YuYao Biotech Files IPO Prospectus: Pioneering Super Molecular Glue Platform Targets Over 10 First-in-Class Therapies for Undruggable Oncology Targets
Recently, an AI-driven innovative small-molecule drug company focused on novel targets and new technologies—Shanghai Yuyao Biotechnology Co., Ltd.(hereinafter referred to as Yuyao Biopharma) announced that its Investigational New Drug (IND) application for YY201, a proprietary small-molecule inhibitor targeting dual phosphorylation sites of STAT3, has been officially accepted by the National Medical Products Administration (NMPA). It is understood that the clinical indications for YY201 are STAT3-driven advanced solid tumors and malignant hematologic malignancies.
This marks another significant breakthrough by Yuyao Biopharma in the field of oncology treatment. Since its establishment in April 2020, this innovative drug developer has achieved remarkable success:
In March 2022, Yuyao Biotech announcedYY001 Clinical Trial Application Officially Approved by the National Medical Products Administration；
Announced in July of the same yearFirst Subject Dosed in Phase I Clinical Trial of YY001 at Shanghai East Hospital；
In April 2023, the company's independently developed“Super Molecular Glue for Constructing Ternary Complexes” Won the Excellence Award in the National Finals of the 2nd National Disruptive Technology Innovation Competition, according to Dr. Chen Huang, Director of the Biological R&D Department, Yuyao Biologics’ self-developed super molecular glue product will soon enter the IND application stage...
As a rising star in the field of innovative drugs, what underlying driving forces enable this company to complete clinical studies and regulatory filings for multiple core products within just three years?
Yuyao Bio was founded byProf. Liu MingyaoEstablished as a biotechnology company, it is dedicated to addressing major unmet clinical needs in pharmaceuticals, led by artificial intelligence and modern innovative drug development technologies, with the mission of advancing global human health.
Professor Liu Mingyao is dedicated toResearch on the Functions and Signal Transduction Mechanisms of G Protein-Coupled Receptors (GPCRs) in Individual Development, as Well as in the Initiation and Progression of Tumors and Major Diseases, and the Development of Novel Drugs Targeting GPCRs。
After more than a decade of strategic development, the team of scientists led by Professor Liu Mingyao has achieved abundant scientific results in basic research, prompting him to consider the translation of these achievements into practical applications.
Building on an established research team and existing scientific achievements, Yuyao Biopharma officially set sail in April 2020, with Professor Liu Mingyao at the helm and the research team powering its progress, gradually securing a place in the biopharmaceutical industry. Although Yuyao Biopharma is a entrepreneurial venture by scientists and appears to be a complete “newcomer,” its rapid growth demonstrates the founding team’s extensive and mature expertise in both scientific research and management.
Based onThe founding team’s in-depth research over the past decade into the functions and mechanisms of challenging drug targets. Since its inception, Yuyao Biopharma has focused on undruggable targets,Pioneered the Super Molecular Glue Technology Platform. Super molecular glue technology focuses on non-E3 ubiquitin ligase-type molecular glues, aiming to recruit highly flexible, abundantly expressed, and exceptionally safe tool proteins (including various chaperones, scaffold proteins, etc.) in the body through exquisitely designed drug candidates. This promotes the formation of stable complexes between the tool proteins and target proteins, thereby preventing the target proteins from interacting with their intended binding partners, blocking interprotein signal transduction, and locking the target proteins.
Schematic Diagram of Yuyao Bio’s Super Molecular Glue. Image source: company official website.
(Company website: http://www.yuyaobiotech.com/)
Traditional small-molecule and antibody drugs primarily modulate protein function by occupying ligand-binding pockets on the protein surface, thereby achieving therapeutic effects. However, in clinical practice, only a small fraction of human proteins are amenable to pharmacological intervention; most targets lack well-defined binding pockets and are difficult to engage with highly potent small-molecule drugs. These targets are referred to as"Undruggable Targets"。
Leveraging small-molecule compounds to target protein degradation has enabled the development of many drug targets that were traditionally considered undruggable. Currently, Proteolysis-Targeting Chimeras (PROTACs) and molecular glue degraders have achieved significant successes in the field of drug discovery for challenging targets.
PROTAC drugs, characterized by their high molecular weight and complex structures, carry the risk of degrading off-target proteins, posing significant challenges in clinical research. In contrast, while degradative molecular glues offer numerous advantages such as low molecular weight, favorable metabolic properties, and oral bioavailability, the majority have been discovered serendipitously. Consequently, this field still faces substantial hurdles, including the difficulty of rational design, a relatively narrow range of targets, and intense competition due to product homogenization.
