Genuine Biotech Submits Files with HKEX for IPO: Innovation-Driven Business Development Empowering Pharmaceutical Industry Upgrade

On 9 November, according to the disclosure from the Hong Kong Stock Exchange (HKEX), Genuine Biotech Limited (hereinafter referred to as "Genuine Biotech") has submitted its application for listing on the Main Board of HKEX, advancing an important step in the company's development. Since its establishment in 2012, Genuine Biotech has consistently upheld its mission of "improve human health through genuine innovation," and has been dedicated to the development, manufacturing, and commercialization of innovative drugs for viral infections, tumors, and cardiovascular and cerebrovascular diseases.
This submission constitutes a significant strategic deployment for Genuine Biotech as it moves toward a new stage of development. Driven by policy support, capital empowerment, and technological innovation, China's pharmaceutical industry is embracing unprecedented development opportunities. Genuine Biotech will seize this opportunity to further enhance its R&D capabilities, expand global markets, and provide better options for unmet clinical needs.

Innovation Breakthrough: R&D Journey and Extended Value of Azvudine

Azvudine, the first product launched by Genuine Biotech, as a Class 1.1 innovative drug, was 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. It was the only oral drug for COVID-19 treatment developed by a Chinese company and approved for marketing before the end of the pandemic. It is an example of Genuine Biotech's comprehensive R&D capabilities of innovative drugs.

With its unique dual-target mechanism of action, Azvudine is the first-in-class dual-target inhibitor worldwide targeting both nucleoside reverse transcriptase and accessory protein Vif, not only effectively suppressing viral replication, but also achieving "both symptomatic and curative treatment" effect by enhancing immune function. In the Phase II clinical trial, Azvudine achieved comparable clinical efficacy at only 1% of the dose level of Lamivudine.

To date, over 10 million bottles of Azvudine have been sold, and its safety and efficacy have been fully validated in real-world studies and 177 papers published by independent third parties.

Recent studies have found that Azvudine has significant inhibitory effects on various tumors. Study results have indicated that, as the only highly selective nucleoside anti-tumor drug with dual-target mechanism developed over the past thirty years, Azvudine selectively inhibits DNA synthesis in tumor cells while regulating immune function, showing significant inhibitory activity against various cancer cells. Currently, Genuine Biotech has laid out systematic plans for developing monotherapy and combination therapy in the field of hematological tumors and solid tumors, and has registered multiple clinical trials.

Whole Industry Chain Layout: Building a Sustainable Development System
Building on the successful commercialization of Azvudine, Genuine Biotech has established rich and highly synergistic innovative R&D pipelines, providing strong momentum for the company's continuous development in core therapeutic areas such as anti-viral and anti-tumor therapies.
Among these, Azvudine is undergoing strategic expansion from anti-viral field to anti-tumor field.
In the field of hematological tumors, the Phase I clinical trial of Azvudine monotherapy has been completed, and the Phase II clinical trial application was accepted by the National Medical Products Administration in September 2025. In the field of solid tumors, Azvudine's expansion covers key indications including non-small cell lung cancer, liver cancer, and colorectal cancer. Latest progress indicates that the IND application for the combination therapy of Azvudine and Dosimertinib for non-small cell lung cancer was approved in September 2025, marking the official entry of this combination therapy into clinical development.

In the field of anti-tumor innovative drug R&D, Genuine Biotech has established product pipelines with unique advantages or significant differential advantages. Among them, Dosimertinib, as a highly active and selective oral epidermal growth factor receptor (EGFR)-targeted drug candidate, has demonstrated excellent safety profile and encouraging preliminary efficacy data in clinical studies. ZSSW-136, as a TOPO1 inhibitor with novel structure, is specifically designed using AI-CADD methods. Preclinical studies have shown that it not only demonstrates more effective inhibition of TOPO1 activity, but also shows significant inhibitory effects on tumor cells resistant to existing TOPO1 inhibitors. This is expected to provide an effective solution for tumors resistant to existing TOPO1 inhibitors and antibody-drug conjugates (ADCs).

