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EYDENZELT® is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR) Celltrion plans to enter the U.S. ophthalmology market to meet diverse needs of patients suffering from various eye conditions INCHEON, South Korea, Oct. 10, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept), for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).[1] Aflibercept is a VEGF inhibitor formulated as an injection for the eye that blocks the growth of new blood vessels and decreases the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PlGF), two growth factors involved in ocular angiogenesis. "Timely access to effective therapies is essential for individuals affected by retinal diseases. We are proud to have EYDENZELT approved by the FDA, and we look forward to expanding the availability and access of biological treatments across the U.S.," said Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. "With EYDENZELT demonstrating biosimilarity to its reference product, we believe this approval will mark a significant milestone in the treatment landscape of retinal diseases—helping physicians broaden their options and improving patient outcomes." The FDA approval was based on a totality of evidence including analytical, nonclinical, and clinical data. In a randomized, double-masked, parallel-group, multicenter phase III study of EYDENZELT, the efficacy, safety, pharmacokinetics, and immunogenicity of EYDENZELT was compared to EYLEA in patients with diabetic macular edema (DME). The 52-week trial included 348 patients with DME. The primary endpoint was the change in best corrected visual acuity measured at week 8 from baseline, comparing EYDENZELT and EYLEA. Results of the study showed that EYDENZELT met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogenicity also showed trends similar to EYLEA. "Advanced age-related macular degeneration (AMD) is a leading cause of irreversible blindness and visual impairment in the world and nearly 20 million people in the U.S. are living with some form of age-related macular degeneration," said Dr. David M. Brown, Director, Retina Consultants of Texas Research Centers, Co-chair, Medical Leadership Board Retina Consultants of America. "EYDENZELT will be an important new addition to our options for the treatment of our patients with serious retinal diseases." EYDENZELT is Celltrion's first FDA-approved biologic product in ophthalmology. EYDENZELT was also approved by the European Commission (EC) in February 2025. ### About EYDENZELT® (aflibercept-boav) EYDENZELT® (aflibercept-boav) is a vascular endothelial growth factor (VEGF) inhibitor referencing EYLEA® (aflibercept). EYDENZELT is approved based on a comprehensive data confirming the therapeutic equivalence EYLEA. In the U.S., EYDENZELT is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR). INDICATIONS EYDENZELT® (aflibercept-boav) is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) IMPORTANT SAFETY INFORMATION EYDENZELT is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, and hypersensitivity to aflibercept or any of the excipients in EYDENZELT. Instruct patients and/or caregivers to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately. There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including aflibercept products. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased. For more information, see Full Prescribing Information. About Celltrion, Inc. Celltrion, Inc. is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has ten biosimilar products approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), and OMLYCLO® (omalizumab-igec) as well as a novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com, and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks EYDENZELT® is a registered trademark of Celltrion, Inc.EYLEA® is a registered trademark of Regeneron Pharmaceuticals Inc. References [1] EYDENZELT U.S. prescribing information (2025) US--24-00028 For further information please contact:Katie Gallagherkgallagher@jpa.com +1 617-657-1324
HONG KONG, Nov. 6, 2025 /PRNewswire/ -- On 5 November 2025, the 8th China International Import Expo (CIIE) opened at the National Exhibition and Convention Center (Shanghai). As a "full-attendance" exhibitor for eight consecutive years, Fosun, together with its overseas member companies and global partners, is showcasing a range of world-leading innovative drugs, advanced medical devices, and achievements in international collaboration at the Fosun Pharma booth in the Medical Equipment and Healthcare Products Exhibition Area. The exhibits focus on core therapeutic areas including oncology, immune-inflammatory disorders, central nervous system, and kidney diseases, highlighting holistic breakthroughs in medical technology, from diagnosis