Shenyang Pharmaceutical University to Transfer Patent for Zhi-Xiong Capsule's Novel Use in Treating Non-Alcoholic Fatty Liver Disease for RMB 5.02 Million
Recently, Shenyang Pharmaceutical University released a public notice on patent transfer and licensing, proposing to transfer the patent“Pharmaceutical Use of Zhixiong Capsules in the Treatment of Non-Alcoholic Fatty Liver Disease”Transferred to Shenyang Kuangyi Technology Co., Ltd., with a proposed transfer price ofRMB 502,000。
Image from the official website of Shenyang Pharmaceutical University
This patent is byZhai JianxiuServed as the lead technical expert. The core innovation lies in expanding the original indications of Zhixiong Capsules—previously limited to treating dizziness and headache caused by blood stasis and collateral obstruction—to uncover, for the first time, a novel pharmaceutical application of this compound traditional Chinese medicine (composed of Hirudo, Ligusticum chuanxiong, Pueraria lobata, Leonurus japonicus, and Salvia miltiorrhiza in a 1:1:1:1:1 ratio) in the preparation of drugs for non-alcoholic fatty liver disease (NAFLD), thereby providing a new traditional Chinese medicine solution for NAFLD treatment.
Non-Alcoholic Fatty Liver Disease (NAFLD)It is a clinically prevalent metabolic stress-induced liver injury disease, with steatohepatitis as its core pathological feature. Without effective intervention, the condition can progressively advance to cirrhosis and even trigger hepatic carcinogenesis and other end-stage liver diseases, posing a serious threat to patients’ liver health and life safety.
Not only is this disease not a single liver lesion, but it is also closely associated with various metabolic disorders such as hyperlipidemia, hypertension, visceral obesity, and cardiovascular diseases, forming a chain reaction of complications that significantly increases the difficulty of comprehensive clinical diagnosis and treatment. The incidence rate among the Chinese population is conservatively estimated to have reached 25%, making the clinical treatment of this disease an urgent public health issue due to the large number of affected individuals.
Among the current clinical treatment approaches for NAFLD,Pharmacological Treatmentis the core approach, primarily divided into three major categories,The first category includes drugs such as polyene phosphatidylcholine and ursodeoxycholic acid, which are used to reduce hepatic fat accumulation; the second category comprises antioxidants such as silymarin; and the third category consists of insulin-sensitizing agents such as rosiglitazone., these three classes of drugs collectively constitute the mainstream clinical treatment regimen for NAFLD and are widely used in clinical practice.
However, currently available mainstream therapeutic agents exhibit significant clinical limitations. While exerting their therapeutic effects, these drugs commonly cause adverse reactions, and long-term use may impose additional burdens on patients’ health. Furthermore, there is still no ideal pharmacological regimen that simultaneously offers safety, efficacy, and long-acting properties, making it difficult to meet the needs of long-term clinical management.
Meanwhile, in the field of proprietary Chinese medicines (PCMs), there is a complete absence of relevant research and reports on the application of compound PCMs for the treatment of non-alcoholic fatty liver disease (NAFLD). Despite their advantages of minimal side effects and holistic regulation, which make them an important direction for the management of metabolic diseases, PCMs remain unexplored in the treatment of NAFLD. Overall, there is an urgent clinical need to develop new drugs with fewer side effects that align with the holistic regulatory requirements of metabolic diseases and offer greater safety in clinical practice. It is also critical to explore new therapeutic pathways using PCMs to address the limitations of existing treatment regimens and meet the clinical diagnosis and treatment needs of the large patient population affected by NAFLD.
The core advantages and innovations of this patented technology lie in the breakthrough expansion of the medical applications of a classic multi-ingredient Chinese proprietary medicine. Its significant efficacy in the treatment of non-alcoholic fatty liver disease (NAFLD) has been rigorously validated through animal experiments. Furthermore, it aligns with the clinical demand for safe treatment regimens with minimal side effects, offering both theoretical and practical value.
First,Unlocking the Full Medicinal Value, as a compound traditional Chinese medicine (TCM) formulated with leech, Chuanxiong Rhizoma, Puerariae Lobatae Radix, Motherwort Herb, and Salviae Miltiorrhizae Radix et Rhizoma in a 1:1:1:1:1 ratio, Zhiqiong Capsules were previously indicated only for symptoms such as dizziness, headache, slurred speech, and limb numbness and pain caused by blood stasis obstructing the collaterals. This technology has, for the first time, discovered and confirmed its applicability in the treatment of non-alcoholic fatty liver disease (NAFLD), thereby filling the gap in the application of this TCM for metabolic liver diseases and providing new insights into the secondary development and expansion of indications for classic TCM formulations.
