月份: 2026 年 6 月

HONG KONG, Jun 9, 2026 - (ACN Newswire via SeaPRwire.com) - Everest Medicines today announced that it has entered into an exclusive licensing agreement with Jiangsu Vcare PharmaTech Co., Ltd. (“Vcare”), for the development, registration and commercialization of Sumecigrel (formerly known as Vicagrel) across the Asia-Pacific region, including Southeast Asia, South Korea, Australia, Hong Kong SAR, Macao SAR, and Taiwan region, China. Pursuant to the agreement, Everest Medicines will pay Vcare PharmaTech an upfront payment of RMB 20 million, along with subsequent milestone payments and commercial supply procurement.This collaboration strengthens the Company’s cardiovascular portfolio and highlights Everest’s continued focus on the Asia-Pacific market, supporting the advancement of its regional strategy and the development of innovative therapies.Sumecigrel is an antiplatelet agent and a new-generation oral P2Y12 receptor antagonist. It is being clinically developed for the treatment and prevention of atherothrombotic events such as acute coronary syndrome (ACS), ischemic stroke (IS) and peripheral arterial disease (PAD). As a novel antithrombotic drug self-developed by Vcare PharmaTech, the product is currently advancing preparations for NDA in China, the United States, Europe.The molecular design of Sumecigrel targets the black box warning associated with clopidogrel resistance. It innovatively optimizes the metabolic pathway of clopidogrel while retaining its active metabolite, striking a better balance between therapeutic benefits and bleeding risks inherent to antiplatelet medications. Featuring faster onset of action, lower dosage, more stable efficacy, better controllable bleeding risks, reduced metabolic burden and broader clinical applicability, Sumecigrel is a novel antiplatelet candidate with prominent Best-in-Class potential. It is expected to address the increasingly personalized demands for antithrombotic therapy and become a blockbuster product in the antithrombotic market.Cardio-cerebrovascular diseases rank among the leading causes of death worldwide. Related fatalities rose sharply to 17.9 million in 2019, accounting for approximately 32% of all global deaths. Around 85% of these deaths were attributed to myocardial infarction (a major type of ACS) and stroke. The death toll from cardio-cerebrovascular diseases further climbed to 19.2 million in 2023.Antiplatelet drugs inhibit platelet activation, adhesion and aggregation to reduce thrombotic risks, and are widely used for the prevention and treatment of atherothrombotic diseases. P2Y12 receptor antagonists are a major category of mainstream antiplatelet medications. Currently marketed products in this class continue to face challenges in balancing variability in efficacy and bleeding risk across patients, and optimizing the overall clinical benefit–risk profile remains an important unmet medical need in this therapeutic area.“This collaboration with Vcare PharmaTech marks another step in strengthening our presence in the Asia-Pacific region,” said Mr. Yifang Wu, Chairman of the Board of Everest Medicines. “Sumecigrel is a next-generation oral P2Y12 receptor antagonist with Best-in-Class potential, offering differentiated clinical benefits and complementing Everest’s cardiovascular pipeline. Leveraging our clinical, regulatory, and commercial capabilities across the Asia-Pacific as a global platform for innovative therapies, Everest will drive Sumecigrel’s development and commercialization to realize its full clinical and commercial value and bring new treatment options to more patients.”"As our novel antithrombotic drug, Sumecigrel represents our first innovative pharmaceutical product, "said Dr. Gong Yanchun, Co-founder, Chairman and CEO of Vcare PharmaTech. "This strategic partnership with Everest Medicines serves as the first step of Sumecigrel’s global commercialization strategy, creating a win-win situation for an original innovation enterprise and an international commercial platform. Powered by AI-driven differentiated original design, Vcare PharmaTech consistently focuses on the development of innovative drugs and leading therapies, standing as a pioneer of the next-generation