Innovative Big Pharma Rises: Hansoh Pharma Launches 7 Blockbuster Drugs and Advances 40 Class 1 New Drug Candidates

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Recently, Hansoh Pharma released its 2023 earnings report, achieving revenue of approximately RMB 10.104 billion (+7.7%) and a net profit attributable to shareholders of approximately RMB 3.278 billion (+26.9%). Among this, revenue from innovative drugs and collaboration products reached about RMB 6.865 billion (+37.1%), accounting for 67.9% of total revenue. After nearly 30 years of development, Hansoh Pharma has become a leading innovation-driven Big Pharma in China. Currently, the company has seven approved innovative drugs on the market, with 42 new drugs (40 Class 1 new drugs) in the clinical application stage or higher. With its internationalization process accelerating, the company is progressively embarking on a new journey of leapfrog development.

Revenue Breaks Through 10 Billion! Income from Innovative Drugs Accounts for 67.9%

Hansoh Pharma was founded in 1995 and began focusing on innovative R&D in 2002, making it one of the earliest companies in China to venture into innovative drug development. In June 2019, Hansoh Pharma was listed on the Hong Kong Stock Exchange (Stock Code: 03692).

In recent years, the proportion of innovative drug revenue of Hansoh Pharma has been increasing year by year, from 18% in 2020 to 67.9% in 2023. This means that after nearly 30 years of development, Hansoh Pharma has successfully transformed into a leading innovation-driven Big Pharma in China.

In recent years, the revenue of innovative drugs from Hansoh Pharma (Unit: billion yuan)

Source: Company announcement, organized by Menet

In terms of 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 as well as other areas, respectively, accounting for approximately 61%, 12.6%, 13.5%, and 12.9% of total revenue.

Hansoh Pharma's Revenue by Therapeutic Area in 2023 (Unit: Billion Yuan)

Source: Company Announcement

In the field of anti-tumor treatment, Hansoh Pharma currently has two self-developed innovative products on the market: Almonertinib Mesylate Tablets (brand name: Amelotin) and Flumatinib Mesylate Tablets (brand name: Haosen Xinfu). Almonertinib, which was first approved in 2020, demonstrated remarkable market potential. In 2022, its sales revenue in China's three major terminals and six key markets (for statistical scope, see the end of this article) exceeded 2.4 billion yuan, representing a year-on-year growth of approximately 47%. In the first half of 2023, it continued to grow at a rate of about 16%.

In the anti-infective field, Hansoh Pharma has two self-developed innovative drugs on the market: Hengmu (Amibufenovir Tablets) and Mailingda (Morinidazole Sodium Chloride Injection). Amibufenovir, which was first approved in 2021, has shown strong market performance. In the first half of 2023, its sales revenue in China's three major terminals and six key markets exceeded 300 million yuan, representing an increase of approximately 240% year-on-year.

In the field of central nervous system, Hansoh Pharma's引进的昕越 (Inebilizumab Injection) was approved for marketing in 2022, being the world's only CD19 antibody approved for adult patients with AQP4 antibody-positive NMOSD; in the field of metabolism and other diseases, Hansoh Pharma's innovative product portfolio mainly includes圣罗莱 (Pegylated Recombinant Human Erythropoietin Beta Injection), and 孚来美 (Polyethylene Glycol Loznaseptide Injection).

Hansoh Pharma's Innovative Drugs Approved for Marketing (Excluding Modified New Drugs)

Source: Menet Comprehensive Database

R&D expenditure exceeds 2 billion! 40 Class 1 new drugs on the way

Dedication to innovative R&D is the foundation of Hansoh Pharma's rapid transformation, which is inseparable from continuous R&D investment and an increasingly robust R&D team. In 2023, the company's R&D expenditure was approximately 2.097 billion yuan, increasing by about 23.8% year-on-year, with the proportion of total revenue rising to 20.8%.

Hansoh Pharma's R&D team consists of over 1,600 people from four research centers located in Maryland, USA, and Shanghai, Changzhou, and Lianyungang in China. Notably, on March 29, the global R&D headquarters of Hansoh Pharmaceutical Group Company Limited broke ground in Shanghai. It will become a world-leading innovative drug R&D base and assume global R&D management functions, acting as the source of cutting-edge scientific innovation and a technology hub for Hansoh Pharma.

R&D Expenditure of Hansoh Pharma in Recent Years (Unit: Billion Yuan)

Source: Company announcement, organized by Menet

From 2023 to date, Hansoh Pharma has seen frequent updates in new drug development in China: the marketing application for the innovative drug Ibrexafungerp Citrate Tablets has been accepted; ten Class 1 new drugs have been approved for clinical trials for the first time; significant progress has been made in several key R&D pipelines such as HS-10241 (c-MET-TKI), HS-10365 (RET-TKI), HS-20089 (B7-H4 ADC), HS-20093 (B7-H3 ADC), HS-20094 (GLP-1/GIP dual receptor agonist), as well as innovative products like Aumolertinib, Amibetinovir, and Fluoromatinib.

