Qilu Pharmaceutical's Pertuzumab Biosimilar (Ansai Zhu®) Approved by China NMPA for HER2-Positive Breast Cancer

Dec 23, 2024 14:47 CST Updated 14:47

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Today(December 23), National Medical Products Administration of China（NMPA）The official website has just announced,Qilu Pharmaceutical's marketing application for pertuzumab biosimilar, submitted under Biologics Category 3.3, has been officially approved.. Public information shows that Pertuzumab isA monoclonal antibody drug targeting the HER2 receptor, the original product has been approved in China for the treatment of breast cancer.。

Screenshot source:NMPA Official Website

Breast cancer is one of the most common cancers globally.Approximately one-fifth of breast cancer cases are considered to be human epidermal growth factor receptor 2 (HER2) positive.HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of various types of tumors such as breast cancer, gastric cancer, lung cancer, and colorectal cancer. The overexpression of HER2 protein may be...HER2The results of gene amplification are often associated with aggressive breast cancer and poor prognosis.

Pertuzumab is a monoclonal antibody drug targeting the HER2 receptor. It is designed to prevent the HER2 receptor from pairing with other EGFR family members to form dimers, thereby blocking the activation of downstream cell signals and inhibiting tumor growth.In addition, the binding of this product to HER2 may also trigger the human immune system to eliminate cancer cells.Pertuzumab Original Product (Trade Name:Perjeta/Patjetto has been approved in China for the adjuvant treatment of HER2-positive early breast cancer patients at high risk of recurrence, as well as withChemotherapy andAnotherMonoclonal Antibody Targeting HER2Trastuzumab in combination, for neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early-stage breast cancer, etc.

In June 2024, Qilu Pharmaceutical announced that the authoritative journal in the field of oncology, British Journal of Cancer (British Journal of Cancer) published online the Phase 3 equivalence clinical trial results of Qilu Pharmaceutical Co., Ltd.'s pertuzumab biosimilar QL1209, which compared QL1209 with the reference product.Neoadjuvant treatment with trastuzumab and docetaxel in HER2-positive, ER/PR-negative, early or locally advanced breast cancer patientsEfficacy and safety. The primary endpoint of the study was the total pathological complete response (tpCR) assessed by the Independent Review Committee (IRC).

A total of 517 patients were randomly assigned to the experimental group and the control group, with 516 patients receiving treatment and included in the full analysis set (FAS) (257 in the experimental group and 259 in the control group). The study results showed,The tpCR rates for the QL1209 group and the control group were 42.75% and 45.17%, respectively. The rate ratio of tpCR between the two groups was 0.95 (90% Confidence Interval [CI], 0.80-1.11), with the 90% CI fully within the pre-defined equivalence margin of 0.76-1.32, confirming that QL1209 is therapeutically equivalent to the original drug.; The ratio of tpCR rate assessed by researchers was 0.92. The breast pathological complete response (bpCR) rates evaluated by the IRC in the two groups reached 50.00% and 51.74%, respectively, while the bpCR rates assessed by researchers were 48.64% and 51.35%, respectively.The objective response rates (ORR) for the QL1209 group and the control group were 82.49% and 81.85%, respectively.

In terms of safety, QL1209 is similar to the original pertuzumab. Regarding immunogenicity, the incidence of positive anti-drug antibodies (ADA) for QL1209 and the original pertuzumab is comparable, and ADA positivity has no significant impact on efficacy, pharmacokinetics, or safety.

Qilu Pharmaceutical previously announced in a press release that this study demonstrated QL1209, combined with trastuzumab and docetaxel as neoadjuvant therapy for HER2-positive, ER/PR-negative early or locally advanced breast cancer patients, has equivalent efficacy and similar safety compared to the original drug. The treatment regimen containing pertuzumab combined with trastuzumab is widely used in all stages of HER2-positive breast cancer treatment.

References:

[1]Information on the Delivery of Drug Approval Documents on December 23, 2024. From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20241223142138172.html

[2]Qilu Pharmaceutical Co., Ltd. recruits patients with early or locally advanced breast cancer . Retrieved Mar 9, 2021, from https://mp.weixin.qq.com/s/RTjSTwxSghx3J2lf6e9X9w

[3] Qilu Pharmaceutical's Pertuzumab Biosimilar Phase III Clinical Study Published in the British Journal of Cancer. Retrieved Jun 28, 2024, from https://mp.weixin.qq.com/s/LrUAjaIV449C15UzuW2_WA

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