After a steep drop in biopharmaceutical IPOs in the first half of 2023, investors have come to expect that the slowdown in new listings of Chinese companies will continue for some time. Without the key influx of cash that equity financing can generate, biopharma companies are ramping up other activities to generate cash, particularly by out-licensing drugs with the potential for global expansion.

Gracell Biotechnologies Inc. is initiating two clinical trials in China in refractory systemic lupus erythematosus for lead candidate GC-012F, a CD19/B-cell maturation antigen dual-targeting CAR T. 

Cansino Biologics Inc. reported positive data in a phase IIb trial evaluating the heterologous mRNA vaccine CS-2034 booster compared to an inactivated vaccine to prevent SARS-CoV-2 infections.

Bayer AG’s copanlisib was approved in China for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. It is the first indication approved in the country for copanlisib, which is entering a market with room to grow but marked by some domestic competition.

Nanjing Sanhome Pharmaceutical Co. Ltd.’s Shengnuodi (alfosbuvir tablets), used as part of a combination treatment for hepatitis C, has been approved by China’s National Medical Products Administration (NMPA) through the priority review and approval procedure.

Coherent Biopharma Co. Ltd. raised $100 million in series B and B+ financing rounds to step up its efforts to develop its bi-targeting ligand-drug conjugate (Bi-XDC) drugs and get them to market. Suzhou, China-based Coherent plans to use its newly expanded war chest to support the clinical trials of three candidates, CBP-1008, CBP-1018 and CBP-1019, as well as an IND application for CBP-8008 in China and the U.S., the company told BioWorld.

Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT)’s NDA for recombinant human insulin capsule ORMD-0801 for type 2 diabetes is under review by the NMPA and, if approved, is expected to be the first oral insulin available in China, where regulators have been on the lookout for new treatment options for the increasingly common disease.

In a deal worth as much as $600 million, Lanova Medicines Ltd. licensed exclusive global rights to Astrazeneca plc for LM-305, an antibody-drug conjugate (ADC) targeting GPRC5D, for multiple myeloma (MM). Lanova will receive up-front and near-term payments of up to $55 million and development and commercial milestone payments of up to $545 million, as well as tiered royalties on net sales worldwide.