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مطارات المملكة: ريادة عالمية في التطوير والتنمية
تعد المملكة العربية السعودية واحدة من الدول الرائدة في منطقة الشرق الأوسط، حيث استطاعت أن تحقق قفزات نوعية في شتى المجالات التي تخدم التنمية المستدامة. ومن بين تلك المجالات التي شهدت تطويراً لافتاً هو قطاع المطارات، الذي أضحى محط أنظار العالم بفضل الاستثمارات الهائلة والرؤى المستقبلية التي تهدف إلى جعل المملكة مركزاً عالمياً للسفر والسياحة. تمتاز مطارات المملكة اليوم بكونها بوابات حديثة تجمع بين التصميم المعماري الفاخر والبنية التحتية المتطورة التي تلبي احتياجات المسافرين والشركات العاملة.الاستراتيجية الوطنية للطيرانتلتزم المملكة برؤية 2030 التي تهدف إلى تنويع اقتصادها وتقليل الاعتماد على النفط. ولتحقيق هذا الهدف، تم تطوير استراتيجية وطنية شاملة لقطاع الطيران، تشمل تحسين البنية التحتية للمطارات وزيادة عدد الرحلات الدولية وتحسين تجربة السفر بشكل عام. تهدف المملكة إلى زيادة طاقة المطارات لتستوعب أكثر من 300 مليون مسافر سنويًا بحلول عام 2030، مما يجعلها واحدة من أكبر مراكز الطيران في العالم.نموذج لمطار الملك خالد الدولييعد مطار الملك خالد الدولي في الرياض مثالًا حيًا على التطور الحديث في مجال المطارات. تم تحسين المطار ليتماشى مع أعلى معايير الجودة العالمية، مع إضافة تقنيات متقدمة مثل بوابات ذكية لتسريع عملية الفحص والترحيب بالمسافرين. إضافة إلى ذلك، تم تجهيز المطار بوسائل الراحة الحديثة والمساحات التجارية التي تلبي احتياجات الجميع من رجال الأعمال إلى العائلات.التكنولوجيا في خدمة تجربة السفرتعتبر التكنولوجيا من أبرز العوامل التي ساعدت في جعل مطارات السعودية منافسة على المستوى العالمي. استخدام الذكاء الاصطناعي والروبوتات في عمليات تسجيل الدخول ومتابعة الأمتعة ساهم بشكل كبير في جعل تجربة السفر أكثر سلاسة وراحة. يمكن للمسافرين الآن إكمال الإجراءات إلكترونيًا دون الحاجة للتواصل المباشر مع الموظفين، مما يقلل من أوقات الانتظار ويُحسّن رضا العملاء.تستخدم مطارات المملكة البيانات الضخمة لتحليل سلوك المسافرين والتنبؤ بطلباتهم المستقبلية. من خلال مراقبة البيانات وتحليلها، يتم تحسين جداول الرحلات وإعادة توزيع الموارد البشرية، مما يسهم في تحسين الكفاءة التشغيلية للمطارات. مثال على ذلك، مطار جدة الجديد الذي يعتمد بشكل كبير على تحليل البيانات لتقديم تجربة مخصصة لكل مسافر.تم تجهيز المطارات السعودية بأحدث التقنيات الأمنية لضمان سلامة المسافرين. يتم استخدام أجهزة متقدمة لفحص الأمتعة وجوازات السفر باستخدام تقنيات التعرف على الوجه، مما يقلل من الوقت اللازم للتفتيش ويحسن الكفاءة بشكل عام. يتماشى ذلك مع الجهود العالمية لتحسين أمان الطيران دون التأثير على تجربة السفر.مطارات المملكة محور للسياحة العالميةازدهرت السياحة بشكل لافت في المملكة، خاصة مع افتتاح وجهات سياحية جديدة مثل مشروع البحر الأحمر ومدينة نيوم. ومع ذلك، تلعب المطارات دورًا هامًا في دعم هذا النمو السياحي حيث تم تحسين الاتصال الجوي بين السعودية وبقية دول العالم.شهدت السنوات الأخيرة إطلاق خطوط طيران جديدة وربطها بمدن رئيسية في آسيا، أوروبا، وأفريقيا. مطار الأمير محمد بن عبد العزيز الدولي في المدينة المنورة يستقبل الآلاف من الحجاج والمعتمرين سنويًا، مما يعكس الدور الثقافي والديني المهم للمملكة.توفر المطارات السعودية خدمات متميزة مثل مكاتب تأجير السيارات، خدمات السياحة الداخلية، والمعلومات السياحية التي تساعد الزوار على اكتشاف المملكة بكل سهولة. إضافة إلى التواجد القوي للفنادق الفاخرة داخل وحول المطارات، مثل فندق تيرمنال 5 في مطار الملك خالد الدولي، الذي يوفر تجربة إقامة متكاملة للمسافرين.استثمارات ضخمة لتطوير البنية التحتيةضخت المملكة استثمارات هائلة لتحديث وتوسيع قدرات بنيتها التحتية للمطارات. هذه الاستثمارات تشمل مشاريع ضخمة مثل مشروع توسعة مطار الملك عبد العزيز الدولي في جدة، الذي أصبح أحد أكبر وأهم المطارات في المنطقة.يشمل المشروع وسائل جديدة لتسهيل حركة الركاب مثل القطار الداخلي والمرافق التجارية الحديثة. إضافة إلى صالات انتظار فائقة الفخامة ومرافق مخصصة لرجال الأعمال. هذا بالإضافة إلى القدرة العالية لاستقبال أكثر من 30 مليون مسافر سنويًا.الجوائز والتقديرات العالميةحصلت مطارات المملكة على جوائز عالمية من جهات مرموقة، مما يعكس التقدم الكبير الذي تم تحقيقه في هذا القطاع. على سبيل المثال، تم تصنيف مطار الدمام الدولي كواحد من أفضل مطارات العالم من حيث مستوى الخدمة والراحة.دور القطاع الخاص في التطويرلم يكن هذا التطور الكبير ليحدث لولا التعاون الوثيق بين القطاعين العام والخاص. شركات مثل "مطارات الرياض" وشركة الطيران الاقتصادي "طيران ناس" ساهمت بشكل مباشر في تحسين مستوى الخدمات وزيادة المنافسة.من أبرز الأمثلة على ذلك، مشروع توسعة مطار الطائف الذي تم بفضل تعاون مستثمرين محليين ودوليين. هذا النوع من المشاريع يدعم الاقتصاد الوطني ويوفر فرص عمل جديدة للمواطنين.