Latest news with #PMDA
Associated Press
27-05-2025
- Business
- Associated Press
Deep Intelligent Pharma Unleashes a New Era of AI-Driven Drug Development at Microsoft Build 2025
Singapore, May 27, 2025 -- Deep Intelligent Pharma (DIP) has officially launched a groundbreaking generative AI platform that promises to redefine how the world develops medicine. Unveiled today at Microsoft Build 2025, where DIP was the exclusive presenter from Asia, the new solution represents a bold leap forward in the fusion of AI and life science innovation. Built in partnership with Microsoft Azure O3, DIP's next-gen platform harnesses multi-agent AI swarms capable of performing scientific writing, statistical reasoning, document validation, and regulatory compliance with superhuman scale and precision. It directly targets one of the most expensive, slow, and error-prone challenges in pharma: the creation of clinical and regulatory documents. 'This isn't just an upgrade — it's a reinvention of how life science companies operate,' said Xing Li, CEO of DIP. 'We've turned months of expert labor into minutes of AI-driven intelligence — bringing speed, accuracy, and scientific depth into perfect alignment.' A Paradigm Shift in Life Science R&D The DIP platform is designed to eliminate the longstanding bottlenecks of pharmaceutical development: Real Results, Real Impact At Build, DIP showcased a live case study in which its AI-authored protocol for a novel cancer immunotherapy was approved by Japan's PMDA with zero revisions — in a single review cycle. The message was clear: generative AI isn't the future of pharma — it's happening now. With over 1,000 pharma clients, 20,000+ submission projects, and 5 billion words processed, DIP is already trusted by industry leaders across Asia and beyond. And now, it's setting a new global standard for how data becomes discovery. Transforming the Economics of Innovation With drug development costs surpassing $2 billion per therapy and timelines stretching 10–15 years, DIP's AI orchestration radically accelerates innovation — helping companies reinvest resources into science instead of paperwork. 'This is AI that thinks like a scientist, writes like a regulator, and moves at the speed of discovery,' added Shinya Yamamoto. 'We're not just helping companies go faster — we're helping them aim higher.' About Deep Intelligent Pharma Founded in 2017, Deep Intelligent Pharma is a pioneering AI company with global offices in Japan, China, and Singapore. Its mission is to empower pharmaceutical and medtech innovators through intelligent automation, turning regulatory complexity into a catalyst for speed, scale, and scientific excellence. DIP has built agent swarms based on generative AI models with outcome based payment model in life science R&D. Contact Info: Name: Xing Li Email: Send Email Organization: Deep Intelligent Pharma Website: Release ID: 89160572 Should you identify any discrepancies, concerns, or inaccuracies in the content provided in this press release or require assistance with a press release takedown, we strongly urge you to notify us promptly by contacting [email protected] (it is important to note that this email is the authorized channel for such matters, sending multiple emails to multiple addresses does not necessarily help expedite your request). Our responsive team is committed to addressing your concerns within 8 hours by taking necessary actions to resolve identified issues diligently or guiding you through the necessary steps for removal. Our dedication lies in providing accurate and reliable information.
