Category: 3. Business

  • Ascletis Announces China National Medical Products Administration Acceptance of New Drug Application for Denifanstat (ASC40), a First-in-Class FASN Inhibitor for Acne Treatment USA – English APAC – English APAC – Traditional Chinese

    -Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo in a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial.

    HONG KONG, Dec. 10, 2025 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces today that its New Drug Application (NDA) for denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor for the treatment of moderate-to-severe acne vulgaris, has been accepted by the China National Medical Products Administration (NMPA).

    “Acceptance of this NDA is an important milestone in our efforts to provide a potentially groundbreaking therapeutic approach for the treatment of moderate-to-severe acne,” said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, “We are excited denifanstat (ASC40) is only one step away from the commercialization.”

    Ascletis has completed Phase II (NCT05104125) and Phase III (NCT06192264) studies of denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris.

    In the Phase III study, denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo. Denifanstat (ASC40) demonstrated a favorable safety and tolerability profile. All denifanstat (ASC40)-related treatment-emergent adverse events (TEAEs) were mild (Grade 1) or moderate (Grade 2). There were no denifanstat (ASC40)-related Grade 3 or 4 TEAEs and no denifanstat (ASC40)-related serious adverse events (SAEs). There were no denifanstat (ASC40)-related permanent treatment discontinuations or withdrawals observed.

    The Phase III study results were presented as an oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France on September 17, 2025 (link).

    The Company recently completed the pre-NDA consultation with the China NMPA for denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris and received positive feedback from NMPA.

    Ascletis licensed denifanstat (ASC40) from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in Greater China.

    About Ascletis Pharma Inc.

    Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, a once-monthly subcutaneously administered amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist and ASC37, an oral GLP-1R/GIPR/GCGR triple peptide agonist for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).

    For more information, please visit www.ascletis.com.

    Contact:

    Peter Vozzo
    ICR Healthcare
    443-231-0505 (U.S.)
    [email protected] 

    Ascletis Pharma Inc. PR and IR teams
    +86-181-0650-9129 (China)
    [email protected]
    [email protected] 

    SOURCE Ascletis Pharma Inc.

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  • We welcome FDA moves to cut primate testing as roadmap begins to take shape – Cruelty Free International

    1. We welcome FDA moves to cut primate testing as roadmap begins to take shape  Cruelty Free International
    2. Simulations Plus Positioned to Capitalize on FDA’s Streamlined Nonclinical Safety Guidance with Adva  pharmiweb.com
    3. CDC Seeks to End Program Using Monkeys in Research  Animal Legal Defense Fund
    4. FDA takes steps to limit non-human primate testing  Pharmaphorum
    5. FDA Endorses Non-Animal Methods for Drug Development, Supporting PETA Scientists’ Diphtheria Therapy Strategy  PETA

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  • Rolls-Royce celebrates the official opening of BAESL, its MRO joint venture in Beijing, China

    Rolls-Royce celebrates the official opening of BAESL, its MRO joint venture in Beijing, China

    Air China, as China’s sole national flag carrier, is a long-term strategic customer for Rolls-Royce. By establishing BAESL jointly, the two companies have deepened their cooperation. In the meantime, it further enhances Air China’s strategic layout in the aircraft maintenance industry chain, improving its overall fleet operational support capabilities.

    As one of four authorised joint-venture overhaul facilities within the Rolls-Royce global services network, BAESL will be an integral part of its worldwide Trent MRO ecosystem, which also consists of two Rolls-Royce maintenance facilities, seven joint-venture or independent Authorised Maintenance Centres, and customer-owned shops.

    Starting from 2026, BAESL will begin introducing overhaul capability for Trent 700, Trent XWB-84 and Trent 1000 engines, with capacity expected to ramp up to 250 overhauls per year by 2034.


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  • improving instant cross-border payments using central bank money settlement (technical report)

    improving instant cross-border payments using central bank money settlement (technical report)

    Rialto focused on low-value transactions such as remittances and other person-to-person payments executed via the traditional banking channel. Despite past efforts to reduce the inefficiencies associated with such payments, FX and settlement remain key frictions.

    In the search for more efficient options, there has been an increasing focus on instant payment-versus-payment (PvP) solutions that allow for fast and reliable access to liquidity in foreign currency.

