Oricell Therapeutics Co. Ltd. has become the latest Chinese biotech to advance an independently developed CAR T therapy, announcing Aug. 10 that China’s regulatory body gave IND approval for Oricar-017. Oricar-017 is the Shanghai-based biotech’s GPRC5D-directed CAR T therapy developed to treat patients with relapsed or refractory multiple myeloma.

Biocity Biopharmaceutics Co. Ltd. is advancing its pipeline of differentiated, modality-independent therapeutics for oncology that include small molecules, monoclonal and bispecific antibodies, as well as antibody-drug conjugates (ADCs). The Wuxi, China-headquartered company is focused on first-in-class molecules for different modalities that can be combined with other treatments, Biocity Co-founder and Executive Vice President Ivy Wang told BioWorld.

Kelun-Biotech Biopharmaceutical Co. Ltd.’s trophoblast cell-surface antigen 2 (Trop2)-targeted antibody-drug conjugate (ADC), SKB-264, met the primary endpoint of progression-free survival (PFS) in a phase III trial in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC), according to an interim analysis.

Both China’s NMPA and the U.S. FDA recently approved the IND applications for a phase I trial of Leads Biolabs’ LBL-034 to treat relapsed or refractory multiple myeloma. The Taiwan FDA also approved Hanchorbio Inc.’s IND application to start a multiregional phase I trial for HCB-101 for advanced solid tumors, and the China Center for Drug Evaluation cleared a phase II trial for Suzhou, China-based Transcenta Holding Ltd.’s TST-002 (blosozumab) for osteoporosis and conditions of reduced bone mineral density. In addition, the NMPA approved Shanghai-based Everest Medicines Ltd.’s application for an extended, post-approval study on Nefecon (targeted-release formulation-budesonide) to treat IgA nephropathy.

China’s National Medical Products Administration (NMPA) accepted Luye Pharma Group Ltd.’s NDA for rotigotine (LY-03003) extended-release microspheres and granted it priority review for treating Parkinson’s disease.

On Aug. 3, Sunho Biologics Inc. filed to list on the Hong Kong Exchange, armed with its antibody and immunocytokine drug pipeline and post-investment valuation of ¥1.41 billion (US$196 million).

Gracell Biotechnologies Inc. stands to gain up to $150 million from an assorted bouquet of private U.S. health care investors to lay a solid foundation for clinical trials of its leading dual-targeting CAR T-cell candidate, GC-012F, and provide a cash runway into the second half of 2026.

Hangzhou and New Jersey-based cancer biotech Adlai Nortye Ltd. – formerly Hangzhou Nuotai Pharmaceutical Co. Ltd. – announced plans to list on Nasdaq with its U.S. IPO filed on July 27.

Artificial intelligence (AI) drug discovery specialist Insilico Medicine Inc. is progressing INS018-055, its lead compound to phase II trials for idiopathic pulmonary fibrosis, a chronic lung disease that results in progressive and irreversible decline in lung function.

Prestige Biopharma Ltd. is mounting efforts to rise rank through the industry with a two-pronged strategy of becoming a global cancer antibody drug developer and contract development and manufacturing organization.