本次申报基于HLX11对比参照药Perjeta产生的数据，包括分析相似性研究及临床比对研究。这些数据都证明了HLX11与参照药Perjeta在质量、安全性和有效性方面的高度相似。Henlius (02696) released an announcement, recently, the company independently developed the biosimilar drug patuzumab HLX11...
According to the Zhito Finance APP, Henlius (02696) announced that recently, the company's independently developed biosimilar drug patuzumab HLX11 (recombinant anti-HER2 domain II humanized monoclonal antibody injection) has had its new drug application (NDA) accepted by the National Medical Products Administration (NMPA) drug review center. The NDA covers indications including: combination with trastuzumab and chemotherapy for adjuvant treatment of patients with high recurrence risk HER2 positive early breast cancer; in combination with trastuzumab and docetaxel for patients with HER2 positive, metastatic or unresectable locally recurrent breast cancer who have not previously received anti-HER2 treatment or chemotherapy for metastatic breast cancer.
HLX11 is the company's independently developed biosimilar drug patuzumab, intended for adjuvant treatment of patients with high recurrence risk HER2 positive early breast cancer in combination with trastuzumab and chemotherapy; and for patients with HER2 positive, metastatic or unresectable locally recurrent breast cancer in combination with trastuzumab and docetaxel, who have not previously received anti-HER2 treatment or chemotherapy for metastatic breast cancer. In November 2021, HLX11 successfully completed phase 1 clinical trials in mainland china. In September 2024, the international multicenter phase 3 clinical trial for HLX11 as neoadjuvant treatment for early or locally advanced breast cancer patients who are HER2 positive and HR negative achieved its primary endpoint.
This application is based on the data generated by comparing HLX11 with the reference drug Perjeta, including analyzing similarity studies and clinical comparison studies. These data have demonstrated the high similarity of HLX11 to the reference drug Perjeta in terms of quality, safety, and efficacy.