and treatment to recovery. Guo Guangchang, Chairman of Fosun International, remarked, "Over the past eight years, the CIIE has continued to grow in influence and innovate, serving as a key window into China's new development paradigm, a platform for advancing high-level opening-up, and a global public good that benefits the international community. We have witnessed and benefited from this 'everlasting' showcase. The CIIE has enabled Fosun's global innovations to continuously transform from 'exhibits' into 'products', while many overseas partners have changed their roles from 'exhibitors' to 'investors'. Fosun believes that healthcare innovation should address unmet clinical needs and bring hope of cure to patients. This year, our showcases in the Medical Equipment and Healthcare Products Exhibition Area center on the latest advancements addressing global clinical needs, with several new products making their debut. We firmly believe that China's high-level opening-up will remain a source of certainty and opportunity for global development. Looking ahead, Fosun will further capitalize on its global industrial advantages to foster more cutting-edge innovations in China, contributing the 'power of Fosun' to fulfill people's aspirations for a better life." Focusing on oncology: advancing from "treatment" to "cure" Fosun is presenting a series of cutting-edge innovative products aimed at advancing oncology from "treatment" to "cure" at this year's CIIE. Among them, the debut product, the Marie Upright Particle Therapy System, has attracted significant attention. As a revolutionary breakthrough in cancer treatment, the Marie Upright Particle Therapy System eliminates the cumbersome structure of conventional particle therapy system, enabling rapid deployment within existing medical facilities. Studies show that the upright positioning enhances precision in tumors located in the lung, breast, abdomen, and other areas. The system supports multiple advanced particle therapy modalities including proton therapy, heavy ion therapy, boron neutron capture therapy (BNCT), and FLASH radiotherapy, offering patients more precise, comfortable, and flexible treatment options. The Marie Upright Particle Therapy System, which received U.S. Food and Drug Administration (FDA) approval in July 2025, is making its debut in China at this year's CIIE. In the field of hematologic oncology, Fosun's Yi Kai Da (ejilunsai injection), China's first CAR-T cell therapy product, continues to share the latest developments in making lymphoma treatment both accessible and curative at the CIIE. This year, Yi Kai Da has made multiple major advances: inclusion in over 110 urban customized commercial health insurances and over 80 commercial insurances; establishment of over 190 high-standard treatment centers across 29 provinces and cities nationwide, benefiting more than 1,000 lymphoma patients; successful first-ever cross-border shipping and usage in Hong Kong SAR and Macau SAR; and a remarkable case of the first patient treated with Yi Kai Da in the Chinese mainland achieving over seven years of high-quality survival. Notably, following Yi Kai Da, the drug registration application of Fosun's second CAR-T product, brexucabtagene autoleucel injection, was accepted by the National Medical Products Administration (NMPA) in September 2025. The declared indication for this application is for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Regarding supportive care in cancer, Fosun is showcasing several innovative drugs that fill treatment gaps in the domestic market. These include the world's first and currently only dual-channel antiemetic, Akynzeo (netupitant and palonosetron hydrochloride capsules); China's first oral thrombopoietin receptor agonist with dual indications for chronic liver disease-associated thrombocytopenia and immune thrombocytopenia, Su Ke Xin (avatrombopag maleate tablets); and the long-acting recombinant human granulocyte colony-stimulating factor, Pei Jin (telpegfilgrastim injection). Additionally, Wan Ti Le (tenapanor hydrochloride tablets), a "CIIE baby" introduced to China through the CIIE, received approval from the NMPA in February 2025. It is indicated for the control of serum phosphorus levels in dialysis patients with chronic kidney disease. This groundbreaking innovation has also been shortlisted as a candidate for Best Pharmaceutical Product at the Prix Galien 2025. Addressing neurological disorders with innovative drugs and devices In recent years, the number of patients with neurological disorders has rapidly increased, with a notable trend toward younger patients. Disorders such as Parkinson's disease, brain tumors, and epilepsy have attracted growing attention. Focusing on unmet clinical needs, Fosun is actively exploring world-leading