الطموح نحو المستقبلتحمل المملكة طموحات أكبر لجعل مطاراتها من بين الأفضل عالميًا. تعتزم تطوير المزيد من المشاريع مثل توسعة مطارات الشمال وتطوير محطات جديدة للشحن الجوي لتلبية الطلب المتزايد على الخدمات اللوجستية.يبرز مطار نيوم كمثال حي على الرؤية المستقبلية. يعتبر هذا المطار جزءًا من مشروع نيوم الكبير الذي يهدف إلى جعل المملكة مركزًا للابتكار والتكنولوجيا والسياحة. يتميز المطار بتصميمه الذكي وتقنياته الفريدة التي تمزج بين الراحة والابتكار.تدرك المملكة أهمية التكيف مع التغيرات العالمية في قطاع السفر، مثل الاهتمام بالاستدامة والطاقة النظيفة. لذلك، تعمل المطارات السعودية على تقليل بصمتها الكربونية من خلال استخدام الطاقة الشمسية وإعادة التدوير.تم نشر هذا المقال على موقع سائح
2026-02-22 01:45:31

Award-Winning Beatbot Sora 70 Robotic Pool Cleaner Now Available for Purchase
RICHMOND, Texas, Feb. 13, 2026 /PRNewswire/ -- Beatbot, a global leader in smart pool robotics, today announced the market availability of the Beatbot Sora 70, its new award-winning robotic pool cleaner that delivers full, automated pool cleaning, covering the water surface, walls, waterline, floor, and shallow platforms, in a single device. After earning five media awards at CES 2026, the Beatbot Sora 70 is now available for pool owners to purchase in two color options, Lavender Purple and Deep Blue. "Beatbot Sora 70 was built around a simple idea: one streamlined product that actually cleans the entire pool," said Jimmy Hu, VP at Beatbot. "From surface skimming to walls, floors, and the waterline, the Beatbot Sora 70 handles everything automatically. It's the only robot in the segment that truly does it all without requiring extra tools or manual steps." The Beatbot Sora 70 is available for purchase beginning February 13 on Beatbot.com. Complete Pool Coverage in One SystemThe Sora 70 features Beatbot's JetPulseTM twin-jet surface skimming technology, designed to actively guide floating debris toward the suction inlet rather than pushing it aside during movement. This is paired with true four-zone cleaning, enabling the robot to clean: The water surface Pool walls The waterline The pool floor In addition, Sora 70 cleans shallow platforms and tanning ledges in water as shallow as 8 inches (20 cm), treating these areas as standard cleaning zones rather than special cases. Navigation and coverage are supported by SonicSenseTM Obstacle Avoidance, which uses ultrasonic sensing to detect obstacles, platform heights, slopes, and transitions, allowing the robot to adapt to different pool designs and layouts. Designed for Hands-Off OperationBeatbot Sora 70 is built for minimal user intervention. It delivers up to 5 hours of floor cleaning on a single charge, features a 6-liter debris capacity to reduce mid-cycle emptying, and automatically parks itself at the pool edge when a cleaning cycle is complete or battery levels are low, enabling easy retrieval. Pricing and AvailabilityThe Beatbot Sora 70 is available for purchase beginning February 13 on the official Beatbot website, with an MSRP of $1,499. Tech Specs[1] Cleaning Coverage: Surface, walls, waterline, floor, platforms Surface Cleaning: JetPulseTM twin-jet surface skimming Obstacle Avoidance: SonicSenseTM ultrasonic obstacle detection Suction Power: 6,800 GPH Debris Capacity: 6L Battery Capacity: 10,000 mAh Runtime: Up to 5 hours (floor cleaning, ECO mode) Up to 7 hours (surface cleaning) Minimum Water Depth: 8 inches Pool Size Coverage: Up to 3,230 sq ft Dimensions: 17.09 × 16.93 × 11.22 inches Weight: 22.9 lbs Ingress Protection: IP68 waterproof About Beatbot Beatbot is the fastest-growing premium robotic pool cleaning brand worldwide. Driven by continuous innovation, it empowers people to perfect pool living and enrich their everyday life. Founded on a mission to reimagine pool care through intelligence and design, Beatbot holds around 500 patents (granted and pending) and is powered by a team where 60% are R&D experts. The company pioneers advanced automation technologies that are effortless, intelligent, and beautifully designed. By inspiring a new standard of living, Beatbot ensures that its technology disappears into the background, giving users back their time, confidence, and pride. [1] *All data above are based on internal testing conducted by Beatbot. Actual performance may vary depending on environment and conditions of use.
