New stock news | RealBio has already sold over 10 million bottles of its core product Azifin in the Hong Kong Stock Exchange secondary listing.
19/02/2025
GMT Eight
According to the disclosure of the Hong Kong Stock Exchange on February 18th, True Biotech Limited (hereinafter referred to as "True Biotech") has filed an application to be listed on the main board of the Hong Kong Stock Exchange, with CICC as its exclusive sponsor. This is the company's second application for listing on the Hong Kong Stock Exchange, after previously filing on August 4, 2022.
The prospectus shows that True Biotech is a biotechnology company focused on the research, development, manufacturing, and commercialization of innovative drugs for the treatment of viral infections, tumors, and cardiovascular and cerebrovascular diseases, with innovation research and development as the drive. Its mission is to improve human health through true innovation, especially in the areas of antiviral and anticancer treatments, exploring and solving the problem of drug resistance in existing treatment options. The company aims to find newer and better treatment options to address unmet clinical needs.
With extensive experience in drug research and development, True Biotech has established a comprehensive research and development platform, including a high-selectivity new nucleoside broad-spectrum antitumor drug development platform, TOPO1 inhibitor and XDC drug development platform, drug target discovery and validation platform, and innovative drug design and optimization platform. These platforms cover the entire drug development process, providing strong technical support and systematic guarantees to accelerate the discovery and development of innovative drugs.
In the field of viral infection treatment, True Biotech's core product Azvudine is an original Class 1 new drug, conditionally approved by the National Medical Products Administration for the treatment of HIV infection in July 2021, and conditionally approved for the treatment of COVID-19 in July 2022, becoming the first oral antiviral drug developed by a Chinese company approved for the treatment of COVID-19 by the National Medical Products Administration. Azvudine has shown outstanding effects in the field of viral infection treatment: not only can it inhibit virus replication, but it can also achieve a combined effect of addressing both symptoms and the cause by enhancing immune function. It has sold over 10 million bottles so far, 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 action mechanism, pioneered a treatment regimen of nucleoside reverse transcriptase inhibitor and Vif accessory protein dual-target inhibition on a global scale.
In addition, in Phase II clinical trials, Azvudine achieved clinical efficacy equivalent to lamivudine (another popular NRTI) at only 1% of the latter's dose level. Due to its significant efficacy in treating viral infections and long-lasting mechanism, the company's Azvudine/CL-197 combination tablets have the potential to become the world's first long-acting, once-weekly oral treatment for HIV. Leveraging its independent research and development capabilities, the company continues to explore new indications and combination therapies for Azvudine in the field of cancer treatment.
In the field of cancer treatment, True Biotech's core product Azvudine has broad-spectrum anti-tumor activity, being the only nucleoside anti-tumor drug with dual mechanisms and high selectivity in the past 30 years. It exerts a dual anti-tumor effect by inhibiting tumor cell DNA synthesis and regulating immune system function. The company is continuously expanding the new indications and combination therapies for Azvudine, including the Azvudine/anti-PD-1 combination therapy for the treatment of liver cancer and colorectal cancer, with animal experiments showing a 100% tumor elimination rate; the Azvudine/doxorubicin combination therapy for the treatment of non-small cell lung cancer, with animal models showing a tumor inhibition rate of 92.82%; and the Azvudine monotherapy and Azvudine/CTX combination therapy for the treatment of hematologic tumors, with animal experimentation showing a significant inhibitory effect on hematologic tumors in monotherapy, and achieving a 100% tumor elimination rate in combination therapy.
Additionally, the TOPO1 inhibitor platform developed by True Biotech's ZS-1003 project uses a groundbreaking non-camptothecin mother nucleus structure, demonstrating broad-spectrum anti-tumor activity. This drug has unique advantages in overcoming common resistance to anti-tumor drugs. Preclinical studies have shown that its inhibitory effect on irinotecan-resistant tumor cells is 400 times that of irinotecan, and it is expected to be widely used as a new type of toxin in various XDCs (such as ADC, PDC, SMDC, etc.) coupled drug projects, providing an effective solution to resistance in a variety of tumors.
Financially, in 2023 and 2024, True Biotech's revenue is expected to be approximately RMB 344 million and RMB 238 million, respectively; during the same period, the annual losses and cumulative losses are expected to be approximately RMB 784 million and RMB 40.042 million, respectively.