innovative solutions. In advanced medical devices, Fosun is once again featuring cutting-edge non-invasive treatments, the magnetic resonance image guided focused ultrasound brain therapy system (MRgFUS brain therapy system) and the world's first 128-channel helium-free Marvel magnetoencephalography (MEG), at the CIIE, providing integrated solutions from precise localization to non-invasive treatment for common neurological disorders such as Parkinson's disease, brain tumors, and epilepsy. To date, more than 25,000 patients worldwide have benefited from the MRgFUS brain therapy system. Its new V2 model, featuring enhanced device compatibility and easier operation, has obtained CE marking in the European Union and U.S. FDA approval. Since its debut at the last CIIE, the MRgFUS brain therapy system has been deployed in over 10 medical institutions in the Chinese mainland, benefiting nearly 1,000 patients. In the field of innovative drugs, Fosun has introduced a world-leading combination therapy for Parkinson's disease, contributing to the continuous improvement of diagnosis and treatment in China. The oral COMT inhibitor, Ongentys (opicapone) is currently the only once-daily COMT inhibitor approved globally, offering convenient dosing that significantly enhances treatment adherence and long-term disease management. Ongentys is already in clinical use in pilot zones such as Boao Lecheng, leveraging special access policies for clinical prescriptions and paving the way for broader national adoption. Integrating global resources to drive local innovation, embracing AI to accelerate breakthroughs Fosun continues to integrate global resources to advance cutting-edge medical technologies in China. Leveraging CIIE's support in transforming "exhibits" into "products", Intuitive Fosun's surgical system has been gradually launched, contributing to the development of a high-quality healthcare system in China. The Da Vinci surgical system, a popular exhibit at the CIIE for eight consecutive years, has witnessed the rapid development of minimally invasive surgery in China. By the end of September 2025, over 480 Da Vinci surgical systems had been installed in more than 370 hospitals across the Chinese mainland, Hong Kong SAR, and Macau SAR, collectively serving over 810,000 patients. This year, Intuitive Fosun is showcasing several surgical systems, including the domestically produced multiport Da Vinci Xi surgical system, the single-port Da Vinci SP surgical system designed for single-incision or natural orifice surgeries, and the Ion Robotic Bronchoscopy that brings breakthrough innovations in lung cancer diagnosis and treatment. To better meet China's clinical needs, Intuitive Fosun Innovation Center has partnered with over 20 grade 3A hospitals accredited by the National Health Commission of the People's Republic of China to establish Da Vinci Surgical System Training Centers, creating an integrated training system that combines clinical practice with education. To date, Intuitive Fosun has established 7 regional training centers across China and trained more than 15,000 medical professionals, promoting the standardized and sustainable development of surgical systems nationwide. In digital transformation, Fosun actively embraces AI and has gradually built a comprehensive digital and intelligent system covering research and development, operations, and product applications. At this year's CIIE, Fosun Pharma is showcasing its PharmAID decision intelligence platform, which deeply integrates leading large model technologies such as DeepSeek, achieving intelligent leaps in drug commercial decision-making, clinical trial prediction, and toxicology optimization. In medical aesthetics, Sisram is presenting revolutionary solutions including Alma IQ, an intelligent skin analysis and consultation solution, and Universkin, the world's first AI-assisted medical-grade skincare line launched in North America, setting new standards for personalized treatment. In healthcare services, Fosun Health continues to explore deep AI applications in assisted diagnosis, treatment quality control, and proactive health management. Leveraging four core hospitals in the Greater Bay Area including Foshan Fosun Chancheng Hospital, Fosun Health has established an internationalized service platform integrating online and offline resources, providing one-stop services from remote consultation to full patient care for individuals from Japan, Bangladesh, Indonesia, Peru, and other countries. Guo Guangchang said, "Looking ahead, Fosun will leverage its long-established innovation and globalization capabilities, collaborating with global partners to continuously drive high-quality development of the pharmaceutical industry and help realize the ambitious vision of 'Healthy China 2030'."
