2026 ADA | Innovent Presents Multiple Clinical and Preclinical Results of Next-Generation Obesity & Metabolic Pipeline

SAN FRANCISCO and SUZHOU, China, June 8, 2026 /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, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, presented multiple clinical and preclinical results of its innovative metabolic and obesity pipeline at the 2026 American Diabetes Association's^® (ADA) Scientific Sessions. This includes three clinical oral presentations of mazdutide (GCG/GLP-1 dual agonist) across adults with type 2 diabetes and obesity, adults with obesity and adolescents with obesity, as well as preclinical data from its IBI3032 and IBI3042, as next‑generation oral daily and weekly GLP‑1 receptor agonists, along with IBI3040 (a novel amylin analog) and IBI3046 (an INHBE-targeting siRNA). Innovent Biologics' differentiated pipeline aims to provide scientific and comprehensive treatment options for weight management and metabolic comorbidities through offering superior tolerability, reduced muscle loss, convenient dosing, durable efficacy, and integrated comorbidity management.

Below is a summary of its early-stage pipeline results:

IBI3032 (daily oral small-molecule GLP-1) Preclinical and Phase 1 Clinical Study Results

Preclinical results:

ADA Reference: IBI3032: An Orally Bioavailable Nonpeptidic GLP-1 Receptor Agonist Advancing Through Phase 1 Clinical Trials (Abstract No.: 1678-P)

IBI3032 is a novel, orally bioavailable non-peptidic GLP-1R agonist discovered via structure-based design, and has now advanced into Phase 1 clinical trials in both China and the United States.

IBI3032 exhibited potent activation of the human GLP-1R (EC₅₀ = 0.53 nM) with high selectivity and minimal β-arrestin recruitment. IBI3032 demonstrated favorable cross‑species pharmacokinetics and a robust preclinical efficacy profile. Pharmacokinetic studies revealed high oral exposure in cynomolgus monkeys, with a bioavailability of 24.5% and a half-life of 6.3 hours.

Importantly, compared to the marketed small‑molecule GLP‑1R agonist Orforglipron, IBI3032 demonstrates significantly superior weight‑loss efficiency—achieving markedly greater body weight loss at half of the dose in preclinical models. In a 28-day study in hGLP-1R knock-in DIO mice, oral IBI3032 produced dose-dependent body weight loss relative to vehicle (1 mg/kg: -1.8%; 6 mg/kg: -8.0%; 12 mg/kg: -10.8%). In a 28-day cynomolgus monkey study, once-daily oral administration of IBI3032 (1 mg/kg) produced 11.2% body weight loss versus vehicle.

This differentiated profile supports its potential as a best‑in‑class oral therapy. Collectively, these findings underscore IBI3032 as a next‑generation oral GLP‑1R agonist that combines true oral convenience, low‑dose efficacy, and accelerated global clinical development.

Phase 1 clinical results:

ADA Reference: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI3032, a Novel Oral Nonpeptide GLP-1 Receptor Agonist: Single- and Multiple-Ascending Dose Studies in Chinese Adults (Abstract No.: 1690-P)

Preclinical studies indicate IBI3032 has a higher oral exposure than other marketed oral small‑molecule GLP‑1 in cynomolgus monkeys and shows encouraging efficacy signals for weight loss in obese cynomolgus monkeys. Based on these preclinical findings, two Phase 1 studies were designed to preliminarily assess the human dose range, weight-loss efficacy signals, and safety and tolerability of IBI3032, further validate the hypothesis of potent weight loss at low doses, and provide key data to inform the subsequent clinical trial design.

Study Design: The single-ascending dose (SAD) study recruited 40 eligible participants with/without overweight or obesity (BMI 20–40 kg/m²) to receive once-daily single doses of IBI3032 at 0.3 mg, 1.0 mg, 3.0 mg and 6.0 mg. The multiple-ascending dose (MAD) study recruited a total of 79 overweight/obese participants (BMI 24–40 kg/m²) to receive once-daily oral IBI3032 for 4 weeks per protocol-specified dose titration ranging from 0.6 mg to 10 mg, aiming to evaluate multiple dose-escalation titration regimens.

Clinical Study Findings:

• Linear pharmacokinetics properties support once-daily oral administration: After a single oral dose, IBI3032's systemic exposure (AUC_inf and C_max) increased in an approximately dose-proportional manner across 0.3–6 mg dose range; peak plasma concentration (T_max) occurred 5–12 hours post-dose. Its terminal elimination half-life is (T_1/2) approximately 2 days, which supports a once-daily dosing regimen. Pharmacokinetics (PK) parameters after 4 weeks of sequential titration in MAD were consistent with SAD and exhibited linear PK characteristics.
• Overall manageable safety profile: IBI3032 showed a manageable safety profile in both SAD and MAD studies; nearly all treatment-emergent adverse events were mild to moderate, with no treatment-related serious adverse events reported. No cases of acute pancreatitis, acute kidney injury, acute gallbladder disease, major adverse cardiovascular events, thyroid C-cell hyperplasia or thyroid carcinoma were reported in either study.
• Gradual dose titration balances weight-loss efficacy and treatment tolerability: Four-week cohort comparisons within MAD study demonstrated that low starting dose with stepwise dose escalation enables substantial weight reduction alongside meaningful improvement in gastrointestinal tolerability. In the cohort starting at 0.6 mg with seven-step escalation to 9 mg (n=12), 4-week treatment led to an average 10.11% body weight reduction after 4 weeks, while vomiting incidence remained at 8.3%. Compared with other cohorts utilizing the aggressive escalation approach with high starting doses and large dose increments, this slow titration regimen with lower initial dose, smaller incremental jumps and prolonged escalation cycle lowers gastrointestinal adverse event risk while retaining weight-lowering efficacy, providing evidence for future clinical dosing regimen development.

