Transplanting an animal organ into a human is now a closer reality following the successful xenotransplantation of a genetically modified pig liver into a patient diagnosed with brain death in China. The operation was intended to evaluate organ function over a 10-day period. This is a complex experimental trial that did not involve removing the patient's liver and still requires further study. However, the positive preclinical results suggest this strategy could save the lives of those waiting for a human organ, at least in certain cases.
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.
Taimed Biologics Inc.’s TMB-365/TMB-380 long-acting combination of broadly neutralizing antibodies regimen for HIV maintenance could reshape HIV treatment management, offering a viable alternative to daily combination antiretroviral therapy (cART), the Taipei-based company said after reporting on phase IIa results.
Astrazeneca plc is investing heavily in China, signing two R&D deals, worth up to about $8 billion in up-front payments and milestones combined, with Chinese companies Harbour Biomed Ltd. and Syneron Bio, establishing a joint venture with Shenzhen Kangtai Biological Products Co. (Biokangtai) for vaccines, and creating a new R&D center in Beijing through another $2.5 billion investment.
Dengue virus (DENV) is a member of the flavivirus family causing dengue fever, a mosquito-borne disease that can be life-threatening. Despite DENV’s widespread presence in over 80 countries and the significant health burden posed by the infection, there is still a critical need for therapeutics and vaccines, with current treatment options only providing supportive care.
Japanese-founded Regcell Inc. has raised $45.8 million and is redomiciling to the U.S. to accelerate clinical development of its pioneering regulatory T-cell (Treg) platform for autoimmune diseases and transplantation.
China’s National Medical Products Administration (NMPA) approved the country’s first injectable teprotumumab biosimilar from Innovent Biologics Inc. under the brand name of Sycume (teprotumumab N-01) to treat thyroid eye disease on March 14. The NMPA on March 15 accepted Simcere Pharmaceutical Group Ltd.’s NDA of deunoxavir marboxil (ADC-189) tablets, a product originally developed by Jiaxing Andicon Biotech Co. Ltd. to treat influenza A and B.
Insilico Medicine founder and CEO Alex Zhavoronkov told BioWorld that he tries to spend as much time as possible in China, because that's where the artificial intelligence (AI) drug development company conducts synthesis and tests for early stage discovery. “And nowadays, not a day goes by without somebody launching an AI drug discovery company,” he said, noting that Chinese AI company Deepseek could be a huge disrupter.
Analysts were pleasantly surprised by the positive phase III data reported for Kyowa Kirin Co. Ltd./Amgen Inc.’s rocatinlimab, a T-cell rebalancing therapy, in moderate to severe atopic dermatitis.
Regenerative medicine company Mesoblast Ltd. is preparing to launch its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil, (remestemcel-L), in March in the U.S. and has priced the treatment at roughly $1.55 million for a full course.
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