Aribio fortifies Arcera alliance with $600M AR-1001 supply deal
Aribio Co. Ltd. signed a $600 million license deal with Acino International AG, an Arcera Life Sciences subsidiary, granting the latter commercial rights to its oral Alzheimer’s disease therapy, AR-1001, in select countries including the Middle East.

Aribio fortifies Arcera alliance with $600M AR-1001 supply deal
Aribio Co. Ltd. signed a $600 million license deal with Acino International AG, an Arcera Life Sciences subsidiary, granting the latter commercial rights to its oral Alzheimer’s disease therapy, AR-1001, in select countries including the Middle East.
Corestemchemon preps US BLA filing for stem cell ALS therapy
Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company officials confirmed to BioWorld during a June 2 interview. Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy that first gained approval in South Korea in 2014 to delay the progression of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disorder also known as Lou Gehrig’s disease.
Microneedles could solve vaccine distribution challenges
Microneedle technology could help simplify vaccine delivery to better support global immunization efforts, and Australia is leading the way in this innovative technology.
Ascletis’ denifanstat meets phase III endpoints in acne
Ascletis Pharma Inc.’s once-daily oral fatty acid synthase inhibitor, denifanstat, demonstrated statistically significant and clinically meaningful improvements compared to placebo, meeting all primary and secondary endpoints in a phase III trial for moderate to severe acne vulgaris.
Ligachem inks two mystery ADC deals with CSPC subsidiary Novarock
Ligachem Biosciences Inc. signed two license agreements with Novarock Biotherapeutics Inc., a subsidiary of CSPC Pharmaceutical Group Ltd., to bring in two of Novarock’s antibodies and create antibody-drug conjugate (ADC) candidates with novel cancer targets.
News in brief
BioWorld Asia briefs for June 10, 2025
Dizal's new chemical entities for lung, blood cancers
Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s LYN/BTK dual inhibitor, DZD-8586, saw tumor shrinkage in 94.1% of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma following Bruton's tyrosine kinase inhibitors, the company reported during an oral presentation at the American Society of Clinical Oncology (ASCO) 2025 conference.
Korea pharma exports rise to quarterly high of $2.5B in Q1
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 implant products to both China and the U.S.
Allay’s $57.5M extends postsurgical pain relief with ATX-101
As it advances its nonopioid analgesic ATX-101 breakthrough therapy through a phase IIb registration trial, Allay Therapeutics secured $57.5 million in a series D round, which included an investment from the company’s Japanese partner.
Biopharma financings rise to $5.55B in May, with VC deals at $1.83B
Biopharma financings totaled $21.38 billion through May 2025, down sharply from $62.57 billion during the same period in 2024, but roughly in line with levels seen in 2023 and 2022. Biopharma companies raised $5.55 billion in May, more than doubling the $2.4 billion raised in April.

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Analysis and data insight

Epimab sells bispecific T-cell engager to Juri in $210M deal
Deals and M&A
Epimab Biotherapeutics Inc. licensed out a development-ready KLK2/CD3 bispecific T-cell engager (TCE) for advanced prostate cancer to Juri Biosciences Inc. through a potential $210 million deal.
BARDA’s $375M to Shionogi for COVID-19 tops early list of 2025 grants
Financings
Biopharma’s nonprofit deal and grant activity continues to settle into a post-pandemic rhythm, with both showing a sustained decline from the elevated levels seen during and even after the COVID-19 era.
Samsung Biologics to spin off biosimilar subsidiary Samsung Bioepis
Newco news
Samsung Biologics Co. Ltd. plans to establish a new holding company and to spin off its biosimilar division, Samsung Bioepis Co. Ltd., by October. The corporate restructuring will draw clear lines between Samsung Biologics’ CDMO operations and Samsung Bioepis’ biosimilar business.
Alteogen merges two subsidiaries, forming Alteogen Biologics
Deals and M&A
Alteogen Inc. completed a merger between two subsidiaries – Altos Biologics Inc. and Alteogen Healthcare Inc. – branding the new entity as Alteogen Biologics Inc.

Financings

Aimedbio’s ₩51B pre-IPO round to fuel new cancer ADCs
Aging
Samsung Medical Center spinoff Aimedbio Inc. announced raising ₩51.1 billion (US$37.15 million) in pre-IPO funding to advance its portfolio of clinical and preclinical antibody-drug conjugate (ADC) candidates.

Australia

Cynata’s MSC cells show positive results across variety of delivery systems
Clinical
The promise of mesenchymal stem cells (MSCs) to heal heart disease could be around the corner thanks to a new delivery method tested by regenerative medicine company Cynata Therapeutics Ltd.

Immutep’s efti shows strong survival data in head and neck cancer
Clinical
Immutep Ltd. announced strong median overall survival of 17.6 months in cohort B of the TACTI-003 (Keynote-PNC-34) phase IIb trial that evaluated eftilagimod alfa in combination with Merck & Co.’s Keytruda (pembrolizumab) as first-line therapy in recurrent/metastatic head and neck squamous cell...
Australia follows Canadian lead; Labor win a sharp rebuke to Trump
Regulatory
Australian biopharma stakeholders welcomed the reelection of Prime Minister Anthony Albanese, who promised to expand Medicare and to invest more in Australian research.

China

China clears Mabwell’s Mailisheng injection to treat neutropenia
Regulatory
Mabwell (Shanghai) Bioscience Co. Ltd. on May 30 gained Chinese approval of Mailisheng (albipagrastim alfa; 8MW-0511) as a subcutaneous injection to treat febrile neutropenia induced by myelosuppressive anticancer treatment, such as radiotherapy and chemotherapy.
China’s Pegbio launches HK$300M Hong Kong IPO
Financings
China’s Pegbio Co. Ltd. launched its IPO on the Hong Kong stock exchange May 19, to raise up to HK$300.82 million (US$38.4 million) to advance visepegenatide (PB-119), its glucagon-like peptide 1 (GLP-1) receptor agonist.
Sirius bags $50M series B2 for cardiovascular siRNA pipeline
Clinical
Sirius Therapeutics Inc. raised nearly $50 million in a series B2 financing round May 9 to support its pipeline of small interfering RNA (siRNA) molecules for cardiovascular disease indications. SRSD-107, a long-acting Factor XI anticoagulant for thromboembolic disorders, is its lead candidate...
Korea pharma stocks rally; Celltrion welcomes US drug pricing
Analysis and data insight
Korean pharmaceutical stocks rose across the board May 13, a day after U.S. President Donald Trump signed off on the most favored nation executive order, a drug pricing policy expected to benefit biosimilar makers in the U.S., according to Celltrion Inc.
China’s NMPA gives thumbs up to Remegen’s ADC targeting HER2
Regulatory
China’s National Medical Products Administration has approved Remegen Co. Ltd.’s antibody-drug conjugate (ADC), disitamab vedotin (RC-48), for treatment of HER2-positive advanced breast cancer in patients with liver metastasis.

Regulatory

Fujirebio Alzheimer’s test wins first FDA clearance
Diagnostics
Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with...

Newco news

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
Astellas Pharma Inc. is setting up a joint venture with Yaskawa Electric Corp. to develop a new cell production platform using Yaskawa’s dual-arm humanoid robot called Maholo.

Science

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,...
At CROI, HIV cure trials raise hopes for broader applicability
Conferences
At the 2025 meeting of the Conference on Retroviruses and Opportunistic Infections (CROI) it was the best of times, it was the worst of times. On the first full day of the conference, reports from the first HIV cure trial conducted in Africa, the...

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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