Anti-thymocyte Globulin (Rabbit)

HONG KONG, Nov. 7, 2024 /PRNewswire/ -- On November 5, the 7th China International Import Expo (CIIE) opened at the National Exhibition and Convention Center in Shanghai. As a seven-time attendee of the CIIE, Fosun showcased the latest achievements in innovation and global operations at its Fosun Pharma booth in Hall 7.1, featuring cutting-edge medical devices and innovative pharmaceuticals that made their debut in China. Guo Guangchang, Chairman of Fosun International, remarked, "Over the past seven years, CIIE has improved every year, becoming a window for China to build a new development framework, a platform for high-level openness, and an international public product for global sharing. Fosun has been a participant, witness, and beneficiary of the CIIE. Leveraging the CIIE platform, our long-term innovations have continually been put into practice, transforming many 'exhibits' into 'products', and converting many overseas partners from 'exhibitors' into 'investors'. This year, we continue to showcase our latest achievements in integrated innovation in the medical device and health sector, including several 'world's firsts' and 'China's firsts'. We firmly believe that China remains a significant opportunity for global development. Together with more overseas companies and global partners, we will promote more cutting-edge innovations to take root in China, moving forward and achieving mutual success on the grand stage of the CIIE." Stars of CIIE Taking Root, Transforming Ion from "Exhibit" to "Product" Healthcare is one of Fosun's main businesses. With CIIE's "spillover effect," several star products from Fosun, supported by the CIIE "accelerator" effect, have successfully entered the market to serve Chinese patients, transforming from "exhibits" into "products". This year, following the popular da Vinci Surgical System, the Ion Robotic Bronchoscopy made its CIIE debut after receiving domestic approval. Since its first appearance at the CIIE in 2019, Ion caught the attention of visitors. By the end of 2022, Ion entered the National Medical Products Administration's 'Green Channel' for innovative products and gained approval in March 2024, with the first commercial application completed in September. Lung cancer is considered the leading cause of cancer deaths, with 1.06 million new cases in China in 2022. The five-year survival rate is only 19.7%, and bronchoscopy is a key diagnostic tool for early lung cancer detection. The Ion bronchoscopy navigation control system offers innovative features for precise, convenient clinical diagnosis, providing new options for patients. By the third quarter of this year, 736 Ion systems had been installed globally, with over 150,000 Ion procedures performed. Outside the CIIE exhibition hall, Fosun is accelerating the localization of advanced medical devices. In June this year, Intuitive Fosun's headquarter industrial base was launched in Shanghai, marking Intuitive's largest R&D, production, and training center in the Asia-Pacific region. At this base, in addition to the Ion shape-sensing bronchoscopy control system, advanced products and core components, including the da Vinci surgical robot, are gradually achieving "Made in China, joint R&D, and global sales." Accelerating Integrated Innovation to Lead in Neurological Disease Treatment Transformation Fosun has long committed to investing in cutting-edge areas of healthcare, fostering a continuous stream of breakthrough "solid achievements" through an open innovation ecosystem involving independent R&D, collaborative development, licensing, and industry investment. These innovations are continually transformed into new drivers of growth. At this year's CIIE, Fosun introduced several latest products that are leading industry transformation. In the field of neurological disease treatment, especially for conditions like essential tremor and Parkinson's disease, patients have long faced challenges with unmet clinical needs. Traditional drug and surgical treatments often have limitations, but advancements in non-invasive treatment technologies have brought new hope to these patients. Fosun has actively responded to this unmet clinical need. At this year's CIIE, the new V2 model of the CNS (Central Nervous System) innovative treatment technology, the V2 model of "Exablate Neuro FUS system" made its debut in China, generating high expectations within the industry. This new model has already received CE certification in Europe and FDA approval in the United States and submitted a registration application to China's National Medical Products Administration in 2024. The V2 model's innovation lies in providing a non-invasive surgical solution