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BioWorld Asia

Wed, Jul 09, 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: Self-amplifying mRNA technology underscored for next big pandemic
  • Man using walker with assistance

    Taiho’s pizuglanstat fails in phase III DMD trial

    In yet another fail for the Duchenne muscular dystrophy (DMD) field, Taiho Pharmaceutical Co. Ltd.’s pizuglanstat (TAS-205) did not meet the primary endpoint in a phase III trial. The phase III Reach-DMD trial, a randomized, placebo-controlled, double-blind and open-label, extension study of pizuglanstat in patients with DMD showed no significant difference in the mean change from baseline to 52 weeks in the primary endpoint of time to rise from the floor in the ambulatory cohort of the study.
  • China approves Simcere’s suvemcitug for ovarian cancer

  • FDA approves Dizal’s sunvozertinib for metastatic non-small-cell lung cancer

  • Veritas, Mitsubishi Gas Chemical partner for new ASO candidates

  • Researchers arm CAR T cells to fight solid tumors

  • Best of BioWorld: Q2

  • News in brief

  • Taiho’s pizuglanstat fails in phase III DMD trial

    In yet another fail for the Duchenne muscular dystrophy (DMD) field, Taiho Pharmaceutical Co. Ltd.’s pizuglanstat (TAS-205) did not meet the primary endpoint in a phase III trial. The phase III Reach-DMD trial, a randomized, placebo-controlled, double-blind and open-label, extension study of pizuglanstat in patients with DMD showed no significant difference in the mean change from baseline to 52 weeks in the primary endpoint of time to rise from the floor in the ambulatory cohort of the study.
  • China approves Simcere’s suvemcitug for ovarian cancer

    China’s National Medical Products Administration gave the green light to Simcere Pharmaceutical Group Ltd.’s Enzeshu (suvemcitug) for treating recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in combination with paclitaxel, liposomal doxorubicin, or topotecan in adults who have received at least one systemic therapy after platinum resistance.
  • FDA approves Dizal’s sunvozertinib for metastatic non-small-cell lung cancer

    Four days ahead of its July 7 PDUFA date, the U.S. FDA granted accelerated approval to Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s sunvozertinib (DZD-9008), branded as Zegfrovy, for treating adults with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations following platinum-based chemotherapy.
  • Veritas, Mitsubishi Gas Chemical partner for new ASO candidates

    Veritas In Silico Inc. (VIS) entered a joint research agreement with Mitsubishi Gas Chemical Co. Inc. to use VIS’s mRNA structural motif analyzing platform technology, called Ibvis, to develop antisense oligonucleotide drug candidates.
  • Researchers arm CAR T cells to fight solid tumors

    Aussie researchers have used CRISPR gene editing tools to “armor” chimeric antigen receptor (CAR) T cells to activate additional cancer-fighting proteins at the tumor site, enabling them to target cancer cells in solid tumors.
  • Best of BioWorld: Q2

    A selection of top news from April through June 2025.
  • News in brief

    BioWorld Asia briefs for July 8, 2025
  • Turn on vitamin A pathway and regenerate an ear

    Lizards, zebrafish, salamanders and tritons can regrow a tail, a fin, or even an entire limb after amputation. Cut a planarian into pieces, and you will end up with a bunch of them. Researchers at the National Institute of Biological Sciences in Beijing have discovered a genetic switch linked to vitamin A. After activating this pathway, they managed to regenerate the ear pinna of a mouse, an animal that previously lacked this ability.
  • Bioversys, Shionogi in CHF529M lung infection collaboration

    Antibiotics specialist Bioversys AG has sealed a potential CHF529 million (US$667.5 million) deal with Shionogi Co. Ltd., in which they will work together on novel ansamycins for treating multidrug-resistant lung infections caused by non-tuberculous mycobacteria.
  • Wuhan Healthgen gets chance at China IPO with SSE market reforms

    Wuhan Healthgen Biotechnology Co. Ltd. gained clearance from the Shanghai Stock Exchange July 1 to list under a recently reinstated IPO growth tier geared towards supporting “unprofitable” biotechnology firms.
  • Biopharma financings total $28.7B in H1, down 59% from 2024

    Biopharma companies raised $7.38 billion across 99 transactions in June 2025, up from $5.55 billion in May and $2.4 billion in April. For the first half of the year (H1), total financings reached $28.74 billion, down 59% from the $70.32 billion raised during the same period in 2024. Although lower than the record-setting levels of 2020 and 2021, the current total aligns more closely with recent years, including $26.57 billion in the first half of 2022 and $30.57 billion in 2023.

