GNI Group Development Pipeline
● Rare Disease● Breakthrough Therapy
| Program |
Modality |
Indication |
Development Stage
Preclinical〉 1〉 2〉 3〉 NDA〉 Marketed |
Region |
Detail |
Hydronidone
F351 |
Small
Molecule |
Liver fibrosis associated
with chronic hepatitis B● |
|
China |
|
Hydronidone
F351 |
Small
Molecule |
MASH - Advanced
Liver Fibrosis |
|
U.S. |
|
DAC
TPD Antibody
Conjugate |
DAC |
Drug discovery platform
for cancer and
inflammatory diseases |
|
China |
|
CDK2 / Cyclin E
Degrader
CG923308 |
TPD |
CDK4/6 inhibitor-resistant
breast cancer and
other solid tumors |
|
Global |
|
TYK2 / JAK1
Degrader
CG620953 |
TPD |
Systemic lupus
erythematosus (SLE),
rheumatoid arthritis (RA) |
|
Global |
|
GSPT1
Degrader
CG009301 |
TPD |
Relapsed/refractory AML,
HR-MDS,
relapsed/refractory ALL,
and solid tumors |
|
China |
|
TRK
Degrader
CG001419 |
TPD |
Cancer-induced
bone pain (CIBP) |
|
Global |
|
TRK
Degrader
CG001419 |
TPD |
Solid Tumors |
|
China |
|
Acetaminophen
Calonal® |
Small
Molecule |
Pain and fever |
|
Japan |
|
| Etanercept BS |
Biosimilar |
Rheumatoid arthritis
and other indications |
|
Japan |
|
| Adalimumab BS |
Biosimilar |
Rheumatoid arthritis,
inflammatory bowel
disease and
other indications |
|
Japan |
|
| Ostabalo® |
Peptide |
Orthopedic disorders |
|
Japan |
|
Pirfenidone
Etuary® |
Small
Molecule |
Idiopathic pulmonary
fibrosis (IPF)● |
|
China |
|
| Pirfenidone |
Small
Molecule |
Dermatomyositis-associated
interstitial lung disease
(DM-ILD)● |
|
China |
|
| Pirfenidone |
Small
Molecule |
Systemic sclerosis-associated
interstitial lung disease
(SSc-ILD)● |
|
China |
|
| Pirfenidone |
Small
Molecule |
Pneumoconiosis |
|
China |
|
| Pirfenidone |
Small
Molecule |
Diabetic kidney
disease (DKD) |
|
China |
|
| Pirfenidone |
Small
Molecule |
Radiation-induced lung injury,
with or without immune
checkpoint inhibitor-related
pneumonitis |
|
China |
|
| F230 |
Small
Molecule |
Pulmonary arterial
hypertension (PAH)● |
|
China |
|
| F528 |
Small
Molecule |
Chronic obstructive
pulmonary disease
(COPD) |
|
China |
|
| F573 |
Small
Molecule |
Acute liver failure (ALF) /
acute-on-chronic liver
failure (ACLF)● |
|
China |
|
● Rare Disease● Breakthrough Therapy
*The development details and schedule may change depending on future progress and other factors.
In addition, the product pipeline shown in the table presents selected major products and does not cover all products.
F351（Hydronidone）
Indication：MASH - Advanced Liver Fibrosis
Overview
MASH (metabolic dysfunction-associated steatohepatitis) is a disease characterized by fat accumulation in the liver, accompanied by inflammation, hepatocellular injury and progressive fibrosis, against a background of metabolic disorders such as obesity and type 2 diabetes. If left untreated, MASH may progress to liver cirrhosis or liver cancer, and the development of effective therapies is currently underway.
