Innovent and SanegeneBio Announce Phase 1 Clinical Data for IBI3016 Presented at American Heart Association (AHA) 2025 Annual Meeting

• IBI3016 demonstrates sustained and potent AGT mRNA suppression with preliminary evidence of antihypertensive efficacy after single-dose subcutaneous administration.
• The clinical Phase 1 data of IBI3016 further support the potential for biannual subcutaneous dosing for the treatment of hypertension. Next-step development is scheduled to initiate soon.

SAN FRANCISCO and SUZHOU, China, Nov. 9, 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, ophthalmology and other major diseases, jointly announced with Sanegene Bio USA Inc. (SanegeneBio), a global clinical-stage biotechnology company focused on developing best-in-class RNAi medicines for obesity, cardiometabolic, and autoimmune diseases, that the preliminary results from the first-in-human (FIH) Phase 1 clinical study of IBI3016 (SanegeneBio's R&D code: SGB-3908), an experimental small interfering RNA (siRNA) medicine targeting angiotensinogen mRNA (AGT), were reported at the 2025 American Heart Association (AHA) scientific sessions. Dr. Fangfang Wang from Peking University Third Hospital, delivered the moderated digital poster presentation of the study results.

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

As of July 1, 2025, 40 healthy subjects and mild hypertensive subjects were enrolled and randomized into 5 cohorts (each cohort had a 6:2 ratio of IBI3016 dose group to placebo group). All subjects were Chinese, with a median age (range) of 37 years (24-54 years), 30% female, mean BMI of 25.2 kg/m², and baseline 24-hour ambulatory blood pressure (BP) mean of 122/74 mmHg. There were no significant differences in baseline characteristics across treatment groups.

Single-dose administration of IBI3016 achieves sustained reduction in AGT levels and demonstrated initial blood pressure-lowering effects

• Following a single-dose administration, serum AGT levels were significantly and durably reduced, with a maximum reduction of over 95%, with sustained inhibition for up to six months: Cohorts 1–5 reached maximum suppression at approximately four weeks, the reductions were 91.7%, 91.4%, 94.7%, 96.2%, and 97.5%, respectively. At three months, the sustained serum AGT reductions were 91.2%, 90.0%, 93.8%, 96.5%, and 97.0% for Cohorts 1-5, respectively. At six months, the serum AGT reductions were 85.9%, 84.0%, 90.8%, 93.8%, and 96.4% for Cohorts 1-5, respectively.
• 3-months after administration, all treated cohorts demonstrated reductions in blood pressure: The 24-hour mean ambulatory daytime systolic/diastolic BP (SBP/DBP) changes from baseline were −8.8/-9.7, −2.1/0.8, −7.1/-5.5, −11.0/-12.5, and −16.7/-14.7 mmHg for Cohorts 1–5, respectively, compared to −3.2/-5.7 mmHg for placebo. Nighttime SBP/DBP changes were −9.4/-3.3, −7.1/-4.9, −15.1/-10.7, −11.6/-6.7, and −16.0/-12.9 mmHg for Cohorts 1–5, respectively, versus −5.0/-2.6 mmHg with placebo.

The safety profile was favorable, with no unexpected safety signals

• IBI3016 demonstrated favorable safety and tolerability over 6 months. No severe adverse events (AEs) or serious adverse events (SAEs) were observed, and no hypotension events occurred. All adverse events reported were mild to moderate in severity and reversible.

Dr. Haiyan Li, the Principal Investigator of the Study and Director of Peking University Third Hospital, stated: "Hypertension is the most prevalent non-infectious disease in China, and the estimated number of adults with hypertension in China is about 245 million. At the same time, hypertension is also the primary risk factor for an increased risk of cardiovascular disease and death. Millions of deaths from cardiovascular disease complicated by hypertension each year create a significant socio-economic burden. Although there are many oral drugs for the treatment of hypertension in clinical practice, there are still problems such as poor medication adherence and aldosterone escape, resulting in a low overall blood pressure control rate. With their unique molecular advantages, siRNAs targeting AGT offer the potential to improve patient adherence and address aldosterone escape by providing durable blood pressure reduction and upstream inhibition of the renin-angiotensin-aldosterone system (RAAS). I am pleased to see the Phase 1 results of IBI3016 presented at the AHA conference. IBI3016 has demonstrated favorable safety and preliminary efficacy in Phase 1 study, laying a solid foundation for subsequent clinical development."