In the anti-viral field, the Phase I clinical trial of the novel oral anti-HIV drug candidate CL-197 has been completed. Its half-life of over 168 hours demonstrates significant advantages as a once-weekly oral long-acting drug. It is expected to become the world's first fully oral long-acting anti-HIV drug, thereby improving patient medication compliance.
Additionally, the drug candidate MTB-1806 indicated for acute ischemic stroke has shown its development potential in preclinical studies. Results from animal experiments have shown that MTB-1806 demonstrated advantages in increasing cerebral infarction inhibition rate after cerebral ischemia and reducing infarct area, while exhibiting good performance in terms of toxicity and tolerability.
The steady advancement of this series of innovative pipelines fully demonstrates Genuine Biotech's R&D capabilities and growth potential in the field of major disease treatment.
Talent Orientation: Building an International R&D Team
Genuine Biotech has always regarded talent as the core driving force for corporate development.
Dr. Du Jinfa, the Company's Chairman of the Board, Executive Director, Chief Executive Officer, and Chief Scientific Officer, is accredited by the Chinese government as a "National Distinguished Expert" and is one of the inventors of the hepatitis C treatment drug Sofosbuvir, which won the Prix Galien USA Award and was commented by Cell magazine as one of the most significant public health achievements of this era. Dr. Du is also one of the inventors of the Company's core pipeline products including Azvudine, long-acting drug candidate CL-197, and anti-tumor drug Dosimertinib, with rich international experience in innovative drug R&D.

Under Dr. Du's leadership, the Company has built an R&D team with professional backgrounds from international pharmaceutical companies or top research institutions, and has established comprehensive R&D platforms, including the highly selective novel nucleoside broad-spectrum anti-tumor drug R&D platform, the TOPO1 inhibitor and XDC drug R&D platform, the drug target discovery and validation platform, and the innovative drug design and optimization platform. These platforms cover the entire drug development process, from early target screening to preclinical studies, and to clinical trials and subsequent optimization, providing strong technical support and systematic assurance for accelerating the discovery and development of innovative drugs.
The Company keeps improving its talent structure and strengthening team building by creating a diversified and international R&D team that provides a constant source of talent power for the Company's sustainable development and innovation breakthroughs.
Future Outlook: Continuous Innovation and Actively Starting a New Chapter

To ensure efficient transformation of R&D achievements, Genuine Biotech has established a complete industrialization system. The Company has built a manufacturing site in Pingdingshan, Henan Province that meets international Good Manufacturing Practice (GMP) standards, with an annual production capacity of 3 billion tablets, marking that its quality management system has reached international standards. Meanwhile, through the R&D centers in Shanghai, Shenzhen, Pingdingshan, and other locations, Genuine Biotech has built a full-chain innovation system covering small-molecule and large-molecule drug R&D and clinical development, providing a solid foundation for the continuous delivery of globally competitive innovative drugs.
In terms of commercialization capabilities, the Company has established a professional and efficient marketing team with a sales network covering more than 50,000 medical institutions across 31 provinces, autonomous regions, and municipalities throughout China.
Through continuous optimization of the marketing system, the depth and breadth of product market coverage have been further expanded, laying a solid foundation for sustainable business development.

Entering a new stage of development, Genuine Biotech will continue to uphold its technology innovation-driven development strategy, dedicate to innovative drug R&D, accelerate the clinical progress of existing product pipelines, and enrich its product portfolio through continuous technological breakthroughs. At the same time, the Company will focus on continuously improving its production quality system and strengthening supply chain capabilities to lay a solid foundation for product value realization, while deepening its business layout to drive the Company to new heights.
Looking ahead, by continuously building independent innovation capabilities and improving its industrial ecosystem, Genuine Biotech will play an increasingly important role in global pharmaceutical innovation and make its due contributions to achieving the "Healthy China" strategic goal and advancing global public health.