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CONSHOHOCKEN, Pa., Jan. 12, 2026 /PRNewswire/ -- Suvoda, a clinical trial technology company, took decisive steps in 2025 toward a more connected and streamlined clinical trial experience for both patients and sites. The company's merger with Greenphire marked a pivotal moment in that journey, strengthening Suvoda's ability to tackle persistent trial operational challenges with a more unified approach. Together with continued product innovation and deployment of AI tools, Suvoda closed the year with growing momentum toward a single, cohesive ecosystem that reduces complexity across the clinical trial lifecycle. "The last twelve months marked an important step forward for Suvoda," said Jagath Wanninayake, CEO of Suvoda. "Our teams worked with care and intention as we brought two strong companies together and delivered new capabilities that reflect what patients and sites actually need. As we enter 2026, we're focused on helping sponsors and sites navigate their trials with clarity while giving patients a smoother, more supportive experience." Making the patient journey easier A defining milestone of the year was the launch of Suvoda's patient app, a clear demonstration of how a unified platform can meaningfully improve the clinical trial experience for patients. The app brings eCOA questionnaires, patient payments, reminders, and visit scheduling into one consumer-grade interface that patients can use on their own devices. This advancement helps participants stay engaged while easing the administrative load for busy sites. Harnessing AI to alleviate administrative burden in clinical trials Suvoda also simplified how study teams access critical information with Sofia, an AI assistant currently deployed in Suvoda IRT with platform expansion in the future. Sofia helps users ask questions and get answers with a generative AI tool, replacing multi-step navigation with quick, clear responses. Built with strong privacy and role-based controls, Sofia supports everyday decision making for study teams without compromising data security or the integrity of the study blind. Recognized for innovation Suvoda's approach earned continued recognition in 2025, including a new patent for its platform architecture, bringing its total to five. Everest Group also named Suvoda a Leader in its RTSM PEAK Matrix® assessment. Across its portfolio, Suvoda released enhancements that improve transparency, data quality, and ease of use, reflecting its ongoing focus on practical innovation that supports real-world trial operations. Positioned for continued growth in 2026 The company anticipates continuing its strong growth in 2026 as pharmaceutical sponsors and CROs increasingly look for unified platforms that reduce trial complexity while supporting exceptional patient and site experiences. "We spent 2025 not only merging two companies, but unifying our technologies, our people, and our mission," Wanninayake said. "That foundation positions us to deliver even greater value in 2026 and beyond. We're ready to support sponsors and sites to meet more of their clinical trial needs and help patients move through their studies with ease and confidence." About Suvoda Suvoda is a global clinical trial technology company with a market-leading, real-time software platform that empowers sponsors and CROs to make confident decisions and sites and patients to take calm, controlled action. Suvoda delivers interconnected, action-driven software solutions and industry-leading services and support, so that even in the most time-sensitive, mission-critical moments, life-changing studies keep moving forward. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest and Iasi, Romania, and Tokyo, Japan. The company maintains customer satisfaction scores that consistently exceed the technology industry average, contributing to the company being selected by trial sponsors and CROs to support more than 2000 trials across more than 95 countries. Suvoda recently merged with Greenphire, a leading provider of clinical trial financial management and patient support tools. To learn more, visit suvoda.com and follow Suvoda on LinkedIn. CONTACT: Robin Abadía Director, External Communications marketing@suvoda.com Logo - https://mma.prnasia.com/media2/1759317/Suvoda_updated_Logo.jpg?p=medium600
The breakthrough tackles a longstanding challenge in genetic medicine with the goal of developing a new generation of curative cell and gene therapies. Developed in collaboration with NVIDIA by training the largest evolutionary AI models on a new, globally collected dataset, accelerated by NVIDIA BioNeMo. The same versatile model also helped design novel antimicrobial peptide molecules with a 97% lab-confirmed success rate, including candidates that appeared highly potent against multidrug-resistant "superbugs." Basecamp Research also adds NVentures as an investor ahead of Series C round following deep technical collaboration on EDEN models. LONDON and CAMBRIDGE, Mass., Jan. 12, 2026 /PRNewswire/ -- Basecamp Research, a frontier AI lab harnessing evolution to design new medicines, today announced the first AI models capable of programmable gene insertion, offering a new way to replace faulty genes and reprogram cells for therapeutic