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BioWorld - Tuesday, December 16, 2025
Home » Newsletters » BioWorld Asia

BioWorld Asia

Aug. 28, 2019

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Other news to note

Cmab Biopharma Inc. and Suzhou Kintor Pharmaceuticals Inc., both of Suzhou, China, are collaborating on the development and manufacturing of Kintor's ALK-1 MAb, a monoclonal antibody targeting activin receptor-like kinase-1 that was licensed from New York-based Pfizer Inc. Read More

South Korean firms Toolgen, Nsage to cooperate on gene-edited cell line R&D

HONG KONG – South Korean biotech Toolgen Inc., based in Seoul, has signed an agreement with another Korean biomedical startup, Nsage Inc., based in Incheon, to cooperate on gene-edited cell line R&D and commercialization. Toolgen is developing genome editing platforms for clinical studies with its CRISPR technology, while Nsage develops next-generation stem cell production and exosome isolation technology. Read More

Fibrogen's roxadustat gets 2nd approval in China

BEIJING – Fibrogen Inc. said its first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor roxadustat (previously FG-4592) won a second approval in China to include more patients with anemia caused by chronic kidney disease (CKD). China, again, is the first market to grant the company the nod to treat patients who are not dialysis-dependent. Read More

Australia: No plans to regulate AI, machine learning via separate pathway

PERTH, Australia – It's likely that Australia will not draft separate guidance or regulations for software applications that use artificial intelligence or machine learning (AI/ML) for drug development or medical devices. Read More

Innovent in-licenses Lilly's diabetes drug

BEIJING – Innovent Biologics Inc., of Suzhou, China, has in-licensed diabetes drug OXM-3 from Eli Lilly and Co. to develop and commercialize it in China. Read More

India lags in regulating AI as development proceeds

NEW DELHI – Artificial intelligence (AI) is increasingly gaining a foothold in India's health care landscape, with investors pouring money into the new technology, companies developing products and regulators looking to come up with much-needed rules. Read More

China on the cusp of regulating AI-based devices

BEIJING – With home-grown artificial intelligence (AI) medical devices under priority review, mainland China is quickly putting together a regulatory framework to more rapidly tap into the power of AI to develop devices and drugs. Read More

Japan to develop assessment system to speed up AI development

HONG KONG – With an aging population and a shortage of doctors, Japan is now working to develop artificial intelligence (AI)-based medicine faster than any other country in Asia. Read More

South Korea's insurance, personal information law slows use of AI devices

HONG KONG – South Korea is actively working to expand its artificial intelligence (AI) capabilities in health care, but outdated regulations and concerns over privacy and profit sharing are proving to be significant stumbling blocks. Read More

Regulatory actions for August 20 – 26, 2019

Read More

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