TIDES Weekly | Global Peptide and Oligonucleotide Therapeutics Highlights (April 4–10)
Ribo Life Science
Small Nucleic Acid Drug Developer
April 7, 2025Day，Suzhou Ribo Life Science Co., Ltd. ("Ribo Life Science") announced that RBD4059, its globally first-in-class and most advanced siRNA drug targeting FXI, has completed patient enrollment for the Phase IIa clinical trial.Marks an important step for Ribo Life Science towards becoming a leader in FXI inhibitor research and development.
FXI Inhibitors Show Promise in Addressing Significant Unmet Clinical Needs in Current Antithrombotic Therapy. RBD4059 achieves its anticoagulant/antithrombotic effect by inhibiting FXI and blocking the activation of the intrinsic coagulation pathway. Compared with current treatment options, FXI inhibition is expected to become a more effective antithrombotic therapy with a lower risk of bleeding.
The Phase IIa clinical trial of RBD4059 is being conducted at Ribo Life Science's own Phase II Clinical Trial Unit (CTU) located in Mölndal, Sweden. The center is managed by an experienced and well-trained medical research team responsible for clinical trials, utilizing advanced imaging and functional assessment technologies, with a focus on endpoint studies in Phase II clinical trials across cardiovascular, pulmonary, renal, and hepatic disease areas.
About Ribo Life Science
Ribo Life Science is an innovative R&D enterprise dedicated to developing RNA interference (RNAi) drugs and is the main pioneer and leader in China's small nucleic acid technology and small nucleic acid pharmaceuticals industry.
April 20257Day, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products AdministrationLatest announcement: Novartis' submissionInclisiran Sodium InjectionNew Indication Marketing Application Accepted.
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In August 2024, Novartis announced positive results from the Phase III V-MONO study. The study aimed to evaluate the efficacy and safety of inclisiran, administered twice yearly, compared to placebo and ezetimibe, in low- to medium-risk patients with atherosclerotic cardiovascular disease (ASCVD) who had not previously received lipid-lowering therapy. The results showed that the study met its primary endpoint, with inclisiran reducing patients' low-density lipoprotein cholesterol (LDL-C) levels.
AboutInclisiran Sodium
Inclisiran Sodium (Inclisiran) is a targetedPCSK9Small interfering RNA (siRNA) therapy, with injections administered twice a year, can reduceLow-Density Lipoprotein Cholesterol(LDL-C) is a long-acting lipid-lowering siRNA therapy.
About Novartis
Novartis is committed to envisioning the future of medicine, improving people's quality of life, and extending human lifespan.We provide high-value drugs that can reduce the greatest disease burden on society through our technological leadership in R&D and innovative accessibility initiatives.
April 20258Day，Lilly registered a Phase I clinical trial on the ClinicalTrials website,The purpose is in overweight or obese patientsEvaluationLong-acting Amylin (Amylin) AgonistEloralintide andEloralintide in combination with Tirzepatide (Tirzepatide) tolerance and side effects. The study drug will be administered via subcutaneous injection (SC). The study plans to enroll 188 patients and is expected to be completed in December this year.
About Tirzepatide
Tirzepatide is a novel therapeutic drug for diabetes, acting as a dual agonist of GLP-1 receptors and GIP receptors. Administered once weekly, it effectively improves glycemic control in patients with type 2 diabetes. Tirzepatide increases insulin secretion by activating the GIP receptor, aiding the body in utilizing and storing glucose more efficiently, thereby lowering blood sugar levels. Additionally, by activating the GLP-1 receptor, it enhances satiety, reduces appetite, assists patients in controlling their diet, and achieves weight loss effects. Tirzepatide has been approved in China for the treatment of obesity and type 2 diabetes.
About Eli Lilly and Company
Eli Lilly and Company is a globally leading pharmaceutical company engaged in the research, development, production, and sales of medicines, dedicated to improving human health through innovation.
