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BioWorld - Thursday, December 4, 2025
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
  • Heart and kidneys

    Hightide’s HTD-1801 outperforms Farxiga in type 2 diabetes

    Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met the primary endpoint showing superior improvements in key cardiometabolic markers in patients with type 2 diabetes compared to Astrazeneca plc’s SGLT2 inhibitor, Farxiga (dapagliflozin), in a head-to-head phase III trial.
  • Subcutaneous biologics maker Bao Pharma prices $128M IPO

  • Otsuka submits NDA for new non-stimulant ADHD therapy

  • China approves Innovent’s picankibart as first domestic IL-23p19

  • Hightide’s HTD-1801 outperforms Farxiga in type 2 diabetes

    Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met the primary endpoint showing superior improvements in key cardiometabolic markers in patients with type 2 diabetes compared to Astrazeneca plc’s SGLT2 inhibitor, Farxiga (dapagliflozin), in a head-to-head phase III trial.
  • Subcutaneous biologics maker Bao Pharma prices $128M IPO

    Bao Pharmaceuticals Co. Ltd., a developer of subcutaneous biologic drugs, priced its IPO at HK$26.38 on Dec. 2, aiming to raise about HK$1 billion (US$128 million). Bao expects net proceeds of HK$921.5 million after expenses, which will fund its “two-anti” strategy – developing both antibody and antibiotic drugs worldwide, mainly in China, the U.S. and Europe.
  • Otsuka submits NDA for new non-stimulant ADHD therapy

    Otsuka Pharmaceutical Co. Ltd. filed an NDA with the U.S. FDA for centanafadine (formerly EB-1020), a new nonstimulant therapy for treating attention-deficit hyperactivity disorder (ADHD) in children, adolescents and adults. Centanafadine is a norepinephrine, dopamine and serotonin reuptake inhibito formulated as a once-daily extended-release capsule.
  • China approves Innovent’s picankibart as first domestic IL-23p19

    China’s National Medical Products Administration gave the nod to Innovent Biologics Inc.’s picankibart (IBI-112), branded as Pecondle, for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
  • Vigencell’s cell therapy for lymphoma meets phase II endpoint

    Vigencell Inc. plans to seek conditional approval in South Korea for VT-EBV-N, an antigen-specific killer T-cell therapy for natural killer T-cell lymphoma, after gaining positive top-line data from a phase II study Nov. 25.
  • Myrio first to develop binders with high affinity/specificity

    Myrio Therapeutics Pty Ltd. has been able to accomplish something no other company has yet been able to crack: to develop binders where both the affinity and the specificity can be increased.
  • HIV remission after heterozygous CCR5Δ32 stem cell transplant

    2025 has been the most challenging year in the efforts to fight HIV since at least the advent of antiretroviral therapy. In a report on “Overcoming disruption, transforming the AIDS response,” released last week ahead of World AIDS Day on Dec. 1, the Joint United Nations Program on HIV/AIDS (UNAIDS) described “a global system in shock” by sharply reduced funding from the U.S. and other wealthy nations. Scientifically, for now, progress is ongoing.
  • News in brief

    BioWorld Asia briefs for Dec. 2, 2025

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Analysis and data insight

  • Deal handshake and arrows sketch on chalkboard

    Biopharma dealmaking climbs 17% in October to $31.9B

    Deals and M&A
    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.
  • Deal handshake with coin, chart background

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

    Deals and M&A
    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...
  • 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...
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for Dec. 2, 2025

  • Financings for Dec. 2, 2025

  • In the clinic for Dec. 2, 2025

  • Other news to note for Dec. 2, 2025

  • Regulatory actions for Dec. 2, 2025

Deals and M&A

  • New Samyang Holdings, Samsung Biologics spin-offs debut on Kospi

  • GSK, LTZ partner to develop myeloid cell engagers

  • Qilu gains China rights to Laekna’s AKT inhibitor in ¥2B deal

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

  • Harbour Biomed launches AI-based antibody development platform

  • 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

Financings

  • Red and blue bispecific antibodies

    Phrontline raises $60M in pre-A+ round for bispecific ADCs

    Antibody-drug conjugate
    Phrontline Biopharma Suzhou Co. Ltd. closed a $60 million pre-A+ financing round led by Lapam Investment, with participation from nine other investors. The funds raised will support Phrontline’s development of next-generation antibody-drug conjugate (ADC) candidates.
  • Ena Respiratory raises AU$34M series B to fund phase II trial

    Infection
  • 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
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

  • FDA Approved stamp

    Henlius, Organon win US FDA approval of first Perjeta biosimilar

    Clinical
    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).
  • 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).
  • Antibodies attacking cancer cell

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

    Deals and M&A
    Takeda Pharmaceutical Co. Ltd. agreed to codevelop and commercialize up to three of Innovent Biologics Co. Ltd.’s immuno-oncology (I-O) and antibody-drug conjugate (ADC) candidates with the signing of a $11.4 billion deal, including $1.2 billion paid up front.
More in China

Clinical

  • Protara sees Chugai blue sky in LMs as phase II data strong

  • Taiho, Cullinan file rolling NDA on phase I/II zipalertinib data

  • J&J pushes to elevate patient voices in Asia

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

  • Clinical trial activity jumps as BioWorld tracks 230 updates in September

  • Metis plans China NDA submission for orally dissolving PBA drug

  • 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

Regulatory

  • Kidneys

    Otsuka’s IgAN therapy gets a thumbs-up from the FDA

    Genitourinary/sexual function
    The priority BLA from Otsuka Pharmaceutical Co. Ltd., of Tokyo, and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization Inc., for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN) has received accelerated approved by the U.S. FDA.
  • FDA investigating Takeda’s Adzynma after reports of death

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

    Cancer
  • South Korea trade deal eases industry’s pharma tariff fears

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

    Analysis and data insight
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

  • Adenosine surge is common thread in ketamine and ECT response

    Neurology/psychiatric
    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...
  • 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.
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:

  • Esperion Therapeutics CEO Sheldon Koenig
  • Trying this at home: Bioxcel steps closer to an sNDA for Igalmi
  • 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

View all

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