Akeso Inc.’s first-in-class trispecific antibody, AK-150, has received IND clearance from China’s National Medical Products Administration (NMPA) for clinical trials in patients with advanced solid tumors. Engineered using Akeso’s AI-driven drug discovery platform and its proprietary Tetrabody technology, AK-150 is a humanized anti-CSF-1R, ILT2 and ILT4 trispecific antibody that achieves multipathway blockade of both innate and adaptive immunity.

Shanghai Unixell Biotechnology Co. Ltd. has obtained IND clearance from the FDA for UX-GIP001, its iPSC-derived allogeneic cell therapy for focal epilepsy. A phase I study will evaluate UX-GIP001 in patients with drug-resistant epilepsy.

Cbio A/S has received European regulatory clearance to begin a first-in-human trial of novoleucel, the company’s next-generation T-cell therapy, in late-stage cervical cancer. The phase I/IIa study will enroll patients with persistent or recurrent cervical cancer at Karolinska University Hospital.

Harbour Biomed Ltd. and Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. have announced IND approval by China’s National Medical Products Administration (NMPA) for HBM-7575 (SKB-575) for the treatment of atopic dermatitis.

China Medical System Holdings Ltd. has received clinical trial approval from China’s National Medical Products Administration (NMPA) for CMS-D008 injection for overweight or obese individuals.

Great Novel Therapeutics Biotech & Medicals Corp.’s epigenetic immunoactivator, GNTbm-38, has received IND clearance from the FDA, enabling initiation of a phase I trial in the U.S. 

Kestrel Therapeutics Inc. has obtained IND approval from the FDA for KST-6051, an oral, small-molecule pan-KRAS inhibitor being developed for the treatment of KRAS-driven cancers.

Sanaregen Vision Therapeutics Inc. has received FDA clearance to conduct a phase I/II trial of SVT-001, an investigational cell therapy for individuals with familial drusen.

Gubra A/S has announced the submission in Germany of a clinical trial application (CTA) for a first-in-human study of GUB-UCN2, the company’s lead asset for weight loss. The planned phase I/IIa trial will enroll both healthy volunteers and individuals with obesity, with and without related co-morbidities. GUB-UCN2 is expected to enter clinical development in the first half of this year.

CF Pharmtech Inc. has announced approval from China’s National Medical Products Administration (NMPA) of an IND application filed by subsidiary Changfeng Suyue Pharmaceutical (Guangzhou) Co. Ltd. for ICF-004.