Tasly：TCM0012 approved for marketing in China.
On June 5, the NMPA official website announced that the Category 1.1 innovative traditional Chinese medicine (TCM) drug Zaoren Ningxin Dropping Pills (formerly known as Anshen Dropping Pills) has been approved for marketing, providing a new treatment option for patients with difficulty maintaining sleep (intermittent sleep) accompanied by daytime dysfunction.
Just one day earlier (June 4), CDE accepted the marketing application for Anweiwei Granules, a Category 1.1 TCM new drug submitted by Tasly for the treatment of common cold with wind-cold syndrome. The two innovative products represent breakthrough progress on two fronts.
I. Breakthrough Category 1 New Drug Approved, Filling Unmet Clinical Needs in China
Zaoren Ningxin Dropping Pills are derived from the clinical experience prescription of master of traditional Chinese medicine Zhang Boli. The formulation is a pure TCM dropping pill composed of four medicinal ingredients including stir-fried Ziziphus jujuba seed and Albizia flower. It is indicated for insomnia caused by heart-liver blood deficiency syndrome, specifically addressing intermittent sleep and difficulty maintaining sleep, while also relieving accompanying symptoms such as dizziness, dry eyes, fatigue, and daytime dysfunction. Data show that the sales of nervous system drugs (TCM) in China’s terminal hospital market exceeded RMB 10 billion in 2025.
In terms of R&D timeline, the NDA for this drug was submitted and accepted by CDE in January 2025. After more than a year, it successfully received marketing approval in June 2026. Phase III clinical data support the product’s advantages: it was significantly superior to placebo in core efficacy indicators such as insomnia severity and sleep quality improvement, while avoiding the side effects of sedative chemical drugs such as drowsiness and dizziness, thus filling the clinical medication gap in the insomnia sub-segment. The approval of Zaoren Ningxin Dropping Pills marks another major TCM innovative product added to Tasly’s portfolio.
II. Marketing Application for Category 1 New Drug Accepted, Targeting the Tens-of-Billions Respiratory Market
Additionally, on June 4, the marketing application for Anweiwei Granules, a Category 1.1 TCM new drug derived from the ancient formula Gegen Tang from Zhang Zhongjing’s Treatise on Cold Pathogenic Diseases (Shanghan Lun), was formally accepted by CDE.
Anweiwei Granules are developed based on optimization of a thousand-year-old formula, primarily indicated for relieving exterior syndrome, dispersing cold, promoting fluid production, relaxing sinews, ventilating the lung, and stopping cough. They focus on the common cold with wind-cold syndrome, comprehensively improving the full spectrum of cold symptoms including aversion to cold, body pain, nasal congestion, fever, sore throat, and fatigue. Previous clinical studies have confirmed its definite efficacy and favorable safety profile, with no significant adverse reactions.
Respiratory system TCM represents a golden track. Data show that sales of respiratory system drugs (TCM) in China’s hospital terminal market exceeded RMB 50 billion in 2025, with the market size exceeding RMB 12 billion in the first quarter of 2026 alone, indicating substantial market potential.
Tasly currently has four proprietary respiratory system TCM drugs, including Huoxiang Zhengqi Dropping Pills and Chaihu Dropping Pills, covering multiple sub-segments such as common cold, cough and asthma, and respiratory inflammation. If successfully approved, Anweiwei Granules will fill the gap in innovative drugs for wind-cold common cold and further perfect the company’s respiratory drug product matrix.
As a leading innovator in TCM in China, Tasly continues to increase investment in the R&D of Category 1.1 innovative TCM drugs, with a rich pipeline reserve. The company currently has four TCM new drugs that have been approved for marketing for the first time in China. Kunyining Granules, dedicated to menopausal syndrome, were approved in December 2021. In addition, two Category 1.1 new drugs, Jiuwei Huaban Pills and Compound Danshen Dropping Pills, have also been approved and entered the clinical stage.
III. Conclusion
Tasly’s TCM innovation is accelerating — Zaoren Ningxin Dropping Pills have been formally approved, filling the medication gap in the insomnia sub-segment; the marketing application for Anweiwei Granules has been accepted, targeting the tens-of-billions RMB respiratory system market. With breakthroughs on both fronts, the company now has four TCM new drugs approved for marketing for the first time, continuously consolidating its leading position.
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