Qingfeng Pharmaceutical's Eribulin Mesilate Injection Approved for Marketing in the U.S.

On June 28, the Eribulin Mesilate Injection developed by Qingfeng Pharmaceutical Group was approved for marketing by the U.S. Food and Drug Administration (FDA), making Qingfeng Pharmaceutical the second pharmaceutical company in the world and the first in China to obtain U.S. ANDA approval for this product.

Eribulin is a synthetic analogue of sponge B isolated from sea sponges. It has a complex structure, many synthetic steps, difficult processing, and complex quality control. It is known as the "Mount Everest" in the pharmaceutical industry.

Eribulin Mesilate injection is used to treat patients with locally advanced or metastatic breast cancer who have previously received at least two chemotherapy regimens (including anthracyclines and taxanes). Breast cancer is the most common malignant tumor in women in China and around the world, and it seriously threatens the health and life of modern women. In 2022, there were 2.3 million new cases of breast cancer and more than 670,000 deaths worldwide, and the incidence of breast cancer has increased year by year. The situation of advanced breast cancer is even more severe. One in 10 new patients is diagnosed with advanced disease each year, and 30% to 40% of early breast cancer patients who have undergone surgery and standardized treatment will develop advanced breast cancer.

There are various treatments for early breast cancer, and the cure rate is very high after standardized surgery and drug treatment. However, for patients with advanced breast cancer, the overall median survival is only 2 to 3 years, and the 5-year survival rate is only about 22% worldwide. Eribulin brings new treatment options for patients with locally advanced or metastatic breast cancer.

Currently, many guidelines and consensuses, including the National Comprehensive Cancer Network (NCCN) guidelines (2019 v1.0), the European Society for Medical Oncology (ESMO) International Consensus on Advanced Breast Cancer (ABC4), the Chinese Anti-Cancer Association Breast Cancer Diagnosis and Treatment Guidelines and Standards (2017 Edition), and the Chinese Advanced Breast Cancer Clinical Diagnosis and Treatment Expert Consensus (2016 Edition), have recommended eribulin as a preferred chemotherapy drug for the treatment of patients with advanced breast cancer.

In recent years, from the successive launch of enzalutamide API and soft capsules in China and the United States, to successfully export of Olaparib tablets, to the FDA approval of Eribulin Mesylate Injection, Qingfeng Pharmaceutical Group's internationalization journey is progressing steadily.

In the future, Qingfeng Pharmaceutical Group will continue to uphold the corporate mission of " Providing sustainable and high-quality service for human health ", be guided by clinical needs, insist on R&D and innovation-driven, and strive to provide global patients with drugs with greater clinical value.