The Phase III Clinical Trial Launch Meeting of Tangning Tongluo Tablets
On January 18, the Phase III clinical trial launch meeting for Beletalent ‘s Tangning Tongluo Tablets in the treatment of non-proliferative diabetic retinopathy(with syndrome of yin deficiency with internal heat and blood stasis obstructing the collaterals of the eyes)was successfully held in the Guangdong-Macao In-depth Cooperation Zone in Hengqin, Guangdong Province. This event marks the project’s entry into a critical research and development phase.
The meeting was hosted by Beletalent (ZHUHAI)Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Guizhou Bailing(hereinafter referred to as “Beletalent” ), co-organized by the Hengqin Guangdong-Macao In-depth Cooperation Zone Pharmaceutical, Medical Device and Cosmetic Association(hereinafter referred to as “Cooperation Zone PMDC Association”), and undertaken by the Contract Research Organization(CRO) Beijing Excellence Future International Consulting Co. Ltd.
The clinical trial launch meeting received high attention and strong support from the Hengqin Working Committee of the CPC Guangdong Provincial Committee, the Guangdong-Macao In-depth Cooperation Zone in hengqin, and medical institutions in the Macao region. The Hengqin Working Committee of the CPC Guangdong Provincial Committee, the Business Service Bureau of the Executive Committee , the Economic Development Bureau , the Cooperation Zone PMDC Association, the Hengqin Guangdong-Macao In-depth Cooperation Zone Greater Health and Biopharmaceutical Industry Association of the Guangdong Macao In depth Cooperation Zone in hengqin and other institutional leaders, the chairman of the sponsor Beletalent and CRO attended. Bi Hongsheng, Principal Investigator of this Phase III trial, director of the Eye Hospital Affiliated to Shandong University of Chinese Medicine, and more than 70 authoritative experts from 23 clinical research centers, the Clinical Trial Center at the Macao University of Science and Technology, and Traditional Chinese Medicine Department of Macao Kiang Wu Hospital participated in the national launch meeting. meeting.
▲Bi Hongsheng, the President of the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine of the Phase III clinical trial group unit, the leading unit of the study and Director of the Ophthalmology Professional Committee of the Chinese Association of Integrative Medicine, delivered a speech.
Tangning Tongluo Tablets are a new traditional Chinese medicine developed by Beletalent through its long-term exploration and inheritance of the treasure trove of ethnic medicine. This medicine is used to treat type 2 diabetes and its complications. From its origin as a folk prescription of the Miao ethnic group to being supported by a project of the National Administration of Traditional Chinese Medicine, and then approved by the National Medical Products Administration to directly proceed to Phase III clinical trials, Tangning Tongluo Tablets have become the first TCM Class 1.1 new drug in China to enter Phase III clinical trials directly, bypassing Phases I and II, based on human use experience since the implementation of the “Special Provisions for the Registration Management of Traditional Chinese Medicine.” Each step has been the result of the research team’s hard work, the support of partners, and the high expectations of all parties involved.
Over the past decade, based on the research findings from authoritative institutions such as the Chinese Academy of Medical Sciences, the University of Hong Kong, and the Chinese People’s Liberation Army (PLA) General Hospital, as well as the research outcomes from the “Special Program for Traditional Chinese Medicine Science and Technology Reserch” supported by the National Administration of Traditional Chinese Medicine, it has been confirmed that Tangning Tongluo Tablets not only have significant blood sugar-lowering effects but also possess unique advantages in the prevention and reversal of diabetic complications. Specifically, in the treatment of diabetic retinopathy, Tangning Tongluo Tablets have demonstrated superior overall efficacy compared to “Calcium Dobesulate,” the only chemical drug recommended for the treatment of diabetic retinopathy. Tangning Tongluo Tablets have shown comprehensive superiority in reducing microcirculatory stasis, improving retinal microcirculation, and reversing pathological changes in retinal blood vessels associated with diabetic retinopathy. These findings have laid a solid foundation for the smooth conduct of the Phase III clinical trial.
At the launch meeting, Director Xia Wen expressed his gratitude to leaders at all levels and the participating research units. Inspired by the favorable industrial policies of the Guangdong-Macao In-depth Cooperation Zone in Hengqin, and coinciding with the special occasion of the 25th anniversary of Macao’s return to the motherland and the 3rd anniversary of the establishment of the Guangdong-Macao In-depth Cooperation Zone in Hengqin, Guizhou Bailing came to Hengqin through its subsidiary Beletalent. With the on-site guidance and support from the Executive Committee of the Guangdong-Macao In-depth Cooperation Zone in Hengqin, the National Medical Products Administration’s Drug Evaluation and Inspection Sub-Center in the Greater Bay Area, and the Guangdong-Macao Pharmaceutical Co., Ltd., Beletalent fully integrated the more than ten years of clinical experience of Tangning Tongluo Tablets as an hospital preparation with the policy, resource, and locational advantages of the Cooperation Zone, which contributed to the successful application for Phase III clinical research of Tangning Tongluo Tablets, an innovative achievement.
▲Xia Wen, Director of Research and Development at Guizhou Bailing and head of Beletalent, delivered a speech.
During the discussion session of the meeting, participating experts actively spoke up, expressing high recognition and great anticipation for the clinical trial. They engaged in an enthusiastic discussion and exchange regarding the implementation of the trial plan, and proposed suggestions for further optimization and improvement. The experts unanimously stated that diabetes treatment has always been a hot and challenging topic in the medical field. The development of Tangning Tongluo Tablets offers new ideas and approaches for treating diabetes with traditional Chinese medicine. They pledged to strictly adhere to international standards and norms during the clinical trial process to ensure the scientific validity, authenticity, and reliability of the research results.
▲Participating experts engaged in a lively and intense discussion.
According to Director Xia Wen, the Phase III clinical trial has already received the “approval to proceed” opinion from the Ethics Review Committee of the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine, the leading unit of the study. With the successful conclusion of the launch meeting, multiple clinical trial centers across the country are about to simultaneously commence patient recruitment, formally kicking off the Phase III clinical trial.
In the furture, Beletalent will provide comprehensive support for the Phase III clinical trial, continuously increase R&D investment, and ensure that every key requirement is adequately supported. The company will also collaborate with each research center to establish an efficient communication and coordination mechanisms, accelerate the new drug development process, and collectively drive the successful completion of the clinical trial of Tangning Tongluo Tablets. This effort aims to bring a new and superior treatment option to a broad patient population with diabetes, thereby transforming the landscape of diabetes treatment.