New stock news | Sanreal Biotech submits application to Hong Kong Stock Exchange for the approval of its core product Azvudis for the treatment of HIV infection and COVID-19 in China.

According to the disclosure by the Hong Kong Stock Exchange on November 9th, Real Biotech Limited (referred to as Real Biotech) has submitted an application to list on the main board of the Hong Kong Stock Exchange, with CICC as its exclusive sponsor. This is the company's third application to list on the Hong Kong Stock Exchange, having previously submitted applications on August 4, 2022, and February 18, 2025. The prospectus shows that Real Biotech is a biotechnology company founded in 2012 with a focus on innovative research and development. The company specializes in the development, manufacturing, and commercialization of innovative drugs for the treatment of viral infections, tumors, and cardiovascular diseases. The company has built a comprehensive drug portfolio, including five candidate drugs: the core product Azvudine, a drug approved in China for the treatment of HIV infection and COVID-19, is being developed as a monotherapy (for the treatment of multiple myeloma, lymphoma, and acute leukemia) and four combination therapies, including Azvudine/PD-1 (for the treatment of liver cancer and colorectal cancer), Azvudine/Dolutinib (for the treatment of non-small cell lung cancer), Azvudine/CL-197 (for the treatment of HIV), and Azvudine/CTX (for the treatment of lymphoma); the core product CL-197, used for long-term treatment of HIV infection; the core product Dolutinib, used for the treatment of non-small cell lung cancer; ZSSW-136 used for the treatment of malignant tumors; and MTB-1806 used for the treatment of acute ischemic stroke. Real Biotech has a strong product pipeline with innovative and continuous innovation capabilities. In the field of viral infection treatment, the companys core product Azvudine, as a Class 1 original new drug, received conditional approval for the treatment of HIV infection in July 2021 and conditional approval for the treatment of COVID-19 in July 2022, becoming the first oral antiviral drug developed by a Chinese company to be approved for the treatment of COVID-19 by the National Medical Products Administration. In the field of cancer treatment, the company's core product Azvudine has broad-spectrum anti-tumor activity and is the only nucleoside anti-tumor drug with a dual mechanism and high selectivity in the past 30 years. In addition, the company's TOPO1 inhibitor platform, using an innovative non-camptothecin core structure, demonstrates broad-spectrum anti-tumor activity. ZSSW-136 is the first small molecule PCC compound discovered by this platform, with unique advantages in overcoming common resistance to anti-tumor TOPO1-targeted drugs. Real Biotech also has strong production, commercialization capabilities, and channel advantages. The company has established its own production facilities with an annual production capacity of approximately 3 billion tablets, which are GMP certified and fully meet current commercialization needs. In addition, the company has established a professional commercialization team and a complete commercialization management system, and has completed the layout of online and offline channels. Azvudine was officially included in the National Basic Medical Insurance Drug List (NRDL) in 2023, and successfully renewed in 2024, with no change in coverage and payment prices, ensuring price stability and wide market access for the product. Azvudine has covered over 50,000 medical endpoints in 31 provinces and cities nationwide, and after obtaining approval for new indications in the future, it can be directly provided through medical institutions without the need for repeated medical institution access procedures, further consolidating its market position. The company uses an omnichannel and strategic promotional model to promote and distribute products, including the commercialized product Azvudine and other candidate drugs to be launched in the future. The company will quickly establish a comprehensive commercial system through marketing, market access, digital promotion, medical value exploration, direct sales, recruitment of distributors, and business excellence to promote product sales, and continue to provide the market with accurate and latest academic research results with clinical value to enhance the market visibility of the company's products. As of June 30, 2025, Real Biotech has successfully reached agreements with 65 offline distributors, largely ensuring the accessibility of products in the market, and has collaborated with nine online distributors in China to establish an online sales channel for Azvudine and successfully realize sales. Financial Information Income The company recorded revenues of RMB 344 million, RMB 238 million, and RMB 16.53 million for the fiscal years 2023, 2024, and the six months ended June 30, 2025, respectively. During the past reporting periods, all of the company's revenues were generated from its first commercialized product, Azvudine. During the past reporting periods, the majority of the company's revenues were derived from the agreements with Shanghai Fosun Pharmaceutical. Gross Loss/Gross Profit The company recorded gross losses of RMB 329 million, gross profits of RMB 165 million, and gross losses of RMB 43.423 million for the fiscal years 2023, 2024, and the six months ended June 30, 2025, respectively. In 2024, the company reported gross profit due to a decrease in inventory write-downs. Net Loss for the Year The company recorded net losses of RMB 784 million, RMB 40.042 million, and RMB 165 million for the fiscal years 2023, 2024, and the six months ended June 30, 2025, respectively. As of the six months ended June 30, 2025, the company reported a net loss of RMB 16.54 million, primarily due to significant research and development expenses for core products and other candidate drugs, inventory write-downs leading to gross losses, and administrative expenses incurred during the reporting period. Industry Overview Antiviral Drug Market