Tumor is one of the leading causes of human death. Tumor is a new organism formed when a cell in a local tissue loses its normal regulation of its growth at the genetic level under the action of various carcinogenic factors, resulting in its clonal abnormal proliferation. Currently, most evidence supports the idea that tumors are monoclonal, i.e., that all cancer cells in a tumor cell population proliferate from a single mutant cell. Tumors may be benign (not cancer) or malignant (cancer). Immuno-oncology, especially immune checkpoint inhibitor (including bispecific antibodies) and CAR-T therapy, are considered as a breakthrough to the treatment of cancer. Hence, YZYBIO devoted a significant amount of effort into the research and development of anti-tumor drugs. Our current pipelines include M701, Y101D, Y150, M802, and Y332.
Age-related disease is one of YZYBIO’s focus areas. Neurodegenerative diseases, degenerative Spine Conditions, degenerative joint and bone disease, age-related macular degeneration etc. are typical clinically geriatric diseases. Age-related macular degeneration (AMD) is a structural abnormal of the macula caused by aging. AMD is mostly observed in the cohort over 45 years old, and the prevalence of this disease is higher in older people，serving as the major reason for blindness and other visual impairments. Most of them are round lesions with normal appearance, blurred vision, deformed vision, and central shadow in the eye. According to fundus symptoms, they are divided into dry age macular degeneration (dAMD) (atrophic) and wet age macular degeneration (wAMD) (exudative ): mild pigmentation disorder in the macula in the early stage of dAMD, the foveal reflection is unclear or disappeared, scattered with drusen, and in the late stage, there may be gold foil-like changes, geographic pigment epithelium atrophy, cyst-like deformation or lamellar holes; in wAMD, macular pigmented epithelial disorders in the early stage, foveal reflection disappear or diffuse, drusen often merge, macular edema, hemorrhage and exudation, retinal serous or hemorrhagic detachment, neovascularization in the mid-stage, and formation of circular disc-shaped scars in the late-stage. YZYBIO has developed Y400 for wAMD, diabetic macular edema (DME) and other ocular neovascularization-related diseases.
Prophylactic vaccines are one of YZYBIO’s major research and development area. Vaccines are proteins that target pathogens or are essential for pathogenic infections (polypeptides, peptides), polysaccharides or nucleic acids, one or more components, directly or through vehicle immunization into the body and induce the body to produce specific humoral and/or cellular immunity, so that the body obtains immunity to prevent the disease. Currently, the application of vaccines has evolved from disease prevention to disease treatment, and there are prophylactic and therapeutic vaccines: prophylactic vaccines are autoimmune preparations made from pathogenic microorganisms (e.g. bacteria, viruses, etc.) and their metabolites, which are artificially attenuated, inactivated or genetically modified for the prevention of infectious diseases, and such vaccines retain the immunogenic properties of pathogens and can safely induce an immune response that confers protection against infection; Therapeutic vaccines refer to natural, synthetic or recombinant gene expression products or products expressed by genetic recombinant technology in organisms that have been infected with pathogenic microorganisms or already had certain diseases, by inducing specific immune responses to treat or prevent the progression of diseases. Currently, there are five major technical routes of vaccines against novel coronaviruses in the world: inactivated vaccine, recombinant protein vaccine, adenovirus vector vaccine, attenuated influenza virus vector vaccine, and nucleic acid vaccine. Y2019 is a new recombinant SARS-CoV-2 subunit protein vaccine developed by YZYBIO in cooperation with Wuhan Institute of Virology in response to the COVID-19 pandemic. YZYBIO has completed Phase Ia clinical trial for Y2019, and obtained approval from the ethic committee in July 2022 to commence a Phase IIa clinical trial of Y2019 in China.
Phase II commenced in Dec 2021; Expect to initiate the Phase III/Pivotal trial in 1H 2024
Phase Ib/II commenced in Nov 2022；
Expect to complete Phase Ib/II in 2H 2024
Phase I commenced in Aug 2021；
Expect to complete Phase I in 2H 2023
Phase I commenced in Aug 2021；
Expect to complete Phase I in 2H 2023
Applying for IND approval for Phase Ib/II；
Expect to complete Phase Ib/II by the end of 2025
Expect to file IND application in Q3 2023;
Expect to initiate Phase Ib/II in Q1 2024
Phase I commenced in July 2021；
Expect to complete in 1H 2024
Obtained the ethic committee approval for Phase IIa
Expect to file IND application in 1H 2023
1.All drug candidates are inhouse developed.
