Evergreen Therapeutics Files IPO Prospectus: 5 of 10 AI-Driven Drug Candidates Cleared by FDA in Just Three Years

CompletionIn the past three years, a total of 10 pipelines have been established, five of which have been approved by the FDA for clinical trials, including two Phase I, two Phase II, and one Phase III clinical trial. Among their pipelines, there are five drugs that represent entirely new molecules, indications, and mechanisms, holding an absolutely leading position globally as Me-Only drugs.

This isEvergreen Therapeutics(Evergreen Therapeutics(hereinafter referred to as: Evergreen Therapeutics), withAn international innovative pharmaceutical enterprise driven by AI technology and quantum computing, achieving astonishing results far surpassing those of other companies in the same tier within three years.

Explore the reasons and stories behind it, such achievements are attributed toThe Precise Application of AI TechnologyAndA team with rich R&D and approval experience。

"AI + Quantum R&D Platform" established for "end-to-end" drug development, and the "former FDA reviewer team" focused on drug backend development services, is well-versed in regulatory rules and clinical evaluation standards for drugs, enabling precise indication selection.These differentiated advantages of Evergreen Therapeutics have enabled it to rapidly and effectively advance its pipeline.

When it comes to the precise application of AI technology, Evergreen Therapeutics' self-developedMagic Insight AI R&D PlatformCan meet the full-process computational needs from finding drug targets and their corresponding molecules, synthesis and optimization, formulation development, pharmacological and toxicological analysis, indication confirmation, clinical trial design to NDA submission.

The Miaowu AI Drug Discovery Platform is divided into three interconnected modules, enabling end-to-end data analysis.The Miaowu-Chem development platform is responsible for designing and optimizing new molecular compounds; the Miaowu-Bio development platform is responsible for determining medication guidelines and corresponding biomarkers; the Miaowu-Clin validation and prediction platform is responsible for precisely locking indications through computation and deriving the optimal clinical solution.This platform combines quantum computing to improve accuracy and efficiency while significantly enhancing the speed of screening and prediction.

Evergreen Therapeutics Pipeline Progress Record

Each pipeline of Evergreen Therapeutics undergoes a commercial evaluation strictly following the operational rules of multinational pharmaceutical companies from the very beginning of its initiation.Within three years, it has developed 10 pipelines based on the urgency of clinical needs., five of which are Me-Only new drugs with entirely new molecules, indications, and mechanisms. Currently, there are a total of5 Pipeline Enter IND Stage，Among them, the EG-001 Idiopathic Interstitial Pneumonia pipeline and the EG-009 COVID-19 Cytokine Storm (oral) pipeline have entered Phase I clinical trials, the EG-009A COVID-19 Cytokine Storm (injectable) pipeline and the EG-301 Dry Age-related Macular Degeneration pipeline have entered Phase II clinical trials, and the EG-007 Endometrial Cancer pipeline has entered Phase III clinical trials.。

EG-301, which was approved by the FDA in February this year to enter Phase II clinical trials, isThe first Me-Only oral new molecular drug developed using AI technology for the treatment of dry age-related macular degeneration in patients over 50 years old.Dry age-related macular degeneration has an absolute clinical need globally. Currently, there are no approved drugs available to treat this disease, nor are there any competitive drug developments targeting the EG-301 site.The market size of indications is approximately 600-900 billion US dollars.。The project took less than 18 months from initiation to entering Phase II clinical trials., markingEvergreen Therapeutics has stepped into the forefront of companies globally developing drugs for dry age-related macular degeneration.。

Currently, Evergreen Therapeutics not only utilizes AI technology itself but also leverages AI technology and international regulatory knowledge to assist domestic and international partners in global new drug development and high-end FDA regulatory services, such as AI-related clinical trial design, Fast Track designation, and breakthrough therapy approval solutions.

Evergreen Therapeutics clearly understands that in the current era of continuous innovation in AI algorithms, "focusing on the later-stage development of AI-driven drugs" is the key to accelerating the pipeline. Meanwhile, innovative drug development is an empirical science that requires the team to have extensive experience in both research and regulatory approval, especially during the process of globalization. In addition to AI technologists and drug development experts, Evergreen’s team also includes experienced professionals.Former FDA Reviewer Team, theyFamiliar with R&D processes and regulations in both China and the US, enabling cross-border collaboration between China and the US, and advancing global synchronized approval processes, etc.

Evergreen Therapeutics currently has its headquarters in Shenzhen, China, which includes the management team and the R&D team, and has established an R&D company in Washington, USA. The US team accounts for one-third of the overall team.The company's founder and core team are mainly composed of former FDA review officials.; Throughout Evergreen Therapeutics both in and outside of ChinaTeam Management, a team of talents who all have executive experience in well-known multinational pharmaceutical companies or experience in innovative drug research and development; itsR&D TeamMore than 80% have overseas study experience, with expertise covering clinical medicine, pharmacology, toxicology, chemical synthesis, and formulation. They also possess extensive experience in the research, development, and market launch of multiple drugs approved by the FDA and EMA.

Sino-US bilateral collaborative office has built an international team and international business.Enable Evergreen Therapeutics to develop all its products for the global market.On the other hand, collaborative office work brings the company closer to the highly regulated U.S. market.More timely understanding of market dynamics and efficient communication with regulatory authorities during the R&D process., ensuring full recognition during the subsequent registration and approval process, paving the way for efficient clinical trials and commercialization of the drug. The company's products are currently prioritized for clinical trials in the United States, with most products adopting global multi-center clinical trials.

At the same time, Evergreen Therapeutics is currently planningBuilding a Large "Dry-Wet Combination" Laboratory in ChinaEnable the "AI quantum core-driven and computational chemistry-led" dry experiments to be closely integrated with "chemistry, biology, and pharmacological experiment-based" wet experiments. This will allow the proprietary Miaowu platform to train algorithm models more effectively, provide timely feedback and error correction, ensure the accuracy of AI platform predictions, and offer reliable evidence for entering clinical trials.

Adhering to the development philosophy of "focusing on clinical needs and benefiting patients worldwide," based on the advantages of the existing talent team and R&D approach, and in line with the new business models of the international pharmaceutical industry and the promotion of AI-driven drug development in China., Evergreen Therapeutics will actively engage in collaborations with large domestic and international pharmaceutical companies,With the help of unique AI + cutting-edge quantum technology, pharmaceutical regulations, and comprehensive capabilities and professional experience in clinical fields, providing a variety of support services related to international drug development.

In the long term, Evergreen Therapeutics will continue to adhere to "Focus on Urgent Clinical Needs"Starting from the pipeline development, relying on its cutting-edge quantum + AI R&D platform, and adopting an efficient machine learning model that combines dry and wet lab approaches,Pipeline R&D Focused on Ophthalmology and Immunology, andEstablish a Large R&D Center，Expand Own Product PipelineAnd efficiently advance the clinical trials of existing pipelines.

As a pioneer in the internationalization of China's innovative pharmaceutical enterprises, it is expected that Evergreen Therapeutics, based on the experience and achievements of "these three years," will strive during "those three years" to extend the value of AI-driven drug development to benefit more patients worldwide.