日期: 2025年12月2日

ANKARA, Turkey, Dec 2, 2025 - (ACN Newswire via SeaPRwire.com) - GEN Pharmaceuticals (GENIL.IS), Türkiye's leading specialty pharmaceutical company, has announced new positive results from its Phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetics (PK) of first-in-class, novel orally administered mitochondria-directed drug candidate SUL-238 in healthy elderly volunteers. The findings were presented at the 18th Clinical Trials on Alzheimer's Disease (CTAD) in San Diego, CA (United States) today.SUL-238 was originally discovered by Sulfateq and has since been further developed through a collaborative effort of Sulfateq and GEN as a novel therapeutic in neurodegenerative diseases.This Phase 1 randomized, double-blind, placebo-controlled study evaluated the safety, tolerability, and pharmacokinetics (PK) after multiple-ascending doses (MAD) of orally administered SUL-238 in healthy elderly men and women (aged ≥40 years). The study included two cohorts with a treatment period of 14 days and a safety follow-up through 14 days after the last dose. 15 healthy adults in each cohort were randomized in a 2:1 ratio to receive SUL-238 or placebo. Total daily dose of SUL-238 was 4000 mg (2000 mg b.i.d., first cohort) or 4500 mg (1500 mg t.i.d., second cohort). SUL-238 demonstrated an excellent safety and tolerability profile after multiple doses in both cohorts, while demonstrating a favourable PK profile and a high cerebrospinal fluid (CSF) penetration, making it a promising candidate for further clinical development in neurodegenerative diseases, including Alzheimer's and Parkinson's diseases.Key Findings:Safety in both cohorts:No clinically significant changes were observed in physical and neurological exams, vital signs, ECG, and clinical laboratory parameters.AE rates were comparable between participants receiving SUL-238 and placebo.All AEs were of mild intensity or considered not related to SUL-238.First cohort PK (2000 mg b.i.d.):SUL-238 was rapidly absorbed with a mean time to maximum plasma concentration (Tmax) reached at 1.25(±0.54) and 1.50(±0.53) hours on day 1 and day 14, respectively.Mean terminal elimination half-life (t1/2) was3.50(±1.06) hours on day 14.Mean trough plasma concentration of SUL-238 was 39.23(±24.31) ng/mL and 41.49(±18.20) ng/mL on day 8 and day 14, respectively.Second cohort PK (1500 mg t.i.d.):SUL-238 was rapidly absorbed, with a mean time to maximum plasma concentration (Tmax) reached at 0.95(±0.16) and 1.00(±0.00) hours on day 1 and day 14, respectively.Mean terminal elimination half-life (t1/2):3.74(±1.84) hours on day 14.Mean trough plasma concentration of SUL-238 was 57.98(±31.08) and 60.63(±64.14) ng/mL on day 8 and day 14, respectively.Abidin Gülmüş, Chairman of GEN, stated:"We're greatly motivated by these new positive results of SUL-238 in our Phase 1 trial, which mark a key advance toward addressing Alzheimer's disease at its biological foundation."Nadir Ulu, MD, PhD, Vice President of R&D at GEN, added:"With its excellent safety and PK profile in this Multiple Ascending Dose Phase 1 trial, SUL-238 continues to represent a very strong drug candidate for further clinical development aimed at meeting the critical unmet needs in neurodegenerative diseases, including Alzheimer's disease.About SUL-238SUL-238 is a novel, first-in-class, hibernation-derived small molecule designed to target mitochondria, the 'powerhouse' of the cell. SUL-238 supports mitochondrial bioenergetics via complex I/IV activation and enhances mitochondrial function in various preclinical models for