Time of India
29-04-2025
- Automotive
- Time of India
Tabletop speed-breakers for 8 Pkl accident-prone sites
Panchkula: The Panchkula Metropolitan Development Authority (PMDA) on Tuesday initiated the installation of 19 tabletop speed breakers at eight high-risk locations throughout the city, aiming to enhance road safety and reduce accidents. The project, following road safety committee guidelines, is being implemented at a cost of Rs 36 lakh. On Tuesday, construction activities were undertaken on the primary road connecting the Panchkula Industrial Area to Rally Chowk via Govt Women's College, Sector 14. The road remained completely closed during construction and will continue to be inaccessible on Wednesday. All vehicles were directed to use alternative routes. The traffic police installed route markers with detailed instructions at strategic points to facilitate smooth traffic flow. According to PMDA, the distribution includes four tabletop speed breakers each at Sector 6-7 light point and Amartex Chowk; three at Tank Chowk; two each at Tau Devi Lal sports stadium, PG College, Sector 1, PG College (Women), Sector 14; and single installations near the DI office and Basantar Enclave in Sector 2. Police records indicate these locations have witnessed numerous fatal and non-fatal road accidents previously. Investigations revealed high-speed vehicular movement as a primary cause, prompting the road safety committee to recommend these tabletops to regulate traffic speed and prevent collisions. The speed breakers will incorporate zebra crossings, cat eyes, and road studs to enhance visibility and safety, alerting drivers about upcoming tabletops to prevent sudden braking. PMDA officials confirmed that the installed studs are designed to be vehicle-friendly and will not cause discomfort to road users. Growing fatalities Panchkula's road accident statistics show concerning trends over three years. The year 2024 recorded 105 deaths from 233 accidents, marking the highest fatality rate. In 2023, 98 deaths occurred in 236 accidents, while 2022 saw 103 fatalities from 238 road incidents. Many of these accidents occurred at the eight identified locations. MSID:: 120735777 413 |
Business Upturn
24-04-2025
- Business
- Business Upturn
Ami Organics receives GMP certification from Japan's PMDA for Ankleshwar Unit II
By Aditya Bhagchandani Published on April 24, 2025, 14:19 IST Ami Organics Ltd announced that its Unit II manufacturing facility in Ankleshwar, Gujarat, has been granted Good Manufacturing Practices (GMP) certification by Japan's Pharmaceutical and Medical Devices Agency (PMDA). The announcement was made via an exchange filing on April 24, 2025. The certified facility manufactures various intermediates used in Active Pharmaceutical Ingredients (APIs). This regulatory approval is a major milestone for the company, enabling it to expand its footprint in the Japanese pharmaceutical market and strengthen its positioning in other highly regulated geographies. The PMDA certification confirms that Ami Organics' manufacturing standards meet the stringent quality and safety norms required by Japanese authorities. It also reinforces the company's global compliance framework and commitment to high manufacturing standards. This recognition is expected to support the company's strategic goal of becoming a trusted partner for global pharmaceutical companies seeking high-quality API intermediates from India. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Always conduct your own research or consult a financial advisor before making investment decisions. Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
Yahoo
14-04-2025
- Business
- Yahoo
Japan Biopharmaceutical Logistics Market to Worth Over US$ 12.20 Billion by 2033
Japan's biopharmaceutical logistics market is propelled by demand for temperature-sensitive advanced therapies, regulatory modernization, and regenerative medicine export goals. Emphasis on sustainable infrastructure and precision logistics addresses ultra-cold storage and trial complexity. Chicago, April 14, 2025 (GLOBE NEWSWIRE) -- According to recent analysis conducted by Astute Analytica, the Japan biopharmaceutical logistics market was valued at US$ 6.34 billion in 2024 and is expected to reach US$ 12.21 billion by 2033, growing at a CAGR of 7.77% during the forecast period 2025-2033. Japan's biopharmaceutical logistics market is expanding due to its rapidly aging population, with over 29% aged 65+ as of 2024. This demographic shift fuels demand for biologics, including monoclonal antibodies and vaccines, which require stringent temperature-controlled logistics. The market, valued at $2.8 billion in 2023, is projected to grow at a 7.3% CAGR through 2030, driven by therapies for cancer, diabetes, and rare diseases. Regulatory emphasis on precision in storage (2°C–8°C for most biologics) and transport has intensified, with deviations causing 15% of product spoilage in 2022. Major logistics firms like Nippon Express and Kintetsu World Express now allocate 30% of cold chain capacity