JLPC(SH:600513) Shang Hai Zheng Quan Bao·2025-12-04 20:03Core Viewpoint - Jiangsu Lianhuan Pharmaceutical Co., Ltd. announced that its subsidiary, Changle Pharmaceutical, has received approval from the National Medical Products Administration for the consistency evaluation of the generic drug Estazolam Tablets, enhancing its product portfolio in the central nervous system treatment field [1][2]. Group 1: Drug Information - Drug Name: Estazolam Tablets - Dosage Form: Tablets - Registration Category: Chemical Drug - Specification: 1mg - Packaging: 10 tablets/board, 10 boards/box; 20 tablets/bottle - Original Drug Approval Number: Guoyao Zhunzi H41020215 - Acceptance Number: CYHB2450585 - Notification Number: 2025B05779 - Application Content: Consistency evaluation of generic drug quality and efficacy [1][3]. Group 2: Market Performance - As of the announcement date, the estimated sales revenue of Estazolam Tablets in domestic sample hospitals for 2024 is approximately 364 million yuan [3]. - Changle Pharmaceutical has obtained 6 production licenses for Estazolam Tablets as of the announcement date [5]. Group 3: R&D Investment - The R&D investment for the consistency evaluation of Estazolam Tablets by Changle Pharmaceutical is approximately 4.752 million yuan (unaudited) as of the announcement date [4]. Group 4: Company Impact - The approval of Estazolam Tablets for consistency evaluation is expected to enhance the company's market share and competitiveness in the generic drug development field, although it is not anticipated to have a significant impact on the company's recent operating performance [6].