use. Trained in collaboration with NVIDIA, these models are driving the development of a new generation of treatments for cancer and inherited diseases. In parallel, Basecamp Research secured an investment from NVentures (NVIDIA's venture capital arm) in its pre-Series C round following years of close technical collaboration, which will help the company to accelerate its research and development efforts. "We believe we are at the start of a major expansion of what's possible for patients with cancer and genetic disease," said John Finn, Chief Scientific Officer at Basecamp Research. "By using AI to design the therapeutic enzyme, we hope to accelerate the development of cures for thousands of untreatable diseases, potentially transforming millions of lives." Programmable Gene Insertion Programmable gene insertion - placing large therapeutic DNA sequences at precise locations in the human genome - has been a central goal in genetic medicine for decades. Existing CRISPR-based approaches can only make small edits and must damage DNA to do so, limiting where and how they can be used. Basecamp Research is the first to demonstrate that AI can design enzymes capable of performing large gene insertion at defined sites in the human genome, opening a long-sought path toward programmable therapies. Basecamp Research's AI-Programmable Gene Insertion (aiPGI™) platform is powered by EDEN, a new family of evolutionary AI models developed with NVIDIA, trained on BaseData™, the company's proprietary genomics dataset - the largest of its kind. The models learn the language of DNA and patterns of evolution, allowing the algorithms to design new, programmable therapies for cancer and genetic disease. In lab results published today in a paper co-authored by NVIDIA, Microsoft and leading academics, [link], the EDEN models designed multiple active insertion proteins for 100% of tested disease-relevant target sites in the human genome, requiring only the genomic target site as a prompt and marking a significant step forward in AI model capability. Basecamp Research has already demonstrated insertion at over 10,000 disease-related locations in the human genome, including therapeutically relevant integration of cancer-fighting DNA into primary human T cells at novel safe-harbour sites. This produced CAR-T cells that show strong killing of cancer cells, showing over 90% tumour-cell clearance in laboratory assays. AI-Designed Molecules To Fight "Superbugs" In another key frontier therapeutic design task targeting the global drug-resistance crisis, the same model proved its versatility by designing a focused library of novel antimicrobial peptides (AMPs) – small proteins with the potential to kill harmful bacteria – with 97% of candidates demonstrating confirmed activity in laboratory tests. In a collaboration with University of Pennsylvania scientists led by Prof. César de la Fuente, the top-performing AMPs showed high potency against critical-priority, multidrug-resistant pathogens, offering a powerful new tool in the fight against dangerous "superbugs." Breakthrough powered by unique data & frontier AI models The EDEN models that power aiPGI™ were trained on over 10 trillion tokens of evolutionary DNA from more than one million newly-discovered species. This data was collected over five years from over 150 locations across 28 countries and five continents as part of a novel data collection strategy pioneered by the company, published in June 2025. The largest EDEN model was trained on 1.95x1024 FLOPS of compute on a cluster of 1,008 NVIDIA Hopper GPUs and accelerated with libraries from NVIDIA BioNeMo, making it comparable in scale to GPT-4 class models and placing it among the most computationally intensive biological models ever reported. Therapeutic assets in development These capabilities underpin Basecamp Research's emerging pipeline of cell and gene therapies, opening the path to treatments that are more precise, predictable and personalised than those available today. The company's goal is to develop potentially curative therapies across a range of cancer and genetic disease indications, powered by continued improvements to BaseData™, the EDEN models and aiPGI™. About Basecamp ResearchBasecamp Research is dedicated to solving major challenges in the life sciences by exploring Beyond Known Biology™. The company builds frontier AI models using BaseData, the world's largest ethically-sourced and globally representative biological dataset. Basecamp Research collects and curates its own biological data through partnerships with more than 152 organizations in 28 countries, giving its AI access to genetic diversity that doesn't exist for models trained on public database sources. This allows Basecamp Research to design novel protein sequences and biological systems that can accelerate therapeutic research and development. Basecamp Research partners with biopharma companies and academic institutions worldwide, and its work has been recognized with honors including Fast Company's Top 10 Most Innovative Companies in Biotech and the FT-backed Sifted AI100 list of Europe's leading AI startups. Learn more at basecamp-research.com.BaseData™, Beyond Known Biology™, EDEN-GLM™ and aiPGI™ are brand names and technologies of Basecamp Research.
