Mei Ri Jing Ji Xin Wen·2025-11-20 07:58Core Viewpoint - Tian Tan Bio's application for a hemophilia drug was withdrawn after 10 months of acceptance due to the need for additional clinical trial data for children under 12 years old, highlighting regulatory scrutiny in the rare disease market [2][11]. Company Summary - Tian Tan Bio's subsidiary Chengdu Rongsheng Pharmaceutical withdrew the registration application for "Recombinant Human Coagulation Factor VIIa Injection," which had a research investment of 266 million yuan [2][5]. - The drug's indication was aligned with that of imported products, focusing on adult and adolescent patients, but lacked data for younger patients, which is now a regulatory requirement [4][11]. - The company had previously completed a Phase III clinical trial, but the latest announcement did not specify age groups for the patient population [4][5]. Industry Summary - The hemophilia drug market in China is dominated by foreign companies, with over 90% market share, and there is a growing demand for domestic alternatives [12][13]. - The recent approval of a similar drug by Zhengda Tianqing, which does not cover children under 12, indicates a gap in the market that domestic companies are trying to fill [8][11]. - Regulatory bodies are pushing for comprehensive data that includes pediatric populations, reflecting a shift towards more inclusive treatment options for rare diseases [11][12]. - The domestic pharmaceutical industry is accelerating its efforts in rare disease drug development, with 21 rare disease drugs approved in the first half of 2025, indicating a positive trend towards addressing unmet medical needs [12][13].