- Strategic MOU enhances market access and extends reach to over 900 hospitals across the region SEOUL, South Korea, Oct. 29, 2025 /PRNewswire/ -- VUNO Inc., a global medical AI company, announced today that it has signed a strategic Memorandum of Understanding (MOU) with Contextflow, an Austrian imaging AI company, and Mesalvo, a German hospital information system (HIS) provider, to jointly advance into the European market with its AI-based cardiac arrest prediction solution, VUNO Med®–DeepCARS®. The MOU was signed on October 27 during a local meeting held in conjunction with the 38th Annual Congress of the European Society of Intensive Care Medicine (ESICM LIVES 2025), which took place from October 25 to 29 in Munich, Germany. Through this agreement, the three companies will collaborate on technical integration, real-world validation, and reimbursement strategies to support the adoption of DeepCARS across European hospitals. Under the MOU, Contextflow will leverage its expertise in reimbursement and regulatory processes for imaging AI solutions in Europe to support DeepCARS' regulatory compliance and market access strategy. Meanwhile, Mesalvo, a major provider of hospital information systems across Europe including Germany, will work on integrating DeepCARS into its electronic health record (EHR) systems and data platforms. Building on the technological integration with Mesalvo's EHR platform, this partnership positions VUNO's DeepCARS to potentially reach over 900 hospitals across Europe. Alongside the MOU signing, VUNO showcased DeepCARS at a dedicated booth at ESICM 2025. Under the slogan "Predict Early, Prevent More," the company highlighted the solution's unique features, real-world clinical cases, and superior predictive performance compared to conventional early warning systems. These efforts drew significant interest from intensive care experts across Europe. Dr. Ye Ha Lee, Founder & CEO of VUNO, commented, "This strategic MOU with Contextflow and Mesalvo marks a significant step toward DeepCARS' expansion into Europe. By working closely with trusted local partners, we aim to set a new global standard in AI-based patient care that European hospitals and medical professionals can rely on." About VUNO VUNO, founded in 2014, is a leading South Korean medical AI company and the developer of the nation's first approved AI-powered medical device. Leveraging cutting-edge AI technology, VUNO analyzes a wide range of medical data—from bio signals such as ECG, respiratory rate and blood pressure to medical images including X-rays, CT scans, and fundus images—to predict critical events and support clinicians in decision-making. Committed to patient-centered innovation, VUNO strives to make high-quality healthcare accessible to everyone, worldwide. About VUNO Med®-DeepCARS® VUNO Med®-DeepCARS®(DeepCARS) is an AI-powered medical device designed to monitor the risk of in-hospital cardiac arrest within the next 24 hours. It analyzes patients' vital signs-including blood pressure, heart rate, respiratory rate, and body temperature-in general wards. As of September 2025, DeepCARS has been implemented across more than 50,000 hospital beds in South Korea, including over 20 tertiary general hospitals, establishing itself as an essential part of care. In 2023, DeepCARS received Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) and is currently undergoing the FDA approval process.
OPUSWAVE Imaging System combines OFDI and IVUS into a single catheter, providing significant potential to reduce procedural time and costs in treating coronary artery disease DualView imaging catheter offers a 150mm maximum pullback length, a 2.6 Fr. imaging profile, 6 Fr. guide compatibility and a variable pullback speed of up to 40mm/second in dual mode SOMERSET, N.J., Oct. 24, 2025 /PRNewswire/ -- Terumo Interventional Systems (TIS), a division of Terumo Corporation, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its OPUSWAVE® Dual Sensor Imaging System. The OPUSWAVE Imaging System features the DualView® imaging catheter, which also received FDA 510(k) clearance. The OPUSWAVE Imaging System combines Optical Frequency Domain Imaging (OFDI) and intravascular ultrasound (IVUS) to enable simultaneous views, offering physicians the ability to comprehensively evaluate coronary artery disease (CAD). While this marks Terumo's imaging debut in the US market, the company is already a recognized leader in the single modality imaging space in Japan, where adoption of imaging in percutaneous coronary intervention (PCI) procedures is the highest in the world. "Importantly, the OPUSWAVE Imaging System allows physicians to maximize imaging efficiency without sacrificing quality when it comes to creating treatment plans to achieve the best outcomes for their patients," said Ghada Farah, President, Terumo