    Rialto’s technical experiment combined PvP and automated FX with tokenised central bank money settlement in a simulated cross-border payment infrastructure by building on previous work by the BIS Innovation Hub such as Project Mariana and Project Nexus.

    The technical report describes the Project Rialto proof of concept, its architecture and design as well as the economic considerations regarding the viability of the Rialto technical approach.

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  • Elon Musk’s SpaceX ‘preparing for 2026 flotation of more than $1tn’ | SpaceX

    Elon Musk’s SpaceX ‘preparing for 2026 flotation of more than $1tn’ | SpaceX

    Elon Musk’s space exploration company SpaceX is preparing to list on the stock market next year in a move that could raise more than $25bn (£19bn) and value the business at more than $1tn, according to reports.

    SpaceX, which designs, builds and launches rockets, is said to have started discussions with banks about an initial public offering (IPO). It could join the stock market in about June or July, according Reuters, which cited an unnamed source familiar with the matter.

    A flotation could rival the market value that the oil company Saudi Aramco achieved during its listing in 2019, which remains the biggest in history. It raised $29bn at the time, at a valuation of $1.7tn.

    SpaceX could raise “significantly more than £30bn”, according to a separate report by Bloomberg, which said Musk was targeting an overall valuation of about $1.5tn.

    Reuters said SpaceX planned to use the funds from the public listing to fund its space-based datacentres, including buying the chips required to run them.

    The company was expected to make about $15bn in revenue in 2025, rising to between $22bn and $24bn in 2026, Bloomberg reported. Most of this is due to come from Starlink, its internet satellite business.

    Last week, media reports suggested SpaceX was in talks with investors about a share sale that would value it at $800bn, pitting it against OpenAI to become the most valuable private company in the world.

    However, Musk said the reports were inaccurate on Saturday. He wrote: “SpaceX has been cashflow positive for many years and does periodic stock buybacks twice a year to provide liquidity for employees and investors. Valuation increments are a function of progress with Starship and Starlink and securing global direct-to-cell spectrum that greatly increases our addressable market.”

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    SpaceX was approached for comment.

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  • South African rand inches up before local retail sales data, US rate decision – Reuters

    1. South African rand inches up before local retail sales data, US rate decision  Reuters
    2. South African rand holds steady ahead of Moody’s rating review  Reuters
    3. Moody’s flags modest growth outlook and persistent fiscal pressures in SA  businessreport.co.za
    4. The Gibbons Report: 8 December 2025  Algoa FM
    5. South African Markets Hold Steady As Investors Await Fed Decision  Finimize

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  • ST Engineering iDirect CTO Sridhar Kuppanna named CTO of the Year by The Fast Mode

    ST Engineering iDirect CTO Sridhar Kuppanna named CTO of the Year by The Fast Mode

    HERNDON, Va., 9 December 2025 – ST Engineering iDirect, a global leader in satellite communications, today announced that its Chief Technology Officer, Sridhar Kuppanna, has been named CTO of the Year (Solution Provider, Global) in the Leadership Excellence category at The Fast Mode Awards 2025. The award recognizes Kuppanna’s visionary leadership in advancing satellite technology and its integration into the global telecommunications ecosystem.

    The inaugural awards program from The Fast Mode, a leading industry media, research and analysis platform, celebrates the organizations and leaders driving innovation in connectivity and digital transformation. The Leadership Excellence category honors executives whose work has significantly shaped the telecom industry through strategic vision, measurable achievements, and forward-looking impact.

    Under Kuppanna’s leadership, ST Engineering iDirect has pioneered breakthroughs in cloud-native satellite ground systems, AI-driven network automation and 5G Non-Terrestrial Networks (NTN). His strategic direction has been instrumental in unifying satellite and terrestrial networks, highlighted by the industry’s first demonstration of interoperability between a cloud-native ground system and a 5G Core. This work is paving the way for a standardized 5G-6G future where satellite connectivity is seamless.

    “I am deeply honored to receive this prestigious award from The Fast Mode,” said Sridhar Kuppanna. “This recognition is a testament to the incredible talent and dedication of the entire ST Engineering iDirect team. Our focus is on building an open, standardized, and interoperable future where satellite and terrestrial networks converge. By harnessing the power of cloud, 5G, and AI, we are committed to delivering autonomous, intelligent networks that redefine the possibilities of global connectivity.”

