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BioWorld - Thursday, March 26, 2026
Breaking News: Early FDA wins: Corcept’s Lifyorli, Denali’s AvlayahBreaking News: Trump administration impacts continue to roil the life sciences sector
  • Blue-gray dollar sign

    Excalipoint closes $68.7M seed round for cancer T-cell engagers

    Excalipoint Therapeutics Inc. launched with an oversubscribed $68.7 million seed financing round to advance a portfolio of T-cell engagers for solid tumors, marking one of the largest early stage financings in China biotech history.
  • Imbiologics crosses $1B market cap with Kosdaq debut

  • How to grow a startup in the AI era: MedTech Spotlight Korea 2026

  • Simcere’s PD-L1/IL-15 bispecific sees early edge in bladder cancer

  • News in brief

  • Excalipoint closes $68.7M seed round for cancer T-cell engagers

    Excalipoint Therapeutics Inc. launched with an oversubscribed $68.7 million seed financing round to advance a portfolio of T-cell engagers for solid tumors, marking one of the largest early stage financings in China biotech history.
  • Imbiologics crosses $1B market cap with Kosdaq debut

    Imbiologics Corp.’s market capitalization reached ₩1.5 trillion (US$1.02 billion) on its Kosdaq debut March 20, as the biotech seeks to become a leading antibody drugmaker for autoimmune diseases.
  • How to grow a startup in the AI era: MedTech Spotlight Korea 2026

    AI and advanced biotechnology are reshaping South Korea’s med-tech sector, but great technology alone is not enough to build a successful medical device company, speakers said at MedTech Innovator’s Medtech Spotlight: New Impact Korea 2026.
  • Simcere’s PD-L1/IL-15 bispecific sees early edge in bladder cancer

    Early clinical data from Simcere Pharmaceutical Group Ltd. suggest its PD-L1/IL-15 bispecific antibody, SIM-0237, could emerge as a next-generation contender in Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer.
  • News in brief

    BioWorld Asia briefs for March 24, 2026
  • Australia’s R&D reset puts biotech translation in focus

    Australia is attempting a once-in-a-generation reset of its innovation system, and biotech industry leaders have lauded the federal government’s independent review into Australia's slipping R&D ranks and its proposals to reverse the decline.
  • China’s pharma rise rattles US policymakers

    U.S. lawmakers and industry experts are raising alarm over China’s expanding dominance across the pharmaceutical supply chain, warning that reliance on Chinese inputs poses a growing national security and public health risk.
  • Kintor’s KX-826 meets phase III endpoints in alopecia

    Kintor Pharmaceutical Ltd.’s topical androgen receptor antagonist, pyrilutamide (KX-826), met the primary endpoint in a pivotal phase III trial in male androgenetic alopecia, and the company will soon file an NDA with China’s National Medical Products Administration.
  • Gilead pens dual-purpose $2B Ouro M&A deal with Galapagos

    Gilead Sciences Inc. said after U.S. market close March 23 that it will acquire privately held Ouro Medicines LLC and its autoimmune BCMA/CD3 bispecific T-cell engager, gamgertamig, in a deal valued at $2.17 billion.

BioWorld Insider podcast

Play buttonThe opioid crisis may not be front and center anymore, but it’s raging still. Elysium Therapeutics Inc. CEO Greg Sturmer talks about his firm’s candidate for a solution to the medical and societal problem.
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Analysis and data insight

  • Arrows pointing upward

    Biopharma deal value jumps 60% to start 2026

    Deals and M&A
    Biopharma deal value reached $61.17 billion in the first two months of 2026, roughly a 60% increase from the $38.11 billion logged in the same period of 2025 and marking the strongest early year total in BioWorld’s records. The surge was driven by unusually strong activity in both months, with...
  • Drug capsules in petri dish

    Latest benchmark shows 35% decline in antibiotics pipeline in past 5 years

    Infection
    Twelve years on from the World Health Organization formally raising the alarm, antimicrobial resistance continues to grow, and despite numerous public and private incentives and initiatives, the pipeline of antibiotics in development is thinner than ever.
  • Collage of businesspeople

    Wave of deals lifts large-cap biopharma stocks

    The BioWorld Biopharmaceutical Index finished 2025 up 24.07%, building slightly on its 23% gain recorded at the end of November. While the increase trailed the Nasdaq Biotechnology Index’s 32.4% rise for the year, it outperformed the broader Dow Jones Industrial Average, which advanced 12.97%.
  • Approved stamp

    China tops US in January drug approvals

    Regulatory
    U.S. FDA approvals began 2026 at a slower pace than usual, with eight approvals recorded in January.
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for March 24, 2026

