On March 26, 2024, Hanson Pharmaceuticals (03692.HK) announced its 2023 annual results. During the reporting period, it achieved operating revenue of approximately RMB 10.104 billion (same unit), an increase of about 7.7% over the same period last year, and net profit of about RMB 3.278 billion, an increase of about 26.9% over the same period last year.
The report shows that in 2023, Hanson Pharmaceuticals' revenue from innovative drugs and cooperative products was about 6.865 billion yuan, an increase of about 37.1% over the previous year, accounting for 67.9% of total revenue. Innovative drugs have become the core driving force for performance growth. Behind its leading innovation strength is continuous investment in R&D. In 2023, Hanson Pharmaceuticals spent about 2,097 billion yuan on R&D, an increase of about 23.8% over the previous year, accounting for 20.8% of total revenue. Up to now, the company has reserves of more than 30 innovative drugs and is carrying out more than 50 clinical trials, and R&D potential is strong.
While deepening independent research and development, Hanson Pharmaceuticals is accelerating global cooperation. In terms of licensing out, GlaxoSmithKline was granted exclusive overseas licenses to develop and commercialize HS-20089 (B7-H4 ADC) and HS-20093 (B7-H3 ADC) respectively in 2023, fully demonstrating the innovative value of the company's high-potential pipeline. In terms of licensing, in August 2023, Hanson Pharmaceuticals signed an agreement with Deqi Pharmaceutical to exclusively be responsible for the commercialization of selinexor (selinexor) and any product containing or composed of selinisol (trade name: Sivio) in mainland China; in March 2024, Hanson Pharmaceuticals and Pumis expanded cooperation on HS-20117/PM1080 to increase EGFR/cMET-ADC drug research and development, and continue to consolidate the company's dominant position in the field of oncology.
By the end of the reporting period, Hanson Pharmaceuticals had introduced a total of 2 commercialization projects, and 9 cooperative projects in the clinical stage had all been approved for clinical trials in China.
Innovative drug performance reaches a new high to create momentum for sustainable growth
In 2023, Hanson Pharmaceuticals' 7th innovative drug Saint Rollaix (pemoxatide injection) was approved for sale, and the innovative drug product portfolio was further expanded. Up to now, the company's 7 approved innovative drugs have all been included in the national health insurance catalogue. With the high-value clinical performance and differentiated advantages of many innovative products, in 2023, Hanson Pharmaceutical continued to improve operational efficiency, efficient organizational structure collaboration, and comprehensively promote product commercialization. The company's revenue from innovative drugs and cooperative products was about 6.865 billion yuan, an increase of about 37.1% over the previous year, accounting for 67.9% of total revenue.
By sector, in 2023, Hanson Pharmaceuticals recorded revenue of about 6.169 billion yuan, 1,269 billion yuan, 1,367 billion yuan, and 1,299 billion yuan in the fields of anti-tumor, anti-infective, central nervous system, metabolism and other diseases, accounting for about 61.0%, 12.6%, 13.5%, and 12.9% of revenue, respectively.
In the field of oncology, Hanson Pharmaceuticals has now launched two self-developed and innovative products: Amex (ametinib mesylate tablets) and Hausen Xinfu (flumatinib mesylate tablets). Ametinib is the first self-developed third-generation EGFR-TKI in China. It has been approved for second-line treatment of EGFR T790M+ advanced NSCLC and first-line treatment of EGFR+ advanced NSCLC, both of which are the first domestically produced products to be approved. Focusing on ametinib, Hanson Pharmaceuticals comprehensively lays out the field of lung cancer and continues to develop multiple indications, including post-operative support and first-line chemotherapy. Currently, many clinical data on ametinib have shown excellent efficacy, and as a grade I or preferred recommendation, it has been included in 8 national diagnosis and treatment guidelines, including the “Chinese Society of Clinical Oncology (“CSCO”) Non-Small Cell Lung Cancer Diagnosis and Treatment Guidelines (2023 Edition). In 2023, Amelot's invention patent “EGFR inhibitors and their preparation and application” also won the 24th “China Patent Gold Award”. In terms of overseas travel, Hanson Pharmaceuticals will continue to promote the regulatory process of the UK Medicines and Healthcare Products Authority (“MHRA”) and the European Medicines Agency (“EMA”) to review marketing license applications for ametinib.
Flumatinib is the first novel second-generation TKI for chronic myeloid leukemia originally developed in China to treat chronic myeloid leukemia (CML) indications. Flumatinib has been recommended for first-line treatment of chronic myeloid leukemia by the “Chinese Guidelines for the Diagnosis and Treatment of Chronic Myeloid Leukemia (2020 Edition)” and the “CSCO Guidelines for the Diagnosis and Treatment of Malignant Hematologic Diseases”.
