Month: 2024-12

SHANGHAI, Dec 2, 2024 - (ACN Newswire via SeaPRwire.com) - Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced that Department of Health of the Government of the Hong Kong Special Administrative Region, China, has accepted Everest’s New Drug Application (NDA) for VELSIPITY(R) (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis. VELSIPITY(R) is an effective and convenient, once-daily, oral treatment for patients with moderately-to-severely active UC that has already been approved in the U.S. and E.U., and other countries, by Everest’s licensing partner, Pfizer. In Everest territories, the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China has approved the NDA for VELSIPITY(R) in April of this year and was implemented in the Guangdong-Hong Kong-Macau Greater Bay Area this October through the "Hong Kong and Macau Medicine and Equipment Connect" policy."Autoimmune disease is a core focus and a significant growth driver for our company. The number of UC patients in China is projected to double from 2019 to 2030 to approximately one million, highlighting the urgent need for novel treatments." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “Previously, VELSIPITY(R) has already been approved in Macau, China, and was implemented in the Greater Bay Area through the connect policy. The company also plans to submit the NDA for approval by China’s National Medical Products Administration (NMPA) this year, with the aim of benefiting more Chinese patients as soon as possible."" This is an important advancement for etrasimod, bringing hope to patients in Hong Kong, China. This new-generation S1P receptor modulator is an oral, once-daily treatment that can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief, " said Prof. Wu Kaichun with the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod’s Asia clinical trial. “We hope China and other Asian countries can obtain approvals as soon as possible to benefit more patients."The acceptance of the NDA was based on results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) that evaluated the safety and efficacy of etrasimod 2 mg once-daily on clinical remission in UC patients with moderately to severely active UC who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12 were naïve to biologic or JAK inhibitor therapy, and these studies were also the only studies for advanced therapies for ulcerative colitis to include patients with isolated proctitis. Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of etrasimod.Everest conducted a multicenter, randomized, double-blind and placebo-controlled Phase 3 trial of etrasimod in Asian countries, including mainland China, China Taiwan and South Korea. This is the largest Phase 3 trial of moderately-to-severely active ulcerative colitis in Asia completed to date, with 340 eligible subjects randomized to treatment with etrasimod or placebo. The previously announced results of the induction period indicate that the clinical remission rate for patients treated with etrasimod 2mg was 25.0%, compared to 5.4% for those treated with placebo (difference 20.4%, p

上海, 2024年12月2日 - (亞太商訊 via SeaPRwire.com) -雲頂新耀（HKEX 1952.HK）是一家專注于創新藥研發、臨床開發、製造和商業化的生物製藥公司，今日宣佈中國香港衛生署已正式受理伊曲莫德（VELSIPITY(R)）用於治療中重度活動性潰瘍性結腸炎成人患者的新藥上市許可申請（NDA）。伊曲莫德是一款每日一次口服的一線先進療法，不僅使用方便、療效佳，而且具有良好的安全性特征。伊曲莫德已於去年10月和今年2月先後在美國和歐盟獲得新藥上市批准，同時，伊曲莫德也於今年4月獲得中國澳門特別行政區藥物監督管理局批准上市，並於今年10月通過「港澳藥械通」政策在粵港澳大灣區落地。雲頂新耀首席執行官羅永慶表示：「我們非常高興看到伊曲莫德的新藥上市許可申請在中國香港獲得正式受理。自身免疫性疾病是我們的重點關注領域和重要價值的潛在增長動力。到2030年，中國的潰瘍性結腸炎患者人數預計將達到約100萬人，超過2019年患者人數的一倍以上，存在迫切且巨大的未被滿足的臨床需求。伊曲莫德已在中國澳門獲批，並通過「港澳藥械通」政策率先在粵港澳大灣區落地。今年我們預計也將在中國大陸地區遞交伊曲莫德的新藥上市許可申請。期待伊曲莫德在更多地區獲批，進一步擴大可及性，造福廣大患者。」伊曲莫德亞太臨床試驗牽頭研究者、世界胃腸病學會執行理事、亞太消化學會副主席、中國人民解放軍空軍軍醫大學附屬西京醫院吳開春教授表示：「祝賀伊曲莫德取得的這一新進展，為中國香港的患者帶來了希望。伊曲莫德具有良好的獲益-風險特征，這種新一代S1P受體調節劑通過每日一次口服的治療方案，可快速起效，並達到無激素緩解、黏膜癒合，可為中重度活動性潰瘍性結腸炎成人患者提供先進的治療選擇。我們期待伊曲莫德在大中華區及其他亞洲國家早日獲批，為患者帶來福音。」伊曲莫德的申請是基於ELEVATE UC III期註冊研究（ELEVATE UC 52和ELEVATE UC 12）的結果，該研究旨在評價既往對至少一種常規治療、生物製劑或Janus激酶（JAK）抑制劑治療失敗或不耐受的中重度活動性潰瘍性結腸炎患者，每日一次服用2mg 伊曲莫德的安全性和療效。在ELEVATE UC 52和ELEVATE UC 12中，納入了一半以上嚴重活動性潰瘍性結腸炎患者（mMS≥7），並有近三分之一患者曾接受過生物製劑或JAK抑制劑治療。伊曲莫德的UC研究也是迄今唯一納入了孤立性直腸炎患者的UC研究。這兩項隨機、雙盲、安慰劑對照研究均達到了所有主要和關鍵次要終點，安全性特征與既往研究一致。在ELEVATE UC 52研究中，第12周時，接受伊曲莫德治療的患者臨床緩解率為27.0%（安慰劑組7.0%, 差異20.0%，P

