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BioWorld - Monday, May 25, 2026
Home » Topics » Regulatory, BioWorld Asia

Regulatory, BioWorld Asia
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China and U.S. flags

Life sciences ‘sweet’ opportunity in US-China talks

May 19, 2026
By Mari Serebrov
No Comments
Of all the issues that could be on the table at the talks between U.S. President Donald Trump and China President Xi Jinping, the life sciences sector is the “sweet spot” for collaboration between the two countries in a way that would benefit the world, Sen. Thom Tillis, R-N.C., said in a Brookings Institution webinar in advance of the two-day summit that starts May 14.
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Magnifying glass on wooden table

Multiple appearances on Priority Watch List leading to action?

May 12, 2026
By Mari Serebrov
No Comments
It’s a sure bet when the U.S. Trade Representative releases its annual Special 301 Report that Chile, China, India, Indonesia, Russia and Venezuela will be on the Priority Watch List. The 2026 report was no exception.
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Hantavirus cells

APAC monitors hantavirus as Singapore isolates 2 from cruise ship

May 12, 2026
By Marian (YoonJee) Chu
No Comments
Singapore’s Communicable Diseases Agency on May 7 said that it isolated two residents for hantavirus testing after the individuals disembarked from an Atlantic cruise ship on May 2 and May 6, respectively. The measure comes in response to the cluster of cases from the cruise ship, MV Hondius, that has resulted in three deaths so far.
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AI generated image for researcher developing antisense oligonucleotides

Bio Korea 2026 kicks off with spotlight on oligonucleotides

May 5, 2026
By Marian (YoonJee) Chu
No Comments
Three decades of trial-and-error, and the resulting safety data, in the oligonucleotide-based therapeutic space have paved way for the present-day innovations and the promise of “programmable,” precision medicine for patients, speakers at Bio Korea 2026 said April 28.
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Art concept for gene therapy research
Chinabio 2026

China’s new IIT rules could reshape early stage drug development

May 5, 2026
By Tamra Sami
No Comments
China’s investigator-initiated trial (IIT) system is increasingly being used to generate early human data in cell and gene therapies, and new changes that widen the pathway are expected to drive more multinational companies to conduct IITs in China, panelists said during the Chinabio Partnering Forum in Shanghai April 28-29.
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Map of Vietnam

USTR calls out trade partners for Rx, med-tech pricing policies

May 5, 2026
By Mari Serebrov
No Comments
For the first time in 13 years, the U.S. Trade Representative (USTR) singled out one of the U.S. trading partners as the worst of the worst when it named Vietnam as a Priority Foreign Country (PFC) in its newly released Special 301 Report.
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Green approved stamp

MFDS clears Curocell’s anbal-cel as first homegrown CAR T therapy

May 5, 2026
By Marian (YoonJee) Chu
No Comments
South Korea’s Ministry of Food and Drug Safety (MFDS) approved Curocell Inc.’s Rimqarto (anbalcabtagene-autoleucel; anbal-cel) April 29 as the first homegrown CAR T-cell therapy to treat patients with advanced diffuse large B-cell lymphomas.
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Acute myeloid leukemia illustration

Delta-Fly eyes NDA path despite AML phase III miss

April 21, 2026
By Tamra Sami
No Comments
Delta-Fly Pharma Inc. is pressing ahead with discussions with the FDA for its lead acute myeloid leukemia (AML) candidate, radgocitabine (DFP-10917), despite a phase III miss on its primary endpoint, instead leaning on earlier-stage efficacy signals and emerging combination data to support a potential path toward conditional approval.
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Lung cancer illustration

FDA grants priority review to Merck-Daiichi’s B7-H3 cancer ADC

April 21, 2026
By Marian (YoonJee) Chu
No Comments
The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer.
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Lung cancer illustration
AACR 2026

Xuanzhu shares dip despite phase III ALK inhibitor data

April 21, 2026
By Marian (YoonJee) Chu
No Comments
Xuanzhu Biopharmaceutical Co. Ltd. reported positive data from a local phase III study of dirozalkib (Xuan Fei Ning), an ALK inhibitor approved in China to treat patients with advanced non-small-cell lung cancer.
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