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Servier Acquires BN104, a Precision Therapy for Acute Leukemia Developed by BioNova Pharmaceuticals

May 23, 2025 11:09 CST Updated 11:09
Servier

International Pharmaceutical Manufacturers

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Content | Servier
Editor | Med-Fine Capital

May 23, 2025 —— Global independent pharmaceutical group Servier andBionova PharmaceuticalsToday, an agreement was announced for Servier's acquisition of BN104, a small molecule menin inhibitor. The drug, developed by Bionova Pharmaceuticals, is used for the treatment of acute leukemia and is currently in Phase 1/2 clinical development. It is expected to become a leading menin inhibitor in its class. Bionova Pharmaceuticals is a biopharmaceutical company driven by clinical research and innovation, dedicated to the development and commercialization of innovative drugs to address unmet medical needs.
Claude Bertrand, Executive Vice President of R&D at Servier, stated: "Servier has always been committed toProviding Breakthrough Therapies for Patients with Rare Tumors and Significant Medical NeedsBionova Pharmaceuticals inAcute Leukemia FieldThe R&D assets align with our strategy in the field of oncology to develop targeted therapies for patient populations with specific genetic mutations or hereditary characteristics.Highly consistent"This acquisition will continue to solidify Servier's leading position in the field of hemato-oncology and further expand the company's R&D pipeline in hematological malignancies."
Dr. Hua Ye, Founder and CEO of Bionova Pharmaceuticals, stated：“Servier has deep professional expertise and a wealth of successful experience in the global development of targeted oncology therapies.Conducive to promoting BN104's early service for acute leukemia patientsWith its global commercial footprint and commitment to precision medicine, we believe Servier is well-positioned to fully unlock the drug's potential.Suitable Partners, and it can bring profound impact to patients worldwide."
According toServier 2030 Strategic GoalsThe group will accelerate the global clinical development of BN104 in mutant acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). There is a significant medical need in these treatment areas, especially for relapsed/refractory patients who urgently require therapies with higher safety and better tolerability. BN104 will help Servier further expand its product portfolio in hematological malignancies.Consolidate the group's leading position in this field and maintain a targeted and differentiated competitive advantage in the targeted product pipeline.。
Medfund Health Fund participated in Bionova Pharmaceuticals' Series B and B+ financing rounds in 2020.
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About the Precision Therapy BN104 for Acute Leukemia
BN104 is a product independently developed by Bionova Pharmaceuticals.Novel, highly active, and highly selective small-molecule drugs, and is expected to become the leading optimal menin inhibitor for treating acute leukemia carrying KMT2A gene rearrangements or NPM1 mutations. The BN104 trial data presented at the 2024 American Society of Hematology (ASH) Annual Meeting showed that, in relapsed or refractory AML patients, the subgroup with KMT2A rearrangements achieved complete remission/partial hematological recovery.Complete remission rate reached 60.9%, with the NPM1 mutation subgroup at 40%., with a tolerable safety profile1(No QTc interval prolongation or ≥Grade 3 differentiation syndrome occurred)In AML patients, the detection rate of KMT2A gene rearrangement is 5%~10%.2The detection rate of NPM1 gene mutations is 20%~30%.3BN104 was obtained in April 2023.Orphan Drug Designation (ODD) granted by the U.S. Food and Drug Administration (FDA), and received FDA approval for the treatment of acute leukemia in October 2023.Fast Track Designation。
About Bionova Pharmaceuticals
Bionova Pharmaceuticals is a biopharmaceutical company driven by clinical research and innovation. Focused on diseases with unmet medical needs in clinical treatment, the company is committed to developing and commercializing innovative drugs to fill therapeutic gaps. Headquartered in Shanghai, Bionova Pharmaceuticals is a rapidly growing startup. Its product pipeline is built on internal research and development, collaborations with cutting-edge biotechnology companies, and the introduction of high-quality projects from overseas. Backed by a strong and experienced professional team, and leveraging the power of capital, Bionova Pharmaceuticals is dedicated to providing high-quality innovative drugs to patients in China and around the world.
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