Sino Biopharmaceutical Limited (“Sino Biopharm” or the “Company”, together with its subsidiaries, the “Group”) (HKEX:1177), a leading innovation-driven pharmaceutical conglomerate in the PRC, has announced its audited financial results for the year ended 31 December 2022.
Oncology Innovative Drugs
— Focus V (Anlotinib Hydrochloride Capsules) has been approved for five indications: third-line non-small cell lung cancer, third-line small cell lung cancer, soft tissue sarcoma, medullary thyroid cancer and differentiated thyroid cancer.
— The Phase III clinical trials of Anlotinib in combination with TQB2450 (PD-L1) for the treatment of first-line small cell lung cancer has completed interim analysis and met the pre-specified endpoint.
— In addition, 12 new indications for Anlotinib have also entered Phase III clinical trials, including the combination of Anlotinib with Penpulimab monoclonal antibody, Anlotinib with TQB2450 (PD-L1), Anlotinib with chemotherapy, and other treatment options, for which marketing applications are expected to be submitted progressively in the next one to two years.
— Annike (Penpulimab monoclonal antibody injection) injection was approved in January 2023 for the treatment of first-line locally advanced or metastatic squamous non-small cell lung cancer with chemotherapy. To date, the product has been approved for two indications: third-line classic Hodgkin’s lymphoma and first-line squamous non-small cell lung cancer. In addition, it has one indication (third-line nasopharyngeal carcinoma) under marketing review.
— F-627 (Efbemalenograstim alpha, long-acting granulocyte colony-stimulating factor) is currently in the marketing application stage. F-627 is currently the only G-CSF drug on the market that has conducted simultaneous research head-to-head with both short-acting and long-acting G-CSF in large sample sizes. Phase III clinical trials have been completed with marketing applications submitted in China and the United States. The Group expects that the marketing application will be approved in China in 2023. With its strong oncology sales team, Sino Biopharm is confident in a smooth launch and rapid market penetration of the product.
Liver Disease Innovative Drugs
— Lanifibranor (pan-PPAR agonist) is an orally-available small molecule. The product is currently undergoing Phase III clinical trials globally, and is the first oral drug for NASH that has entered Phase III clinical trials in China, to address a large clinical unmet need in the China NASH market.
Respiratory System Innovative Drugs
— Ensitrelvir (3CL protease inhibitor) is a novel oral drug for the treatment of COVID-19. The drug has the potential to become a good oral drug for the treatment of COVID-19.
Surgery/Analgesia Innovative Drugs
— PL-5, an antimicrobial peptide product that is the first newly designed non-antibiotic antimicrobial drug with a broad antibacterial spectrum. The product has completed a Phase III clinical study in China for the treatment of secondary wound infections, and the Group expects to file a marketing application within this year. When the product is launched, it will be the first antimic robial peptide product available in China.
— As of the end of the reporting period, the Group’s generic drug products, with annual revenue of more than RMB500 million (excluding exclusive products), have been included in the scope of centralized drug procurement. The stock of generic drugs that has not been included in the scope of centralized drug procurement has been cleared, hence, eliminating its risk exposure in centralized drug procurement.
During the year, the Group recorded revenue of approximately RMB28.78 billion, an increase of approximately 7.1% over last year. Profit attributable to the owners of the parent company was approximately RMB2.54 billion. Earnings per share attributable to the owners of the parent company were approximately RMB13.66 cents, a decrease of approximately 82.4% over last year. Excluding the share of profits and losses of associates and a joint venture (net of related tax and non-controlling interests), one-off adjustments for the impairment and fair value changes of certain assets and liabilities (net of related tax and non-controlling interests), fair value losses of current equity investments, share-based payments, loss on extinguishment of partial convertible bond, fair value gain of convertible bond embedded derivative component, effective interest expenses, exchange gain and fair value losses of derivative financial instruments in relation to foreign currency forward contracts of the convertible bond debt component, adjusted non-HKFRS profit attributable to the owners of the parent was approximately RMB2.99 billion, an increase of around 16.4% over last year. The Group’s liquidity remains strong, with total fund reserve at approximately RMB22.96 billion, including cash and bank balances classified under current assets of approximately RMB12.07 billion, bank deposit classified under non-current assets of approximately RMB6.35 billion, and the wealth management products of approximately RMB4.54 billion in aggregate.
The Board of Directors has recommended a final dividend payment of HK6 cents per share. Together with the interim dividend of HK6 cents already paid, the total dividend for the year amounted to HK12 cents (2021: HK8 cents).
