Hansoh Pharmaceutical Surpasses RMB 10 Billion Revenue Milestone, Driven by Innovation and Strong Product Portfolio

On March 26, 2024, Hansoh Pharma (03692.HK) released its 2023 annual performance report, achieving revenue of approximately RMB 10.104 billion during the reporting period, representing an increase of about 7.7% compared to the same period last year, and net profit of approximately RMB 3.278 billion, marking a year-on-year growth of about 26.9%.

Report: In 2023, the revenue from Hansoh Pharma's innovative drugs and collaboration products reached approximately RMB 6.865 billion, increasing by about 37.1% year-on-year. The proportion of such revenue to total income rose to 67.9%, making innovative drugs the core driver of performance growth. Behind this leading innovation capability lies continuous investment in R&D. In 2023, Hansoh Pharma’s R&D expenditure amounted to approximately RMB 2.097 billion, marking a year-on-year increase of about 23.8%, and its proportion to total income rose to 20.8%. To date, the company has over 30 innovative drugs in its pipeline, with more than 50 clinical trials ongoing, demonstrating strong R&D momentum.

While deeply focusing on independent research and development, Hansoh Pharma accelerates the advancement of global collaborations. In terms of license out, in 2023, Hansoh Pharma granted GlaxoSmithKline exclusive overseas licenses for the development and commercialization of HS-20089 (B7-H4 ADC) and HS-20093 (B7-H3 ADC), fully demonstrating the innovative value of the company's high-potential pipeline. In terms of license in, in August 2023, Hansoh Pharma signed an agreement with Antengene to exclusively handle the commercialization of selinexor and any products containing or composed of selinexor (brand name: Xpovio) in China. In March 2024, Hansoh Pharma expanded its collaboration with Premas on HS-20117/PM1080, increasing investment in EGFR/cMet-ADC drug development, further solidifying the company’s leading position in the oncology field.

As of the end of the reporting period, Hansoh Pharma had cumulatively introduced two commercially staged projects, and all nine clinical-stage collaborative projects have been approved for clinical trials in China.

Innovative Drug Performance Reaches New Highs

Build Sustainable Growth Momentum

In 2023, Hansoh Pharma's 7th innovative drug, Saint Rolei (Pemostim Injection), was approved for marketing, further expanding its innovative drug portfolio. To date, all seven of the company’s approved innovative drugs have been included in the National Medical Insurance Catalog. With the high clinical value and differentiated advantages of multiple innovative products, Hansoh Pharma continued to enhance operational efficiency in 2023, ensuring effective collaboration within its organizational structure and comprehensively advancing product commercialization. The revenue from the company’s innovative drugs and collaborative products reached approximately RMB 6.865 billion, representing a year-on-year increase of about 37.1%, and accounting for 67.9% of total revenue.

By therapeutic area, in 2023, Hansoh Pharma recorded revenues of approximately RMB 6.169 billion, RMB 1.269 billion, RMB 1.367 billion, and RMB 1.299 billion in the oncology, anti-infective, central nervous system, and metabolic diseases and others segments, respectively, accounting for approximately 61.0%, 12.6%, 13.5%, and 12.9% of total revenue.

In the field of oncology, Hansoh Pharma currently has two self-developed innovative products on the market: Almonertinib Mesylate Tablets (Almele) and Flumatinib Mesylate Tablets (Haosen Xinfu).

Ameitinib is the first domestically developed third-generation EGFR-TKI in China, approved for two indications: second-line treatment of EGFR T790M+ advanced NSCLC and first-line treatment of EGFR+ advanced NSCLC, both being the first approvals by a Chinese manufacturer. Centered on Ameitinib, Hansoh Pharma has comprehensively expanded its presence in the lung cancer field, continuously exploring multiple indications, including post-surgical adjuvant therapy and combination with first-line chemotherapy.

Currently, multiple clinical data of Aumolertinib have demonstrated excellent efficacy, and it has been recommended as a Level I or first-line treatment in eight national diagnosis and treatment guidelines, including the "CSCO Guidelines for Diagnosis and Treatment of Non-Small Cell Lung Cancer (2023 Edition)" by the Chinese Society of Clinical Oncology (CSCO).

In 2023, the invention patent of Almonertinib, "EGFR Inhibitors and Their Preparation and Application," was also awarded the 24th "China Patent Gold Award." In terms of international expansion, Hansoh Pharma will continue to advance the regulatory procedures for the marketing authorization application review by the UK Medicines and Healthcare products Regulatory Agency ("MHRA") and the European Medicines Agency ("EMA") for Almonertinib.

Flumatinib is the first novel second-generation TKI independently developed in China for the treatment of Chronic Myeloid Leukemia (CML). Flumatinib has been recommended 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 Hematological Diseases" as a first-line treatment for Chronic Myeloid Leukemia.

In the anti-infective field, Hansoh Pharma has two self-developed innovative drugs on the market: Hengmu (Amitinovir Tablets) and Mailingda (Morniflaxin Sodium Chloride Injection).

