Great news! Qingfeng Pharmaceutical's Enzalutamide API and Soft Capsules are approved for marketing in the United States

On September 26, the enzalutamide API and soft capsule developed by Qingfeng Pharmaceutical, a subsidiary of Qingfeng Pharmaceutical Group, were approved for marketing by the U.S. Food and Drug Administration (FDA). This is the first API and preparation approved by the FDA for Qingfeng Pharmaceutical Group, marking an important step for Qingfeng Pharmaceutical Group on its internationalization path and a significant milestone.

Enzalutamide soft capsules are approved in the United States for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). It is a product that can treat three different types of advanced prostate cancer.

Enzalutamide is an androgen receptor inhibitor, which was originally approved by the FDA in August 2012. It can not only block the binding of androgens to receptors, but also inhibit the transfer of receptors to the cell nucleus and the binding of androgen receptors to DNA. Therefore, it is not only an androgen receptor antagonist, but also has an inhibitory effect on the androgen signaling pathway, thereby regulating the proliferation of prostate cancer cells.

Prostate cancer is the second most common cancer in men worldwide and the fifth leading cause of cancer death in men. According to the latest global cancer burden data released by the World Health Organization's International Agency for Research on Cancer (IARC), there are 1.41 million new cases of prostate cancer worldwide, and the incidence rate ranks fourth among all types of cancer.

Treatment for prostate cancer is often selected based on disease stage, risk of progression, and life expectancy. Enzalutamide combined with androgen deprivation therapy is the preferred treatment for metastatic castration-sensitive prostate cancer and one of the first-line treatments for castration-resistant prostate cancer. In a real-world study of metastatic castration-resistant prostate cancer, enzalutamide significantly prolonged the median overall survival and reduced the risk of patient death compared with abiraterone, which is also a first-line treatment drug, and is a better choice for patients with comorbidities. It is now widely recommended by authoritative domestic and foreign guidelines such as China's "Guidelines for the Diagnosis and Treatment of Prostate Cancer (2022)", the US NCCN "Clinical Practice Guidelines for Prostate Cancer (2023.V1)", and the European ESMO "Clinical Practice Guidelines for the Diagnosis, Treatment and Follow-up of Prostate Cancer (2020)".

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.