• After 12 weeks of treatment, the 4 mg and 6 mg mazdutide groups achieved reductions in BMI from baseline of 8.78% and 10.99%, respectively, with corresponding body weight reductions of 7.72 kg and 8.65 kg. These results were significantly superior to those observed in the placebo group (BMI reduction: 1.73%; weight reduction: 1.42 kg; with nominal P values < 0.01). Furthermore, multiple metabolic parameters improved simultaneously.
• Mazdutide demonstrated a favorable overall safety and tolerability profile. All enrolled subjects completed the protocol-specified visits. Throughout the study period, there were no serious adverse events (SAEs) reported in the mazdutide groups, and no subjects discontinued treatment due to adverse events (AEs).
• there are currently no approved weight-loss medications specifically indicated for children and adolescents in China. A Phase 3 registrational clinical trial for adolescent obesity is scheduled to be initiated soon.

SAN FRANCISCO and SUZHOU, China, Dec. 12, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announced that the Phase 1b clinical study of mazdutide injection (a glucagon-like peptide-1 [GLP-1] and glucagon [GCG] dual receptor agonist, R&D code: IBI362) in Chinese adolescents with obesity met its primary endpoint.

The global issue of childhood and adolescent obesity continues to escalate. According to a UNICEF report, the global obesity rate among children and adolescents aged 5–19 has risen from 3% to 9.4% since the year 2000. Obesity has now become a more prevalent form of malnutrition than underweight, affecting one in every ten school-aged children and adolescents (approximately 188 million individuals) and placing them at risk for severe health conditions ^[1].

The situation regarding obesity prevention and control among Chinese children and adolescents is equally severe. The combined detection rate of overweight and obesity among children and adolescents aged 7–18 in China surged from 1.2% in 1985 to 23.4% in 2019—an 18.1-fold increase. Notably, the obesity detection rate alone soared from 0.1% in 1985 to 9.6% in 2019, representing a staggering 75.6-fold rise ^[2].

Adolescent obesity is associated with numerous long-term health risks, including hypertension, dyslipidemia, type 2 diabetes, metabolic syndrome, and psychological and behavioral issues. Furthermore, there are currently no approved weight-loss medications specifically indicated for children and adolescents in China ^[3], highlighting a significant unmet clinical need.

This study is a multicenter, randomized, double-blind, placebo-controlled Phase 1b clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and weight-loss efficacy of mazdutide in Chinese adolescents with obesity. A total of 36 adolescent participants (≥12 and <18 years old) with obesity were enrolled. All participants had undergone dietary and exercise intervention for at least 12 weeks prior to enrollment but achieved less than 5% reduction in body mass index (BMI). The participants met the obesity criteria specified in the Chinese national standard "WS/T 586‑2018 Screening for Overweight and Obesity in School-Age Children and Adolescents," with 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 either mazdutide 4 mg, mazdutide 6 mg, or placebo (with dose escalation) and a total treatment duration is 12 weeks.

The study results demonstrate that mazdutide, administered via weekly multiple subcutaneous injections following a dose-titration regimen, exhibited a favorable overall safety and tolerability profile in Chinese adolescent participants with obesity. All subjects completed the protocol-specified visits. No serious adverse events (SAEs) were reported in the mazdutide treatment groups during the study period, and no subjects discontinued the study due to adverse events (AEs). The most frequently reported adverse events were gastrointestinal reactions, all of which were mild or moderate in severity. The pharmacokinetic profile of mazdutide was similar between adolescents and adults. The clinically validated safe and effective exposure range established in adults adequately covered the drug exposure levels observed with the 4 mg and 6 mg doses in adolescents.

After the 12-week treatment period for Chinese adolescents with obesity, the mazdutide treatment groups demonstrated statistically significant reductions in both key efficacy endpoints—BMI and body weight—confirming the weight-loss efficacy of mazdutide in this population.

Specifically, compared to baseline, the 4 mg and 6 mg mazdutide groups achieved relative reductions in BMI of 8.78% and 10.99%, and in body weight of 7.87% and 9.93%, respectively. The absolute weight reductions were 7.72 kg and 8.65 kg, respectively. These results were statistically superior to those in the placebo group (BMI reduction: 1.73%; body weight reduction: 1.19% or 1.42 kg), with all between-group comparisons reaching statistical significance (all nominal P values < 0.01). Furthermore, the 6 mg group showed numerically greater efficacy compared to the 4 mg group, suggesting a dose-dependent trend.

Beyond weight loss, favorable trends of improvement were also observed in the mazdutide groups for multiple metabolic parameters, including waist circumference, blood pressure, blood lipids, serum uric acid, liver transaminase levels, and glycemic control indicators. These findings indicate that mazdutide may provide adolescents with obesity not only with weight reduction but also with multiple metabolic benefits.

Based on the positive safety and efficacy results from this Phase 1b study, Innovent plans to initiate a Phase 3 registration clinical trial in adolescent participants with obesity or overweight in the near future. This initiative aims to bring this potential treatment to the large population of adolescents with obesity or overweight in China as early as possible.

