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.

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.

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Analysis and data insight

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.
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.
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.
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....

Financings

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.

Australia

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...

China

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 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.
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 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.

Regulatory

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...

Newco news

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.

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,...

podcast microphone, sound waves on purple background Breakthrough 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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