Innorna Co. Ltd. has obtained IND clearance from the FDA for IN-026, enabling the company to initiate a phase I study of this mRNA-based therapy for refractory gout.
CF Pharmtech Inc. has announced IND approval by China’s National Medical Products Administration (NMPA) for ICF-001, a long-acting inhalation powder candidate for the treatment of pulmonary hypertension and related severe pulmonary diseases.
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.
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