Feipeng Biotechnology Co., Ltd.

DONGGUAN, China, Feb. 28, 2025 /PRNewswire/ -- Fapon Biopharma, a biotech innovator in developing therapeutic antibodies and fusion proteins, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for FP008, its first-in-class immunocytokine designed to address the unmet need in patients with solid tumors refractory to anti-PD-1 therapy. FP008 is a novel anti-PD-1×IL-10M fusion protein with a unique mechanism of action (MOA) and therapeutic potential for anti-PD-1 naïve or resistant patients. IL-10 monomer (IL-10M) engineering significantly reduces its hematologic toxicity, while the anti-PD-1 antibody enhances IL-10M activity by PD-1 targeted enrichment and cis-activation. PD1 targeted antibodies drive the differentiation of effector CD8(+) T cells into terminally exhausted status. In the latest pre-clinical experiment conducted by Fapon Biopharma, FP008 effectively counteracted this process through IL-10M, significantly reducing the anti-PD-1 antibody-mediated exhaustion of CD8(+) T cells. In mouse experiments, FP008 exhibited potent anti-tumor effects, significantly increased the infiltration of intratumoral CD8(+) T cells, reduced their terminal exhaustion differentiation and enhanced the ability of terminally exhausted CD8(+) T cells to produce and secrete IFN-γ and GZMB. In addition, FP008 showed encouraging safety and pharmacokinetics profile in cynomolgus monkey, and demonstrated favorable developability. This breakthrough offers a new treatment choice for patients who have limited options and could potentially transform the treatment paradigm for solid tumors. Fapon Biopharma is actively seeking strategic partnerships with biopharmaceutical companies worldwide to co-develop FP008 through clinical trials or further commercialization. "Global collaboration is central to our vision," stated President Vincent Huo. "We invite partners to leverage our robust preclinical data and clinical-stage asset to jointly advance innovative products in tumor immunotherapy." About Fapon Biopharma Fapon Biopharma specializes in discovering and developing biologics for treating cancers, autoimmune diseases and other diseases where there are unmet medical needs. Leveraging cutting-edge technologies, we have built advanced drug discovery platforms, including an antibody discovery platform based on the globally leading mammalian cell display technology, a platform for generating IL-10M fusion proteins, and a platform for developing multispecific antibodies using Fibody and nanobodies. With a differentiated pipeline of leading drug candidates, we have established capabilities that cover the entire drug development process from drug discovery, preclinical research, Chemistry, Manufacturing and Controls (CMC) to early clinical development. Committed to innovation, we strive to deliver safer, more efficacious, affordable, and accessible biologics for everyone. For more information about FP008 and partnership opportunities, please visit our website () or contact our Business Development team. Max Wang: [email protected]; Liyan Gao: [email protected] SOURCE Fapon Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

DONGGUAN, China, Oct. 30, 2024 /PRNewswire/ -- Fapon, a global leading life sciences company, is thrilled to announce its PSP CLIA reagent solution which demonstrates promising outcomes in extensive clinical validation studies targeting Chinese population. Leveraging its strategic partnership with Abionic SA and LASCCO SA, Fapon has gained exclusive rights to utilize the PSP biomarker for sepsis diagnosis in China. Recently, Abionic announced that its innovative sepsis early detection test, IVD CAPSULE PSP, has received 510(k) clearance from the US Food and Drug Administration (FDA). This approval marks a significant advancement in the diagnosis and treatment of sepsis. Pancreatic Stone Protein (PSP) is an emerging sepsis biomarker used by clinicians as a screening tool for the early-detection of sepsis 24 - 48h earlier than current standards to support critical time-sensitive decisions. Produced by the pancreas and immune cells, PSP levels increase in response to infections and inflammation and has demonstrated significant sensitivity and specificity in detecting sepsis, particularly in critically ill patients. Clinical studies have shown that elevated PSP levels correlate closely with the progression of sepsis, allowing healthcare professionals to activate sepsis bundles earlier and improve outcomes. The FDA clearance highlights the marker and test's accuracy and reliability, supported by existing certifications from the EU CE, EU IVDR, and the Australian Therapeutic Goods Administration (TGA). This sets the stage for PSP test's global implementation, emphasizing