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BioWorld Asia

Thu, May 29, 2025
Breaking News: 100 days of uncertaintyBreaking News: 100 days of uncertaintyBreaking News: 100 days of uncertainty
  • DNA NGS genome sequencing

    GC Genome plans $30M IPO to diversify genomic products, suppliers

    GC Genome Corp. priced a Kosdaq offering of 4 million shares at ₩10,500 per share May 27, entailing a gross ₩42 billion (US$30.5 million) raise in early June. The Yongin, South Korea-based genomics subsidiary of GC Biopharma Corp. fixed its shares price to the top of its ₩9,000 to ₩15,000 price band May 27 after conducting demand forecasting on domestic and international institutional investors from May 19 to May 23.
  • Adalta sees promise in new 'East to West' strategy for T-cell therapies

  • Alteogen merges two subsidiaries, forming Alteogen Biologics

  • Annji's phase I/II positive in spinal, bulbar muscular atrophy

  • Samsung Biologics to spin off biosimilar subsidiary Samsung Bioepis

  • AP Bio heads to phase I with bispecific for HER2-resistant tumors

  • GC Genome plans $30M IPO to diversify genomic products, suppliers

    GC Genome Corp. priced a Kosdaq offering of 4 million shares at ₩10,500 per share May 27, entailing a gross ₩42 billion (US$30.5 million) raise in early June. The Yongin, South Korea-based genomics subsidiary of GC Biopharma Corp. fixed its shares price to the top of its ₩9,000 to ₩15,000 price band May 27 after conducting demand forecasting on domestic and international institutional investors from May 19 to May 23.
  • Adalta sees promise in new 'East to West' strategy for T-cell therapies

    Adalta Ltd. is outlicensing all of its internal products and focusing instead on inlicensing early stage T-cell assets from Asia, mostly from China, Adalta CEO Tim Oldham told BioWorld. Dubbed its “East to West” strategy, Adalta is integrating Asia's prowess in T-cell therapy development with the efficiency and quality of Australia's clinical and manufacturing ecosystem to create a pathway connecting Eastern innovation in cellular immunotherapies with Western regulated markets and patients.
  • Alteogen merges two subsidiaries, forming Alteogen Biologics

    Alteogen Inc. completed a merger between two subsidiaries – Altos Biologics Inc. and Alteogen Healthcare Inc. – branding the new entity as Alteogen Biologics Inc.
  • Annji's phase I/II positive in spinal, bulbar muscular atrophy

    Annji Pharmaceutical Co. Ltd.’s rosolutamide (AJ-201, JM-17) achieved positive results in a phase I/II trial in adults with spinal and bulbar muscular atrophy, also known as Kennedy’s disease.
  • Samsung Biologics to spin off biosimilar subsidiary Samsung Bioepis

    Samsung Biologics Co. Ltd. plans to establish a new holding company and to spin off its biosimilar division, Samsung Bioepis Co. Ltd., by October. The corporate restructuring will draw clear lines between Samsung Biologics’ CDMO operations and Samsung Bioepis’ biosimilar business.
  • AP Bio heads to phase I with bispecific for HER2-resistant tumors

    Although HER2-targeted therapies have become a mainstay in cancer treatment, some tumors evade them by stripping away the portion of the HER2 receptor that most therapies are built to recognize and bind to, but Taiwan’s AP Biosciences Inc. is developing bispecific antibody AP-402 to address treatment-resistant HER2+ cancers.
  • Cancer drug specialist Immuneoncia raises $24M in Kosdaq listing

    Immuneoncia Therapeutics Inc. raised ₩33.9 billion (US$24 million) from its Kosdaq listing May 19. Shares closed at ₩7,500 – 108% higher than its offering price of ₩3,600 per share. Immuneoncia, a joint venture founded in 2016 between Seoul, South Korea-based Yuhan Corp. and San Diego-based Sorrento Therapeutics Inc., noted that the funds will support R&D operations until 2026.
  • SY-9453 shows efficacy at treating tumors with MTAP deficiency