Compared to traditional molecular glue technology,Yuyao Biologics’ Super Molecular Glue Technology Demonstrates Three Major Advantages：
First, drugs developed based on the supramolecular glue platform are not limited by traditional E3 ubiquitin ligases.Theoretically applicable to any undruggable target。
Second, Super Molecular GlueCan directly form a ternary complex with the target protein by engaging chaperones or scaffold proteins., offering more comprehensive and efficient inhibition with a lower risk of drug resistance.
Third, Super Molecular GlueModular design is feasible, molecular glues are formed by the organic combination of two modules: one part is used to bind to the target protein, and the other part is used to bind to the chaperone protein. This technologyIt can be scaled up to target more "undruggable" protein targets and enable organ-specific drug delivery, achieving ultra-precise treatment for specific diseases, particularly cancer.。
According to publicly available information from Yuyao Biotech, in April 2023, the company’s independently developed “Super Molecular Glue for Ternary Complex Formation” technology won the Excellence Award at the national finals of the Second National Disruptive Technology Innovation Competition.
“Yuyao Biotech’s self-developed super molecular glue product is also set to enter the IND-enabling stage in the near future. We aim to submit the Investigational New Drug (IND) application as soon as possible and look forward to obtaining IND approval smoothly, ultimately bringing products developed based on our super molecular glue technology into clinical trials,” said Dr. Chen Huang.
In addition to its supramolecular glue technology platform, Yuyao Biopharma has also gradually established three other major biotechnology platforms since its inception—GPCR Drug Development Platform, “Undruggable” Drug Development Platform, and AI-Assisted Drug Development Platform。
Building on the team’s decade-plus research accumulation, the company has established a GPCR drug development platform equipped with comprehensive GPCR cell models and gene-knockout animal models, enablingTargeted screening and research of over 300 GPCRs。
Currently in Yuyao Bio's product pipelineIncludes three GPCR-targeted drugs。
The “Undruggable” drug development platform, also known as the drug development platform for difficult-to-drug targets, primarily focuses on developing drugs by studying such challenging targets. Currently, the scientific team at Yuyao Biopharma has established capabilities through both internal development and external collaborations,Established a Novel "Drug Pocket" Discovery Strategy Based on Structural Biology and Artificial Intelligence (AI), leveraging technologies such as AI-based virtual screening to achieve an efficient model for the discovery and optimization of innovative target drugs.
In addition, the AI-powered drug development platform also fuels product research at Yuyao Biopharma.
Within the AI-assisted drug development technology platform, the scientific team at Yuyao Biologics has fully leveraged its strengths in computer-aided design and artificial intelligence to establish aA comprehensive AI-driven drug R&D platform covering new target discovery, candidate drug mining, drug design, drug synthesis, pathophysiological research, and new indication development. The company also empowers its GPCR drug development platform and Undruggable drug development platform through an AI-assisted drug development technology platform, significantly shortening product R&D cycles and improving R&D efficiency.
With the support of its three major platforms, Yuyao Biotech hasLayout of 10 product pipelines, including more than 10 global first-in-class products such as EP4, STAT3, and Pan-Ras.. Currently, these pipelines primarily target indications such as refractory and recurrent solid tumors, hematologic malignancies, neurodegenerative diseases, and autoimmune disorders.
According to Dr. Chen Huang, YY001 is currently nearing the successful completion of its Phase I clinical trial and is advancing to Phase II, while YY201 has already been accepted by the National Medical Products Administration (NMPA). These developments will significantly boost the team’s confidence.
YY001 Pipeline, image sourced from the company’s official website
YY201 pipeline, image sourced from the company's official website
On December 30, 2022, Yuyao Biotech announced that it had completedPre-A Round Financing of Nearly 100 Million Yuan, investors in this round include Lingcheng Venture Capital, Xingyao Hesheng, Mingyu Venture Capital, and Tianxiang Industrial. The funds raised will be used to advance the clinical development of the company’s globally first-in-class product pipeline, enhance its technology platforms for AI-driven drug discovery, molecular glues, and GPCR, and expand its R&D laboratories.
Yuyao Biopharma has been able to rapidly stand out in the fiercely competitive landscape of new drug development, owing on one hand to Professor Liu Mingyao’s influence in the field of biomedical research and the strong execution capabilities of its young team, and on the other hand to the company’s commitment to developing first-class therapeutic products based on clinical needs, thereby ensuring the competitiveness of its product pipeline.
In terms of collaborative drug development, the company leverages its robust scientific and technical capabilities while also partnering with leading domestic universities and research institutions. Throughout these collaborations, Yuyao Biotech serves as the primary entity for product development, providing technical services to academic and research partners, who in turn offer technical support to Yuyao Biotech. This mutual cooperation has yielded significant achievements in both academic and industrial R&D. Furthermore, given that product development is closely tied to theoretical foundations, Yuyao Biotech actively engages in academic research to continually strengthen the theoretical underpinnings of its product development efforts.
