Fapon Biotech, Inc.

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

Mesh Bio secures funding for refining digital twin engine Singaporean startup Mesh Bio has received undisclosed funding from East Ventures to assist with its regional expansion. The company is currently working on a digital twin solution for managing rising cases of chronic diseases, particularly in Southeast Asia, where 62% of all deaths in the region are due to non-communicable conditions. Mesh Bio's DARA health intelligence platform provides multidimensional patient data in near real-time. It also delivers predictive analytics to identify patients at risk of chronic diseases. Its fresh funding will help further develop its digital twin engine, as well as expand its services across Southeast Asia, mainly in Indonesia, Malaysia, and the Philippines. DeepTek scores 510(k) for AI CXR solution DeepTek Medical Imaging from India has obtained the United States FDA's 510(k) clearance for its AI chest x-ray solution. Its CXR Analyser uses deep learning to automatically identify, categorise, and highlight abnormalities, including lung, pleural, and cardiac pathologies and foreign bodies and hardware, in chest x-rays. The technology can help reduce radiologist workload by 30%-50%, claims DeepTek co-founder Dr Amit Kharat in a statement. This is DeepTek's second 510(k) clearance after the ones granted for its radiology workflow management solution Augmento earlier in May. Halodoc takes on Indonesia's budding IVD market Telehealth platform Halodoc has entered into a strategic cooperation agreement with life science organisation Fapon to jointly develop Indonesia's nascent in-vitro diagnostics market. Under their partnership, they will establish a joint venture that will deliver IVD solutions. Fapon will share its two decades' worth of experience in developing technological solutions to support Halodoc in local IVD research and manufacturing. The latter will leverage its channels and industry connections to expedite the introduction of IVD solutions in the market. This collaboration comes as demand for IVD products, technologies, and services has increasingly grown in Indonesia. Docquity Jobs expands to Indonesia, Philippines Docquity, a healthcare professionals network in Southeast Asia, has expanded its region-wide online job portal to Indonesia and the Philippines. First launched in 2022 in Malaysia, Docquity Jobs now has around 400 employers on board and about 6,000 average monthly organic visits from job-seeking healthcare professionals.