On Dec. 27, 2023, Sanegene Bio USA Inc. (SanegeneBio) and Innovent Biologics, Inc. (Innovent) announce that they have entered into a collaboration agreement to co-develop SGB-3908, an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension. Innovent also obtains an exclusive option to license in the future development, manufacturing and commercialization rights of SGB-3908.

SGB-3908 is an IND-enabling stage siRNA drug developed based on SanegeneBio's proprietary LEAD™ (Ligand and Enhancer Assisted Delivery) platform. Under the terms of the agreement, both parties will be jointly responsible for the development of SGB-3908 to certain stage. Innovent will receive an exclusive option to pay different option exercise fees to obtain the exclusive development, manufacturing, and commercialization license of SGB-3908 in different areas worldwide. After Innovent exercises its option, SanegeneBio will be eligible to receive subsequent milestone payments, as well as tiered royalties based on net sales.

Both parties will leverage their respective strengths, combining the cutting-edge RNA technology strength of SanegeneBio, and Innovent’s rich clinical development experience and established commercialization capability to accelerate the development and ensure the commercial success of this innovative siRNA drug candidate so that it can benefit more hypertension patients as early as possible.

“SGB-3908 utilizes the company's LEAD™ platform technology with independent intellectual property rights. Through the modular design of delivery ligands, delivery enhancer, sequence-dependent and position-specific chemical modifications, it can accurately knockdown the mRNA and protein expression levels of disease-causing genes and maintain excellent drug potency and efficacy duration. We are delighted to collaborate with Innovent on this promising asset. Innovent has deep expertise in R&D and extensive experience in clinical development and commercialization, combined with the advanced siRNA drug discovery technology of SanegeneBio, it will help us to unlock the full potential of RNAi technology, accelerate the clinical development and commercialization of our pipeline, and meet the unmet medical needs of the hypertension patients.” said Dr. Weimin Wang, founder and chief executive officer of SanegeneBio.

“We are delighted to collaborate with SanegeneBio in developing the AGT siRNA drug candidate for the treatment of hypertension. Innovent strategically invested in the CVM area years ago, and has advanced multiple new-generation pipeline assets into late-stage development. SINTBILO® (anti-PCSK9 monoclonal antibody) has been approved for the treatment of hyperlipidemia, mazdutide (GLP-1R/GCGR dual agonist) for the treatment of diabetes and obesity is about to submit its first NDA, IBI311 (IGF-1R monoclonal antibody) for the treatment of thyroid eye disease has entered into a Phase 3 clinical trial, and IBI128 (XOI inhibitor) for the treatment of hyperuricemia is also in global Phase 3 clinical trials. This collaboration further broadens Innovent 's strategic presence in the CVM area. SGB-3908 has entered into the IND-enabling stage, and we look forward to working with SanegeneBio to advance the development of this drug as soon as possible, hoping to bring the innovative treatment to the broad hypertension patients.” said Dr. Yongjun Liu, President of Innovent.

AGT is the upstream precursor in the Renin-Angiotensin-Aldosterone System (RAAS), a cascade which has demonstrated function in blood pressure regulation, and the inhibition of AGT has shown well-established anti-hypertension effects. SGB-3908 can inhibit the synthesis of AGT in the liver, potentially leading to durable reductions of AGT protein, further causing a decrease in angiotensin (Ang) II, and ultimately resulting in vasodilation and lowering blood pressure.

Hypertension is a common chronic disease that currently affects over 1 billion people worldwide. It not only increases the risk of cardiovascular and cerebrovascular diseases while also potentially leading to complications such as kidney damage and impaired vision. With the aging population and the prevalence of risk factors such as obesity, lack of physical exercise, and unhealthy diet, the prevalence of hypertension is still increasing globally. There are effective anti-hypertension treatments in clinical practice, however, these treatments have some disadvantages, for example the anti-hypertension drugs need to be taken every day, and hypertension is difficult to perceive when symptoms are not severe, which can lead to noncompliance in taking medicine. Poor compliance has become a major challenge in the treatment of hypertension, with less than 20% of hypertension patients achieving long-term effective control ^[1]. As an alternative solution to address this challenge in the treatment of hypertension, siRNA drugs can directly knockdown the expression of AGT, with the advantages of long efficacy duration, good safety, and high compliance, thus is expected to bring better treatment options and long-term benefits to patients.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to discover and develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to discovering and developing, manufacturing and commercializing high-quality innovative medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, and ophthalmology diseases to enhance the quality of the patients' lives. Innovent has 10 products in the market, including TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules ), FUCASO® (Equecabtagene  Autoleucel Injection) and SINTBILO® (Tafolecimab Injection). Additionally, we have 2 NDA under NMPA review, 5 assets in Phase III or pivotal clinical trials, and 19 more molecules in early clinical stage.

Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. We strive to work with many collaborators to help advance the biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives.

About SanegeneBio

SanegeneBio is an emerging RNAi-based company developing innovative RNA interference (RNAi) therapeutics driven by the cutting-edge delivery technology. Founded in 2021, SanegeneBio was led by a team of industry-leading experts and has operations in both the US and China. Since its incorporation, SanegeneBio has successfully established proprietary chemical modification platform, hepatic and extrahepatic delivery platforms, enabling tissue-specific delivery of a wide range of RNA therapeutics to efficiently knock down disease-causing genes. Our fast-growing RNAi portfolio covers a broad range of therapeutic areas including cardiovascular and metabolic diseases, immunology-related diseases, and nervous system diseases. Among them, our first RNAi drugs have entered into the clinical stage, and several pipelines are in progress simultaneously. SanegeneBio is committed to developing transformational RNAi medicines through striving for scientific innovation to address unmet medical needs worldwide and change the lives of patients and families. For further information, please visit: www.sanegenebio.com  and engage with us on LinkedIn.

For further information about SGB-3908, please visit: 1) The clinical trial application of an siRNA drug developed by SanegeneBio and Innovent for the treatment of hypertension has been accepted by the CDE; 2) SanegeneBio and Innovent Announce FPD in a Phase 1 Clinical Trial of SGB-3908

Reference：

[1] Global report on hypertension: the race against a silent killer, WHO 2023, https://www.who.int/publications/i/item/9789240081062