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04-21 2020

Luye Pharma's Lipusu® Recommended as a First-line Salvage Chemotherapy for Advanced HER2-negative Breast Cancer in the 2020 CSCO Guidelines on Diagnosis and Treatment of Breast Cancer

Author:Luye Life Sciences

Expert Committee on Breast Cancer of the Chinese Society of Clinical Oncology (CSCO BC), an authoritative Chinese oncology institution, recently published the 2020 CSCO Guidelines on Diagnosis and Treatment of Breast Cancer. Lipusu®, an innovative paclitaxel liposome formulation developed by Luye Pharma, has been included in the latest CSCO Guidelines as a first-line salvage chemotherapy treatment for advanced human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

In this new edition of the guidelines, Lipusu® was recommended as a first-line salvage chemotherapy treatment for patients with recurrent or metastatic HER2-negative breast cancer who have failed to respond to prior treatment with anthracyclines or prior treatment with taxanes and anthracyclines.

Lipusu® is a nano paclitaxel liposome formulation. It is the only paclitaxel liposome preparation for injection currently available in the world, indicated for breast cancer, non-small cell lung cancer and ovarian cancer. With its unique ability to target tumors and lymph nodes, and a relatively long half-life, the drug is a more potent anticancer agent with better drug safety and tolerance. Paclitaxel-based drugs are among the most commonly-used drugs for treating breast cancer. In Chinese clinical practice, the efficacy of paclitaxel liposome is equivalent to that of solvent-based paclitaxel, with lower adverse reactions such as hematotoxicity, neurotoxicity, muscle and joint pain, and allergic reaction. Paclitaxel liposome is considered to be a safer taxane in China.

In the past 16 years since its launch, Lipusu® has been used by over 2 million patients, and its proven efficacy and comparative safety in long-term clinical practice have been widely recognized by doctors and patients. The value of Lipusu® has achieved widespread consensus, and it has been recommended by multiple authoritative guidelines and expert consensuses. Previously, Lipusu® was recommended as a first-line treatment by the 2019 CSCO Guidelines on Diagnosis and Treatment of Primary Lung Cancer, and was also included in the Expert Consensus on the Clinical Application of Taxanes for the Treatment of Gynecologic Malignancies and the Expert Consensus on the Clinical Application of Taxanes for the Treatment of Breast Cancer (2020). In addition, Lipusu® was also included in the China Guidelines on Radiotherapy for Esophageal Cancer (2019) as the primary choice for multiple combination radiotherapies.

A Luye Pharma Group management representative said: "The inclusion of Lipusu® in the 2020 CSCO Guidelines on Diagnosis and Treatment of Breast Cancer will further extend the clinical application of this product in relevant indications, providing benefits for more patients. We will continue to work on various post-launch studies involving the expansion of its indications as well as its use in combination with other drugs, to provide further evidence to support its clinical application."

Authored by the Guidelines Working Committee of the CSCO, the CSCO Guidelines are prepared in accordance with evidence-based medicine and experts' opinions, while taking into account differences in access to diagnosis and treatment due to uneven regional development. The 2020 CSCO Guidelines on Diagnosis and Treatment of Breast Cancer provide an update for the 2019 Guidelines based on the latest clinical studies and clinical practices. Highlights of the 2020 Guidelines include international progress, China's contributions, and drug accessibility.

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