Development Pipeline
Gyre Therapeutics
● Rare Disease● Breakthrough Therapy
● Rare Disease● Breakthrough Therapy
F351（Hydronidone）
Indication:MASH - Advanced Liver Fibrosis
Overview
Metabolic dysfunction-associated steatohepatitis (MASH) is a disease characterized by fat accumulation in the liver against a background of metabolic abnormalities such as obesity and type 2 diabetes, leading to inflammation,
hepatocellular injury, and progression of fibrosis. If left untreated, it may advance to cirrhosis or hepatocellular carcinoma. Currently, the development of effective therapeutic drugs is underway.
F351 is a novel compound developed by Shanghai Genomics, Inc., a subsidiary of the GNI Group, and is a derivative of pirfenidone. It is a dual inhibitor of the TGF-β signaling pathway, which plays a critical role in hepatic stellate cell proliferation and organ fibrosis. Based on the results of nonclinical studies, including animal experiments, as well as clinical trials conducted to date, F351 has demonstrated efficacy in preventing or treating liver fibrosis and cirrhosis.
News
2025/5/23
Regarding the Results of the Phase 3 Clinical Trial of Liver Fibrosis Treatment Drug F351 in China
2018/12/20
米国におけるF351第1相臨床試験結果に関するお知らせ
F351（Hydronidone）
Indication："Chronic Hepatitis B Liver Fibrosis"
Overview
In Asian countries, including Japan and China, hepatitis B virus (HBV) and hepatitis C virus (HCV) infections are the primary causes of liver cirrhosis. F351, a novel compound developed by GNI Group’s subsidiary Shanghai Genomics Co., Ltd., has demonstrated effectiveness in preventing or treating liver fibrosis and cirrhosis based on non-clinical studies and clinical trials. Liver disease is considered a “national affliction” in China. Chronic viral hepatitis can lead to liver fibrosis, which, without proper intervention, may progressively worsen over time and potentially result in death.
Furthermore, we have conducted various animal experiments to confirm the effectiveness of F351 for renal fibrosis, which is similar to liver fibrosis. These experiments have shown that F351 demonstrates excellent characteristics against renal fibrosis as well, and it is expected to become a promising new drug in the future.
News
2025/5/23
Regarding the Results of the Phase 3 Clinical Trial of Liver Fibrosis Treatment Drug F352 in China
Etuary®（Pirfenidone）
Indication：Idiopathic Pulmonary Fibrosis(IPF)
Overview
Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease of unknown cause (idiopathic). It is characterized by chronic inflammation occurring in the lung interstitium, the tissue located deep within the lungs, which gradually progresses to fibrosis (hardening and thickening), leading to a decline in respiratory function. Pirfenidone is one of the two currently approved therapies for IPF in China.Learn more about Etuary®
Etuary®（Pirfenidone）
Indication：Pneumoconiosis
Overview
Pneumoconiosis remains the most common and severe occupational disease in China, with more than 450,000 surviving patients and thousands of new cases reported each year. It results from long-term inhalation of mineral dusts such as silica or coal, which triggers persistent inflammation and progressive fibrosis of the lung tissue. Over time, this excessive scar formation causes diffuse fibrosis and irreversible loss of lung function. Despite its prevalence and severity, there is currently no approved therapy in China that specifically targets the fibrotic mechanisms underlying pneumoconiosis.
Based on recent expert consensus, China’s pneumoconiosis treatment landscape represents a significant unmet medical need, underscoring the importance of developing therapies specifically designed to slow or halt the progression of fibrosis and improve long-term outcomes for affected patients.
Based on recent expert consensus, China’s pneumoconiosis treatment landscape represents a significant unmet medical need, underscoring the importance of developing therapies specifically designed to slow or halt the progression of fibrosis and improve long-term outcomes for affected patients.
News
Etuary®（Pirfenidone）
Indication：Radiation-Induced Lung Injury(RILI) With or Without Immune-Related Pneumonitis(CIP)
Overview
Radiation-induced lung injury (RILI) is a pulmonary disorder caused by thoracic radiotherapy in cancer treatment. It typically develops within several weeks to months after irradiation and is classified into early-onset radiation pneumonitis and late-onset pulmonary fibrosis.