Real-world data analysis suggests that families with at least one member using Novo Nordisk's GLP‑1 RA for weight management tend to reduce spending on alcohol and cigarettes. JAKARTA, Indonesia, Jan. 12, 2026 /PRNewswire/ -- At the international scientific congress ObesityWeek® held late last year in Atlanta, United States, Novo Nordisk presented findings from a real-world analysis of grocery spending data from more than 200,000 households.[1] The analysis found that households with at least one person using Novo Nordisk's GLP‑1 RA for weight management showed a year-on-year reduction in overall grocery spending compared with households not using similar medicines—most notably in purchases of alcohol and tobacco/cigarette products. These findings indicate a potential association between the use of Novo Nordisk's GLP‑1 medicine for weight management and reduced alcohol and tobacco consumption at the household level. In Indonesia, obesity is becoming an increasingly concerning health issue. Based on the latest national health survey, the number of adults living with obesity and excess abdominal fat continues to rise. In simple terms, it is currently estimated that around 1 in 4 adults in Indonesia live with obesity or carry excess fat around the waist. Obesity is not just about appearance—people living with obesity face a higher risk of type 2 diabetes, high blood pressure, heart disease, stroke, and joint pain, which can affect quality of life and increase the financial burden on families. In this analysis, researchers assessed household spending data on daily groceries across two 12‑month periods. Data were collected through recurring surveys between April 2024 and April 2025 from a large consumer panel that recorded shopping receipts and completed surveys on household information, medicine use, and habits. Results showed that households with at least one user of Novo Nordisk's GLP‑1 RA for weight management experienced a year-on-year reduction in grocery spending, driven mainly by lower spending on alcohol and tobacco/cigarette products, compared with households without a GLP‑1 RA user. While this analysis cannot prove that the medicine directly causes behavioural changes, the findings suggest that obesity treatment may help support healthier everyday choices, such as reducing alcohol consumption and smoking. As the analysis was conducted at the household level, these potential benefits may also extend to other family members living with the medicine user. "We already know that Novo Nordisk's GLP‑1 medicine has proven effects on weight loss, as well as broader health benefits, so it's exciting to see signs that it may also support people with obesity in making healthier everyday choices," said Dr. Filip K. Knop, chief medical officer at Novo Nordisk. "The latest findings showing a reduction in alcohol and tobacco spending in households using this therapy are very encouraging. They point to the potential for this treatment to support people living with obesity—and those they live with—in fostering healthier behaviours. This real-world analysis explores potential broader effects of the therapy and builds on the recent INFORM real-world study investigating its impact on food noise (persistent thoughts about eating) in people living with obesity." Real-world analyses such as this have limitations. The results can only show a potential relationship (association), not prove that the medicine directly causes behavioural changes. The data were captured at the household level, so it is not possible to confirm who in the household purchased or consumed alcohol or cigarettes. Reduced spending may suggest reduced consumption, but additional evidence is needed to confirm this. "In Indonesia, we see obesity becoming more common, often alongside other conditions such as diabetes and hypertension. Many patients feel it is entirely their fault, when in fact obesity is a complex medical condition that requires support," said dr. Riyanny Meisha Tarliman, Clinical, Medical, and Regulatory Director at Novo Nordisk Indonesia. "Our hope is that Indonesians increasingly view obesity as a condition that can—and should—be managed seriously, with support from doctors and appropriate