A historic moment for Traditional Chinese Medicine (TCM) “going global” has been frozen in time on the shores of the South China Sea.
On August 27, 2026, Tangning Tongluo Tablets, a Class 1.1 innovative TCM drug developed by Guizhou Bailing, officially received the pre-approval for clinical trial from the Macao Pharmaceutical Administration Bureau.
One Approval, Three Firsts
This approval marks the first TCM clinical trial pre-approval issued by the Macao Pharmaceutical Administration Bureau since its establishment; it is also the first case of an unmarketed innovative TCM drug being approved under a different overseas drug regulatory system; and it makes Tangning Tongluo Tablets the first TCM innovative drug to simultaneously advance Phase III clinical trials in both the mainland and Macau. A single approval that simultaneously sets new records in Macau’s review history and the history of TCM going global.
Human Use Experience as Evidence, Dual Recognition from Two Regulatory Systems
Tangning Tongluo Tablets is a Class 1.1 innovative TCM drug that Guizhou Bailing has been developing for over a decade. In November 2024, its application for the treatment of diabetic retinopathy (DR), backed by robust real‑world human use experience data from hundreds of thousands of patients, was directly approved by China’s National Medical Products Administration (NMPA) to enter Phase III clinical trials. Now, after a scientific, rigorous, and comprehensive review of the submitted dossier, the Macao Pharmaceutical Administration Bureau has also determined that the drug complies with Macau’s current regulations and granted direct approval for Phase III clinical trials. The same product has earned recognition from two international review systems, validating the feasibility and persuasiveness of the “human use experience” pathway.
Hengqin-Macau Synergy: “One Product, Dual Submission” Going Global
Behind this breakthrough lies the precise implementation of the “R&D in Hengqin + Registration in Macau” dual‑platform strategy. In 2023, Beletalent settled in the Guangdong‑Macau In‑Depth Cooperation Zone in Hengqin, and its subsidiary, MACAO G-RX CO.,LTD., serves as the sponsor and drug holder for the new drug application in Macau. Partnering with Kiang Wu Hospital, which meets Macau’s GCP requirements, and leveraging Macau’s “1+4” strategy for moderate economic diversification and the Pharmaceutical Activities and Proprietary Chinese Medicine Registration Law, as well as the full‑chain services of the Guangdong‑Macau Traditional Chinese Medicine Technology Industrial Park, the company has synchronised registration applications in both regions and pioneered the “one product, dual submission” model nationwide. TCM going global is not just about exporting products, but also about exporting technologies, standards, and culture – this is the deeper value of the Hengqin‑Macau synergy.
A Prologue Has Begun, A Bigger Story Is Unfolding
From the Miao mountains of Guizhou, to the innovation hub of Hengqin, and then to Macau as a gateway to the world – this first‑ever approval from the Macao Pharmaceutical Administration Bureau is not just a permit; it is a key that opens a replicable door for the international translation of innovative TCM drugs. As Mr. Xia Wen, head of the enterprise, put it: “We aim not only to bring TCM products to the world, but also to spread TCM technologies and culture globally.”
On the shores of the South China Sea, a bridge connecting China with the world is being quietly strengthened – on one side lies the clinical wisdom accumulated over millennia of TCM; on the other, the scientific rigour of modern drug evaluation systems. August 2026 may well prove to be the starting point of an even greater story.
