New Stock News | Genuine Biotech Limited has submitted a secondary application to the Hong Kong Stock Exchange, with core product Azvudine having sold over 10 million bottles

According to the Hong Kong Stock Exchange's disclosure on February 18, Genuine Biotech Limited (hereinafter referred to as Genuine Biotech) has submitted an application to list on the main board of the Hong Kong Stock Exchange, with China International Capital Corporation as its sole sponsor. This is the company's second application for listing on the Hong Kong Stock Exchange, having previously submitted an application on August 4, 2022.

The prospectus shows that Genuine Biotech is a biotechnology company driven by innovative research and development, focusing on the development, manufacturing, and commercialization of innovative drugs for the treatment of viral infections, tumors, and cardiovascular diseases. Its mission is to improve human health through genuine innovation, particularly in the fields of antiviral and antitumor therapies, exploring and addressing resistance issues in existing treatment options. The company aims to find newer and better treatment solutions to address unmet clinical needs.

With rich experience in drug development, Genuine Biotech has established a comprehensive research and development platform, including a high-selectivity novel nucleoside broad-spectrum antitumor drug development platform, a TOPO1 inhibitor and XDC drug development platform, a drug target discovery and validation platform, and an innovative drug design and optimization platform. These platforms cover the entire drug development process, from early target screening to preclinical research, clinical trials, and subsequent optimization, providing strong technical support and systematic assurance for accelerating the discovery and development of innovative drugs.

In the field of viral infection treatment, Genuine Biotech's core product, Azvudine, as a Class 1 innovative drug, received conditional approval from the National Medical Products Administration in July 2021 for the treatment of HIV infection and received conditional approval in July 2022 for the treatment of COVID-19, becoming the first oral antiviral drug developed by a Chinese company approved by the National Medical Products Administration for the treatment of COVID-19. It has demonstrated excellent efficacy in the treatment of viral infections: not only can it inhibit viral replication, but it can also achieve a dual effect by enhancing immune function. To date, over 10 million bottles have been sold, and its safety and efficacy have been confirmed in real-world data and in 70 papers published by independent third parties. Azvudine, with its unique dual-target mechanism of action, has pioneered a treatment regimen that targets both nucleoside reverse transcriptase and Vif auxiliary protein globally.

Additionally, in Phase II clinical trials, Azvudine achieved comparable clinical efficacy to Lamivudine (another popular NRTI) at only 1% of the latter's dosage level. Due to its significant efficacy against viral infections and long-acting mechanism, the company's Azvudine/CL-197 combination tablet has the potential to become the world's first fully oral long-acting HIV treatment drug taken once a week. The company is also continuously expanding the new indications and combination therapy applications of Azvudine in tumor treatment through its independent research and development capabilities In the field of tumor treatment, Genuine Biotech has discovered that its core product Azvudine possesses broad-spectrum anti-tumor activity, making it the only nucleoside anti-tumor drug with dual mechanisms and high selectivity in the past 30 years. It exerts dual anti-tumor effects by inhibiting DNA synthesis in tumor cells and regulating immune system function. The company is continuously expanding the new indications and combination therapies for its core product Azvudine, including the Azvudine/anti-PD-1 combination therapy for the treatment of liver cancer and colorectal cancer, with animal experimental data indicating a 100% tumor elimination; the Azvudine/Doratinib combination therapy for the treatment of non-small cell lung cancer, with animal models showing a tumor inhibition rate of 92.82%; as well as Azvudine monotherapy and Azvudine/CTX combination therapy for the treatment of hematological tumors, with animal experimental data showing significant inhibitory effects of monotherapy on hematological tumors and achieving 100% tumor elimination in combination therapy.

In addition, the TOPO1 inhibitor platform developed under the ZS-1003 project by Genuine Biotech employs an innovative non-camptothecin core structure, demonstrating broad-spectrum anti-tumor activity. This drug has unique advantages in overcoming common anti-tumor drug resistance. Preclinical studies indicate that its inhibitory effect on irinotecan-resistant tumor cells is 400 times that of irinotecan; and it is expected to be widely applied as a new type of toxin in various XDC (such as ADC, PDC, SMDC, etc.) conjugated drug projects, providing effective solutions to address resistance in various tumors.

In terms of finances, Genuine Biotech's revenue for 2023 and 2024 is approximately RMB 344 million and RMB 238 million, respectively; during the same period, the total annual loss and comprehensive loss are approximately RMB 784 million and RMB 40.042 million, respectively.