Innovent Announces Phase 1b Clinical Study Results of Mazdutide in Chinese Adolescents with Obesity Presented as an Oral Report at the American Diabetes Association (ADA) Scientific Sessions

SAN FRANCISCO and SUZHOU, China, June 6, 2026 -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the results from a phase 1b clinical study of mazdutide (R&D code: IBI362), the world's first approved glucagon (GCG)/glucagon‑like peptide‑1 (GLP‑1) dual receptor agonist, in Chinese adolescents with obesity were presented as an oral presentation (1133-OR) at the 2026 American Diabetes Association (ADA) Scientific Meeting. Dr. Lei Qian, Chief R&D Officer (General Biomedicine) of Innovent, served as the presenting author and presented on‑site. The study completed enrollment of all participants in Aug. 2025. Results showed that mazdutide 4 mg and 6 mg demonstrated a manageable safety and tolerability profile in Chinese adolescents with obesity. Once‑weekly treatment for 12 weeks rapidly achieved clinically meaningful weight loss and multiple metabolic benefits, providing important evidence for the treatment of adolescent obesity and potentially filling the gap in weight‑loss medications for adolescents in China. Based on the positive results of this study, Innovent Biologics has initiated a registrational Phase 3 clinical trial of mazdutide in Chinese adolescents with obesity, with the goal of benefitting the large population of adolescents with obesity or overweight as soon as possible. Adolescent Obesity: An Unmet Treatment Need in China – No Approved Weight‑Loss Drug Childhood and adolescent obesity has become a major public health issue both in China and globally. Globally, the prevalence of overweight or obesity among children and adolescents aged 5–19 years surged from 8% in 1990 to 20% in 2022¹. National surveillance data from China (2015–2019) showed an obesity prevalence of 7.9% among those aged 6–17 years². The World Obesity Federation projects that China will have approximately 62 million children with obesity by 2030³. Obesity in children and adolescents not only affects physical growth and motor function but may also lead to multiple long‑term health problems. A substantial body of research has confirmed that obesity is closely associated with hypertension, type 2 diabetes, hyperlipidemia, metabolic syndrome, and mental health issues during both childhood and adulthood4-6， Because childhood obesity tends to track into adulthood, early intervention is essential to halt the progression of metabolic diseases and reduce the long‑term burden of chronic conditions. Although GLP-1 receptor agonists have recently received regulatory approval for the treatment of adolescent obesity in several countries, no weight‑loss drug has yet been specifically approved for children and adolescents in China – representing a substantial unmet clinical need for Chinese adolescents with obesity. Latest Research Findings: Safe, Effective Weight Loss and Metabolic Improvement Developing safe and effective weight‑loss medications tailored to Chinese adolescents with obesity, and engaging both parents and children in weight management, are key to addressing the clinical challenges of adolescent obesity. This Phase 1b clinical study of mazdutide in Chinese adolescents with obesity adopted a randomized, double-blind, placebo-controlled design to evaluate for the first time in China, the safety, tolerability, and pharmacokinetic profile of multiple doses of mazdutide in this population. A total of 36 Chinese adolescents (aged 12 to <18 years) with obesity who had achieved <5% BMI reduction despite at least 12 weeks of diet and exercise control were enrolled. Obesity was defined based on BMI meeting the obesity criteria of the Chinese national standard WS/T 586‑2018: BMI at or above the 95th percentile for age and sex, with criteria aligned with adult standards at age 18 years. Participants had a median age of 14.0 years, a mean baseline BMI of 34.12 kg/m², and a mean baseline body weight of 95.83 kg. They were randomized in a 1:1:1 ratio to receive mazdutide 4 mg, mazdutide 6 mg, or placebo for a total treatment duration of 12 weeks. The primary endpoints were safety and tolerability. Results showed that mazdutide 4 mg and 6 mg demonstrated a manageable safety and tolerability profile in Chinese adolescents with obesity. All participants completed all protocol-required visits. During the study, no serious adverse events (AEs) or severe treatment-emergent adverse events (TEAEs) occurred in the mazdutide groups, and no participant discontinued treatment due to AEs. The most common The most frequently reported TEAEs were decreased appetite (33.3% with mazdutide 4 mg; 58.3% with mazdutide 6 mg; 25.0% with placebo), vomiting (25.0%; 50.0%; 0), diarrhea (25.0%; 41.7%; 16.7%) and nausea (25%; 41.7%; 0). Vomiting, diarrhea and nausea were all mild or moderate in severity and occurred during dose escalation. Furthermore, the study showed that the pharmacokinetic profile of mazdutide in adolescents was consistent with that observed in adults, and the clinically validated safe and effective exposure range in adults covered the exposure levels of the 4 mg and 6 mg doses in adolescents. In addition to a manageable safety profile, mazdutide also demonstrated significant weight loss efficacy and multiple metabolic benefits in Chinese adolescents with obesity. Onceweekly mazdutide treatment for 12 weeks rapidly achieved clinically meaningful weight loss and multiple metabolic benefits. The mean BMI decreased from baseline by 8.78% in the mazdutide 4 mg group and by 10.99% in the 6 mg group, with corresponding body weight reductions of 7.87% (7.72 kg) and 9.93% (8.65 kg), respectively. These results were statistically superior to placebo (1.73% BMI reduction; 1.19% (1.42 kg) weight reduction), with nominal P values all <0.01 for each comparison of a mazdutide dose group versus placebo. Beyond weight loss, improvements in waist circumference, blood pressure, lipid profiles, and glucose metabolism parameters were observed in the mazdutide groups, suggesting that mazdutide provides metabolic benefits beyond weight loss alone for adolescents with obesity. From Adults to Adolescents: Mazdutide Provides a Full‑Cycle Metabolic Management Solution As the world's first and only