therapy, rather than through self-blame. No one should have to face obesity alone. Through the right education and access to trusted information, we hope to drive a shift in obesity care in Indonesia," she added. Amid these challenges, education and access to reliable information are essential to help people and patients make better health decisions. As part of its education commitment, Novo Nordisk provides a health information platform via NovoCare.id. On NovoCare, the public can find easy-to-understand information on obesity, diabetes, and other chronic diseases, including healthy lifestyle tips, myth-versus-fact explanations about obesity, and guidance on discussing treatment decisions with healthcare professionals based on trusted information. Novo Nordisk's GLP‑1 medicine for weight management is a prescription medicine provided following consultation with a healthcare professional and used as an adjunct to a reduced-calorie diet and increased physical activity to help adults with obesity—or overweight with weight-related conditions—manage their weight.[2] Obesity is often associated with other conditions such as type 2 diabetes, high blood pressure, elevated blood lipids, heart disease, and joint pain. Across multiple clinical studies, GLP‑1 therapy for weight management has been shown to help many patients achieve significant weight loss and improve several risk factors related to cardiovascular and metabolic health. About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,500 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.id, Facebook, Instagram, X, LinkedIn, and YouTube. References [1] Arnaut T, Kazantseva K, Kvist K, et al. Changes in Alcohol/Tobacco Spending Among Users and Non-Users of Semaglutide for Weight Management. Poster presentation at ObesityWeek® 2025; 4–7 November 2025; Georgia World Congress Center (GWCC), Atlanta, Georgia, USA. [2] Wegovy® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/wegovy-epar-product-information_en.pdf. Last accessed: October 2025.
HANGZHOU, China, SHANGHAI and BOSTON, Jan. 12, 2026 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as "Lynk Pharmaceuticals"), a clinical stage innovative drug development company focused on developing innovative therapies for immune and inflammatory diseases, today announced positive topline results from its Phase III clinical trial evaluating zemprocitinib (LNK01001) in patients with moderate to severe active rheumatoid arthritis (RA). The study met its primary and key secondary efficacy endpoints, demonstrating statistically significant improvements versus placebo (P < 0.0001), with a favorable safety and tolerability profile. This randomized, double-blind, placebo-controlled Phase III study (CTR20232969, NCT06276998) evaluated the efficacy and safety of zemprocitinib in patients with moderate to severe active RA who had an inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs). The trial was led by Professor Xiaofeng Zeng from Peking Union Medical College Hospital and Chinese Academy of Medical Sciences, and enrolled a total of 430 patients, who were randomized 1:1 to receive zemprocitinib 12 mg twice daily or placebo (PBO) twice daily. The primary endpoint was the proportion of patients achieving an ACR20 response at Week 24, with key secondary endpoints including the proportion of patients achieving ACR50 and DAS28 (CRP) ≤ 3.2 at Week 24. The study results showed that response rates in the zemprocitinib treatment group were significantly higher than those in the placebo group across all primary and key secondary efficacy endpoints, with the differences reaching statistical significance. Specifically, the ACR20 response rates at Week 12 and Week 24 vs. PBO were 74.0% versus 29.9% (P < 0.0001) and 79.1% versus 39.7% (P < 0.0001), respectively. The ACR50 response rates at Week 12 and Week 24 vs. PBO were 41.4% versus 9.3% (P < 0.0001) and 55.8% versus 22.0% (P < 0.0001), respectively. The proportion of patients achieving DAS28 (CRP) ≤ 3.2 at Week 12 and Week 24 vs. PBO were 51.2% versus 15.0% (P < 0.0001) and 67.0% versus 23.4% (P < 0.0001), respectively. In terms of safety, zemprocitinib was generally well tolerated. The majority of treatment emergent