Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a significant stock increase of nearly 6%, with a cumulative rise of over 65% in the month, following the announcement of its drug JSKN003 receiving orphan drug designation (ODD) from the FDA for the treatment of gastric cancer and gastroesophageal junction cancer [1][1]. Company Summary - JSKN003 is developed using Corning Jereh's proprietary glycosylation site-specific conjugation platform and is a HER2 dual-targeted antibody-drug conjugate (ADC) [1]. - The orphan drug designation (ODD) is part of the FDA's initiative to encourage the development of innovative drugs for diseases affecting fewer than 200,000 patients in the U.S. [1]. Industry Summary - The ODD status will facilitate subsequent research, development, registration, and commercialization efforts in the U.S., providing various policy supports such as funding for research expenses, tax reductions for clinical research costs, waivers for prescription drug user fees, and expedited review processes for market approval [1]. - Following approval, the drug is expected to enjoy a seven-year exclusivity period in the U.S. market [1].
港股异动 | 康宁杰瑞制药-B(09966)再涨近6% 月内累涨逾65% JSKN003获美国FDA孤儿药资格认定