Hua Medicine Ltd. has received marketing approval from China's NMPA for its glucokinase activator (GKA), Huatangning (dorzagliatin tablets), for two indications: as a monotherapy to improve blood glucose control for drug-naïve type 2 diabetes patients and in combination with metformin in metformin-tolerated type 2 diabetes patients to control blood glucose level. It marks the first GKA drug to gain approval in any market, according to Hua. Read More
A new analysis of Actinogen Medical Ltd.’s phase II Xanadu trial showed that in biomarker-positive patients with mild Alzheimer’s disease there was a clear clinical effect with lead compound Xanamem not seen in the earlier trial. Read More
Connect Biopharma Holding Ltd.’s IL-4Rα binding candidate, CBP-201, yielded positive data in a pivotal trial in patients with moderate to severe atopic dermatitis in China, positioning the company to engage with Chinese regulators in the next several months to discuss a potential NDA filing. Read More
CSPC NBP Pharmaceuticals Co. Ltd. entered an agreement that will grant it exclusive rights to Harbour Biomed Co. Ltd.’s anti-FcRn antibody, batoclimab (HBM-9161), in greater China, including Hong Kong, Macau and Taiwan. Read More
Aim Vaccine Co. Ltd. priced an IPO on the Hong Kong Stock Exchange, raising HK$70.01 million (US$9 million) to fund work on its late-stage vaccine pipeline. Its shares increased only 3.09% on debut Oct. 6 but closed the week at HK$24.80, up 54% over its listing price of HK$16.16. Read More
A strong third quarter has pushed biopharma financings ahead of several pre-pandemic years, as follow-on offerings and private placements picked up the pace. IPOs and venture capital rounds dipped below prior quarters, but the overall amount raised so far this year has placed 2022 as the fifth best financing year among the last 10, ahead of both 2019 and 2017. Read More
CSL Ltd. subsidiary Seqirus inked a $30.1 million deal with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop and evaluate two influenza A subtype H2Nx (avian flu) vaccines in a phase I trial. Read More
A review of Australia’s National Medicines Policy was begun in August 2021 but was paused until after the federal election in May to allow stakeholders more time to provide feedback. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: AN2, Ascletis, Clarity, Connect, Kubota, Kubota Vision, Newamsterdam, Oravax Medical, Taurx. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Adamis, Astellas, Beigene, Biontech, Immune-Onc, Merck, NFL Biosciences, Pantherna, Ridgeback, Shionogi, Themis Medicare. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: ABVC, Eiger, Hugel, Immutep, Revive, Takeda, Transcenta. Read More