    As announced by The Fast Mode on 1 December 2025, winners will be honored at the LiveX Kuala Lumpur 2026 summit on 6 February 2026. The event will bring together industry leaders to explore the technologies and strategies shaping AI-first telecommunications.

    *****

    Media contact:
    Donna Armstrong
    Brodeur
    Email: darmstrong@brodeur.com


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  • Kyndryl strengthens tech systems for MEDVIDA

    Kyndryl strengthens tech systems for MEDVIDA

    MADRID, December 10, 2025 — MEDVIDA Partners, a Spanish insurer specializing in the acquisition, integration and optimization of life insurance businesses, has signed an agreement with Kyndryl (NYSE: KD), a leading provider of mission-critical enterprise technology services. Under this collaboration, Kyndryl will help MEDVIDA Partners improve the user experience for its professionals and strengthen the security, resilience, and robustness of its technology operations.

    The collaboration aims to optimize the management of the insurer’s technology systems by applying high standards of quality, service and security, enabling the company to meet regulatory requirements and evolving market trends. In addition, the company will be able to leverage Kyndryl Bridge, an AI-powered open integration platform, with advanced capabilities in automation, governance, observability, and AI-driven insights for predictions and optimization.

    “At MEDVIDA Partners, we count on top-tier partners like Kyndryl for the execution of our strategy of consolidation and modernization of technology assets,” said Thomas Esclavard, Chief Technology Officer, MEDVIDA Partners. “This collaboration allows us to rely on cutting-edge capabilities in cybersecurity, automation and observability, significantly strengthening the resilience and security of our operations. At the same time, it lays the foundation for a highly scalable infrastructure and operating model, ready to accompany the acquisition and agile integration of new businesses.” 

    “We are proud that MEDVIDA Partners has trusted Kyndryl and its consulting services to support compliance with a demanding regulatory environment and the transformation of the systems that accelerate its operations,” said Antonio Rodríguez Perales, Vice President, Kyndryl Spain and Portugal. “We are committed to delivering innovation and strengthening security through the best technology to continue to bring value to our customers.” 

    Kyndryl’s expertise in cybersecurity, cloud, IT consulting, mainframe modernization and digital workplace will enable it to provide MEDVIDA Partners with access to the technologies they need to support their business processes.

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  • TDK wins Gold Award from WICI Japan Integrated Report Award 2025

    TDK wins Gold Award from WICI Japan Integrated Report Award 2025

    TDK Corporation (TSE:6762) announces that TDK has won the Gold Award from the WICI Japan Integrated Report Award 2025 for the second consecutive year. It is an award program organized by WICI Japan (the Japan chapter of the World Intellectual Capital/Assets Initiative-WICI).

    WICI Japan established the WICI Japan Award for Excellence in Integrated Reporting in 2013 as a way to promote integrated reporting activities in Japan.

    TDK United Report 2025 (Integrated Report) was praised for its near-perfect integrated reporting and could be a model for other companies integrated reports. Also, it was highly acclaimed as a company whose management is carried out with integrated thinking, and whose medium- to long-term value creation capabilities are shown in an easy-to-understand manner in relation to each stakeholder, with the expectation that it will continue to increase its corporate value.

    TDK’s Integrated Report was renamed “TDK United Report” starting in 2025. Based on TDK’s unique corporate culture of functional equality, the report is structured to show how the efforts of TDK United team members (employees) contribute to maximizing FCF (Free Cash Flow), reducing cost of capital, improving the expected growth rate, and enhancing corporate value.