    About 15% of all cancers have co-deletion of both the MTAP and CDKN2A genes, which results in sensitization to MAT2A inhibitors, thus opening a therapeutic window in these cancer types. MAT2A inhibitors have demonstrated efficacy in MTAD-deficient cancers. Shouyao Holdings (Beijing) Co. Ltd. has developed and released data for their MAT2A inhibitor SY-9453 for the treatment of MTAP-deficient cancers.
  • A novel inhibitor of FAK for treating multiple cancers

    In their ongoing search for effective small-molecule inhibitors of focal adhesion kinase (FAK), researchers at Beijing Normal University and collaborators started from a promising lead compound that they previously described.
  • News in brief

    BioWorld Asia briefs for May 27, 2025

BioWorld Insider Podcast

Play buttonRobert Williamson, CEO of Triumvira Immunologics, and Hernan Bazan, CEO of South Rampart Pharma, discuss bracing for tariffs, NIH grant cuts and gifting China a biopharma leadership position.
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Analysis and data insight

  • Atzumi and Vanrafia among 3 NMEs approved by US FDA in April

    Regulatory
    The U.S. FDA approved 20 drugs for market in April, slightly down from 22 in March, 16 in February and 12 in January. This brings the total number of FDA approvals for the first four months of 2025 to 70, a decrease from 77 in the same period last year but higher than the 50 drugs approved during...
  • Trump tariff EO signing

    South Korea urges US to exempt pharma, allies from tariffs

    Regulatory
    South Korean government and biopharmaceutical industry representatives urged American policymakers May 7 to refrain from imposing tariffs on pharmaceutical imports, and to spare allies if pharma tariffs are deemed necessary. Both Korea’s Ministry of Health and Welfare on May 4 and the Korea...
  • Jorge A. Goldstein at Bio Korea 2025

    US legal issues to track in pharma, biotech

    Conferences
    Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs...
  • Illustration of Won currency, graph, up arrows

    Korea pharma stocks rally; Celltrion welcomes US drug pricing

    Regulatory
    Korean pharmaceutical stocks rose across the board May 13, a day after U.S. President Donald Trump signed off on the most favored nation executive order, a drug pricing policy expected to benefit biosimilar makers in the U.S., according to Celltrion Inc.
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for May 20, 2025

  • Financings for May 27, 2025

  • In the clinic for May 27, 2025

  • Other news to note for May 27, 2025

  • Regulatory actions for May 27, 2025

Deals and M&A

  • Rznomics in $1.3B Lilly pact to make hearing loss RNA editor drug

  • Pfizer bets $6B+ on 3Sbio’s bispecific PD-1/VEGF antibody

  • Qilu nabs China rights to Minghui’s B7-H3 ADC for up to $186M

  • Shionogi to acquire Japan Tobacco pharma companies for $1.1B

  • Dimerix strikes $601M Amicus deal for kidney disease drug DMX-200

  • US capital crunch pushes China biotechs to roundabout financings

  • Chinabio 2025: Europe-China pharma deals rise as US markets shut

  • Ono terminates development of Chordia’s cancer drug candidate

  • Biopharma M&As plunge in Q1, while $66.86B in deals beats 2024 average

  • Ten March deals passed $1B, totaling $25.31B in value

Financings

  • HKEX on phone, digital stock chart

    Hengrui to raise up to $1.27B in Hong Kong listing

    IPO
    Hengrui Pharmaceuticals Co. Ltd. announced a global offering on the Hong Kong Stock Exchange to raise up to $1.27 billion to advance its growing pipeline focused on oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience.
  • China’s Pegbio launches HK$300M Hong Kong IPO

    Diabetes
  • Sirius bags $50M series B2 for cardiovascular siRNA pipeline

    Clinical
  • Three Korea biotechs prep for May IPOs

    Analysis and data insight
  • ‘Everything is possible’: Pharmas navigate US market uncertainties

    Europe
More in Financings

Australia

  • 3D illustration of mesenchymal stem cells

    Cynata’s MSC cells show positive results across variety of delivery systems

    Clinical
    The promise of mesenchymal stem cells (MSCs) to heal heart disease could be around the corner thanks to a new delivery method tested by regenerative medicine company Cynata Therapeutics Ltd.
  • Immutep’s efti shows strong survival data in head and neck cancer