neurodegenerative, cardiovascular, and renal diseases, as well as in accelerated aging. SUL-238 exhibits the capability to cross the blood-brain barrier and has undergone extensive safety evaluation in preclinical and clinical Phase 1 studies. GEN licenses SUL-238 from Sulfateq B.V. for neurodegenerative disease applications.About GEN:Founded in 1998, GEN is Türkiye's leading specialty pharmaceutical company, focused on developing innovative therapies across multiple therapeutic areas. Through significant R&D investments and global collaborations, GEN is committed to advancing healthcare worldwide. The company develops and manufactures high-quality, competitive products at its GMP-certified production facility and continues its bold efforts in original drug development via two dedicated R&D centers.About Sulfateq:Sulfateq B.V. is an early-stage Dutch biotech company that fosters strategic collaborations with academic and industrial research centres to accelerate the development of innovative new medicines. It has developed a novel class of small molecules, the SUL-compounds, that maintain mitochondrial health.For more information:www.genilac.com.trwww.sulfateqbv.comContact InformationBulutay GüneşSr. Head of Corporate Brandb.gunes@genilac.comFatih GörenInvestor Relations Managerf.goren@genilac.comSOURCE: GEN İlaç ve Sağlık Ürünleri A.Ş. Copyright 2025 ACN Newswire via SeaPRwire.com. All rights reserved. www.acnnewswire.com

安卡拉，土耳其, 2025年12月2日 - (亚太商讯 via SeaPRwire.com) - 土耳其领先的专科制药公司GEN Pharmaceuticals（GENIL.IS）宣布，其针对首创口服线粒体靶向药物候选物 SUL-238 的安全性、耐受性和药代动力学（PK）的 I 期临床试验在健康老年志愿者中取得新的积极结果。该研究成果于今日在美国加利福尼亚州圣地亚哥举行的第 18 届阿尔茨海默病临床试验大会（CTAD）上公布。SUL-238 最初由 Sulfateq 公司发现，随后通过 Sulfateq 与 GEN 的合作研发，成为治疗神经退行性疾病的新型药物。这项 I 期随机、双盲、安慰剂对照研究评估了健康老年男性和女性（≥40 岁）口服 SUL-238 进行多次递增剂量（MAD）后的安全性、耐受性和药代动力学（PK）。研究包含两个队列，治疗期为 14 天，并在最后一次给药后进行为期 14 天的安全性随访。每个队列的 15 名健康成人按 2:1 比例随机分配接受 SUL-238 或安慰剂。SUL-238 每日总剂量为4000 mg（首组：2000 mg，每日两次）或 4500 mg（次组：1500 mg，每日三次）。在两组受试者中，SUL-238 经多次给药后均表现出优异的安全性和耐受性，同时具有良好的药代动力学特征和高脑脊液（CSF）渗透性，使其成为阿尔茨海默病和帕金森病等神经退行性疾病进一步临床开发的潜在候选药物。主要发现：两组安全性：体格检查、神经系统检查、生命体征、心电图及临床实验室参数均未见临床显著变化。SUL-238 组与安慰剂组不良事件发生率相当。所有不良事件均为轻度或与 SUL-238 无关。第一组药代动力学（2000 mg b.i.d.）：SUL-238 吸收迅速，第 1 天和第 14 天达到血浆峰浓度（Tmax）的平均时间分别为 1.25(±0.54)小时和 1.50(±0.53)小时。第 14 天平均终末消除半衰期(t1/2)为 3.50(±1.06)小时。第 8 天和第 14 天 SUL-238 平均谷浓度分别为 39.23(±24.31) ng/mL 和41.49(±18.20) ng/mL。第二组药代动力学（1500 mg t.i.d.）：SUL-238 吸收迅速，平均血浆峰浓度达峰时间（Tmax）分别为第 1 天 0.95(±0.16)小时和第 14 天 1.00(±0.00)小时。第 14 天平均终末消除半衰期(t1/2)：3.74(±1.84)小时。第 8 天和第 14 天 SUL-238 平均谷浓度分别为 57.98(±31.08)和 60.63(±64.14)ng/mLGEN 董事长 Abidin Gülmüş 表示：“SUL-238 在 I 期临床试验中取得的新成果令人振奋，这标志着我们朝着从生物学根源治疗阿尔茨海默病迈出了关键 ”一步。GEN 研发副总裁 Nadir Ulu 医学博士补充道：“在本次多剂量递增 I 期试验中，SUL-238 展现出卓越的安全性和药代动力学特征，继续成为极具潜力的候选药物，有望满足包括阿尔茨海默病在内的神经退行性疾病领域亟待解决的关键 ”需求。关于 SUL-238SUL-238 是一种创新的首创冬眠衍生物小分子药物，旨在靶向细 “ ”——胞的 能量工厂 线粒体。该药物通过激活复合物 I/IV 支持线粒体生物能代谢，并在多种神经退行性疾病、心血管疾病、肾脏疾病及加速衰老的临床前模型中增强线粒体功能。SUL-238 具有穿透血脑屏障的能力，已在临床前和临床 I 期研究中经过全面的安全性评估。GEN 从 Sulfateq B.V.获得 SUL-238 的神经退行性疾病应用许可。关于 GEN：GEN 成立于 1998 年，是土耳其领先的专科制药企业，专注于多个治疗领域的创新疗法研发。通过重大研发投入和全球合作，GEN 致力于推动全球医疗健康事业发展。公司在GMP 认证的生产基地开发制造高品质、具竞争力的产品，并通过两个专业研发中心持续推进原创药物研发工作。关于 Sulfateq：Sulfateq B.V.是一家荷兰早期生物技术公司，致力于与学术及工业研究机构建立战略合作，加速创新药物的研发进程。该公司开发了一类新型小分子化合物——SUL 化合物，可维持线粒体健康。更多信息：www.genilac.com.trwww.sulfateqbv.com 联系方式Bulutay Güneş企业品牌高级主管b.gunes@genilac.comFatih Gören投资者关系经理f.goren@genilac.com来源：GEN 制药与健康产品股份有限公司 Copyright 2025 亚太商讯 via SeaPRwire.com. All rights reserved. www.acnnewswire.com