  • Financings for March 3, 2026

  • In the clinic for March 24, 2026

  • Other news to note for March 24, 2026

  • Regulatory actions for March 24, 2026

Deals and M&A

  • Samsung is adding trials and EHR access to Galaxy devices

  • G2Gbio secures license deal, ₩20B investment from Samsung Epis

  • Sanofi licenses Sino Biopharm’s JAK/ROCK drug for $1.4B

  • Eli Lilly commits $500M to boost South Korea’s biomedical sector

  • Roche to invest ₩710B in South Korea over five years

  • Rapport’s RAP-219 gets more phase III funding with Tenacia deal

  • Returning to pulmonary hypertension, GSK buys 35Pharma

  • Asahi Kasei’s $920M Aicuris buy boosts its antiviral armory

  • GSK nabs two Frontier Biotech siRNA assets in $1B deal

  • Astellas and Vir in $1.3B deal for CD3 T-cell engager

Financings

  • Lee Byoung-chul, CEO, Kanaph

    Kanaph’s $27M IPO to aid multi-modality cancer, immune portfolio

    Cancer
    Multi-modality platform company Kanaph Therapeutics Inc. raised ₩40 billion (US$26.7 million) through its Kosdaq stock sale March 16, becoming the first Korean biotech to go public this year. The Seoul-based company’s shares (KOSDAQ:0082N0) climbed to ₩70,000 in intraday trading before closing at...
  • Kanaph, Imbiologics to kick off 2026 Korea biotech, med-tech IPOs

    Medical technology
  • Innovacell’s $91M Tokyo IPO to fund incontinence cell therapies

    Aging
  • Ascletis raises $107M to advance oral GLP-1 to phase III trials

    Clinical
  • Quantx raises $85M to advance oral immunology drugs

    Newco news
More in Financings

Australia

  • Silhouette and psychedelic sky

    Australia publishes first clinical practice guideline for psychedelics

    Clinical
    Australia has released the first clinical practice guideline for the appropriate use of methylenedioxymethamphetamine-assisted psychotherapy for post-traumatic stress disorder, but clinicians caution that evidence, infrastructure and access remain works in progress.
  • Mixed phase II results still point to path forward for AISA-021

    Clinical
    Although Aisa Pharma Inc’s cilnidipine (AISA-021) failed to meet the primary endpoint, multiple secondary endpoints showed statistically significant improvement in treating sclerosis-associated Raynaud's phenomenon, potentially positioning the drug for a phase III program in a disease with no...
  • Telix advances PSMA radiotherapy challenger to Pluvicto

    Clinical
    Australia’s Telix Pharmaceuticals Ltd. is advancing a potential challenger to Novartis plc’s dominant prostate cancer radioligand therapy, Pluvicto (lutetium [177Lu] vipivotide tetraxetan), after reporting that the safety lead-in portion of its global phase III Prostact trial met its primary...
  • CSL taps Lilly to de-risk IL-6 drug following dismal earnings

    Deals and M&A
  • Australia launches world-first pediatric mRNA brain cancer trial

    Clinical
  • Omnigeniq’s journey from space science to drug design

    Newco news
  • Rage Bio enters clinic with inhaled oligonucleotide in COPD

    Financings
More in Australia

China

  • Illustration of inflamed spine

    China’s Qyuns moves IL-17 biologic toward first approval

    Regulatory
    Qyuns Therapeutics Co. Ltd. has moved closer to its first commercial product after China’s National Medical Products Administration (NMPA) accepted its NDA for IL-17 antibody crusekitug (QX-002N) for treating ankylosing spondylitis (AS), a chronic inflammatory disease that affects the spine and...
  • Fallopian tubes, ovaries and uterus

    China approves first noninvasive therapy for cervical precancer

    Medical technology
    China’s National Medical Products Administration has approved Asieris Pharmaceuticals Co. Ltd.’s cold light photodynamic drug-device combination product, Cevira (APL-1702, hexaminolevulinate hydrochloride), which is used as a nonsurgical therapy for treating patients with cervical intraepithelial...
  • Cancer tumor in breast illustration

    Systimmune’s iza-bren hits phase III breast cancer goals in China

    Clinical
    In a boon for licensee Bristol Myers Squibb Co., Systimmune Inc.’s next-generation cancer drug, izalontamab brengitecan (iza-bren), hit both progression-free survival and overall survival endpoints in a phase III trial of Chinese patients with advanced triple-negative breast cancer.
  • US taking a closer look at China biotech subsidies