F351 is a novel investigational compound developed by Shanghai Genomics, a subsidiary of GNI Group, and is a derivative of Etuary®. It inhibits hepatic stellate cell proliferation and the TGF-β signaling pathway, both of which play important roles in organ fibrosis. Nonclinical studies, including animal studies, and clinical studies conducted to date have demonstrated its potential to prevent or treat 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：Liver fibrosis associated with chronic hepatitis B
Overview
In Japan, China and other Asian countries, infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) is a major cause of liver cirrhosis. F351 is a novel investigational compound developed by Shanghai Genomics, a subsidiary of GNI Group, and is a derivative of Etuary®. It inhibits hepatic stellate cell proliferation and the TGF-β signaling pathway, both of which play important roles in organ fibrosis. Nonclinical studies, including animal studies, as well as clinical studies conducted to date have demonstrated its potential to prevent or treat liver fibrosis and cirrhosis.
In China, liver disease is a major public health issue. Persistent viral hepatitis can lead to liver fibrosis, which may progressively worsen over time and, without appropriate intervention, can ultimately be fatal.
In addition, various animal studies have been conducted to evaluate the efficacy of F351 in renal fibrosis, a condition similar to liver fibrosis. F351 has also demonstrated favorable characteristics in renal fibrosis, supporting its potential as a promising new therapeutic candidate.
News
2026/5/13
Announcement of Acceptance of New Drug Application (NDA) for F351 for the Treatment of Chronic Hepatitis B-induced Liver Fibrosis in China
2026/3/18
Announcement of Priority Review Designation by China’s NMPA for F351, a Treatment for Chronic Hepatitis B–Induced Liver Fibrosis
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 is a chronic lung disease that causes inflammation and scarring (fibrosis) of the lungs as a result of inhaled dust and fine particles accumulating in lung tissue. China has approximately 433,000 diagnosed patients, with an additional estimated population of up to 600,000 patients who have not been properly diagnosed. The economic burden of the disease in China is estimated at approximately RMB 8 billion annually. There remains a significant unmet medical need for the disease both in China and worldwide.
News
2025/10/16
Notice of Completion of Subject Enrollment in the Phase 3 Clinical Trial of Pirfenidone Capsule for the Treatment of Pneumoconiosis
Etuary®（Pirfenidone）
Indication：Radiation-induced lung injury, with or without immune checkpoint inhibitor-related pneumonitis
Overview
Radiation-Induced Lung Injury (RILI)
Radiation therapy is a cornerstone of lung cancer treatment; however, approximately 5–25% of patients develop lung injury*1, which may limit the ability to increase therapeutic radiation doses and thereby restrict treatment efficacy.
Immune Checkpoint Inhibitor-Related Pneumonitis (CIP)
Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment; however, approximately 13–19% of patients develop CIP. CIP accounts for approximately 35% of deaths resulting from immune-related adverse events (irAEs) and frequently leads to treatment discontinuation.*2
Reference 1: Radiation-Induced Lung Injury
Reference 2: Immune checkpoint inhibitor therapy-related pneumonitis: How, when and why to diagnose and manage (Review)
News
2026/4/20
Notice Regarding Enrollment of the First Patient in a Clinical Trial of Pirfenidone for a New Indication in Cancer-Related Pulmonary Complications 各 位
2025/4/01
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-associated 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
2018/6/16
中国におけるアイスーリュイのCTD-ILD（強皮症）を適応症とした第3相臨床試験開始のお知らせ
Etuary®（Pirfenidone）
Indication：Diabetic kidney disease (DKD)
Overview
Diabetic kidney disease (DKD) is a form of chronic kidney disease (CKD) caused by diabetes.
DKD clinically manifests as specific structural and functional changes in the kidneys of patients with diabetes.
It is also a major driver of the progression of CKD to end-stage renal disease (ESRD) and is one of the major diseases associated with renal fibrosis.
As one of the serious complications of diabetes, DKD in China is characterized by a high prevalence as well as low levels of awareness, treatment and disease control.
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 originally developed by U.S.-based EpiCept Corporation (now Immune Pharmaceuticals Inc.) as an inhibitor of hepatocyte cell death. It is a potent and irreversible inhibitor of caspases, enzymes that play a central role in cell death and inflammatory responses.
