San Francisco and SuzhouJune 8, 2026 /PRNewswire/ — Innovent Biologics, Inc. (HKEX: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major diseases such as oncology, autoimmune, metabolic, cardiovascular, and ophthalmology, today announced the presentation of multiple oral reports on Mazdutide, as well as early clinical and preclinical data from its next-generation weight loss and metabolic pipeline, including IBI3032 (oral small molecule GLP-1 daily formulation), IBI3042 (oral small molecule GLP-1 weekly formulation), IBI3040 (Amylin), and IBI3046 (INHBE siRNA), at the 2026 American Diabetes Association (ADA) Scientific Sessions. Innovent Biologics has established a differentiated and innovative pipeline with a gradient approach in the global weight loss and related metabolic comorbidity fields, committed to providing more scientific, comprehensive, and long-term treatment options for patients with obesity and metabolic diseases worldwide.
The following is a summary of the data released from the early pipeline:
Preliminary Preclinical and Phase I Clinical Study Results of IBI3032 (Oral Small Molecule GLP-1 Daily Formulation)
Summary of Preclinical Study Results for IBI3032:
ADA Reference: IBI3032: An Orally Bioavailable Non-Peptide GLP-1 Receptor Agonist Advancing to Phase 1 Clinical Trials (Abstract Number: 1678-P)
IBI3032 is a novel non-peptide oral GLP-1 receptor agonist discovered through structure-based design. IBI3032 potently activates the GLP-1 receptor (EC₅₀ = 0.53 nM) with high selectivity and minimal β-arrestin recruitment. The drug demonstrates favorable cross-species pharmacokinetic profiles and robust preclinical efficacy. Pharmacokinetic studies showed that IBI3032 has high oral exposure in cynomolgus monkeys, with a bioavailability of 24.5% and a half-life of 6.3 hours.
Compared to the marketed small molecule GLP-1 receptor agonist Orforglipron, IBI3032 exhibited significantly superior weight loss effects in preclinical models—achieving greater body weight reduction at half the dose. In a 28-day weight loss efficacy study in hGLP-1R knock-in DIO mice, oral administration of IBI3032 produced dose-dependent body weight reductions relative to the vehicle control group (1 mg/kg: -1.8%; 6 mg/kg: -8.0%; 12 mg/kg: -10.8%). In a 28-day study in cynomolgus monkeys, once-daily oral administration of IBI3032 (1 mg/kg) resulted in an 11.2% body weight reduction compared to the control group.
The oral convenience of IBI3032, along with its demonstrated high efficacy at low doses in preclinical models, supports its potential as a best-in-class oral GLP-1 small molecule.
Summary of Phase I Clinical Study Results for IBI3032:
ADA Reference: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI3032, a Novel Oral Non-Peptide GLP-1 Receptor Agonist: Single and Multiple Ascending Dose Studies in Chinese Adults (Abstract Number: 1690-P)
Preclinical data have already demonstrated the advantage of higher in vivo exposure of IBI3032 compared to similar oral GLP-1 small molecules at the same dose. Based on these data, this early Phase I clinical study aims to preliminarily evaluate the human dose range, weight loss efficacy signals, and safety/tolerability of IBI3032, further validating the scientific hypothesis of achieving high weight loss potential at low doses, and providing key data to support subsequent clinical protocol design.
Study Design: Single Ascending Dose (SAD) Study: Enrolled a total of 40 subjects with BMI between 20–40 kg/m², with four single oral ascending dose groups: 0.3 mg, 1.0 mg, 3.0 mg, and 6.0 mg. Multiple Ascending Dose (MAD) Study: Enrolled a total of 79 overweight or obese subjects with BMI between 24–40 kg/m², receiving daily oral administration for 4 weeks (target dose range 0.6–10 mg), exploring various dose titration strategies.
Clinical Study Results Show:
- Linear Pharmacokinetics (PK) Suitable for Once-Daily Oral Dosing: Following single oral administration, exposure (AUCinf and Cmax) of IBI3032 increased approximately dose-proportionally over the 0.3–6 mg dose range, with plasma concentrations reaching peak (Tmax) approximately 5–12 hours post-dose. Its terminal half-life is approximately 2 days, supporting once-daily dosing. In the MAD study, PK characteristics after 4 weeks of titration were consistent with the SAD study, demonstrating linear pharmacokinetics.