Vancouver, British Columbia--(ACN Newswire via SeaPRwire.com - November 28, 2024) - Military Metals Corp. (CSE: MILI) (OTCQB: MILIF) (FSE: QN90) (the "Company" or "MILI") is pleased to report that it has completed additional staking of claims surrounding the Last Chance antimony-gold property, located in Nye County, Nevada, just over 70km north of the town of Tonapah and 12km due west of Kinross' Round Mountain gold mine. The Company recently entered into a letter of intent to acquire the Last Chance antimony-gold property. Please refer to the Company's news release dated November 14, 2024, for additional details about the Last Chance property.Scott Eldridge, Chief Executive Officer of the Company, commented, "Antimony prices have now risen to $38,000 USD per tonne, making antimony the top performing commodity thus far for 2024. China's export restriction that came into play September 15, 2024, has created a supply crunch that has magnified the need for domestic development of defense sector metals. This additional staking solidifies complete coverage of what we believe is the entire mineralized system surrounding the Last Chance antimony-gold property."Location map, Last Chance PropertyTo view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/10818/231755_11f4bf32b4999b42_001full.jpgHistorical antimony-gold occurrences and a solitary shaft where limited historical production is recorded occur within a sequence of Paleozoic carbonates and Lower Mesozoic metamorphosed shales and carbonates; A series of ultramafic dykes as well as younger felsic intrusives and extrusives cut this sequence at several locations. Mineralization is structurally controlled, with folding, faulting and quartz veining seen throughout the metamorphosed sedimentary sequence at several locations across the property.A fence of claims was staked surrounding the Last Chance property to ensure that additional ground considered potentially prospective remains available to the Company when it begins its first field campaign scheduled for Q2/2025.The technical contents of this release were reviewed and approved by Avrom E. Howard, MSc, PGeo, geological consultant to Military Metals and a qualified person as defined by NI 43-101.About Military Metals Corp. The Company is a British Columbia-based mineral exploration company that is primarily engaged in the acquisition, exploration and development of mineral properties with a focus on antimony.ON BEHALF OF THE BOARD of DIRECTORSFor more information, please contact:Scott EldridgeCEO and Directorscott@militarymetalscorp.comFor enquiries, please call 604-722-5381 or 604-537-7556This news release contains "forward-looking information". Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-Looking information in this news release includes statements related to the completion of a binding agreement and closing of the acquisition of the Last Chance Gold Property, as well as future plans for exploration activities, and assumptions related to the continuation of the global demand for antimony. A variety of factors, including known and unknown risks, many of which are beyond our control, could cause actual results to differ materially from the forward-looking information in this news release. These include meeting the conditions to close the acquisition of the Last Chance Gold Property, geopolitical developments related to the supply of antimony, the continued use of antimony and availability of alternatives, availability of capital and labour in respect of the properties that are the subjects of this news release, the results of any future exploration activities, which cannot be guaranteed, and such other factors as may impact both and any future activities in respect of the properties. Additional risk factors can also be found in the Company's public filings under the Company's SEDAR+ profile at www.sedarplus.ca. Forward-Looking statements contained herein are made as of the date of this news release and the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward looking statements if circumstances, management's estimates or opinions should change, except as required by securities legislation. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements.The Canadian Securities Exchange has neither approved nor disapproved the information contained herein and does not accept responsibility for the adequacy or accuracy of this news release.To view the source version of this press release, please visit https://www.newsfilecorp.com/release/231755 Copyright 2024 ACN Newswire via SeaPRwire.com.

