The kickoff meeting for the top-level design of the Phase III clinical trial protocol for Bai Mai Ointment in the treatment of diabetic peripheral neuropathy will be held.

Release time:

2024-12-12 13:13

The nation’s first ethnic medicine—Qizheng Tibetan Medicine Bai Mai Ointment—that has been exempted from Phase II clinical trials and is proceeding directly to confirmatory clinical trials has achieved new progress. On December 7, the top-level design meeting for the Phase III clinical trial protocol of Qizheng Tibetan Medicine Bai Mai Ointment for the treatment of diabetic peripheral neuropathy was held in Changchun.

The Qizheng Tibetan Medicine Bai Mai Ointment is developing its review and evaluation evidence system based on the “three integrations” approach, leveraging a key national research and development project under the 13th Five-Year Plan. It has accumulated relevant “human-use experience.” Following proactive consultations, on August 24, 2024, it received the “Notice of Approval for Clinical Trials of Drugs” (Notice No.: 2024LP01954), becoming the first ethnic medicine in China to be exempted from Phase II clinical trials and allowed to proceed directly to confirmatory clinical trials. As the principal investigator of this project, Academician Tong Xiaolin, Chief Researcher at the China Academy of Chinese Medical Sciences and Director of the Department of Endocrinology at Guang’anmen Hospital of the China Academy of Chinese Medical Sciences, hopes that the attending endocrinologists—both traditional Chinese medicine and Western medicine specialists—will offer professional and forward-looking advice on the study protocol design. Unlike oral formulations, topical Chinese medicinal preparations hold significant importance for patients suffering from diabetic peripheral neuropathy. Building on the research conducted under the 13th Five-Year Plan, the Bai Mai Ointment has already completed evidence-based studies and obtained high-quality human-use experience.

Epidemiological survey data from 2020 show that the prevalence of diabetes among Chinese adults aged 18 and above is approximately 11.2%. Diabetes can lead to a variety of chronic complications, among which diabetic neuropathy is the most common chronic complication of diabetes. It is a major contributing factor to falls and fractures, causing significant suffering for patients and severely impacting their ability to work and their quality of life.

In 2023, the national “13th Five-Year Plan” key R&D project of the Ministry of Science and Technology—“Demonstration Development Study on the Treatment of Tibetan Medical Major Disease, White Pulse Disease, Using the Classic Tibetan Medicines Ruyi Zhenbao Tablets and Bai Mai Ointment”—passed the comprehensive performance evaluation conducted by the China National Center for Biotechnology Development and was completed with high quality. This project has provided a new Tibetan medicine-based solution for acute ischemic stroke and diabetic peripheral neuropathy. Concurrently, the clinical study on the use of Bai Mai Ointment for the treatment of distal diabetic peripheral neuropathy also confirmed that Bai Mai Ointment can significantly alleviate symptoms such as limb numbness and pain in patients with diabetic peripheral neuropathy.

Xia Haijian, President of Qizheng Tibetan Medicine, stated that the company will continue to deepen its commitment, uphold integrity while fostering innovation, and remain steadfastly patient-centered. Qizheng Tibetan Medicine is even more confident in the project team; under the guidance of Academician Tong and other experts, the company will meticulously design and execute the Phase III clinical trial for Bai Mai Ointment, swiftly advancing the approval and launch of Bai Mai Ointment for the new indication of treating diabetic peripheral neuropathy, thereby benefiting more patients suffering from this condition.

Reporting media: China National Medicine Network

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