2026-02-13 14:00:00

Groundbreaking Innovations from TCL Transform How Fans Enjoy the Olympic Winter Games in Milano Cortina and Around the World
Technology enhances athlete comfort and connection throughout the event MILAN, Feb. 13, 2026 /PRNewswire/ -- With the Olympic Winter Games in full swing, Worldwide Olympic Partner TCL is playing a key role in supporting how millions of people enjoy Milano Cortina 2026 around the world by supplying advanced display technology and expertise for the International Broadcast Centre (IBC), the central technical hub for global media coverage operated by Olympic Broadcasting Services (OBS). The company has provided large quantities of TV screens, as well as commercial display screens and a large-scale LED installation, to empower media organizations in bringing the Olympic Winter Games to global audiences with exceptional clarity and fidelity. Additionally, TCL has equipped the IBC's visitor exhibition area with its latest flagship innovation, the groundbreaking TCL X11L SQD-Mini LED TV. Standing for Super Quantum Dot, it sets a new standard for display technology with unmatched brightness and contrast, exceptional color performance, an industry‐first, ultra‐slim, borderless design, and top‐tier audio—creating an unparalleled visual and audio experience. TCL also provided its 65-inch televisions for the Main Press Center (MPC) to help the world's media follow every moment of the action, and additional TVs across Olympic venues. Among the provided TVs, the 55" screens will play a vital role in supporting the "Athlete Moment," where athletes can see and speak with family and friends at home immediately after their events with unmatched clarity. By making it feel as though their loved ones are at their side, TCL's technology is helping to create powerful moments of connection and celebration throughout the Olympic Winter Games. Yiannis Exarchos, the CEO of OBS, said: "We are delighted to welcome TCL as a Worldwide Olympic Partner. Only a select number of companies globally have the scale, capability, innovation, and technology required to meet the demands we face as the host broadcaster of the Olympic Games—and even fewer pair that with a deep understanding of Olympic values and the power of the Olympic Winter Games to bring people together." Beyond supporting the competition and broadcast, TCL is also enhancing daily life in the Anterselva and Livigno Olympic Villages by providing smart home appliances, supporting athletes' comfort through technology thanks to the smart washing machines and dryers that keep competition gear fresh. Additionally, the Plaza of the Milano Olympic Village features a space showcasing TCL's latest innovations, including AI-enabled air conditioners and TCL RayNeo AR glasses. The glasses are the ideal partner for athletes as they offer real-time translation through augmented reality and can provide navigation cues and information as they explore Milan. Li Dongsheng, Founder and Chairman of TCL said: "The Olympic Games provide an unmatched spectacle of excitement and excellence and our aim is to ensure that fans on-site, athletes, and audiences worldwide are able to enjoy the event in new ways. Through our groundbreaking technology, we're proud to know that viewers can feel closer to the action than ever before." Such technology also elevates the at-home excitement around the Olympic Winter Games, capturing the spectacle of the competition with an extraordinary degree of realism. Part of TCL's vision of a 'screen universe', these innovations have been developed through TCL's robust global infrastructure built over 27 years, comprising 47 R&D centers and 39 manufacturing bases serving over 1.3 billion users around the world. This track record has helped TCL rank as the Global Top 2 TV brand and the Global No. 1 brand for Mini LED TV shipments, securing a 29.4% market share in the category. About TCL Founded in 1981, TCL—short for "The Creative Life"—embodies creativity in every aspect of life. As a leading technology company, TCL is dedicated to delivering innovative solutions—including TVs, audio products, smart home devices, display technologies, and clean energy—that enhance customer experiences through TCL Industries and TCL Technology. As of now, with 47 R&D centers and 39 manufacturing bases globally, TCL operates in over 160 countries and regions, cementing its position as a globally competitive smart technology brand. To further inspire greatness, TCL has become an official Worldwide Olympic and Paralympic Partner in the Home Audiovisual Equipment and Home Appliances category.
2026-02-13 13:57:00

Nova Technology Marks a Promising Start in AI Expansion Across Hong Kong and the Middle East
SHANGHAI, Feb. 9, 2026 /PRNewswire/ -- Nova Technology, a leading AI technology company in China's insurance industry, today announced early progress in its international expansion strategy. In Hong Kong, Nova Technology has partnered with several leading local insurers on AI technology and AI-powered claims services. In the Middle East, its flagship AI claims product has secured a collaboration with an innovative UAE-based insurance company. These partnerships mark a promising start to Nova Technology's global deployment of insurance AI solutions. In the Hong Kong market, Nova Technology is leveraging its core competencies in AI-driven claims management and risk control to deliver AI-powered claims services for a global insurance group. The company has also worked with a leading Hong Kong life insurer to upgrade and deploy its market-proven AIGC solution—previously validated in the domestic market—across Southeast Asia. The solution has been localized to align with regional business practices and regulatory requirements, supporting stable and scalable implementation. Marking its inaugural entry into the Middle East, Nova Technology has been selected as the AI technology partner for an innovative UAE-based insurer, providing AI-driven risk control capabilities and an end-to-end AI claims solution to support the modernization of the insurer's core operations. As the global insurance industry accelerates its digital and intelligent transformation, Chinese technology companies are entering a more pragmatic, execution-focused phase of international expansion. Nova Technology noted that both Hong Kong and the Middle East are highly representative markets, characterized by stringent regulation, complex product structures, and sophisticated operations. These factors place higher demands on the stability, compliance, and real-world applicability of AI technologies, making the two regions important proving grounds for insurance AI solutions. As a mature insurance market, Hong Kong has traditionally focused on premium health coverage. In recent years, it has gradually expanded toward mid-tier and inclusive health products. As coverage broadens, insurers face increasing complexity in underwriting and claims management, driving demand for more precise risk assessment and more efficient claims handling. In this context, AI is playing a growing role in managing complex claims, analyzing risk, and supporting product design. By contrast, the Middle East insurance market remains in a development phase, with sustained population growth driving rapid demand for health insurance. While expanding coverage and improving customer experience, insurers are also facing higher requirements for claims efficiency, regulatory compliance, and digital operations. In this environment, AI is primarily used to enhance operational efficiency and scalability, helping insurers manage rapid growth and increasingly diverse customer needs. To address the distinct requirements of different markets, Nova Technology continues to refine its AI offerings. Its flagship solutions—including Risk Insight for risk control, Alamos for customer lifecycle management, and Lop Nor for claims—are being enhanced with market-specific knowledge bases aligned with local regulations, medical practices, and business processes. This approach supports effective deployment across multiple markets. Sam Lu, CEO of Nova Technology, said, "Our collaborations with insurance institutions in Hong Kong and the Middle East demonstrate that our insurance AI solutions can perform effectively across diverse regulatory and operational environments. We will continue to leverage scalable, production-ready AI capabilities to help insurers strengthen risk management, improve operational efficiency, and enhance service quality." Based on operational results for the six months ended June 30, 2025, Nova Technology's LLMs achieved an accuracy rate of 98% in claims review scenarios. The average automation rate for claims adjudication reached around 70%, peaking at 80%, with more than 200 million underwriting reviews and claims investigations processed in total. These capabilities have helped insurers reduce loss ratios by 10 to 23 percentage points, while significantly improving automation and operational efficiency across underwriting and claims workflows. Looking ahead, Nova Technology will continue innovating around real-world insurance scenarios, enabling its AI solutions to deliver enduring value across global insurance markets and support the industry's ongoing intelligent transformation.
