Since our inception in 2014, we have built a pipeline of drug candidates targeting diabetes and other metabolic diseases. Our pipeline currently comprises our Core Product, Efsubaglutide Alfa, which is being developed for the treatment of obesity and being overweight, and metabolic dysfunction-associated steatohepatitis (MASH), as well as five candidates in the pre-clinical stage. We successfully obtained regulatory approval in January 2025 for Efsubaglutide Alfa for the treatment of type 2 diabetes (T2D) in China.
WE MAY NOT BE ABLE TO SUCCESSFULLY DEVELOP AND/OR MARKET OUR CORE PRODUCT FOR ADDITIONAL INDICATIONS.
Our Business Model
Our core business model is to discover, develop and commercialize innovative therapies for diabetes and other metabolic diseases. As of the Latest Practicable Date, all of our drug and drug candidates have been in-house developed by us. To complement our internal efforts, we may also collaborate with third parties on the clinical development and commercialization of our drug candidates.
Our Core Product — Efsubaglutide Alfa
Our Core Product, Efsubaglutide Alfa, is a humanized and long-acting GLP-1 receptor agonist approved in China. Our Core Product is competing against other similar GLP-1 receptor agonist approved drugs and pipeline candidates in the market, and we were approved to commercialise our Core Product in China for T2D only and are conducting Phase IIb/III clinical trial of our Core Product for obesity and being overweight. We have obtained IND approvals from the FDA and the NMPA for our Core Product for the treatment of MASH but have not yet commenced clinical trial for this indication. Our Core Product is a GLP-1 receptor agonist generated by our Recombinant Fusion Protein Platform. GLP-1-based therapy has demonstrated its comprehensive clinical benefits. In addition to its effective, glucose- dependent control of blood sugar levels, GLP-1-based therapy supports weight management and provides significant beneficial effects for the cardiovascular system, liver, kidneys, and central nervous system. The diagram below shows the mechanisms of GLP-1-based therapy acting on various organ systems in the human body.
Type 2 Diabetes
Efsubaglutide Alfa is designed for the treatment of T2D and other metabolic diseases. Efsubaglutide Alfa’s clinical studies have demonstrated its fast action, strong and sustained efficacy, long half-life, and favorable safety profile.
‧ Efsubaglutide Alfa showed fast action, strong and sustained efficacy. With first four-week treatment, patients with T2D experienced a 1.1% reduction in hemoglobin A1c (HbA1c) levels with Efsubaglutide Alfa monotherapy (3.0 mg) in a Phase III clinical trial. Efsubaglutide Alfa also demonstrated outstanding glucose-lowering effects. In a randomized double-blind placebo control Phase III clinical trial, Efsubaglutide Alfa monotherapy with 1.0 mg and 3.0 mg dosing resulted in a statistically and clinically significant reduction in HbA1c of 1.7% and 2.2%, respectively, from their baselines at week 24.
‧ Efsubaglutide Alfa exhibited a long average half-life of 204 hours. The extended long-acting effect of Efsubaglutide Alfa enables low drug administration frequency in long-term disease management.
‧ Efsubaglutide Alfa has favorable safety profile. No cases of drug related level 2 or higher hypoglycemia were observed in Efsubaglutide Alfa’s clinical trials.
Efsubaglutide Alfa is a humanized and long-acting GLP-1 receptor agonist approved in China. Our BLAs for Efsubaglutide Alfa for the treatment of T2D both as a monotherapy and in combination with metformin were accepted by the NMPA in September 2023. Both therapies were approved in January 2025. We commercially launched Efsubaglutide Alfa for the treatment of T2D in China in February 2025.
In addition, we are actively pursuing the global expansion of Efsubaglutide Alfa. Based on the clinical trial results of Efsubaglutide Alfa in China, we received BLA approval of Efsubaglutide Alfa for T2D in Macau in June 2025. In the same month, we submitted BLA application in Southeast Asian country and plan to submit another BLA application in Latin American country in the second half of 2025. Upon the approval of these initial applications, we plan to continue to pursue additional BLA approvals across other jurisdictions in Southeast Asia and Latin America to satisfy the unmet medical demand in these regions. The regulatory authorities in these global jurisdictions will review the clinical trial data of Efsubaglutide Alfa in China and determine whether additional clinical trials are required in their respective jurisdictions before granting approval.
