phase III COMFORT™ data point towards a better safety profile for Piclidenoson as compared to Otezla, the leading oral therapy for […]