On December 30, 2024, Arnatar Therapeutics, a partner company of Apricot Capital, received clinical trial approval by default from the Center for Drug Evaluation (CDE) of the National Medical Products Administration for its self-developed new chemical entity Class I new drug, ART101 Injection (application number CXHL2401113). The drug is intended for the treatment of hypertension, marking an important step in the field of hypertension treatment. Ding Tai Group, also a partner company of Apricot Capital, served as the core partner for the non-clinical research work of the ART101 project.
About RAAS and ART101 InjectionRenin-Angiotensin-Aldosterone System (RAAS) InhibitorsHyperkalemia、Hypotension and acute renal failure and other adverse reactions.In addition, the existing oral antihypertensive drugs have a short half-life, resulting in poor patient medication adherence. Some even require combination therapy, increasing the risk of drug interactions and side effects.Disclosed preclinical and clinical studies show that targeting AGTOligonucleotide DrugsBy inhibiting the liver AGT mRNA level, the production of liver AGT can be reduced, thereby lowering the systemic AGT levels and achieving the purpose of blood pressure reduction.ART101 Injection, as an siRNA drug independently developed by Arnatar, reduces AGT protein production by targeting and inhibiting the expression of liver AGT mRNA, thereby achieving a blood pressure-lowering effect.Ding Tai Group Assists ART101 InjectionNonclinical Studies of Oligonucleotide DrugsDing Tai team provides full support for the non-clinical research of ART101 injection with leading professional technology, rich project experience and high-quality resources.We have completed the ART101 project in a compliant, high-quality, and efficient manner.Non-clinical pharmacokinetics and safety evaluation (covering general toxicology, local toxicity, immunogenicity and immunotoxicity, safety pharmacology and other tests) were conducted, and the registration application materials were written and consulting support services were completed with high quality and speed., laying a solid foundation for the successful clinical approval of this product.Under the trend of new drug project initiation, research and development, evaluation, and approval oriented by clinical value, the scientific planning and meticulous design of non-clinical and clinical study plans are crucial for the successful development of oligonucleotide candidate drugs.Ding Tai Group, with its profound accumulation in the field of oligonucleotide drugs, has assisted several new drug research and development enterprises both in China and internationally in achieving the rapid transformation of oligonucleotide drugs, covering multiple disease areas such as ophthalmology, the central nervous system, and metabolism.We continuously monitor the latest developments in non-clinical safety assessments, pharmacokinetics, and pharmacodynamics of oligonucleotide drugs, while deeply tracking the R&D progress, clinical development pathways, and regulatory review focal points of trending products.Ding Tai Group always adheres to the premise of scientificity and the guidance of pharmaceutical policies, committing to provide in-depth empowerment for oligonucleotide drug development with integrated services ranging from non-clinical to clinical stages, as well as registration submissions, helping new drug research enterprises accelerate innovation transformation and benefit a wide range of patients!Arnatar Therapeutics was founded in 2022 and is committed to becoming a high-tech innovative drug research and development enterprise with independent intellectual property rights, using novel antisense nucleic acid technologies (siRNA and ASO) as its platform. The founding team of Arnatar Therapeutics consists of world-renowned experts in the field of antisense nucleic acid pharmaceuticals and drug development, working alongside industry veterans with years of experience in RNA Biology, drug target selection, and small nucleic acid chemical synthesis. Currently, Arnatar Therapeutics is focusing on the research and development of innovative drugs based on novel antisense nucleic acid technology. The company actively promotes complementary cooperation with industry partners and academic institutions to accelerate drug development, striving to contribute to alleviating patient suffering.
Jiangsu Dingtai Drug Research (Group) Co., Ltd., established in 2008, is a novel CRO dedicated to providing integrated R&D solutions in specific disease areas for global pharmaceutical enterprises and research institutions.Ding Tai Group adheres to the values of integrity, focus, cooperation, and excellence, with the mission of focusing on scientific evaluation, facilitating innovation transformation, and improving the quality of life. Relying on a top-tier technical service team deeply rooted in the industry, through highly scientific and professional operational strategies, the group builds and refines corporate management, focusing on deep empowerment from disease mechanisms to disease models, non-clinical research, clinical medicine to clinical translation.