for clinically drug-resistant essential tremor and tremor-dominant Parkinson's disease, while also being compatible with a broader range of MRI models, further enhancing the accessibility of this technology. Last year, Fosun, in partnership with Insightec, showcased the "Exablate Neuro" at CIIE, drawing much attention and continuous interest in collaboration. Leveraging the CIIE's "spillover effect", Fosun Pharma and Insightec established a joint venture, Fosun-Insightec, in February this year. The venture is focused on the marketing and developing clinical efforts of Exablate Neuro FUS system in improving the lives of patient living with essential tremor and Parkinson's disease, working to help them regain their quality life and wellbeing. Focusing on innovating to meet real customer needs is a core methodology for Fosun. Data shows that Fosun has made long-term investments in technological innovation, with an investment of RMB 3.5 billion in the first half of this year. Connecting Globally to Enhance Accessibility of Innovative Drugs, Benefiting more Patients Leveraging the CIIE's openness, Fosun also presented innovative products focused on solid tumors, hematological tumors, and immune-inflammatory conditions. Fosun's seven-year journey at CIIE has facilitated the introductions of global products and enabled the export of local innovations to benefit more patients worldwide. In 2017, Fosun introduced China's first CAR-T cell therapy product, Yi Kai Da (ejilunsai injection). Since then, by continuously participating in the CIIE, Fosun has enabled the public to gain an in-depth understanding of this advanced therapy. At this year's CIIE, Fosun highlighted Yi Kai Da's latest developments in the "accessibility and treatability" in lymphoma treatment. Yi Kai Da is now included in over 110 urban customized commercial health insurances and more than 80 commercial insurances, created a new path of payment mode for patients; and over 170 high-standard treatment centers across 28 regions in China providing treatments for over 900 lymphoma patients, achieving revolutionary innovative breakthroughs for cancer care. As a global company rooted in China, Fosun has an extensive industrial presence in over 35 countries and regions worldwide, with robust global R&D capabilities and impressive progress. This year, Fosun also showcased several innovative products, including the world's first and only dual-channel fixed-dose combination oral formulation, Akynzeo® oral (Netupitant and Palonosetron hydrochloride), which blocks both NK-1 and 5-HT3 receptors; the immunoglobulin Thymoglobulin® for improving transplant patient outcomes; the world's first oral targeted medication for psoriasis, Otezla® (apremilast tablets); a new third-generation COMT inhibitor Ongentys® (Opicapone) for managing symptom fluctuations in adult Parkinson's disease patients; and Parsabiv® (Etelcalcetide Hydrochloride Injection), the only peptide-based calcimimetic for treating secondary hyperparathyroidism in adult dialysis patients with chronic kidney disease. Guo Guangchang concluded, "Participating in CIIE has been a top priority for Fosun for seven consecutive years. We have witnessed CIIE become a crucial platform for global companies to share in China's development opportunities and deepened our global partnerships through this platform. We believe the CIIE stage will continue to expand, and Fosun's journey of innovation and globalization will grow broader." SOURCE Fosun WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SAB-142 has completed Phase 1 enrollment of all planned cohorts in healthy volunteers and is progressing to enroll patients with type 1 diabetes in the last cohort of the study. Target dose of SAB-142 2.5mg/kg completed with no observation of serum sickness. SAB-142 remains on track for a topline Phase 1 data readout by the end of the year. MIAMI, Sept. 09, 2024 (GLOBE NEWSWIRE) -- SAB BIO (Nasdaq: SABS) (the “Company” or “SAB”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform developing a human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today will offer a trial update on SAB-142 during its presentation at the European Association for the Study of Diabetes (EASD) 60th Annual Meeting in Madrid. SAB’s Executive Vice President and Chief Medical Officer Alexandra Kropotova, MD, MBA will present “Protecting pancreatic beta cells with multi-target immunotherapy: SAB-142.” SAB-142 is a first-in-class human anti-thymocyte immunoglobulin being developed as a disease-modifying treatment to delay the onset and progression of T1D. “We are pleased with the continued progress of SAB-142 and its emerging safety profile to date,” noted Dr. Kropotova on the data. “Our trial