On September 14, Yayo Biotech received an FDA IND clinical approval (IND173030) for its independently developed Class 1 innovative drug, ATR kinase inhibitor YY2201 tablets. The approved indication is for the treatment of advanced solid tumors.
Image source: FDA approval document
Shanghai Medicilon Inc. (Medicilon), as a partner of Yayo Biotech, provided comprehensive R&D services for the development of YY2201 tablets. These services included pharmaceutical research (covering both APIs and formulations), preclinical studies (including pharmacokinetics and safety evaluation), and IND registration submission, fully ensuring efficient and high-quality drug development.
YY2201 tablets, independently developed by Yayo Biotech, are an oral small-molecule ATR inhibitor. These tablets are off-white to light yellow, round, and film-coated, appearing yellow when the coating is removed. In a series of completed non-clinical pharmacology, toxicology, and pharmacokinetics studies, YY2201 has demonstrated good in vitro and in vivo activity, favorable pharmacokinetic properties, and safety. It holds promise in addressing the unmet clinical needs of cancer patients.
ATR, or Ataxia Telangiectasia and Rad3-related protein, is a key kinase involved in DNA repair. Upon DNA damage, ATR activates downstream signaling pathways, halting the tumor cell cycle and facilitating homologous recombination repair of damaged DNA. This process helps to maintain cell survival. However, in tumors, ATR's regulation of apoptosis becomes dysfunctional, allowing tumor cells to evade programmed cell death. Genomic instability and mutagenesis are key mechanisms in the development and progression of tumor cells. Targeting DNA repair-related kinases can induce a "synthetic lethality" effect in tumor cells, making ATR kinase inhibitors highly promising for tumor treatment applications. In addition, ATR plays a crucial role in cell growth and proliferation. Studies have shown that the loss of both alleles of ATR leads to early embryonic lethality. The primary mechanism of ATR inhibitors is to suppress the S-phase and G2/M cell cycle checkpoints, leading to increased replication stress (RS) and forcing premature entry into mitosis, causing a crisis. This process triggers homologous recombination repair (HRR) during the S and G2 phases and induces DNA double-strand breaks (DSBs). Therefore, selective inhibition of ATR offers a new approach for tumor treatment and provides a valuable tool for tumor research. Although no ATR inhibitors have been officially approved for the global market yet, research and development in this field are progressing at an unprecedented pace, indicating the significant potential of ATR inhibitors in future tumor therapies.
The FDA IND approval for Yayo Biotech's YY2201 tablets marks a milestone achievement that not only highlights Yayo Biotech's strong capabilities in cancer research and development but also serves as a high recognition of its innovative potential.
In the intense competition of new drug development, speed and quality are crucial. Medicilon, as an experienced player in the preclinical R&D field, has dedicated two decades to this endeavor. With a keen insight into industry needs and continuous expansion, Medicilon has successfully built a "One-Stop Preclinical Biopharmaceutical R&D Service Platform." This platform seamlessly integrates every critical step from drug discovery and pharmaceutical research to preclinical studies, creating an efficient and smooth R&D chain. It provides strong support for the rapid approval of new drugs for clinical use.
It is worth noting that Medicilon has established a comprehensive and advanced efficacy evaluation system in the cutting-edge field of oncology drug development. The company boasts over 440 types of tumor efficacy models, including 118 types of PD in situ models, syngeneic tumor transplantation models, xenograft models, and humanized tumor transplantation models. This has allowed Medicilon to accumulate significant R&D strength and experience, continuously driving innovation in oncology drug development.
Medicilon congratulates Yayo Biotech on the FDA clinical approval of YY2201 tablets and looks forward to positive results in the clinical trials, which will bring hope to patients with advanced tumors. At the same time, Medicilon will continue to focus on the innovation and development of its one-stop biomedical R&D service platform, providing higher quality and faster service support for global drug development.
Striving for excellence, pursuing perfection, harmonious development, and continuous innovation! Yayo Biotech was founded by several returnee scientists and domestic medical and pharmaceutical experts. Located in the Jiangbei New District Pharmaceutical Valley of Nanjing, Jiangsu, it is a comprehensive pharmaceutical R&D and manufacturing company. The company completed its initial financing in 2019 and was introduced as a key project into the Pharmaceutical Valley by the Jiangbei New District of Nanjing in 2020.
The company has a well-established organizational structure and quality management system, along with a comprehensive documentation system that effectively ensures quality control throughout the entire lifecycle of its pharmaceuticals. On June 25, 2022, the company received a "Drug Manufacturing License" issued by the Jiangsu Provincial Drug Administration. With strong development capabilities, the company leverages its research outcomes and support from capital to become a nationally recognized technology-based small and medium-sized enterprise, currently applying for national high-tech enterprise status. The company is dedicated to the research and development of targeted drugs, with several innovative drugs currently under development and patents granted in countries such as China, the United States, the European Union, and Japan. In the second half of 2024, the company plans to initiate its first Phase I clinical study for an innovative drug, with expectations to conduct no fewer than two Phase I and one Phase II clinical studies within the next two years.
The company has currently applied for three invention patents and obtained five authorizations in China, the United States, Japan, and Europe. One of the invention patents has successfully been applied for in mainland China and Taiwan, and through the PCT international application, it has successfully entered countries and regions such as Europe, the United States, Japan, South Korea, Canada, Australia, Brazil, and India.
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