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Polyene phosphatidylcholine injection has entered the new version of the national basic drug catalog

On July 9, the National Health Commission, the National Administration of Traditional Chinese Medicine, and the National Disease Control Bureau announced the 2026 version of the National Essential Medicines List. Dioleoylphosphatidylcholine Injection (trade name: Sifu®) was successfully included in the list, becoming one of the five liver disease treatment drugs listed. This represents full recognition by the state of the clinical value, quality level, and safety of Dioleoylphosphatidylcholine Injection, as well as an important achievement for Haisco to bring high-quality medicines to more patients.

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Source of image: National Essential Medicine List2026 Edition)

 

The National Essential Medicine System is an important component of China's basic medical care system. It serves to meet the basic medication needs of the population, promote rational use of medicines, and advance hierarchical diagnosis and treatment. The inclusion of polyene phosphatidylcholine injection in the national essential medicine list will further enhance the accessibility and coverage of this product in medical institutions at all levels, especially at grassroots levels. It will better satisfy the standardized treatment needs of patients with liver diseases, and contribute to improving the quality of grassroots medical services and advancing the construction of a healthy China.


Polyene phosphatidylcholine injection is an important product for liver cell membrane repair injections in China. It is the exclusive first imitation drug of Haisco.Approved for market launch in 2005, it is used for the treatment of hepatitis, chronic hepatitis, liver necrosis, cirrhosis, hepatic coma (including premonitory hepatic coma), fatty liver (also seen in diabetics), bile obstruction, poisoning, preventing recurrence of gallstones, treatment before and after surgery, especially hepatobiliary surgeries, pregnancy toxics (including vomiting), psoriasis, neurodermatitis, and radiation syndrome.

LaunchFor over 20 years, the doe烯 phosphatidylcholine injection has accumulated evidence-based medical research. As of June 2026, more than 1,000 related academic papers have been published. The research areas include viral liver diseases, alcoholic liver disease, metabolic-related fatty liver disease, drug-induced liver injury, autoimmune liver disease, cirrhosis, liver failure, and liver cancer.


In recent years, research on polyene phosphatidylcholine injection has continued to deepen, and it has been completed.3 large-sample real-world studies, and 3 SCI papers published; additionally, 4 study results were presented in poster sessions at the AASLD (American Association for the Study of Liver Diseases) Annual Meeting and EASL (European Association for the Study of Liver Diseases) Annual Meeting. A recent cohort study included in the poster at the EASL Annual Meeting showed that the 1860 mg/day PPC group was more effective for DILI and had good tolerance.


Polyene phosphatidylcholine injection has been approved33 authoritative guidelines and expert consensus recommendations at home and abroad, including 10 clinical pathways and 4 interpretations of clinical pathways (therapeutic drugs). Polyene phosphatidylcholine injection was included in the national basic medical insurance catalog in 2009 and is available in over 7,000 medical institutions nationwide, benefiting nearly 100 million patients. As the national basic drug system continues to improve, polyene phosphatidylcholine injection is expected to expand its coverage in grassroots medical institutions and county-level medical markets, promoting standardized medication and allowing more patients to access high-quality medical resources.

 

Currently, Haisco has laid out its plans in key treatment areas such as anesthesia and analgesia, chronic disease metabolism, digestive liver diseases, respiratory system, autoimmunity, and tumors.26 innovative drug projects of category 1 have been established, covering pre-clinical research.ⅠPeriod,ⅡPeriod,ⅢA hierarchical research and development system for phase I clinical trials.Four innovative drugs of category 1 were approved for market release, and all are included in the national basic medical insurance catalog.


Among them, cyclopenthol, as an innovative intravenous anesthetic with independent intellectual property rights in China, this yearAt the end of May, it was approved by the U.S. Food and Drug Administration (FDA) for market release, marking a new breakthrough in the entry of domestic innovative intravenous anesthetics into the U.S. market. Global-first weekly oral hypoglycemic drug acarbose, the world's first third-generation calcium channel modulator cligabalin, and innovative drugs such as Anruikefen for adult patients with mild to moderate pain after abdominal surgery and moderate-severe pruritus related to chronic kidney disease during maintenance hemodialysis have been introduced into clinical use and included in the national basic medical insurance catalog, providing new treatment options for related diseases.

In the future, Haisco will continue to enhance its R&D innovation, production and supply capabilities, and introduce more safe, effective and accessible high-quality medicines, contributing further to the health of the people and the high-quality development of China's pharmaceutical industry.


“National Essential Medicine List”(2026 Edition)‌will be onSeptember 1, 2026‌Formal implementation begins. This is the fourth update and adjustment after the new healthcare reform was launched.‌‌

 

References

1、Guowei Pharmaceutical Policy Letter [No. 17 of 2026 - Notice on the Issuance of the National Essential Medicines List (2026 Edition) - National Essential Medicines List (2026 Edition). In the "Notes" column of the picture, a “△” indicates that the medication should be used by a physician with appropriate prescription qualifications or under the guidance of a specialist, and monitoring and evaluation should be strengthened. The antibacterial drugs in the list should be implemented in accordance with the relevant regulations on the management of clinical use of antibacterial drugs.

https://www.nhc.gov.cn/yaozs/c100098/202607/0f4f2bdcfead449f8412453373522470/files/%E5%9B%BD%E5%AE%B6%E5%9F%BA%E6%9C%AC%E8%8D%AF%E7%89%A9%E7%9B%AE%E5%BD%95%EF%BC%882026%E5%B9%B4%E7%89%88%EF%BC%89.pdf

2、Front Pharmacol. 2022 Mar 7;13:806787.

3、Kong M, Li J, Chen Y. The dosage effect of polyene phosphatidylcholine injection for treating patients with acute drug-induced liver injury: a cohort trial [EB/OL]. International Liver Congress 2026 / European Association for the Study of the Liver (EASL) Congress 2026, Barcelona, Spain, 2026. Poster SAT-071.

4. Patent application document (Authorization announcement date: November 24, 2010, Certificate number: 702172).