Diabetes associated complications are the leading cause of death. According to Frost & Sullivan, diabetes prevalence reached 589.0 million globally and 148.0 million in China in 2024. Driven by the growing patient prevalence, increasing healthcare awareness, enhanced patient accessibility to medications and the continuous innovation in anti-diabetic medications, the global diabetes drug market is expected to increase from US$99.3 billion in 2024 to US$139.4 billion in 2034, while the China diabetes drug market is expected to increase from RMB71.2 billion in 2024 to RMB146.4 billion in 2034, according to the same source.
Nevertheless, various prevention methods, such as lifestyle interventions, are adopted to reduce the risk or progression of T2D. In addition, there are innovative treatment options, including oral formulations of GLP-1RAs that are approved and currently under development in China, that may offer alternative approaches to patients. The availability and advancement of these preventive measures and treatment options may potentially limit the market potential and commercial prospects of our Core Product Efsubaglutide Alfa which is a GLP-1RA injection.
Obesity and being overweight
We have been developing Efsubaglutide Alfa for the treatment of obesity and being overweight. Efsubaglutide Alfa showed dual effects on glycemic and body weight control. Efsubaglutide Alfa also led to significant improvements in cardiometabolic risk markers compared to placebo. This included greater reductions in waist circumference, Body Mass Index (BMI) and enhancements in various lipid parameters.
We initiated a Phase IIa clinical trial of Efsubaglutide Alfa for the treatment of obesity and being overweight in China in March 2024, and completed this trial in November 2024. We initiated a Phase IIb/III clinical trial of Efsubaglutide Alfa for the treatment of obesity and being overweight in China in March 2025 and expect to complete this trial in the fourth quarter of 2026.
Obesity and being overweight are major contributors to chronic diseases such as diabetes and cardiovascular diseases. Beyond their physical health implications, they also lead to significant social and psychological challenges. According to Frost & Sullivan, the prevalence of obesity or being overweight in 2024 reached 3,575.0 million and 639.4 million globally and in China, respectively. The obesity or being overweight drug market in China is currently in its early stage, reaching only RMB4.2 billion in 2024, compared to US$16.9 billion globally for the same year. Both global and China obesity or being overweight drug markets are expected to grow rapidly at a CAGR of 21.5% and 30.6%, respectively, from 2024 to 2028, highlighting a substantial market potential.
GLP-1-based therapy has demonstrated multiple therapeutic benefits, including lowering blood glucose levels, promoting weight loss, reducing food intake, regulating lipid metabolism, and decreasing fat accumulation. Therefore, GLP-1-based therapy has substantial potential to address weight management and improve metabolic health. According to Frost & Sullivan, the global GLP-1 obesity or being overweight drug market is expected to increase from US$14.7 billion in 2024 to US$33.8 billion in 2028, representing a CAGR of 23.2%, while the GLP-1 obesity or being overweight drug market in China is expected to increase from RMB0.4 billion in 2024 to RMB9.5 billion in 2028, representing a CAGR of 123.3%.
MASH
We have been developing Efsubaglutide Alfa in treating MASH. MASH is a life- threatening disease. It could lead to liver scarring, cirrhosis or even liver cancer. Approximately 4.9% and 3.1% population suffered from MASH globally and in China in 2024, respectively.
Efsubaglutide Alfa’s potential efficacy for the treatment of MASH has been demonstrated in pre-clinical studies. In an in vivo study on MASH-afflicted rhesus monkeys, 12 weeks of subcutaneous administration of Efsubaglutide Alfa resulted in a 40% reduction in liver fat content, a statistically significant decrease in Metabolic Dysfunction-Associated Fatty Liver Disease Activity (MAS) scores and an evident improvement in liver fibrosis without serious adverse effects. We obtained IND approval from the FDA in March 2023 to conduct a Phase IIa clinical trial of Efsubaglutide Alfa for the treatment of MASH. We also obtained IND approval from the NMPA for Efsubaglutide Alfa for the treatment of MASH in March 2025. We plan to initiate a multi-center Phase IIa clinical trial for MASH in the U.S. and China in 2026.
