Innovent and Sanegene Announce Positive Phase I Clinical Results of IBI3016 (AGT siRNA) for Hypertension at AHA 2025

Nov 10, 2025 08:03 CST Updated 08:03

Innovent

High-end Biologics Developer

SANEGENEBIO

Small Nucleic Acid Drug Developer

Single dosing of IBI3016 demonstrates sustained and potent reduction of AGT levels with preliminary antihypertensive efficacy.
The clinical Phase I study data of IBI3016 further supports its potential for subcutaneous administration every six months to achieve blood pressure reduction, and subsequent clinical development is about to commence.

November 10, 2025, San Francisco, USA, and Suzhou, China — Innovent Bio (Stock Code: 01801.HK), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs in major disease areas such as oncology, autoimmune disorders, metabolic diseases, cardiovascular conditions, and ophthalmology, and SanegeneBio USA Inc. ("SanegeneBio"), a clinical-stage global biotechnology company focused on the development of RNAi therapies, jointly announcedThe main results of the first-in-human (FIH) Phase I clinical study of the small interfering RNA (siRNA) drug IBI3016 (SGB-3908, developed by SANEGENEBIO), which targets angiotensinogen (AGT), were presented at the digital poster session of the 2025 American Heart Association (AHA) Scientific Sessions. Dr. Fangfang Wang from Peking University Third Hospital delivered an oral presentation of the findings on-site.。

This FIH study (NCT06501586 / CTR20242500) is a randomized, double-blind, placebo-controlled, single ascending dose trial conducted in healthy subjects and patients with mild hypertension, aiming to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) profiles following subcutaneous administration of IBI3016.

As of July 1, 2025, a total of 40 healthy subjects and subjects with mild hypertension were randomly assigned to five cohorts (the ratio of IBI3016 dose group to placebo group in each cohort was 6:2). All subjects were Chinese, with a median age (range) of 37 years (24-54 years), 30% were female, and the average BMI was 25.2 kg/m².^², the baseline 24-hour ambulatory blood pressure mean was 122/74 mmHg. There were no significant differences in baseline characteristics among the groups.

IBI3016 Single Dose Achieves Long-Lasting and Potent AGT Level Reduction and Preliminary Blood Pressure Decrease

After a single dose, serum AGT levels were significantly and persistently reduced by more than 95% at maximum, remaining stable over a period of six months.：
Cohort 1~5 IBI3016 dose groups reached maximum reductions of 91.7%, 91.4%, 94.7%, 96.2%, and 97.5%, respectively, at approximately 4 weeks. At 3 months, the sustained reductions in each dose group were 91.2%, 90.0%, 93.8%, 96.5%, and 97.0%, respectively. At 6 months, the reductions in each dose group were maintained at 85.9%, 84.0%, 90.8%, 93.8%, and 96.4%, respectively.
At 3 months, all dose groups of IBI3016 achieved a reduction in blood pressure.：
The changes in 24-hour average daytime ambulatory systolic/diastolic blood pressure relative to baseline for IBI3016 dose groups in Cohorts 1~5 were −8.8/−9.7, −2.1/+0.8, respectively.-7.1/-5.5, -11.0/-12.5, and -16.7/-14.7 mmHg, compared to -3.2/-5.7 mmHg in the placebo group.The changes in average nocturnal dynamic systolic/diastolic blood pressure for each dose group were −9.4/−3.3, −7.1/−4.9, respectively.−15.1/−10.7, −11.6/−6.7, and −16.0/−12.9 mmHg, compared to −5.0/−2.6 mmHg in the placebo group.

Good safety and tolerability, with no unexpected safety signals

IBI3016 demonstrated good safety and tolerability within 6 months, with no severe adverse events (AE) or serious adverse events (SAE) observed, and no hypotension events occurred. All adverse events were mild to moderate and reversible.