original innovation in the global antiplatelet field. We will accelerate the global R&D and registration progress of Sumecigrel, consolidate its global competitive edges, and contribute Chinese innovation to the diagnosis and treatment of cardiovascular diseases across the Asia-Pacific and the world at large."As a next-generation P2Y12 receptor antagonist, Sumecigrel has completed Phase I, Phase II, China-US PK/PD bridging study and Phase III clinical trials. It has demonstrated favorable efficacy and safety with solid clinical value, and is poised to become an improved treatment option for patients with ACS, IS and PAD.Of note, the addition of Sumecigrel further enriches Everest Medicines’ cardiovascular portfolio. As the Company continues to expand its presence in the CKM (cardiovascular, kidney and metabolic) disease space, Sumecigrel is expected to strengthen its cardiovascular product portfolio and generate synergies with existing products and pipeline assets, further deepening the Company’s presence in related therapeutic areas.From a strategic perspective, this collaboration represents another important step in Everest Medicines’ ongoing efforts to deepen its presence across the Asia-Pacific region. Notably, the Company has continued to advance strategic partnerships and resource integration across the region. Through its collaboration with Mabworks, Everest secured the commercialization rights to Bejescin®, a third-generation anti-CD20 therapy, in multiple Asia-Pacific markets, further strengthening its portfolio in nephrology and autoimmune diseases. Industry observers believe that the licensing of Sumecigrel reflects Everest Medicines’ continued commitment to the Asia-Pacific market and its strategy of accelerating the regional development and commercialization of innovative therapies. As its regional product portfolio and operating capabilities continue to expand, Everest Medicines is well positioned to further leverage its integrated biopharmaceutical platform and accelerate the value realization of innovative therapies across the Asia-Pacific region. Copyright 2026 ACN Newswire via SeaPRwire.com. All rights reserved. www.acnnewswire.com

上海, 2026年6月9日 - (亞太商訊 via SeaPRwire.com) - 華領醫藥（「公司」，香港聯交所股份代號：2552.HK）今日宣布，公司攜全球首創葡萄糖激酶激活劑（GKA）多格列艾汀（dorzagliatin，商品名：华堂宁（R），香港地區商品名：華領片（R）, MYHOMSIS（R））的一系列研究成果亮相第86屆美國糖尿病協會（ADA）科學年會，以口頭報告+壁報展示形式，多維度呈現了公司以代謝穩態技術平台為核心，在聯合用藥協同增效、大規模上市後真實世界證據、AI精準診療和個性化診療工具等關鍵領域的突破性進展，進一步支持了多格列艾汀從源頭上修復血糖穩態的機制優勢，提示了多格列艾汀在2型糖尿病（T2D）、代謝相關脂肪性肝病（MASLD）、肥胖、青少年發病型成人糖尿病2型 (MODY2)等複雜代謝性疾病領域的用藥潛力，持續鞏固了華領醫藥在全球血糖穩態研究領域的領先地位。一、依托代謝穩態平台，拓寬泛代謝疾病治療佈局多格列艾汀以「血糖傳感器」葡萄糖激酶（GK）為核心靶點，通過修復2型糖尿病患者受損的GK功能和表達，提升T2D患者血糖調控器官的葡萄糖敏感性，實現胰腺-肝臟-腸道多器官協同調控，從而改善患者血糖穩態，為糖尿病及一系列代謝紊亂疾病提供了全新的治療範式。基於這一獨特機制，華領醫藥在本屆ADA重點公布三項聯合用藥在代謝性疾病動物模型中的研究。結果顯示，多格列艾汀與口服小分子GLP‑1受體激動劑、甲狀腺激素受體激動劑（THR-β agonist）、泛PPAR激動劑（pan-PPAR agonist）等藥物聯用後可產生協同效應，有望在降糖之外實現減重、調脂、降尿酸、改善胰島素敏感性等多重獲益。其中，華領醫藥通過口頭報告展示了多格列艾汀聯合口服小分子GLP‑1受體激動劑orforglipron的臨床前研究成果，該研究首次在動物模型中證實，GKA與口服小分子GLP‑1受體激動劑的協同作用，為穩態修復+腸促胰素激活的口服聯合方案提供機制與數據支撐。不僅如此，研究結果提示，聯合用藥有望解決臨床應用中影響GLP-1受體激動劑用藥依從性的一大常見難題--胃腸道耐受性問題。該項研究採用hGLP‑1R轉基因伴隨飲食誘導肥胖（DIO）小鼠模型，模擬人類肥胖伴2型糖尿病的病理狀態，經4周每日一次口服給藥，系統評估了單藥與聯合治療在血糖控制、胰島素分泌、體重、血脂及安全性等方面的差異。在藥物機制上，多格列艾汀可修復胰島、肝臟、腸道的GK功能，重塑血糖穩態，提升葡萄糖刺激的胰島素分泌（GSIS），促進內源性GLP‑1分泌；orforglipron則直接激活GLP-1受體，強效減重、降糖、改善血脂，但存在胃腸道不良反應風險。本次壁報展示的研究結果顯示，聯合治療在以下方面存在協同效應：- 協同強效降糖：聯合用藥組呈現協同降糖效應，降糖效果顯著優於單藥，且具有減少兩藥用量的潛力（低劑量聯用可達高劑量單藥效果）；orforglipron還可放大多格列艾汀對β細胞功能與肝臟糖代謝的改善作用。- 顯著提升β細胞功能：多格列艾汀改善DIO小鼠的β細胞功能，聯合用藥後胰島素分泌功能與敏感性呈協同增益，實現更優血糖控制與β細胞保護。- 維持減重獲益與血脂調節獲益：聯合用藥組保留orforglipron的減重效果以及對於血脂的調節獲益。- 安全性與耐受性：聯合用藥整體耐受良好，無新增不良信號；劑量節約可顯著減少噁心、嘔吐等GLP‑1類常見胃腸道反應，提升長期依從性。該研究提示，聯合用藥實現了降糖、減重、調脂三重協同，在顯著降低空腹與餐後血糖的同時，可減少GLP‑1受體激動劑的用量，降低胃腸道不良反應，有望為2型糖尿病合併肥胖患者提供更高效、更耐受，且具備差異化優勢的口服聯合方案。未來，華領醫藥還將進一步開展臨床研究，驗證聯合用藥在人群中的療效與安全性，探索最佳劑量配比與適用人群。華領醫藥還通過壁報展示了另外兩項聯合用藥研究成果：1、在飲食誘導肥胖模型小鼠實驗中，多格列艾汀與THR-β激動劑Resmetirom聯合用藥，在MASLD小鼠模型中，能夠協同改善機體代謝狀態、發揮肝臟保護作用，有效優化血糖管控、調節血脂水平、降低尿酸，减輕肝纖維化病變。此項研究結果表明，多格列艾汀與THR-β激動劑聯合治療方案，對MASLD和T2D具備良好的臨床應用潛力。2、多格列艾汀與pan-PPAR激動劑 Chiglitazar聯合使用，在MASLD合併肥胖糖尿病小鼠模型中，展現出顯著的協同代謝獲益，降糖療效優於單藥治療，同時，可以優化基礎糖代謝水平，提升葡萄糖刺激狀態下的糖分代謝效率。該聯合方案相比單藥治療可更有效改善小鼠糖耐量、降低胰島素抵抗、提升胰島素敏感性與 β 細胞功能，並升高高密度脂蛋白膽固醇水平，證實聯用方案對MASLD相關代謝紊亂具有良好調控潛力，為後續開展臨床研究、探索其在代謝及肝臟疾病領域的治療價值提供了重要臨床前支撐。