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

  • Jerome Kim, of IVI, speaking at the Global Vaccine Forum

    Self-amplifying mRNA technology underscored for next big pandemic

    Cancer
    Experts in mRNA convened at the Global Vaccine Forum (GVF) 2025 to weigh the present and future of vaccine technology, including emerging innovations in self-amplifying mRNA (sa-mRNA) and drug delivery platforms.
  • Multiple myeloma illustration

    Cullinan deals $712M to test Genrix bispecific TCE in autoimmune

    Deals and M&A
    Cullinan Therapeutics Inc. swept up ex-China rights to a multiple myeloma (MM)-targeting BCMAxCD3 bispecific T-cell engager (TCE) velinotamig from Chongqing Genrix Biopharmaceutical Co. Ltd. via a potential $712 million deal June 4. The plan is to repurpose the cancer drug to autoimmune disease.
  • Red and blue bispecific antibodies

    3Sbio revs on with phase II data in tight PD-1/VEGF bispecific race

    Clinical
    3Sbio Inc. reported interim phase II study results of its PD-1/VEGF bispecific antibody, SSGJ-707 – a “fabulous” asset, according to Pfizer Inc. CEO Albert Bourla, that landed in Pfizer’s cancer arsenal via a potential $6 billion deal in May, of which $1.2 billion was paid up front.
  • South Korea flag with stock chart, gold coins

    Korea biotech roundup: four financings, six R&D deals mid-June

    Deals and M&A
    Four biotech companies from South Korea announced new or planned financings mid-June, including GC Genome Corp. Rznomics Inc., G2Gbio Inc. and Mezzion Pharma Co. Ltd. Six major mid-June deals included R&D pacts between Y-Biologics Inc. and Crosspoint Therapeutics, Daewoong Pharmaceutical Co. Ltd....
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for June 24, 2025

  • Financings for July 8, 2025

  • In the clinic for July 8, 2025

  • Other news to note for July 8, 2025

  • Regulatory actions for July 8, 2025

Deals and M&A

  • After axing 95% workforce, Vor bets $4B+ on Remegen’s telitacicept

  • Henlius licenses Hanchorbio’s phase II checkpoint inhibitor HCB-101

  • Torrent Pharma to buy JB Pharma from KKR in $3B M&A deal

  • Abion strikes $1.3B antibody drug deal with unidentified partner

  • Otsuka licenses Harbour’s bispecific T-cell engager for $670M

  • Avata, Oceanus partner on cannabidiol for epilepsy, schizophrenia

  • Pfizer’s $6.15B 3Sbio deal tops May’s biopharma activity

  • Nextcure stock drops near 30% on $745M ADC deal with Simcere

  • Aribio fortifies Arcera alliance with $600M AR-1001 supply deal

  • Epimab sells bispecific T-cell engager to Juri in $210M deal

Financings

  • Polyactiva implant

    Polyactiva raises $25M series C to advance U.S. clinical programs

    Ophthalmic
    Ophthalmology company Polyactiva Pty Ltd closed a AU$40 million (US$25 million) series C round to advance late-stage clinical trials in the U.S. of its lead candidate, PA-5108.
  • Innovent raises HKD$4.3B to advance R&D pipeline, global expansion

    Cancer
  • Keymed launching Stapokibart, advancing pipeline, with $125M raise

    Monoclonal antibody
  • Transthera raises $25M with Hong Kong IPO; stock up 78% on debut

    Cancer
  • Jyong’s $20M US IPO to help refile NDA of urological botanic drug

    Regulatory
More in Financings

Australia

  • Pills shaded in psychedelic colors

    Medibank first to cover psychedelic treatment in Australia

    Neurology/psychiatric
    Australia’s largest health insurance company, Medibank Private Ltd., is the first to reimburse for psychedelic treatment in Australia, funding Emyria Ltd.’s MDMA (3,4-methylenedioxy-methamphetamine) program for post-traumatic stress disorder offered through the Perth Clinic.
  • Nibec stock soars 30% on $435M peptide deal with US biotech

