Rebio Biotech submitted to the Hong Kong Stock Exchange, leading nucleic acid drug company expected to debut on the capital market.

On April 25th, Suzhou Ruibo Biotechnology Co., Ltd. (hereinafter referred to as "Ruibo Biotechnology" or "the Company") officially submitted the A1 listing application to the Hong Kong Stock Exchange. Established in 2007, Ruibo Biotechnology focuses on the development of RNA interference (RNAi) technology and the industrialization of nucleic acid drugs, and is one of the earliest pioneers in this field globally. In the course of its development, the company has received strategic investments from well-known institutions such as Junlian Capital, Guotou Innovation, Guofeng Investment, and Panlin Capital. Focusing on siRNA breakthrough therapy, leading the wave of nucleic acid drug development in China After small molecules and antibody drugs, nucleic acid drugs as a new treatment paradigm are forming the third wave of modern pharmaceuticals, with over 20 nucleic acid drugs approved for market globally. According to Frost & Sullivan data, the global nucleic acid drug market is expected to grow from $2.7 billion in 2019 to $4.6 billion in 2023, with a compound annual growth rate of 14.3%. With constant technological advancements, increasing approvals for market entry, and continuous clinical validation, the global nucleic acid drug market is expected to accelerate its growth, reaching $46.7 billion by 2033. Among nucleic acid drugs, small interfering RNA (siRNA) drugs are the most disruptive direction in nucleic acid drug development, with the potential to break the traditional high-risk research and development model of innovative drugs. On one hand, siRNA technology can increase the clinical development success rate from less than 10% for traditional drugs to over 60%. On the other hand, it can significantly shorten the development cycle, with only 20-24 months from target identification to clinical application. Additionally, for many patients with chronic diseases, the long-acting mechanism of siRNA drugs allows for a single dose to maintain efficacy for 6-12 months, greatly improving treatment outcomes and patient compliance. Internationally, companies that have positioned themselves in siRNA therapy include Alnylam, Arrowhead, Novartis, Novo Nordisk, among others. Ruibo Biotechnology, which submitted its application to the Hong Kong Stock Exchange, is the Chinese company with the most clinical stage assets in the nucleic acid drug sector, and has established a rich pipeline of siRNA drugs through independent innovation, covering multiple diseases including cardiovascular, metabolic, renal, liver diseases, especially in the treatment of chronic diseases. The market for chronic disease treatment still has significant unmet patient needs, with long-acting treatment options represented by nucleic acid drugs being considered a new breakthrough in the field of chronic diseases. In 2021, Novartis' siRNA drug Inclisiran, targeting the PCSK9 protein, was approved by the FDA for the treatment of high cholesterol levels, with only two subcutaneous doses needed per year, demonstrating the potential of nucleic acid drugs in the field of chronic disease treatment. Currently, several nucleic acid drugs are being developed globally for the treatment of conditions such as high lipid levels, hypertension, high blood sugar, signaling the start of a new competition in the development of chronic disease treatments. According to the prospectus, Ruibo Biotechnology currently has six self-developed siRNA drugs in clinical trial stages, targeting seven indications, with four entering phase 2 clinical trials; there are also more than 20 early-stage assets in continuous advancement. The company's core product RBD4059, for cardiovascular, metabolic, and kidney diseases, is the first globally to advance to clinical trials and has the fastest progress (First-In-Modality); the key product RBD5044 has Best-In-Class potential; the key product RBD1016 in the field of liver diseases is essential for combined therapy for hepatitis B virus and key to achieving functional cure. Other pipeline candidates also have global leading FIC or BIC potential. Ruibo Biotechnology's core product RBD4059 is the first siRNA drug globally developed for the treatment of thrombotic diseases and has the fastest clinical development progress, currently in phase 2 clinical trials. RBD4059 works by inhibiting FXI and blocking the activation of the endogenous coagulation pathway to achieve its anticoagulant/antithrombotic effects, not only expected to become a more effective antithrombotic treatment method, but also with the advantage of lower bleeding risks. Its long-acting nature allows for low frequency administration to improve patient compliance, making it the best treatment choice for a large number of thrombotic disease patients. Thrombotic diseases have become one of the leading global causes of death, with one-fourth of global deaths related to thrombotic diseases. According to Frost & Sullivan data, by 2023, there will be approximately 383 million thrombotic disease patients globally, expected to increase to 414 million by 2033. Currently, there is no approved FXI-targeting drug for the treatment of thrombotic diseases globally. In October 2024, RBD4059 completed phase 1 clinical trials with healthy subjects in Australia, and obtained approval from the European Medicines Agency (EMA) to initiate phase 2a clinical trials in August of the same year. In February 2025, patients were enrolled in the phase 2a trial, with an expected completion by the end of 2025. In the field of high lipids, Ruibo Biotechnology's key drug in development, RBD5044, is the second globally to enter clinical development targeting APOC3 with siRNA, holding the best potential among similar siRNA candidates for the treatment of high triglyceride levels. According to Frost & Sullivan data, the estimated global prevalence of adult lipid abnormalities is around 40%, affecting approximately 3 billion people annually, with high triglyceride levels accounting for 25% of all cases. By 2023, approximately 800 million people around the world are affected by high triglyceride levels, expected to reach 900 million by 2033. However, existing treatments for high triglyceride levels have certain limitations, such as liver toxicity, myopathy, gastrointestinal disturbances, and pancreatitis risks. As of December 31, 2024, there is no approved APOC3-targeted therapy for the treatment of high triglyceride levels. RBD5044, with its low frequency administration and long-lasting efficacy using siRNA therapy, is expected to provide a more convenient treatment choice for patients compared to the paradigm of daily dosing. Additionally, Ruibo Biotechnology's RBD7022, the second globally to enter clinical development, also holds promising prospects for the treatment of