上述研究共同驗證了多格列艾汀憑藉其恢復代謝穩態的核心優勢，可以與多種靶點藥物形成協同，有望持續拓寬在肥胖、MASLD等泛代謝疾病領域的治療佈局。二、大規模上市後真實世界研究支撐臨床廣泛應用本屆ADA年會上，華領醫藥同時公布了大規模上市後真實世界研究「BLOOM研究」的更多核心數據，研究聚焦多格列艾汀在常規臨床場景中的應用，旨在評估多格列艾汀在各類不同臨床特徵的廣泛2型糖尿病患者中使用的長期安全性與療效。BLOOM研究覆蓋中國80家臨床中心，共納入2024例2型糖尿病患者（其中男性佔62%，平均年齡55.5歲，平均BMI值 25.1，糖尿病病程7.9年，基線HbA1c為7.8%），隨訪週期長達52週，全面評估了多格列艾汀在真實臨床場景中單藥或聯合其他降糖藥治療的長期安全性與有效性。研究人群高度貼近臨床實際，涵蓋不同年齡、病程、基線血糖水平、合併用藥與併發症狀態，包括老年患者、腎功能不全患者、聯用包括胰島素在內的多種降糖藥的複雜患者，結果顯示：- 52週治療期內，無藥物相關嚴重不良事件（SAE），無嚴重低血糖事件，有臨床意義的低血糖發生率低於1%，與3期臨床相比未觀察到新的不良反應；- 經52週治療，患者整體HbA1c較基線顯著下降，血糖達標率（HbA1c<7%）明顯提升；- 在基線HbA1c≥8% 的中重度血糖升高患者中，HbA1c降幅達1.11%，顯示出對血糖控制不佳患者的治療效果；- 無論單藥使用，還是與二甲雙胍、SGLT‑2抑制劑、DPP‑4抑制劑、GLP‑1受體激動劑、胰島素等聯合使用，均觀測到穩健降糖數據。BLOOM研究以大樣本、長週期、多中心真實世界數據，驗證了多格列艾汀在不同2型糖尿病人群及多種治療方案中，均展現出良好的安全性數據與穩定的血糖控制效果，為其在真實世界臨床實踐中的應用提供了有力支持此外，研究者還公布了一項真實世界研究的中期結果。該項前瞻性觀察性研究納入的真實世界255例2型糖尿病（T2D）患者，多數病程久、多藥聯用（含胰島素）治療，目前該研究中已完成6個月隨訪並有基線CGM數據的T2D共有190例，按基線TIR分為三組：TIR≤50%、50%70%，經多格列艾汀治療6個月後評估療效，研究結果如下圖所示：（各組HbA1c水平均有下降，基線TIR≤50%組降幅最高）（基線TIR不達標的兩組TIR水平均獲提升，基線TIR達標組TIR依然可以維持達標）（各組胰島β細胞功能均較前有所增加，但基線TIR≤50%組HOMA-β改善顯著）本研究的6個月中期亞組分析顯示：針對病程久、多藥聯用的真實世界T2D患者，多格列艾汀存在明確的降糖獲益；對於基線TIR差、血糖嚴重失控的患者，用藥後HbA1下降、TIR提升、胰島β細胞功能加強、胰島素抵抗改善，實現整體血糖穩態修復。該研究為複雜T2D患者臨床降糖治療新選擇提供了依據。三、AI深度賦能：構建糖尿病精準分型、預測與診療一體化新體系圍繞葡萄糖激酶（GK）核心機制，華領醫藥將人工智能（AI）、大語言模型（LLM）與臨床大數據深度融合，開發覆蓋療效預測、糖尿病緩解預測、單基因糖尿病分型、醫學智能教育等AI工具。本屆ADA會議，華領醫藥也進行了相關研究的報告- GK Charger智能知識平台：LLM驅動的交互式臨床教育系統。GK Charger是一款基於大語言模型（LLM）開發的AI賦能的醫學教育平台，整合了分子機制、藥理特性、臨床研究、指南共識與真實世界證據，可將葡萄糖激酶相關的複雜科學概念轉化為臨床及患者適用的循證內容。臨床醫生、研究者、患者和普通大衆均可隨時提問，平台可將複雜的科學概念轉化為臨床場景適用、患者易於理解的循證答案。GK Charger為精準醫學教育提供了可擴展的框架，既促進了複雜生物醫學知識的整合與傳播，也為2型糖尿病中GK靶向療法的臨床應用提供了有力支持。- 血糖控制與糖尿病緩解預測模型：個體化治療决策工具基於多格列艾汀臨床研究數據，華領醫藥構建了面向臨床醫生的療效預測模型，可預測患者接受多格列艾汀治療後的HbA1c應答率與糖尿病緩解率等關鍵指標，為2型糖尿病個體化診療與精準醫療提供了全新實用工具，未來隨著數據持續積累將進一步拓展其應用價值。- GK突變AI精準解析系統：加速MODY2精準診斷與用藥指導GK突變是導致MODY2的主要原因，華領醫藥構建了近千個GK突變數據庫，結合蛋白結構分析、蛋白進化模型、AI大語言模型等，開發了GK突變智能解析系統，可在數秒內完成突變位點定位、功能影響判斷、疾病風險評估及對多格列艾汀的應答預測，整體準確率達90%。該工具有望為MODY2快速基因診斷，指導靶向用藥提供依據，提升單基因糖尿病精準診療效率與可及性。此外，華領醫藥還公布了一項創新檢測技術，可直接用於試劑盒開發，為糖尿病短期血糖波動評估、臨床精準檢測提供更可靠、更穩定、更高效的工具。學術榮譽值得注意的是，華領醫藥研究與發現技術部高級總監馮令戈成功斬獲ADA Early Career Abstract Award（青年研究者摘要獎），獲得全球糖尿病研究領域的學界認可。該獎項旨在表彰糖尿病領域處於職業早期、具備突出學術潛力與原創貢獻的優秀研究者，是全球糖尿病學界對青年科學家的重要官方認可。基於其在多格列艾汀研發、AI輔助糖尿病精準治療算法開發等領域的長期積累和努力，此次獲獎不僅體現了華領醫藥相關研究工作的科學質量, 也進一步彰顯了華領醫藥在創新藥物研發、AI賦能糖尿病診療領域的前沿探索得到全球學術界認可，助力中國創新藥研發力量持續走向世界舞台中央。從聯合療法拓寬泛代謝疾病版圖，到真實世界證據築牢長期安全有效，再到AI 驅動精準診療全流程升級與創新檢測技術突破，華領醫藥在本次ADA年會上的系列成果，全方位、多層次、系統性印證了多格列艾汀作為全球首創GKA的機制獨特性、臨床應用廣泛性，不僅具有從「源頭」上治療2型糖尿病的潛力，也有望加速推進多格列艾汀在肥胖、MASLD、MODY2等泛代謝疾病領域，在更廣泛人群、更多代謝疾病中的臨床研究與適應症拓展。【本新聞稿所含信息源自第86屆美國糖尿病協會（ADA）科學年會公開展示的資料。本文旨在概述華領醫藥於該會議上公布的研究進展與創新成果，僅供投資者、分析師及醫療衛生專業人士瞭解科研與企業動態之用。本文件不構成任何投資建議。其中涉及的對未來預期、管綫進展或監管時間表的描述均屬前瞻性陳述，受各類風險及不確定因素影響，實際結果可能與預期存在重大差異。】關於華領華領醫藥（「本公司」）是一家總部位於中國上海的創新藥物研發和商業化公司，在美國、中國香港設立了公司。華領醫藥專注於未被滿足的醫療需求，為全球患者開發全新療法。華領醫藥彙聚全球醫藥行業高素質人才，融合全球創新技術，依託全球優勢資源，研究開發突破性的技術和産品，引領全球糖尿病醫療創新。公司核心産品华堂宁（R）（多格列艾汀片）以葡萄糖傳感器葡萄糖激酶為靶點，提升2型糖尿病患者的葡萄糖敏感性，改善患者血糖穩態失調。2022年9月30日，华堂宁（R）已獲得中國國家藥品監督管理局（NMPA）的上市批准，用於單獨用藥或者與二甲雙胍聯合用藥，治療成人2型糖尿病。對於腎功能不全患者，無需調整劑量，是一款可用於腎功能損傷的2型糖尿病患者的口服降糖藥物。2026年2月，多格列艾汀（商品名：MYHOMSIS（R），華領片（R））獲得中國香港特別行政區政府衛生署藥物辦公室的上市批准。詳情垂詢華領醫藥網址：www.huamedicine.com投資者電郵：ir@huamedicine.com媒體電郵：pr@huamedicine.com Copyright 2026 亞太商訊 via SeaPRwire.com. 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SHANGHAI, Jun 9, 2026 - (ACN Newswire via SeaPRwire.com) - Hua Medicine ("the Company", stock code: 2552.HK) presented a series of breakthrough research findings on dorzagliatin (Trade name: HuaTangNing, Trade name in Hong Kong: MYHOMSIS(R)), the world’s first-in-class glucokinase activator (GKA), at the 86th Scientific Sessions of the American Diabetes Association (ADA). Through oral and poster presentations that demonstrated the breadth and depth of its science, the Company showcased data from its Metabolic Homeostasis Technology Platform, spanning combination therapies, large-scale real-world outcomes, AI-powered precision medicine, and personalized care tools.Collectively, the presentations continued to demonstrate the significance of dorzagliatin’s mechanism of action – restoring glucose homeostasis at its root cause – and its therapeutic potential across a spectrum of complex metabolic diseases including Type 2 diabetes (T2D), Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), obesity, and Maturity-Onset Diabetes of the Young