- Manageable Overall Safety Profile: The SAD and MAD studies showed that IBI3032 has a manageable overall safety profile. The vast majority of adverse events were mild to moderate in severity, with no drug-related serious adverse events. No subjects in either study experienced acute pancreatitis, acute kidney injury, acute gallbladder disease, major adverse cardiovascular events, thyroid C-cell hyperplasia, or thyroid carcinoma.
- Gradual Dose Titration Strategy Balances Weight Loss Efficacy and Tolerability: Comparison of multiple titration groups over the 4-week MAD study suggests that adjusting the starting dose and dose escalation strategy can significantly optimize gastrointestinal tolerability while maintaining potent weight loss. In the “small steps, fast pace” dose group (N=12), starting at 0.6 mg and titrating up to 9 mg in 7 steps, subjects achieved an average body weight reduction of 10.11% after 4 weeks of treatment, with a vomiting incidence of 8.3%. Compared to aggressive titration cohorts with higher starting doses and steeper dose increments, the “small steps, fast pace” regimen, by employing a lower starting dose, small incremental steps, and a relatively extended titration period, preserved excellent weight loss efficacy while reducing the risk of gastrointestinal adverse events, providing a basis for dosing regimen design in subsequent clinical development.
Currently, IBI3032 is in further Phase I clinical development, continuously exploring and optimizing dose titration regimens to leverage the advantages of high oral exposure and low dose administration of IBI3032 to achieve safe, tolerable, and highly effective weight loss.
Preclinical Study Results of IBI3040 (Novel Amylin Analog)
ADA Reference: A Novel Amylin Analog Demonstrates Superior Weight Loss Efficacy in Preclinical Models (Abstract Number: 3077-LB)
IBI3040 is a highly potent dual agonist of the amylin receptor and calcitonin receptor. It is expected to enter human studies in 2026.
In a 2-week study conducted in a diet-induced obesity (DIO) rat model, IBI3040 administered every 3 days at doses of 2 nmol/kg and 10 nmol/kg resulted in dose-dependent body weight reductions of 8.82% and 11.11%, respectively, compared to the vehicle control group. In another DIO rat model study, the combination of IBI3040 with Semaglutide achieved a greater body weight reduction (-14.7%), compared to -10.12% for IBI3040 alone and -3.01% for Semaglutide alone, suggesting an additive effect of the combination.
Compared to cagrilintide, IBI3040 exhibits a superior pharmacokinetic profile, with high solubility and stability at physiological pH (7-8) without fibril formation. It has the potential for pre-mixed administration with various GLP-1s, further enhancing efficacy while maintaining low-cost delivery device options.
Compared to cagrilintide and eloralintide, IBI3040 demonstrates stronger receptor activation capability, significant weight loss efficacy, and synergistic potential when combined with GLP-1. These data support the development of IBI3040 as a next-generation amylin analog backbone drug for obesity treatment.
Preclinical Study Data of IBI3042 (Weekly Oral GLP-1 Small Molecule)
ADA Reference: IBI3042: A Novel Oral Once-Weekly Small Molecule GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes and Obesity (Abstract Number: 2543-P)
IBI3042 is a potentially first-in-global weekly oral GLP-1 receptor agonist small molecule drug, expected to enter first-in-human clinical studies in 2026.
Systematic evaluation of the pharmacokinetic and pharmacodynamic characteristics of IBI3042 in hGLP-1 receptor knock-in mice and obese cynomolgus monkey models indicates that IBI3042 has the potential to provide a treatment option for patients with diabetes and obesity that combines efficacy advantages with dosing convenience via a once-weekly oral administration regimen.
IBI3042 demonstrates excellent weight loss effects:
IBI3042 is expected to enable weekly dosing, offering patients with diabetes and obesity a glucose control and weight loss solution with better compliance and higher quality of life, redefining the future standard of metabolic disease management.