high cholesterol levels associated with PC (PCSK9 protein.)SK9 targeted siRNA. As of now, the only approved PCSK9 targeted siRNA drug for treating high cholesterol is Inclisiran, with a global sales of 754 million USD in 2024, a year-on-year growth rate of 112%. The preclinical and Phase 1 clinical trial results of RiboBio's RBD7022 have shown comparable LDL-C reduction effects to Inclisiran, highlighting its potency, long-lasting effects, and potential for dosing once every six months, making it a strong competitor in the field. In addition, the company has reached an exclusive agreement with Shandong Qilu Pharmaceutical Co., Ltd. ("Qilu Pharmaceutical") in December 2023 for the development, production, and commercialization of RBD7022 in mainland China, Hong Kong, and Macau, with a total transaction amount of 700 million RMB.Another key R&D product of the company, RBD1016, is a siRNA candidate drug for the treatment of chronic hepatitis B, and is an important pillar therapy for achieving functional cure of hepatitis B in the future. The results of the phase 1 clinical trial of RBD1016 have confirmed that HBsAg continued to decrease after a single dose, demonstrating good safety and tolerability. The phase 2a clinical trial of RBD1016 has completed enrollment of all clinical trial patients in November 2024. As of now, no siRNA drug has been approved globally for the treatment of chronic hepatitis B. It is worth mentioning that the above important R&D products of Ribo Bio have been developed using the company's independently developed RiboGalSTAR liver-targeted delivery platform, representing the global innovative technological frontier and demonstrating good safety, efficacy, and prolonged action in clinical studies so far. As one of the earliest domestic enterprises focusing on the development of nucleic acid drugs, Ribo Bio has established a strong global intellectual property portfolio. As of December 31, 2024, Ribo Bio has a total of 458 patents in major jurisdictions including China, the European Union, the United States, and Japan, including 229 granted patents and 229 patents pending, covering nucleic acid sequences, chemical modifications, targeted delivery technologies, combination therapies, and clinical applications, making it one of the companies with the most patents in the global nucleic acid drug industry. Driven by a global R&D strategy and management team, self-developed technology platforms have been recognized by multinational pharmaceutical companies. Ribo Bio has established mature clinical professional teams and clinical trial bases in Europe through its global strategy, evolving from a biotechnology company to an international pharmaceutical company, successfully entering the forefront of the global nucleic acid drug industry. In the competitive global biopharmaceutical landscape, Ribo Bio's development is attributed to its dual driving forces of global R&D strategy and international management team. The management team assembled by the company possesses deep international perspectives and industry-leading expertise, with each member having decades of experience in multinational pharmaceutical companies, injecting strong strategic decision-making and execution capabilities into the company. In terms of research and development system construction, Ribo Bio has built a global research and development network. A team of nearly 300 R&D personnel, led by international experts who have served as executives in global multinational companies, is focused on drug discovery and pre-clinical research in China. The Beijing R&D center, relying on independently developed core technology platforms and advanced experimental equipment, continuously explores innovative targets, while the Suzhou R&D center focuses on drug chemistry and CMC development and production, providing solid comprehensive support from laboratory research to clinical trials. Ribo Bio is one of the few nucleic acid drug development companies with comprehensive self-owned CMC capabilities globally, not only possessing advanced process development, chemical analysis, technology transfer, and regulatory filing integrated systems, but also having production lines that meet EU GMP standards and are QP certified, supporting the company's drug development from early research to Phase 3 clinical trials. In its overseas layout, the Swedish research center Ribocure AB acts as a strategic pivot, integrating research facilities with the Ribocure Clinic CTU clinical trial base, strictly following international regulatory and ICH standards. Ribocure AB has independently initiated two phase 2 clinical trials, with an expected enrollment of over 100 patients, significantly enhancing clinical research efficiency and quality. In addition, the company has made groundbreaking progress in liver-targeted delivery technology with its RiboOncoSTAR technology platform, a globally leading tumor-targeting technology platform that supports the development of various potential first-in-class oncology therapies. The RiboPepSTAR technology platform, targeting other extrahepatic tissues, has observed significant therapeutic effects superior to existing treatment methods in multiple disease models in the kidney and central nervous system, with good safety. Relying on advanced technology platforms, Ribo Bio has reached the only technology platform-based cooperation in the RNAi field between a Chinese biotechnology company and a global multinational company to date, with a total transaction value exceeding $2 billion. The authorization of technology platform cooperation is more meaningful than single species authorization, demonstrating multinational pharmaceutical companies' high recognition of Ribo Bio's research platform and scientific research capabilities. In January 2025, Ribo Bio announced the achievement of the first milestone in its collaboration with Boehringer Ingelheim, highlighting once again the solid technology platform of the company, as well as the excellent international cooperation capabilities of the team in less than a year since the project started. From technological breakthroughs to global pipeline layout, from independent research and development to international collaboration, Ribo Bio has been deeply cultivating the field of nucleic acid drugs for 18 years. Currently, the company has established a unique competitive barrier in the global nucleic acid pharmaceutical race and is accelerating towards becoming a leading global biopharmaceutical company. In the future, Ribo Bio will continue to innovate and globalize, accelerating towards the deep sea of biopharmaceuticals, bringing more groundbreaking treatment solutions to global patients, filling clinical treatment gaps, writing a new chapter in the development of Chinese nucleic acid drug research and development, and driving Chinese RNAi technology to the forefront of the world.