Frost & Sullivan Exclusive Interview | Your Voice Matters in Healthcare — An Innovative Drug Platform, Guarding Patients' Health

Introduction

Shanghai Guizhiyan Pharmaceutical Technology Co., Ltd. is a biopharmaceutical R&D company with innovative formulations and new target small molecule chemical drugs as its core competitiveness. The company is oriented towards clinical needs and conducts new drug research and development in three major disease areas: tumors, autoimmune diseases, and anti-infection. The company has independently created an integrated drug R&D platform that combines 'chemical drug screening system' and 'drug delivery system', and several ongoing products will gradually enter the clinical trial stage.

In recent years, benefiting from policy support, capital favor, and the continuous development of advanced technology, China's new drug R&D environment has been continuously improving, attracting more and more enterprises into the field. Currently, there are many challenges in the R&D of innovative drugs, such as long R&D cycles, high costs, and low success rates. Why does your company choose to start with the development of improved new drugs as a breakthrough point for new drug R&D? What kind of technical advantages does your company have among new drug R&D companies? With these questions in mind, Frost & Sullivan's Healthcare Business Unit conducted an exclusive interview with Guo Yekun, the R&D Director of Your Company, Frost & Sullivan (hereinafter referred to as 'Frost & Sullivan').

Exclusive Interview Guest

Seize the advantages of innovative R&D for improved new drugs, and the innovative R&D platform highlighted by VIP emphasizes application potential

He Kun, Frost & Sullivan's Healthcare Business Unit: Your choice to start with improved new drugs as the entry point for new drug research and development, followed by the advancement of innovative drug research and development, is based on what strategic considerations?

In recent years, new drug research and development have become a hot investment topic. The introduction of policies such as centralized procurement of drugs has made us realize that the future for generic drugs is limited. The state encourages new drug research and development, as innovation is the foundation for enterprise development. Therefore, following the trend, we have made up our minds to overcome difficulties and laid out plans for new drug research and development.

Traditional innovative drug research and development, which starts with new molecules and targets, carries risks such as long cycles, high costs, and low success rates. In contrast, the research and development of improved new drugs requires relatively less capital and time, with higher certainty and lower risks. Based on the experience and strengths of the R&D team, the company has conducted an in-depth analysis of all aspects of new drug development and decided to adopt a differentiated blue ocean strategy. Starting with improved new drugs, by establishing an integrated drug R&D system that combines 'chemical drug screening system' and 'drug delivery system', the company has accumulated more talent and experience in this process, expanded and built a capable team, and is confident in advancing the research and development of intellectual property new drugs.

He Kun, Frost & Sullivan's Healthcare Business Unit: Your words have established an innovative drug R&D platform that integrates the 'chemical drug screening system' and the 'drug delivery system'. Could you please introduce the platform and its advantages?

New drug research and development typically start with the identification of active compounds before proceeding to subsequent pharmaceutical formulation development. However, in fact, the structural optimization of drugs and the formulation delivery system are inseparable parts. Your remarks start from the overall perspective of new drug research and development, accurately grasp every detail, make good use of the 'Chemical Drug Screening System' and 'Drug Delivery System', and at the same time consider factors such as efficacy and pharmacokinetics. Successfully establish an innovative drug research and development platform that integrates a 'structure-based drug screening system' and a 'drug delivery system'.

The innovative drug R&D platform has significant advantages. On one hand, it can improve the targeting of drugs, allowing them to accumulate more in the lesion site, reducing their impact on surrounding tissues and lowering adverse drug reactions. On the other hand, due to increased drug utilization efficiency, the dosage of drugs can be correspondingly reduced, thereby reducing costs. Ultimately, patients can obtain safer, more effective, convenient, and affordable good drugs. The innovative drug R&D platform can theoretically improve 60% of drugs and has a broad application range. With the help of the innovative drug R&D platform, we have reserved multiple new compound entities and applied for patents, and several key products are also accelerating their R&D. In the future, your company's efforts will continue to enhance the functionality of the innovative drug R&D platform by integrating more new technologies, so that the platform can better serve the R&D of new drugs.