its potential impact on sepsis diagnostics. In October 2023, Fapon entered into a strategic cooperation agreement with Abionic SA and LASCCO SA. This alliance grants Fapon exclusive rights to utilize the PSP biomarker for sepsis diagnosis in China. Leveraging this collaboration and the test's recent FDA approval, Fapon is in the development and commercialization of PSP on its chemiluminescent immunoassay (CLIA) analyzer within the territory. Beyond its focus in sepsis, Fapon is dedicated to advancing research in a range of critical areas, including infectious diseases, neurodegenerative disorders, anti-aging, AI-driven biomarkers and others. We continually strengthen our R&D capabilities through the establishment of global research centers, recruitment of industry-leading experts, and strategic licensing collaborations and investments in breakthrough technologies. Moving forward, Fapon is committed to providing more innovative, high-quality IVD products and services, and bringing earlier, more accurate, more convenient, and more accessible diagnostic solutions to our partners. About Fapon Fapon is a global leading life sciences company dedicated to providing integrated solutions and services for diagnostics, biopharma and biotherapy. Integrating a one-stop solution on raw materials, reagents and innovative open instrument platforms, the Company has grown into a leading supplier in in-vitro diagnostics. Fapon boasts advanced innovations in therapeutics technologies and AI algorithm platforms with data insights that contribute to a better and healthier world. Supported by its strong global R&D, manufacturing, sales and service network, Fapon's products have established presence in 68 countries and regions, serving more than 2,500 business partners worldwide. Follow us on LinkedIn (Fapon) or visit our website SOURCE Fapon WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SAN DIEGO, June 3, 2024 /PRNewswire/ -- At Bio International Convention 2024, which is taking place here in San Diego during June 3-6, Fapon Biopharma, an innovator in developing therapeutic antibodies and fusion proteins, has announced an immunocytokine with modified IL-10M fused to anti-PD-1 antibody, codenamed FP008. This fusion protein provides a promising therapeutic strategy for solid tumors refractory to anti-PD-1 therapy. The groundbreaking announcement is a testimony to Fapon Biopharma's strength in developing anticancer drugs. FP008 is a patent-pending drug candidate developed by Fapon Biopharma using cutting-edge antibody technology. It stands out as a first-in-class biologic candidate combining IL-10M (an attenuated IL-10 monomer variant) and an anti-PD-1 antibody, providing a targeted therapy with enhanced efficacy while significantly reducing the challenging toxicity associated with wtIL-10. This is a critical advancement in the field. FP008 not only reduces the apoptosis of the exhausted CD8+ T cells and restores their activity in vitro, but also significantly increases the level of CD8+ T cells within the tumor microenvironment, exhibiting a potent anti-tumor effect in vivo. It exhibited good druggability and was well tolerated in a toxicity study of up to 10 mpk in cynomolgus monkeys. As a result, FP008 is a viable drug candidate. FP008 is poised to have a substantial impact on immunotherapy for cancer in patients who do not respond to existing treatments. The company aims to present it to a global audience and seek partners to drive its development for the benefit of cancer patients around the world eventually. Fapon Biopharma plans to submit an IND application for FP008 to the FDA in early 2025. The company remains committed to developing more effective and more accessible therapeutics with consistent innovation and collaboration. About Fapon Biopharma Fapon Biopharma specializes in discovering and developing biologics for treating cancers, autoimmune diseases and other diseases where there are unmet medical needs. Leveraging cutting-edge technologies, we have built advanced drug discovery platforms, including an antibody discovery platform based on the globally leading mammalian cell display technology, a platform for generating IL-10M fusion proteins, and a platform for developing multispecific antibodies using Fibody and nanobodies. With a differentiated pipeline of leading drug candidates, we have established capabilities that cover the entire drug development process from drug discovery, preclinical research, Chemistry, Manufacturing and Controls (CMC) to early clinical development. Committed to innovation, we strive to deliver safer, more efficacious, affordable, and accessible biologics for everyone. Media contact: Tina Chen Fapon Group Email: [email protected] SOURCE Fapon