Type 2 (MODY2).The new research findings strengthen Hua Medicine’s position as a global leader in glucose homeostasis research.I. Leveraging Metabolic Homeostasis Platform to Expand Therapeutic Landscape for Metabolic DiseasesDorzagliatin targets glucokinase (GK), the body’s fundamental glucose sensor, by repairing impaired GK function and expression in patients with Type 2 diabetes to enhance glucose sensitivity. Through coordinated multi-organ regulation across the pancreas, liver, and intestines, dorzagliatin fundamentally restores glucose homeostasis and addresses a broad spectrum of metabolic disorders.Building on this unique mechanism, Hua Medicine presented three combination therapy studies in animal models of metabolic disorder at ADA 2026. The data demonstrate that dorzagliatin acts synergistically with oral small molecule GLP-1 receptor agonists, THR-β agonists, and pan-PPAR agonists. It delivers benefits well beyond glycemic control, including weight reduction, lipid modulation, uric acid reduction, and improved insulin sensitivity.In an oral presentation, Hua Medicine reported preclinical findings evaluating dorzagliatin in combination with the oral small molecule GLP-1 receptor agonist orforglipron. In a significant scientific first, this study demonstrated synergies between a GKA and a small molecule GLP-1RA in animal models, providing a mechanistic and clinical rationale for an oral combination regime that pairs homeostasis restoration with incretin activation. Taken together, the dose-sparing effect, where low-dose combinations achieved comparable efficacy to high-dose monotherapy, addresses one of the most common barriers to GLP-1RA adherence in clinical practice: gastrointestinal tolerability.The study used diet-induced obese (DIO) human GLP-1R transgenic mice, which recapitulate human obesity-associated Type 2 diabetes. The 4-week once-daily oral treatment systematically evaluated monotherapy and combination therapy across key efficacy and safety parameters, including glycemic control, insulin secretion, body weight and lipid profiles.In this model, dorzagliatin repairs GK function across the pancreas, liver, and intestines to restore glucose homeostasis, enhance glucose-stimulated insulin secretion (GSIS), and promote endogenous GLP-1 secretion.Orforglipron directly activates GLP-1 receptors to induce robust weight loss, glycemic control, and lipid improvement; although it also carries the risk of adverse gastrointestinal (GI) events.Synergistic Glycemic Control: Combination therapy produced superior glucose-lowering effects versus monotherapy and enabled dose sparing potential, with low-dose combinations achieving efficacy comparable to high-dose monotherapy. Orforglipron amplified dorzagliatin-mediated improvements in β-cell function and hepatic glucose metabolism.Enhanced β-Cell Function: Dorzagliatin improves the β-cell function of DIO mice, and combined treatment synergistically boosted insulin secretion and sensitivity for better glycemic control and β-cell protection.Preserved Weight and Lipid Benefits: The combination fully retained orforglipron-induced weight reduction and lipid-lowering effects.Favorable Safety and Tolerability: The combination was well tolerated with no new safety signals. Dose sparing markedly reduced common GLP-1RA-related GI side effects such as nausea and vomiting, improving long-term adherence.Together, these complementary mechanisms across glycemic control, weight loss, and lipid improvement, position the potential combination as a highly effective, well-tolerated, and differentiated oral option for T2D patients with obesity. Hua Medicine plans to advance clinical studies to evaluate efficacy, safety, optimal dosing, and target patient populations most likely to benefit.Hua Medicine also presented the findings of two additional combination therapy studies in poster presentations:1.Dorzagliatin + Resmetirom (THR-β Agonist): In DIO mice with MASLD, the combination synergistically improved systemic metabolism and exerted hepatoprotective effects, optimizing glycemic control, regulating lipids, reducing uric acid, and alleviating hepatic fibrosis. This supports the clinical potential of dorzagliatin for T2D patients with