to biopharma, up from 18% in 2020. Additionally, 62% of hospitals now mandate real-time temperature tracking for biologics, up from 45% in 2021. Government initiatives, including subsidies for cold chain infrastructure, aim to reduce spoilage costs, which hit $240 million annually in 2023. Collaborations between pharma giants (e.g., Takeda) and logistics providers to deploy IoT-enabled containers have reduced transit errors by 22% since 2022. Download Free Sample Pages: Key Findings in Japan Biopharmaceutical Logistics Market Market Forecast (2033) US$ 12.21 million CAGR 7.77% By Logistics Type Cold Chain Logistics (71.76%) By Service Type Transportation Service (43.53%) By Product Type Vaccine (30.03%) By Mode of Transportation Air Transport (50.83%) By End User Pharmaceutical & Biotech Companies (54.80%) Top Drivers Aging population (30% >65) driving biologics demand for chronic diseases. Gene therapy regulatory reforms (PMDA 2023 guidelines) spurring clinical trial logistics. Export-focused regenerative medicine (iPSC therapies) requiring global GDP compliance. Top Trends AI-driven rural cold chain hubs for decentralized home healthcare distribution. Solar-powered warehousing + hybrid refrigerated trucks meeting 2050 net-zero mandates. Blockchain-IoT platforms minimizing biologics spoilage via real-time predictive analytics. Top Challenges Talent shortages in GDP-compliant ultra-cold (-80°C) logistics operations. High costs of precision infrastructure for small-batch advanced therapies. Cross-border standardization gaps between Japan's J-GDP and global CEIV protocols. Regulatory overhauls Shape Biopharma Logistics Compliance and Innovation Japan's Pharmaceuticals and Medical Devices Agency (PMDA) enforced revised GDP guidelines in April 2024, mandating blockchain for temperature data integrity and stricter audit trails. Non-compliance fines in the biopharmaceutical logistics market now exceed $500,000 per violation, up from $200,000 pre-2023. These rules align with ICH Q12 standards, requiring 99.5% temperature accuracy for biologics during transit. Logistics providers have invested $380 million in AI-powered predictive analytics to preempt equipment failures, reducing delays by 18% in Q1 2024. The PMDA's 'Green Cold Chain' initiative also incentivizes eco-friendly practices, with 25% tax rebates for firms using sustainable refrigerants like CO2-based systems. Additionally, the 2024 Biologics Safety Act requires real-time GPS tracking for high-value shipments (e.g., gene therapies), which constitute 12% of Japan's biopharma logistics volume. Custom brokers report a 30% rise in licenses for specialized biopharma transporters since 2022, reflecting heightened compliance complexities. Despite this, 40% of small logistics firms struggle to upgrade legacy systems, creating consolidation opportunities for giants like Sagawa Express. Cold Chain Infrastructure Investments Address Urban-Rural Distribution Gaps Japan's biopharmaceutical logistics market providers are racing to close urban-rural cold chain gaps, with 75% of advanced biologics distributed in Tokyo, Osaka, and Nagoya as of 2024. Rural areas face 23% longer delivery times, risking product efficacy. To counter this, Yamato Holdings launched 12 regional hubs in 2023 with -20°C storage, expanding reach to 88% of prefectures. The government's $1.2 billion Bio-Logistics Corridor project, active since 2022, funds drone deliveries for remote regions, cutting vaccine shipment times by 35%. Cold chain storage capacity grew 19% YoY in 2024, hitting 12.3 million cubic meters, yet demand outpaces supply by 8%. Mitsubishi Logistics now uses autonomous EVs with solar-powered refrigeration, reducing energy costs by 27%. However, rural clinics still experience 14% more temperature excursions than urban counterparts, per 2024 MHLW data. Partnerships with local pharmacies for 'last-mile' biologics storage have increased 40% since 2023, though scalability remains challenged by Japan's mountainous terrain. Strategic Alliances and M&A Reshape Market Competitive Dynamics The Japanese biopharmaceutical logistics market has been transformed by specific strategic moves, as evidenced by the Q3 2024 data showing 22 pharmaceutical M&A deals valued at $512.7 million. A notable technological implementation comes from the TriNetX-Fujitsu joint venture, which has established TriNetX Japan K.K., integrating the TriNetX LIVE™ platform that connects over 200 million patient records with Fujitsu's specialized healthcare cloud platform. This joint venture has implemented a federated system specifically designed to comply with Japan's stringent data privacy regulations, enabling secure handling of anonymous patient data for research purposes. The collaboration has directly impacted drug development timelines through the utilization of anonymized EHR data, particularly beneficial for Japan's aging population studies. The market dynamics of the Japan biopharmaceutical logistics market are further shaped by specific regulatory developments, particularly the Economic