HENLIUS(02696.HK): Hanbeiyou (Pertuzumab Injection) Approved by NMPA for HER2-positive Breast Cancer Treatment

NewTimeSpace News: Shanghai Henlius Biotech Co., Ltd. (02696.HK) released an inside information announcement on May 29, 2026, stating that its self-developed Hanbeiyou (Pertuzumab Injection) has been granted marketing approval by the NMPA.

Hanbeiyou is a biosimilar of pertuzumab developed in-house. Its approved indications are as follows:
Early breast cancer: Combined with trastuzumab and chemotherapy for neoadjuvant therapy of patients with HER2-positive locally advanced, inflammatory or early breast cancer; and for adjuvant therapy of HER2-positive early breast cancer patients with high recurrence risk.

Metastatic breast cancer: Combined with trastuzumab and docetaxel for patients with HER2-positive metastatic or unresectable locally recurrent breast cancer.

The approval is based on comprehensive reviews of comparative studies between Hanbeiyou and the reference product, including analytical similarity, pharmacokinetic similarity and clinical comparative trials. The results have verified high similarity between the two products in terms of quality, safety and efficacy.

Previously, the Biologics License Application for Hanbeiyou was approved by the U.S. FDA in November 2025, and its marketing authorization was granted by the European Commission in April 2026. According to IQVIA MIDAS™ data, pertuzumab recorded total sales of about RMB 2.728 billion in China in 2025.

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