MASLD.2.Dorzagliatin + Chiglitazar (Pan-PPAR Agonist): The combination of dorzagliatin and the pan-PPAR agonist chiglitazar demonstrates significant synergistic metabolic benefits in DIO mice model of MASLD. The glucose-lowering effect is superior to monotherapy. At the same time, it optimizes basal glucose metabolism and improves glucose disposal following glucose challenge. Compared with monotherapy, this combination regimen more effectively improves glucose tolerance, reduces insulin resistance, enhances insulin sensitivity and β-cell function, and elevates high-density lipoprotein cholesterol levels in mice. These findings underscore the potential of this combination to address metabolic dysregulation in MASLD and provide important preclinical support for subsequent clinical research to explore its therapeutic value in the metabolic and liver diseases.Together, these studies demonstrate that dorzagliatin’s core mechanism of restoring metabolic homeostasis operates synergistically with multiple targeted agents, supporting its therapeutic potential in obesity, MASLD, and other metabolic disorders.II. Large-Scale Post-Marketing Real-World Study (BLOOM) Validates Long-Term Efficacy and SafetyAt ADA 2026, Hua Medicine presented further key results from the BLOOM study, a large-scale post-marketing real-world investigation of dorzagliatin in routine clinical settings.BLOOM aims to evaluate the long-term safety and effectiveness of dorzagliatin in a broad, clinically diverse population of people with Type 2 diabetes. The BLOOM study enrolled 2,024 patients with Type 2 diabetes across 80 clinical centers in China (62% male; mean age 55.5 years; mean BMI 25.1 kg/m²; mean diabetes duration 7.9 years; baseline HbA1c 7.8%) with dorzagliatin treatment and follow-up lasting up to 52 weeks. It evaluated long-term safety and effectiveness of dorzagliatin as monotherapy or in combination with other anti-diabetic agents in real clinical settings, including elderly patients, people with renal impairment, and those on complex multiple-drug regimens including insulin. The study results demonstrated that:During the 52-week treatment period, no drug-related serious adverse events (SAEs) or severe hypoglycemia were reported over 52 weeks. Clinically meaningful hypoglycemia remained <1%, no new adverse events were seen compared with Phase â…¢ clinical trials.After 52 weeks, HbA1c was significantly reduced from baseline, and the proportion of patients achieving HbA1c <7% increased markedly.In patients with moderate-to-severe hyperglycemia (baseline HbA1c ≥8%), HbA1c decreased by 1.11%.Robust glycemic control was observed with dorzagliatin monotherapy and in combination with metformin, SGLT-2i, DPP-4i, GLP-1RA, and insulin.The BLOOM study’s large sample size, long 52-week duration, and multi-center real-world design provide robust evidence of dorzagliatin’s strong safety profile and consistent glycemic control across diverse T2D patients and therapeutic regimens found in real world clinical practice.Hua Medicine also presented interim findings from a real-world prospective observational study enrolling 255 patients with Type 2 diabetes who had baseline continuous glucose monitoring (CGM) data. The majority of patients had long disease duration and were already receiving multi-drug regimens including insulin. Among this population, 190 T2D patients completed the six-month follow-up. The results are shown in the figure below: (HbA1c declined across all subgroups, with the greatest reduction observed in patients whose baseline TIR ≤50%)( TIR increased in the two subgroups with suboptimal baseline TIR, while the group with baseline TIR meeting the target maintained satisfactory TIR levels.)