Interventional Systems. "By combining the advanced imaging capabilities of OFDI and IVUS into a single catheter, the OPUSWAVE Imaging System also creates a strong opportunity to shorten procedural time and costs in treating CAD." What makes the OPUSWAVE Imaging System unique is the DualView imaging catheter, which offers a 150mm maximum pullback length. It also has a 2.6 Fr. imaging profile, 6 Fr. guide compatibility, advanced hydrophilic coating, and a variable pullback speed of up to 40mm/second in dual mode. "The OPUSWAVE Imaging System is an ideal technology for interventional cardiologists who perform image-guided PCI," said Michael J. Martinelli, MD, FACC, FSCAI and Chief Medical Officer, Terumo Medical Corporation. "This innovative imaging system provides the opportunity for physicians to take advantage of the benefits of both OFDI and IVUS in the assessment and treatment of any lesion morphology. Instead of having to commit to one imaging tool, they now have the flexibility to access both imaging modalities with a single catheter." About Terumo Interventional SystemsTerumo Interventional Systems (TIS), a division of Terumo Corporation, is a market leader in minimally invasive entry site management, lesion access, and therapeutic intervention. TIS offers a complete, solution-based product portfolio used in advanced coronary, peripheral and endovascular treatments with strategic initiatives in Transradial Access, Complex Coronary Intervention, Peripheral Artery Disease and Embolotherapy. TIS combines innovative research and development with a deep market understanding to create a pipeline of industry-leading devices that deliver clinical value, economic benefit, and enhanced patient outcomes. More information can be found at www.terumois.com. About Terumo Terumo (TSE: 4543) is a global medical innovation company. Guided by an unwavering commitment to patients, and driven by the passion of our associates, we strive to fulfill our Group Mission of "Contributing to Society through Healthcare." Founded in Tokyo in 1921, we provide a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions. More information can be found at www.terumo.com.
LEHI, Utah, Oct. 23, 2025 /PRNewswire/ -- Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company pioneering therapies that target the root causes of inflammation-driven diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its investigational medicine ofirnoflast (HT-6184) for the treatment of Myelodysplastic Syndromes (MDS) — a group of bone marrow disorders characterized by ineffective blood cell production and a risk of progression to acute myeloid leukemia (AML). The FDA grants Orphan Drug Designation to therapies intended for the treatment, prevention, or diagnosis of rare diseases or conditions that affect fewer than 200,000 people in the United States at the time of designation. "This designation underscores the potential of our approach in Myelodysplastic Syndromes and supports our commitment to developing new treatment options for patients living with MDS," said David Bearss, PhD, Chief Executive Officer of Halia Therapeutics. "Ofirnoflast represents a first-in-class approach to modulating inflammasome biology, an upstream driver of inflammation, with the goal of restoring healthy bone marrow function." Ofirnoflast is a selective NEK7 allosteric modulator designed to prevent the formation and promote the disassembly of the NLRP3 inflammasome, a central driver of chronic inflammation in multiple diseases. In MDS, inflammasome activation is increasingly recognized as a key contributor to ineffective hematopoiesis and bone marrow failure. By modulating NEK7, ofirnoflast aims to restore immune balance and improve blood-cell production without broad immunosuppression. "Inflammasome biology represents a promising frontier for hematologic innovation," said Alan F. List, MD, member of Halia Therapeutics' Scientific Advisory Board and former President and CEO of Moffitt Cancer Center. "Ofirnoflast's approach is distinctive in that it seeks to modulate the underlying inflammatory drivers of MDS rather than just its downstream effects. This strategy has the potential to redefine how inflammation-linked bone marrow failure is treated." Under the FDA's Orphan Drug Act, orphan-drug status provides several incentives, including tax credits for qualified clinical testing, exemption from FDA user fees, and potential for seven years of U.S. market exclusivity upon approval. The FDA also administers grant programs to support clinical research and advance the development of therapies for rare diseases. About Myelodysplastic Syndromes (MDS) Myelodysplastic Syndromes are a group of bone marrow disorders characterized by defective blood-cell formation, leading to anemia, infection risk, and bleeding complications. MDS