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BioWorld - Thursday, July 16, 2026
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Regulatory actions for May 12-18, 2020

May 19, 2020
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Abivax, Aim Immunotech, Akebia, Algernon, Ascletis, Astrazeneca, Biosig Technologies, Can-Fite, Carsgen, Cytodyn, Daiichi Sankyo, Enzychem Lifesciences, Immunic, Kancera, Leading Biosciences, Moderna, Nantkwest, Novocure, Pharmazz, Restem, Scimount, Seattle Genetics, Takeda, Teva, Vistagen, Zai Lab.
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News in brief

May 12, 2020
BioWorld Asia briefs for May 12.
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Diagnosing the state of COVID-19 testing

May 12, 2020

The challenges to deploy diagnostic and surveillance testing for the COVID-19 pandemic will persist at least until a vaccine is ready if not well beyond that milestone. In our series “Diagnosing the state of COVID-19 testing,” BioWorld MedTech explores the complexities of developing accurate, properly regulated tests to help bring the world back online with confidence.


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Lungs, COVID-19 test tube, health care worker in PPE

Proteona to use single-cell proteogenomics platform for Australian COVID-19 vaccine trial

May 12, 2020
By David Ho
HONG KONG – Singapore-based Proteona Pte. Ltd. has started a partnership to characterize the clinical response to a new COVID-19 vaccine, with clinical trials soon to start at Flinders Medical Centre testing the candidate developed in collaboration with Adelaide, Australia-based Vaxine Pty Ltd.
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HKEX building

AR antagonist developer Kintor set to raise up to $240M via HKEX IPO this month

May 12, 2020
By Elise Mak
BEIJING – Androgen receptor (AR)-related disease specialist Kintor Pharmaceutical Ltd., of Suzhou, China, is looking to raise up to HK$1.861 billion (US$240 million) in a Hong Kong IPO to advance its small-molecule AR antagonists, proxalutamide and pyrilutamide, both of which have first- and best-in-class potential.
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Crystalgenomics in good position after signing camrelizumab license agreement

May 12, 2020
By Gina Lee
HONG KONG – After inking a recent deal with China’s Jiangsu Hengrui Medicine Co. Ltd., South Korea’s Crystalgenomics Inc. is celebrating its 20th anniversary by seeking more partners to further develop its anti-PD-1 inhibitor pipeline.
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Patient given oral swab

Support for human challenge trials gaining traction to accelerate COVID-19 vaccine work

May 12, 2020
By Nuala Moran
LONDON – Support is growing for human challenge trials in COVID-19 to be approved in order to speed up development of effective vaccines against the pandemic infection. The World Health Organization (WHO) has just released guidelines for assessing the ethical acceptability, saying such trials would allow for more rapid and standardized testing, accelerating development and enabling candidates to be prioritized.
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Australia’s CSL Behring begins development of plasma treatment from recovered COVID-19 patients

May 12, 2020
By Tamra Sami
PERTH, Australia – CSL Behring Australia, a subsidiary of CSL Ltd., will begin developing an anti-SARS-CoV-2 plasma product to treat people with serious complications of COVID-19.
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Bridge Biotherapeutics receives MFDS approval for EGFR drug in lung cancer

May 12, 2020
By Gina Lee
HONG KONG – South Korea’s Bridge Biotherapeutics Inc. wrapped up the week by announcing its awaited IND clearance for its epidermal growth factor receptor tyrosine kinase inhibitor, BBT-176, for non-small-cell lung cancer.
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Hanmi seeks domestic approval for Korea’s first neutropenia biologic

May 12, 2020
By Gina Lee
HONG KONG – South Korea’s Hanmi Pharmaceutical Co. Ltd. has filed a new drug approval application for Rolontis (eflapegrastim) with the country’s Ministry of Food and Drug Safety (MDFS).
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