Sanegene Bio

At SanegeneBio, our awesome scientific teams in Boston and Suzhou/ Shanghai are advancing a differentiated pipeline powered by our proprietary and novel LEAD™ RNAi platform.  Today, we are announcing expansion of our management team with the appointment of Marc Abrams, Ph.D. as Chief Technology Officer and Head of US Operations. Marc brings 20 years of leadership experience in oligonucleotide therapeutics and targeted delivery of genetic medicines, most recently as CSO of Carbon Biosciences and SVP of Discovery Research at Dicerna Pharmaceuticals (a Novo Nordisk company). He has also held several roles of increasing responsibility at Merck and Co., Inc., and has served on our Scientific Advisory Board. Together, we are committed to developing life-changing RNAi therapeutics.

On December 10, 2024, Sanegene presented promising preclinical and phase I clinical trial results for its siRNA therapeutic, SGB-9768, targeting complement factor C3, at the 8th Complement-Based Drug Development Summit held in Boston, USA. This drug aims to lower complement factor C3 levels to treat various complement-mediated diseases, including IgA nephropathy, C3 glomerulopathy, immune-complex-mediated membranoproliferative glomerulonephritis, dry age-related macular degeneration, paroxysmal nocturnal hemoglobinuria, and other renal and hematologic disorders. SGB-9768 is expected to become the "first in China and a globally leading" siRNA drug targeting complement factor C3. Sanegene is conducting a randomized, double-blind, placebo-controlled, single ascending dose Phase I study in both New Zealand and China. The primary objective is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SGB-9768 in healthy subjects. The first subjects were dosed in May 2024 in New Zealand and in August 2024 in China. As of December 1, 2024, a total of 55 subjects have been randomized to receive either SGB-9768 or placebo. Trial data indicate that after a single subcutaneous injection, SGB-9768 demonstrated good safety and tolerability. Additionally, a dose-dependent, significant, and sustained reduction in C3 levels and complement pathway activity was observed. Compared to other siRNA products targeting the same pathway, SGB-9768 demonstrates greater C3 target protein knockdown at lower doses. Dr. Yuyan Jin, Senior Vice President of Clinical and Non-Clinical Development at Sanegene, stated: "SGB-9768 utilizes Sanegene's proprietary GalNAc liver-targeting delivery platform, which ensures excellent safety and positions us at the forefront of global innovation in siRNA therapeutics for complement-mediated diseases. The latest Phase I clinical trial data further reinforced SGB-9768's potential as a breakthrough siRNA therapy, offering new treatment options for patients with complement-mediated kidney diseases, ophthalmic diseases, and hematologic disorders. These results also validate the safety and efficacy of our in-house GalNAc platform in humans. We are highly encouraged by these findings and looking forward to advancing subsequent clinical trials. We believe SGB-9768 will continue to demonstrate its potential as a 'best-in-class' C3-targeting siRNA drug." For further information please visit: https://lnkd.in/gDx2MKTx

We hereby announce that our Chief Executive Officer, Dr. Weimin Wang will present the latest developments on our LEAD™ technology at RNA LEADERS USA CONGRESS on September 5. #RNALeaders https://lnkd.in/dhTfJ4VB

On Aug. 6th, 2024, SanegeneBio announced the first subject dosed in a Phase I clinical trial of SGB-9768 in Huashan Hospital of Fudan University in Shanghai, China.   SGB-9768 is an siRNA drug candidate targeting the complement component 3 (C3) mRNA for the treatment of complement-mediated kidney diseases. The Phase I clinical trial is a randomized, double-blind, placebo-controlled, and single ascending doses (SAD) study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SGB-9768 in healthy volunteers. Preclinical studies have demonstrated that SGB-9768 has superior potency, safety and tolerability profile than benchmark compounds. SGB-9768 has the advantages of low dosing frequency and long-term efficacy. Since entering the Phase 1 clinical trial in New Zealand in early 2024, SGB-9768 has been dosed in multiple cohorts of subjects, demonstrating a favorable safety and tolerability profile.   Dr. Yuyan Jin, Senior Vice President of Clinical and Non-Clinical Development at SanegeneBio, stated: "This is another important milestone for SGB-9768. The rapid initiation and progress would not be possible without the strong support from the research center at Huashan Hospital of Fudan University, as well as the great efforts of our teams. This also shows that SanegeneBio is in a leading position in the R&D of innovative siRNA drugs for the treatment of complement-related diseases. SGB-9768 is developed using SanegeneBio's proprietary GalNAc platform with a favorable safety profile. We look forward to the performance of SGB-9768 in the clinical trials, and hope that SGB-9768 can bring more and better treatment options to the global patients with complement-mediated diseases." For further information, please visit: https://lnkd.in/gYzmYkjQ

