Macau’s first Phase III clinical trial of an innovative traditional Chinese medicine (TCM) drug, involving Tangning Tongluo Tablets, was launched at Kiang Wu Hospital yesterday, marking a milestone in local clinical research and the city’s TCM industry, according to the project’s launch ceremony held at the lecture hall of the Kiang Wu Hospital Dr. Henry Y.T. Fok Specialist Medical Centre.
Tangning Tongluo Tablets* (糖寧通絡片), an innovative TCM drug designed to treat non-proliferative diabetic retinopathy**, received the first clinical trial pre-licence for a new TCM drug from the Pharmaceutical Administration Bureau (ISAF) in August to conduct a Phase III clinical trial at Kiang Wu Hospital, the private hospital said in a statement.
The project represents the first TCM new drug clinical trial to receive Macau’s advance approval, the first Phase III clinical trial of a Chinese patent medicine in Macau, and the first innovative TCM drug to undergo Phase III clinical trials simultaneously across mainland China and Macau.
Lao Kuok Hou, a senior TCM physician at Kiang Wu Hospital and the project’s principal investigator, said the drug helps alleviate vision problems caused by diabetic retinopathy. It has already completed about 360 cases in Phase III clinical trials in the Chinese mainland, with six cases set to be conducted in Macau.
Kiang Wu Charitable Association Vice President Lo Chio Kam said during her presentation that the launch represents an important breakthrough in the alignment of pharmaceutical regulatory rules and the mutual recognition of clinical data between Guangdong and Macau. She added that it provides a replicable pathway for the “Macau registration + Hengqin production” development model.
Kiang Wu Hospital Deputy Director Xie Xuebin noted that the hospital’s TCM Department has grown into a professional team of over 80 members, recording about 250,000 patient visits last year. The hospital currently utilises nine TCM hospital preparations from the mainland in clinical settings, with positive safety and efficacy records and cumulative usage exceeding 80,000 units.
Fu Yongge, deputy director of the Executive Committee of the Guangdong-Macao In-Depth Cooperation Zone in Hengqin, said the zone will continue to deepen institutional mechanisms and regulatory alignment between Hengqin and Macau to facilitate the registration and launch of more innovative TCM drugs.
*The name of the tablet translates to “Calming [blood] sugar and unblocking the micro-collaterals”. The name directly reflects its therapeutic role in TCM – “Tang-Ning” addresses the root cause: lowering and stabilising blood glucose levels; “Tong-Luo” addresses the secondary microvascular complications: improving microcirculation and treating conditions like diabetic retinopathy, neuropathy, and diabetic foot ulcers. – Gemini
** Non-proliferative diabetic retinopathy (NPDR) is the early to intermediate stage of diabetic retinopathy, characterised by damage to the small blood vessels in the retina caused by prolonged high blood sugar. – Gemini
Kiang Wu Hospital representatives and guests participate in yesterday’s ribbon-cutting ceremony to mark the official launch of the first Phase III trial of a TCM drug Macau at the lecture hall of the Kiang Wu Hospital Dr. Henry Y.T. Fok Specialist Medical Centre. GCP stands for “Good Clinical Practice”. – Photo: Sherwin Hng