Hengmu is the first domestically developed oral anti-hepatitis B virus drug in China. It has been included in the "CSCO Guidelines for the Diagnosis and Treatment of Liver Cancer (2022 Edition)" as a Level I recommendation, and in the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)" jointly issued by the Chinese Society of Hepatology and the Chinese Society of Infectious Diseases as the preferred drug recommendation.

In 2023, the 144-week data update of the Phase III pivotal registration clinical study of Hengmu was selected for LBA and presented at the 74th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). The results once again confirmed the efficacy and safety of long-term treatment in patients with chronic hepatitis B. In addition, the 48-week data from the Phase III pivotal registration clinical study of Hengmu were published in *Alimentary Pharmacology & Therapeutics*, and the 96-week data were published in the *Journal of Clinical and Translational Hepatology*. Both publications demonstrated Hengmu's potent anti-hepatitis B virus efficacy as well as its bone and renal safety.

In the field of central nervous system, Hansoh Pharma's引进的昕越 (Inebilizumab Injection) was approved for marketing in 2022. It is the world's only humanized anti-CD19 monoclonal antibody for treating AQP4 antibody-positive NMOSD. 昕越 (Inebilizumab Injection) has been included in the *Chinese Guidelines for the Diagnosis and Treatment of Neuromyelitis Optica Spectrum Disorders (2021 Edition)* and received a Class A recommendation. Currently, the partner is conducting global multicenter clinical trials, including centers in China, for IgG4-related disease (IgG4-RD) and myasthenia gravis (gMG).

In the field of metabolism and other diseases, Hansoh Pharma's innovative product portfolio mainly includes Saintloran (Pegmocept Injection) and Fulaimi (Polyethylene Glycol Losenanotide Injection).

Pemodapeg is the world's only approved EPO mimetic peptide, indicated for the treatment of anemia caused by chronic kidney disease (CKD), including adult non-dialysis patients not receiving erythropoiesis-stimulating agent (ESA) therapy and adult dialysis patients receiving short-acting erythropoietin (EPO) therapy.

In 2023, the Phase III pivotal clinical trial data of **Saintloratide** was published in *The Lancet* subsidiary journal, *eClinicalMedicine*. It demonstrated its role as a highly specific EPO receptor agonist. Compared with short-acting ESAs, it has a longer half-life, allowing for once-every-four-weeks dosing, which provides greater convenience to patients and helps improve treatment adherence.

Fulaimi is the first original innovative GLP-1RA weekly formulation produced in China, and also the world's first PEGylated GLP-1RA weekly formulation, offering a new medication option for Chinese diabetes patients. Fulaimi has been included in the "Chinese Type 2 Diabetes Prevention and Treatment Guidelines (2020 Edition)" released by the Chinese Diabetes Society (CDS).

Differentiated Expansion of R&D Pipeline

Deeply Explore Clinical Value

Leading drug innovation R&D capabilities, scientific development strategies, and efficient execution are becoming the long-term sustainable competitiveness of Hansoh Pharma.

In 2023, Hansoh Pharma continued to strengthen independent research and development, accelerate the connection of global resources, and has now built up a series of innovative drug pipelines at various R&D stages. The professional R&D team consists of approximately 1,671 researchers from four R&D centers located in Shanghai, Lianyungang, Changzhou, and Maryland, USA. The company is further exploring potential pipelines in leading fields such as oncology, anti-infectives, central nervous system, metabolism, and autoimmune diseases, achieving multiple R&D advancements.

According to the annual report, the listing application for Hansoh Pharma's innovative drug Ibrexafungerp has been accepted; eight Class 1 innovative drugs have newly entered the clinical stage. Key R&D pipelines such as HS-10241 (c-MET-TKI), HS-10365 (RET inhibitor), HS-20089 (B7-H4 ADC), HS-20093 (B7-H3 ADC), HS-10241 (GLP-1/GIP dual receptor agonist), along with innovative products like Aumolertinib, Hengmu, Haosen Xinfu, and Fulaimi, have all achieved significant R&D progress. These achievements were showcased at academic conferences including ASCO, AACR, ELCC, WCLC, ESMO, ESMO Asia, AASLD, ASH, IDF, or featured in authoritative international medical journals such as The Lancet's eClinicalMedicine and Frontiers in Pharmacology.

Effectively Implement ESG Commitments

Always Firmly Committed to Responsible Innovation

In 2023, Hansoh Pharma's MSCI (Morgan Stanley Capital International) rating was upgraded to AA, reaching a leading level among global peers, thanks to its outstanding performance in corporate governance, scientific research innovation, talent development, social responsibility, environmental protection, and information disclosure.

In addition, the company has been successfully selected for inclusion in the S&P Global 2024 Sustainability Yearbook (Global Edition), ranking first in ESG scores among pharmaceutical companies in mainland China; it was also included in the inaugural S&P Global 2023 Sustainability Yearbook (China Edition), securing a place in the top 1% of the industry with significantly leading ESG scores and earning the honor of "Industry Best Progress Company."

Editor: Liuli

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