Data from MiNe Network shows that Hansoh Pharma currently has 42 novel drugs (excluding already marketed drugs and new indications) at the clinical trial application stage or above, including 40 Class 1 novel drugs and 1 imported Class 5.1 novel drug, covering key areas such as oncology, anti-infectives, central nervous system, metabolic diseases, and autoimmune disorders. The company anticipates that in the next three years, it will file 8-10 IND applications and 2-3 NDA applications annually. By 2025, over 15 innovative drugs (including new indications) are expected to be launched, with revenue from innovative drugs accounting for more than 80%.

Anti-tumor is a key focus area for Hansoh Pharma, which has developed a pipeline targeting multiple pathways including CDK4/6, EGFR, PIK3, c-Met, RET, Bcr-Abl, and HIF-2α, covering subtypes such as lung cancer, breast cancer, ovarian cancer, leukemia, and renal cell carcinoma. Aumolertinib and Flumatinib have been approved for marketing, with ongoing clinical trials exploring various indications and combination therapies. HS-10241 (c-Met inhibitor) and HS-20090 (Denosumab biosimilar) have entered Phase III clinical trials, while HS-10342 (CDK4/6 inhibitor), HS-20089 (B7-H4 ADC), and HS-20093 (B7-H3 ADC) are currently in Phase II clinical trials.

It is worth mentioning that in the current ADC track, which is crowded with pharmaceutical companies both in China and abroad, Hansoh Pharma has not chosen popular targets such as HER2, TROP2, or EGFR. Instead, it has differentially laid out potential targets like B7-H3 (HS-20093, Phase II) and B7-H4 (HS-20089, Phase II). Whether in terms of R&D speed or indication layout, it holds significant competitive advantages. This shows that Hansoh Pharma follows a strategy in new drug development that is guided by clinical needs and emphasizes differentiated R&D.

In the anti-infective field, Morinidazole and Aimitinovir have been approved for marketing; Ibrexafungerp (a novel glycogen synthase inhibitor with a triterpenoid structure) has been submitted for NDA for the treatment of vulvovaginal candidiasis (VVC); Pegylated Thymosin Alpha 1 is a thymic immunomodulator, and its indication for HBeAg-positive chronic hepatitis B has progressed to Phase III clinical trials.

Self-developed + BD bidirectional efforts, steadily advancing the internationalization process

While deeply committed to independent research and development, Hansoh Pharma is also accelerating global collaborations. Through licensing, co-development, and other methods, the company is quickly integrating into the international pharmaceutical ecosystem. This further enhances its innovation capabilities and strategic pipeline of innovative products, promoting the output and commercialization of novel drugs.

In recent years, Hansoh Pharma has carried out more than 10 BD transactions, of which two are already in the commercialization stage and nine have been approved for clinical trials in China. Through these BD transactions, on one hand, competitive early-stage projects or mature innovative products have been introduced to form combination therapies with the company’s self-developed products, greatly enhancing R&D efficiency and further exploring the clinical value of its self-developed products. On the other hand, the cooperation with emerging technology platforms such as AI platforms and GalNAc-asiRNA platforms has been strengthened.

Recent Years' License-In Situation of Hansoh Pharma

Source: Company announcement, organized by Menet

In addition, Hansoh Pharma has reserved multiple self-developed high-potential products that are either first-in-class (FIC) or best-in-class (BIC). Through cooperation with MNCs, it is steadily expanding into the international market.

In October and December 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), respectively. Currently, no ADC drugs targeting B7-H4 or B7-H3 have been approved globally. For the HS-20089 project, Hansoh Pharma will receive an upfront payment of $85 million and milestone payments of up to $1.485 billion. For the HS-20093 project, the company will receive an upfront payment of $185 million and milestone payments of up to $1.525 billion.

Conclusion

After years of accumulation and沉淀, Hansoh Pharma has successfully built a robust global innovation ecosystem. In the highly competitive innovative drug environment, the company has established a differentiated development path tailored to its own strengths. Building on its existing products and areas of expertise, Hansoh Pharma is implementing a vertically integrated strategy to deepen its market presence, leveraging synergies between products and utilizing established channel advantages. As a result, the leading position of this pharmaceutical giant is expected to become even more prominent.

Source: MiNeiNet database, company announcements, etc.

Note: The drug competition pattern of China's three major terminals and six major markets by Menet, the statistical scope includes: urban public hospitals and county-level public hospitals, urban community centers and township health centers, urban physical pharmacies and online pharmacies. It excludes private hospitals, private clinics, and village health rooms, as well as pharmacies in counties, villages, and towns. The sales figures are calculated based on the average retail price of products at the terminal. Data statistics are as of March 26th. If there are any omissions, corrections are welcome!