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  • At least 19 dead in collapse of two buildings in Morocco’s Fes: State media | Infrastructure News

    At least 19 dead in collapse of two buildings in Morocco’s Fes: State media | Infrastructure News

    The death toll from the destruction of the buildings includes several children.

    At least 19 people have been killed and 16 injured by the collapse of two buildings in…

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  • Meet the new breed of blemish-busting ingredients for grown-ups

    Meet the new breed of blemish-busting ingredients for grown-ups


    When most people think of acne – the blackheads, pustules, cysts, etc, that may surface on skin with excess sebum – a certain stereotype emerges, that of the pimply adolescent being tossed around…

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  • New Infection Guidelines Could Save Lives in Nursing Homes

    New Infection Guidelines Could Save Lives in Nursing Homes

    Whether they’re there for a few days after a hospital stay, or living there long term, people in nursing homes are especially vulnerable to infections.


    From bacteria that have evolved to resist most antibiotics, to common viruses that cause flu…

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  • Euclid Reveals What Wakes Sleeping Black Holes

    Euclid Reveals What Wakes Sleeping Black Holes

    Almost every massive galaxy is has a supermassive black hole at its core, an object containing millions or even billions of times the mass of our Sun. Most of these giants simply lurk in the darkness, quietly consuming material from…

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  • Machado Won’t Pick Up Peace Prize in Person, Nobel Director Says – The New York Times

    1. Machado Won’t Pick Up Peace Prize in Person, Nobel Director Says  The New York Times
    2. Nobel laureate’s whereabouts unknown ahead of ceremony  Dawn
    3. Machado will be in Oslo for Nobel Peace Prize, Nobel institute says  Reuters
    4. Nobel officials unsure…

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  • Pakistan’s progress lies in protection of human rights: Abbasi

    Pakistan’s progress lies in protection of human rights: Abbasi




    Federal Minister for Railways Muhammad Hanif Abbasi Wednesday emphasized that the path to Pakistan’s progress lies in the complete protection and promotion of human rights.
    In his message…

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  • A Doctor at Apple Reveals 9 Hidden Apple Watch Health Features

    A Doctor at Apple Reveals 9 Hidden Apple Watch Health Features

    An Apple Watch can be used for countless tasks — making phone calls, responding to text messages and reading emails, to name just a few — but did you know that this smartwatch is also a powerhouse when it comes to monitoring and supporting your…

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  • 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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  • Nnena Kalu ‘makes history’ by winning Turner Prize 2025

    Nnena Kalu ‘makes history’ by winning Turner Prize 2025

    A British Nigerian artist who produces large-scale draped sculptures and vortex-like circular drawings has become the first person with a learning disability to claim the Turner Prize, one of contemporary…

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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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