The U.S. National Security Commission on Emerging Biotechnology (NSCEB) is urging Congress to reinvest in American biotechnology because “the U.S. is dangerously close to falling behind China,” according to a May 8 report. "The United States is locked in a competition with China that will define the coming century," said NSCEB Chair Senator Todd Young (R-Ind.). “Biotechnology is the next phase in that competition. It is no longer constrained to the realm of scientific achievement. It is now an imperative for national security, economic power and global influence.”
Phase I/II trial results of sacituzumab tirumotecan (sac-TMT; Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.) published in Nature Medicine came a month after China’s National Medical Products Administration gave clearance to Kelun-Biotech’s supplemental NDA of sac-TMT to treat advanced non-small-cell lung cancer (NSCLC).
China approved 48 first-in-class innovative drugs, as well as a significant number of medications for pediatric and rare diseases, thanks to measures aimed at enhancing review efficiency and accelerating patient access to novel therapies, according to a report released by China’s National Medical Products Administration.
Following news of U.S. President Donald Trump’s 10% across-the-board tariffs on Australian exports to the U.S., Australia’s Securities Exchange shed nearly AU$55 billion in losses Thursday morning. Even so, pharmaceuticals have escaped the tariffs for now. In China, Trump’s tariffs are not a big concern for China’s health care because drugs and active pharmaceutical ingredients are exempted from the tariffs. Even if tariffs are imposed in the future, Chinese pharmaceutical companies have already significantly de-risked themselves in recent months by increasing out-licensing models with U.S. partners.
South Korea’s Ministry of Food and Drug Safety on April 8 cleared Barythrax injection (GC-1109) as the world’s first recombinant anthrax vaccine. The product was codeveloped by GC Biopharma Corp. and Korea Disease Control and Prevention Agency.
Australia’s top universities are looking more to Asia for research collaborations following threats from the Trump administration to stop funding research at institutions that don’t comply with U.S. narratives.
Otsuka Pharmaceutical Development & Commercialization Inc. filed its BLA with the U.S. FDA for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN). The company’s first BLA, sibeprenlimab is a monoclonal antibody (MAb) that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN.
The U.S. FDA rejected, for the second time, Elevar Therapeutics Inc.’s NDA of a novel combination therapy for advanced liver cancer, which comprised Jiangsu Hengrui Pharmaceutical Co. Ltd.’s PD-1 inhibitor camrelizumab and HLB Co. Ltd.’s small-molecule tyrosine kinase inhibitor, rivoceranib.
The U.S. FDA approved 16 drugs in February, up from 12 in January but still falling short of the 2024 monthly average of 19 approvals. Just two of those were new molecular entities (NMEs), continuing a slower pace compared to the year’s average of slightly more than four NMEs per month.
Nature Cell Co. Ltd. won U.S. FDA breakthrough therapy designation of its autologous adipose-derived mesenchymal stem cell therapy, Jointstem, March 20, becoming the first Korean company to earn the label in the field of cell therapy.
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