Second,Clear Therapeutic Efficacy with Multi-Dimensional Mechanisms of ActionSystematic experimental validation was conducted using a rat model of non-alcoholic fatty liver disease (NAFLD) induced by a high-fat diet. The results confirmed that Zhixiong Capsules can ameliorate the condition through multiple key targets. Specifically, the capsules significantly alleviated hepatic steatosis and reduced body weight and liver index in model rats. They also effectively regulated blood lipid levels by decreasing plasma total cholesterol, triglycerides, and low-density lipoprotein cholesterol, while increasing high-density lipoprotein cholesterol content. Furthermore, Zhixiong Capsules mitigated liver injury, as evidenced by reduced plasma levels of liver injury-related markers such as alanine aminotransferase and lactate dehydrogenase. Additionally, they lowered hepatic oxidative stress levels by enhancing the activities of superoxide dismutase and glutathione peroxidase, and reducing the contents of malondialdehyde and oxidized low-density lipoprotein, thereby achieving therapeutic effects on NAFLD through multiple pathways.
Third,Aligning with the Core Needs of Clinical Medication, compared with the common side effects of existing chemical drugs for clinical treatment of NAFLD, Zhixiong Capsules, as a traditional Chinese medicine, naturally possess the advantages of minimal side effects and holistic regulation. Their application in the treatment of NAFLD not only provides a novel therapeutic option for clinical practice but also effectively avoids the adverse effects associated with conventional chemical drugs, thereby better meeting the clinical needs for long-term management and treatment of metabolic disorders such as non-alcoholic fatty liver disease.
Fourth,The technical solution is supported by clear experimental evidence and is feasible for implementation., the patent clarifies the therapeutic efficacy at different doses through controlled experiments involving a blank control group, a model group, a positive drug group, and low- and high-dose Shuixiong Capsule groups. This provides rigorous experimental data support for subsequent clinical translation, dosage studies, and practical application, ensuring that this new medical use is not merely a theoretical concept but has a solid foundation for actual translation and clinical application.
The market for liver disease medications, which includes drugs currently used to treat non-alcoholic fatty liver disease (NAFLD), is in a phase of steady expansion, with the overall landscape demonstratingChemical Drugs Dominate the Clinical Mainstream, Growth Rate of Proprietary Chinese Medicine Market Gradually Increases, and Demand in Sub-sectors Continues to Be Releasedcore characteristics. Driven by the inelastic demand from patients with chronic liver diseases, the therapeutic segment for liver disorders has become a stable-growth niche within the pharmaceutical market. As a key subsegment, non-alcoholic fatty liver disease (NAFLD) has emerged as a major growth engine for the liver disease therapeutics market, owing to its expanding patient population, and has attracted significant attention from both the pharmaceutical industry and capital markets.
Sanofi's Polyene Phosphatidylcholine Capsules(Brand name: Essentiale) is a classic clinically used hepatotherapeutic agent. It is an Over-the-Counter (OTC) Class A drug covered under Category B of the National Medical Insurance. Its core active ingredient is natural polyene phosphatidylcholine extracted from plants. This component contains abundant unsaturated fatty acid groups and is highly similar in structure to the cell membranes of human hepatocytes, which is key to its hepatoprotective efficacy. The primary indications include adjunctive improvement of toxic liver injury caused by drugs, toxins, chemicals, and alcohol. It is also suitable for alleviating symptoms such as loss of appetite and right upper quadrant pressure in patients with fatty liver disease and hepatitis. Clinically, it is used as an adjunctive therapy for non-alcoholic fatty liver disease (NAFLD) and can be combined with other medications for the diagnosis and treatment of various liver conditions, including drug-induced liver injury and hepatitis.
Polyene Phosphatidylcholine Capsules, the world’s first phospholipid-based hepatoprotective agent approved for the treatment of fatty liver disease, alcoholic liver disease, and other conditionsSince its entry into the Chinese market, it has secured a significant position in the high-end hepatoprotective drug market by virtue of its well-defined clinical efficacy, and is currently one of the mainstream medications for adjunctive therapy of liver diseases in China. The drug enjoys broad market application scenarios; it is not only routinely used in the gastroenterology and hepatology departments of hospitals at all levels, but also highly accessible through retail pharmacy channels as an over-the-counter (OTC) medication, thereby meeting the needs of patients with chronic liver disease for home-based management.
