PERTH, Australia – The majority of stakeholders support the Therapeutic Goods Administration’s (TGA) proposal to restructure Australia’s device essential principles to align with the requirements under the new EU Medical Device Regulations (EU MDR), but there was little support to align with the International Medical Device Regulators Forum (IMDRF) essential principles and principles of labeling.

HONG KONG – India has been slowly easing restrictions on the export of its med-tech products, giving hope to domestic manufacturers looking to meet global demand for their output. “We are pleased to share that many of the routine IVD diagnostic kits falling under HSN code 3822 have been removed from export restrictions and a few specific items related to COVID-19 testing retained,” Rajiv Nath, the forum coordinator for the Association of Indian Medical Device Industry (AIMED), told BioWorld recently.

BEIJING – Three-year-old Asia-focused startup Everest Medicines Ltd. closed one of the biggest financing rounds in China’s health care market this year, adding $310 million to its war chest. The firm is aiming to advance its late-stage assets in-licensed from global partners to the China market soon.

Hong Kong – South Korea’s Lunit Inc. is currently in the process of applying for U.S. FDA approval for Lunit Insight Mmg, its AI software that analyzes mammography images to detect breast cancer. Other markets that the company targets entering include South America, the Middle East, and Asia Pacific, Jussarang Lee, communications manager at Lunit, told BioWorld. Founded in 2013, the Seoul-based company uses artificial intelligence to develop cancer diagnostics and therapeutics.

HONG KONG – Israel-based Vayyar Imaging Ltd. and Hong Kong-based Meditemi Co. Ltd. have teamed up to create a more intelligent care robot that provides a range of remote monitoring capabilities, including early detection of COVID-19 symptoms.

BEIJING – Three-year-old Asia-focused startup Everest Medicines Ltd. closed one of the biggest financing rounds in China’s health care market this year, adding $310 million to its war chest. The firm is aiming to advance its late-stage assets in-licensed from global partners to the China market soon.

KARACHI, Pakistan – Beyond stepping up manufacturing of the medical devices it needs to fight COVID-19, Pakistan is using technology platforms to reach out to a large diaspora for help. The country is taking steps to leverage limited resources through a more comprehensive system of telehealth applications that allow for faster self-diagnosis and make it possible to tap into the expertise of Pakistani doctors.

BEIJING – Besides advancing its recombinant adenovirus type-5 vector (Ad5) vaccine for COVID-19, Cansino Biologics Inc. is making a new attempt to develop an mRNA lipid nanoparticle (mRNA-LNP) vaccine together with Canadian company Precision Nanosystems Inc., of Vancouver, British Columbia.

BEIJING – Androgen receptor (AR)-related disease specialist Kintor Pharmaceutical Ltd., of Suzhou, China, raised $240 million on the Hong Kong Stock Exchange (HKEX) on May 22 by issuing 92.3 million shares at HK$20.15 apiece. The IPO was oversubscribed by 551 times, showing the city’s biotech fever.