Porton Supports BioNova’s BN104 Program in Achieving Milestone Entry into Overseas Markets

On August 20, 2025, the team from BioNova Pharmaceuticals Ltd. (hereinafter referred to as BioNova) visited the Shanghai Minhang R&D Center of Porton Pharma Solutions Ltd. (hereinafter referred to as Porton), where the two parties jointly held the “Annual Collaboration Review and Award Ceremony for Excellence in BN104 Project Delivery.”

BN104, the core pipeline independently developed by BioNova, is a novel small-molecule menin inhibitor designed for acute leukemia patients, currently in the phase 1/2 clinical stage. BN104 has been recognized by the FDA as an orphan drug and has been granted fast-track status to treat acute leukemia. Data presented at the 2024 ASH Annual Meeting demonstrated an excellent safety profile. In patients with relapsed/refractory AML, complete remission rates were 60.9% in the KMT2A rearrangement subgroup and 40% in the NPM1 mutation subgroup. This pipeline was acquired by international pharmaceutical company Servier in May of this year, confirming its global clinical value.

Behind the steady progress of the BN104 project pipeline, the key support from Porton has been indispensable. During the supply period of the BN104 clinical trial drugs, Porton’s formulation team overcame the time constraints of the arduous task to complete the technology transfer and deliver the trial drugs on time. The team took the initiative to optimize the production process and worked overtime, from technology transfer planning to production quality control. With professional knowledge and innovative ideas, the team ensured that the clinical trial drugs, which carried the hopes of patients and the expectations of the client, were delivered on schedule. BioNova highly praised Porton’s rigor and efficiency throughout the entire project execution and awarded Porton the Trusted Partner Award.

BioNova is a biopharmaceutical company with a strong focus on innovation in clinical research and development. BioNova is committed to developing and commercializing innovative drugs to fill therapeutic gaps for diseases that have unmet medical needs in clinical care. Headquartered in Shanghai, BioNova is a rapidly growing startup. The product pipeline is based on in-house R&D, collaborations with cutting-edge biotech companies, and the introduction of high-quality projects from overseas. With a strong and experienced team of professionals and the power of capital, BioNova is committed to providing high-quality innovative medicines to patients in China and around the world.

With over 4,200 employees and 18 operations and commercial offices across the US, EU, and China, Porton Pharma Solutions provides global pharmaceutical and biotech companies with innovative, reliable, and end-to-end process R&D and GMP manufacturing services across Small Molecules, Tides, Biologics and Conjugates (ADCs, AOCs, PDCs, RDCs, etc.), as well as Advanced Therapy Medicinal Products.

We are committed to a customer-centric approach and have been recognized through awards by industry forums and global pharmaceutical and biotech companies for our process innovation, supply chain performance, and compliance with global quality and EHS standards. We constantly strive for excellence and to enable the public's early access to good medicines.