approved GCG/GLP1 dual receptor agonist, mazdutide has demonstrated potent weight loss, reduction of visceral fat, and metabolic improvement in multiple adult Phase 3 studies. Clinical studies have shown mazdutide achieves up to 20% weight loss (in adults with obesity and without T2D), reduces liver fat content by over 80%, decreases waist circumference by up to 14 cm and neck circumference by up to 3 cm, while also improving cardiovascular and metabolic parameters including blood glucose, blood pressure, lipid profile, uric acid, and transaminase levels—offering comprehensive benefits. Mazdutide has now expanded its research scope to adolescents with obesity, aiming to address the challenge of obesity among Chinese adolescents and further contribute to the Healthy China 2030 strategy. Dr. Lei Qian, Chief R&D Officer (General Biomedicine), Innovent, commented: “We are delighted that the first clinical study of mazdutide in adolescents with obesity has achieved positive results and has been presented at the international scientific meeting. The study demonstrates that mazdutide recapitulates its potent weight loss and multiple metabolic improvement effects observed in adult studies among Chinese adolescents with obesity, providing a solid scientific basis for subsequent clinical development. Currently, there is no approved weight‑loss drug for children and adolescents in China, and this breakthrough fully validates the therapeutic potential of mazdutide across different age groups. We will accelerate the registrational Phase 3 study and the development of additional indications for this innovative therapy, and the relevant study results will also be published in academic journals. We hope that mazdutide will soon benefit the large population of adolescents with obesity or overweight in China, offering them an effective treatment option with a favorable safety profile. Innovent will continue to expand innovative products across multiple therapeutic areas, addressing unmet patient needs with diverse treatment options, honoring the trust patients have placed in us, and bringing benefits to more lives.” About Mazdutide Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, mazdutide may offer additional benefits beyond those of GLP-1 receptor agonists, such as promoting insulin secretion, lowering blood glucose and reducing body weight. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies. It has also shown benefits in reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, as well as improving insulin sensitivity. Mazdutide has been conducted in or completed a total of nine Phase 3 clinical studies, including: GLORY-1: A Phase 3 trial (Mazdutide 4 mg and 6 mg) in Chinese participants with overweight or obesity. GLORY-2: A Phase 3 trial (Mazdutide 9 mg) in Chinese participants with moderate-to-severe obesity. DREAMS-1: A Phase 3 trial in treatment-naïve Chinese participants with T2D. DREAMS-2: A Phase 3 trial comparing Mazdutide and dulaglutide in Chinese T2D participants with inadequate glycemic control on oral antidiabetic drugs. DREAMS-3: A Phase 3 trial comparing Mazdutide and semaglutide in Chinese participants with T2D and obesity. GLORY-3: A Phase 3 trial comparing Mazdutide and semaglutide in Chinese participants with overweight/obesity and metabolic dysfunction-associated fatty liver disease (MAFLD). GLORY-OSA: A Phase 3 trial in Chinese participants with OSA and obesity. GLORY-YOUNG: A Phase 3 trial in Chinese adolescents with obesity. GLORY-H: A Phase 3 trial in Chinese participants with obesity and hypertension. Among these, the first five Phase 3 studies have met primary endpoints, and the latter four Phase 3 trials remain ongoing. In addition, several clinical studies of mazdutide are ongoing, including studies in metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF) and a head-to-head comparation of high-dose mazdutide versus tirzepatide for the treatment of moderate-to-severe obesity. *Mazdutide has received NMPA approval for two indications: Long-term weight control in adult patients As an adjunct to dietary control and increased physical activity in adults with initial BMI: ≥28 kg/m² (obesity), or ≥24 kg/m² (overweight) plus ≥1 weight-related comorbidity (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver disease, obstructive sleep apnea syndrome). Glycemic control in adults with T2D: Monotherapy: Adults with inadequately controlled T2D after diet/exercise intervention alone. About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 18 products in the market. It has 5 assets in Phase III or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, “Start with Integrity, Succeed through Action,” Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug or unapproved indication. This article is intended for scientific and educational purposes only and should not be construed as a recommendation or suggestion for any treatment or drug. If you feel unwell, please be sure to follow your physician's advice for medication and treatment. Ramucirumab injection (Cyramza®), selpercatinib capsules (Retevmo®), and pirtobrutinib tablets (Jaypirca®) were developed by Eli Lilly and Company. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. References https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight#:~:text=The%20prevalence%20of%20overweight%20(including,1990%20to%2020%25%20in%202022? February 25, 2026. The National Health Commission organized the Chinese Center for Disease Control and Prevention the NCC and the NC for CDiseases. Report on Nutrition and Chronic Disease Status of Chinese Residents (2020). Published online 2020. Barata Cavalcanti O, Barquera S, Baur L, et al. World Obesity Atlas 2022. 2022. www.worldobesity.org#worldobesityatlas. Bray GA, Kim KK, Wilding JPH, World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obes Rev. 2017;18(7):715-723. doi:10.1111/obr.12551. Daniels SR, Arnett DK, Eckel RH, et al. Overweight in children and adolescents: pathophysiology, consequences, prevention, and treatment. Circulation. 2005;111(15):1999-2012. doi:10.1161/01.CIR.0000161369.71722.10. Small L, Aplasca A. Child Obesity and Mental Health: A Complex Interaction. Child Adolesc Psychiatr Clin N Am. 2016;25(2):269-282. doi:10.1016/j.chc.2015.11.008.

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