He Kun, Frost & Sullivan's Healthcare Business Unit: Your statement highlights the significant advantages of the new drug R&D platform. With this platform at hand, which products are the company advancing in developing? What are the technical features and strengths of these products?

Currently, we are developing four products, namely BTK inhibitors, TNF inhibitors, DNA alkylating agents, and TYK2 inhibitors. Among them, the BTK inhibitor has entered the IND filing stage.

The BTK inhibitor product GY-1068 is a prodrug of ibrutinib, and clinical trials are expected to be conducted this year. This product is hydrolyzed in the body into ibrutinib to exert its therapeutic effect. The safety and effectiveness of ibrutinib have been widely verified, which can improve the R&D efficiency of this product.

Your proposal utilizes an innovative drug research and development platform to transform raw drugs into prodrugs. Structural modification can avoid the first-pass effect of drugs, reduce the burden on the liver, and improve drug bioavailability; custom formulations can increase drug dissolution and enhance absorption efficiency.

Animal experiment data show that GY-1068 can accumulate in lymphoma lesions, reducing the amount of drug in the systemic circulation. While ensuring efficacy, it also reduces adverse drug reactions.

Existing research data suggest that GY-1068 has better tolerability and safety compared to ibudilizumab while achieving equivalent or even better efficacy, which can improve patient compliance and has significant clinical value.

Adhere to our original aspiration, and we value it so much that we go all out to provide patients with affordable good-quality medicines

He Kun, Frost & Sullivan's Healthcare Business Unit: Could you please introduce the entrepreneurial journey and founding philosophy behind your work?

Since its establishment in 2015, Genentech has established the concept of 'patient-centered, clinically driven innovation in affordable drugs.' Initially, Genentech focused on generic drug development, aiming to provide patients with affordable medications and accumulating research and development experience while obtaining multiple invention patents. In 2018, Genentech adjusted its development strategy and decided to engage in new drug research and development.

The leadership team of Guizhiyuan is experienced and has a profound foundation in compound synthesis, project management, registration, operation management, product management, financial management, and other areas over the years. The company's R&D team has a high level of strategic thinking and professional competence, with strong execution capabilities, ensuring efficient project implementation.

He Kun, Frost & Sullivan's Healthcare Practice: Why are you interested in an innovative technology platform that combines structural design with drug delivery systems?

Since 1998, I have been engaged in drug research and development, with in-depth knowledge spanning from drug synthesis to R&D, from formulation development to clinical trials. After joining Your Words, I took on the responsibility for the company's R&D work. When developing a new drug R&D platform, we conducted in-depth research and exploration, screened and compared various technologies for new drug R&D, and validated models. Eventually, we determined to develop a new drug R&D platform that combines structural design with delivery systems, and successfully established an innovative multi-technology, multidisciplinary R&D platform for new drugs.

Continuously enhancing R&D capabilities,Your words will safeguard the health of more patients.

He Kun, Frost & Sullivan's Healthcare Practice: How do you plan to maintain your competitive edge in the field of new drug research and development? What are your future plans or outlooks?

Firstly, regarding new drug research and development, your remarks will focus on three major areas: tumors and their adjuvant treatments, immune system diseases, and anti-infective treatments. We have already reserved some candidate drugs. Viral infections are also an important direction for your remarks' future new drug research and development. Secondly, we hope to establish a brand effect. The existing products under research by Your remarks mainly target hematological tumors (lymphoma and multiple myeloma), which usually require combination therapy. We hope to establish a product portfolio concept for this field or certain indications and expand it to areas such as immune system diseases in the future. Finally, regarding the innovative drug research and development platform, Your remarks will adhere to two cores: structural optimization and dosing system. We will continuously accumulate and refine technical experience, integrate more and newer technologies into the research and development platform, enhance the technical strength of the platform, and help Your remarks develop more and better new drugs.

Looking ahead, your company's focus will be on existing R&D projects, continuously enhancing its competitiveness, and gradually transitioning from the development of improved new drugs to innovative drug research. Future financing will mainly be used for the construction of R&D centers and the research of existing projects. Your company hopes that through relentless efforts, it can become a distinctive Chinese R&D force among global innovative drug R&D enterprises.