    Clinical
    Immutep Ltd. announced strong median overall survival of 17.6 months in cohort B of the TACTI-003 (Keynote-PNC-34) phase IIb trial that evaluated eftilagimod alfa in combination with Merck & Co.’s Keytruda (pembrolizumab) as first-line therapy in recurrent/metastatic head and neck squamous cell...
  • Australia follows Canadian lead; Labor win a sharp rebuke to Trump

    Regulatory
    Australian biopharma stakeholders welcomed the reelection of Prime Minister Anthony Albanese, who promised to expand Medicare and to invest more in Australian research.
  • Annual US 301 trade report has louder bark

    Regulatory
  • FDA issues CRL for Telix's glioma imaging agent, wants more data

    Regulatory
  • Telix’s brain cancer radiotherapy shows phase II survival benefit

    Clinical
  • Tryptamine to test injectable psilocybin for binge eating disorder

    Clinical
More in Australia

China

  • Disitamab vedotin

    China’s NMPA gives thumbs up to Remegen’s ADC targeting HER2

    Regulatory
    China’s National Medical Products Administration has approved Remegen Co. Ltd.’s antibody-drug conjugate (ADC), disitamab vedotin (RC-48), for treatment of HER2-positive advanced breast cancer in patients with liver metastasis.
  • AACR 2025: D3 Bio, Immvira present solid tumor, brain cancer data

    Clinical
    Shanghai-based D3 Bio (Wuxi) Co. Ltd. showed positive results for its lead candidate, next-generation KRAS G12C inhibitor, D3S-001, also known as elisrasib, in patients with KRAS G12C mutation cancers, including patients previously treated with first-generation KRAS G12C inhibitors. Presented at...
  • Innovent’s IBI-302 meets phase II endpoints in neovascular AMD

    Ocular
    Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in phase II, showing a gain of 10 or more letters in visual acuity from baseline at one year in Chinese patients with neovascular age-related macular degeneration.
  • Green approved stamp

    Akeso hot with FDA cancer win, nods in China, new data

    Clinical
    The intriguing VEGFxPD-1 bispecific antibody space gained oomph with phase III results disclosed April 23 by Akeso Pharmaceuticals Inc. related to Harmoni-6, testing ivonescimab in combination with platinum-based chemotherapy compared with Tevimbra (tislelizumab, Beigene Ltd.), a PD-1 inhibitor...
  • China adds Ascentage's lisaftoclax, olverembatinib to guidelines

    Regulatory
    Ascentage Pharma Group Corp. Ltd. said two of its novel candidates have been included in the 2025 Chinese Society of Clinical Oncology Guidelines, including its in-house developed Bcl-2 selective inhibitor, lisaftoclax (APG-2575), which is under review in China and could be the first domestically...
More in China

Clinical

  • Nuevocor draws $45M series B for gene therapy in rare heart disease

  • Orum halts US study of DAC cancer asset after patient death

  • Remegen’s lupus drug surfaces with phase III myasthenia gravis data

  • Hightide’s HTD-1801 meets phase III endpoints in type 2 diabetes

  • Radiopharmaceuticals stake more territory in breast cancer care

  • More failures for TIGIT: Beigene shutters phase III lung cancer trial

  • Opthea shutters phase III trials in wet AMD

  • February’s phase III wins include Qyuns’ ankylosing spondylitis data

  • Otsuka submits first BLA to FDA for sibeprenlimab in IgAN

  • Daewoong sees end of CS Pharma deal; new starts in cancer, DTx

Regulatory

  • Neurons with dendrites affected by amyloid plaques in Alzheimer's disease

    Fujirebio Alzheimer’s test wins first FDA clearance

    Diagnostics
    Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with...
  • First bespoke gene editing therapy treats rare metabolic disease

    Science
  • FDA shift from animal testing fuels organoid, organ-on-chip demand

    Artificial intelligence
  • South Korea approves record number of biosimilars in 2024

    Analysis and data insight
  • FDA clears Satsuma’s Atzumi for migraine

    Neurology/psychiatric
More in Regulatory
 

Newco news

  • Colorized scanning electron microscope image of regulatory T cells and antigen-presenting cells.

