On September 27, Henlius (02696.HK) announced that a recent international multicenter Phase 3 clinical study conducted on HLX11, a biosimilar of pertuzumab independently developed by the company, intended for neoadjuvant therapy for early or locally advanced HER2-positive and HR-negative breast cancer, has met its primary study endpoint.

This study is a multicenter, randomized, double-blind, parallel-controlled Phase 3 clinical trial aimed at comparing the efficacy and safety of HLX11 with the original drug Perjeta as part of the overall treatment regimen for neoadjuvant therapy in HER2-positive, HR-negative early or locally advanced breast cancer patients. Eligible subjects were randomized in a 1:1 ratio to receive either HLX11 or the original drug Perjeta in combination with trastuzumab and docetaxel therapy once every three weeks for a total of four cycles. The primary endpoint of the study was the overall pathologic complete response (tpCR) rate evaluated by an Independent Review Committee (IRC). Secondary endpoints included tpCR rate evaluated by investigators, breast pathology complete response (bpCR) rate, objective response rate (ORR), event-free survival (EFS), disease-free survival (DFS), safety, pharmacokinetics, and immunogenicity. The primary endpoint of this study has been achieved.

As of the date of this announcement, the marketed pertuzumab injection globally is Roche's Perjeta (Chinese brand name: 帕捷特). According to the latest data from IQVIACHPA and IQVIAMIDASTM (provided by IQVIA, a global pharmaceutical and healthcare industry professional information and strategic consulting services provider), in 2023, sales of pertuzumab injection products in China and globally were approximately RMB 3.387 billion and USD 3.622 billion, respectively.