The principal investigator of the study, Director Haiyan Li from the Third Hospital of Peking University"Hypertension is the most prevalent non-communicable disease in China, with an estimated 245 million adults affected. It is also the leading risk factor for increased cardiovascular disease incidence and mortality. Millions of deaths from cardiovascular diseases associated with hypertension occur each year, imposing a significant socioeconomic burden. Despite numerous oral medications available for hypertension treatment, issues such as poor medication adherence and aldosterone escape persist, resulting in suboptimal overall blood pressure control. siRNA targeting AGT, with its unique molecular advantages, achieves long-term blood pressure reduction and inhibits the renin-angiotensin system (RAAS) activity at its source, effectively improving patient adherence and potentially addressing aldosterone escape. I am pleased to see the Phase I research results of IBI3016 presented at the AHA conference, demonstrating good safety and preliminary efficacy, laying a solid foundation for subsequent clinical development."

Dr. Lei Qian, Chief Development Officer of Innovent Bio's Integrated PipelineStated: "Innovent Bio is committed to becoming a leading innovative pharmaceutical company in the field of chronic diseases, benefiting a wide range of patients with innovative therapies. siRNA-based drugs, with their long-lasting effects and stable efficacy, have demonstrated significant application potential in chronic disease areas requiring long-term management, such as cardiometabolic disorders. Relying on SANEGENEBIO's technological advantages in siRNA drug development and Innovent Bio's extensive experience in clinical development for cardiovascular metabolic diseases, we have successfully obtained the interim results of the Phase I clinical trial for IBI3016, which gives us confidence for later-stage clinical development. We will adhere to scientific rigor and high-quality, efficient clinical development, closely collaborate with SANEGENEBIO, and strive to bring this innovative therapy to a broad population of hypertension patients as soon as possible."

Dr. Jin Yuyan, Senior Vice President of Clinical and Non-clinical at SANEGENEBIO"Hypertension still represents a significant unmet clinical need globally. As a transformative RNAi-based innovative therapeutic, IBI3016 has the potential to address existing issues such as poor adherence to traditional drugs and aldosterone escape. With the dedicated collaboration and professional commitment of Peking University Third Hospital Research Center, Innovent Bio, and SANEGENEBIO, the Phase I trial of IBI3016 has achieved promising interim results, which were presented at an international conference. The findings indicate that IBI3016 demonstrates favorable safety, sustained AGT inhibition, and preliminary blood pressure-lowering effects in both healthy volunteers and patients with mild hypertension, providing robust support for subsequent clinical development. Moving forward, we will continue our close collaboration with Innovent Bio to execute the clinical development plan efficiently, fully advancing the R&D progress of IBI3016. Our goal is to achieve positive outcomes as soon as possible, fully unlocking its therapeutic value and delivering a more effective, safer, and superior adherence-focused innovative treatment option for patients with hypertension."

About Hypertension

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Hypertension, as a common chronic disease, has seen the global number of patients rise to 1.4 billion, yet only about 20% of them have achieved effective control through medication or lifestyle interventions.^[1]Hypertension not only increases the risk of cardiovascular and cerebrovascular diseases but also may lead to complications such as kidney damage and vision loss. With the aging population and the prevalence of risk factors like obesity, lack of physical activity, and unhealthy diets, the global prevalence of hypertension continues to rise. Although there are currently effective antihypertensive treatments available in clinical practice, these medications need to be taken daily. Since hypertension is often asymptomatic or presents with mild symptoms, patients may forget to take their medication, leading to poor adherence—a major challenge in the current treatment of hypertension. With the breakthrough advancements in RNA interference (RNAi) technology and targeted delivery systems, siRNA therapies utilizing GalNAc conjugation technology have shown great potential in the field of hypertension treatment. These innovative therapies, through long-acting and precise regulation of pathogenic gene expression, have the potential to completely transform the traditional treatment model where hypertensive patients need to "take medication daily."

About IBI3016

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IBI3016 (SANEGENEBIO R&D Code: SGB-3908) is a siRNA drug targeting Angiotensinogen (AGT) co-developed by Innovent Bio and SANEGENEBIO for the treatment of hypertension. IBI3016, developed using SANEGENEBIO's proprietary GalNAc liver-targeting delivery technology platform with independent intellectual property rights, inhibits AGT synthesis through the RNAi mechanism. Preclinical trial data show that IBI3016 can inhibit the synthesis of AGT in the liver, potentially leading to a sustained reduction in AGT protein, further reducing Ang II, ultimately resulting in vasodilation and blood pressure reduction.