Security Bill's classification of pharmaceutical goods as "critical items." While major players like Nippon Express and DHL Logistics are adapting to these regulations, specific compliance measures from these companies are still being developed and implemented. The broader M&A landscape in early 2024 shows a trend toward smaller-scale acquisitions, with the Asia-Pacific region experiencing a 24% year-on-year decrease in transaction volume, totaling $132 billion. This trend is reflected in the biopharma sector's Q4 2024 median deal value of $800 million. The TriNetX-Fujitsu partnership specifically addresses social issues through Fujitsu's "Fujitsu Uvance" business model, which aims to eliminate drug loss in Japan by creating an ecosystem that effectively leverages medical data. These specific developments indicate a market shift toward technology-driven partnerships and smaller, more strategic acquisitions rather than large-scale consolidations. Have questions? Inquire about this report before purchasing: Advanced Technology Integration Enhances Supply Chain Visibility and Efficiency Japan's biopharmaceutical logistics market is leveraging cutting-edge technologies to mitigate risks in temperature-sensitive shipments, with AI and blockchain adoption surging 47% since 2022. Real-time monitoring systems now cover 78% of biologics shipments as of Q1 2024, up from 52% in 2021, driven by Pharma 4.0 initiatives from METI. These systems reduce human intervention by automating temperature adjustments, slashing excursion rates to 3.2% in 2024 from 8.5% in 2020. Blockchain's immutable ledger usage has grown exponentially, with 65% of logistics firms integrating it for audit trails, ensuring compliance with PMDA's revised Good Distribution Practices (GDP). For instance, Mitsui & Co.'s collaboration with IBM Japan in 2023 enabled end-to-end data transparency for mRNA vaccines, reducing regulatory approval delays by 30%. Today, IoT-enabled smart pallets, deployed by 40% of third-party logistics (3PL) providers in the biopharmaceutical logistics market, predict maintenance needs using vibration sensors, lowering equipment downtime by 25%. Meanwhile, AI-driven route optimization tools, like NEC's 2024 Cloud Logistics Platform, cut fuel costs by 18% while maintaining 99.1% on-time delivery rates for biologics. This tech convergence is critical as Japan's biopharma imports rise (up 22% YoY in 2024), demanding seamless coordination between ports, airports, and inland hubs. Sustainability Initiatives Reshape Cold Chain Energy Consumption and Design Japanese firms active in the biopharmaceutical logistics market face mounting pressure to decarbonize, with cold chains contributing 12% of the sector's carbon emissions in 2023. The 2024 Revised Energy Conservation Act mandates a 30% reduction per shipment by 2030, spurring investments in renewable energy-powered warehouses. Solar-equipped cold storage facilities, like those operated by Konoike Transport, now cover 15% of national capacity, up from 4% in 2020, reducing grid dependence by 40%. Hydrogen fuel cell refrigeration units, piloted by JR Freight in 2023, cut per-truck emissions by 58% and are slated for nationwide rollout by 2025. Biodegradable phase-change materials (PCMs), adopted by 28% of packagers, extend temperature stability by 20% while reducing polystyrene waste, which previously comprised 35% of packaging debris. The PMDA's 'Green Label' certification, introduced in 2024, grants tax breaks to companies achieving full circularity in cold chain packaging—a standard met by only 9% of firms so far in the biopharmaceutical logistics market. Challenges persist, however: sustainable refrigerants like CO2 and ammonia cost 22% more than traditional fluorinated gases, squeezing mid-sized players. To bridge this gap, METI's $150 million Green Cold Chain Fund offers low-interest loans, spurring a 65% jump in eco-upgrades since 2023. Talent Shortages and Automation Define Workforce Strategies in Biopharma Logistics A crippling 34% shortage of qualified cold chain technicians in 2024 is accelerating automation across Japan's biopharmaceutical logistics market. The gap stems from an aging workforce—35% of specialists will retire by 2027—and insufficient STEM graduates entering the field (only 12% in 2023 vs. 21% in South Korea). Firms like Sagawa Express are responding by deploying AI-guided robotics in 60% of warehouses, up from 18% in 2021, to handle labeling, sorting, and inventory. Autonomous forklifts, integrated with digital twins, have reduced loading errors by 44% at Nippon Express's Osaka hub since 2023. Meanwhile, augmented reality (AR) tools train new hires 50% faster by simulating temperature excursion scenarios, addressing the 6-month backlog in certification programs. The government's 2024 Robotics Subsidy Program offsets 25% of automation costs, prompting a 300% spike in collaborative robot (cobot) installations for QC tasks. Yet, human oversight remains critical: PMDA mandates at least one GDP-certified supervisor per shipment, creating