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BioWorld - Wednesday, May 20, 2026
Home » Topics » Regulatory

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3D illustration of human digestive system
Immuno-oncology

Innocare Pharma’s ICP-B208 gains IND clearance in China

May 7, 2026
No Comments
Beijing Innocare Pharma Tech Co. Ltd. has received IND approval from China’s National Medical Products Administration (NMPA) for ICP-B208, an antibody-drug conjugate targeting CDH17, which is highly expressed in gastrointestinal cancers, including colorectal, gastric and biliary tract cancers and pancreatic ductal adenocarcinoma.
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Magnifying glass on wooden table

Multiple appearances on Priority Watch List leading to action?

May 6, 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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Antibodies attacking cancer cell
Immuno-oncology

Simcere Zaiming’s SIM-0613 cleared to enter clinic in China

May 6, 2026
No Comments
Simcere Zaiming Pharmaceutical Co. Ltd.’s SIM-0613 for injection has received clinical trial approval from China’s National Medical Products Administration (NMPA), enabling initiation of a clinical trial for advanced solid tumors.
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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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Prescription drug bottle, pills shaped in $ sign

White House looks to expand MFN pricing for $530B-plus in savings

May 5, 2026
By Mari Serebrov
No Comments
Amid calls for transparency on the most-favored nation (MFN) pricing deals U.S. President Donald Trump has reached with 17 biopharma companies, the White House Council of Economic Advisers released a report May 5 detailing how the volunteer MFN policy works and touting the $530 billion-plus in savings it’s projected to deliver over the next 10 years.
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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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Map of Vietnam

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

May 4, 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.
Read More

First PROTAC: Arvinas’ Veppanu wins FDA nod in breast cancer

May 1, 2026
By Jennifer Boggs
No Comments
A month ahead of its June 5 PDUFA date, Arvinas Inc.’s vepdegestrant gained U.S. FDA approval for use in a specific type of advanced or metastatic breast cancer, becoming the first proteolysis targeting chimera, or PROTAC, drug to reach the market.
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