Partnership drives clinical research, hands-on student training, and access to cutting-edge medical technologiesPETALING JAYA, Malaysia, Dec 2, 2025 - (JCN Newswire via SeaPRwire.com) - AdipoLABs Co., Ltd. and Red & Blue Co., Ltd. from Korea, together with their Malaysian subsidiary, AdipoLABs Healthcare (M) Sdn Bhd, today officially opened the new AdipoLABs regional office for Asia-Pacific, marking a strategic expansion to strengthen its leadership in non- invasive healthcare and build a robust MedTech ecosystem in Malaysia and across ASEAN.As a research and development-focused medical company, its presence is expected to drive knowledge transfer, foster R&D collaboration, provide industry-standard training, and enhance the country’s preventive healthcare capabilities. Tocommemorate this milestone, the company also signed two Memoranda of Understanding (MoUs) with the University of Cyberjaya (UoC), formalising a partnership to advance healthcare innovation, clinical research, and talent development.“By uniting our hyperthermia technology with local expertise and academic rigour, we’ll expedite the adoption of advanced solutions and improve patient outcomes worldwide. We envision this collaboration as a blueprint for international healthcare partnerships,” said Mr. Han Sung-ho, CEO of AdipoLABs Co., Ltd.A cornerstone of the first MoU is a comprehensive internship programme with UoC’s Physiotherapy programmes under the Faculty of Health, offering six-month placements and potential job opportunities to give students invaluable real-world experience. Students from the Faculty of Health will gain hands-on expertise with AdipoLABs’ Pain Bot device, enhancingtheir skills in pain detection and treatment, while students from the School of Biomedical Engineering will support AdipoLABs’ technical operations, strengthening after-sales service and device maintenance.As part of the partnership, AdipoLABs will implement a strategic client engagement initiative, where interns may be placed at client facilities to demonstrate device effectiveness and provide on-site support. This initiative highlights the interns’ value, encourages potential permanent employment, and ensures optimal use of the technology. The collaboration also extends to clinical research, with UoC professors and students conducting studies on various AdipoLABs medical devices, generating evidence-based insights to be published in reputable journals and scientifically validating the technologies.“We’re thrilled to collaborate with the University of Cyberjaya to cultivate local talent and drive Malaysian healthcareinnovation. This partnership offers UoC students invaluable hands-on experience with technologies like Pain Bot. It also expands our clinical research, enhancing pain management solutions for patients across Malaysia and ASEAN. We are dedicated to empowering future healthcare leaders,” said Dr. Isaac R. Joseph, Director of AdipoLABs Healthcare (M) Sdn Bhd.In a parallel effort to advance physiotherapy education, AdipoLABs Malaysia, Red & Blue Co., Ltd., and UoC signed a second MoU focused on knowledge transfer and medical device donation. Under this agreement, AdipoLABs Malaysia willdonate a Pain Bot unit to UoC, giving students access to cutting-edge pain detection and treatment technology and enhancing their knowledge and skills in innovative musculoskeletal pain management methods.AdipoLABs, a Ministry of Health (MOH)-registered medical-device establishment under the Medical Device Authority(MDA), anchors this collaboration with proven regulatory credibility and a strong commitment to quality and innovation. Their certified standing reinforces UoC’s ambition to accelerate evidence-based research and industry-ready healthcare solutions.