(β-cell function improved in all groups, with a marked elevation in HOMA-β seen in the subgroup with baseline TIR ≤50%)This subgroup analysis of the 6-month interim results indicates that dorzagliatin provides meaningful efficacy in glycemic control among real-world T2D patients that are characterized by long duration of disease and high prevalence of combination therapy with multiple antidiabetic agents, including insulin. Even in patients with severely compromised baseline TIR, clinically meaningful reductions in HbA1c, improved TIR, enhanced β-cell function, and reduced insulin resistance were observed, collectively indicating the restoration of glucose homeostasis.III. Deep Integration of AI Builds an Integrated System for Precision Diabetes Classification, Prediction, and CareBy integrating artificial intelligence (AI), large language models (LLM), and clinical big data around the core GK mechanism, Hua Medicine has developed a full suite of AI tools for efficacy prediction, diabetes remission forecasting, monogenic diabetes classification, and intelligent medical education.1.GK Charger: An LLM-powered interactive medical education platform that integrates molecular mechanisms, pharmacological profiles, clinical studies, guidelines, and real-world evidence. It translates complex GK-related scientific concepts into clinically actionable and non-specialist-friendly evidence-based content for clinicians, researchers, patients, and the public, supporting scalable precision medical education and adoption of GK-targeted therapies.2.Glycemic Control and Diabetes Remission Prediction Models: Clinician-oriented predictive tools built on dorzagliatin clinical data to estimate the probability of HbA1c response and diabetes remission after treatment. These web-based applications support personalized T2D management and precision medicine, with performance expected to improve as data accumulates.3.AI-Powered GK Variant Analysis System: A precision tool for MODY2 built on a database of approximately 1,000 GK variants, combining structural analysis, evolutionary modeling, and LLMs. It delivers 90% accurate predictions of variant location, functional impact, disease association, and dorzagliatin response in seconds, accelerating genetic diagnosis and targeted medication guidance for MODY2.Hua Medicine also introduced a novel ATP-independent enzymatic cycling system for highly efficient glucose removal from biological samples without generating oxidative byproducts or depleting ATP, preserving native metabolome integrity. It enables accurate quantification of 1,5-anhydroglucitol (1,5-AG), a key marker for short-term glycemic variability, supporting reliable and high-throughput precision diabetes testing.Academic RecognitionNotably, Lingge Feng, Senior Director of Research and Discovery Technology at Hua Medicine, was awarded the ADA Early Career Abstract Award, earning recognition from the global diabetes research community. The award honors outstanding early-career investigators in the diabetes field who demonstrate exceptional academic potential and original contributions, representing an important official endorsement from the global diabetes community.With long-standing expertise in dorzagliatin development and AI-enabled precision diabetes therapeutics, this recognition not only reflects the scientific quality of Hua Medicine’s research efforts, but also underscores the growing international academic recognition of Hua Medicine’s cutting-edge work in innovative drug R&D and AI-powered diabetes care, further advancing innovative Chinese pharmaceutical research onto the world stage.From combination therapies expanding metabolic disease indications, to real-world evidence validating long-term safety and efficacy, to AI-driven precision care and breakthrough diagnostic technologies, Hua Medicine’s 2026 ADA data comprehensively validate the mechanistic uniqueness and broad clinical utility of dorzagliatin—the world’s first commercialized GKA. Beyond Type 2 diabetes, these findings are expected to accelerate clinical development and label expansion into obesity, MASLD, MODY2, and other metabolic disorders to benefit broader patient populations.This press release contains information that is in the public domain following presentation(s) at the 86th ADA Scientific Sessions. It is issued for informational purposes to shareholders, investors, analysts and healthcare professionals. Nothing in this release should be construed as investment advice. Where applicable, statements regarding future expectations, pipeline progression or regulatory timelines are forward-looking statements subject to risks and uncertainties — actual results may differ materially.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 30, 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 T2D patients with with renal function impairment. In February 2026, dorzagliatin (Trade name: MYHOMSIS(R)) was approved for marketing by the Pharmaceutical Services of the Department of Health of the Government of the Hong Kong Special Administrative Region of China.For more informationHua MedicineWebsite: www.huamedicine.comInvestors: ir@huamedicine.comMedia: pr@huamedicine.com Copyright 2026 ACN Newswire via SeaPRwire.com. All rights reserved. www.acnnewswire.com

