China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan. 2, 2025.
With obesity drugs taking the U.S. and global markets by storm and more than 100 clinical programs currently in progress for the drugs, the U.S. FDA released a draft guidance Jan. 7 to help sponsors develop drugs and biologics for weight reduction and long-term maintenance of body weight.
Xeltis BV completed enrollment in the EU pivotal trial for its restorative vascular access conduit, Axess. The prospective study will investigate the patency, safety and performance of Axess in adult patients with end-stage renal disease requiring vascular access to start or maintain hemodialysis therapy.
CSPC Pharmaceutical Group Ltd.’s antibody-drug conjugate SYS-6045 has been granted clearance by China’s National Medical Products Administration (NMPA) to enter clinical trials.
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China of SYH-2059 tablets for interstitial lung disease, including idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.
What does it mean for a confirmatory trial to be “underway”? That’s a question that’s been plaguing some drug sponsors, especially those in the ultra-rare disease space, since the U.S. Congress, in 2023, gave the FDA the authority to require that a confirmatory trial be underway at the time accelerated approval is granted.
South Korea’s government continued to ramp up investment in its pharmaceutical and med-tech sector in 2025, including a 7.2% hike for the Ministry of Health and Welfare’s budget and a near 15% increase in funding to research and develop innovative biotechnologies.
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