The pharmaceutical company incubated by Jingtai Technology - Xige Biotechnology

Xige Biotechnology announced that its self-developed first-in-class targeted drug SIGX1094 has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for gastric cancer.

https://www.signettx.com/news-information/105.html

$XTALPI(02228.HK)

As the world's first targeted therapy for diffuse gastric cancer, SIGX1094, which has received ODD from the FDA, will enjoy a series of policy benefits, such as tax deductions for clinical trial costs, exemption from new drug NDA application fees (approximately $4.3 million in 2025), a seven-year market exclusivity period after approval, special research funding support, and priority review vouchers under a series of U.S. orphan drug incentive policies. In terms of review, developers of orphan drugs can apply for priority review from the FDA, shortening the review period and accelerating the product's market launch. These incentives will further expedite the market entry process of SIGX1094, ensuring that patients in urgent need of effective treatment solutions can benefit as soon as possible.

Currently, Xige Biotechnology is conducting a multi-center Phase I clinical trial for SIGX1094, aiming to evaluate its safety and efficacy in diffuse gastric cancer and other advanced solid tumors. Previously, SIGX1094 has received IND approvals from the U.S. FDA and the National Medical Products Administration (NMPA) of China, and the FDA's ODD authorization will further accelerate the global development process of SIGX1094.

This case is quite valuable. 2228 is a shareholder of this company, and Signet's office in Shenzhen is located one floor above the Crystal Technology Shenzhen office. Signet's drug development largely relies on the front-end services provided by 2228