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BioWorld - Wednesday, November 19, 2025
Breaking News: Arrowhead’s plozasiran cleared for FCS; Ionis patent duel awaitsBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
  • Deal handshake with coin, chart background

    ABL Bio’s Grabody lands second $2.6B deal, this time with Lilly

    ABL Bio Inc. inked a license and research agreement with Eli Lilly and Co. worth up to $2.6 billion to develop multiple therapeutics using the Grabody-B platform. Under the terms announced Nov. 12, ABL will receive a $40 million up-front payment and up to $2.56 billion in development, regulatory and commercialization milestones, plus tiered royalties on net sales.
  • Qilu gains China rights to Laekna’s AKT inhibitor in ¥2B deal

  • FDA clears Kura/Kyowa’s Komzifti in r/r NPM1 mutant AML

  • Harbour Biomed launches AI-based antibody development platform

  • Henlius, Organon win US FDA approval of first Perjeta biosimilar

  • Third Arc Bio licenses Adagene tech for CD3 T-cell engagers

  • News in brief

  • ABL Bio’s Grabody lands second $2.6B deal, this time with Lilly

    ABL Bio Inc. inked a license and research agreement with Eli Lilly and Co. worth up to $2.6 billion to develop multiple therapeutics using the Grabody-B platform. Under the terms announced Nov. 12, ABL will receive a $40 million up-front payment and up to $2.56 billion in development, regulatory and commercialization milestones, plus tiered royalties on net sales.
  • Qilu gains China rights to Laekna’s AKT inhibitor in ¥2B deal

    Laekna Inc. outlicensed select rights to LAE-002 (afuresertib), an oral pan-AKT kinase inhibitor licensed from Novartis AG in 2018, to Qilu Pharmaceutical Co. Ltd. under a potential ¥2.045 billion (US$287.23 million) deal.
  • FDA clears Kura/Kyowa’s Komzifti in r/r NPM1 mutant AML

    The U.S. FDA gave the thumbs up to Kura Oncology Inc./Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, to treat relapsed, refractory (r/r) nucleophosmin1 (NMP1)-mutant acute myeloid leukemia (AML). The approval of the drug, branded Komzifti, came more than two weeks ahead of the Nov. 30 PDUFA date.
  • Harbour Biomed launches AI-based antibody development platform

    Harbour Biomed is stepping up its antibody discovery process by using AI to develop innovative therapeutics. “We have done great through the traditional way of generating leads and designing molecules, but there’s a major gap as some therapeutics cannot reach the desired location or common targets,” Harbour Biomed founder, chairman and CEO Jingsong Wang told BioWorld.
  • Henlius, Organon win US FDA approval of first Perjeta biosimilar

    Shanghai Henlius Biotech Inc. and Organon & Co. announced Nov. 17 that the U.S. FDA cleared Poherdy (pertuzumab-dpzb) as the first and only interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc./Roche Holding AG).
  • Third Arc Bio licenses Adagene tech for CD3 T-cell engagers

    In a deal worth up to $840 million, Third Arc Bio Inc. is licensing Adagene Inc.’s Safebody technology platform to generate two masked CD3 T-cell engagers against unique tumor associated antigens.
  • News in brief

    BioWorld Asia briefs for Nov. 18, 2025
  • J&J pushes to elevate patient voices in Asia

    Up to 77% of patients with non-small-cell lung cancer in Asia-Pacific rely almost entirely on their physicians to decide their treatment, even though 69% of physicians say they encourage shared decision-making. That disconnect remains one of the region’s biggest obstacles to improving outcomes, Anthony Elgamal, vice president of Oncology Asia Pacific at Johnson & Johnson Innovative Medicine, told BioWorld.
  • ‘Most complete’ map of oral microbiome enables links to systemic disease

    South Korean researchers led by Lee In-suk of Yonsei University have reported the most complete oral microbiome catalog to date, with more than 72,000 genomes. Detailed in Cell Host & Microbe on Nov. 12, 2025, the database is expected to serve as a universal platform for academia and enable “precision microbiome medicine” for the industry, Lee told BioWorld.
  • Adenosine surge is common thread in ketamine and ECT response