    TDK United Report 2025 can be downloaded on the TDK website.
    https://www.tdk.com/system/files/integrated_report_pdf_2025_en.pdf

    More details about the award can be found at the website below (only in Japanese).
    https://wici-global.com/index_ja/wp-content/uploads/2025/12/20251202wiciaward.pdf

    About TDK Corporation

    TDK Corporation (TSE:6762) is a global technology company and innovation leader in the electronics industry, based in Tokyo, Japan. With the tagline “In Everything, Better” TDK aims to realize a better future across all aspects of life, industry, and society. For over 90 years, TDK has shaped the world from within; from the pioneering ferrite cores to cassette tapes that defined an era, to powering the digital age with advanced components, sensors, and batteries, leading the way towards a more sustainable future. United by TDK Venture Spirit, a start-up mentality built on visions, courage and mutual trust, TDK’s passionate team members around the globe pursue better—for ourselves, customers, partners, and the world. Today, the state-of-the-art technologies of TDK are in everything, from industrial applications, energy systems, electric vehicles, to smartphones and gaming, at the core of modern life. TDK’s comprehensive, innovative-driven portfolio includes cutting-edge passive components, sensors and sensor systems, power supplies, lithium-ion and solid-state batteries, magnetic heads, AI and enterprise software solutions, and more—featuring numerous market-leading products. These are marketed under the product brands TDK, EPCOS, InvenSense, Micronas, Tronics, TDK-Lambda, TDK SensEI, and ATL. Positioning the AI ecosystem as a key strategic area, TDK leverages its global network across the automotive, information and communication technology, and industrial equipment sectors to expand its business in a wide range of fields. In fiscal 2025, TDK posted total sales of USD 14.4 billion and employed about 105,000 people worldwide.

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  • Record-Breaking Size for a Laser Powder Bed Fusion Structure

    Record-Breaking Size for a Laser Powder Bed Fusion Structure

    LINKOPING, Sweden and LOS ANGELES, Dec. 10, 2025 /PRNewswire/ — Today, Divergent Technologies, Inc. (Divergent) and Saab announced the delivery of initial fuselages for a Saab future product concept of an autonomous aircraft.

    The fuselage, jointly designed and manufactured by Saab and Divergent, was developed and realized with no unique tooling or fixturing, instead utilizing Divergent’s fully digital, software-defined manufacturing assets. The Divergent Adaptive Production System (DAPS™) is an end-to-end structural engineering design and manufacturing system leveraging AI-driven design, industrial-rate additive manufacturing, and universal robotic assembly to deliver structures that are faster to develop, higher performance, and lower cost than their conventionally designed and manufactured alternatives.

    Watch: Saab x Divergent – Creating Hardware as Software – Intro (YouTube)

    The structure will be amongst the largest laser powder bed fusion structures to ever undergo powered flight, marking both a significant technical achievement in demonstrating the absolute scale of Divergent’s fixtureless assembly technology while highlighting the continued expansion of Divergent’s capabilities to ever more demanding applications. The full structure stretched 15 feet in length and comprised 26 unique printed parts, each joined and bonded in the company’s fixtureless robotic assembly cell.

    “This collaboration with Saab highlights what becomes possible when ambitious aircraft concepts are paired with an end-to-end, software-defined manufacturing platform,” said Lukas Czinger, Co-founder and CEO of Divergent. “By tightly integrating digital design, additive manufacturing, and automated assembly, our teams were able to realize a large-scale fuselage structure aligned with Saab’s vision, while moving with a level of speed, flexibility, and structural integration that traditional approaches cannot match.”

    “Adopting Divergent’s additively manufactured and digitally designed structures in this effort has given our joint team unparalleled flexibility in this development process,” said Axel Bååthe, head of Saab’s Rainforest. “We see digital design and advanced manufacturing as a key enabler of our collaborative success in this project.”

    Divergent
    Divergent has created the world’s first end-to-end software-hardware production system for industrial digital manufacturing – the Divergent Adaptive Production System (DAPS™) – allowing customers to design, additively manufacture, and automatically assemble complex structures for automotive, aerospace, and defense applications. DAPS transforms the economics, speed, and scalability of defense vehicle manufacturing by optimizing designs, dematerializing structures, and eliminating upfront capex. For more information, please visit www.divergent3d.com.

    Saab
    Saab is a leading defence and security company with an enduring mission, to help nations keep their people and society safe. Empowered by its 27,000 talented people, Saab constantly pushes the boundaries of technology to create a safer and more sustainable world. Saab designs, manufactures and maintains advanced systems in aeronautics, weapons, command and control, sensors and underwater systems. Saab is headquartered in Sweden. It has major operations all over the world and is part of the domestic defence capability of several nations.

    The Rainforest is Saab’s internal startup for transformative innovation, for more information please visit https://thernfrst.io/

    SOURCE Divergent Technologies, Inc.

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