KUALA LUMPUR, Nov 26, 2024 - (ACN Newswire via SeaPRwire.com) - GoKardz, a trailblazing platform in digital business networking, proudly announces the launch of its Enterprise Module, an innovative solution designed to empower companies to create their company pages, onboard employees seamlessly, and maximize the potential of digital business cards. This addition merges traditional networking with advanced digital solutions to enhance connectivity and maintain brand identity, all while giving companies full control over their organizational presence.Enterprise Solutions for Modern BusinessesWith GoKardz’s Enterprise Module, companies can create customized company profiles and onboard employees effortlessly, equipping them with unique and customizable digital business cards that reinforce their brand identity. Employers gain full control over onboarding, ensuring a smooth, centralized process that guarantees all employees are equipped and up-to-date.Beyond individual digital business cards, businesses can now:Promote Products and Services: Increase brand exposure and engagement through GoKardz’s marketplace, showcasing offerings for maximum visibility.Advertise Open Positions: Post full-time, contractual, or freelance job opportunities, attracting top talent to meet business needs.Leverage Analytics: Gain actionable insights into visitor interactions, such as views of employee cards and clicks on links (e.g., website, email, phone), analytics that were previously impossible with traditional paper business cards.Reallocate Cards: Seamlessly transfer cards to new employees during transitions, maintaining continuity without any gaps in information.Seamless Digital ExperienceThe platform’s intuitive interface ensures companies can manage their digital assets and branding consistently across the organization. Employees can easily share their digital business cards through QR codes, NFC technology, Apple Wallets, and other methods, facilitating instant, scalable sharing while reducing environmental impact from traditional business cards.A Sustainable and Data-Driven Approach to NetworkingAs businesses increasingly turn to digital solutions, GoKardz leads the way in aligning technological innovation with environmental responsibility. By embracing digital business cards, companies not only improve their networking efficiency but also take a step towards sustainability. The analytics tools further support data-driven decision-making, empowering businesses to refine their outreach strategies based on real-time engagement metrics.A Word from Our LeadersAmaresh, Co-Founder of GoKardz, shared his vision:“At GoKardz, we’re committed to redefining professional networking with sustainable, data-driven solutions. Our enterprise tools help businesses modernize, reduce their environmental footprint, and optimize outreach strategies for greater impact.”Kuber Ventures, the venture studio that invested in GoKardz, emphasized:“Our investment in GoKardz stems from its ability to address a key gap in digital networking. The new Enterprise Module amplifies this vision by providing companies with innovative and efficient solutions that foster sustainable business growth.”With GoKardz, companies can confidently modernize their approach to networking, reduce their environmental impact, and gain valuable insights previously lost with traditional methods.GoKardz is available on iOS and Android, ready to transform the way professionals and businesses network and grow.For more information, visit www.gokardz.comMedia Contact: komal@mianext.com Copyright 2024 ACN Newswire via SeaPRwire.com.

SHANGHAI, Nov 30, 2024 - (ACN Newswire via SeaPRwire.com) - Hua Medicine (the “Company”, HKEx stock code: 2552) announced today that the Company has successfully completed a Phase I clinical trial on its 2nd generation GKA candidate in U.S. at the 9th China BioMed Innovation and Investment Conference (CBIIC).The Phase Ia clinical trial of the second-generation GKA (HM-002-1005) was conducted in the United States in 40 subjects with Type 2 diabetes (T2D). This trial was randomized, double-blind, placebo-controlled, single-dose, focusing on safety, tolerability, and pharmacokinetics. The second-generation GKA is a novel molecular entity with optimized physicochemical properties, holding new patents, and serving as the prodrug of dorzagliatin (HMS5552). This study designed for once-daily oral administration. Its aim is to extend the drug's action duration in the body through sustained-release technology, enhance patient compliance, and prolong the stimulation of GLP-1 secretion in the intestines.The Single Ascending Dose (SAD) study demonstrates that HM-002-1005 tablets can be rapidly converted to HMS5552 in the human body, with minimal exposure level of prodrug in both blood and urine. The t1/2 (biological half-life) after a single dose of HM-002-1005 tablets was prolonged compared to dorzagliatin tablets. The Cmax of HMS5552 in plasma after a 184.5mg single dose is comparable to the plasma concentration of HMS5552 after a 75mg single dose of dorzagliatin tablet; likewise, the daily AUC of HMS5552 in plasma after a single dose of HM-002-1005 tablets is comparable to the exposure level of HMS5552 after a 75mg BID dose of dorzagliatin tablets. The research indicates that HM-002-1005 tablets are near-completely converted to HMS5552 in human, and its pharmacokinetic characteristics support for once-daily oral administration. The development of HM-002-1005 tablets not only contributes to enhancing patient medication adherence and effectively control blood glucose levels within 24 hours; meanwhile, it also offers the opportunity to explore