2.The Company has completed a Phase Ia clinical trial for Y2019 in China in August 2022 which evaluates the safety and tolerability of Y2019 in healthy adults. This Phase Ia clinical trial of Y2019 is equivalent to a typical Phase I trial for healthy adults. The Company has obtained an approval from the ethic committee in July 2022 to commence a Phase IIa clinical trial of Y2019 for healthy adults in China. The Company may, depending on its business plan, conduct a Phase Ib clinical trial to expand the potential subject of Y2019 and evaluate the safety and tolerability of Y2019 in teenagers and children aged 17 years or younger in the future. This potential Phase Ib clinical trial is a different and independent clinical trial from the Phase Ia trial of Y2019, and will also be equivalent to a typical Phase I clinical trial for teenagers and children aged 17 years or younger.
3.The Company has transferred all the rights and assets of Y400 to CMS Ophthalmology. The Company is entitled to receive an upfront payment, milestone payments upon the occurrence of certain pre-agreed milestone events, and tiered royalties based on net sales.
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Process development and Production plays a critical role throughout biopharmaceutical candidate lifecycle from early discovery all the way to post-marketing surveillance, including target validation, genetic engineering, cell line development, cell culture/purification process development, formulation development and GMP-compliant manufacturing.
High expression level in cell line development : YZYBIO utilize world-leading expression system (CHO GS-KO，etc.) to design and generate antibodies with different structures. As such, YZYBIO are able to produce stable cell lines with high expression level.
High expression level in upstream process development. : To improve the titers of target BsAbs, YZYBIO optimizes the manufacturing process by adopting the Fed-Batch mode. With the optimized techniques, we are able to achieve the average expression level for Check-BODY molecules and Nano-YBODY™ molecules of approximately 6.0g/L and 8.0g/L, respectively, far beyond the industry average in China.
High purity in downstream development. : Through downstream development and optimization, YZYBIO is able to achieve high purity of our BsAbs, which has led to a favourable safety profile of the candidates. The total yield of BsAbs in our purification process can reach 75%, and the purity of the drug substance can reach 99%, with low levels of impurities.
Formulation development: YZYBIO is able to produce different types of drug products, such as liquid and lyophilized dosage forms. Through the formulation screening and optimization, the formulations are able to reach high concentration with low product viscosity and great stability.
GMP-compliant manufacturing: YZYBIO had a pilot manufacturing base with the scale of 500L in total to accommodate the manufacturing demands for our Phase I to Phase II clinical trials.
YZYBIO has developed a comprehensive quality management system （QMS） in accordance with the regulations of NMPA and FDA, ICH Q8 and other biopharmaceutical regulations, including GMP and the standards of the Chinese and American Pharmacopoeia. YZYBIO’s QMS covers all aspects of operations, including process development, procurement, product manufacturing, product storage, and transportation.
YZYBIO has established comprehensive QC and QA procedures to ensure that product operations meet relevant regulatory and internal quality requirements. We implement QC measures for the entire production process, mainly including control and inspection of raw materials, control of production process, inspection of intermediate and products, establishment of internationalized product release standards, research on product stability, and management of deviations, changes and risk evaluations during product development and manufacturing.
YZYBIO complies with all quality regulations in all major aspects and has passed all product release standards, developing more than 30 kinds of platform analytical methods, including physicochemical analysis, analysis of protein content, purity and impurity, and safety assessment, meeting the regulatory requirements of both NMPA and FDA.These platform assays can speed up our development progress. We also validate some of these methods for release testing and stability studies, and ensure the data integrity and product quality.
Adhering to the quality police of " Quality Is the First in Innovative Product Development", our QMS focuses on personnel training, data integrity, quality risk management, and continuous improvement for delivering high quality drug products.
YZYBIO actively seeks to form strategic collaborations with resourceful partners to support the development and maximize the commercial value of our drug candidates. These collaborations allow us to utilize clinical, financial, and commercial resources of our partners, and provide us with opportunities to explore innovative modalities and therapies that employ new mechanisms through cooperation with other innovative drug developers.