Mabwell Bioscience Co. Ltd. and Aditum Bio Management Co. LLC announced, in after-market hours Sept. 17, an agreement to forge a new company called Kalexo Bio Inc. and load the biotech with a preclinical dyslipidemia asset via a potential $1 billion global license deal.

Patients with relapsed/refractory multiple myeloma (r/r MM) treated with Carsgen Therapeutics Holdings Ltd.’s CAR T therapy, zevorcabtagene autoleucel (zevor-cel, CT-053), have shown durable responses lasting nearly five years.

China’s National Medical Products Administration is arguably more active than regulatory agencies in many nations in advancing guidance for AI in medical technology, but Chang-Hong Whitney, President/CEO of Whitney Consulting Ltd., told BioWorld that the premarket review process still carries some unpredictability.

Alimetry Ltd. is making waves far beyond its home market with its first-in-class wearable Gastric Alimetry device that measures gut function – an area long considered a black box in gastroenterology.

Japan’s Pharmaceuticals and Medical Devices Agency has traditionally been less than receptive to clinical data from other nations, but that aversion is slowly giving way. Ames Gross of Pacific Bridge Medical told BioWorld that a trial conducted in another nation with significant representation of those of Japanese ancestry can go a long way toward obviating the need for a trial conducted in Japan.

Artificial intelligence is no longer just a supporting tool in biotechnology – it is beginning to define the way drugs are discovered, tested and advanced into the clinic, speakers said during the Bio Hong Kong conference Sept. 10 to 13.

The Hong Kong biotech sector saw record growth this year, expanding 13%, fueled largely by investment in innovation ranging from CRISPR gene editing tools, cell therapies and artificial intelligence in drug discovery, speakers at the BIO Hong Kong conference said Sept. 10.

China was already making strides to lead the biotechnology industry in many key areas such as cell therapies and AI, but the chaotic nature of the Trump administration and the turmoil in the U.S. has catapulted China’s status as a more “dependable” partner, presenters said during the Bio Hong Kong conference, Sept. 10 to 13.

“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”

South Korea’s Ministry of Food and Drug Safety announced Sept. 12 plans to significantly raise drug application fees for biosimilars but slash their review times starting next year.