In recent years, the global biopharmaceutical environment has continued to deepen reforms, with policies driving innovation and transformation across the entire biopharmaceutical industry chain, fostering "new quality productivity."”Becoming the Engine of Biopharmaceutical Development.On August 27, Hansoh Pharma released its 2024 interim performance report, with all performance indicators showing positive trends. This fully demonstrates the comprehensive strength of this big pharma, which has been rooted in China's pharmaceutical industry for nearly 30 years, actively adapting to internal and external environmental changes, continuously innovating and breaking through, and maintaining steady development while accelerating its globalization process.Financial reports show that in the first half of 2024, Hansoh Pharma achieved operating revenue of 6.506 billion yuan, a year-on-year increase of 44.2%; net profit was 2.726 billion yuan, a year-on-year increase of 111.5%. Among this, the revenue from the company’s innovative drugs and collaborative products reached 5.032 billion yuan, increasing by 80.6% year-on-year, accounting for 77.4% of total revenue; R&D expenditure was 1.196 billion yuan, a year-on-year increase of 28.7%.Driven by both in-house R&D and business development (BD), Hansoh Pharma is accelerating the expansion of its globalized, differentiated, and high-quality product pipeline, with over 30 innovative drugs currently undergoing more than 50 clinical studies. Notably, in addition to its traditionally strong oncology segment, Hansohn's non-oncology product pipeline is gradually expanding.As of the end of the reporting period, Hansoh Pharma has cumulatively introduced 11 collaboration projects, with 9 in clinical stages and 2 projects having entered the commercialization stage. Meanwhile, Hansohn Pharma is actively seeking out-licensing opportunities for its proprietary pipeline products, granting GlaxoSmithKline (GSK) exclusive overseas licenses for two products: HS-20089 (B7-H4 ADC) and HS-20093 (B7-H3 ADC). Notably, HS-20093 was recently granted Breakthrough Therapy Designation by the U.S. FDA.Overall, in the first half of 2024, Hansoh Pharma continued to demonstrate leading advantages in innovative drug research and development, commercialization, and corporate operations, with a strategy of "independent research and development + external cooperation."”Dual-Engine Driving Strategy Continues to Unleash Growth Potential, "Innovation + Internationalization”Has become a new driving force for the long-term sustainable growth of Hansoh Pharma.Innovative Product Revenue Surges 80.6%, Almonertinib Accelerates Clinical Value Delivery
As of June 2024, Hansoh Pharma has seven innovative drugs on the market (Ameile®, Hansoh Pharma®、Fulaimi®, Hengmu®、Xinyue®, Saint Laurent®Ji Mai Ling Da®) and the corresponding nine indications have been included in the National Medical Insurance Catalog.Thanks to the continuous growth of a diversified portfolio of innovative products in oncology, infectious diseases, central nervous system disorders, metabolic diseases, and other therapeutic areas, as well as the steady progress of global collaborations, Hansoh Pharma's revenue from innovative drugs and collaborative products reached approximately RMB 5.032 billion in the first half of 2024, representing a year-on-year increase of about 80.6%, and accounting for 77.4% of total revenue. Notably, revenue from the oncology segment amounted to RMB 4.475 billion, contributing to 68.8% of the total revenue.The anti-tumor sector has always been the core advantage field of Hansoh Pharma. As the top innovative product of Hansoh Pharma, Amelotinib®With significant differentiated advantages, it has quickly achieved a leading position in niche markets.Ameitinib, the first domestically developed third-generation EGFR-TKI in China by Hansoh Pharma, has become a significant growth driver for the company's performance. Currently, six third-generation EGFR-TKIs have been launched in China, and as the first domestically approved drug, Ameile.®Continues to maintain a first-mover advantage in R&D and commercialization progress.In addition to the two approved indications — second-line treatment for EGFRT790M+ advanced NSCLC and first-line treatment for EGFR+ advanced NSCLC — multiple indications for Hansoh Pharma's Aumolertinib, including adjuvant therapy post-surgery and combination with first-line chemotherapy, have initiated several phase studies. Among them, the fastest progressing indications are adjuvant treatment for NSCLC and maintenance therapy for inoperable Stage III NSCLC patients following concurrent chemoradiotherapy, with the New Drug Application (NDA) accepted in Q3 2024. Previously, Hansoh Pharma announced that Aumolertinib in combination with a c-Met inhibitor had entered the pivotal clinical stage for previously treated EGFRm NSCLC.At the same time, according to Hansoh Pharma's financial report, multiple studies on Aumolertinib were published in 2024 ASCO, 2024 ELCC, and "Frontiers in Pharmacology." Hansoh Pharma stated that it will continue to advance the regulatory review process for the marketing authorization application of Aumolertinib by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).According to a research report by CITIC Securities, with the development of new indications and exploration of combination therapies, the value of Aumetinib will be further enhanced, and its peak sales are expected to exceed 6 billion yuan.Self-developed + BD High-efficiency Collaboration, Oncology and Non-oncology Innovation
