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BioWorld - Friday, June 19, 2026
Home » Topics » Regulatory, BioWorld Asia

Regulatory, BioWorld Asia
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China U.S. deal

Competitive approach better than restricting deals with China?

June 9, 2026
By Mari Serebrov
No Comments
The recent introduction of the bipartisan Biotech Investment National Security Act in the U.S. House has industry and venture capitalists urging lawmakers to take a breath, step back, and consider a less invasive approach than restricting U.S. biopharma deals with Chinese innovators.
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Red wooden approved stamp

NMPA gives conditional nods to drugs by Lupeng, Vcare, Staidson

June 9, 2026
By Marian (YoonJee) Chu
No Comments
China’s National Medical Products Administration (NMPA) on June 4 granted conditional approvals to two oncology drugs from Lupeng Pharmaceutical Co. Ltd. and Vcare Pharmatech Co. Ltd., as well as one hemophilia drug developed by Staidson Biopharmaceutical Co. Ltd.
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Illustration of cancer on the esophagus

Japan backs Oncolys virus therapy for esophageal cancer

June 9, 2026
By Tamra Sami
No Comments
Japan has granted marketing approval to Oncolys Biopharma Inc.’s oncolytic adenovirus product, Telomelysin (suratadenoturev, OBP-301), for treating esophageal cancer in patients who are not eligible for curative resection or chemoradiotherapy. The approval marks the first oncolytic adenovirus product approved for esophageal cancer.
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Wuxi Apptec signage

Wuxi Apptec insists it’s ‘not a Chinese military company’

June 9, 2026
By Mari Serebrov
No Comments
Wuxi Apptec isn’t going down without a fight after the U.S. Department of Defense added it to the Section 1260H list June 8 as a designated “Chinese military company,” which makes it a “biotechnology company of concern” under the Biosecure Act. “Such designation is mistaken and baseless,” the global contract research, development and manufacturing organization said in an open letter to its life sciences partners. “We will pursue every available avenue to correct this mistake.” That includes appealing the designation.
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U.S. Capitol building

BMS-Hengrui deal strikes panic in Washington

June 2, 2026
By Tamra Sami
No Comments
On the heels of the multibillion-dollar licensing deal between Bristol Myers Squibb Co. and Jiangsu Hengrui Pharmaceuticals Co. Ltd., Chairman John Moolenaar (R-MI), of the House Select Committee on the Chinese Communist Party, sent a letter to Treasury Secretary Scott Bessent urging him to add biotechnology as a prohibited technology under the Comprehensive Outbound Investment National Security (COINS) Act of 2025.
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Cybersecurity data lock

China launches long-awaited drug data protection rules

June 2, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration has issued final implementation measures for drug trial data protection that mark a significant step toward aligning China’s pharmaceutical intellectual property framework with global standards.
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Xocova blister pack

FDA clears Shionogi’s Xocova as first COVID-19 prevention pill

June 2, 2026
By Marian (YoonJee) Chu
No Comments
The U.S. FDA approved Shionogi & Co. Ltd.’s Xocova (ensitrelvir) as the first oral post-exposure prophylactic option in the U.S. to prevent COVID-19, with the decision coming ahead of a PDUFA target date of June 16.
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China map/flag with silhouettes of business people

China deals highlight biopharma evolution, reports LEK

June 2, 2026
By Tamra Sami
No Comments
In 2025, China’s outbound life sciences and biopharma deals reached nearly $100 billion, about 12 times the level seen in 2021, underscoring how quickly global appetite for Chinese assets has accelerated, according to a recent report by L.E.K. Consulting.
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Floating antibody drug conjugates

TROP2 ADCs progress into first-line for lung, breast cancers

May 28, 2026
By Marian (YoonJee) Chu
No Comments
Multiple updates on TROP2-directed antibody-drug conjugates (ADCs) for lung and breast cancers highlight both progress made and opportunities for improvement for the targeted class of cancer therapeutics.
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Stem cells

China’s new IIT rules expected to wipe out ‘gray market’

May 26, 2026
By Tamra Sami
No Comments
New regulations tighten regulatory oversight of China’s investigator-initiated trials (IITs) but legitimize the pathway that will be open to other modalities beyond cell and gene therapies.
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