Checkpoint inhibitor-related pneumonitis (CIP) is an autoimmune form of pneumonitis that occurs when immune checkpoint inhibitors used in cancer immunotherapy trigger the immune system to attack normal lung tissue.
Currently, there is no established standard therapy for lung injuries induced by radiotherapy or cancer immunotherapy. In particular, when both conditions occur simultaneously, it is difficult to distinguish between RILI and CIP. Despite their significant side effects, corticosteroids remain the standard treatment.
Pirfenidone acts on the underlying causes involved in the progression of lung injury by inhibiting fibrotic pathways, and therefore has the potential to become a novel therapeutic option for patients receiving radiotherapy or immunotherapy.
News
2026/4/20 2025/4/01
Notice Regarding Enrollment of the First Patient in a Clinical Trial of Pirfenidone for a New Indication in Cancer-Related Pulmonary Complications 各 位
がん関連肺合併症への適応拡大に向けたピルフェニドンの臨床試験申請承認のお知らせ
Etuary®（Pirfenidone）
Indication：Dermatomyositis Interstitial Lung disease (DM-ILD)
Overview
Interstitial lung disease (ILD) affects lung function by thickening the lung interstitium due to excessive production and accumulation of collagen, resulting in a wide variety of symptoms.
The interstitium is a lacy network of body tissue that supports the alveoli, which are like small grape-like sacs, and contains capillaries that facilitate gas exchange between blood and air. The potential causes of interstitial lung disease are inflammation, scarring, and edema.
In addition, dermatomyositis (DM) is an autoimmune disease characterized by inflammation of the skin and muscles.
The interstitial lung disease that develops in association with this condition is specifically referred to as DM-ILD.
Etuary®（Pirfenidone）
Indication：Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)
Overview
Interstitial lung disease (ILD) affects lung function by thickening the lung interstitium due to excessive production and accumulation of collagen, resulting in a wide variety of symptoms.
The interstitium is a lacy network of body tissue that supports the alveoli, which are like small grape-like sacs, and contains capillaries that facilitate gas exchange between blood and air. The potential causes of interstitial lung disease are inflammation, scarring, and edema.
Systemic sclerosis (SSc) is a rare autoimmune disease characterized by fibrosis (hardening) of the skin and internal organs, and it can also involve the lungs.
The interstitial lung disease (ILD) that develops in association with SSc is called SSc-ILD, and it is considered one of the major causes of pulmonary fibrosis.
News
Etuary®（Pirfenidone）
Indication：Diabetic Kidney Disease (DKD)
Overview
Diabetic kidney disease (DKD) is a form of chronic kidney disease (CKD) caused by diabetes.
DKD manifests clinically as specific structural and functional changes in the kidneys of diabetic patients.
Moreover, DKD is a leading cause of CKD progression to end-stage renal disease (ESRD) and is one of the representative diseases that cause renal fibrosis.
News
2016/8/17
アイスーリュイの適応症拡大による糖尿病腎症治療薬としての 中国における治験許可申請承認に関するお知らせ
F573
Indication：Acute Liver Failure (ALF) / Acute-on-Chronic Liver Failure (ACLF)
Overview
F573 is a dipeptide compound developed by the US company EpiCept (now Immune Pharmaceuticals Inc.) as a candidate inhibitor of liver cell death, with a strong and irreversible inhibitory effect on caspases, enzymes that play a central role in cell death and inflammatory responses.
China is one of the world’s largest markets for liver disease due to infection with the hepatitis B virus.
In the final stage of severe hepatitis, there is a possibility of large-scale hepatocyte death, and apart from existing antiviral drugs, the remaining option of liver transplantation is an extremely expensive last resort, making the urgent development of new drugs highly desirable.
