CSI Smart Finance News — Hisun Pharmaceutical (600267.SH) announced on the evening of December 22 that the company has received notification from the U.S. Food and Drug Administration (FDA) that the Investigational New Drug (IND) application for its self-developed HS387 tablets has been approved. The company is now authorized to conduct clinical trials in the United States. The drug is intended for the treatment of advanced solid tumors, including high-grade serous ovarian cancer and non-small cell lung cancer (NSCLC).
According to the announcement, HS387 is a selective KIF18A inhibitor. It previously received a "Drug Clinical Trial Approval Notice" from China's National Medical Products Administration (NMPA), a milestone the company disclosed on July 2, 2025. In November 2025, the company submitted the IND application to the U.S. FDA and recently obtained approval. To date, while several KIF18A inhibitors have entered the clinical development stage globally, no such drugs have yet been approved for market launch.
The company cautioned that, pursuant to U.S. drug registration laws and regulations, the drug must still undergo a series of clinical trials and obtain formal FDA approval before it can be marketed. This development is not expected to have a significant impact on the company's business operations in the short term.
Corporate data shows that Hisun Pharmaceutical aims for precision and efficiency in R&D, striving to build a product pipeline with differentiated competitive advantages. The company has established an innovative drug R&D center in Shanghai to accelerate its global R&D footprint. Driven by a dual-engine model of independent R&D and external collaboration, the company has formed strategic partnerships with numerous premium domestic and international research institutes and biotech firms, creating a multi-level and multi-dimensional R&D network.
In the first three quarters of 2025, Hisun Pharmaceutical achieved a total operating income of 7.923 billion yuan, with a net profit of 461 million yuan.

https://finance.eastmoney.com/a/202512223598574474.html