Viral infection is one of the major treatment areas in the global pharmaceutical market. In 2023, the global and Chinese antiviral drug markets were USD 73.6 billion and USD 7.8 billion, accounting for 5.0% and 3.4% of the global and Chinese pharmaceutical markets, respectively. The global antiviral drug market has grown from USD 54.4 billion in 2018 to USD 73.6 billion in 2023, with a compound annual growth rate of 6.3%. The market is expected to reach USD 101.1 billion by 2030, with a compound annual growth rate of 4.6% from 2023 to 2030. The Chinese antiviral drug market has grown from USD 3.5 billion in 2018 to USD 7.8 billion in 2023, with a compound annual growth rate of 17.1%. The market is expected to further increase to USD 21.8 billion by 2030, with a compound annual growth rate of 15.8% from 2023 to 2030. HIV Drug Market HIV is a virus that attacks and destroys CD4+ T cells in the immune system, making patients susceptible to infections and other diseases. In 2023, the global number of HIV-infected patients reached 42.9 million. It is estimated to reach 48.7 million by 2030, with a compound annual growth rate of 1.8% from 2023 to 2030. In China, the number of HIV-infected patients reached 1.6 million in 2023, expected to increase to 2.0 million by 2030, with a compound annual growth rate of 3.5% from 2023 to 2030. As more individuals are expected to carry HIV for a longer time, combating HIV remains a significant challenge for the global healthcare system. The global HIV drug market has grown from USD 35.3 billion in 2018 to USD 43.1 billion in 2023, with a compound annual growth rate of 4.1%. It is estimated to reach USD 59.5 billion by 2030, with a compound annual growth rate of 4.7% from 2023 to 2030. Innovative therapies are expected to continue driving growth in developed and emerging markets. Nucleoside drugs, as recommended by the WHO for all frontline antiretroviral therapy for HIV-infected patients, play a pivotal role in the HIV drug market and have tremendous growth potential. The Chinese HIV drug market has grown from USD 304.5 million in 2018 to USD 636.2 million in 2023, with a compound annual growth rate of 15.9%. It is expected to reach USD 2,327.5 million by 2030, with a compound annual growth rate of 20.4%, significantly higher than the estimated compound annual growth rate of the global HIV drug market during the same period. This growth reflects increased diagnoses and treatments, as well as the expectation of more innovative HIV drugs being included in the NRDL, leading to a greater number of patients receiving innovative HIV drugs. In recent years, newly approved cART drugs with increased efficacy and safety have become the most widely used HIV drugs globally. Cancer Drug Market As a leading cause of death globally, the number of new cancer cases worldwide increased from 18.1 million in 2018 to 20.8 million in 2023. Due to aging populations, the number of cancer cases is projected to reach 24.5 million by 2030. by cancer mortality, cancer is the second leading cause of disease in China. Over the past five years, the number of new cancer cases in China has steadily increased from 4.4 million in 2018 to 4.9 million in 2023, and is projected to reach 5.6 million by 2030. From 2018 to 2023, the global cancer drug market expanded from USD 128.1 billion to USD 228.9 billion, with a compound annual growth rate of 12.3%, and is expected to reach USD 419.8 billion by 2030, with a compound annual growth rate of 9.1% from 2023 to 2030. In 2023, the Chinese cancer drug market increased from USD 23.8 billion to USD 34.1 billion, with a compound annual growth rate of 7.2%, and is expected to reach USD 77.5 billion by 2030, with a compound annual growth rate of 12.4%. Meanwhile, the Chinese cancer drug market is undergoing structural changes with the introduction of targeted therapies and immunotherapies. In 2023, chemotherapy drugs, targeted therapy drugs, and immunotherapy drugs accounted for approximately 47.5%, 42.4%, and 10.1% of the Chinese cancer drug market, respectively. Over the next decade, the growth rates of targeted therapy drugs and immunotherapy drugs are expected to far exceed that of chemotherapy drugs, with the former and the latter expected to become the first and second largest segments of the Chinese cancer drug market by market value in 2030. Board of Directors and Management Information The board of directors currently consists of eight directors, including three executive directors, two non-executive directors, and three independent non-executive directors. The board's powers and duties include convening shareholder meetings, reporting on board work at shareholder meetings, determining business and investment plans, preparing annual financial budgets and financial reports, developing profit distribution schemes, and exercising other powers and functions entrusted by the rules, as well as performing other functions and duties entrusted by the rules. Equity Structure Mr. Chao Yang Wang, the founder of Real Biotech, holds a 46.89% stake through Trinity Venture and 1.23% through Creative Summit, for a total of 48.12%. According to the prospectus, Trinity Venture is wholly-owned by Mr. Wang. Under the Securities and Futures Ordinance, Mr. Wang is regarded as having an interest in the shares held by Trinity Venture. In addition, Creative Summit is wholly owned by Trinity Venture, which is fully owned by Mr. Wang. Under the Securities and Futures Ordinance, Trinity Venture and Mr. Wang are each regarded as having an interest in the shares held by Creative Summit. Intermediary Team Sponsor: China International Finance Hong Kong Securities Limited Company Legal Advisor: (1) Hong Kong Legislation and U.S. Law: Dechert LLP; (2) Chinese Law: Jingtian & Gongcheng LLP; (3) Cayman Islands Law: Conyers Sponsor Legal Advisor: (1) Hong Kong Legislation and U.S. Law: Winston & Strawn; (2) Chinese Law: AllBright Law Offices Auditors and Reporting Accountants: Ernst & Young Industry Consultant: Frost & Sullivan (Beijing) Consulting Co., Ltd. Shanghai Branch Compliance Consultant: Guotai Junan Financing Limited