The Biosecure Act passed its first milestone in the U.S. House May 15 when the Oversight Committee voted 40-1 to favorably report the bill to the full House for a vote. Under the act, H.R. 8333, federal agencies would be prohibited from procuring biotechnology equipment or services from a “biotechnology company of concern” and from contracting, either directly or through a subcontract, with anyone that would use such equipment or services to perform the contract.

The process of manufacturing autologous T-cell therapies is technically challenging when compared with other oncology drugs, making the overall cost of developing CAR T therapies significantly higher. A challenging reimbursement environment for drugs listed on China’s National Reimbursement Drug List also means that most patients will have to pay out of pocket to access CAR T therapies. Taken together, complex logistics – production, manufacturing and supply chain – and complicated administration requirements are key bottlenecks that inflate the input costs involved in developing these specialized treatment options.

As of Jan. 31, 2024, there were more than 300 CAR T trials registered in China, surpassing the U.S. and becoming the country with the most CAR T therapy clinical trials. Among them, CD19 is the most frequently studied target, according to BioWorld and Cortellis. The rapid evolution of CAR T-cell therapies in China has escalated over the past decade from the start of the first clinical trials in 2013 to the country becoming an established host for CAR T-cell-related trials by 2017, according to Yongxian Hu and researchers from Zhejiang University in Hangzhou, China. Chinese cell therapy companies – backed by $2.37 billion in funding in 2021 – have since significantly increased basic research and trial output for CAR Ts, which was welcomed by large patient demand.

Royal Philips NV may feel it has had enough recent interaction with the U.S. FDA, but the company is now in receipt of a warning letter from the agency over a facility located in Suzhou, China. The FDA was none too fond of the facility’s handling of a contract manufactured data cable used in CT systems because of malfunctions that may have delayed diagnostic imaging procedures, representing yet another regulatory distraction for a company that recently cleared a long-running conflict with the FDA over CPAP machines.

China’s National Medical Products Administration (NMPA) has issued a guidance for human factors engineering (HFE) of medical devices, a document that by some accounts aligns fairly well with guidance from the U.S. FDA. However, Yvonne Limpens, manager of the human factors program at Emergo by UL, said NMPA may push for domestic HFE testing on imported devices because of a perception that device usability may be different in China than in other nations, thus adding to the cost of doing business in the world’s second most populous nation.

Does the NIH have the ability to screen for U.S. security issues in its award of research grants? That question is at the heart of an April 2 letter the Republican leadership of the House Energy and Commerce Committee sent to the Government Accountability Office in which it asked the government watchdog to examine the extent to which the NIH “adequately safeguards research funds from national security concerns related to the Chinese military or over the unethical use of human beings in research studies, especially from entities of concern in China.”

China’s National Medical Products Administration has cleared China Grand Pharmaceutical and Healthcare Holdings Ltd. to advance radiopharmaceutical agent ITM-11 (177Lu-edotreotide) to phase III trials in gastroenteropancreatic-neuroendocrine tumors

The U.S. FDA has followed up on reports of problematic syringes made by several companies in mainland China, recommending that U.S. suppliers, consumers and health care organizations stop using these products unless no alternatives are available. The agency said it has issued warning letters to three of these companies, at least one of which appears to have been the supplier of Monoject syringes that have been the subjects of recent FDA recalls.

Wuxi Apptec quit its membership in the Biotechnology Innovation Organization (BIO) after U.S. Congressman Rep. Mike Gallagher (R-Wis.) sent a March 5 letter to Attorney General Merrick Garland, asking the Department of Justice to investigate BIO because its lobbying efforts on behalf of Wuxi suggested it was operating as an unregistered agent of a foreign company while advancing the interests of the People’s Republic of China and the Chinese Communist Party.

Shanghai Fosun Pharmaceutical Co. Ltd has formed a partnership with seven other investors to form an investment fund partnership that plans to invest ¥5 billion (US$695M) in local biotech and med-tech companies in Shenzhen, China. The target fund will concentrate on local biotechs, including cell and gene therapy companies, as well as other industries, with 70% to be invested in the biomedical industry.