About Innovent Bio

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"Start with trust, achieve through action." Developing high-quality biologics that are affordable for the general public is the mission and goal of Innovent Bio. Founded in 2011, Innovent Bio is dedicated to the research, production, and commercialization of innovative drugs in major disease areas such as oncology, autoimmune disorders, metabolic diseases, and ophthalmology, ensuring our work benefits more lives. The company has received approval for 16 products: Sintilimab Injection (Tyvyt®), Bevacizumab Injection (Byvasda®), Adalimumab Injection (Sulinno®), Rituximab Injection (Hanliko®), Pemigatinib Tablets (Pemazyre®), Olverembatinib Tablets (耐立克®), Ramucirumab Injection (Cyramza®), Selpercatinib Capsules (睿妥®), Idecabtagene Vicleucel Injection (福可苏®), Tolokib Injection (信必乐®), Fluorouracil Injection (达伯特®), Pitobrutinib Tablets (捷帕力®), Tarextumab Capsules (达伯乐®), Liothyronine Tablets (奥壹新®), Tezepelumab N01 Injection (信必敏®), and Mazdutide Injection (信尔美®). Currently, two additional products are under review by the NMPA, four new drug molecules have entered Phase III or pivotal clinical trials, and another 15 new drug candidates have entered clinical studies.

Innovent Bio has reached more than 30 strategic cooperation agreements with international partners such as Eli Lilly, Roche, Takeda, Sanofi, Incyte, and MD Anderson Cancer Center. While continuously developing innovative drugs and pursuing its own growth, Innovent Bio adheres to the development philosophy of economic construction centered on the people. Over the years, the company has always upheld scientific benevolence, adhered to a "patient-centered" approach, cared for patients and their families, and actively fulfilled social responsibilities. The company has successively initiated and participated in multiple public welfare drug assistance programs, enabling more and more patients to benefit from advances in life sciences by gaining access to and being able to afford high-quality biologics. To date, Innovent Bio's patient assistance programs have benefited more than 200,000 ordinary patients, with a total value of drug donations reaching 3.6 billion RMB. Innovent Bio hopes to work together with everyone to enhance the development level of China’s biopharmaceutical industry to meet the public's demand for accessible medicines and their aspirations for health and well-being.

For more details, please visit the company website: www.innoventbio.com or the company LinkedIn account: Innovent Biologics.

Statement:

1. Innovent Bio does not recommend the use of any unapproved drugs/indications.

2. Ramucirumab Injection (Cyramza®), Selpercatinib Capsules (Retsevmo®), and Pirtobrutinib Tablets (Jaypirca®) were developed by Eli Lilly and Company.

About SANEGENEBIO

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SANEGENEBIO is a global integrated clinical-stage biotechnology company focused on the development of RNAi therapies. Relying on its proprietary GalNAc liver delivery platform and the industry-leading LEAD™ (Ligand and Enhancer Assisted Delivery, a novel ligand and enhancer co-delivery) extrahepatic delivery platform, the company is committed to addressing significant unmet clinical needs in the fields of obesity, cardiometabolic diseases, and immune-mediated disorders. Founded in 2021 and led by a pioneering team with deep expertise in the RNAi field, SANEGENEBIO has research and development centers in Suzhou, Shanghai, China, and Boston, USA, and has received support from well-known venture capital firms. Our core breakthrough lies in overcoming the multi-tissue delivery challenges of RNAi drugs. The LEAD™ platform enables efficient and specific delivery of siRNA to extrahepatic tissues such as fat, muscle, immune cells, and the central nervous system, achieving highly efficient, safe, and long-lasting silencing of disease-causing genes while significantly reducing dosing frequency. SANEGENEBIO has established a rapidly growing pipeline of investigational products, including four clinical-stage drug candidates (one in Phase II clinical trials and three in Phase I clinical trials) and multiple preclinical programs. We adhere to a clear vision: to develop innovative therapies with "Best-In-Class" and "First-In-Class" potential, advancing RNAi therapies as standard clinical treatments across a wide range of disease areas, and bringing a new generation of transformative treatment options to patients worldwide. For more information, please visit SANEGENEBIO's official website: www.sanegenebio.com.

References

[1]. WHO. Global report on hypertension 2025.

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