On Aug 2nd, 2024, SanegeneBio and Innovent today announced the first participant has been successfully dosed in a Phase 1 First-in-Human (FIH) clinical trial of SGB-3908.   SGB-3908 (Innovent's R&D code: IBI3016) is an siRNA drug candidate targeting Angiotensinogen (AGT) for the treatment of hypertension. Preclinical studies have demonstrated that SGB-3908 significantly reduces serum AGT protein levels and associated biomarkers (ANG I, ANG II) in hypertensive cynomolgus monkeys, resulting in marked and sustained blood pressure reduction without observed safety concerns such as hypotension. SGB-3908 is developed using SanegeneBio's next-generation proprietary siRNA technology platform, which enhances drug potency and durability while maintaining favorable safety and tolerability profiles. In December 2023, SanegeneBio and Innovent entered into a strategic collaboration to co-develop SGB-3908. Innovent also maintains an exclusive option to license the future development, manufacturing and commercialization rights of SGB-3908.   This FIH study (NCT06501586) is a Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses (SAD) of SGB-3908 in healthy volunteers and patients with mild hypertension, aiming to support the further clinical development of SGB-3908.   Dr. Yuyan Jin, Senior Vice President of Clinical and Non-Clinical Development at SanegeneBio, stated: "Hypertension represents a significant unmet clinical need globally. SGB-3908, as a transformative RNAi therapy, has demonstrated superior drug activity, sustained efficacy, and favorable safety and tolerability profiles in preclinical studies. The rapid initiation and progress of the Phase 1 study of SGB-3908 would not have been possible without the strong support from the research center at Peking University Third Hospital, as well as the collaborative efforts of the clinical teams at Innovent and Sanegene. We look forward to continued close collaboration with Innovent as we diligently execute the clinical development plan for SGB-3908 and achieve positive outcomes. Our ultimate goal is to fully realize the therapeutic potential of SGB-3908, offering a more effective, safer, and patient-friendly treatment option for individuals with hypertension." For further information, please visit: https://lnkd.in/gkhf3EEJ

This year is SanegeneBio's 3rd year anniversary. We are Celebrating! Happy birthday to SanegeneBio.   In the past three years, SanegeneBio has made many outstanding achievements with the team efforts. Entering the next milestone, we will continue working together to keep moving forward towards our mission of "becoming a world-class RNAi biopharmaceutical innovator and serve patients in need worldwide".

SanegeneBio's two siRNA drugs were approved for clinical trial in China Recently, SanegeneBio announced that the clinical trial applications of SGB-9768 injection and SGB-3908 injection were approved in China.   SGB-9768 is an siRNA drug targeting the complement component 3 (C3) protein for the treatment of complement-mediated kidney diseases, which was approved for Phase I clinical trial in New Zealand in February 2024. SGB-9768 is delivered to liver using SanegeneBio's proprietary novel GalNAc platform technology, to reduce C3 through RNA interference, thereby inhibiting the complement pathway activity. The preclinical data showed that SGB-9768 could be administered every 3 or 6 months and continuously reduce C3 level, and has superior potency than benchmark compounds, with good safety and tolerability profile. SGB-9768 has the advantages of low dosing frequency and long-term efficacy, and could potentially become China's first and world-leading siRNA drug targeting C3.   SGB-3908 is an siRNA drug targeting Angiotensinogen (AGT) for the treatment of hypertension. SGB-3908 is delivered to liver using SanegeneBio's proprietary novel GalNAc platform technology, to 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. The preclinical data showed that SGB-3908 significantly reduced the AGT protein and related biomarkers (ANG I, ANG II) in the serum of cynomolgus monkeys with hypertension, achieving a significant long-term antihypertensive efficacy without safety issues such as low blood pressure.   “SGB-9768 and SGB-3908 have the potential to be life-transforming RNAi therapeutics for the treatment of complement-mediated kidney diseases and hypertension respectively, and the quick approval of clinical trial applications has again demonstrated the operation efficiency and dedicated efforts of SanegeneBio team, which is of great significance for us as a biotech with 3-years history. We will advance the clinical trials of these two drug candidates rapidly and make positive progress, aiming to provide more and better treatment options for patients worldwide.” said Dr. Weimin Wang, Founder and Chief Executive Officer of SanegeneBio. To learn more about Sanegenebio, please visit our website: https://lnkd.in/gG7kXbtt

