South Korea is moving ahead with its biggest reform of drug review and pricing in more than a decade, reflecting a wider shift across Asian markets to reward innovation and tighten controls on generics.

The U.S. FDA declined to approve, for a third time, an investigational liver cancer drug regimen comprising HLB Co. Ltd.’s rivoceranib and Jiangsu Hengrui Pharmaceutical Co. Ltd.’s camrelizumab, reportedly citing issues from a drug manufacturing facility inspection.

The House Select Committee on China launched an investigation into clinical trials involving U.S. companies that are conducted at Chinese military hospitals and in Xinjiang, China.

Despite the Biosecure Act’s five-year wind-down period that isn’t expected to start until mid-2028, Wuxi Apptec is already feeling the repercussions of being added last month to the U.S. Department of War’s Section 1260H list.

China’s National Medical Products Administration approved Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid tumors. The autologous Claudin18.2-targeted CAR T was approved for patients with Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma who have failed at least two prior lines of therapy.

Decades of research are helping unravel the “black box” of the brain. The second article in BioWorld’s series on the Brain-Computer Interface (BCI) field looks at how simultaneous breakthroughs in AI technology are pushing the BCI field from a theoretical concept to a potential real-world, clinical option for individuals, particularly in China where the National Medical Products Administration greenlighted the world’s first invasive BCI system – Neuracle Medical Technology Co. Ltd.’s Neural Electronic Opportunity – for clinical use in March 2026.

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.

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.

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.

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.