adverse events (TEAEs) were mild to moderate in severity (Grade 1–2). The incidence of serious adverse events was comparable between the zemprocitinib and placebo groups, and no new safety signals were observed. The overall safety profile was consistent with previous studies. The primary results of this study are planned to be formally presented at an upcoming international scientific conference. Professor Xiaofeng Zeng, the principal investigator of this study from Peking Union Medical College Hospital and Chinese Academy of Medical Sciences, said: "Rheumatoid arthritis is a chronic, progressive autoimmune disease that can severely impact patients' quality of life and physical health. In this Phase III study, zemprocitinib demonstrated strong efficacy, showing statistically significant improvements across the primary and key secondary efficacy endpoints, while maintaining a favorable safety and tolerability profile. These results suggest that zemprocitinib has the potential to offer a new treatment option for this patient population." Dr. Zhao-Kui (ZK) Wan, Founder and Chief Executive Officer of Lynk Pharmaceuticals, said: "We are very encouraged by the positive topline results from this Phase III trial of zemprocitinib. This represents the first disclosed trial results in China for a selective JAK1 inhibitor in patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to prior biologic therapies. We believe that zemprocitinib, as a promising oral therapy, has the potential to offer a meaningful new treatment option for patients with rheumatoid arthritis. We would also like to express our sincere gratitude to the patients, investigators, and all teams involved for their dedication and contributions in achieving this important milestone." Gaobo Zhou, Chief Investment Officer of Simcere, said: "As the commercialization partner of zemprocitinib, we are pleased to see the strong performance of this Phase III study in rheumatoid arthritis. These results further highlight the therapeutic potential of zemprocitinib. We will continue to support its subsequent development and remain committed to bringing improved oral treatment options to patients with rheumatoid arthritis." About Zemprocitinib (LNK01001): Zemprocitinib (LNK01001) is a highly selective, next generation JAK1 inhibitor with best in class potential, being developed for the treatment of rheumatoid arthritis, ankylosing spondylitis, atopic dermatitis, and vitiligo. Compared with first-generation JAK inhibitors with lower selectivity, zemprocitinib exhibits significantly greater selectivity for JAK1, which may enhance efficacy while reducing off-target adverse effects. Zemprocitinib potently and dose-dependently inhibits multiple inflammation-related signaling pathways mediated by JAK1. In March 2022, Lynk Pharmaceuticals entered into a commercialization collaboration with Simcere to jointly advance the development and commercialization of zemprocitinib for rheumatoid arthritis and ankylosing spondylitis in Greater China. About Lynk Pharmaceuticals: Lynk Pharmaceuticals, a clinical stage company, was founded by senior drug R&D experts and executives from Pfizer, Merck, and Johnson & Johnson. Lynk Pharmaceuticals is dedicated to the discovery and development of innovative drugs for the treatment of immune and inflammatory diseases. Driven by a higher goal, Lynk Pharmaceuticals aims to be a market leader to address unmet medical demands by the development of innovative therapies. We thrive to provide differentiated innovative therapies to benefit patients globally. To date, Lynk Pharmaceuticals has independently developed several innovative new drug candidates and successfully completed a number of clinical studies. About Simcere: Simcere Pharmaceutical Group Limited (2096.HK) is a pharmaceutical company driven by innovation and focusing on four therapeutic areas including Neuroscience, Oncology, Autoimmune Diseases and Anti-infection. We proactively explore areas with significant unmet needs, and our mission is For patients, for life. Driven by our in-house R&D efforts and synergistic innovation, Simcere has established strategic cooperation partnerships with many innovative companies and research institutes.