2026-02-09 08:20:00

Ispire Technology Inc. Reports Financial Results for Fiscal Second Quarter 2026
Ongoing Focus on Collections Drives 19% Reduction in Net Accounts Receivable since June 30, 2025Cash of $17.6 Million at December 31, 2025 LOS ANGELES, Feb. 6, 2026 /PRNewswire/ -- Ispire Technology Inc. (NASDAQ: ISPR) ("Ispire," the "Company," "we," "us," or "our"), an innovator in vaping technology and precision dosing, today reported financial results for the second quarter of fiscal 2026, for the three months ended December 31, 2025. Fiscal Second Quarter 2026 Financial Results Revenue of $20.3 million versus $41.8 million for the second quarter of fiscal 2025. Gross profit of $3.5 million compared to $7.7 million for the second quarter of fiscal 2025. Gross margin of 17.1% compared to 18.5% for the second quarter of fiscal 2025. Total operating expenses of $10.3 million compared to $15.1 million for the second quarter of fiscal 2025. Net loss of $6.6 million, compared to net loss of $8.0 million in the second quarter of fiscal 2025. "This quarter represented an inflection point for Ispire during its yearlong cost cutting and customer quality rationalization efforts and we believe future quarters will see top line growth, consistent cash flows and bottom-line improvement. We are confident we have laid a solid foundation for future success," commented Michael Wang, Co-Chief Executive Officer of Ispire. "During the second quarter of fiscal 2026, we maintained our focus on prioritizing high-quality revenue, and reinforcing our disciplined and intentional approach to sustainable growth. This was particularly evident in our efforts to reduce net accounts receivable, which continues to have strong success. Over the second fiscal quarter we reduced net accounts receivable by 19.5% to $37.9 million, compared to $47.0 million at the end of fiscal year 2025." "We continue to lay important groundwork across core areas of the business, including the ramp up of our manufacturing capabilities in Malaysia as we prepare to increase production throughout fiscal 2026. Momentum continues to build for our proprietary G-Mesh technology, with several large and mid-sized nicotine manufacturers engaged in discussions to evaluate its use in next-generation vaping devices, as we work toward potential licensing and partnership opportunities. In addition, our IKE Tech joint venture is making steady global progress, collaborating with regulators across Europe, Southeast Asia, and the Middle East to support the broader adoption of age-gating technology as a safer industry standard. In the US, although most adult consumers want flavored e-cigarettes, nearly all of the flavored e-cigarettes are both unauthorized by the FDA and sold through illicit channels. While we welcome the US Federal Government's strengthened enforcement mandate of the illicit trade of vapes, we believe that such enforcement can only be truly effective by pairing it with the creation of a robust, legal market of FDA authorized flavored e-cigarette products. Ispire, with IKE, is a key player in the creation of this market of legal, approved products, using its technologies to both prevent youth-access, ensure product authenticity and provide solutions to secure devices before misuse occurs. This is where we are seeing macro tailwinds in our favor relating to the US FDA's stated position on flavored ENDS products and age-gating. Since October 2025, the FDA's explicit position is that you must have age gating technology if you want flavored products approved. Ispire, through its IKE joint venture, has one of the leading and most low friction technologies in this space, and we look forward to capitalizing on this opportunity in due time", Mr. Wang concluded. Jay Yu, Chief Financial Officer of Ispire, said, "The second quarter of fiscal 2026 reflects continued progress as we focused on strengthening the Company's financial foundation. Disciplined cost controls drove a year-over-year decline in operating expenses, which decreased from $15.1 million to $10.3 million over the second fiscal quarter, highlighting the impact of our efficiency initiatives. Our net accounts receivable also declined to $37.9 million as of December 31, 2025, compared with $47.0 million as of June 30, 2025, reflecting our ongoing focus on higher-quality customers. These actions position the Company for enhanced financial flexibility and support sustained value creation over the long term." Financial Results for the Fiscal Second Quarter Ended December 31, 2025 Ispire reported revenue of $20.3 million for the fiscal second quarter ended December 31, 2025, versus $41.8 million for the prior comparable period. The decrease in revenue is due to the strategic shift away from lower quality cannabis customers, resulting in a decrease of overall product sales. For the second quarter of fiscal 2026, gross profit was $3.5 million compared to $7.7 million in the prior comparable quarter. Gross margin was 17.1% compared to 18.5% for the second quarter of fiscal 2025. The decrease in gross margin was primarily due to changes in product mix with less higher margin products being sold during the three months ended December 31, 2025. Total operating expenses were $10.3 million for the second fiscal quarter of 2026, compared to $15.1 million for the same period last year. Net loss was $6.6 million or $0.12 per share for the fiscal second quarter of 2026, versus a net loss of $8.0 million, or $0.14 per share for the fiscal second quarter of 2025. At December 31, 2025, Ispire held cash of $17.6 million and working capital of $3.5 million. Conference Call The Company will conduct a conference call at 8:00 am ET on Friday, February 6, 2026, to discuss the results, followed by a Q&A session. To listen to the conference call, please dial in using the information below. When prompted upon dialing-in, please ask for the "Ispire Technology Call." Date: Friday, February 6, 2026 Time: 8:00 am ET Dial-In Numbers: United States 877-451-6152 or International +1 201-389-0879 This conference call will be webcast live and can be accessed by all interested parties at https://viavid.webcasts.com/starthere.jsp?ei=1749224&tp_key=1ec45fe266. Please access the link at least fifteen minutes prior to the start of the call to register, download, and install any necessary audio software. A playback will be available until 11:59 pm ET on Friday, February 20, 2026. To listen, please dial 1-844-512-2921 or 1-412-317-6671. Use the passcode 13758138 to access the replay. About Ispire Technology Inc.Ispire is engaged in the research and development, design, commercialization, sales, marketing and distribution of branded e-cigarettes and cannabis vaping products. The Company's operating subsidiaries own or license more than 400 patents worldwide. Ispire's branded e-cigarette products are marketed under the Aspire name and are sold worldwide (except in the U.S., People's Republic of China and Russia) primarily through its global distribution network. The Company also engages in original design manufacture (ODM) relationships with e-cigarette brands and retailers worldwide. The Company's cannabis products are marketed under the Ispire brand name primarily on an ODM basis to other cannabis vapor companies. Ispire sells its cannabis vaping hardware in the US, Europe and South Africa and it recently commenced marketing activities and customer engagement in Canada and Latin America. For more information, visit www.ispiretechnology.com or follow Ispire on Instagram, LinkedIn, Twitter and YouTube. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended ("Securities Act") as well as Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended, that are intended to be covered by the safe harbor created by those sections. Forward-looking statements, which are based on certain assumptions and describe the Company's future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate," "strategy," "future," "likely" or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the Company's strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the Company's actual results and financial condition to differ materially from those indicated in the forward-looking statements. Such forward-looking statements include, but are not limited to, risks and uncertainties including those regarding: whether the Company may be successful in re-entering the U.S. ENDS market; the approval or rejection of any PMTA submitted by the Company; whether the Company will be successful in its plans to further expand into the African market; whether the Company's joint venture with Touch Point Worldwide Inc. d/b/a/ Berify and Chemular Inc. (the "Joint Venture") may be successful in achieving its goals as currently contemplated, with different terms, or at all; the Joint Venture's ability to innovate in the e-cigarette technology space or develop age gating or age verification technologies for nicotine vaping devices; the Company's ability to collect its accounts receivable in a timely manner; the Company's business strategies; the ability of the Company to market to the Ispire ONETM; Ispire ONETM's success in meeting its goals; the ability of its customers to derive the anticipated benefits of the Ispire ONETM and the success of its products on the markets; the Ispire ONETM proving to be safe; and the risk and uncertainties described in "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations," "Cautionary Note on Forward-Looking Statements" and the additional risk described in Ispire's Annual Report on Form 10-K for the year ended June 30, 2025 and any subsequent filings which Ispire makes with the SEC. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this press release relate only to events or information as of the date on which the statements are made in this press release. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events except as required by applicable law. You should read this press release with the understanding that our actual future results may be materially different from what we expect. ISPIRE TECHNOLOGY INC.UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS(In $USD, except share and per share data) December 31,2025 June 30,2025 Assets Current assets: Cash $ 17,565,334 $ 24,351,765 Restricted cash 50,000 - Accounts receivable, net 37,878,353 39,664,145 Inventories 5,037,414 6,647,970 Prepaid expenses and other current assets 3,120,978 2,244,505 Total current assets 63,652,079 72,908,385 Non-current assets: Accounts receivable, net of current portion - 7,367,158 Property, plant and equipment, net 2,599,861 2,952,800 Intangible assets, net 2,474,037 2,232,620 Right-of-use assets – operating leases 4,335,355 5,030,005 Other investment 2,000,000 2,000,000 Equity method investment 9,129,213 9,515,546 Other non-current assets 210,617 210,617 Total non-current assets 20,749,083 29,308,746 Total assets $ 84,401,162 $ 102,217,131 Liabilities and stockholders' equity Current liabilities Accounts payable $ 3,137,235 $ 4,172,476 Accounts payable – related party 42,444,624 52,420,256 Contract liabilities 4,971,135 4,861,250 Accrued liabilities and other payables 6,818,397 8,099,991 Income tax payable 12,590 - Borrowing – current portion 1,146,766 1,146,766 Operating lease liabilities – current portion 1,659,698 1,838,815 Total current liabilities 60,190,445 72,539,554 Non-current liabilities: Amount due to a related party 29,000,000 25,000,000 Borrowing – net of current portion 231,978 805,361 Operating lease liabilities – net of current portion 2,642,156 3,267,522 Total non-current liabilities 31,874,134 29,072,883 Total liabilities 92,064,579 101,612,437 Commitments and contingencies Stockholders' (deficit)/equity: Common stock, par value $0.0001 per share; 140,000,000 shares authorized; 57,289,864 and 57,193,734 shares issued and outstanding as of December 31, 2025 and June 30, 2025 5,729 5,719 Treasury stock, at cost (105,489) (60,488) Additional paid-in capital 50,593,580 48,833,601 Accumulated deficit (57,927,041) (48,065,267) Accumulated other comprehensive loss (230,196) (108,871) Total stockholders' (deficit)/equity (7,663,417) 604,694 Total liabilities and stockholders' (deficit)/equity $ 84,401,162 $ 102,217,131 ISPIRE TECHNOLOGY INC.UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS ANDCOMPREHENSIVE LOSS(In $USD, except share and per share data) Three Months EndedDecember 31, Six Months EndedDecember 31, 2025 2024 2025 2024 Revenue $ 20,286,556 $ 41,827,860 $ 50,637,440 $ 81,166,173 Cost of revenue 16,811,955 34,105,289 42,016,067 65,769,224 Gross profit 3,474,601 7,722,571 8,621,373 15,396,949 Operating expenses: Sales and marketing expenses 1,476,328 2,061,664 3,041,172 5,053,911 Credit loss expenses 4,209,201 4,183,998 5,973,453 7,286,079 General and administrative expenses 4,663,939 8,836,964 9,176,924 15,679,883 Total Operating expenses 10,349,468 15,082,626 18,191,549 28,019,873 Loss from operations (6,874,867) (7,360,055) (9,570,176) (12,622,924) Other income (expense): Interest income 104,922 59,755 200,394 59,841 Interest expense (100,191) (13,073) (212,367) (24,537) Exchange gain (loss), net 290,237 (245,173) 300,039 (127,588) Other income, net 83,574 19,934 12,991 38,333 Total Other income (expense), net 378,542 (178,557) 301,057 (53,951) Loss before income taxes (6,496,325) (7,538,612) (9,269,119) (12,676,875) Income taxes (106,586) (460,031) (592,655) (916,784) Net loss $ (6,602,911) $ (7,998,643) $ (9,861,774) $ (13,593,659) Other comprehensive income (loss) Foreign currency translation adjustments (113,433) 73,470 (121,325) (81,467) Comprehensive loss $ (6,716,344) $ (7,925,173) $ (9,983,099) $ (13,675,126) Net loss per share Basic and diluted $ (0.12) $ (0.14) $ (0.17) $ (0.24) Weighted average shares outstanding: Basic and diluted 57,258,218 56,658,012 57,257,938 56,629,666 For more information, kindly contact: IR Contacts:KCSA Strategic CommunicationsPhil Carlson212-896-1233ispire@kcsa.comPR Contact:Ellen Mellody570-209-2947EMellody@kcsa.com
