In reporting positive data from a phase III study of sugemalimab in treating stage III non-small-cell lung cancer (NSCLC), Cstone Pharmaceuticals Co. Ltd. and Eqrx Inc. have the first anti-PD-L1 monoclonal antibody demonstrating progression-free survival in patients with concurrent or sequential chemoradiotherapy. The data built on positive data released in August from another phase III study showing sugemalimab (CS-1001) prolonged PFS when used as a first-line treatment for stage IV squamous and nonsquamous NSCLC plus standard-of-care chemotherapy, hitting the study’s primary endpoint. Read More
HONG KONG – In the midst of a COVID-19 crisis, India has waived the need for “well-established” foreign vaccines to undergo local trials. That could open doors for vaccines by Pfizer Inc., Johnson & Johnson and Moderna Inc. Read More
China is making strides in cell and gene therapy, notably so with a 61% surge in the number of clinical trials in six years, a new report by Ernst & Young showed. While analysts noted the increasing innovation efforts and cross-border collaborations, concerns remain if quality will be compromised by speed. Read More
HONG KONG – Following a wave of concern about the efficacy of two COVID-19 vaccine candidates developed by China National Pharmaceutical Group (Sinopharm), interim analysis of an ongoing phase III trial, published May 26 in the Journal of the American Medical Association, has shown that adults receiving at least one dose of either of the company’s two inactivated SARS-CoV-2 vaccines had significantly reduced the risk of symptomatic COVID-19. Read More
Engine Biosciences Pte. Ltd., a Singapore and Silicon Valley-based company using machine learning, combinatorial genetics and other technologies to hasten the discovery of gene interactions and biological networks underlying disease, has raised $43 million in series A financing. Polaris Partners led the round, which the company said would help it expand its portfolio of precision oncology therapeutics, prepare for its first clinical programs, and scale its technology platform. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief, including: 9 Meters, ACM, Aim Immunotech, Altimmune, Astrazeneca, Beroni, Beyond Air, Boan Biotech, Bristol Myers Squibb, Circassia, Clarus, Dyadic International, Havah, Inhalon, La Jolla Institute for Immunology, Onk Therapeutics, Pfizer, RDIF, Recce, Roche, Shenzhen Smoore Technology, Synbal, Syngene International, Taiwan Liposome, Tella, Tetra, Transthera, University Hospital Zurich, Walter and Eliza Hall Institute of Medical Research, Xencor, Zydus Cadila. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Affamed, Ascletis, Foresee, Gannex, Glaxosmithkline, Hightide, Humanigen, Immunitybio, Mezzion, Ocugen, Optimus, PCI, TLC, Vir. Read More