China represents one of the world's largest markets for liver disease, largely due to hepatitis B virus infection. At the terminal stage of severe hepatitis, extensive hepatocyte death may occur. Apart from existing antiviral therapies, liver transplantation is an extremely costly last-resort treatment option, highlighting the urgent need for the development of new therapies.
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
F528 is an anti-inflammatory small-molecule drug candidate being developed for the treatment of chronic obstructive pulmonary disease (COPD). F528 is a novel anti-inflammatory agent that acts by inhibiting multiple inflammatory cytokines and may modify the progression of COPD while exhibiting extremely low toxicity in vivo.
F230
Indication：Pulmonary arterial hypertension (PAH)
Overview
F230, a selective endothelin A receptor antagonist, is an innovative drug candidate initially researched by Eisai Co., Ltd. In March 2020, GNI Group licensed from Eisai the rights to manufacture, develop and commercialize F230 in China for the treatment of pulmonary arterial hypertension (PAH). F230 is a small-molecule compound designed to selectively block the endothelin A receptor. By targeting this pathway, F230 may suppress pulmonary vascular remodeling and increases in pulmonary arterial pressure, potentially slowing the progression of PAH.
News
2025/6/11
Announcement of First Dosing in Phase 1 Clinical Trial of F230 for Pulmonary Arterial Hypertension (PAH) by Gyre Therapeutics
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
2025/12/15
Completion of Phase 1 Clinical Trial and Positive Results of CG001419, a Novel Non-Opioid Pain Product Candidate Developed by Key Subsidiary Cullgen
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：Relapsed/refractory AML, HR-MDS, relapsed/refractory ALL, and solid tumors
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.
News
2024/10/9
（開示情報の経過）主要子会社Cullgenが開発するCG009301 IND承認に関するお知らせ
CG923308
Indication：CDK4/6 inhibitor-resistant breast cancer and other solid tumors
Overview
The cell cycle is the fundamental process governing cellular growth, DNA replication, and division; its dysregulation is a hallmark of major human pathologies, most notably cancer.
The cell cycle process is tightly regulated by cyclin-dependent kinases (CDKs), a family of enzymes that remain catalytically inactive until bound to specific regulatory cyclins. In particular, the cyclin E-CDK2 complex serves as the critical G1/S switch, acting as a molecular gatekeeper to ensure DNA synthesis begins only when the cell is fully prepared for division. Elevated cyclin E—driven by gene amplification or protein overexpression—locks this switch in a constitutive “on” state, driving uncontrolled proliferation. This aberration is prevalent in several aggressive malignancies, including ovarian, endometrial, gastroesophageal, breast, and lung cancers, and serves as a primary mechanism of resistance to CDK4/6 inhibitors in HR+ HER2- breast cancer.
Developing specific, effective therapeutics targeting cyclin E-CDK2 addresses a profound unmet medical need and offers a paradigm-shifting opportunity for both clinical practice and the commercial market. To this end, Gyre is developing CG923308, a highly potent and selective dual degrader of CDK2 and cyclin E. In preclinical models characterized by cyclin E amplification or CDK4/6 inhibitor resistance, CG923308 demonstrated precise target degradation and outperformed leading late-stage clinical CDK2 inhibitors in blocking cell proliferation and achieving durable tumor suppression. Furthermore, CG923308 exhibits a favorable pharmacokinetic (PK) and safety profile.
CG620953
Indication：Systemic lupus erythematosus (SLE), rheumatoid arthritis (RA)
Overview
Autoimmune diseases, including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and inflammatory bowel disease (IBD), arise from systemic immune dysregulation that leads to chronic inflammation. This persistent inflammatory state triggers a maladaptive wound-healing response characterized by the excessive deposition of extracellular matrix components, leading to fibrosis and the progressive loss of organ function. Despite a rapidly evolving therapeutic landscape, a significant number of patients continue to experience inadequate disease control or treatment-limiting toxicities, highlighting a critical unmet medical need for therapies that target both inflammatory and fibrotic pathways.