    Deals and M&A
    Nibec Co. Ltd. announced May 28 the signing of a potential $435 million license deal for NP-201, its phase II-ready peptide-based pulmonary fibrosis therapy candidate, with an undisclosed U.S.-based biotech company.
  • Adalta sees promise in new 'East to West' strategy for T-cell therapies

    Deals and M&A
    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...
  • Cynata’s MSC cells show positive results across variety of delivery systems

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

    Deals and M&A
  • Immutep’s efti shows strong survival data in head and neck cancer

    Clinical
  • Australia follows Canadian lead; Labor win a sharp rebuke to Trump

    Regulatory
More in Australia

China

  • CAR T cell attacking cancer cells

    China’s NMPA accepts Carsgen’s NDA for Claudin18.2-targeted CAR T

    Regulatory
    China’s National Medical Products Administration (NMPA) has accepted for review Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), an autologous CAR T candidate targeting Claudin18.2 for treating Claudin18.2-positive advanced gastric/gastroesophageal...
  • Hong Kong Department of Health director and assistant directors

    Hong Kong to set up CMPR as medical products authority by 2026

    Regulatory
    Hong Kong’s Department of Health (DH) announced plans to establish a new medical products regulatory agency called the Hong Kong Centre for Medical Products Regulation (CMPR) by the end of 2026.
  • Mazdutide injection device and product packaging

    China clears mazdutide as first dual GCG/GLP-1RA for weight loss

    Regulatory
    Innovent Biologics Inc. announced June 27 that it gained National Medical Products Administration’s (NMPA) approval of mazdutide as a new weight loss therapy for obese or overweight patients in China. Mazdutide is a dual glucagon/glucagon-like peptide-1 (GCG/GLP-1) receptor agonist originally...
  • Drug Farm harvests new immunomodulators with AI-gene editing tech

    Newco news
    Shanghai Yao Yuan Biotechnology Ltd., also known as Drug Farm, is advancing a portfolio of immune-modulating therapies for various indications including hepatitis B virus, hepatocellular cancer and a relatively new rare genetic disease called ROSAH, an acronym for retinal dystrophy, optic nerve...
  • FDA icons

    FDA scrutinizing trials sending US patient cells to China

    Regulatory
    Using informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient.
More in China

Clinical

  • Immuno Cure, Pharmjet partner on needle-free HIV vaccine trial

  • Moderna expands mRNA tech to latent viruses, cancer, rare disease

  • Corestemchemon preps US BLA filing for stem cell ALS therapy

  • Dizal's new chemical entities for lung, blood cancers

  • Daiichi and Merck pull accelerated approval BLA for ADC

  • Anatara takes a second look at Garp after phase II IBS miss

  • Regeneron boosts obesity pipeline with Hansoh’s GLP-1/GIP for $2B

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

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

  • AACR 2025: D3 Bio, Immvira present solid tumor, brain cancer data

Regulatory

  • Flag of South Korea with skyscrapers in the background

    Korea pharma exports rise to quarterly high of $2.5B in Q1

    Analysis and data insight
    South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of...
  • China clears Mabwell’s Mailisheng injection to treat neutropenia

    European Society for Medical Oncology
  • Samsung Biologics to spin off biosimilar subsidiary Samsung Bioepis

    Analysis and data insight
  • Fujirebio Alzheimer’s test wins first FDA clearance

    Diagnostics
  • First bespoke gene editing therapy treats rare metabolic disease

    Science
More in Regulatory
 

Newco news

  • Alteogen headquarters in Daejeon, South Korea

    Alteogen merges two subsidiaries, forming Alteogen Biologics

    Analysis and data insight
    Alteogen Inc. completed a merger between two subsidiaries – Altos Biologics Inc. and Alteogen Healthcare Inc. – branding the new entity as Alteogen Biologics Inc.
  • AP Bio heads to phase I with bispecific for HER2-resistant tumors

    Cancer
    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...
  • 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
  • Harbour Biomed newco HBM Alpha pens $395M hyperplasia drug deal

    Analysis and data insight
  • Hummingbird migrates ADCs, tech to newco Callio’s $187M debut

    Financings
  • Biomissile’s multispecific antibodies harness NK cell engagers

    Cancer
More in Newco news

Science

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

    Clinical
    Nuevocor Pte. Ltd. has closed a $45 million series B, enabling it to move lead gene therapy NVC-001 into the clinic in the treatment of an inherited form of cardiomyopathy.
  • 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,...
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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