“AdipoLABs’ partnership with the University of Cyberjaya is more than a collaboration, it is a direct investment in the next generation of healthcare professionals. With the introduction of advanced rehabilitative technologies, our students gain access to international-standard tools and real-world innovation that will shape their confidence, competence, and future careers,” said Professor Dr. David Whitford, Vice-Chancellor of the University of Cyberjaya.Further strengthening this collaboration, Professor Dr. Yoo Seung-mo from South Korea, the inventor of the Pain Bot, will serve as an Adjunct Professor at UoC. Dr. Yoo will provide on-site training and ongoing remote mentorship, ensuringstudents receive the highest level of expertise in utilising the Pain Bot technology and applying advanced pain detection and treatment techniques.Together, UoC and AdipoLABs are positioned to drive forward Malaysia’s healthcare innovation agenda with greater confidence and impact.For more information on University of Cyberjaya or AdipoLABs Healthcare (M) Sdn Bhd, kindly visit: University of Cyberjaya – Premier University in Malaysia or adipolabs-msia.com – AdipoLABs Healthcare MalaysiaABOUT UNIVERSITY OF CYBERJAYA (UOC)The University of Cyberjaya is a premier institution located in Malaysia's first smart city, offering a transformative educational experience on a state-of-the-art, eco-friendly campus. The University was recently ranked in the top 1,000 universities in the world under the QSWorld University Rankings and is also currently ranked top 450 under the QS Asia University Rankings 2026.The University is renowned for its excellence in medicine, teaching, employability, facilities, and social responsibility. Additionally, itholds a Top 601+ ranking in the Times Higher Education Sustainability Impact Rankings, excelling in Top 200 for Good Health and Well-being (SDG 3).Founded in 2005 with a focus on medicine and pharmacy, the University has expanded to offer over 50 programmes across diverse fields such as medicine, health sciences, nursing, pharmaceutical sciences, psychology, business, and biomedical engineering. With a globalcommunity of over 10,000 students and over 13,000 alumni, the University is shaping future leaders who are making significant contributions to various industries. The University’ impact is reflected in its graduates, who have contributed to innovations in healthcareduring the COVID-19 pandemic, participated in international humanitarian missions, and made significant advancements across industries such as business and biomedical engineering.The University is guided by Chancellor Tan Sri Dato' Seri Dr. Noor Hisham Abdullah, a prominent figure in global healthcarefor World Health Organization (WHO) initiatives and former Director-General of the Malaysian Ministry of Health. Chairman Professor Tan Sri Dato' Dr. Mohd Amin Jalaludin, former Vice-Chancellor of the University of Malaya, provides strategic governance as Chairman of the Board of Governors. Under the leadership of Vice Chancellor Professor Dr. David Whitford, the University is strengthening itsglobal outlook and academic excellence. The university can be contacted at +603 8313 7000.About AdipoLABs Co., Ltd.AdipoLABs Co., Ltd. is a South Korean medical device company specialising in innovative hyperthermia cancer treatment technology. The company is the manufacturer of the Remission 1℃, a high-frequency hyperthermia device used in hospitals worldwide as an adjunct therapy for cancer treatment. With a commitment to research and