results to date definitively demonstrate a lack of serum sickness for our SAB-142 compound, which is a key differentiation compared to rabbit anti-thymocyte globulin. SAB-142 has demonstrated this fully human anti-thymocyte globulin has an improved safety benefit and the potential to preserve endogenous C-peptide and prevent the progression of type 1 diabetes. We continue to gather SAB-142 data that supports our commitment to developing a disease modifying immunotherapy to change the lives of people impacted by type 1 diabetes.” SAB commenced the Phase 1 clinical trial investigating safety, tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of SAB-142 in November 2023. The primary objective of the trial is two-fold: (1) to generate data on differentiated safety and immunogenicity of this human immunoglobulin, and (2) to establish a proof of biological activity (POBA) for SAB-142. The Phase 1 study is a randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous SAB-142 first in healthy volunteers and thereafter in participants with T1D. Enrollment of healthy volunteers has been completed for all planned cohorts. SAB has completed the dosing of 2.5mg/kg with SAB-142 – its targeted dose - with no observation of serum sickness. Additionally, SAB has elected to add a T1D patient cohort to establish safety, tolerability, pharmacokinetic and immunogenicity profile of SAB-142 in patients with T1D prior to initiation of an upcoming Phase II SAFEGUARD study in patients with new-onset T1D. SAB is now progressing to enroll patients with T1D to supplement the last cohort of the study. About SAB-142 SAB-142 is a human alternative to rabbit anti-thymocyte globulin (ATG). SAB-142’s mechanism of action is analogous to that of rabbit ATG, which has been clinically validated in multiple clinical trials for type 1 diabetes, demonstrating the ability to slow down disease progression in patients with new or recent onset of Stage 3 type 1 diabetes. Two clinical trials have shown that a single, low dose of 2.5mg/kg rabbit ATG has demonstrated the ability to modulate the body’s immune response to help slow beta cell destruction and preserve the ability of these cells to generate insulin, which the body needs to regulate blood sugar and carry out all human activities. SAB-142, like rabbit ATG, directly targets multiple immune cells involved in destroying pancreatic beta cells. By stopping immune cells from attacking beta cells, this treatment has the potential to preserve insulin-producing beta cells. However, most humans treated with rabbit ATG develop serum sickness and anti-drug antibodies from exposure to the rabbit-derived antibody. SAB-142 is a human antibody, intended to allow safe, consistent re-dosing for type 1 diabetes, a lifelong chronic disease, without the potential risk of inducing major adverse immune reactions that can occur with the administration of an animal ATG. About SAB Biotherapeutics, Inc. SAB BIO (SAB) is a clinical-stage biopharmaceutical company focused on developing human, multi- targeted, high-potency immunoglobulins (IgGs), without the need for human donors or convalescent plasma, to treat and prevent immune and autoimmune disorders. The Company’s lead asset, SAB-142, targets T1D with a disease-modifying therapeutic approach that aims to change the treatment paradigm by delaying onset and potentially preventing disease progression. Using advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™, the only transgenic animal with a human artificial chromosome, SAB’s DiversitAb™ drug development production system can generate a diverse repertoire of specifically targeted, high-potency, human IgGs that can address a wide range of serious unmet needs in human diseases without the need for convalescent plasma or human donors. For more information on SAB, visit: www.SAB.bio and follow SAB on LinkedIn. Forward-Looking Statements Certain statements made in this current report that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “to be,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including, the development and efficacy of our T1D program and other discovery programs, including the results of our clinical studies related to SAB-142. These statements are based on the current expectations of SAB and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, as may be amended or supplemented from time to time, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/. Except as otherwise required by law, SAB disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise. CONTACTS Kaelan Hollon Media Relations:khollon@sab.bio Investor Relations: Kevin GardnerLifeSci Advisorskgardner@lifesciadvisors.com Chris CalabreseLifeSci Advisorsccalabrese@lifesciadvisors.com