2026-02-06 12:00:00

Delonix Bioworks Announces IND Clearance for DX-104, a Novel Engineered MenB OMV Vaccine Candidate, in China and Australia
SHANGHAI, Feb. 6, 2026 /PRNewswire/ -- Delonix Bioworks, a clinical-stage biotechnology company developing next-generation bacterial vaccines, recently announced that its Group B meningococcal (MenB) vaccine candidate, DX-104, has received Investigational New Drug (IND) clearance from China's National Medical Products Administration (NMPA). This follows the successful completion of Clinical Trial Notification (CTN) procedures and ethics committee approval in Australia in January 2026. Delonix plans to initiate Phase I clinical trials in the near term to evaluate the safety and immunogenicity of DX-104 in human subjects. Invasive meningococcal disease (IMD) is a life-threatening bacterial infection that disproportionately impacts infants, adolescents, and young adults. Serogroup B has emerged as a predominant cause of IMD globally, accounting for approximately 50% of cases with a rising prevalence trend. While vaccines like GSK's Bexsero® and Pfizer's Trumenba® have established the commercial and clinical value of MenB prevention—with Bexsero recording approximately $1.58 billion in sales in 2025—significant global gaps in access and strain coverage remain. DX-104 is an engineered MenB vaccine candidate developed using Delonix's proprietary OMV Plus® platform. The platform leverages precisely engineered outer membrane vesicles (OMVs) with intrinsic adjuvant properties to optimize immunogenicity. In preclinical studies, DX-104 induced robust serum bactericidal antibody (SBA) responses without the need for external adjuvants. Furthermore, DX-104 has achieved commercial-scale production with high batch-to-batch consistency, ensuring a reliable global supply chain as the candidate advances toward potential commercialization. "The dual regulatory clearances in China and Australia mark a transformative milestone for Delonix Bioworks as we transition into a clinical-stage company," said Qiubin Lin, CEO and Founder of Delonix Bioworks. "This is a crucial step in our global strategy to deploy engineered bacterial vaccines that are designed to be highly immunogenic, well-tolerated, and scalable. We are committed to addressing the urgent unmet medical needs of patients worldwide." About Delonix BioworksDelonix Bioworks is a clinical-stage biotechnology company at the forefront of developing next-generation genetically engineered bacterial vaccines. Leveraging its proprietary OMV Plus® platform, the company produces high-yield, cost-effective, and precisely engineered outer membrane vesicles (OMVs) designed for superior antigen presentation and immunogenicity. Delonix is dedicated to advancing a robust pipeline of first-in-class and best-in-class programs addressing critical unmet needs, including vaccines for Meningococcal B, pertussis, gonorrhoeae, and K. pneumoniae. For more information, please visit https://delonixbio.com/ or contact BD@delonixbio.com
2026-02-06 12:00:00

LakeShore Biopharma Announces Receipt of Buyer Group Notice and Postponement of Extraordinary General Meeting of Shareholders
BEIJING, Feb. 6, 2026 /PRNewswire/ -- LakeShore Biopharma Co., Ltd ("LakeShore Biopharma" or the "Company") (OTCPK: LSBCF; OTCPK: LSBWF), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that it has received a notice, dated February 4, 2026, from legal counsel to a group (the "Buyer Group") consisting of Oceanpine Skyline Inc. ("Parent"), Oceanpine Merger Sub Inc. ("Merger Sub"), Oceanpine Capital Inc., Oceanpine Investment Fund II LP, Crystal Peak Investment Inc., Adjuvant Global Health Technology Fund, L.P., Adjuvant Global Health Technology Fund DE, L.P., Superstring Capital Master Fund LP, MSA GROWTH FUND II, L.P., and Epiphron Capital (Hong Kong) Limited, relating to the previously announced going-private transaction of the Company whereby the Buyer Group agreed to take the Company private at a price of $0.90 per share pursuant to an Agreement and Plan of Merger (the "Merger Agreement"), dated November 4, 2025, by and among the Company, Parent and Merger Sub. According to the notice, the Buyer Group asserted that the arbitral awards received by the Company from the Kaifeng Arbitration Commission on January 21 and January 22, 2026—previously disclosed in the Company's current report on Form 6-K furnished with the Securities and Exchange Commission (the "SEC") on January 29, 2026—and the resulting financial liability of approximately RMB576,500,000 constitute a "Company Material Adverse Effect" under the Merger Agreement. The Buyer Group asserted that a condition precedent to Parent's obligation to close the Merger (as defined in the Merger Agreement) is that no Company Material Adverse Effect (as defined in the Merger Agreement) shall have occurred, and the Buyer Group has determined that a Company Material Adverse Effect has occurred and that the Buyer Group has the right not to consummate the Merger. The Buyer Group indicated that it would not attend or cast votes at the upcoming extraordinary general meeting (the "EGM"), scheduled for February 12, 2026, to consider and vote on, among other matters, the proposal to authorize and approve the Merger Agreement, the plan of merger required to be filed with the Registrar of Companies of the Cayman Islands, and the transactions contemplated thereby, including the Merger. The Buyer Group expressed its willingness to engage in good faith discussions with the Company to explore amendments to the transaction terms to facilitate a mutually acceptable resolution and the successful completion of the transaction. In light of this development, the Company has decided to postpone the previously announced EGM. Any proxy cards that have been submitted to the Company in respect of the EGM will be disregarded. Shareholders of record as of 5 p.m. Cayman Islands time on January 16, 2026 will each receive a copy of the notice regarding the postponement of the EGM. The notice will also be available on the Company's website at https://investors.lakeshorebio.com/index.html and on the SEC's website at http://www.sec.gov. The Company will carefully review and evaluate the Buyer Group's claims and the Company's options, and will provide further updates as required under applicable law. About LakeShore Biopharma Co., Ltd LakeShore Biopharma, previously known as YS Biopharma, is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a new generation of preventive and therapeutic biologics targeting Rabies, Hepatitis B, Influenza, and other virus infections. The Company operates in China, Singapore, and the Philippines, and is led by a management team that combines rich local expertise and global experience in the biopharmaceutical industry. For more information, please visit https://investors.lakeshorebio.com/. Forward-Looking Statements This press release contains statements that may constitute "forward-looking" statements. These forward-looking statements include, without limitation, the Company's business plans and development, which can be identified by terminology such as "may," "will," "expect," "anticipate," "aim," "future," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. LakeShore Biopharma may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about LakeShore Biopharma's beliefs, plans and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: the possibility that events may arise that result in the termination or amendment of the Merger Agreement; the possibility that competing offers will be made; the possibility that financing may not be available; the possibility that various closing conditions for the transaction may not be satisfied or waived; and other risks and uncertainties discussed in documents filed with the SEC by the Company, as well as the Schedule 13E-3 and the proxy statement filed by the Company; the Company's goals and strategies; the Company's future business development, financial condition and results of operations; its ability to provide efficient services and compete effectively; its ability to maintain and enhance the recognition and reputation of its brands; general economic and business conditions globally and in China and assumptions underlying or related to any of the foregoing. Further information regarding these and other risks, uncertainties or factors is included in the Company's filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law. For investor inquiries, please contact: IR TeamTel: +86 (10) 8920-2086Email: ir@lakeshorebio.com
2026-02-06 12:00:00

CQG Enters into Agreement for Acquisition by Broadridge
Combination to Create End-to-End Trading Suite for Global Futures and Options Markets DENVER, Feb. 6, 2026 /PRNewswire/ -- CQG, a leading provider of futures and options trading, execution management and market connectivity, today announced it has entered into an agreement with global Fintech leader Broadridge Financial Solutions, Inc. (NYSE:BR) for Broadridge to acquire CQG. CQG will add complementary execution management, algorithmic trading and analytics capabilities to Broadridge's order management and client connectivity solutions, creating an end-to-end trading suite for global futures and options markets. "Our combined capabilities will provide a global multi-asset class trading experience defined by speed, scale and intelligence," said Ryan Moroney, CEO of CQG. "Broadridge's deep global reach and front-to-back capabilities and our expertise in front-office execution management and connectivity will enable clients to trade smarter, access new markets and adapt faster in an increasingly connected futures and options marketplace. The CQG team is truly excited to join a company with the history and successful track record of Broadridge." "The acquisition of CQG will accelerate Broadridge's mission to deliver advanced, highly connected trading solutions on a global scale," said Frank Troise, President of Broadridge's Trading and Connectivity Solutions business. "Integrating CQG's advanced execution management, analytics and connectivity technologies with Broadridge's leading order management and connectivity solutions will create a unified platform in futures and options that simplifies trading complexity, improves transparency and workflow efficiency, and enhances Broadridge's digital asset trading capabilities." Moroney added: "Broadridge has been a terrific partner since we decided to integrate some of our technologies a few years ago, and the team has made it clear they value our talented employees, culture, loyal client base, rapid delivery of new functionality and innovation. In this fast-moving environment, we believe the shared values between our firms, along with our combined global reach, significant resources and complementary technology make this transaction so compelling for CQG and exactly the right step for our employees and customers." Terms of the transaction, which are not expected to have a material impact on Broadridge's financial results, were not disclosed. The transaction is expected to close early in Broadridge's fiscal fourth quarter that ends June 30, subject to customary closing conditions, including regulatory approvals. The expanded offering is designed to better support the evolving end-to-end needs of clients across a broad spectrum of segments, including futures commission merchants (FCMs), institutional investors, retail brokers, proprietary trading firms, commodity trading advisors (CTAs) and hedge funds. Clients will benefit from flexible, scalable solutions designed to support their growth objectives, accelerate speed to market, and deliver a powerful, fully integrated trading experience for institutional and professional retail market participants alike. About CQG CQG provides the industry's highest performing solutions for traders, brokers, commercial hedgers and exchanges for their market-related activities globally, including trading, market data, advanced technical analysis, risk management, and account administration. The firm partners with the vast majority of futures brokerage and clearing firms and provides Direct Market Access (DMA) to more than 45 exchanges through its global network of co-located Hosted Exchange Gateways. CQG technology serves as the front end for a variety of exchanges and is increasingly employed as the over-the-counter matching engine for important new markets. CQG's server-side order management tools for spreading, market aggregation, and smart orders are unsurpassed for speed and ease of use. Its market data feed consolidates 85 sources, including exchanges worldwide for futures, options, fixed income, foreign exchange, and equities, as well as data on debt securities, industry reports, and financial indices. One of the longest-serving technology solutions providers in the industry, CQG has won numerous awards for its trading software, technical analysis and multi-asset trading platform. CQG is headquartered in Denver, with sales and support offices and data centers in key markets globally, providing services in more than 60 countries. For more information, visit www.cqg.com. About Broadridge Broadridge Financial Solutions (NYSE: BR) is a global technology leader with trusted expertise and transformative technology, helping clients and the financial services industry operate, innovate and grow. The firm powers investing, governance and communications for its clients – driving operational resiliency, elevating business performance and transforming investor experiences. Broadridge's technology and operations platforms process and generate over 7 billion communications annually and underpin the daily average trading of over $15 trillion in equities, fixed income and other securities globally. A certified Great Place to Work®, Broadridge is part of the S&P 500® Index, employing over 15,000 associates in 21 countries. For more information, visit www.broadridge.com.