Today, Yuyao Biotech has established over 5,000 square meters of office and R&D laboratory space at the Wendu Science and Technology Park in Minhang District, Shanghai. As the company continues to expand, its future strategic plans have become increasingly clear.
Dr. Chen Huang stated that the company’s next stepWe will continue to advance the clinical studies of our two primary drug products., and will also conduct in-depth research on products related to supermolecular adhesives, advancing the project application process for supermolecular adhesive products. In addition, Yuyao Biotech willContinue to Expand Team Building, seeking like-minded, outstanding talents to join our team, enabling the company’s R&D products to reach the market sooner and make greater contributions to the treatment of oncological diseases.
YuYao Biopharma was co-founded by Professor Liu Mingyao, one of the first batch of Distinguished Professors in China, and Dr. Zhou Wenbo. Its R&D team comprises a group of outstanding domestic and international talents with profound backgrounds in basic research and extensive industry experience in chemical synthesis, bioactivity screening, drug metabolism and safety evaluation, as well as computer science and artificial intelligence.
Dr. Zhou Wenbo, the company’s CEO, has over 10 years of experience in drug synthesis and has long been engaged in the development of drugs targeting undruggable targets. His research on a drug targeting the undruggable target STAT3 was published as first or corresponding author in internationally renowned journals, including Clinical Cancer Research and Journal of Medicinal Chemistry, and received funding from the National Natural Science Foundation of China. As an outstanding young entrepreneur, he has been selected for prestigious talent programs such as the “National Excellent Postdoctoral Fellows in Innovation and Entrepreneurship” and the “Shanghai Young Science and Technology Leaders (35 Under 35) Program.”
Dr. Peng Shihong, Vice President of the Company, has dedicated over a decade to the screening and functional mechanism research of novel anti-tumor drugs. He is primarily responsible for the Company’s biological R&D, project management, and drug registration activities. During his tenure, he successfully completed the Investigational New Drug (IND) applications for two of the Company’s products. In 2022, he was selected for the “Rising Star Talent Program” by the Shanghai Municipal Science and Technology Commission.
Dr. Tong Xiaotian, Vice President of the Company, brings nearly 20 years of experience in new drug research and development. He oversees project development and management within the Company’s Medicinal Chemistry Department, with responsibilities spanning project initiation, drug molecule design, and synthesis, covering all stages of preclinical drug development. Dr. Tong previously held positions at Sandia Pharmaceutical Technology (Shanghai) Co., Ltd. and Shanghai Porton Pharma Solutions Co., Ltd.
Dr. Chen Jianfeng, the company’s Chief Medical Officer, brings nearly 20 years of experience in clinical development of new drugs and team management. He has served at leading multinational pharmaceutical companies such as Roche, GlaxoSmithKline, and Novo Nordisk, as well as renowned domestic pharmaceutical firms including Jiangsu Hansoh Pharmaceutical, Hutchison MediPharma, and ImmuneOnco. Dr. Chen possesses extensive expertise in building and managing clinical medicine and operations teams, as well as in formulating and implementing clinical development strategies.
Dr. Chen Huang, Director of Biological R&D, brings 10 years of experience in molecular and cellular biology and tumor mechanism research. He oversees the company’s biological modeling, screening, and evaluation efforts, and was selected for the Shanghai Municipal Science and Technology Commission’s “Qimingxing Talent Program” in 2023.
Dr. Lu Jian, Director of the Department of Metabolism and Safety Assessment, brings nearly a decade of experience in new drug research and development. He oversees drug metabolism and toxicology studies for the company’s product pipeline. Dr. Lu has extensive research expertise in small-molecule drug metabolism, pharmacokinetics, and safety evaluation. He pioneered the construction and characterization of multiple gene-knockout and humanized rat models for drug-metabolizing enzymes, applying these models to drug metabolism-related research.
Dr. Li Zeng, Director of AI Drug Design, is primarily responsible for building the company’s AI technology platform. He has conducted in-depth research in bioinformatics, pharmaceutics, and deep learning, and specializes in predicting small-molecule properties using deep learning techniques. In particular, he leverages graph neural network frameworks for small-molecule structure-based molecular design, as well as the optimization of drug toxicology and other properties. He has advanced multiple new drug development pipelines into clinical studies.
Dr. Chen Xianmin, Deputy Director of Medicinal Chemistry, assists Dr. Tong Xiaotian, Director of Medicinal Chemistry, in project and management operations within the Drug R&D Department. He possesses extensive experience in compound synthesis, process development, and team management.