Qyuns Therapeutics Co. Ltd. signed a potential $1.07 billion license deal with Roche Holding AG, granting the latter exclusive rights to QX-031N – a human thymic stromal lymphopoietin and interleukin-33)-targeting bispecific antibody.

Based on positive phase III study results, Metis Techbio is planning to file an NDA for its AI-derived orally disintegrating tablet drug candidate for pseudobulbar affect, MTS-004, in China next year.

Based on positive phase III study results, Metis Techbio is planning to file an NDA for its AI-derived orally disintegrating tablet drug candidate for pseudobulbar affect, MTS-004, in China next year.

CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with SYH-2061 injection for the treatment of IgA nephropathy and other complement-mediated diseases.

Takeda Pharmaceutical Co. Ltd. agreed to codevelop and commercialize up to three of Innovent Biologics Co. Ltd.’s immuno-oncology (I-O) and antibody-drug conjugate (ADC) candidates with the signing of a $11.4 billion deal, including $1.2 billion paid up front.

China’s National Medical Products Administration (NMPA) recently met with a delegation from Singapore’s Health Sciences Authority (HSA) to discuss cooperation in the two agencies’ regulation of medical products, part of a series of efforts by NMPA to expand its use of regulatory reliance.

CF Pharmtech Inc. raised HK$607.67 million (US$78.12 million) through the sale of 41.19 million H shares on the Hong Kong Stock Exchange (HKEX) Oct. 8. The proceeds will be used to advance the Suzhou, China-based drug developer’s portfolio of inhalation candidates for respiratory diseases.

CF Pharmtech Inc. raised HK$607.67 million (US$78.12 million) through the sale of 41.19 million H shares on the Hong Kong Stock Exchange (HKEX) Oct. 8. The proceeds will be used to advance the Suzhou, China-based drug developer’s portfolio of inhalation candidates for respiratory diseases.

Sichuan Biokin Pharmaceutical Co. Ltd. has gained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with [177Lu]-BL-ARC001 injection.

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.