demand for hybrid roles blending tech and regulatory skills. Salaries for such roles rose 19% in 2024, reflecting fierce competition, but attrition rates still hover at 14% due to high stress. Pandemic Preparedness and Stockpiling Reshape Inventory Management Priorities Japan's post-pandemic biopharmaceutical logistics market strategies prioritize redundancy, with the National Health Ministry doubling vaccine stockpiles to 240 million doses in 2024. This follows 2021's influenza-COVID co-circulation crisis, which exposed vulnerabilities in just-in-time inventory models, causing 23% of clinics to report biologic shortages. Distributed storage models now dominate, with 65% of firms using multi-location hubs (vs. 38% in 2021) to insulate against regional disruptions like Typhoon Hagibis II in 2024, which halted Kansai-area deliveries for 72 hours. AI-driven demand forecasting tools, such as Fujitsu's Biologics Inventory Optimizer, dynamically adjust stock levels, reducing overstock waste by 31% while maintaining 98% fill rates. The PMDA's new 'Resilience Index' rating, mandatory since April 2024, grades logistics providers in the biopharmaceutical logistics market on backup power capacity (+20% YoY growth in generator-equipped warehouses) and alternative transport contracts. Partnerships with airlines like ANA and JAL now guarantee 36% of biologics airfreight capacity during emergencies, up from 15% pre-pandemic. However, smaller hospitals still lack onsite mRNA freezer farms, relying on 3PLs for 89% of ultra-cold chain needs—a dependency that spiked costs by 18% during 2024's RSV vaccine rush. Japan Biopharmaceutical Logistics Market Major Players: Cencora Corporation (World Courier) ITOCHU Logistics Corp Nippon Express Co., Ltd DHL International GmbH United Parcel Service of America, Inc. Mitsubishi Logistics Corporation GREEN8 Co., Ltd. Other Prominent Players Key Segmentation: By Logistics Type Cold Chain Logistics Non- Cold Chain Logistics By Service Type Storage Service Transportation Service Packaging Service Monitoring and Tracking Service By Product Type Vaccines Blood Products Specialty Drug Monoclonal Antibodies Others By Mode of Transportation Air Transport Ground Transport Water Transport By End User Pharmaceutical & Biotech Companies Academic & Research Institutions Hospitals and Specialty Clinics Others Looking for expert insights? Request an online presentation of the report from our analyst: About Astute Analytica Astute Analytica is a global market research and advisory firm providing data-driven insights across industries such as technology, healthcare, chemicals, semiconductors, FMCG, and more. We publish multiple reports daily, equipping businesses with the intelligence they need to navigate market trends, emerging opportunities, competitive landscapes, and technological advancements. With a team of experienced business analysts, economists, and industry experts, we deliver accurate, in-depth, and actionable research tailored to meet the strategic needs of our clients. At Astute Analytica, our clients come first, and we are committed to delivering cost-effective, high-value research solutions that drive success in an evolving marketplace. Contact Us:Astute AnalyticaPhone: +1-888 429 6757 (US Toll Free); +91-0120- 4483891 (Rest of the World)For Sales Enquiries: sales@ Follow us on: LinkedIn | Twitter | YouTube CONTACT: Contact Us: Astute Analytica Phone: +1-888 429 6757 (US Toll Free); +91-0120- 4483891 (Rest of the World) For Sales Enquiries: sales@ Website: in to access your portfolio
Yahoo
08-04-2025
- Business
- Yahoo
Poxel Announces Regulatory Approval by Japanese Authorities to Expand TWYMEEG® Package Insert to Include Type 2 Diabetes Patients with Renal Impairment
Approval by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan enables TWYMEEG® (Imeglimin) to be prescribed to type-2 diabetic patients with moderate to severe renal impairment. This approval is based on the results of the Phase 4 TWINKLE study Sumitomo Pharma to immediately start promoting the use of the product in this new patient population, further supporting efforts to maximize TWYMEEG opportunity in Japan This regulatory milestone could also support Poxel's strategy and ongoing discussions to develop and commercialize Imeglimin outside of Japan LYON, France, April 08, 2025--(BUSINESS WIRE)--Regulatory News: POXEL SA (Euronext : POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today announces that the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has approved the revision of TWYMEEG® package insert for patients with renal impairment with eGFR (estimated glomerular filtration rate) less than 45 mL/min/1.73m2. This approval follows positive topline results from the post-marketing clinical study TWINKLE (TWYMEEG® in diabetic patients with renal impairment: A post-marketing long-term study) in Japanese type 2 diabetic patients with renal impairment, which confirmed TWYMEEG®'s safety and tolerability profile, as announced last August1. Based on these results, discussions with the Japanese