News
2023/3/28
First Subject Enrolled for Phase II Clinical Trial of F573
2022/1/20
(Progress of Disclosed Matters) First Dosing of F573 Phase I Clinical Trial in China
F528
Indication：Chronic Obstructive Pulmonary Disease(COPD)
Overview
Chronic obstructive pulmonary disease (COPD) is a collective term for conditions such as chronic bronchitis and emphysema. It is mainly caused by smoking and is a progressive lung disease characterized by chronic decline in respiratory function.
F528 is an anti-inflammatory small-molecule drug candidate developed for the treatment of COPD. F528 is a novel compound with anti-inflammatory activity that acts by inhibiting multiple inflammatory cytokines, and it has the potential to modify the progression of COPD while demonstrating extremely low toxicity in the body.
F230
Indication：Pulmonary Arterial Hypertension (PAH)
Overview
F230, a novel endothelin A (ETA) receptor-selective antagonist, was initially developed by the Japanese pharmaceutical company Eisai Co., Ltd. In March 2020, the Group obtained exclusive rights for the manufacturing, development, and commercialization of F230 for the treatment of PAH in China from Eisai. F230 is a small molecule compound designed to selectively block the ETA receptor. By targeting this pathway, it may suppress pulmonary vascular remodeling and reduce pulmonary arterial pressure, potentially preventing the progression of PAH.
News
2020/3/23
エーザイ株式会社とのライセンス契約について
CG001419
Indication：Acute and Chronic Pain
Overview
Opioids, such as morphine, are known for their strong analgesic effects but also for their high risk of dependence. Current treatment guidelines recommend limiting the use of opioids and instead encourage the use of NSAIDs (nonsteroidal anti-inflammatory drugs), although these alternatives are often insufficient for adequate pain control.
In the past 20 years, only one non-NSAID, non-opioid drug has been approved by the U.S. FDA for acute pain treatment.
Cullgen is also expanding the use of CG001419 to the pain management field and initiated a Phase 1 trial in 2025 targeting acute and chronic postoperative pain with a non-opioid approach.
CG001419 possesses a novel mechanism of action and high selectivity, distinct from TRK inhibitors and anti-NGF antibodies. It may overcome the challenges related to side effects and limited efficacy that have been seen in pain treatments involving TRK inhibitors.
News
2025/1/23
主要子会社Cullgenが開発する急性及び慢性疼痛を対象とした TRK分解剤CG001419の第1相臨床試験（被験者投薬）開始についてのお知らせ
CG001419
Indication：Solid Tumors
Overview
Although recent advancements in treatments such as molecular targeted therapies have been made for solid tumors, many cases still face challenges such as specific protein abnormalities and drug resistance. As a result, there is a strong need for the development of therapies with novel mechanisms of action and greater selectivity.
Cullgen's drug discovery technology utilizes targeted protein degraders to suppress cancer cell proliferation signals and achieve antitumor effects. This degradation-based approach is gaining attention because, unlike conventional inhibitors, it directly degrades target proteins, potentially overcoming drug resistance and long-term side effects.
Cullgen is currently conducting a Phase 1 clinical trial in solid tumors using its orally administered TRK (tropomyosin receptor kinase) inhibitor candidate, CG001419, and is aiming to expand its application to a broader range of cancer types and conditions.
News
2023/7/31
（開示情報の経過）連結子会社Cullgenの中国におけるTRK分解剤CG001419の第I/II相臨床試験（被験者投薬）開始についてのお知らせ
CG009301
Indication：Leukemia and MYC+ cancers
Overview
Cullgen is developing a novel drug candidate, CG009301, which selectively degrades the protein GSPT1 for the treatment of high-risk hematologic malignancies, including acute myeloid leukemia (AML).
GSPT1 plays a critical role in supporting protein translation in rapidly proliferating leukemia cells, and its degradation is expected to induce cancer cell death.
Among hematologic cancers, AML is one of the most common subtypes of leukemia in adults, characterized by the abnormal proliferation of immature myeloid cells and impaired differentiation into normal blood cells.
A Phase I clinical trial of CG009301 was initiated in China in April 2025.