Rosiglitazone Hydrochloride Tablets, manufactured by Zhejiang Sansheng Mandi Pharmaceutical Co., Ltd., are a classic clinical thiazolidinedione anti-diabetic chemical drug., it is a prescription drug included in Category B of the National Reimbursement Drug List. The mainstream specification is 2 mg × 14 tablets per box. The active ingredient is rosiglitazone hydrochloride. The medication is supplied as film-coated tablets, which appear white or off-white after removal of the coating. Storage requires protection from light and airtight sealing. The primary indication is type 2 diabetes mellitus, particularly for patients who fail to achieve glycemic targets with other antidiabetic agents. It can be used as monotherapy in conjunction with dietary control and exercise for glycemic management, or in combination with metformin or sulfonylureas, thereby accommodating diverse clinical needs in the diagnosis and treatment of type 2 diabetes.
Rosiglitazone Hydrochloride Tablets, as a commonly used insulin sensitizer for the clinical treatment of type 2 diabetes, hold a significant position in the diabetes diagnosis and treatment market. Yilixi, manufactured by Zhejiang Sansheng Mandi Pharmaceutical, is a mainstream domestically produced formulation in this category. Leveraging mature manufacturing processes, well-established efficacy, and competitive pricing, it has become a common choice for endocrinology departments across healthcare institutions at all levels for treating type 2 diabetes. The market application of this drug is highly focused on the clinical management of type 2 diabetes. It is routinely prescribed in general hospitals and specialized diabetes hospitals, and its use has been promoted in chronic disease management at primary healthcare institutions, supported by coverage under medical insurance policies. This meets the long-term medication needs of a broad population of patients with type 2 diabetes, particularly those exhibiting insulin resistance.
The present patent relates toZhichuan Capsules for the Treatment of Non-Alcoholic Fatty Liver Diseasefor pharmaceutical applications, leveraging its unique product attributes and well-defined clinical value, it boasts extremely broad market development prospects, with its core potential reflected inPolicies, Markets, and ProductsThree Major Dimensions.
First, sustained policy support strongly aligns with the development trends of traditional Chinese medicine.The Chinese government is vigorously promoting the revitalization of Traditional Chinese Medicine (TCM), encouraging the exploration of new indications and industrial translation of classic multi-ingredient TCM proprietary medicines. Meanwhile, guidelines on the integrated TCM and Western medicine approach for the prevention and treatment of chronic liver diseases are being continuously implemented. This has created a favorable policy environment for the inclusion of Zhixiong Capsules into clinical care pathways and their subsequent market promotion. Furthermore, its status as a TCM proprietary medicine aligns closely with the current clinical development trends in liver disease management.
Second, it precisely fills market gaps and perfectly aligns with core clinical needs.Currently, there are no proprietary Chinese medicines specifically indicated for the treatment of non-alcoholic fatty liver disease (NAFLD). This patent discloses and validates, for the first time, a novel medical use of Zhixiong Capsules in the treatment of NAFLD. As a multi-component proprietary Chinese medicine with experimentally confirmed, multi-dimensional therapeutic effects, Zhixiong Capsules feature minimal side effects and are suitable for long-term management. This product precisely addresses the core clinical need for safe pharmacotherapy in NAFLD, effectively compensating for the limitations of conventional chemical drugs regarding adverse effects and holistic regulation. Consequently, it possesses a solid market demand foundation among the vast population of NAFLD patients.
Third, the product boasts strong competitiveness and a solid foundation for commercialization.This patent has been validated through systematic animal experiments, which confirmed that Zhixiong Capsules exert therapeutic effects by targeting multiple key mechanisms, including improving hepatic steatosis, regulating blood lipid levels, alleviating liver injury, and reducing hepatic oxidative stress. The efficacy is well-defined and supported by rigorous experimental data, providing a solid technical foundation for subsequent clinical translation and the development of dosing regimens.
Meanwhile, the patent has been successfully transferred to the enterprise, effectively facilitating the translation of technological achievements from research to industry. Leveraging the assignee’s commercialization strategy, channel development, and market operational capabilities, this technology can be rapidly industrialized, thereby bridging the gap between laboratory research and clinical market application.