Immutep Ltd.’s lead immunotherapy candidate eftilagimod (IMP-321, efti) met the primary endpoint in its phase II trial evaluating the combination of efti and Merck & Co. Inc.’s Keytruda (pembrolizumab) as first-line treatment of non-small-cell lung cancer (NSCLC), reporting final data that show an overall response rate of 40.4%. Read More
Que Oncology Inc.’s Q-122 significantly reduced the frequency and severity of moderate and severe vasomotor symptoms, or hot flashes, in women taking endocrine therapy for breast cancer, and phase II results showed associated improvement in quality of life, compared with placebo. Read More
Zenas Biopharma LLC has raised $118 million in a series B round to support a global phase III trial of its lead asset as well as other immunotherapies for autoimmune diseases in its pipeline. The study, expected to begin in 2023, will evaluate obexelimab for the treatment of patients with immunoglobulin G4-related disease in late 2022. Read More
China’s National Medical Products Administration (NMPA) awarded Akeso Inc. breakthrough therapy designation for its PD-1 checkpoint inhibitor/VEGF bispecific antibody, ivonescimab (AK-112), combined with docetaxel for locally advanced or metastatic non-small-cell lung cancer (NSCLC) in patients who failed to respond to prior PD-(L)1 inhibitors combined with chemotherapy. Read More
Nona Biosciences Co. Ltd., a subsidiary of Harbour Biomed Therapeutics Ltd. launched in November to provide “idea to IND” services, has struck a deal with Moderna Inc. to develop nucleic acid-based immunotherapies. The candidates will be based on Harbour’s heavy chain only antibody discovery platform. Read More
NRG Therapeutics Ltd. has closed a £16 million (US$18.3 million) series A round to take forward programs in Parkinson’s disease and amyotrophic lateral sclerosis, after pinning down the target of its brain penetrant small molecules. Read More
GSK plc said it will restrict the second-line maintenance indication for ovarian cancer drug Zejula (niraparib) to only patients with deleterious or suspected germline BRCA mutations, at the request of the FDA, in a sign that U.S. regulators aren’t going to relax scrutiny on PARP inhibitors any time soon. Read More
Fresh off announcing a new $1.2 billion joint drug discovery and development project with Sanofi SA, Insilico Medicine Inc. founder and CEO Alex Zhavoronkov joined a chorus of executives at the Asia Summit on Global Health in proclaiming the critical importance of partnership between biopharma, tech companies, and regulators, even amid rising tensions between China and the West. Read More
Easy access to financing, talent, and connection to sizable potential markets are Hong Kong’s advantages to develop the health care robotics industry, according to speakers at the Asia Summit on Global Health. Read More
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. Read More
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. Read More
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. Read More