In the field of anti-infection, Hanson Pharmaceuticals has two self-developed innovative drugs on the market: Hengmu (amitinofovir tablets) and Melinda (morpholinidazole sodium chloride injection). Hengmu is the first oral anti-hepatitis B virus drug originally developed in China. It has been included in the “CSCO Liver Cancer Diagnosis and Treatment Guidelines (2022 Edition)” and was included in the “Chronic Hepatitis B Prevention and Treatment Guidelines (2022 Edition)” jointly issued by the Hepatology Branch and the Infectious Diseases Branch of the Chinese Medical Association, and recommended as the preferred drug. In 2023, the 144-week data update for the Hengmu Phase III key registered clinical study was selected for LBA and released at the 74th Annual Meeting of the American Society for Liver Disease Research. The study results once again verified the efficacy and safety of long-term treatment for patients with chronic hepatitis B. Furthermore, the 48-week data from the Hengmu Phase III key registered clinical study was published in “Aliment Pharmacol Therapeutics”, and the 96-week data was published in the “Journal of Clinical and Translational Hepatology”, which all proved Hengmu's good anti-hepatitis B virus efficacy and bone and kidney safety.
In the field of central nervous system, Xinyue (inelizumab injection) introduced by Hanson Pharmaceuticals was approved for marketing in 2022. It is the only humanized anti-CD19 monoclonal antibody to treat AQP4 antibodi+NMOSD in the world. Xinyue has now been included in the “Chinese Guidelines for the Diagnosis and Treatment of Neuromyelitis Optica Spectrum Diseases (2021 Edition)” and received category A recommendations. Currently, partners are conducting global multi-center clinical research on IgG4-related diseases (IgG4-RD) and myasthenia gravis (gMG), including the Chinese center.
In the field of metabolism and other diseases, Hanson Pharmaceuticals' innovative product portfolio mainly includes Saint Rollaix (pemoxatide injection) and Fremex (polyethylene glycol rosenatide injection). Pemoxatide is the only EPO mimetic peptide approved for marketing in the world. It has been approved for the treatment of anemia caused by chronic kidney disease (CKD), including adult non-dialysis patients not treated with erythropoiesis stimulants (ESA), and adult dialysis patients receiving short-acting erythropoietin (EPO) treatment. In 2023, key clinical trial data from Saint Lorraine Phase III was published in the “The Lancet” (The Lancet) sub-journal “eClinicalMedicine”, showing that it is a highly specific monthly agonist for EPO receptors. Compared with short-acting ESAS drugs, it has a longer half-life and is administered every four weeks, bringing more convenience to patients and helping to improve treatment adherence.
Freimei is the first GLP-1RA weekly formulation developed and innovated in China. It is also the world's first PEG-based GLP-1RA weekly preparation, providing new medication options for diabetics in China. Freimei has been included in the “Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)” published by the Diabetes Branch (CDS) of the Chinese Medical Association.
Differentiate and expand R&D pipelines to dig deeper into clinical value
Leading innovative drug research and development capabilities, scientific development strategies, and efficient execution are becoming the long-term sustainable competitiveness of Hanson Pharmaceuticals. In 2023, Hanson Pharmaceuticals continued to strengthen independent research and development to accelerate access to global resources. The company now has a series of innovative drug pipelines at different stages of research and development. The professional R&D team consists of about 1,671 researchers from four R&D centers located in Shanghai, Lianyungang, Changzhou, and Maryland, USA, to further expand potential pipelines in advantageous fields such as anti-tumor, anti-infection, central nervous system, metabolism, and self-immunity, and has achieved many R&D advances.
According to the annual report, the company's marketing application for 1 innovative drug, Ibrexafungerp (Ibrexafungerp), was accepted; 8 new Class 1 innovative drugs entered the clinical phase. Many key research lines such as HS-10241 (c-Met-TKI), HS-10365 (RET inhibitor), HS-20089 (B7-H4ADC), HS-20093 (B7-H3 ADC), and HS-10241 (GLP-1/GIP double agonist), as well as innovative products such as ametinib, Hengmu, Howson Xinfu, and Freimei have all made key R&D progress and appeared at ASCO, AACR, ELCC, WCLC, ESMO, ESMO Asia, AASLD, Academic conferences such as ASH and IDF, or published in the “Lancet” sub-magazines eClinical Medicine, Front. Pharmacol. and other authoritative international medical journals.
Implement ESG promises and always be firm in responsible innovation
With outstanding performance in the fields of corporate governance, scientific research and innovation, talent development, social responsibility, environmental protection, and information disclosure, Hanson Pharmaceuticals' MSCI (Ming Sheng) rating jumped to AA in 2023, reaching the leading level of global peers. Furthermore, the company was successfully selected for the S&P Global (S&P Global) “Sustainability Yearbook (Global Edition) 2024”, which ranked first in the pharmaceutical industry in mainland China; it was also selected as the “Sustainable Development Yearbook (China Edition) 2023” first published by S&P Global (S&P Global), which ranked the best 1% in the industry with a leading ESG rating and won the “Best Progressive Company in the Industry” award.