    Researchers from the Chinese Institute for Brain Research, the Chinese Academy of Medical Sciences, and their collaborators have identified adenosine as the driving force behind the rapid, fast-acting antidepressant effects of ketamine and electroconvulsive therapy (ECT). “Our journey into this area of research began over a decade ago, around 2013, when the clinical world was buzzing with excitement about ketamine's remarkably rapid antidepressant effects,” Minmin Luo, co-senior author of the study, told BioWorld.
  • Biopharma dealmaking climbs 17% in October to $31.9B

    Biopharma dealmaking activity remained strong in October, with total deal value reaching $31.86 billion, a 17% increase from $27.15 billion in September and ranking as the second-highest month in 2025 after June’s $35.43 billion.

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Analysis and data insight

  • Business, data, dollars illustration

    Biopharma financings jump 86% in October, raising $13.2B

    Financings
    Biopharma financings from January through October 2025 totaled $61.45 billion, roughly in line with the $61.04 billion raised during the same period in 2023 but down sharply from last year’s $93.83 billion.
  • Nonprofit stamp

    Biopharma nonprofit dealmaking and grants stabilize in a new normal

    Deals and M&A
    Biopharma partnerships involving nonprofits have declined sharply since peaking during the pandemic. Deal value surged from $5.18 billion in 2019 to $21.44 billion in 2021, driven by COVID-19 collaborations and vaccine-related funding, before falling to $7.99 billion in 2022 and $754.6 million in...
  • Row of white dice with people icons, red die with scissors

    Big pharma drives surge in biopharma job cuts in 2025

    Asia-Pacific
    In 2025, the biopharma industry has undergone a wave of workforce reductions that surpasses previous years’ trends. Multiple major pharma companies have announced sizeable job cuts, driven by a convergence of shifting regulatory terrain, vaccine slowdowns and cost-structure rationalization.
  • Health professional holding stethoscope with health icons

    Clinical trial activity jumps as BioWorld tracks 230 updates in September

    Clinical
    In September 2025, BioWorld recorded 230 clinical trial updates spanning phases I through III, up sharply from 95 in August, 140 in July and just below 254 in June. Among these, 22 phase III trials reported positive outcomes, while four ended in failure and another three produced mixed results.
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for Oct. 21, 2025

  • Financings for Nov. 18, 2025

  • In the clinic for Nov. 18, 2025

  • Other news to note for Nov. 18, 2025

  • Regulatory actions for Nov. 18, 2025

Deals and M&A

  • Celltrion signs $744M deal with Kaigene, $500M with Mustbio

  • Lilly moves deeper into RNAi with $1.2B Sanegene obesity deal

  • Qyuns and Roche partner in $1B+ bispecific antibody deal

  • Boehringer licenses Kyowa Kirin's small molecule for autoimmune disease

  • Celltrion, Portrai in $87M R&D deal to discover new drug targets

  • Neurocrine to license Transthera NLRP3 inhibitor in $881M deal

  • Innovent rings up $11.4B deal with Takeda for three I-O/ADC assets

  • Aimedbio’s solid tumor ADC asset goes to Boehringer in $1B deal

  • Aimedbio’s solid tumor ADC asset goes to Boehringer in $1B deal

  • Chugai licenses Rani’s robotic drug delivery technology in $1B deal

Financings

  • Ena Respiratory's INNA-051

    Ena Respiratory raises AU$34M series B to fund phase II trial

    Infection
    Ena Respiratory Pty Ltd. raised an AU$34 million (US$22.4 million) series B round to advance INNA-051, its nasal spray for symptomatic viral respiratory infections, to phase II trials. New investors in the Melbourne-headquartered company include the Gates Foundation and Flu Lab. Existing investors...
  • Radiopharm Theranostics raises AU$35M to advance pipeline

