New Trastuzumab Biosimilar Approved by FDA for HER2-Overexpressing Breast and Gastric Cancers

Shanghai Henlius Biotech's initial biosimilar has already been granted approvals by the European Commission and National Medical Products Administration.

Shanghai Henlius Biotech (Henlius), a biopharmaceutical company based in Shanghai, recently announced that the FDA has approved HERCESSI (HLX002; trastuzumab-strf), a trastuzumab biosimilar that was developed and manufactured by Henlius. HLX002 has received approval in the United States for the adjuvant treatment of HER2-overexpressing breast cancer, as well as HER2-overexpressing metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. In July 2020, it received approvals for commercialization from the European Commission (EC) and in August 2020 from the National Medical Products Administration (NMPA).

This is the company's latest FDA-approved biosimilar, further expanding its portfolio. Established in 2010, Herlius specializes in developing biologic therapies for a range of medical conditions including oncology, autoimmune diseases, and ophthalmic diseases. At the time of writing, the company has introduced five products in China, with two marketing approvals and 19 indications approved globally.The company has obtained good manufacturing practice certification from China, the European Union, and the US for the production of its self-developed antibody drugs.

In a press release, Jason Zhu, executive director, chief executive officer, and chief financial officer of Henlius, emphasized the company's commitment to patient care. He highlighted their dedication to providing high-quality, effective, affordable, and accessible treatment options. Zhu also mentioned Henlius' plans to promote HLX02 in over 40 markets worldwide, addressing the concerns of patients.

In the press release, Henlius highlighted that breast cancer is the second most commonly diagnosed cancer. In 2024, the United States is expected to see over 370,000 new cases of breast cancer. It is worth noting that approximately 15-20% of breast tumors fall under the category of HER2-positive breast cancers. The prevalence of HER2 positivity in gastric cancer ranges from 12-23%. Trastuzumab has a crucial role in the treatment of HER2-positive breast and gastric cancer. Henlius submitted a package of analytical, pre-clinical, and clinical study data for HLX002, which led to its approval. This involved thorough and detailed analytical studies, a study to compare pharmacokinetics in Phase I, and a Phase II clinical study conducted at multiple centers worldwide.

Source: Shanghai Henlius Biotech, American Cancer Society, National Comprehensive Cancer Network