KOSICE, SLOVAKIA, June 9, 2026 - (ACN Newswire via SeaPRwire.com) - The original film by Vlado Zelezňák Jr. has achieved remarkable international success. The new Slovak-Japanese animated sci-fi film Angel & Meow celebrated its World Premiere by winning the prestigious Crystal Pine Award. The film proved its quality against an immense global competition of nearly 1,000 entries from 81 countries. This achievement is particularly notable as the film was produced as a fully independent project by the Slovak company GONG Art Company, led by Vlado Zelezňák Sr.The success took place at the 14th International Sound & Film Music Festival (ISFMF) in Varazdin, Croatia, which ranks among the world’s three most significant festivals dedicated to film music and sound. The gala ceremony was held in the magnificent historic setting of the Croatian National Theatre (HNK Varazdin).In the Company of Oscar Winners and Hollywood Stars The winners were selected by a prestigious international jury consisting of elite professionals—recipients and nominees of Oscar, Emmy, BAFTA, Grammy, and César awards. The jury president for this year was the legendary and respected actor Ciarán Hinds. Widely considered one of the most acclaimed actors of his generation, Hinds is known to audiences for global blockbusters such as Game of Thrones, Harry Potter and the Deathly Hallows, the Oscar-winning drama Belfast, and the animated phenomenon Frozen.Slovak creators stood on stage alongside the world’s absolute elite. Other award-winning personalities at this year’s festival included Hollywood actor Simon Pegg (Mission: Impossible, Star Trek), who received a Lifetime Achievement Award, and Oscar-winning sound designer James Mather (Top Gun: Maverick). The Slovak team shared the spotlight with elite sound professionals from the film Sirât, including Yasmina Praderas (Goya winner and Oscar nominee) and Laia Casanovas (European Film Award and Goya winner).Personal Moments from the Festival Stage The heart and engine of the project is Slovak producer, screenwriter, composer, and sound designer Vlado Zelezňák Jr., who accepted the award directly from the festival directors. During the gala, he experienced unforgettable personal encounters with the world’s biggest film stars."When we stood on stage after the announcement, I expressed my appreciation to the jury president, Ciarán Hinds, for his work. I was delighted that he already recognized our film—he responded immediately with a wide smile by singing the title of our project. It was a pleasant and spontaneous experience," recalls Vlado Zelezňák Jr.The meeting with Hollywood actor Simon Pegg was equally emotional. "I spoke with Simon on the day of the World Premiere, where I had the opportunity to introduce our film to him personally. When we met again on stage the next day during the awards ceremony, it was great to see that he was familiar with Angel & Meowand congratulated me with a smile again. These moments are a huge encouragement for my future work," adds the Slovak creator.The entire event was managed by the festival founders. The gala was hosted by Artistic Director Ozren K. Glaser, who publicly congratulated Vlado Zelezňák Jr. on stage, while Executive Director Marijana Glaser ceremoniously presented the Crystal Pine Award. "Our huge thanks go to the three main organizers from the Glaser family—Marijana, Ozren, and producer Zeljko Glaser. I would like to express my appreciation for their excellent, professional organization and for building a festival of a truly Hollywood standard, where one felt like they were at the Oscars from the very first moment," concludes Vlado Zelezňák Jr.A World Premiere of Visual Poetry Before