development, AdipoLABs strives to improve patient outcomes andcontribute to a future free from the burden of disease. AdipoLABs has a global presence, with branches in India, China, and Malaysia.About AdipoLABs Healthcare (M) Sdn BhdAdipoLABs Healthcare (M) Sdn Bhd, established in Malaysia in 2018, is a subsidiary of AdipoLABs Co., Ltd. As the sole distributor of AdipoLABs medical devices in Malaysia and authorised representative for sales, marketing, and after-sales service throughout the ASEAN region, the company is committed to bringing innovative, non-invasive medical devices and innovative solutions to the Southeast Asian market. The company works closely with an international team of researchers, doctors, lab technicians, and engineers toprovide cutting-edge healthcare technology to the ASEAN market. Dr. Isaac R. Joseph and Mr. Moses Balagopal are the Directors and Co-founders of AdipoLABs Healthcare (M) Sdn Bhd.About Red & Blue Co., Ltd.Red & Blue Co., Ltd. is a South Korean company specialising in the development and distribution of advanced medical devices andhealthcare solutions. As a key partner of AdipoLABs Co., Ltd., Red & Blue Co., Ltd. is committed to supporting education and traininginitiatives that promote the effective use of innovative pain detection and pain treatment techniques. Dr. Yoo works closely with healthcare professionals and academic institutions to advance the field of pain management and improve patient outcomes.Issued by MNAIR PR Consultancy Sdn Bhd on behalf of University of Cyberjaya and AdipoLABs Healthcare (M) Sdn Bhd Contacts for Media Enquiries:MNAIR PR Consultancy Sdn Bhd Ameera HaniAssociate Director, Public Relations+6014 2243296ameera@mnairpr.comUniversity of Cyberjaya (UoC) Ehya NadzeriCommunicationsCyberjaya Education Group Berhad gcmc@cyberjaya.edu.my Copyright 2025 ACN Newswire via SeaPRwire.com. All rights reserved. www.acnnewswire.com

香港, 2025年12月2日 - (亚太商訊) - 试验数据再次验证，HTD1801靶向2型糖尿病发生及发展的根源性问题，实现更全面的心血管代谢综合获益。君圣泰医药（股票代码：2511.HK），一家专注于开发多功能创新疗法，以解决代谢性慢病未满足临床需求的创新药公司，宣布HTD1801在2型糖尿病（T2DM）患者中开展的与达格列净头对头的临床III期试验（HARMONY）取得了积极的结果，试验达到主要终点，并在多项关键心血管代谢指标的改善上优于达格列净。HARMONY（NCT06415773）是一项随机、双盲、阳性药物对照的III期临床研究（N=369），旨在评估HTD1801与达格列净相比，在二甲双胍治疗后血糖控制不佳的成年T2DM患者中的有效性与安全性。研究的主要终点为：治疗24周后HbA1c相对于基线的变化（非劣效界值为0.4%）。次要终点包括多项心血管代谢指标。- 达成主要终点：HTD1801治疗24周后，HbA1c的最小二乘（LS）均值变化为-1.12%，达格列净组为-0.93%（LS均值差异：-0.20%；95% CI：-0.37 ~ -0.03；P < 0.001）。- 达成多项次要终点：相较达格列净，HTD1801在LDL-C与non-HDL-C降低方面明显更优，需要新增或强化他汀类治疗的患者比例也显著低于达格列净组。HTD1801还在多个心血管代谢指标的改善上优于达格列净，如治疗后有更高比例的患者达到HbA1c<7.0%的控制目标，以及更大的Lp(a)降幅。- HTD1801具有良好的安全性与耐受性，严重不良事件的发生率为3.8%（达格列净组为4.4%）。HTD1801组最常见的不良事件为轻至中度胃肠道不良反应，且未见严重低血糖事件。综合而言，相较于SGLT2抑制剂，HTD1801通过同时调控代谢与炎症通路，更精准地靶向T2DM的核心病理机制，可为T2DM患者带来更为全面的临床获益。继 SYMPHONY-1和SYMPHONY-2试验之后，HARMONY是HTD1801第三项取得积极结果的III期试验，进一步验证了其成为心肾代谢疾病（CKM）基础治疗药物的强大潜力。君圣泰医药计划于今年内启动HTD1801项目的新药上市申请（NDA）。该临床试验的主要研究者，前国际糖尿病联盟（IDF）副主席、北京大学糖尿病中心主任、北京大学人民医院内分泌和代谢科主任纪立农教授指出："HARMONY研究数据显示HTD1801降糖效果优于降糖药物SGLT2抑制剂达格列净，同时比具有已经被证明有显著心肾保护作用的达格列净有更强的降低导致动脉粥样硬化性心血管的低密度脂蛋白的作用，并减少他汀类药物的治疗需求。这提示HTD1801 可能具有更强的改善动脉粥样硬化性心血管疾病的潜力。我们非常期待该药物上市，使这项创新疗法惠及患者。"君圣泰医药的创始人、董事长兼首席执行官刘利平博士表示："HARMONY研究数据读出是HTD1801全球开发进程中的又一项关键里程碑。随着三项III期临床试验的相继成功完成，作为全球首创且兼具"一药多效"特性的创新药物，HTD1801持续展现其治疗潜力，有望补充甚至突破SGLT2抑制剂的治疗边界，为T2DM患者提供更全面的治疗方案。"关于HTD1801HTD1801是一款全球首创的新分子实体，旨在解决心肾代谢系统疾病（CKM）的未满足临床需求。HTD1801作为单一分子，是具有独特双机制的口服抗炎及代谢调节剂（AIMM），通过激活AMPK及抑制NLRP3炎症小体发挥其生物学活性；这种互补协同的双机制作用可有效解决代谢问题。全球多项临床结果验证HTD1801具有"一药多效"的特性，能够为患者带来综合获益，包括改善胰岛素敏感性、血糖控制、血脂降低、肾脏保护、体重减轻、肝脏获益及抗炎等。基于此，HTD1801有潜力成为CKM领域的基础性治疗药物。 Copyright 2025 亚太商讯 via SeaPRwire.com. All rights reserved. www.acnnewswire.com