Reistone Biopharma Co. Ltd. said both doses of the JAK1 inhibitor ivarmacitinib, tested against moderate to severe atopic dermatitis (AD) in a multinational phase III trial, met the study’s co-primary endpoints, delivering significant improvements on a common measure of disease severity vs. placebo. It’s the first National Class A new drug for AD that is designed and developed in China, according to the company.
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.
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.
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.
Think Surgical Inc. has just received a $100 million investment from a new investor, South Korea’s KDB Investment Global Healthcare, a private equity firm that is wholly owned by Korea Development Bank. The Fremont, Calif.-based orthopedic surgical robotic company will use the funds to bring new products to market. Stuart Simpson, president and CEO of Think Surgical, confirmed that it will go towards supporting “successful new product commercialization.”
Nousq Pte Ltd. has been declared the winner of the 2022 Asia Pacific Accelerator program with its pediatric ear tube insertion device. Singapore-based Nousq’s victory was determined by a live audience vote on during the Medtech Innovator Asia Pacific 2022 Grand Finals, organized by medical device accelerator Medtech Innovator and the Asia Pacific Medical Technology Association (APACMed).
Rainmed Medical Ltd.'s coronary angiography-derived fractional flow reserve system (caFFR system) was approved by Australia’s TGA for precision diagnosis of coronary artery diseases.
Aim Biotech Pte. Ltd. has launched a lab tool that can closely model human disease. The organic system can add vascularization and immune competence to organoids, spheroids and tumor biopsies. This allows for the creation of a more defined and tunable microenvironment that more closely emulates the complexity of human physiology.
Japan’s Ministry of Health, Labour and Welfare (MHLW) has given Intuitive Surgical Inc. the green light for its Da Vinci SP surgical system. The surgical system has been cleared for use in general surgeries, thoracic surgeries (excluding cardiac procedures and intercostal approaches), urologic surgeries, gynecological surgeries, and trans-oral head and neck surgeries.
Cerecin Inc. has successfully closed the first tranche of a series IIB financing with investors from South Korea, with SK Securities Co. Ltd. and KNT Investment LLC leading the round.