Chinese heart valve specialist Microport Cardioflow Medtech Corp. (HKEX:2160) launched an IPO in Hong Kong on Feb. 4, raising HK$2.5 billion (US$324 million) by issuing 205.62 million shares at HK$12.20 apiece. With J.P. Morgan, Citi and CICC backing the IPO, the stock opened at HK$21.50, up 76% from the offer price. The pre-revenue med-tech firm, spun off from Microport Scientific Corp. in 2020, develops transcatheter aortic valve implantation (TAVI) products for valvular heart diseases, and is especially known for its Vitaflow series.

PERTH, Australia – Micro-X Ltd. completed an AU$30.5 million (US$23.27 million) placement to expand its U.S. footprint for its lightweight digital mobile X-ray systems. The funds raised will drive market expansion of Adelaide, Australia-based Micro-X’s Rover digital mobile X-ray system that is designed for deployed military medical facilities, and to scale up its Carestream DRX Revolution Nano, a mobile lightweight digital X-ray system for hospitals.

HONG KONG – Seegene Inc. has developed a COVID-19 test kit that is able to both detect and identify multiple mutant variations of the virus. “Getting test results from the Allplex SARS-CoV-2 Variants Ⅰ Assay takes two hours, which is normally how long getting results from a PCR test takes,” a Seegene spokesperson told BioWorld.

HONG KONG – Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted approval for Biocryst Pharmaceuticals Inc.’s Orladeyo (berotralstat), the first and only drug for prophylactic treatment of hereditary angioedema (HAE) approved in the country. Biocryst’ partner, Torii Pharmaceutical Co. Ltd., will launch the drug after completing pricing negotiations with the Japanese National Health Insurance System (NHI). Tokyo-based Orphanpacific Inc., Biocryst’s representative in Japan, holds the marketing authorization.

Illumina Inc. and Sequoia Capital China are collaborating to launch a startup ecosystem in China. The Sequoia Capital China Intelligent Healthcare Genomics Incubator, Powered by Illumina, will support life sciences startup companies in the field of genomics. Illumina for Startups will offer sequencing systems and reagents, lab space in China, and expertise. Sequoia Capital China will provide investment and business guidance.

HONG KONG – Shortly after Australia’s recent provisional approval for the mRNA-based COVID-19 vaccine Comirnaty (tozinameran), originally developed by Pfizer Inc. and Biontech SE, Hong Kong has approved it, too, for emergency use ahead of rivals developed in mainland China. It is the first vaccine to be approved in the Chinese territory, made possible through a collaboration between Biontech and Shanghai Fosun Pharmaceutical Group Co. Ltd.

PERTH, Australia – Sydney-based Cyclopharm Ltd. raised AU$30 million (US$23.19 million) in a private placement that will enable the company to launch its Technegas combination product in the U.S.

PERTH, Australia – Following consultation with medical device stakeholders in 2019 and 2020, the Therapeutic Goods (Medical Devices) Regulations 2002 were amended to clarify some existing requirements and to introduce new requirements for software-based medical devices. The new rules that go into effect on Feb. 25, 2021, clarify the boundary of regulated software products, introduce new classification rules, and provide updates to the essential principles for software-based medical devices.

HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has greenlighted Seoul-based Vuno Inc.’s artificial intelligence (AI)-based solution Vuno Med Deepbrain for use as a class III medical device, which is a classification for moderate risk level devices. The MFDS approval was given on Dec. 29, 2021, a Vuno spokesperson told BioWorld, but the company only disclosed the approval earlier in the week. The reasons for the delayed announcement were not disclosed.

PERTH, Australia – The majority of medical device and biopharma industry respondents agreed that Australia’s Therapeutic Goods Administration (TGA) responded effectively to COVID-19, but they want to see the agency improve its processes to act faster and with more clarity, according to the TGA’s annual stakeholder survey.