Shenzhen Xinyue Biotech Files IPO Prospectus Highlighting Proprietary DEL3.0 Platform for First-in-Class Drug Discovery

China Needs Genuine Innovative Drugs!

This is the personal insight He Xun has gained after深耕ing in the pharmaceutical field for 30 years.

He Xun graduated from Tsinghua University, starting from the most basic level as a team leader in a pharmaceutical enterprise, then moving up to workshop director, and later to production and R&D department manager, chief engineer, vice general manager, and finally general manager. He Xun has a profound understanding and deep accumulation in the research, production, and sales of biopharmaceuticals, with successful experience in turning around multiple enterprises to achieve profitability.

However, the longer He Xun has been working in the industry, the more acutely he feels its pain points: "After 2015, with the continuous advancement of the overseas high-level talent introduction program, the consistency evaluation policy, and the 4+7 volume-based procurement, China has moved from the era of generic drugs to the era of rapid follow-up in innovative drug development. The key to new drug research and development is whether we can screen out the best lead compounds with the fastest speed and lowest cost. Drug screening has always been a tough issue for China as it strives to enter the era of original innovation in new drug development."

In order to break through the key common technology bottlenecks in the industrial chain, promote the transformation of achievements, and build a collaborative innovation ecosystem. In 2019, initiated by He Xun and serving as the general manager, the plaque was awarded by Li Xi, Secretary of the Guangdong Provincial Party Committee, and Ma Xingrui, Governor of Guangdong Province.Guangdong Small Molecule New Drug Innovation CenterOfficially established.

In 2021,The first project incubated by Guangdong Small Molecule New Drug Innovation Center — NewDEL Biotech, He Xun serves as the chairman.

Currently, the biotechnology platform and product pipeline of NewDEL Biotech have been successfully established. Relying on the self-innovated DNA Encoded Library (DEL) technology, the company engages in innovative drug development and technical services, which can significantly improve the success rate of drug screening. The company has also completed an angel round of financing worth tens of millions of yuan, led by Cowin Venture Capital.

In 2016, He Xun met Professor Li Xiaoyu for the first time and began to learn about DEL technology, which he highly regarded.

DEL technology was proposed in 1992 by American molecular biologists Professor Sydney Brenner and Professor Richard Lerner.Professor Li XiaoyuHaving studied in the DEL field for nearly 20 years,One of the academic leaders in the global DEL technology field, repeatedly selected for Elsevier's list of Highly Cited Chinese Scholars, onceScreened target lead compounds for many large pharmaceutical enterprises at home and abroad using DEL technology., achieving a series of breakthrough research results in the DEL field.

The most critical link in the innovative drug industry chain is research and development. Approximately one-third of new drug development costs are allocated to the new drug discovery and preclinical stages, which take three to six years. Drug discovery and development are characterized by their time-consuming nature and high risks. The entire process from identifying lead compounds to bringing an innovative drug to market often requires testing tens of thousands of compounds. This highlights the crucial importance of improving the success rate of new drug discovery in drug development.

DEL Technology Brings Hope to Addressing the Low Success Rates and Efficiency in Drug Discovery.

DEL technology is a novel high-throughput drug screening technology that combines the advantages of combinatorial chemistry and high-throughput screening to efficiently identify small molecules with high affinity for target proteins, capable ofSignificantly increase the success rate of drug development, reduce R&D costs, and shorten the R&D cycle.

With the rapid accumulation of drug research and development data and the accelerated advancement of artificial intelligence (AI) technology, the application of AI in new drug discovery is increasing, with its advantages becoming prominently evident.

He Xun explained: "DEL Technology: A Breakthrough from 0 to 1, enabling rapid and low-cost "needle in a haystack" screening,There is great hope for developing First-in-class drugs.; AI technology is from 1 to 2, based on existing big data, using machine learning modeling to predict and further modify and optimize the structure of target candidate molecules."

