Changchun High-tech: Subsidiary GenSci's 128-patch product receives Orphan Drug designation from the US FDA

LightningPacketLoss · 2026-03-11T23:47:01+00:00

Changchun High-tech's subsidiary has been granted orphan drug designation by the FDA for GenSci128 tablets, indicated for pancreatic cancer. This designation will support its subsequent research and development, including tax credits and market exclusivity, driving the company's business expansion and enhancement of core competitiveness.

LightningPacketLoss

2026-03-11 23:47:01

Abstract generation in progress

Recently, Changchun High-tech announced that its subsidiary has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for GenSci128 tablets, indicated for the treatment of pancreatic cancer. Previously, GenSci128 had received approval to conduct clinical trials in China and the United States.

This orphan drug designation will provide policy support for the subsequent research, development, and review of GenSci128 in the U.S., including tax credits for clinical trial costs, exemption from new drug application fees, and a seven-year market exclusivity period after approval.

The company stated that if subsequent clinical trials progress smoothly, it will help expand the business structure and enhance core competitiveness.

(Changchun High-tech Announcement)

(Edited by: Yang Yan, Lin Chen)

Keywords: Healthcare

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