Dr. Lei Qian, Chief R&D Officer of General Biomedicine from Innovent, stated: "Innovent is committed to becoming a leader in chronic disease therapeutics, bringing innovative medicines to patients. With their long-acting effects and stable efficacy, siRNA drugs have shown great application potential in chronic conditions such as cardiometabolic diseases that require sustained, long-term management. Leveraging SanegeneBio's expertise in siRNA drug discovery and Innovent's extensive clinical experience in cardiovascular and metabolic diseases, we have achieved positive results from the Phase 1 clinical study of IBI3016. The positive outcomes have reinforced our confidence as we advance to the next stage of clinical development. We will continue to uphold scientific rigor and high-quality, efficient clinical execution, collaborating closely with SanegeneBio to accelerate the development of this innovative therapy and bring meaningful benefit to people living with hypertension as soon as possible"

Dr. Yuyan Jin, Senior Vice President of Clinical and Non-Clinical Development at SanegeneBio, stated: "There is still a huge unmet clinical need for hypertension worldwide. IBI3016 as a transformative RNAi innovative therapeutic that promises to address existing issues such as poor adherence to traditional drugs and aldosterone escape. With the full cooperation and professional investment of the Peking University Third Hospital, Innovent and SanegeneBio, the Phase 1 study of IBI3016 has achieved encouraging preliminary results and orally reported at the international conference. The study demonstrates that IBI3016 exhibits a favorable safety profile, sustained AGT inhibition, and preliminary antihypertensive effects in both healthy subjects and patients with mild hypertension, strongly supporting its subsequent clinical development. In the future, we will continue to work closely with Innovent to efficiently implement the clinical development plan, strive to achieve positive results as soon as possible, fully release its therapeutic value, and bring more effective, safer and better compliant innovative treatment options to hypertensive patients."

About Hypertension

Hypertension is a common chronic disease, with 1.4 billion cases worldwide, but only about 20% of patients are effectively controlled through medication or lifestyle interventions ^[1]. High blood pressure not only increases the risk of cardiovascular and cerebrovascular diseases but can also lead to complications such as kidney damage and vision loss. The prevalence of hypertension is increasing globally with an aging population and the prevalence of risk factors such as obesity, physical inactivity, and unhealthy diet. At present, there are effective antihypertensive treatments in clinical practice, but antihypertensive drugs need to be taken every day, and hypertension is not easy to detect when the symptoms are not serious, which will cause patients to forget to take medicine, and poor compliance has become a major challenge in the treatment of hypertensive diseases. With breakthroughs in RNA interference technology and targeted delivery systems, siRNA therapies using GalNAc conjugation technology have shown great potential in the field of hypertension treatment. This innovative therapy is expected to completely change the traditional treatment model of hypertension patients who need to take "daily medication" by regulating the expression of disease-causing genes through long-term and precise regulation.

About IBI3016

IBI3016 (R&D code: SGB-3908) is a GalNAc-conjugated experimental RNAi-based medicine targeting AGT, jointly developed by Innovent and SanegeneBio for the treatment of hypertension. It is designed to inhibit the synthesis of AGT through RNA interference (RNAi). Preclinical trial data show that IBI3016 can inhibit the synthesis of AGT in the liver, which may lead to a lasting decrease in AGT protein, further leading to a decrease in Ang II, and ultimately dilating blood vessels and lowering blood pressure.

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 16 products in the market. It has 2 new drug applications under regulatory review, 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, 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).

About SanegeneBio

SanegeneBio is a global, venture-backed, fully-integrated biotechnology company focused on developing RNAi-based therapeutics. Founded in 2021, SanegeneBio is led by a team of RNAi pioneers with unrivaled experience in this Nobel Prize-winning technology. With R&D operations in Boston, Shanghai and Suzhou, our vision clear – RNAi technology will power blockbuster medicines in diverse therapeutic areas, improving the quality and longevity of life for countless patients in the coming years. Our fast-growing pipeline includes experimental medicines for autoimmune nephropathies, obesity, and cardiometabolic indications. SanegeneBio has initiated clinical trials for several experimental medicines, and is committed to developing potential best-in-class and first-in-class therapeutics which leverage our industry-leading and differentiated LEAD™ tissue-selective RNAi delivery technology. For more information, please visit: www.sanegenebio.com and engage with us on LinkedIn.

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References:

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

SOURCE Innovent Biologics