Kintor Pharmaceutical Ltd.’s topical androgen receptor antagonist, pyrilutamide (KX-826), met the primary endpoint in a pivotal phase III trial in male androgenetic alopecia, and the company will soon file an NDA with China’s National Medical Products Administration.
Excalipoint Therapeutics Inc. launched with an oversubscribed $68.7 million seed financing round to advance a portfolio of T-cell engagers for solid tumors, marking one of the largest early stage financings in China biotech history.
Early clinical data from Simcere Pharmaceutical Group Ltd. suggest its PD-L1/IL-15 bispecific antibody, SIM-0237, could emerge as a next-generation contender in Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer.
Excalipoint Therapeutics Inc. launched with an oversubscribed $68.7 million seed financing round to advance a portfolio of T-cell engagers for solid tumors, marking one of the largest early stage financings in China biotech history.
Qyuns Therapeutics Co. Ltd. has moved closer to its first commercial product after China’s National Medical Products Administration (NMPA) accepted its NDA for IL-17 antibody crusekitug (QX-002N) for treating ankylosing spondylitis (AS), a chronic inflammatory disease that affects the spine and sacroiliac joints.
Newco R1 Therapeutics Inc. has launched with an oversubscribed $77.5 million series A, providing the means to take AP-306, a potentially first-in-class hyperphosphatemia therapy through phase IIb development in patients with chronic kidney disease.
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.
Qyuns Therapeutics Co. Ltd. has moved closer to its first commercial product after China’s National Medical Products Administration (NMPA) accepted its NDA for IL-17 antibody crusekitug (QX-002N) for treating ankylosing spondylitis (AS), a chronic inflammatory disease that affects the spine and sacroiliac joints.
China’s National Medical Products Administration has approved Asieris Pharmaceuticals Co. Ltd.’s cold light photodynamic drug-device combination product, Cevira (APL-1702, hexaminolevulinate hydrochloride), which is used as a nonsurgical therapy for treating patients with cervical intraepithelial neoplasia grade 2.