Annual Review | Highlights of Genuine Biotech in 2024

Successful IND Approval and Clinical Trial Initiation for Azvudine for the Treatment of Solid Tumors, Accelerating Innovations in Anti-Tumor Treatment

In September, the investigational new drug (IND) application for Azvudine (clinical study code: GEN-725) for the indication of solid tumors was approved by the Center for Drug Evaluation (CDE), National Medical Products Administration, and the clinical trial of monotherapy in patients with advanced solid tumors was approved. This project has officially initiated clinical trials in Shanghai. In April, the preclinical anti-tumor data of Azvudine was presented at the 2024 American Association for Cancer Research (AACR) Annual Meeting, where the company published the immunological anti-tumor effect of Azvudine at an international academic conference for the first time. The preclinical data showed that Azvudine has a unique anti-cancer mechanism. As a highly selective nucleoside drug, it inhibits the proliferation of cancer cells effectively by terminating the elongation of DNA chain in tumor cells, as well as by interfering with the activity of various enzymes involved in the synthesis of nucleic acids in cancer cells. At the same time, Azvudine can also act as an immunomodulator, reducing the levels of myeloid-derived suppressor cells (MDSCs) in the tumor microenvironment significantly, and promoting the infiltration and proliferation of CD3+CD8+ T cells, CD3+CD4+ T cells, and natural killer (NK) cells, thereby exerting a tumor inhibitory effect. In addition, Azvudine has significant synergistic effects when used in combination with anti-PD-1 antibody.

Multiple Blockbuster R&D in Parallel, Promoting Drug Innovation at Source

As a biopharmaceutical company driven by innovation, Genuine Biotech places paramount importance on "innovative research and development" as the cornerstone of the company's growth. In 2024, in addition to the initiation of clinical trials for Azvudine for anti-tumor indication, the company also made progress in several R&D projects: In the antiviral field, all phase I clinical subjects of CL-197, a next-generation oral long-acting HIV candidate, have been out of group and data analysis is ongoing. This drug is expected to become the world's first fully oral, long-acting anti-HIV drug. In the human organoid trial of the novel TOPO1 inhibitor with global intellectual property rights in subjects resistant to Irinotecan, this candidate drug showed significant anti-tumor effects, with an inhibitory activity against Irinotecan-resistant tumor cells 400 times as high as that of Irinotecan! It also showed significant anti-tumor effects in Irinotecan-resistant PDX animal studies, and is expected to be developed as a drug that is effective against tumors resistant to TOPO1 inhibitors, including Irinotecan. As an effective payload toxin, this novel inhibitor has been applied in various XDC (e.g., ADC, PDC, and SMDC) R&D projects to provide effective solutions for various drug-resistant tumors. Both external collaborations and global licensing create significant clinical application value as well as market value. Azvudine in combination with Dosimertinib produces significant synergistic effects in the treatment of non-small cell lung cancer, and the IIT data and preclinical study data are promising. An IND application has been submitted to the CDE. In addition, a new ADC is under development. Its new monoclonal antibody against prostate-specific membrane antigen (PSMA) features a newly designed structure, which can effectively cleave the hydrophilic linker and cytotoxic payload. Preclinical studies have shown that the candidate drug has a tumor growth inhibition rate of up to 95%, demonstrating good tumor growth inhibition and good safety. We plan to develop its use in multiple tumor indications, including prostate cancer, bladder cancer, and kidney cancer.

Strong Commercial Sales Model Developed for Stable Revenues for the Company's Long-Term Development

In September, Genuine Biotech and Fosun Pharma reached an agreement that Genuine Biotech withdrew the exclusive commercialization right of Azvudine. At the same time, Genuine Biotech has established a well-functional professional commercialization team and a complete commercialization management system, and has adopted an online plus offline full-channel, strategic academic promotion model to promote and sell products, including the commercialized product Azvudine and products to be marketed. Offline, Azvudine has been admitted to more than 50,000 medical institutions in 31 provinces and municipalities across China, which are not only the bridges between products and markets, but also the cornerstone of achieving extensive market coverage and efficient supply; online, we have successfully entered into strategic cooperation with several head e-commerce platforms in China and achieved sales. These provide continuous and stable sales revenue for the company's long-term development.

Strategic Cooperation with Zhongyuan Bank Promoting the Rapid Development of the Company

In October, Genuine Biotech and Zhongyuan Bank entered into a strategic cooperation agreement in Zhengzhou, Henan Province, signifying deepened bank-enterprise cooperation and energizing innovation and development in the pharmaceutical industry with technology finance. The cooperation provides a strong financial driver for the company's innovation and development, accelerates the transformation and industrialization of R&D achievements, and promotes the company's sustainable and stable development.

Successful Renewal in the National Reimbursement Drug List Benefiting a Broad Range of Patients

In November, Genuine Biotech's self-developed Azvudine Tablets (trade name: Jiebeian®) was successfully renewed in the National Reimbursement Drug List（2024), once again confirming the innovative and clinical values of Azvudine.

Several Academic Achievements Published in International Reputed Journals, Clinical Values Highly Recognized by Experts

In March, Jiang Jiandong, academician of the Chinese Academy of Engineering, in cooperation with multiple research teams, published a paper on the enhancement of immunity by Azvudine in the international reputed journal Acta Pharmaceutica Sinica B (APSB): Azvudine was mainly enriched in the thymus after entering the body. After three times of phosphorylation were completed in the thymus, the virus was eliminated, and more competent CD4+ cells were activated to enhance the immune function of the body. In February, investigators from Peking Union Medical College Hospital published a meta-analysis of Azvudine for the treatment of COVID-19 in the international reputed academic journal of virology, Virology Journal, which included the treatment results of 7746 patients from 17 studies, confirming that Azvudine is safe and effective in the treatment of COVID-19. Professor Wang Guiqiang, Chief of the Department of Infectious Diseases at Peking University First Hospital, presented the safety data of Azvudine at the industry conference held in Chengdu in August: As Azvudine cured more than ten million patients with COVID-19, the incidence of adverse reactions reported was only 0.02%.

Several Honors Witnessing Innovative Value

In June, MENET released the "2023 Top 100 Innovation List Series for Biopharmaceutical Enterprises in China". Genuine Biotech once again made it to the "Top 30 Innovative Small-Molecule Pharmaceutical Enterprises in China", marking the third consecutive year since 2021 that the company has received this honor. In December, the "2024 China Biopharmaceutical Industry Chain Innovation Billboard" was officially announced. Azvudine, independently developed by Genuine Biotech, was honored with the "Best Commercial Return Award (Chemical Drug)" for its outstanding performance during its three years on the market. In the same month, the People's Government of Henan Province granted the first prize of Henan Provincial Technical Invention Award to the project "development and application of the Class 1 innovative drug for the dual-target treatment of AIDS" of Azvudine. As early as in 2022, the project "Development and Application of Azvudine Tablets for the Treatment of COVID-19" won the first prize of Henan Provincial Technical Invention Award. Winning the prize again further affirms Azvudine Tablets' innovative, clinical, and social value.

Series of Reports Gaining High Attention, Single Popular Article with Over 3 Million Views

Thanks to a series of real-world study results, sufficient productive capacity reserves, and successful renewal in the latest National Reimbursement Drug List, Azvudine has received frequent attention from and reported by authoritative central media, local official media, numerous social media, among others, with over 3 million views on a single report.