Bevacizumab

TAIPEI, Feb. 19, 2025 /PRNewswire/ -- NaviFUS Corp. is dedicated to advancing non-invasive treatments for complex brain disorders, a challenging area in medical innovation. By using ultrasound technology for both diagnosis and therapy, NaviFUS exceeds the signal processing capabilities of traditional medical devices. This is made possible by Taiwan's advanced chip technology, which positions NaviFUS as a global leader in focused ultrasound-based treatment solutions. This cutting-edge technology integrates ICT capabilities into high-end medical devices seamlessly. The core technologies of the NaviFUS system include transcranial focused ultrasound and therapeutic guidance tracking, primarily used in drug delivery for brain diseases and neuromodulation. These innovations offer new hope for patients with brain cancer and drug-resistant epilepsy. Strong Industry Backing and Global Collaboration NaviFUS has secured significant support from domestic venture capital firms and ICT industry leaders. Key investors include Andy T.C. Chiu, Chairman of Top Taiwan Venture Capital, Stan Shih, Founder of Acer and Chairman of Himalaya Venture Capital, and Max Wu, Chairman of the Spring Foundation of National Chiao Tung University. The company also partners with YoungTek Electronics Corp. Chairman Bily Wang, who contributed to the development of the clinical trial device Model-101. Additionally, collaborations with Genovate Biotechnology Co., Ltd. Specialized in new drug development and Dr. Neal Kassell, Chairman of the Focused Ultrasound Foundation (FUSF), along with leading global clinical experts, are accelerating the development and application of NaviFUS technology. Breakthrough Clinical Achievements NaviFUS successfully completed a Phase II clinical trial in Taiwan in combination with Bevacizumab, a second-line drug for recurrent glioblastoma (rGBM). The trial showed: Progression-free survival at six months (PFS-6): 66.7% (vs. historical 42.6%) Median progression-free survival (PFS): 8.9 months (vs. historical 4.2 months) Due to its strong safety and efficacy, NaviFUS is now conducting a pivotal clinical trial under the guidance of Taiwan's regulatory agency. In drug-resistant epilepsy, clinical studies indicate that the NaviFUS system significantly reduces seizure frequency and duration, offering new treatment options for patients unresponsive to multiple drug therapies. Phase II trials are ongoing in Taiwan, along with pilot studies in Australia and the United States. Expanding Global Reach with Key Partnerships NaviFUS serves leading medical centers specializing in brain tumor and epilepsy treatments. A strategic partnership with Brainlab, a global leader in surgical navigation systems, enhances treatment precision and real-time monitoring. Brainlab's network of 6,300 hospital partnerships in 120 countries is instrumental in NaviFUS' international expansion. Driving Taiwan's Global Leadership in Smart Healthcare Chairman Jen Chen emphasized that Taiwan's government is prioritizing the biomedical industry, with a focus on internationalizing smart healthcare solutions, as highlighted by Acer founder Stan Shih during NaviFUS' pre-listing presentation. NaviFUS is Taiwan's first and only high-end medical device company leveraging advanced chip integration and chip deployment, cementing its leadership in the global market. As the demand for non-invasive brain treatments grows, NaviFUS is poised to lead the way in providing precise, non-invasive, and highly effective treatments for brain diseases. About NaviFUS Corp.: NaviFUS is a pioneering biotech company developing a novel focused ultrasound (FUS) platform for blood-brain barrier (BBB) opening, enhancing drug delivery and advancing neuromodulation. Our technology improves treatment outcomes for patients with brain diseases such as glioblastoma and epilepsy, ultimately empowering CNS patients by extending survival and improving quality of life. SOURCE NaviFUS Corp. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The therapy treats multiple myeloma. Credit: luchschenF/Shutterstock. Dr Reddy’s Laboratories has signed a licence agreement with Shanghai Henlius Biotech to develop and commercialise HLX15, a daratumumab biosimilar candidate to Johnson & Johnson ’s (J&J) Darzalex & Darzalex Faspro. Darzalex & Darzalex Faspro are indicated to treat multiple myeloma. The partnership leverages Dr. Reddy’s worldwide commercial network along with Henlius’ expertise in biosimilar development. A recombinant anti-CD38 fully human monoclonal antibody injection, HLX15 comes in both intravenous and subcutaneous formulations. Henlius will oversee development, manufacturing and supply, with potential earnings of up to $131.6m, including an upfront payment of $33m along with milestone payments. It is also set to obtain royalties on HLX15’s annual net sales. Dr Reddy’s will have exclusive commercialisation rights for the candidate in the US and Europe. Dr Reddy’s CEO Erez Israeli stated: “We are pleased to collaborate with Henlius to make this daratumumab biosimilar available to patients in the US and Europe. Over the years, we have created a portfolio of biosimilar products that are being marketed in several emerging markets. “The launch of our pegfilgrastim through our collaborator in the US in 2023, and bevacizumab in the UK last year, marked the start of our biosimilars journey in regulated markets.” By following a stepwise approach, HLX15’s development aligns with the biosimilar guidelines set by regulatory authorities including the European Medicines Agency, the US Food and Drug Administration (FDA), and the National Medical Products Administration (NMPA). A Phase I study of the biosimilar, concluded in June 2024, achieved its primary endpoint, demonstrating similar safety, immunogenicity and pharmacokinetics to the reference candidate sourced from the European Union, China, and the US. Further comparative efficacy studies are in progress. In August 2024, Dr Reddy’s and its division Aurigene Pharmaceutical Services entered a non-binding memorandum of understanding with Kainomyx to jointly develop and commercialise an accessible anti-malarial drug.