Company Overview - Xinji Pharmaceutical, founded in 2007 and headquartered in Guangzhou, China, is an innovative pharmaceutical technology company in the clinical stage, focusing on two core technology platforms: soluble microneedle formulation technology and nasal inhalation formulation technology [3] - The company's first core product, Dexmedetomidine Hydrochloride Microneedle Patch, is designed for preoperative sedation in pediatric and adult patients, aiming to enhance patient comfort and clinical efficiency by overcoming the limitations of intravenous sedatives [3] - As of December 18, 2025, the Dexmedetomidine Hydrochloride Microneedle Patch has entered Phase IIa clinical trials for pediatric patients in China, with Phase II trials for adult patients expected to commence in Q1 2026 [3] Product Pipeline - The second core product, XJN010, is developed based on the nasal inhalation formulation platform, aiming to deliver active pharmaceutical ingredients through the nasal-brain pathway, bypassing the gastrointestinal tract and blood-brain barrier [4] - XJN1102, a soluble microneedle transdermal patch for treating type 2 diabetes and long-term weight control, is in the preclinical stage, with IND applications planned for submission to NMPA and FDA in Q4 2026 [4] - XJN2503, a clinical-stage nasal inhalation formulation for rapid relief and prevention of nausea and vomiting related to chemotherapy, radiotherapy, and postoperative recovery, is also set for IND submission to NMPA in Q4 2026 [4] Financial Information - Research and development expenses for the fiscal years 2023, 2024, and the first half of 2025 were approximately RMB 18.43 million, RMB 16.41 million, and RMB 11.62 million, respectively [5] - Revenue for the fiscal years 2023, 2024, and the first half of 2025 was approximately RMB 54.09 million, RMB 49.03 million, and RMB 28.14 million, respectively [6] Industry Overview - The preoperative sedation market in China is expected to grow steadily, with the pediatric sedation patient population projected to increase from 9.06 million in 2020 to 10.23 million by 2032, reflecting a compound annual growth rate (CAGR) of 1.79% from 2028 to 2032 [8] - The overall market for preoperative sedation in China was approximately RMB 7.36 billion in 2020, with expectations to exceed RMB 7.6 billion by 2024 and reach around RMB 8.24 billion by 2032, driven by rising surgical volumes and increased demand for comfort-oriented medical services [12] - The global sedation market is also expanding, with a projected growth from USD 8.64 billion in 2020 to USD 10.39 billion by 2032, with pediatric sedation showing a higher growth rate compared to adult sedation [14]
新济医药递表港交所 核心产品XJN010已于中国进入II期临床试验
Zhi Tong Cai Jing·2025-12-24 08:32