    Japan’s Regcell launches in US with $45.8M to advance Treg platform

    Financings
    Japanese-founded Regcell Inc. has raised $45.8 million and is redomiciling to the U.S. to accelerate clinical development of its pioneering regulatory T-cell (Treg) platform for autoimmune diseases and transplantation.
  • Astellas-Yaskawa JV to build robot-based cell production platform

    Deals and M&A
    Astellas Pharma Inc. is setting up a joint venture with Yaskawa Electric Corp. to develop a new cell production platform using Yaskawa’s dual-arm humanoid robot called Maholo.
  • Harbour Biomed newco HBM Alpha pens $395M hyperplasia drug deal

    Analysis and data insight
    HBM Alpha Therapeutics Inc. signed a potential $395 million licensing deal Feb. 26 with an unnamed “business partner” for its endocrine asset, HAT-001, adding another contender to the congenital adrenal hyperplasia space.
  • Hummingbird migrates ADCs, tech to newco Callio’s $187M debut

    Financings
  • Biomissile’s multispecific antibodies harness NK cell engagers

    Cancer
  • Ligachem gets rights to Daan’s antibody for solid tumor ADCs

    Deals and M&A
  • Aussie spinout could change blood pressure paradigm with low-dose poly pill

    Clinical
More in Newco news

Science

  • Commander proteins linked to lysosomal dysfunction in Parkinson’s

    Neurology/psychiatric
    Genes associated with lysosomal dysfunction increase the risk of Parkinson’s disease (PD), according to a study led by scientists at Northwestern University. The discovery also explains why some people who carry a pathogenic variant of the GBA1...
  • Australian researchers discover new compound to treat long COVID

    Infection
    Researchers have developed a new compound that can prevent long COVID symptoms in mice that could lead to a future drug for the debilitating condition in humans. Developed by researchers at the Walter and Eliza Hall Institute of Medical Research...
  • Pandemic potential is plentiful, but the next bug’s specifics are known unknown

    Conferences
    Compared to other forms of prevention, a unique issue for pandemic preparedness is that it is forever unclear what pathogen, exactly, the world needs to be prepared for. There are an estimated 300,000 viruses that infect mammals; add in birds, and...
  • Ten days of normal survival of a pig liver in a human being

    Drug design, drug delivery and technologies
    Transplanting an animal organ into a human is now a closer reality following the successful xenotransplantation of a genetically modified pig liver into a patient diagnosed with brain death in China. The operation was intended to evaluate organ...
  • Long COVID science is progressing, though therapies have not yet followed

    Conferences
    In 2020, the Conference on Retroviruses and Opportunistic Infections (CROI) was the first scientific conference to move from in-person to virtual due to the COVID-19 pandemic. On the fifth anniversary of the virtual conference, and the pandemic,...
  • At CROI, HIV cure trials raise hopes for broader applicability

    Conferences
    At the 2025 meeting of the Conference on Retroviruses and Opportunistic Infections (CROI) it was the best of times, it was the worst of times. On the first full day of the conference, reports from the first HIV cure trial conducted in Africa, the...
More in Science

BioWorld Insider Podcast

One-on-one with medical innovators

podcast microphone, sound waves on purple backgroundBreakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.


Recent episodes:

  • The importance of balancing AI and people in drug development
  • Two CEOs discuss bracing for tariffs, NIH grant cuts and
    gifting China biopharma leadership position
  • As biopharma investments stumble, med tech surges
  • Mega money well spent? Mammoth mergers fall short of the dream
  • Healing the health divide for women
  • Modifi gets creative on the rocky road to a multibillion-dollar buyout
  • A quantum leap into the future of drug development
  • Gene and cell therapies will propel innovation, says Astellas CCO
  • Capricor’s CEO pursues a BLA and talks rare disease
  • The first half of 2024 was strong as M&As and financings dominate

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