Cellpoint B.V. has picked up U.S and European rights to a chimeric antigen receptor T-cell (CAR T) therapy from Shenzhen Pregene Biopharma Co. Ltd. Cellpoint will develop and commercialize the candidate, PRG-1801, for the treatment of hematological indications. Read More
Telix Pharmaceuticals Ltd. has in-licensed Eli Lilly and Co.’s olaratumab antibody, agreeing to pay $5 million up front for exclusive worldwide rights to develop and commercialize radiolabeled forms of the antibody for the diagnosis and treatment of human cancers. Read More
Shares of Suzhou, China-based Kintor Pharmaceutical Ltd. (HKEX:9939) rose to HKD28.85 (US$3.68), up HKD14.87, or 106%, after the firm reported top-line data from the phase III multiregional trial with proxalutamide in people with mild to moderate COVID-19 infection, regardless of vaccination status or risk factors. Read More
Shanghai Allist Pharmaceuticals Co. Ltd.’s third-generation EGFR tyrosine kinase inhibitor, furmonertinib, met its primary endpoint in a phase III trial, demonstrating longer progression-free survival vs. first-generation EGFR TKI Iressa (gefitinib, Astrazeneca plc) as first-line therapy for locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer. Read More
Ark Biopharmaceutical Co. Ltd.’s phase III testing its ziresovir in infants hospitalized with respiratory syncytial virus (RSV) infection produced positive top-line results, meeting both the primary endpoint of reduction in signs and symptoms (S&S) score (p=0.002) and a key secondary endpoint of reduction in viral load (p=0.006) compared with placebo. The company said it is the first oral RSV antiviral to be successful in phase III. Read More
Biopharma financings for the first quarter of 2022 are at a five-year low, with 65.8% less money and 53% fewer transactions than a year ago. The industry raised $13.1 billion through 249 financings, compared with $38.3 billion from 529 transactions in 2021. Read More
Harbour Biomed Therapeutics Ltd. has out-licensed a preclinical bispecific antibody, HBM-7022, to Astrazeneca plc in a global licensing deal worth up to $350 million. Read More
Everest Medicines Ltd. has formed a partnership with China Resources Pharmaceutical Group (CR Pharma) to co-launch an independent company to focus on the development of messenger RNA (mRNA) vaccines. Read More
The China Securities Regulatory Commission has issued draft rules to permit U.S. auditors to examine U.S.-listed Chinese companies on April 2, 2022, following a provisional list by the U.S. SEC. The draft rules specified the requirement for the overseas-listed companies and relevant securities service providers to disclose confidential materials in overseas offerings and listing. Read More
Medicine shortages have been of particular concern during the COVID-19 pandemic, and Australia’s Therapeutic Goods Administration said it would seek to amend regulations to allow imports of overseas substitute drugs if the Australian drug has been discontinued and canceled from the Australian Register of Therapeutic Goods. Read More
The quixotic course of the cancer therapy Ontak continues with new top-line data from Citius Pharmaceuticals Inc. The company’s phase III study of I/Ontak (E-7777), a reformulation of previously FDA-approved oncology treatment Ontak (denileukin diftitox), was consistent with the prior formulation. No new safety signals were identified in treating persistent or recurrent cutaneous T-cell lymphoma. Read More
NEC Corp. subsidiary NEC Oncoimmunity AS recently received $4.8 million from the Coalition for Epidemic Preparedness Innovations to fund the development of vaccines for SARS-CoV-2 variants and other betacoronaviruses. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research annual meeting, including: Antengene, Coherus, Junshi. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Akston, Antengene, Athersys, Beigene, Direct Biologics, Eurcure, Everest, Healios, Kintor, Meji Seika, Sanbio, United Biomedical, VBI Vaccines, Veru. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Accutar, Amniotics, Ascletis, Beigene, Cansino, Glaxosmithkline, Henlius, Ilias, Innovent, Junshi, JW, Novartis, Novavax, Roche, Sellas, Serum Institute, Tonix, Triastek, Vir. Read More