primarily affects older adults and can progress to acute myeloid leukemia (AML). Current therapies, including hypomethylating agents and growth factors, often provide limited benefit and do not address the underlying inflammatory biology of the disease. About Ofirnoflast (HT-6184) Ofirnoflast (HT-6184) is Halia Therapeutics' lead investigational compound and a first-in-class NEK7 modulator that regulates activation of the NLRP3 inflammasome — an upstream molecular complex involved in chronic inflammation. The drug is currently being evaluated across multiple disease areas, including: Myelodysplastic Syndromes (MDS) – completed Phase 2 study evaluating safety and hematologic outcomes Obesity (in combination with semaglutide) – ongoing Phase 2 study targeting adipose inflammation and metabolic dysregulation Alzheimer's Disease – early-stage program focused on genetically at-risk populations About Halia Therapeutics, Inc. Halia Therapeutics is a clinical-stage biopharmaceutical company developing therapies that leverage genetic resilience to restore the body's natural ability to resolve inflammation. By targeting the NEK7–NLRP3 inflammasome axis, Halia's pipeline addresses a spectrum of chronic inflammatory and degenerative diseases, including hematologic disorders, metabolic disease, and neurodegeneration. To learn more, visit www.haliatx.com or follow Halia Therapeutics on LinkedIn and X (Twitter). Media Contact:Taylor AveiDirector, Business Development Halia Therapeutics, Inc.info@haliatx.com+1 (385) 355-4315 Leigh Salvo New Street Investor Relationsleigh@newstreetir.com Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about the potential therapeutic benefits of ofirnoflast, the company's clinical development plans, regulatory strategies, and commercial opportunities. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These risks include uncertainties related to clinical trial results, regulatory approval processes, competitive developments, and the company's ability to secure adequate funding for continued operations. Halia Therapeutics undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.
TAIPEI, Oct. 23, 2025 /PRNewswire/ -- AnnJi Pharmaceutical Co., Ltd. (AnnJi, TWSE: 7754) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for AJ201, the first-in-class for therapy for spinal and bulbar muscular atrophy (SBMA, also known as Kennedy's disease). "Receiving the Fast Track Designation for AJ201 marks a significant milestone for AnnJi," said Dr. Wendy Huang, CEO and Chairperson of the Board of AnnJi. "Alongside the Orphan Drug Designations granted by both the U.S. FDA and EMA, this recognition reinforces AJ201's potential to address the unmet needs of patients with SBMA. Backed by a strong global patent portfolio, we remain committed to advancing AJ201 into Phase 3 development and to working closely with the FDA to potentially deliver the first approved treatment for SBMA in more than two decades." About SBMA and AJ201 SBMA, or Kennedy's disease, is a rare X-linked inherited neuromuscular disorder caused by CAG repeat expansion in the androgen receptor (AR) gene. The resulting mutant AR protein contributes to muscle and neuron degeneration through mechanisms involving cellular toxicity, oxidative stress, and neuroinflammation. SBMA affects ~1 in 40,000 males globally and currently has no FDA-approved treatment. AJ201, also known as JM17, is a novel investigational compound that has shown potential in reducing mutant AR toxicity and improving motor function in preclinical SBMA models. At the molecular level, it promotes degradation of pathogenic mAR protein, induces expression of antioxidant enzymes, proteasome subunits, and heat shock proteins, all of which may slow disease progression (Bott et al., 2016). About AnnJi Pharmaceutical AnnJi Pharmaceutical Co., Ltd. (TWSE: 7754) is a clinical-stage drug development company focused on the development of innovative small molecules (NCEs). The company is dedicated to addressing high unmet medical needs in the fields of neurology, dermatology, and immune-inflammatory diseases, including rare diseases, such as Kennedy's disease (SBMA) and Idiopathic Pulmonary Fibrosis (IPF). AnnJi is committed to develop innovative therapies that improve the quality of life for patients suffering from neglected chronic diseases. We focus on advancing high-quality, differentiated, and innovative drug candidates, and collaborating with global pharmaceutical partners. Upon achieving proof-of-concept in phase II clinical trials, we aim to out-license our products for further co-development and commercialization, with the goal of bringing them to global markets and driving sustainable growth for the company. Contact: Anne Yu; anne.yu@ajpharm.com
A12 藝術空間
FDA Approval
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