Pipeline Quality and Quantity Rise Together
Through efficient collaboration between independent research and external cooperation, Hansoh Pharma continues to deepen its oncology sector in 2024, scientifically exploring global potential pipelines and accelerating the layout in anti-infective, central nervous system, metabolic, and autoimmune fields.During the reporting period, the key innovative drugs that received clinical approval for the first time from Hansoh Pharma included:In the first half of 2024, Hansoh Pharma's core pipeline products HS-20093 (B7-H3 ADC), HS-20094 (GLP-1/GIP receptor dual agonist), and HS-10370 (KRAS G12C inhibitor) achieved multiple key clinical advancements and were respectively presented at prestigious academic conferences such as 2024 ASCO, 2024 ADA, and 2024 AACR, fully demonstrating their clinical value and gaining international authoritative recognition, as follows:HS-20093（B7-H3 ADC）。HS-20093Is a targeted therapy independently developed by Hansoh PharmaB7-H3Antibody-drug conjugates. In2024ASCOAt the annual meeting,HS-20093In relapsed or refractory bone and soft tissue sarcomaIIThe study was presented in the form of an oral report.IIPreliminary data from a small sample size during the periodHS-20093In patients with previously heavily treated recurrent or refractory bone and soft tissue sarcoma, it demonstrated strong antitumor activity, surpassing historical data of existing standard treatments in clinical practice, with good safety and tolerability. Clinical research data supports this.HS-20093Subsequent development in bone and soft tissue sarcomas.
HS-20094（GLP-1R/GIPRDual-target Agonist)。HS-20094Is a glucagon-like peptide independently developed by Hansoh Pharma-1Receptor (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor dual agonist, administered once weekly via subcutaneous injection.In2024 ADAAt the annual meeting,HS-20094ⅡPhase Clinical Research Data in Poster+Live Q&A Format for Electronic Posters Released at the Conference.The results showed,HS-20094In2Type diabetes subjects showed good safety and tolerability characteristics, and demonstrated excellent hypoglycemic and weight-loss efficacy.
HS-10370 (KRAS G12C Inhibitor)。HS-10370 is an orally potent, highly selective small molecule KRAS G12C inhibitor independently developed by Hansoh Pharma.At the 115th American Association for Cancer Research (AACR) Annual Meeting held in April 2024, the Phase I clinical study results of HS-10370 as a single agent in advanced solid tumors were presented in a poster.The study results showed that HS-10370 had good safety and tolerability characteristics in patients with advanced solid tumors.And has shown good efficacy in the treatment of KRAS G12C-mutated advanced solid tumors, especially advanced non-small cell lung cancer (NSCLC), offering a promising new treatment option for patients.
In terms of external cooperation, Hansoh Pharma reached three BD collaborations in 2024:In March, Hansoh Pharma expanded its collaboration with Pumis on HS-20117 (EGFR/c-Met ADC) within the global cooperation region.
In April, Hansoh Pharma reached a collaboration with Quanxin Biotechnology to develop and commercialize the HS-20137 monoclonal antibody in China (including Hong Kong, Macao, and Taiwan);
In August, LP-168 (BTKi) non-oncology indications China (including Hong Kong, Macao and Taiwan) rights were obtained from Lupeng Pharma.
Notably, according to earlier announcements, HS-20137 monoclonal antibody and LP-168 (BTKi) are part of Hansoh Pharma's deepened exploration and strategic layout in the autoimmune field.To further build a frontier scientific innovation hub and technological highland, in March 2024, Hansoh Pharma's global R&D headquarters began construction in Shanghai, with a total project area of over 90,000 square meters. To date, Hansoh Pharma's professional R&D team consists of approximately 1,700 researchers from four R&D centers located in Maryland, USA, and Shanghai, Changzhou, and Lianyungang in China, demonstrating the company’s strong innovative momentum.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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