Recently，Novo NordiskThe company announced plans to invest up to USD 1.09 billion (approximately DKK 6 billion) in expanding its existing plant in Montemor, Brazil. This newly built production base will mainly focus on its core products: GLP-1 class hypoglycemic drugs.OzempicAnd the weight-loss drug Wegovy.
According to the company's plan, the production base is expected to be completed by 2028 and will create more than 500 high-tech jobs. Novo Nordisk's investment in Brazil this time is one of the largest pharmaceutical investments in history. This huge amount of fundsWill be used to introduce advanced aseptic production processes, expand warehouse capacity, and build new high-quality control laboratories.
About Novo Nordisk
Novo Nordisk was founded in 1923 and is a global leading biopharmaceutical company headquartered in Copenhagen, the capital of Denmark. Our goal is to drive change to defeat diabetes and other serious chronic diseases such as obesity, rare blood disorders, and endocrine disorders.
April 20259Day，Jingyin Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its new drug SRSD216, allowing clinical trials to proceed. This significant milestone marks another crucial step forward for Jingyin Pharmaceuticals in addressing unmet medical needs of patients with atherosclerotic cardiovascular disease (ASCVD) globally. Notably, the Phase I clinical trial in China has already completed the dosing of its first subject on April 8.
About ASCVD and Hyperlipoproteinemia(a)
Atherosclerotic cardiovascular disease (ASCVD) is the most common cause of death worldwide. Dyslipidemia is considered a key factor in the development of ASCVD. DespiteLow-Density Lipoprotein Cholesterol(LDL-C) has always been regarded as the primary lipid indicator and intervention target for ASCVD. However, numerous studies have shown that lipoprotein(a) [Lp(a)] is an independent risk factor for ASCVD and is not influenced by age, diet, or exercise. Currently, lipid-lowering drugs have limited effects on reducing Lp(a). Therefore, there is a significant unmet clinical need for drugs that directly target Lp(a).
AboutSRSD216 Injection
SRSD216 Injection is a novel double-stranded small interfering ribonucleic acid (siRNA). It specifically modulatesLPAGenes reduce the production of hepatic Apo(a) and lower the levels of circulating Lp(a). Preclinical in vivo studies have shown that a single administration reduced Lp(a) levels by nearly 100%, with effects lasting over six months, and no significant safety events were observed.
AboutJingyin Pharmaceuticals
Sirius Therapeutics) is a clinical-stage biotechnology company with a mission for human health and well-being, focusing on the global development of next-generation nucleic acid innovative therapies in the field of cardiometabolic diseases, striving to become a leader in revolutionizing chronic disease prevention and treatment.
2025On April 10, Novartis, a globally leading innovative pharmaceutical company, announced plans to invest $23 billion in U.S. infrastructure over the next five years to ensure that all critical drugs provided by Novartis for American patients will be manufactured in the United States. This commitment will allow Novartis to expand its existing manufacturing, research, and technology operations nationwide, with 10 facilities, including seven brand-new ones.The plant has created nearly 1,000 new jobs for Novartis and in the United States.Approximately 4,000 jobs have been added. Production capacity will cover active pharmaceutical ingredients (APIs) and biologic drug substances, as well as secondary production and packaging.
In the next five years, Novartis will:
Establishment of a Biomedical Research and Innovation Center in San Diego, California, as its second global R&D center in the United States
Build four new production facilities in the state to be confirmed, three of which will produce biologics, active pharmaceutical ingredients, drug assembly and packaging, and one will produce chemical active pharmaceutical ingredients, oral solid dosage forms and packaging.
Building Two New Radioligand Therapy (RLT) Manufacturing Plants in Florida and Texas
Expansion of three RLT manufacturing plants in Indianapolis, Indiana, Millburn, New Jersey, and Carlsbad, California
About Novartis
Novartis is committed to reimagining medicine to improve people's quality of life and extend human lifespan.We provide high-value drugs that can reduce the greatest disease burden on society through our technological leadership in R&D and innovative accessibility initiatives.