The clinical trial application of an siRNA drug developed by SanegeneBio and Innovent for the treatment of hypertension has been accepted by the CDE On May 8, 2024, SanegeneBio announced that the clinical trial application of SGB-3908 injection, an siRNA drug for the treatment of hypertension, has recently been officially accepted by the China Center for Drug Evaluation (CDE) of the National Medical Products Administration. SGB-3908 is an siRNA drug targeting Angiotensinogen (AGT) for the treatment of hypertension. The preclinical trial data showed that SGB-3908 significantly reduced the AGT protein and related biomarkers (ANG I, ANG II) in the serum of cynomolgus monkeys with hypertension, achieving a significant long-term antihypertensive efficacy without safety issues such as low blood pressure. SGB-3908 utilizes SanegeneBio's proprietary innovative siRNA drug platform technology, providing the drug with excellent potency and duration, as well as good safety and tolerability. "We are delighted that SGB-3908 has reached another important milestone, which demonstrates the execution efficiency of our team and further enriches SanegeneBio's product portfolio in cardiovascular and metabolic diseases. It is the close cooperation and concerted effort of both parties in the past months that drives the rapid progress of this project. We look forward to keeping the momentum of great cooperation between both parties to accelerate the clinical trial of SGB-3908, and benefit the hypertensive patients as soon as possible with better treatment options." said Dr. Weimin Wang, Founder and Chief Executive Officer of SanegeneBio. About SGB-3908 SGB-3908, an siRNA-GalNAc conjugate targeting Angiotensinogen (AGT) for the treatment of hypertension, is delivered to liver using SanegeneBio's novel LEAD™ GalNAc platform to inhibit the synthesis of AGT in the liver through RNA interference. 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. In December 2023, SanegeneBio and Innovent jointly announced that they entered into a collaboration agreement to co-develop SGB-3908, and Innovent obtained an exclusive option to license in the future development, manufacturing and commercialization rights of SGB-3908 in different regions.

SanegeneBio siRNA drug targeting C3 has been approved for Phase I clinical trial in New Zealand Sanegene Bio Inc. (SanegeneBio) announced that its siRNA drug SGB-9768 for the treatment of complement mediated diseases has recently been approved by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and the Health and Disability Ethics Committee (HDEC) to conduct Phase I clinical trial in New Zealand. SGB-9768 is a RNAi drug targeting the complement C3 (C3) protein, and is SanegeneBio's second siRNA drug to enter into clinical development. SGB-9768, an siRNA-N-acetylgalactosamine (GalNAc) conjugate targeting C3, is delivered to liver using SanegeneBio's novel LEAD™ GalNAc platform to reduce production of complement component 3 through RNA interference. The advantages of GalNAc platform have been also fully verified, including safety, effectiveness, and stability. SGB-9768 can be administered every 3 or 6 months, with the advantages of low dosing frequency, good patient compliance, and long-term efficacy. SGB-9768 can continuously reduce C3 synthesis and has been shown in preclinical studies with superior efficacy than benchmark compounds, , showing its potential to be the best-in-class siRNA drug targeting C3. The Phase I, randomized, double-blind, placebo-controlled, and single-dose escalation study is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of SGB-9768 in adult healthy volunteers. "SGB-9768 is SanegeneBio’s first siRNA drug in the field of immune related diseases to enter into the clinical development, using our proprietary LEAD™ GalNAc delivery platform, and has demonstrated excellent potency, duration, and safety in the preclinical studies. We will accelerate the phase I clinical trial of SGB-9768 and look forward to the verification and demonstration of the excellent compound in clinical as soon as possible. At the same time, SanegeneBio will continue to deeply explore the full potential of C3 program, push forward its development in various complement mediated diseases, and provide more and better treatment options for patients with immune related diseases." said Dr. Weimin Wang, Founder and Chief Executive Officer of SanegeneBio.

Say hello to our new logo! Since its establishment, SanegeneBio has achieved rapid growth. In 2024, this will be a new chapter in our development. Today we're launching a new logo. The new logo is based on the initial letters "S" and "g" of the company name "Sanegene" and revolves around the core concept of "innovation, pioneering and responsibility". We believe that gene, sail and white dove can interpret our brand image. At the same time, we use brighter blue and red to convey our notion that we are not only technological and rigorous, but also energetic and warm. The new logo presents the core value of SanegeneBio in a more intuitive manner, vividly reflecting SanegeneBio's vision of "Realize full potential of RNAi technology. Bring life-changing RNA medicines to reality".