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.
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.
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.
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.
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.
Asian health care-focused private equity firm Quadria Capital announced the final close of its Fund III with $1.07 billion in total commitments to transform health care across Asia, which is expected to drive 40% of global health care growth by 2030.
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.
CSPC Pharmaceutical Group Ltd. on May 30 disclosed that the company was engaged in ongoing negotiations with unnamed, independent third parties regarding three license deals and collaborations that could total up to $5 billion combined.
In yet another China antibody-drug conjugate (ADC) deal, Astellas Pharma Inc. is inlicensing a phase I/II ADC targeting Claudin 18.2 from Evopoint Biosciences Co. Ltd. for up to $1.34 billion.
Regeneron Pharmaceuticals Inc. is adding to its obesity pipeline by in-licensing Hansoh Biomedical Co. Ltd.’s phase III dual glucagon-like peptide 1 (GLP-1)/gastric inhibitory polypeptide (GIP) receptor agonist, HS-20094, for up to $2 billion.