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ENClinical Research Progress | Successful Conclusion of the Clinical Trial Summary Meeting for Xiao'er Huaji Granules
Release time：2025-01-01
Recently, the clinical trial summary meeting for the pediatric modified dosage form - Xiao'er Huaji Granules, sponsored by Hainan Huluwa Pharmaceutical Group Co., Ltd. and organized by Leadingpharm CXO · Deep Blue Ocean Bio-Pharmaceutical, was successfully held.
Relevant personnel including Fan Guanwei, Deputy Director of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine (the leading institution for clinical research), Rong Ping, Deputy Director of the Pediatrics Department, Liu Fang, Director of the Institutional Office, as well as institutional heads and principal investigators from 10 participating centers, together with Liu Quanguo, Technical Director of Hainan Huluwa Pharmaceutical Group Co., Ltd., and Zhang Ronghuo, Vice President of Leadingpharm and General Manager of Zhengzhou Shenlanhai (a contract research organization), attended the meeting both on-site and online. The meeting was chaired by Director Liu Fang.
At the meeting, under the organization of Professor Hu Siyuan, the overall PI of the project, experts from participating research institutions conducted in-depth analysis and discussions on data acquisition and result conclusions of the study. They unanimously agreed that Xiao'er Huaji Granules showed significantly better efficacy than the placebo in improving the main symptoms of infantile food stagnation (such as loss of appetite and abdominal distension) caused by internal retention of milk and food. Additionally, the incidence of adverse reactions was low, indicating good safety.
The successful holding of this meeting marks a phased achievement in the research and development of Xiao'er Huaji Granules, which can provide strong evidence support for the subsequent NDA (New Drug Application). The successful launch of this product in the future will solve the problems of difficulty in taking the original tablets and insufficient compliance in children. Hainan Huluwa Pharmaceutical Group Co., Ltd. and Leadingpharm will adhere to the "people-oriented" concept, actively promote the marketing process of Xiao'er Huaji Granules to meet the clinical needs of domestic pediatric digestive system medications, and contribute more to the comprehensive implementation of the "Healthy China" strategy.
Relevant personnel including Fan Guanwei, Deputy Director of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine (the leading institution for clinical research), Rong Ping, Deputy Director of the Pediatrics Department, Liu Fang, Director of the Institutional Office, as well as institutional heads and principal investigators from 10 participating centers, together with Liu Quanguo, Technical Director of Hainan Huluwa Pharmaceutical Group Co., Ltd., and Zhang Ronghuo, Vice President of Leadingpharm and General Manager of Zhengzhou Shenlanhai (a contract research organization), attended the meeting both on-site and online. The meeting was chaired by Director Liu Fang.
At the meeting, under the organization of Professor Hu Siyuan, the overall PI of the project, experts from participating research institutions conducted in-depth analysis and discussions on data acquisition and result conclusions of the study. They unanimously agreed that Xiao'er Huaji Granules showed significantly better efficacy than the placebo in improving the main symptoms of infantile food stagnation (such as loss of appetite and abdominal distension) caused by internal retention of milk and food. Additionally, the incidence of adverse reactions was low, indicating good safety.
The successful holding of this meeting marks a phased achievement in the research and development of Xiao'er Huaji Granules, which can provide strong evidence support for the subsequent NDA (New Drug Application). The successful launch of this product in the future will solve the problems of difficulty in taking the original tablets and insufficient compliance in children. Hainan Huluwa Pharmaceutical Group Co., Ltd. and Leadingpharm will adhere to the "people-oriented" concept, actively promote the marketing process of Xiao'er Huaji Granules to meet the clinical needs of domestic pediatric digestive system medications, and contribute more to the comprehensive implementation of the "Healthy China" strategy.
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