    Cancer
  • Inhalation drug developer CF Pharmtech raises $78M in Hong Kong IPO

    Respiratory
  • September biopharma financings jump 54% to $7.12B

    Analysis and data insight
  • Full-Life nabs $77M for radiopharmaceuticals, Belgium GMP site

    Cancer
More in Financings

Australia

  • 3D illustration showing presence of tumor inside prostate gland

    Advancell sets new radiopharma standard in prostate cancer

    Clinical
    Aussie radiopharma company Advancell Co. Ltd. unveiled promising early clinical data that could redefine how advanced prostate cancer is treated by targeted alpha therapies in the radiopharmaceutical space.
  • Argenica’s stroke drug shows positive trends in functional outcomes

    Clinical
    Although Argenica Therapeutics Ltd.’s stroke drug, ARG-007, saw mixed results in top-line phase II data, new data in functional outcomes studies showed signs the drug helped patients think more clearly, regain independence, and enjoy a better quality of life after stroke.
  • Genentech $569M deal lifts Starpharma stock 73%

    Deals and M&A
    Starpharma Holdings Ltd.’s stock shot up 73% on the news that it is outlicensing its dendrimer enhanced product drug delivery technology to Roche Holding AG subsidiary Genentech Inc. in a deal worth more than $569 million.
  • Australia bets on mRNA as Moderna builds regional hub

    Analysis and data insight
  • Piecing mosaic of APAC regulations key to Asia biotech growth

    Analysis and data insight
  • Argenica’s stock drops 56% on mixed phase II results

    Clinical
  • Propanc to acquire $100M of Ethereum to accelerate pipeline

    Financings
More in Australia

China

  • Haisheng Zhang, CEO, Signet

    Signet builds new model for gastric cancer drug discovery

    Newco news
    Signet Therapeutics founder Haisheng Zhang is betting on organoids and AI to outsmart diffuse gastric cancer and the limits of traditional “clean” drug design.
  • Cross-section of brain

    Lumosa’s stroke drug meets phase IIb endpoints in China

    Clinical
    Lumosa Therapeutics Co. Ltd.’s intravenous odatroltide (LT-3001) met the primary endpoints in a phase IIb trial in China in patients with acute ischemic stroke, paving the way for a pivotal phase III study.
  • Illustration of nasopharyngeal carcinoma

    Lepu’s MRG-003 cleared as China’s first EGFR ADC for advanced NPC

    Cancer
    Lepu Biopharma Co. Ltd. said Oct. 30 it won Chinese approval of a novel antibody-drug conjugate (ADC), Meiyouheng (becotatug vedotin injection), making it China’s first epidermal growth factor receptor (EGFR)-directed ADC for advanced nasopharyngeal cancer (NPC).
  • Chris Lai, cofounder and CEO, Metis at Nanoforge launch

    Metis plans China NDA submission for orally dissolving PBA drug

    Clinical
    Based on positive phase III study results, Metis Techbio is planning to file an NDA for its AI-derived orally disintegrating tablet drug candidate for pseudobulbar affect, MTS-004, in China next year.
  • World with digital overlay

    BIX 2025: What ‘radical’ changes in US, China mean for bio sector

    Analysis and data insight
    Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.
More in China

Clinical

  • Takeda’s mezagitamab shows lasting kidney function in IgA nephropathy

  • Hanmi’s efpeglenatide hits phase III endpoints in obesity

  • Astellas’ zolbetuximab misses pancreatic cancer phase II endpoint

  • Takeda ditches cell therapy business

  • Real-world data illuminates Rakuten's Alluminox solid tumor platform

  • More stem cell, gene therapies progressing in clinic for ALS

  • Carsgen’s zevor-cel CAR T shows long-term survival in MM

  • QL Biopharm’s monthly GLP-1 meets phase II endpoints

  • Can AI be used in every aspect of drug development?