Our Other Pipeline Products
In addition to Efsubaglutide Alfa, we have been developing pre-clinical stage and IND-enabling drug candidates for the treatment of AD and metabolic diseases including obesity, being overweight, MASH, type 1 diabetes (T1D) and T2D. These drug candidates leverage advanced scientific research and technology, aiming to provide innovative, effective solutions for these diseases that currently lack effective therapies.
YN014 for Alzheimer’s disease (AD)
YN014 is a drug candidate for the treatment of AD. This drug candidate utilizes an innovative therapeutic regimen rationalized by the protection of neuron cells while reducing the production and release of beta-amyloid (A), phosphorylated tau protein, proteins that are relevant to the onset of AD, while suppressing the activity of microglial cells causing inflammation in the brain. We have completed all pre-clinical studies for YN014 and are currently preparing for the IND submission. We plan to submit an IND application to the FDA for YN014 in the first half of 2026.
AD is the leading cause of dementia globally. According to Frost & Sullivan, the prevalence of AD in China has grown from 11.3 million in 2018 to 14.5 million in 2024 at a CAGR of 4.3% and is expected to reach 16.8 million by 2028 and 20.8 million by 2034. The economic burden of AD is growing substantially, covering not only the costs of symptomatic treatments but also substantial expenses for adjunctive medications, management of complications, and specialized care. Current treatments for AD mainly aim at relieving symptoms, with only a few having the ability to slow disease progression, underscoring significant unmet clinical needs.
YN401 for Type 1 Diabetes
T1D is an autoimmune disease caused by T cell-mediated autoimmune destruction of the islet cells, resulting in a significant loss of the cell mass. YN401 is an innovative drug candidate targeting cell-specific target with dual mechanisms of cell protection, proliferation promotion, and autoimmunity suppression for the treatment of T1D. YN401 is currently in the IND-enabling stage, and we plan to submit an IND application for it in 2025 or 2026.
YN209 for MASH
We have also been developing YN209 for the treatment of MASH. YN209 is a drug candidate targeting liver-specific pathway for the treatment of MASH. Based on pre-clinical studies including in vitro studies, we identified a specific myokine, a type of cytokines secreted by the human body that targets fatty liver. By optimizing the structure of this natural hormone, we developed YN209, a candidate for treating MASH. YN209 specifically targets liver cells to exert hepatic actions by suppressing free fatty acid production (lipogenesis), enhancing fat breakdown (lipolysis) and boosting free fatty acid beta oxidation to improve mitochondrial function with the autophagy process, which helps clear damaged cells. YN209 is currently in the IND-enabling stage, and we plan to submit an IND application for it in 2026.
YN203 for Type 2 Diabetes
YN203 is a recombinant fusion protein targeting glucagon receptors (GCGR) for the treatment of T2D. YN203 has dual targeting mechanisms for the liver and pancreas. In the liver, it inhibits the signaling pathways mediated by GCGR, reducing hepatic gluconeogenesis.
In the pancreas, it promotes cell growth and inhibiting apoptosis, leading to pancreatic -cell proliferation, and increasing insulin synthesis and secretion. YN203 is currently in the pre-IND stage, and we plan to submit an IND application for it in 2026.
YN202 for Obesity and being overweight
We have also been developing YN202 for the treatment of obesity and being overweight.
YN202 is a recombinant fusion protein targeting the ghrelin receptor (GHS-R) binding domain. Ghrelin is a hormone that stimulates appetite and promotes fat storage. YN202 competes with ghrelin for binding to the GHS-R receptor, regulating peripheral circulating levels of ghrelin and obesity-related hormones, thereby inducing a feeling of satiety and reducing food intake, which results in weight loss. YN202 is currently in the pre-IND stage, and we plan to submit an IND application for this drug candidate in 2026.
Source: Innogen-B (02591) Prospectus (IPO Date : 2025/08/07) |