Preclinical Study Data of IBI3046 (INHBE siRNA)
ADA Reference: IBI3046: A siRNA Targeting INHBE Achieves High-Quality, Long-Lasting Weight Control in Preclinical Studies (Abstract Number: 2662-P)
IBI3046 is a long-acting RNAi candidate molecule targeting liver INHBE. It effectively silences INHBE mRNA expression in mouse models and is expected to enter first-in-human clinical studies in 2026. Results from DIO model studies show that IBI3046 inhibits weight gain, reduces fat mass, and preserves lean body mass while upregulating lipolysis-related genes, suggesting its dual potential to improve energy metabolism and optimize body composition. Further studies indicate that the combination of IBI3046 with GLP-1 analogs has the potential to support GLP-1 dose reduction while maintaining anti-obesity efficacy and continuously preserving lean body mass advantages. In terms of non-clinical safety, IBI3046 demonstrated good tolerability in monkeys at doses ≥300 mg/kg, supporting its subsequent clinical translation.
Dr. Lei Qian, Chief Research Officer (Integrated Pipeline) of Innovent Biologics, stated: “At this year’s ADA Annual Meeting, Innovent Biologics showcased a series of our latest research findings in the weight loss and metabolic fields, which is of significant importance to our goal of becoming an emerging leader and innovation driver in the metabolic treatment area. The multiple oral presentations on Mazdutide, covering clinical data from patients with type 2 diabetes and obesity, obese adults, to obese adolescents, systematically demonstrate its differentiated advantages as a GCG/GLP-1 dual receptor agonist in weight loss, glucose lowering, and metabolic improvements across diverse populations. Facing the still significant unmet needs in the global obesity treatment landscape, we have built a comprehensive global innovative pipeline. The data presented at this conference represents an important milestone achievement of this strategy. We will continue to delve into areas such as tolerability optimization, long-lasting weight loss, simplified dosing, and comprehensive management of complications, aiming to create more complete treatment solutions for patients with obesity and metabolic diseases.”
About Innovent Biologics
“Start with Integrity, Succeed through Action.” Developing high-quality biologics that are affordable for the people is the mission and goal of Innovent Biologics. Founded in 2011, Innovent Biologics is dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major diseases such as oncology, autoimmune, metabolic, and ophthalmology, so that our work can benefit more lives. The company has 18 approved products on the market: Sintilimab Injection (Tyvyt®), Bevacizumab Injection (Byvasda®), Adalimumab Injection (Sulinno®), Rituximab Injection (Dabohua®), Pemigatinib Tablets (Pemazyre®), Olverembatinib Tablets (Nerlynx®), Ramucirumab Injection (Cyramza®), Selpercatinib Capsules (Retevmo®), Equecabtagene Autoleucel Injection (Fucaso®), Tafolecimab Injection (Sibeprenlimab®), Fuzerlisib Tablets (Dabote®), Pirtobrutinib Tablets (Jaypirca®), Taletrectinib Capsules (Dabole®), Lirentinib Tablets (Aoyixin®), Teprotumumab N01 Injection (Sibemin®), Mazdutide Injection (Xinerme®), Pikangqibai Injection (Xinmeiyue®), and Ipilimumab N01 Injection (Daboxin®). Currently, 1 product is under NMPA review, 4 new drug molecules have entered Phase III or pivotal clinical studies, and 14 new drug candidates have entered clinical research.
The company has established over 30 strategic collaborations with international partners such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD Anderson Cancer Center. While continuously innovating and developing its own drugs and pursuing its own growth, Innovent Biologics adheres to the people-centered development philosophy of economic construction. Over the years, it has always been guided by scientific conscience, adhered to a “patient-centered” approach, cared for patients and their families, and actively fulfilled its social responsibilities. The company has successively initiated and participated in multiple drug assistance programs, enabling more and more patients to benefit from advances in life sciences and to afford and access high-quality biologics. To date, Innovent Biologics’ patient assistance programs have benefited over 200,000 ordinary patients, with a total drug donation value of RMB 4 billion. Innovent Biologics hopes to work together with everyone to improve the development level of China’s biopharmaceutical industry, to meet the people’s need for accessible medication and their aspirations for a healthy life.
For more information, please visit the company’s website: www.innoventbio.com or the company’s LinkedIn account Innovent Biologics.
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Disclaimer: 1. Innovent Biologics does not recommend the use of unapproved drugs/indications. |
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2. Ramucirumab Injection (Cyramza®), Selpercatinib Capsules (Retevmo®), and Pirtobrutinib Tablets (Jaypirca®) were developed by Eli Lilly and Company. |
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