Yehui Pharmaceuticals' BN104 Receives Fast Track Designation from FDA for the Treatment of Relapsed/Refractory Acute Leukemia

Introduction:

On October 24th, Yehui Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to BN104 for the treatment of relapsed/refractory acute leukemia. This designation signifies the FDA's recognition of BN104's therapeutic potential and their anticipation for its impact in addressing the unmet medical needs of patients with life-threatening acute leukemia. Yehui Pharmaceuticals is committed to providing high-quality innovative drugs to patients in China and globally. BN104 is the company's first independently developed project, and it recently initiated a Phase I clinical trial in China in September of this year. The FTD received further accelerates the international development of BN104. Yehui Pharmaceuticals will engage in more frequent and flexible communication with the FDA based on evolving data to expedite BN104's clinical development in the United States, ensuring that the target patients in need can benefit from it at the earliest opportunity, said Dr. Hua Ye, Founder and CEO of Yehui Pharmaceuticals.

About BN104:
BN104 is a novel, highly selective oral Menin inhibitor designed and discovered by Yehui Pharmaceuticals. Menin inhibitors are considered a potential breakthrough targeted therapy for acute leukemia, particularly for patients with MLL gene rearrangements or NPM1 gene mutations, as recognized by the academic community.

In April 2023, BN104 received Orphan Drug designation (ODD) from the FDA. In August and September 2023, BN104 obtained clinical trial permissions (IND) in China and the United States, respectively. On October 19th, 2023, BN104 administered its first patient dose (FPI) in China.

Conclusion:
The Fast Track designation granted by the FDA to BN104 for the treatment of relapsed/refractory acute leukemia represents an encouraging milestone for Yehui Pharmaceuticals. This recognition underscores the FDA's expectations regarding BN104's therapeutic potential, and it will facilitate the international development of BN104. Yehui Pharmaceuticals is dedicated to advancing BN104's clinical development in the United States through frequent and flexible communication with the FDA based on evolving data. The ultimate goal is to provide early benefits to the target patients with clinical needs. BN104's unique profile as an oral Menin inhibitor holds promise as a potential breakthrough treatment for acute leukemia, and further clinical trials will shed more light on its efficacy and safety profile.