SHANGHAI, Jan. 8, 2026 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that China's National Medical Products Administration (NMPA) has approved the New Drug Application for Serdexmethylphenidate Chloride and Dexmethylphenidate Hydrochloride Capsules (Aizhida) for treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older in China. Aizhida is a central nervous system stimulant indicated for the treatment of ADHD. Each once-daily capsule contains serdexmethylphenidate (SDX), a prodrug of dexmethylphenidate, co-formulated with immediate-release dexmethylphenidate (d-MPH) in a fixed ratio designed to provide both rapid and extended symptom control.After ingestion, the immediate-release d-MPH component is rapidly absorbed to provide early onset of effect, while SDX is gradually converted to d-MPH in the lower gastrointestinal tract, supporting sustained therapeutic exposure throughout the day. Aizhida was approved by the U.S. FDA in March 2021 as a once-daily treatment option for patients with ADHD 6 years of age and older. Figure 1. Each Aizhida capsule contains 70% SDX and 30% d-MPH. ADHD is a common, chronic neurodevelopmental disorder that typically begins in childhood and may persist into adulthood. It is primarily characterized by age-inappropriate levels of inattention and/or hyperactivity-impulsivity. In China, the prevalence of ADHD in children and adolescents is estimated at approximately 6.4%, affecting over 23 million individuals. Studies have shown that symptoms persist into adolescence for 60%-80% of patients, and into adulthood for roughly half of cases. Current ADHD treatment options in China are limited, and currently available medications do not fully meet clinical needs in terms of both efficacy and safety for many patients. Some patients discontinue treatment due to suboptimal response, side effects, or dosing inconvenience, highlighting the need for additional therapeutic options. Robust Clinical Data Addresses Unmet Need: In a pivotal Phase III clinical trial in Chinese patients with ADHD, Aizhida met both the primary and key secondary endpoints. The study demonstrated statistically significant and clinically meaningful improvements in core ADHD symptoms compared to placebo at all assessment time points. With limited treatment options in China and historical supply constraints for traditional single-agent therapies, the approval of this innovative combination product offers an important new choice for clinicians and patients. Unique Dual Mechanism for Rapid Onset and All-Day Coverage: Aizhida combines immediate-release and prodrug-based extended-release technologies. Its 'rapid onset + full-day coverage' profile positions it to reshape the ADHD treatment paradigm in China. As the first ADHD medication in China to deliver both rapid onset and sustained symptom control, it fills a key clinical gap and has the potential to become a preferred treatment option. Professor Yi Zheng, Chief Expert at Beijing Anding Hospital, Capital Medical University, and Lead Principal Investigator of the Aizhida Phase III trial in China, commented: "ADHD is one of the most common neurodevelopmental disorders in childhood, with potential impact lasting into adulthood, posing long-term challenges to learning, social functioning, and family life. While the prevalence in Chinese children is around 6.4%, treatment options—especially innovative ones balancing efficacy and safety—remain insufficient. The approval of Aizhida provides clinicians with a new therapeutic tool. We anticipate its real-world application will help improve the treatment landscape for ADHD patients in China, offering new hope particularly for those with suboptimal response or tolerance to existing therapies." Professor Jing Liu, Director of the Child Psychiatry Center, Peking University Sixth Hospital, and Lead Principal Investigator of the Aizhida Phase III trial in China, added: "We are committed to advancing standardized diagnosis and treatment for pediatric mental disorders in China. Comprehensive intervention is essential for ADHD, with pharmacotherapy being a foundational component. The approval of a new drug not only increases options but also prompts deeper reflection on optimizing treatment strategies. We hope the approval of Aizhida will enrich ADHD treatment approaches and contribute to better long-term outcomes, which is the ultimate goal of our clinical research." About ArkBio ArkBio is a global biotech company focused on developing innovative therapeutics for respiratory and pediatric diseases. Founded in 2014, it has built core technology platforms and a differentiated R&D pipeline through in-house R&D efforts and external collaboration. Key drug assets include ziresovir (AK0529), the first direct-acting RSV antiviral with positive pivotal phase III results, and AK3280, a potentially best-in-class drug with positive phase 2 results to treatment idiopathic pulmonary fibrosis. Another core product Aizhida (AK0901) was recently approved in China for ADHD and has now entered the commercial launch phase. ArkBio has established strategic partnerships with several multinational pharmaceutical companies and academic institutes, including Roche, Genentech, the Scripps Research Institute, the Institute of Microbiology of Chinese Academy of Sciences, domestic and international biotechnology companies, as well as venture capital institutions. For more information, please visit: www.arkbiosciences.com Investor Inquiries: IR@arkbiosciences.com
