Shanghai, China, April 29, 2024 - Shanghai Henlius Biotech, Inc. (2696.HK) announced its financial results for the first quarter of 2024 (Q1 2024). Following the company’s achievement of its first year profits in 2023, Henlius fully utilized its well-established advantage to optimise the commercialisation layout based on the patient-centric strategies and achieved a continuous development. During the reporting period, Henlius’ revenue reached about RMB1.349 billion, mainly due to the expanding sales and increased market competitiveness of flagship products including HANQUYOU and HANSIZHUANG. HANQUYOU and HANSIZHUANG recorded sales of RMB671 million and RMB334 million, respectively.
HANQUYOU: Further expands its market coverage
HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe) is one of Henlius' core anti-tumour products, as well as the the first product sold and promoted in Chinese mainland by the company’s in-house commercialisation team. The product is indicated for the treatment of HER2-positive breast cancer and gastric cancer. Due to its advantages of 150mg/60mg dual dosage and preservative-free formulation, HANQUYOU further expanded its market share in China, benefiting over 180,000 Chinese patients to date. Furthermore, Henlius continues to expand the sales network of HANQUYOU. The company had about 600 professionals for HANQUYOU, covering 6 major sales regions and about 3,700 hospitals in China.
In addition, as one of the pioneers of domestic biopharmaceuticals going global, HANQUYOU has successfully been approved for marketing in over 40 countries and regions, including the United States, the United Kingdom, Germany, Spain, France, Italy, Switzerland, Australia, Singapore, Argentina, Brazil, etc., making it a Chinese mAb biosimilar approved in China, the EU and the U.S.. Meanwhile, the product’s accessibility has been further improved. It is now reimbursed nationally in countries including China, the UK, France, and Germany. From 2023 to date, the overseas commercialisation of HANQUYOU managed to include the markets of the U.S., Thailand, the Philippines and Brazil. And its marketing applications in the Canada have also been accepted and expected to be approved in 2024, probably to benefit more patients worldwide.
HANSIZHUANG: Gains competitive edge through differentiated commercial layout
Henlius’ first innovative product HANSIZHUANG (serplulimab) is the world’s first anti-PD-1 monoclonal antibody (mAb) approved for the first-line treatment of small cell lung cancer (SCLC). HANSIZHUANG was launched in China in March 2022，and has been approved for 4 indications including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), extensive stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC), benefiting over 60,000 Chinese patients so far. Additionally, the 5th new drug application (NDA) of HANSIZHUANG for the first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC) has been accepted by the National Medical Products Administration (NMPA). With differentiated strategies in commercialisation and outstanding clinical performance, HANSIZHUANG has earned wide recognitions in the market and led to rapid sales uptick. By the end of 2023, its sales team has been expanded to approximately 580 people, completed tendering and procurement platform listing in all provinces in China. Moreover, HANSIZHUANG has been included into 80 provincial/city-customized commercial medical Insurance(Huiminbao) including Shanghai, Fujian, Shanxi, Chongqing, Nanjing, Suzhou, Chengdu, Jinan, Xiamen etc., and its accessibility has been enhanced through various channels.
On the other hand, Henlius continues to expand HANSIZHUANG’s global footprint, which now covers more than 70 countries and regions including the U.S., Europe, Southeast Asia and MENA. In December 2023, HANSIZHUANG was approved for marketing in Indonesia, becoming the first China anti-PD-1 mAb successfully approved in Southeast Asia. And in Q1 2024, Henlius has finished the first international shipment of HANSIZHUANG. Furthermore, the company submitted marketing applications for HANSIZHUANG in Thailand, Singapore, Malaysia to further promote the product in Southeast Asia. In March 2023, HANSIZHUANG’s Marketing Authorization Application (MAA) for ES-SCLC has been validated by the European Medicines Agency (EMA), which is expected to be approved in 2024. Moreover, Henlius has initiated a head-to-head bridging trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC, and planned to submit the Biologic License Application (BLA) to the U.S. FDA in 2024. In Q1 2024, an Innovation Passport designation has been awarded to HANSIZHUANG for the treatment of ES-SCLC by the U.K. Innovative Licensing and Access Pathway Steering Group, which marked its entry into the U.K.’s Innovative Licensing and Access Pathway (ILAP) and is expected to promote the presence of the product in the U.K. Henlius is also advancing HANSIZHUANG-based tumour immuno-combination therapies and has initiated over 10 clinical trials worldwide.
Adhering to the vision of patient-centricity, Henlius will further strengthen its commercialisation capabilities as a biopharma, drive differentiated innovation and deepen its global commercial presence, so as to consolidate the best-in-class capabilities of “integrated research, manufacturing and commercialisation” and advance steadily towards high-quality development, enabling more high-quality innovative outcomes to benefit patients worldwide.