  • The ‘molecular revolution’ driving R&D of new cancer therapeutics

Regulatory

  • U.S. President Donald J. Trump (left) and South Korea President Lee Jae-myung at the ROK-U.S. summit

    South Korea trade deal eases industry’s pharma tariff fears

    Biosimilar
    The Korea Biotechnology Industry Organization on Oct. 30 welcomed the bilateral trade deal between the U.S. and South Korea announced during U.S. President Donald Trump’s state visit alongside the Asia-Pacific Economic Cooperation forum in Gyeongju, South Korea.
  • Trump hits drug imports with 100% tariffs, starting Oct. 1

    Asia-Pacific
  • Make In India initiative still advancing, but most devices imported

    Asia-Pacific
  • China a great AI med-tech market, but premarket review unpredictable

    Artificial intelligence
  • PMDA more open to use of clinical data from other nations

    Asia-Pacific
More in Regulatory
 

Newco news

  • SK Biopharm execs

    SK Bio, Eurofarma launch Mentis Care for digital epilepsy care

    Artificial intelligence
    SK Biopharmaceuticals Co. Ltd. and Eurofarma Laboratórios SA launched a new joint venture called Mentis Care Inc. Oct. 21, dedicated to developing an AI-powered platform for epilepsy management.
  • Kalexo enters dyslipidemia fray with preclinical siRNA candidate

    Deals and M&A
    Mabwell Bioscience Co. Ltd. and Aditum Bio Management Co. LLC announced, in after-market hours Sept. 17, an agreement to forge a new company called Kalexo Bio Inc. and load the biotech with a preclinical dyslipidemia asset via a potential $1 billion global license deal.
  • Braveheart licenses Hengrui's heart drug HRS-1893 in $1B deal

    Deals and M&A
    Braveheart Bio Inc. is paying $65 million up front to license Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s oral hypertrophic cardiomyopathy drug candidate called HRS-1893.
  • Proteina’s PPI Landscape to help reshape antibody drug design

    Financings
  • Aussie gene therapy company emerges from stealth

    Ocular
  • Purpose-driven longevity fund launches in face of regulatory issues

    Financings
  • In ongoing mRNA evolution, SML Biopharm sights new cancer vaccines

    Clinical
More in Newco news

Science

  • Opportunity, risks of cell therapy to tackle aging and disease

    Analysis and data insight
    Stem cells are a promising therapeutic modality to fight aging and age-related disease, speakers at the Bio-Plus Interphex Korea 2025 said. Progress in cell-based longevity medicine is being made, they added, although safety, ethical and...
  • Bio Japan 2025: Nobel Prizes invigorate Japan’s bio industry

    Conferences
    Bio Japan 2025 was abuzz with the news that Japan has once again snagged the Nobel Prize in Physiology or Medicine, with Shimon Sakaguchi winning for his discovery of a subtype of CD4-expressing T cells that affect the immune response. Earlier...
  • 2025 Nobel honors autoimmunity discoveries

    Analysis and data insight
    The Nobel Committee announced today that it has awarded the 2025 Nobel Prize in Physiology or Medicine to three scientists for their discovery of regulatory T cells, which are a critical part of the way the body prevents autoimmune attacks.
  • Allergens attack by way of pores in epithelial cell membrane

    Chinese scientists have discovered a common mechanism by which structurally distinct proteins elicit an allergic reaction, showing they cause the formation of pores in epithelial airway cells.
  • Australian researchers identify world-first treatments to prevent HTLV-1 infection

    Collaboration
    Around 10 million people globally live with the life-threatening human T-cell lymphotropic virus type-1 (HTLV-1), yet it remains a poorly understood disease that currently has no preventative treatments and no cure.
  • Proteomics finds surprise commonalities as well as differences in neurodegenerative diseases

    Biomarkers
    The switch will be flicked today to make the world’s largest dementia-related proteomics dataset freely available to researchers, at the same time as members of the consortium which compiled it publish the proteomics signatures of major...
More in Science

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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.


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  • Esperion Therapeutics CEO Sheldon Koenig
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  • 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
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  • Healing the health divide for women
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  • A quantum leap into the future of drug development
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