Recently, Henlius, a controlling subsidiary of Fosun Pharma, and Organon jointly announced that HLX11, a pertuzumab biosimilar independently developed by Henlius and commercialized by Organon outside China, has received marketing approval from Brazil's National Health Surveillance Agency (ANVISA) for patients with HER2-positive breast cancer, making it the first pertuzumab biosimilar approved in Brazil. Henlius has out-licensed the product's commercialization rights outside China to Organon.
HLX11 is administered by intravenous infusion in combination with trastuzumab and docetaxel for patients with HER2-positive, metastatic or unresectable locally recurrent breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. In combination with trastuzumab and chemotherapy, it is also indicated for neoadjuvant treatment of HER2-positive locally advanced, inflammatory or early-stage breast cancer (tumor >2 cm or node-positive), and for adjuvant treatment of HER2-positive early-stage breast cancer at high risk of recurrence.
HER2-positive breast cancer accounts for approximately 15% to 20% of all breast cancer cases. Brazil's National Cancer Institute (INCA) estimates that more than 78,000 new female breast cancer cases will be diagnosed each year in Brazil from 2026 to 2028.
The Brazil approval follows HLX11's approvals in the United States and the European Union, granted by the U.S. FDA in November 2025 and the European Commission in April 2026. The product is planned to launch in Brazil and the EU in 2027, with regulatory submissions in other markets to follow through 2028.

Source: https://finance.sina.com.cn/stock/estate/integration/2026-11-10/doc-iniyfeci2777735.shtml