Process and Advantages of Live Cell Screening Technology

(Reference DEL technology paper: Nat. Rev. Methods Primers, 2022.2:3)

DEL technology requires DNA encoding, followed by the identification of unique DNA sequences of small molecules through a DNA sequencer. Previously, due to the limited widespread use of high-throughput sequencers, long sequencing times, and high costs, the application of DEL technology was restricted. After 2010, with the advancement of next-generation sequencing technology, DEL technology developed rapidly.The top 20 pharmaceutical companies internationally have already established DEL screening departments or formed collaborative research partnerships with DEL biotechnology enterprises.Among them, GSK acquired Praecis's DEL technology platform, and the new drug under development is already in the clinical stage.

Based on the existing DEL technology, DEL 2.0 technology developed by NewDEL Biotech can be applied toCell-based Screening，Compared with the biochemical model of the previous generation technology, the screening of DEL2.0 technologyCloser to the real in vivo environment, the quality of the target lead compounds obtained through screening is higher, and the success rate of transformation is also higher.

Currently, NewDEL Biotech is refining the DEL 3.0 technology platform. He Xun stated: "DEL 3.0 technology combines DEL and AI to achieve complementarity. DEL provides high-quality big data for constructing AI models, and conversely, AI can help build higher-quality DNA-encoded compound libraries, further enhancing the efficiency and drug-likeness of new drug screening."

Based on its proprietary DEL technology, NewDEL Biotech is establishing an innovative drug lifecycle system focused on the design, R&D, and industrialization of First-in-class drugs to address unmet clinical needs.

In terms of business layout, NewDEL Biotech not only has self-developed pipelines but also supplements its existing pipelines through various methods such as co-development with partners and collaborative research with scientific institutions. At the same time, it provides technical services to help research units and pharmaceutical companies screen active compounds. With the increasing number of DEL screening target projects, the company will have numerous new drug projects available for License out in the future.

On its self-developed pipeline, NewDEL Biotech has screened out more than 10 lead compounds using DEL technology, focusing on the layout of multiple drug pipelines for anti-tumor immunity, including novel tumor immune checkpoint inhibitors.

"Anti-tumor immunity is a huge, unmet market. This field is highly competitive, butMost drugs are the result of Fast Follow, while NewDEL Biotech possesses an original DEL3.0 technology platform, focusing on the source of new drug development, with the potential to screen out First-in-class drugs."So we are not afraid of competition and have full confidence," said He Xun.

Currently, NewDEL Biotech's cooperation methods, such as collaborative research and development with scientific research institutions and joint development with enterprises, have already borne fruit in December last year.Sign Technical Transfer Agreement with Jinan University, with a total contract value exceeding 300 million RMB, collaborates with Professor Ding Ke's team from Jinan University to jointly develop a new generation of targeted anti-tumor drugs.NewDEL Biotech Partners with Lead Discovery and Nanjing Crystal Precision for New Drug DevelopmentDevelopment of Immune-Oncology Drugs Targeting Novel Targets.

"Developing drugs must focus on differentiation; the previous 'thoughtless' follower-style innovation no longer works."The trend of new drug development in China will increasingly focus on original innovation.If it is not original innovation, incremental innovation also has prospects, but it requires a significant investment of R&D resources and funds for fundamental research. In other words,Innovative drug companies must have core technologies to continuously enrich their pipelines and secure their survival space.”

According to He Xun, the DEL 3.0 technology platform will be completed in the first half of 2022. In the first half of 2023, NewDEL Biotech will file an IND for a drug candidate, moving it into the clinical stage. In the future, the company will continue to enhance the DEL technology platform and expand its applications into areas such as DEL+PROTAC and DEL+allosteric site drug development (DEL+X), advance its R&D pipeline, actively engage in long-term collaborations with top pharmaceutical companies and institutions both domestically and internationally, and build a globally leading innovative drug enterprise using differentiated technologies.