Professor Ni Xin, Principal Investigator of the study from Beijing Children's Hospital, Capital Medical University, stated: "The issue of adolescent obesity is becoming increasingly severe, emerging as a major concern both nationally and globally. The results of this study are highly encouraging. They demonstrate that mazdutide offers a novel therapeutic approach for Chinese adolescents with obesity, characterized by potent weight-loss efficacy and a favorable safety profile. Adolescents could have better chance to adopt positive and healthy lifestyle changes supported with an effective pharmacotherapy."

Professor Gong Chunxiu, Principal Investigator of the study from Beijing Children's Hospital, Capital Medical University, stated: "Treating childhood obesity is challenging. The reversal of elevated body weight through lifestyle education alone has a low success rate, and persistent obesity is prone to progression and the development of complications. Notably, the benefits brought by mazdutide, as evidenced by robust data, have demonstrated an effect that significantly surpasses weight management alone. In the study participants, we observed favorable trends of comprehensive improvement across multiple metabolic parameters, including waist circumference, blood pressure, blood lipids, serum uric acid, and blood glucose levels. This holds profound significance for potentially halting the progression from adolescent obesity to clinical obesity and metabolic syndrome in adulthood. These data reveal the advantages of mazdutide as a GCG/GLP-1 dual receptor agonist: it not only achieves effective weight loss but may also fundamentally improve the multiple metabolic disorders associated with obesity, thereby offering patients more comprehensive health benefits."

Dr. Lei Qian, Chief R&D Officer of General Biomedicine at Innovent Biologics, stated: "There are currently no weight-loss medications approved for children or adolescents in China. The breakthrough achieved by mazdutide in the field of adolescent obesity has robustly validated its therapeutic potential across different age groups of patients. We have observed that mazdutide reproduces the potent weight-loss efficacy and multiple metabolic benefits in adolescents that were demonstrated in adult studies. Furthermore, its pharmacokinetic profile is similar to that in adults. This provides a solid scientific foundation for its further clinical development. We will accelerate the exploration of this innovative therapy for additional indications, striving to benefit a broader population of patients with obesity across different age groups and with varying treatment needs."

About Mazdutide

Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and commercialization of mazdutide, a dual GCG /GLP-1 receptor agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, in addition to the effects of GLP-1 receptor agonists on promoting insulin secretion, lowering blood glucose and reducing body weight, mazdutide may also increase energy expenditure and improve hepatic fat metabolism through the activation of glucagon receptor. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies, as well as reducing waist circumference, blood lipids, blood pressure, serum uric acid, liver enzymes, liver fat content and improved insulin sensitivity.

Seven Phase 3 clinical studies of mazdutide have been initiated or completed, including:

• GLORY-1: in Chinese adults with overweight or obesity;
• GLORY-2: in Chinese adults with moderate to severe obesity;
• DREAMS-1: in Chinese drug-naive adults with type 2 diabetes;
• DREAMS-2: comparing mazdutide to dulaglutide in Chinese adults with type 2 diabetes inadequately controlled with oral antidiabetic drugs;
• DREAMS-3: comparing mazdutide to semaglutide in Chinese adults with type 2 diabetes and obesity;
• GLORY-3: comparing mazdutide to semaglutide in Chinese adults with overweight or obesity and metabolic dysfunction-associated fatty liver disease (MAFLD);
• GLORY-OSA: in Chinese adults with obstructive sleep apnea (OSA) and obesity.

Among these, the first five Phase 3 clinical studies have met their primary endpoints, while the other two Phase 3 studies are ongoing.

Furthermore, mazdutide is currently being evaluated in several additional ongoing clinical studies. These include trials investigating its use in metabolic dysfunction-associated steatohepatitis (MASH), heart failure with preserved ejection fraction (HFpEF), and a higher-dose head-to-head clinical study against tirzepatide for the treatment of moderate-to-severe obesity.

*Mazdutide has received NMPA approval for two indications:

First Indication: as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial Body Mass Index (BMI) of:

• BMI ≥ 28 kg/m² (obesity); or
• BMI ≥ 24 kg/m² (overweight) in the presence of at least one weight-related comorbid condition (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver, or obstructive sleep apnea syndrome and etc.);

Second Indication: glycemic control in adults with type 2 diabetes:

Monotherapy

For adults with type 2 diabetes who have inadequate glycemic control despite diet and exercise interventions.

Combination Therapy

For adults with T2D who still have poor glycemic control despite:

Diet and exercise, plus Metformin and/or sulfonylureas, or Metformin and/or SGLT2 inhibitors (SGLT2i).

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 17 products in the market. It has 1 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 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 (s)/indication (s).

Forward-looking statement

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

[1] https://news.un.org/zh/story/2025/09/1140658

[2] Prevalence trends and projection of overweight and obesity among children and adolescents aged 7-18 years in China from 1985 to 2019. Chinese Journal of Preventive Medicine, 2023, 57(4): 461-469.

[3] Guidelines for Diagnosis and Treatment of Obesity (2024 Edition). National Health Commission of the People's Republic of China.

Source: Innovent Biologics Related Stocks: HongKong:01801 HongKong:1801 OTC:IVBIY