SHANGHAI, Jan. 6, 2026 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that China's National Medical Products Administration (NMPA) has approved the New Drug Application for Serdexmethylphenidate Chloride and Dexmethylphenidate Hydrochloride Capsules (Azstarys®) for treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older in China. Azstarys® is a central nervous system stimulant indicated for the treatment of ADHD. Each once-daily capsule contains serdexmethylphenidate (SDX), a prodrug of dexmethylphenidate, co-formulated with immediate-release dexmethylphenidate (d-MPH) in a fixed ratio designed to provide both rapid and extended symptom control.After ingestion, the immediate-release d-MPH component is rapidly absorbed to provide early onset of effect, while SDX is gradually converted to d-MPH in the lower gastrointestinal tract, supporting sustained therapeutic exposure throughout the day. Azstarys® was approved by the U.S. FDA in March 2021 as a once-daily treatment option for patients with ADHD 6 years of age and older. Figure 1. Each Azstarys® capsule contains 70% SDX and 30% d-MPH ADHD is a common, chronic neurodevelopmental disorder that typically begins in childhood and may persist into adulthood. It is primarily characterized by age-inappropriate levels of inattention and/or hyperactivity-impulsivity. In China, the prevalence of ADHD in children and adolescents is estimated at approximately 6.4%, affecting over 23 million individuals. Studies have shown that symptoms persist into adolescence for 60%-80% of patients, and into adulthood for roughly half of cases. Current ADHD treatment options in China are limited, and currently available medications do not fully meet clinical needs in terms of both efficacy and safety for many patients. Some patients discontinue treatment due to suboptimal response, side effects, or dosing inconvenience, highlighting the need for additional therapeutic options. Robust Clinical Data Addresses Unmet Need: In a pivotal Phase III clinical trial in Chinese patients with ADHD, Azstarys® met both the primary and key secondary endpoints. The study demonstrated statistically significant and clinically meaningful improvements in core ADHD symptoms compared to placebo at all assessment time points. With limited treatment options in China and historical supply constraints for traditional single-agent therapies, the approval of this innovative combination product offers an important new choice for clinicians and patients. Unique Dual Mechanism for Rapid Onset and All-Day Coverage: Azstarys® combines immediate-release and prodrug-based extended-release technologies. Its 'rapid onset + full-day coverage' profile positions it to reshape the ADHD treatment paradigm in China. As the first ADHD medication in China to deliver both rapid onset and sustained symptom control, it fills a key clinical gap and has the potential to become a preferred treatment option. Professor Yi Zheng, Chief Expert at Beijing Anding Hospital, Capital Medical University, and Lead Principal Investigator of the Azstarys® Phase III trial in China, commented: "ADHD is one of the most common neurodevelopmental disorders in childhood, with potential impact lasting into adulthood, posing long-term challenges to learning, social functioning, and family life. While the prevalence in Chinese children is around 6.4%, treatment options—especially innovative ones balancing efficacy and safety—remain insufficient. The approval of Azstarys® provides clinicians with a new therapeutic tool. We anticipate its real-world application will help improve the treatment landscape for ADHD patients in China, offering new hope particularly for those with suboptimal response or tolerance to existing therapies." Professor Jing Liu, Director of the Child Psychiatry Center, Peking University Sixth Hospital, and Lead Principal Investigator of the Azstarys® Phase III trial in China, added: "We are committed to advancing standardized diagnosis and treatment for pediatric mental disorders in China. Comprehensive intervention is essential for ADHD, with pharmacotherapy being a foundational component. The approval of a new drug not only increases options but also prompts deeper reflection on optimizing treatment strategies. We hope the introduction of Azstarys® will enrich ADHD treatment approaches and contribute to better long-term outcomes, which is the ultimate goal of our clinical research." Azstarys® is a registered trademark of Corium, LLC in the United States. About ArkBio ArkBio is a global biotech company focused on developing innovative therapeutics for respiratory and pediatric diseases. Founded in 2014, it has built core technology platforms and a differentiated R&D pipeline through in-house R&D efforts and external collaboration. Key drug assets include ziresovir (AK0529), the first direct-acting RSV antiviral with positive pivotal phase III results, and AK3280, a potentially best-in-class drug with positive phase 2 results to treatment idiopathic pulmonary fibrosis. Another core product Azstarys® (AK0901) was recently approved in China for ADHD and has now entered the commercial launch phase. ArkBio has established strategic partnerships with several multinational pharmaceutical companies and academic institutes, including Roche, Genentech, the Scripps Research Institute, the Institute of Microbiology of Chinese Academy of Sciences, domestic and international biotechnology companies, as well as venture capital institutions. For more information, please visit: www.arkbiosciences.com Investor Inquiries: IR@arkbiosciences.com
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