the Maximum Tolerated Dose above 150mg daily to achieve better efficacy. The 75 mg BID dose regiment was developed under the concept of Minimum Therapeutic Effective Dose in Chinese T2D patients who suffered from an impairment of insulin secretion and significant reduction of early phase insulin. The different disease characters of T2D with obesity in western patient population would benefit dorzagliatin from its effects on GLP-1 secretion and improvement of insulin sensitivity.With the confirmation that the exposure level of HM-002-1005 tablets at 184.5mg is comparable to dorzagliatin tablets at 75mg (BID), we will further optimize the dosage form followed by a Multiple Ascending Dose (MAD) clinical development of the 2nd generation GKA in China and the United States.Dr. Li CHEN, founder and CEO of Hua Medicine, stated, “Hua Medicine has always been committed to treating Type 2 diabetes at its root cause by restoring patients’ ability to autonomously regulate blood glucose levels. Over the course of a decade, the Company has selected dosing and clinical research protocols that are safe and effective for the majority of Chinese diabetes patients, leading to the successful development of GKA and the clinical application of dorzagliatin. Building on this foundation, the Company will undergo a strategic upgrade by further exploring the therapeutic potential of GKA, enriching its product pipeline and seeking partners both domestically and internationally, in order to benefit a broader range of patients, expand into global markets, and effectively establish the brand identity of GKA medications while maximizing the commercial potential of our global first-in-class drugs.”About Hua MedicineHua Medicine (The “Company”) is an innovative drug development and commercialization company based in Shanghai, China, with companies in the United States and Hong Kong. Hua Medicine focuses on developing novel therapies for patients with unmet medical needs worldwide. Based on global resources, Hua Medicine teams up with global high-calibre people to develop breakthrough technologies and products, which contribute to innovation in diabetes care. Hua Medicine's cornerstone product HuaTangNing (Dorzagliatin tablets), targets the glucose sensor glucokinase, restores glucose sensitivity in T2D patients, and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin for adult T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with renal function impairment.For more informationHua MedicineWebsite: www.huamedicine.comInvestorsE-mail: ir@huamedicine.comMediaE-mail: pr@huamedicine.com Copyright 2024 ACN Newswire via SeaPRwire.com.

SHANGHAI, Nov 30, 2024 - (ACN Newswire via SeaPRwire.com) - Hua Medicine (the “Company”, HKEx stock code: 2552) announced today that the Company has successfully completed its SENSITIZE study on the mechanism by which dorzagliatin improves the β-cell glucose sensitivity at the 9th China BioMed Innovation and Investment Conference (CBIIC).The SENSITIZE study was initiated by Professor Juliana Chan, an international endocrinology specialist at The Chinese University of Hong Kong, as the lead researcher. It is the first clinical study in Asian populations to evaluate the impact of GKA on β-cell glucose sensitivity in the populations with varying degrees of impaired glucose tolerance using the technology of hyperglycemic clamp. The study aims to explore the impairment of glucokinase (GK) function and clinical characteristics in different types of glucose dysregulation, providing new scientific evidence on the pathophysiology of Asian Type 2 diabetes and the central role of GK in blood glucose regulation.The SENSITIZE 2 study results announced at CBIIC demonstrate that a single dose of dorzagliatin restores GK enzyme activity, significantly improving the second-phase insulin secretion and β-cell glucose sensitivity in individuals with impaired glucose tolerance (IGT) in hyperglycemic clamp study. In addition, the SENSITIZE 1 study previously reported at the 2022 ADA annual meeting showed that dorzagliatin directly restores the activity of GK mutants, leading to significant improvements in the second-phase insulin secretion and β-cell glucose sensitivity in patients with glucokinase monogenic diabetes (GCK-MODY or MODY-2), and significantly enhance basal insulin secretion in newly diagnosed type 2 diabetes patients.Hua Medicine will continue to investigate β-cell glucose sensitivity improvement and incretin effect in response of repeated dose of dorzagliatin in individuals with intermediate hyperglycemia (IH) and Type 2 diabetes, in order to establish personalized intervention and treatment management plans for prediabetic and Type 2 diabetes patients.About Hua MedicineHua Medicine (The “Company”) is an innovative drug development and commercialization company based in Shanghai, China, with companies in the United States and Hong Kong. Hua Medicine focuses on developing novel therapies for patients with unmet medical needs worldwide. Based on global resources, Hua Medicine teams up with global high-calibre people to develop breakthrough technologies and products, which contribute to innovation in diabetes care. Hua Medicine's cornerstone product HuaTangNing (Dorzagliatin tablets), targets the glucose sensor glucokinase, restores glucose sensitivity in T2D patients, and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin for adult T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with renal function impairment.For more informationHua MedicineWebsite: www.huamedicine.comInvestorsE-mail: ir@huamedicine.comMediaE-mail: pr@huamedicine.com Copyright 2024 ACN Newswire via SeaPRwire.com.