    Regulatory
    U.S. scrutiny of China’s trade practices, especially in the biotech sector, continues to escalate as the U.S. International Trade Commission launches two factfinding investigations Congress mandated in the fiscal 2026 appropriations.
  • Jiuyuan seeks approval of Wegovy biosimilar in China

    Regulatory
    China’s National Medical Products Administration has accepted for review Jiuyuan Genetic Biopharmaceutical Co. Ltd.’s drug application for Jikeqin, a biosimilar product to Novo Nordisk A/S’s Wegovy (semaglutide) for obesity.
More in China

Clinical

  • Otsuka’s repinatrabit shows phase II efficacy in PKU adolescents

  • Immutep stock plummets 90% on efti phase III failure in NSCLC

  • Kyowa Kirin discontinues rocatinlimab trials due to safety issues

  • Tanabe’s dersimelagon hits phase III endpoint in rare disorder

  • Early data lift Immunofoco’s solid tumor CAR T program

  • Takeda’s zasocitinib meets phase III psoriasis endpoints

  • Hutchmed plans China NDA filing of sovleplenib in rare anemia

  • November phase III successes led by HIV wins from Gilead, Merck

  • Patient deaths prompt halt in Merck-Daiichi phase III in lung cancer

  • Radiopharm Theranostics’ RAD-101 meets brain metastases endpoints

Regulatory

  • doctor, checklist, apple, prescription bottle and blood glucose meter illustration

    Hightide wins China NDA acceptance for oral metabolic therapy

    Endocrine/metabolic
    China’s National Medical Products Administration (NMPA) has accepted for review Hightide Therapeutics Inc.’s NDA for HTD-1801 for type 2 diabetes, marking the Shenzhen-based company’s first NDA submission and a major step toward commercialization.
  • Japan approves first iPSC therapy for Parkinson’s disease

    Musculoskeletal
  • Korean ARPA-H to invest ₩162B in nine projects in 2026

    Medical technology
  • Taiwan to invest $752M in biopharma security over four years

    Aging
  • Japan endorses two iPSC drugs for approval under CEA pathway

    Aging
More in Regulatory
 

Newco news

  • Illustration of CTLA-4 protein structure

    Harbour Biomed spins out newco in $1.2B CTLA-4 deal

    Deals and M&A
    Harbour Biomed is spinning out newco Solstice Oncology and is outlicensing its CTLA-4 antibody, porustobart (HBM-4003), to the newco in a cash and equity deal worth more than $1.2 billion.
  • AI meets antibody design: Galux draws $29M series B for drug R&D

    Financings
    Galux closed a ₩42 billion (US$29 million) series B round Feb. 10, led by Yuanta Investment to bring AI-driven “rational design” to the protein drug development process, already heavily influenced by human engineering. 
  • Vibrant aims to tame EGFR tumors with masked TCEs

    Cancer
    After raising $61 million in a series B round, Vibrant Therapeutics Inc. is gearing up to begin a U.S. phase I trial with its lead program, VIB-305, a masked T-cell engager (TCE) for treating EGFR-positive solid tumors.
  • Hits’ Hyperlab launches as ‘virtual AI lab’ for new drug discovery

    Protein
  • Myrio first to develop binders with high affinity/specificity

    Clinical
  • Signet builds new model for gastric cancer drug discovery

    Cancer
  • SK Bio, Eurofarma launch Mentis Care for digital epilepsy care

    Digital health
More in Newco news

Science

  • Targetable ‘high-plasticity cell state’ important for cancer progression, drug resistance

    Cancer
    Cancer cells expand through mutations – but not just through mutations. They also change their behavior in the absence of underlying genetic alterations. Such plasticity helps the cells both adapt to the cellular stress fueled by out-of-control...
  • Sea anemone venom acts as a senolytic tool against cancer

    Aging
    The sea anemone Stichodactyla helianthus, which carpets the Caribbean seafloor, may hold the key to eliminating the senescent cells that survive cancer therapy. A collaboration led by Spanish scientists across several international research...
  • In 2025, autoimmune work notches scientific, economic successes

    Deals and M&A
    In October, the Nobel Committee awarded the 2025 Nobel Prize in Physiology or Medicine to Shimon Sakaguchi, Mary Brunkow and Fred Ramsdell for their discoveries in the field of autoimmunity.
  • Romidepsin offers hope for high-risk neuroblastoma

    Cancer
    Australian researchers have found a drug combination that can bypass the cellular defenses in neuroblastoma that lead to relapse, and the discovery could lead to better treatment strategies for children whose cancers have stopped responding to...
  • HIV remission after heterozygous CCR5Δ32 stem cell transplant

    Cancer
    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,...
  • 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...
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:

  • Finding a better, longer-lasting fix in opioid overdose
  • 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

View all

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