Central to the pathogenesis of autoimmune diseases are the dysregulation of cytokine signaling pathways, particularly those mediated by the Janus kinase (JAK) family. JAK1 and TYK2 (Tyrosine Kinase 2) are two JAK family members that serve as critical intracellular transducers for various pro-inflammatory cytokine receptors. In many autoimmune disorders, aberrant JAK1 and TYK2 signaling drives a self-sustaining inflammatory feedback loop. While JAK1 is a primary mediator of the broad inflammatory cascades characteristic of rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), TYK2 is more specifically implicated in the Type I interferon signatures and interleukin pathways that define lupus and psoriasis. Consequently, the selective targeting of these two kinases has emerged as a compelling therapeutic strategy for suppressing pathologic signaling while minimizing systemic side effects, with the potential to improve therapeutic outcomes in autoimmune diseases.
Gyre is developing CG620953, a highly potent and selective dual degrader of TYK2 and JAK1. In preclinical studies, CG920953 demonstrated selective target degradation and outperformed commercialized TYK2 and JAK1 selective inhibitors in reducing disease activity. CG620953 also exhibits a favorable pharmacokinetic (PK) and safety profile, providing rationale for further evaluation in the clinic.
Calonal®（Acetaminophen）
Indication：Pain and fever
Overview
CALONAL® is an antipyretic analgesic containing acetaminophen as its active ingredient. It is widely used for the relief of pain associated with various diseases and conditions, as well as for the reduction of fever and pain associated with acute upper respiratory tract infections and in pediatric patients.
Acetaminophen is believed to exert its analgesic effect by acting on the central nervous system to reduce sensitivity to pain, while its antipyretic effect is thought to result from its action on the thermoregulatory center, promoting heat dissipation. CALONAL® is used across a broad range of patients, from children to adults, and is one of the leading acetaminophen products supporting pain management and antipyretic treatment in clinical practice in Japan.
Etanercept BS
Indication：Rheumatoid arthritis and other indications
Overview
Etanercept BS is a biosimilar of etanercept used for the treatment of rheumatoid arthritis and other inflammatory diseases. Etanercept exerts anti-inflammatory and anti-rheumatic effects by acting as a soluble TNF receptor that binds to TNFα and other TNF molecules involved in inflammatory responses, thereby preventing them from binding to TNF receptors on cell surfaces. In Japan, it is indicated for rheumatoid arthritis, including the prevention of structural joint damage, in patients who have had an inadequate response to conventional therapies, as well as for polyarticular juvenile idiopathic arthritis with active disease. The product is manufactured and marketed by Mochida Pharmaceutical Co., Ltd. and distributed by AYUMI Pharmaceutical Corporation.
Biosimilars are biological products that have been demonstrated to have comparable quality, safety, and efficacy to their reference biologic products. They are expected to contribute to expanding treatment options for patients and reducing healthcare costs.
Adalimumab BS
Indication：Rheumatoid arthritis, inflammatory bowel disease and other indications
Overview
Adalimumab BS is a biosimilar of adalimumab, a fully human monoclonal antibody targeting human TNFα. Adalimumab specifically binds to TNF, an inflammatory cytokine, and neutralizes its biological activity by inhibiting the interaction between TNF and TNF receptors on cell surfaces, thereby suppressing inflammatory responses. In Japan, it is used to treat a broad range of autoimmune and inflammatory diseases, including rheumatoid arthritis, psoriatic diseases, ankylosing spondylitis, juvenile idiopathic arthritis, intestinal Behçet’s disease, Crohn’s disease, ulcerative colitis, and non-infectious uveitis.
Ostabalo®
Indication：Orthopedic disorders
Overview
OSTABALO® is a bone-forming osteoporosis treatment containing abaloparatide as its active ingredient and is indicated for osteoporosis in patients at high risk of fracture. Abaloparatide is a synthetic peptide analog based on a portion of human parathyroid hormone-related protein (PTHrP) and selectively acts on the parathyroid hormone type 1 receptor (PTH1 receptor) expressed on osteoblasts. Once-daily subcutaneous administration increases osteoblast activity and promotes bone formation, thereby increasing bone mass.