regulatory authorities were initiated by Sumitomo Pharma, resulting in the approval that will be officially implemented by Sumitomo Pharma as of April 8, 2025. "The approval of the revised TWYMEEG® package insert from the regulatory authorities in Japan is a major milestone for Sumitomo Pharma allowing us to address a key patient population, particularly elderly individuals with renal impairment, who are faced with limited treatment options. TWYMEEG® is an important asset in our existing diabetes franchise, and we remain fully committed to support its sales trajectory, building on the safety and tolerability profile observed from TWINKLE study", stated Koichi Kozuki, Executive Officer, Corporate Regulatory Compliance & Quality Assurance Division, Senior Vice President, Head of Corporate Regulatory Compliance & Quality Assurance Division of Sumitomo Pharma. "This regulatory achievement, combined with recent patent approvals, further strengthens TWYMEEG®'s prescription strategy in a large patient population with high unmet medical need", added Thomas Kuhn, Chief Executive Officer of Poxel. "Given the high prevalence of renal impairment among type-2 diabetic patients, this approval further strengthens the product's commercial potential in other Asian territories." This milestone builds on the newly granted patent (n°7635474) by the Japanese Patent Office to Poxel2 covering the use of Imeglimin in type-2 diabetic patients with moderate to severe renal impairment until 2039, strengthening TWYMEEG®'s patent portfolio in Japan and protecting its use in this population. Poxel previously received the grant of this patent in China3, the world's second largest type-2 diabetes market, further supporting ongoing discussions initiated by Poxel to develop Imeglimin beyond Japan. About TWYMEEG® TWYMEEG® is the first agent in a class of tetrahydrotriazine-containing molecules. It is thought that the Drug shows a glucose lowering effect by both a pancreatic action that promotes glucose concentration-dependent insulin secretion and an extra-pancreatic action that improves glucose metabolism in the liver and skeletal muscle (suppression of gluconeogenesis and improvement of glucose uptake), through acting on mitochondria. The Drug has the potential to prevent endothelial and diastolic dysfunction, which could provide protective effects on micro- and macrovascular defects induced by diabetes. It may also have protective effects on pancreatic β cell survival and function. Owing to its unique mechanism of action, the Drug is widely used for glucose lowering in the treatment of type 2 diabetes, either as monotherapy or as an add-on to other therapies for this purpose. In October 2017, Sumitomo Pharma concluded a development and commercialization partnership agreement for Japan, Chinese mainland, Taiwan, Korea and nine Southeast Asian countries with Poxel SA (Head Office: Lyon, France; CEO: Thomas Kuhn) and started selling the Drug in Japan in September 2021. In September 2024, Sumitomo Pharma and Poxel amended this agreement, whereby Poxel received the rights back from Sumitomo for all territories under the agreement except Japan. About Sumitomo Pharma Co., Ltd. Sumitomo Pharma Group defines its Mission as "To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide." By pouring all our efforts into the research and development, the Group aims to provide innovative and valuable pharmaceutical and healthcare solutions to people in Japan and around the world in order to realize its Mission. The Group will remain committed to research and development with the aim of continually discovering excellent pharmaceuticals, regenerative medicine/cell therapy, non-pharmaceutical products, and others with a focus on the Psychiatry & Neurology and Oncology as priority disease areas. For more details, please visit website: About Poxel SA Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R-pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG® (Imeglimin), Poxel's first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan. For more information, please visit: All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by or including words such as "target," "believe," "expect," "aim," "intend," "may," "anticipate," "estimate," "plan," "project," "will," "can have," "likely," "should," "would," "could" and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release. __________________________1 "Sumitomo Pharma and Poxel Announce Topline Results from Post-Marketing Clinical Study on TWYMEEG® for the Treatment of Type 2 Diabetes in Japan", August 7, 20242 "Poxel Announces Grant of New Patent in Japan for the Use of Imeglimin in Type-2 Diabetic Patients with Renal Impairment", on March 31, 20253 "Poxel Announces the Grant of Patent in China Protecting the Use of Imeglimin for Type-2 Diabetic Patients with Renal Impairment", on January 20, 2025 View source version on Contacts Contacts - Investor relations / Media NewCapAurélie Manavarere, Théo Martin / Arthur Rouilléinvestors@ +33 1 44 71 94 94 Sign in to access your portfolio
