Henlius Showcases Four Latest Research Findings at CSCO 2019

From September 18 to 22, the 22nd National Clinical Oncology Conference and the 2019 CSCO Annual Academic Meeting were held in Xiamen, a coastal city. Clinicians, researchers, speakers, corporate representatives, and industry media from across China and abroad gathered for this premier academic event, which is the largest and most prestigious in the field of clinical oncology in China. Henlius presented and showcased four latest research findings at various sessions.

At this year’s CSCO Annual Meeting, in addition to presenting interim data for the biosimilars HLX02 (trastuzumab for injection) and HLX01 (Hanlikang®, rituximab injection), as well as the innovative biologics HLX10 (recombinant humanized anti-PD-1 monoclonal antibody injection) and HLX07 (recombinant humanized anti-EGFR monoclonal antibody injection), Henlius also set up a booth in Hall B5 to deliver comprehensive and multifaceted presentations to attendees.

The Company has established a comprehensive, integrated biopharmaceutical platform encompassing research, development, and commercial-scale manufacturing. Since its inception in 2010, the Company has adhered to a product development philosophy centered on synergy and integrated innovation. It operates three R&D centers in Shanghai (China), Taipei (China), and California (USA), which collaborate closely to ensure high productivity and cost-effective R&D processes. The Company has developed a diversified, high-quality product pipeline targeting oncology and autoimmune diseases, comprising more than 20 candidate innovative monoclonal antibodies and tumor immunotherapy combination regimens.

In terms of quality requirements, Henlius has established a comprehensive quality management system that complies with the quality standards of the United States, the European Union, and China. Since the completion of its commercial production facility in 2015, the company has passed inspections by the European Union Qualified Person (QP) and possesses GMP-certified production capabilities. As a pioneer in the domestic application of single-use bioreactor technology, Henlius has reduced capital expenditure by 50% and production costs by 25%–30% through its effective utilization, thereby building commercial production capabilities characterized by significant cost advantages and a robust quality management system.

Henlius is committed to building an innovative commercial operating model. The approval and launch of Hanlikang® on February 22, 2019, marked the Company’s official entry into the commercialization phase. With the appointment of Mr. Zhang Wenjie as Senior Vice President and Chief Commercial Officer in March 2019, Henlius has established a professional and efficient international commercial operations team, equipped with comprehensive business planning and product marketing strategies. Meanwhile, through commercial collaboration agreements with Fosun Pharma and globally renowned pharmaceutical companies such as Accord, Cipla, Biosidus, Jacobson, and KG Bio, Henlius works jointly to expand its product coverage to more markets worldwide, fulfilling its noble mission of “benefiting global patients with high-quality biologics.”

Looking ahead, Henlius will always prioritize patient interests, remain rooted in China while keeping a global perspective, provide more trustworthy and affordable products for patients, lead the development of China’s biopharmaceutical industry, and embark on a new journey.

Henlius is a leading biopharmaceutical company in China, dedicated to providing high-quality, affordable innovative biologics to patients worldwide, with its product portfolio covering oncology, autoimmune diseases, and other therapeutic areas. Since its establishment in 2010, the company has adhered to a product development philosophy centered on global collaboration and integrated innovation. With R&D centers in Shanghai and Taipei, China, as well as in California, the United States, Henlius possesses significant advantages in synergistic efficiency. The company’s core product development strategy combines biosimilars with innovative therapies, starting with biosimilars and progressively developing innovative monoclonal antibody products. By integrating its independently developed anti-PD-1 and PD-L1 monoclonal antibodies, Henlius pioneered immuno-combination therapies in China. It has proactively established a diversified pipeline of innovative monoclonal antibodies and tumor immuno-combination therapies, building a comprehensive biopharmaceutical platform that spans research, development, and commercial-scale manufacturing.

To date, one product has been successfully launched, two products have had their New Drug Applications (NDAs) accepted by China’s National Medical Products Administration (NMPA), and one product has had its Marketing Authorization Application (MAA) accepted by the European Union. More than 20 clinical trials are being conducted globally across 14 products and six combination therapy regimens. Notably, the company’s first blockbuster product, Hanlikang® (rituximab injection), received NDA approval from the NMPA in February 2019, becoming the first biosimilar approved for marketing in China. The NDAs for HLX03 (adalimumab injection) and HLX02 (trastuzumab for injection) have been accepted by the NMPA and are now under priority review. HLX02 has fully initiated international multi-center Phase III clinical trials in Ukraine, Poland (EU), and the Philippines, making it the first domestic biosimilar to conduct international multi-center Phase III clinical studies. Its MAA was accepted by the European Medicines Agency (EMA) in June 2019. Furthermore, the company has progressively launched multiple clinical studies globally on tumor immunotherapy combinations involving HLX10 with its proprietary products, including HLX04 (bevacizumab biosimilar) and HLX07 (anti-EGFR monoclonal antibody), as well as chemotherapy regimens.