Cover Story: Chinese Medicine Injections Face Rigorous Regulation for the First Time
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The deaths first surfaced in a scattering of headlines: a toddler in Heilongjiang, a patient in Anhui, clusters of severe allergic reactions in hospitals across China. Each case shared one unsettling detail — the drug involved was a traditional Chinese medicine injection, a class of products used for decades, trusted by millions and supported by enormous sales.
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- Traditional Chinese medicine (TCM) injections, widely used and profitable in China, have caused repeated adverse events and deaths, while operating under lax regulatory standards.
- In 2025, China introduced strict new regulations mandating safety and efficacy reassessment for all pre-2019 TCM injections, likely forcing up to two-thirds of products off the market.
- Compliance costs are high, industry consolidation is expected, and experts say only evidence-backed products will survive the transition to stricter, evidence-based drug evaluation.
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Who’s Who
- Wuhan Wuyao Pharmaceutical Co. Ltd.
- Wuhan Wuyao Pharmaceutical Co. Ltd. mass-produced the first bupleurum injection, which emerged during World War II when battlefield infections were rampant. This company was instrumental in bringing this traditional Chinese medicine injection into widespread production by the 1950s.
- Beijing Duheng Zhidao Medical Technology Co. Ltd.
- Beijing Duheng Zhidao Medical Technology Co. Ltd. is a contract research organization specializing in traditional Chinese medicine (TCM) products. Its chief executive, Qiao Chunsheng, notes that several companies with best-selling TCM injections have approached them for research partnerships, anticipating that their expertise will be crucial under new, stricter regulations.
- Beijing Sunshine Hohe Drug Research Co. Ltd.
- Beijing Sunshine Hohe Drug Research Co. Ltd. currently has a high demand for its contract research services. Chen Jie, their deputy head of the TCM division, noted that inquiries are from companies with products in the national insurance catalog, typically generating over 50 million yuan ($7.05 million) annually. He believes these companies have the financial resources to invest in necessary research.
- Guangxi Wuzhou Pharmaceutical (Group) Co. Ltd.
- Guangxi Wuzhou Pharmaceutical (Group) Co. Ltd. is a major producer of Traditional Chinese Medicine (TCM) injections. Between 2017 and 2023, the company generated over 10 billion yuan in cumulative sales from these products.
- Harbin Zhenbao Pharmaceutical Co. Ltd.
- Harbin Zhenbao Pharmaceutical Co. Ltd. is a major producer of TCM injections, generating over 10 billion yuan in cumulative sales between 2017 and 2023. This places them among the top companies in the Chinese TCM injection market.
- KPC Pharmaceutical Inc.
- **KPC Pharmaceutical Inc.** was a major producer of Traditional Chinese Medicine (TCM) injections, generating over 10 billion yuan in cumulative sales between 2017 and 2023. These injections, which are herbal extracts delivered intravenously, are currently undergoing increased regulatory scrutiny in China.
- China Shineway Pharmaceutical Group Ltd.
- China Shineway Pharmaceutical Group Ltd. generated 33.6% of its revenue from TCM injections. Its core products, Qingkailing and Guanxinning injections, experienced significant sales declines of 40.8% and 52.7% respectively. This contributed to a 13.4% drop in the company's net profit.
- Kanion Group Co. Ltd.
- Kanion Group Co. Ltd. is a manufacturer of Traditional Chinese Medicine (TCM) injections, including Reduning and Ginkgo injections. The company reported a nearly 20% decline in both revenue and net profit.
- Dali Pharmaceutical Co. Ltd.
- Dali Pharmaceutical Co. Ltd. was delisted in February 2025 due to its market capitalization falling below 500 million yuan. The company produced Xingnaojing and Shenmai injections, which are Traditional Chinese Medicine (TCM) injections.
- Kunming Longjin Pharmaceutical Co. Ltd.
- Kunming Longjin Pharmaceutical Co. Ltd. was warned in April that it might face delisting. This is due to shrinking coverage of its Dengzhanhua injections in lower-tier hospitals, indicating the company's struggles within the changing TCM injection market.
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What Happened When
- World War II (1939-1945)：
- The first TCM injection, bupleurum, emerged during the Second World War to treat battlefield infections.
- By the 1950s：
- Wuhan Wuyao Pharmaceutical Co. Ltd. began mass production of TCM injections.
- By the 1990s：
- Multiple types of TCM injections became routine in Chinese hospitals and widely prescribed.
- 2004：
- A TCM injection caused 18 cases of acute intravascular hemolysis.
- 2006：
- More than 10 people died from an allergic reaction to a Houttuynia injection.
- Between 2006 and 2009：
- Several injections, including Houttuynia, Yinzhihuang, and Shuanghuanglian, were linked to severe adverse events and deaths, leading to emergency suspensions and public outcry.
- 2009：
- The former drug regulator launched its first safety reassessment campaign for TCM injections.
- 2010：
- Technical guidance for safety reassessment was issued, and select products were prioritized for review.
- 2015：
- China’s modern drug review system was established; data verification led to withdrawal of over 70% of TCM-related drug registration applications.
- 2016：
- Hospital sales of NRDL and essential-medicine-listed TCM injections peaked at 21.2 billion yuan.
- 2017：
- Regulators revived the initiative to reassess all TCM injections as part of broader drug approval reforms.
- Between 2017 and 2023：
- Three major TCM injection products surpassed 20 billion yuan in cumulative hospital sales.
- 2022：
- Hospital sales of NRDL and essential-medicine-listed TCM injections hit a low of 8.6 billion yuan.
- 2022-12-12：
- Photo taken of a TCM injection production facility in Shanghai.
- 2023：
- A modest rebound in TCM injection hospital sales to 10.5 billion yuan attributed to looser reimbursement policies.
- 2023：
- A regulation was released to clarify differentiated evaluation pathways for TCM drugs.
- Late 2023：
- China’s NMPA formed a 28-member expert group led by Zhang Boli to address reforms in TCM injection regulation.
- December 2023：
- Patients received TCM injection in a hospital in Heilongjiang (photographed).
- As of 2024：
- 58 injection products are listed in the National Reimbursement Drug List (NRDL).
- 2024：
- A national procurement alliance included eight TCM injections in a 30 billion yuan collective tender.
- 2024：
- National volume-based procurement for TCM injections entered its third round, reducing prices by an average of 68% for certain products.
- 2024：
- Several provincial governments began to cap daily treatment costs for some TCM injections at approximately 5 yuan.
- 2024：
- TCM injections accounted for 33.6% of China Shineway Pharmaceutical Group Ltd.’s revenue, but sales of its core products (Qingkailing and Guanxinning injections) fell by 40.8% and 52.7% respectively, and net profit dropped 13.4%.
- February 2025：
- Dali Pharmaceutical Co. Ltd. was delisted after its market cap fell below 500 million yuan.
- April 2025：
- Kunming Longjin Pharmaceutical Co. Ltd. issued a delisting risk alert owing to tightening restrictions.
- September 19, 2025：
- NMPA, NHC, and NATCM jointly released the draft policy 'Notice on Promoting Post-Market Evaluation of TCM Injections.'
- October 17, 2025：
- NMPA’s Center for Drug Evaluation published the 'Basic Technical Requirements for Post-Market Research and Evaluation of TCM Injections.'
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