Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Ascentage, Asieris, Beigene, Biomebank, Biontech, Brexogen, GSK, J Ints, Moderna, Novavax, Pfizer, Sanofi, Sinovac, Swedish Orphan Biovitrum, Takeda, YS.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Ambrx, Astellas, Astrazeneca, Dong-A ST, Famygen Life Sciences, Fibrogen, Harbour Biomed, Kao, Kirin, Medicox, Moderna, Neurobo, Nona, Novocodex, Ocuphire, Oramed, Pfizer, Polifarma Ilac Sanayi VE Ticaret, Precisionlife, SK, Sosei, Telix.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Acelyrin, Affibody, Atom Bioscience, Bridge, Enanta, Inmagene, Novavax, Que Oncology, Resolve, Sirnaomics, Telix, Vaxxas.
Innovent Biologics Inc. said that, compared to a placebo, both doses of its anti-PCSK-9 monoclonal antibody tafolecimab tested in a phase III trial “yielded significant and durable reductions” in low-density lipoprotein cholesterol levels and showed a favorable safety profile in Chinese patients with non-familial hypercholesterolemia.
Luye Pharma Group has received marketing approval from China’s NMPA for the triple monoamine reuptake inhibitor Ruoxinlin (toludesvenlafaxine hydrochloride) to treat patients with major depressive disorder, a condition that “has become one of the most prevalent mental disorders in China, causing a heavy burden on patients, their families and the entire society,” said Luye President Yang Rongbing.
AI drug discovery specialist Insilico Medicine Inc. has landed a multiyear research deal with Sanofi SA to develop candidates for up to six new targets in undisclosed indications. The collaboration included $21.5 million up front for Insilico, and as much as $1.2 billion in additional payments from Sanofi if key research, development and sales milestones are met. The agreement also includes mid-single to up to low double-digit tiered royalties for any products developed.