Sales: Sales revenue contributed by new products and innovative drug products rises relied on a strong sales system
The Group continues to focus on developing innovative medicines in four therapeutic areas and has benefited significantly from the continuous and huge investment it has made in R&D over the years. During the year, sales revenue from new products (products launched within five years) launched amounted to RMB12.51 billion, a 19.8% year-on-year increase, accounting for 43.5% of the Group’s total revenue for the year, up from 38.9% for last year. Revenue from innovative drugs amounted to RMB6.75 billion, up by 20.0% year-on-year, and accounted for 23.5% of the Group’s total revenue.
During the year, the Group’s sales contribution continued to be led by drugs in the areas of oncology, surgery/analgesia, liver disease and respiratory system. Among them, the sales of oncology medicines amounted to approximately RMB9.19 billion, up by approximately 14.3% for last year, representing approximately 31.9% of the Group’s revenue. The sales of surgery/analgesia and liver disease amounted to approximately RMB4.88 billion and RMB3.84 billion, respectively, representing approximately 17% and 13.3% of the Group’s revenue, respectively. In addition, sales contributions from various areas such as respiratory, cardio-cerebral vascular medicines and others were comparable. Among them, the sales of respiratory and cardio-cerebral vascular medicines accounted for approximately 10.2% and 9.4% of the Group’s revenue, respectively.
R&D: Continued to focus on R&D of innovative medicines, emphasizes protection of intellectual property rights
The Group has continued to focus its R&D efforts on new medicines in four therapeutic areas, namely
oncology, liver disease, respiratory system and the surgery/analgesia. As of the end of the reporting period, the Group has 103 products under development, including 53 oncology products, 12 liver disease products, 26 respiratory system products, and 12 surgery/analgesia products, involving a total of 58 Category I innovative products.
The Group also emphasizes the protection of intellectual property rights. It encourages its member enterprises to apply for patent applications as a means to enhance the Group’s core competitiveness. During the year, the Group filed 1,006 new patent applications and received 280 authorized patent notices.
Prospects: Focus on main four therapeutic areas while the innovation and transformation have entered the harvest stage
As the pharmaceutical industry is likely to pick up rapidly. The Group has closely followed the development of the country, society and industry, and adjusted its development strategy in a timely manner. It has actively conducted organizational integration, optimized the internal organizational structure of the Group, and accelerated construction of business teams across different channels, in order to grow its business rapidly and deliver results in a stable manner.
According to important guidelines of the Country such as the “14th Five-Year Plan for Bioeconomy” and Key Tasks for Deepening the Reform of the Medical and Healthcare System in 2022. Sino Biopharma regards innovation and transformation as integral to its strategic development, and is focused on four main therapeutic areas: oncology, hepatitis, respiratory, and surgery/ analgesia. It has been mapping out innovative drug projects with best-in-class (BIC) and first-in-class (FIC) potential, and is driving innovative development through its dual engines: internal research and development, and commercial expansion. At present, the Group’s innovation and transformation have entered the harvest stage. In the next three years, more than 10 innovative drug products will be launched, and over 40 innovative drugs in the pipeline may be launched by 2030, further promoting the high-quality development of the Group, realizing the revenue target of HK$100 billion by 2030, and becoming a leading innovative pharmaceutical group in the world. In addition, as the cornerstone of generic drugs, the Group will continue to deploy special generic drugs that have broad market prospects and are highly competitive, and through efficient and stable production maintain steady revenue growth from generic drugs.
Under the four main strategies of “organizational integration, comprehensive innovation, internationalization, and digitalization”, the Group will further consolidate resources, improve operational efficiency, accelerate and facilitate cooperation at home and abroad, and promote global innovation and development.
About Sino Biopharmaceutical Limited (HKEX:1177)
Sino Biopharmaceutical Limited is a leading, innovative R&D-driven pharmaceutical conglomerate in the PRC. Its business encompasses a fully-integrated chain which covers an array of R&D platforms, a line-up of intelligent production and a strong sales system. The Group’s products have gained a competitive foothold in various therapeutic categories with promising potential, comprising a variety of biopharmaceutical and chemical medicines for tumors, liver diseases, respiratory system diseases and surgery/analgesia.
Sino Biopharma is a constituent stock of the following indices: MSCI Global Standard Indices – MSCI China Index, Hang Seng Index, Hang Seng China Enterprises Index, Hang Seng Composite Index, Hang Seng Healthcare Index, Hang Seng SCHK Mainland China Healthcare Index, Hang Seng Composite LargeCap Index, Hang Seng Composite LargeCap & MidCap Index, Hang Seng China (Hong Kong-listed) 100 Index and Hang Seng Stock Connect Hong Kong Index, etc. Sino Biopharm was ranked as one of “Asia’s Fab 50 Companies” by Forbes Asia for three consecutive years in 2016, 2017 and 2018.
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Topic: Press release summary