Changchun High-Tech Industry (Group) Co.,Ltd. has announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., recently received notification from the U.S. Food and Drug Administration (FDA). The FDA has granted Orphan Drug Designation (ODD) to the GenSci128 tablet for the treatment of pancreatic cancer.

GenSci128 is a new chemical drug classified as a Category 1 therapeutic. It falls under the "505b1" new drug registration category in the United States. The drug acts as a selective reactivator targeting the TP53Y220C mutation and is intended for treating locally advanced or metastatic solid tumors carrying this mutation. These tumors include pancreatic cancer, ovarian cancer, breast cancer, and colorectal cancer, among others.

The granting of orphan drug status is expected to provide GenSci128 with certain policy supports during its subsequent research, development, and review process in the U.S. for pancreatic cancer treatment. These supports include, but are not limited to, tax credits for clinical trial costs, exemption from new drug application fees, and a seven-year period of market exclusivity post-approval, which is independent of patent protection.

If the subsidiary's subsequent clinical trials proceed successfully, it will help the company broaden its business structure, optimize its product portfolio, enrich and enhance its strategic product pipeline, and ultimately improve its core competitiveness.