Industry Pioneer and 'King of First-to-Generic' Forge $1B-Valued Partnership to Advance China's First Long-Acting siRNA Lipid-Lowering Drug

Dec 27, 2023 07:20 CST Updated 07:20

Ribo Life Science

Small Nucleic Acid Drug Developer

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

December 27, 2023 / eMedClub News /--Today, Suzhou Ribo Life Science Co., Ltd. ("Ribo Life Science") announced that it has signed a technology licensing agreement with Qilu Pharmaceutical Co., Ltd. ("Qilu Pharmaceutical"). Qilu Pharmaceutical will obtain the rights for clinical development, manufacturing, and commercialization of the anti-PCSK9 small nucleic acid new drug RBD7022 within Greater China. Ribo Life Science will receive an upfront payment and milestone payments totaling over 700 million RMB, as well as royalty rates in the high double digits.

RBD7022 is a GalNAc-conjugated siRNA drug developed by Ribo Life Science based on its proprietary RIBO-GalSTAR® liver-targeting delivery technology, aimed at treating hyperlipidemia. By inhibiting the expression of PCSK9 protein, it reduces lysosomal degradation of low-density lipoprotein receptors (LDL-R) and lowers LDL-C levels in the blood. It is intended for patients with familial hypercholesterolemia and ASCVD patients whose LDL-C levels remain inadequately controlled after statin therapy. The drug is currently in Phase I clinical trials.

Preclinical data show that RBD7022 has favorable safety characteristics and potent lipid-lowering effects. Its lipid-lowering action demonstrates stable lipid reduction levels and long-lasting efficacy, with a single dose maintaining effectiveness for several months. It can inhibit LDL-C by more than 50%, potentially achieving dosing intervals of several months or even longer, significantly enhancing patient compliance.

Overview of PCSK9 Small Nucleic Acid Drug Pipeline (Organized by E-Pharma Guest)

This is the first large-scale external licensing by Ribo Life Science in its 16-year history. As a leading pioneer and major player in China's small nucleic acid technology and small nucleic acid pharmaceuticals industry, Ribo Life Science has established an independent and fully integrated small nucleic acid drug R&D platform that supports the entire lifecycle of small nucleic acid drugs from early-stage research to industrialization. Its self-developed GalNAc small nucleic acid drug delivery technology platform, RIBO-GalSTAR®, features highly specific liver targeting, high efficiency, and long-lasting effects, making it internationally competitive.

Dr. Zicai Liang, founder and CEO of Ribo Life Science, stated: "Ribo Life Science has globally competitive capabilities and a rich pipeline layout in the cardiovascular metabolism field. We are very pleased to reach this collaboration with Qilu Pharmaceutical. Qilu Pharmaceutical possesses excellent new drug transformation and commercialization capabilities. We believe that this cooperation will significantly accelerate the clinical development and commercialization process of RBD7022, bringing innovative small nucleic acid therapies to Chinese patients as soon as possible."

The 3rd Nucleic Acid Drug Development Forum

Applications of Self-replicating mRNA in Cancer and Rare Diseases
Novel Lipid Nanoparticle mRNA Delivery System
Artificial Intelligence-Driven Personalized Immunotherapy for Tumors
Production and Quality Control of mRNA
Progress of the World's Innovative mRNA Product for HPV-Positive Head and Neck Cancer
Progress in mRNA Infectious Disease Drug Development
Development and Application of Circular RNA
Research Progress in the Development of siRNA Dual-Target Drug Design
Research Limitations and Trends of siRNA in Hepatitis B Treatment
The Modification of ASO and the Application of Self-Delivery Technology
Delivery and CMC Strategies for GalNAc-Conjugated Small Nucleic Acids
Advantages and Challenges of Engineered tRNA Design
saRNA Therapy and Delivery Technology of Small Nucleic Acid Drugs

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Collaboration, Speeches, Synchronous Recruitment Ongoing

Qilu Pharmaceutical's recent introduction of RBD7022 marks the only siRNA drug targeting PCSK9 in China to have entered Phase I clinical trials. Previously, Qilu Pharmaceutical also made strides in nucleic acid drug development, establishing a technical platform for nucleic acid vaccines or drugs that supports mRNA and siRNA drug discovery and preclinical research. Additionally, their nanomedicine technology platform enhances the capabilities of mRNA and siRNA therapies. In 2021, Qilu Pharmaceutical acquired the siRNA therapy AB-729 from Arbutus for up to $285 million, intended for the treatment or prevention of hepatitis B. The drug has now advanced to Phase II clinical trials, demonstrating strong efficacy along with good safety and tolerability.

Qilu Pharmaceutical has achieved remarkable success in fast-follow in recent years. Only this year, several blockbuster drugs such as Olaparib Tablets, Aflibercept Intravitreal Injection Solution, and Etanercept have been successfully launched. This pipeline introduction also aligns with Qilu Pharmaceutical's development strategy of "anchoring international pharmaceutical frontier technologies and fully exploring all potential opportunities in drug development for major disease areas."

Dr. Tao Weikang, Vice President of Qilu Pharmaceutical Group and General Manager of the Global Innovation R&D System, stated: "Qilu Pharmaceutical is striving to build an industry-leading innovative drug R&D pipeline. We are continuously making efforts in the field of chronic disease treatment, including cardiovascular diseases, to address unmet clinical needs by expanding and improving our product pipelines across different therapeutic areas. Ribo Life Science is a leader in China's small nucleic acid pharmaceuticals. We are very pleased to collaborate with Ribo Life Science, using local innovation to benefit a wide range of patients in China. We look forward to joining forces with Ribo Life Science in the small nucleic acid field to rapidly advance this highly promising innovative drug to market, tap into the Chinese market, and achieve win-win cooperation."

It is hoped that this powerful collaboration can accelerate the R&D progress of China-produced anti-PCSK9 small nucleic acid new drugs and open up a new era for China-produced long-acting lipid-lowering medications.

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