an Elite Audience The World Premiere of Angel & Meow, held on May 22 at CineStar Varazdin, played to a fully packed theater. The audience consisted of an elite group of nominated composers, sound designers, and filmmakers from around the world. The premiere was attended in person by living legends of the film industry, such as Oscar-winning sound mixer Mark Ulano (Titanic, Inglourious Basterds), as well as singer and producer Kathy Kelly from the legendary group The Kelly Family.In addition to high-quality animation and visuals, the international jury praised the film’s powerful sound design, original score, and the overall story, all created by Vlado Zelezňák Jr. The visual and animation components were crafted by a top-tier Japanese team in Tokyo, led by director and lead animator Clemhyn Escosora from Adarnia studio (a subsidiary of Fuji Corp.).Global Sound Design and a Soundtrack as a Narrator Since the story relies on the pure power of image and sound, the meticulously designed sound and film music step into the spotlight, taking on the role of the primary narrator alongside the animation. The resulting soundtrack is exceptionally rich, varied, and intense."The sound design was created all over the world. While atmospheric sounds were recorded directly on the streets and coast of Cannes, the orchestral and electronic music was composed in studios in Slovakia. To achieve absolute authenticity, we recorded live animals and constantly experimented with sound," explains Vlado Zelezňák Jr. Over the 15-minute runtime, the viewer experiences diverse musical landscapes—from massive orchestral passages and intimate piano and guitar moments to pure sci-fi sounds of analog Moog synthesizers and wind instruments.Sound in the Hands of a Living Legend The final sound mastering was handled in the USA by an absolute legend in the field—Vlado Meller, in his prestigious American studio. Throughout his rich career, he has collaborated with icons such as Céline Dion, Andrea Bocelli, and the Red Hot Chili Peppers. Meller recently exclusively finished Dolby Atmos mastering for Michael Jackson’s legendary albums for Sony USA, released in conjunction with the recently unveiled biographical film hit Michael.Angel & Meow has shown from the very start that independent Slovak production from the GONG Art Company workshop, combined with an original script, film music, and sound design, can successfully stand its ground on the international stage against the world's biggest productions.About GONG Art Company30 Years of Creativity and Innovation GONG Art Company is an established pillar of the Slovak audiovisual scene with a nearly 30-year history. The company is renowned for its long-standing technological and creative co-production work with Slovak National Television and Radio, providing comprehensive music production for iconic projects such as Hviezdička and Zlatá brána. The company has been awarded multiple Gold and Platinum records for its music production and children's audio titles.Today, GONG operates as a modern production house focused on international film co-productions. The company manages its own film projects, with in-house recording studios dedicated to film scoring and sound design. This infrastructure allows for simultaneous production across multiple works—while the soundtrack for Angel & Meow was being composed in one studio, another was handling sound post-production for the documentary Man from the Mountain, which is also heading to international film festivals this year.GONG is also the founder of the global platform FMC (Film Music Contest & Festival), which connects elites from Hollywood and Netflix with global talent. The team regularly participates in key industry markets such as Cannes (Marché du Film), Annecy (MIFA), and Berlinale (EFM), building on a tradition of high-quality original work with the ambition to succeed in the global market.More information: www.angelandmeow.com Media Contact: Mgr. Vlado Zelezňák JR. Phone: +421 911 789 888 Email: press@angelandmeow.com Facebook: https://www.facebook.com/angelandmeowmovie/ Instagram: https://www.instagram.com/angelandmeowmovie/  Copyright 2026 ACN Newswire via SeaPRwire.com. All rights reserved. www.acnnewswire.com