2026-02-06 12:00:00

Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals") prepares for the launch of PYQUVITM (deflazacort) oral suspension, the first of a new branded-generic rare disease product line
BASKING RIDGE, N.J., Feb. 6, 2026 /PRNewswire/ -- Aucta Pharmaceuticals is pleased to announce the late January launch of PYQUVI oral suspension 22.75 mg/mL. PYQUVI, a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older, is bioequivalent to Emflaza® (deflazacort) oral suspension 22.75 mg/mL. PYQUVI will be available exclusively through a specialty pharmacy, offering an option for patients with DMD who prefer to receive deflazacort via a specialty pharmacy channel. "Patients living with Duchenne muscular dystrophy and their families often face complex treatment-access considerations, including navigating evolving standards of care and insurance coverage variability that can delay timely therapy. These challenges add to the daily burden of a progressive condition such as Duchenne muscular dystrophy and underscore the importance of clear pathways to appropriate treatment and support," said Dr. Marie Tan, Associate Director of Medical Affairs, Clinical Operations, and Pharmacovigilance at Aucta Pharmaceuticals, Inc. "As part of the PYQUVI launch, Aucta plans to offer a patient support program focused on access and specialty pharmacy coordination for eligible patients." The launch of PYQUVI marks Aucta Pharmaceuticals' first commercial branded-generic product in the United States. Building on this milestone, Aucta Pharmaceuticals will be introducing ZELVYSIATM (sapropterin dihydrochloride) Powder for Oral Solution. ZELVYSIA is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria (PKU). ZELVYSIA is to be used in conjunction with a Phe-restricted diet. ZELVYSIA is anticipated to launch in March 2026, shortly following the introduction of PYQUVI. Together, these launches represent a significant step forward in Aucta Pharmaceuticals' branded generic portfolio. It also underscores our commitment to providing treatment options for patients and families affected by rare conditions. Emflaza® is a registered trademark of PTC Therapeutics, Inc. INDICATION PYQUVITM is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. IMPORTANT SAFETY INFORMATION PYQUVI is contraindicated in patients with a hypersensitivity to deflazacort or any of the inactive ingredients. WARNINGS AND PRECAUTIONS Alterations in Endocrine Function: Corticosteroids can cause serious and life-threatening endocrine alterations, especially with chronic use. Monitor for Cushing's syndrome, hyperglycemia, and adrenal insufficiency after withdrawal. Risk is higher in patients with hypopituitarism, primary adrenal insufficiency, congenital adrenal hyperplasia, altered thyroid function, or pheochromocytoma. Acute adrenal insufficiency or "withdrawal syndrome" may occur if discontinued abruptly and can be fatal; taper gradually. Dose may need to be increased during times of medical stress. Immunosuppression and Increased Risk of Infection: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections, which can be severe or fatal. Signs of infection may be masked. Advise patients/caregivers to report recent infections or vaccinations. Patients without prior chickenpox or measles should avoid exposure and contact their healthcare provider immediately if exposed. Alterations in Cardiovascular/Renal Function: Monitor blood pressure; dietary salt restriction and potassium supplementation may be needed. Gastrointestinal (GI) Perforation: Risk is increased in patients with certain GI disorders (e.g., active or latent peptic ulcers, diverticulitis, recent intestinal anastomoses, inflammatory bowel disease). Signs may be masked. Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, depression, and psychosis. Advise patients to seek medical attention if symptoms develop or worsen. Effects on Bones: Prolonged use increases risk of osteoporosis, and vertebral and long bone fractures. Monitor bone density with chronic use. Ophthalmic Effects: May cause cataracts, ocular infections, or glaucoma. If corticosteroids are used for >6 weeks, monitor intraocular pressure. Vaccination: Do not administer live or live-attenuated vaccines during immunosuppressive corticosteroid therapy. Administer such vaccines at least 4 to 6 weeks before starting PYQUVI. Serious Skin Rashes: Toxic epidermal necrolysis has been reported. Discontinue at the first sign of rash, unless the rash is clearly not drug related. Effects on Growth and Development: Long-term use of corticosteroids may slow growth and development in children. Thromboembolic Events: Observational studies have shown an increased risk. Use with caution in at-risk patients. ADVERSE REACTIONS The most common adverse reactions (≥10% and greater than placebo) are Cushingoid appearance, weight gain, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, and nasopharyngitis. DRUG INTERACTIONS Moderate or strong CYP3A4 inhibitors: Use one third of the recommended PYQUVI dose. Moderate or strong CYP3A4 inducers: Avoid concomitant use as efficacy may be reduced. To report SUSPECTED ADVERSE REACTIONS, contact Aucta Pharmaceuticals, Inc. at 1-800-655-9902, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full Prescribing Information, including Instructions for Use. INDICATION ZELVYSIATM (sapropterin dihydrochloride) is a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients 1 month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). ZELVYSIA is to be used in conjunction with a Phe-restricted diet. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hypersensitivity Reactions, Including Anaphylaxis: Avoid use in patients with a history of anaphylaxis to sapropterin. Discontinue treatment if anaphylaxis occurs and initiate appropriate medical care. Continue dietary Phe restrictions. Upper Gastrointestinal (GI) Mucosal Inflammation: Serious GI adverse reactions (eg, esophagitis, gastritis, ulcer, bleeding) have been reported. Monitor for signs and symptoms. Hypophenylalaninemia: May occur; increased risk in children Blood Phe Monitoring: Frequent blood Phe monitoring is required to ensure levels remain in the desirable range. Prolonged high Phe can cause severe neurologic damage (eg, intellectual disability, developmental delay, microcephaly, delayed speech, seizures, behavioral abnormalities). Prolonged low Phe can lead to catabolism and adverse developmental outcomes. Active management of dietary protein and Phe restriction is required. Lack of Biochemical Response: Not all patients with PKU respond. Assess response through a therapeutic trial; response cannot be pre-determined by laboratory testing. Interactions with Levodopa: May cause seizures, exacerbation of seizures, overstimulation, or irritability. Monitor for changes in neurologic status. Hyperactivity: Monitor for signs of hyperactivity. ADVERSE REACTIONS The most common adverse reactions (incidence ≥4%) are headache, rhinorrhea, pharyngolaryngeal pain, diarrhea, vomiting, cough, and nasal congestion. DRUG INTERACTIONS Folate Synthesis Inhibitors (e.g., methotrexate, valproic acid, phenobarbital, trimethoprim): May decrease BH4 and increase Phe. Monitor Phe more frequently; adjust dosage as needed. PDE-5 Inhibitors (e.g., sildenafil, vardenafil, tadalafil): Both ZELVYSIA and PDE-5 inhibitors may induce vasorelaxation and hypotension. Monitor blood pressure. To report SUSPECTED ADVERSE REACTIONS, contact Aucta Pharmaceuticals, Inc. at 1-800-655-9902, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full Prescribing Information, including Patient Information, and Instructions for Use. About Aucta Pharmaceuticals, Inc. Aucta Pharmaceuticals, Inc. is a research and technology-based pharmaceutical company focusing on the development and commercialization of niche generic and branded specialty products. The company's corporate strategy is to focus on proven molecules and, through innovation, create new therapeutics with lower scientific risk that fulfill unmet medical needs. Its specialty division has a therapeutic focus in neurology/epilepsy, nasal delivery, and other specialty fields. For more information, visit www.auctapharma.com.
2026-02-06 11:59:00

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