Ongoing Development in Phase 1: Additional Phase 1 clinical study of IBI3032 is ongoing to further explore and refine optimal dose titration schemes. Leveraging its differentiated attributes of superior oral exposure and low effective therapeutic dose, the program aims to validate the molecule's potential of potent weight loss under acceptable safety and tolerability.

IBI3040 (novel Amylin) Preclinical Results

ADA Reference: IBI3040, a Novel Amylin Analog, Induces Superior Weight Loss in Preclinical Models (Abstract No.: 3077-LB)

IBI3040 is a highly potent agonist of the amylin and calcitonin (CTR) receptors. In a 2-week study in DIO rats, IBI3040 at 2 and 10 nmol/kg Q3D resulted in dose-dependent reductions in body weight of 8.82% and 11.11%, respectively, compared to vehicle-treated rats. In another study, the combination of IBI3040 and semaglutide resulted in a greater weight reduction of −14.7%, whereas monotherapy with IBI3040 or semaglutide produced weight losses of −10.12% and −3.01% in DIO rats, respectively, indicating an additive effect of the combined treatment. Compared to cagrilintide, IBI3040 displays a favorable PK profile, high solubility, and stability without fibril formation at physiological pH (7-8).

IBI3040 demonstrates superior receptor activation, robust weight loss effects compared to cargrilintide and eloralintide, and synergistic potential with semaglutide, supporting its development as a next-generation amylin analog for obesity treatment.

IBI3042 (weekly oral small-molecule GLP-1) Preclinical Results

ADA Reference: IBI3042: A Novel Oral Once-Weekly Small-Molecule GLP-1 Receptor Agonist for Type 2 Diabetes and Obesity (Abstract No.: 2543-P)

IBI3042 is potentially the world's first once-weekly oral small-molecule GLP-1 receptor agonist candidate entering clinical studies by the end of 2026. The weekly dosing potential is offering a compelling new option for patients seeking a more convenient and manageable long-term treatment for type 2 diabetes and obesity.

IBI3042 exhibited GLP-1R activation in cAMP assays, but showed no β-arrestin recruitment in NanoBiT assays. In human GLP-1 receptor knock-in (GLP-1R KI) mice, IBI3042 (0.4 mg/kg P.O.) maintained significant glucose-lowering effects for at least 7 days, outperforming Orforglipron at the same dose.

In diet-induced obese (DIO) humanized GLP-1 receptor knock-in mice, IBI3042 at 1 mg/kg twice weekly showed comparable efficacy to Orforglipron 1.5 mg/kg once daily, while the 3 mg/kg twice-weekly dose demonstrated superior efficacy. In contrast, Orforglipron at 3 mg/kg twice weekly showed no notable efficacy.

In obese cynomolgus monkeys, IBI3042 produced robust, dose-dependent body weight reduction with twice-weekly oral dosing (1.5–4.5 mg/kg). The 1.5 mg/kg twice-weekly regimen achieved efficacy comparable to Orforglipron 1 mg/kg once daily, while the 4.5 mg/kg twice-weekly regimen demonstrated superior body weight reduction. Furthermore, the 7 mg/kg once-weekly regimen also matched the efficacy of Orforglipron 1 mg/kg once daily.

These compelling results position IBI3042 as a promising once-weekly oral treatment for obesity and type 2 diabetes, delivering a significantly more convenient and effective dosing option for patients.

IBI3046 (novel INHBE siRNA) Preclinical Results

ADA Reference: IBI3046, an INHBE siRNA, Enables High Quality and Long-Lasting Weight Control in Preclinical Study (Abstract No.: 2662-P)

IBI3046 is an INHBE-silencing RNAi therapeutic designed to enhance adipose lipolysis with sustained effects.

IBI3046 demonstrated potent and durable mRNA knockdown in hINHBE KI mouse model. In the efficacy study, IBI3046 resulted in a 13% reduction in body weight and a 50% decrease in fat mass relative to control. In combination therapy, IBI3046 administered with a low dose of GLP-1RA achieved 20% body weight loss and a 80% reduction in fat mass. Combining IBI3046 with GLP-1RAs may synergistically enhance fat loss while mitigating key limitations of current anti-obesity regimens. In addition, IBI3046 extended the duration of suppressed weight regain following drug withdraw.

IBI3046 enables Q3M-6M dosing, offering diabetes and obesity patients improved adherence and quality of life for glucose and weight control, thereby can potentially redefine the standard of metabolic disease management.

Dr. Lei Qian, Chief R&D Officer (General Biomedicine) of Innovent, stated, "At this year's ADA Scientific Sessions, we are pleased to present a series of new data in obesity and metabolic diseases, which is an important step in establishing Innovent as an emerging leader and innovator in this field. The multiple oral presentations of mazdutide, across adults with type 2 diabetes and obesity, adults with obesity and adolescents with obesity, further highlight its differentiated profile as a GCG/GLP‑1 dual receptor agonist in terms of weight loss, glycemic control and metabolic benefits. In addition, the data on IBI3032 (oral daily GLP-1 small molecule), IBI3042 (oral weekly GLP-1 small molecule), IBI3040 (amylin) and IBI3046 (INHBE siRNA) represent key progresses of our next‑generation obesity pipeline with global potential, which are designed to address unmet needs around tolerability, muscle preservation, dosing convenience, durability of weight loss and management of obesity‑related comorbidities."

About Innovent

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 1 asset under NMPA review, 4 assets in Phase 3 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.

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SOURCE Innovent Biologics