ICAM-1

NATICK, Mass., April 28, 2025 /PRNewswire/ -- AffyImmune Therapeutics, Inc., a clinical-stage biopharmaceutical company, today announced an abstract detailing its affinity-tuned CAR T therapy AIC100 will be presented at the American Association for Cancer Research (AACR) Annual Meeting, held April 25-30, 2025 at McCormick Place Convention Center in Chicago, IL. "We look forward to presenting our updated Phase 1 data at AACR, and to provide interim safety and efficacy results from our Phase 1 Dose Escalation trial evaluating AIC100 CAR T therapy in patients with advanced thyroid cancers," said Daniel Janse, CEO, AffyImmune. "These results mark progress, as we plan the next steps for our affinity-tuned CAR T therapies for patients with unmet medical need." Presentation Details: Title: ICAM-1 directed chimeric antigen receptor (CAR) T cells (AIC100) in patients with Advanced Thyroid cancers: Clinical and translational data from the phase 1 dose escalation study Presenter: Dr. Samer Ali Srour, University of Texas MD Anderson Cancer Center, Houston, TX Session Type: Oral Presentation – Clinical Trials Plenary Session Abstract Number: CT206 Date and Time: April 29, 2025 10:15AM – 12:15PM CST Location: McCormick Place Convention Center in Chicago, Illinois About AffyImmune Therapeutics AffyImmune is a clinical-stage biopharmaceutical company committed to developing novel, first-in-class, affinity-tuned CAR T cell therapies to transform the lives of patients with cancer. The Company's proprietary technology utilizing ICAM-1/LFA-1 interaction can potentially address all critical CAR T challenges such as toxicity, antigen loss, T-cell trafficking and exhaustion, while also allowing in vivo tracking of the CAR T cells. Its lead candidate, AIC100, is an ICAM-1-directed CAR T therapy being developed for patients with advanced thyroid cancer. AffyImmune is developing a focused pipeline of therapeutics targeting ICAM-1 in oncologic indications with high unmet medical need. AffyImmune is based in Natick, MA. For more information, visit . Contacts Media Daniel Janse AffyImmune Therapeutics [email protected] (508) 960-1526 SOURCE AffyImmune Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BAT2506, a tumor necrosis factor-alpha (TNF-alpha) blocker, is a Phase 3 biosimilar candidate to Simponi® (golimumab) Agreement will provide Accord BioPharma with future U.S. commercialization rights to BAT2506, while Bio-Thera will maintain responsibility for product development, manufacturing, and supply RALEIGH, N.C., Feb. 10, 2025 /PRNewswire/ -- Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncology, immunology and critical care therapies, announced today that it has reached an exclusive commercialization and license agreement with Bio-Thera Solutions ("Bio-Thera") for BAT2506, a biosimilar candidate to Simponi® (golimumab). BAT2506 is a proposed golimumab biosimilar developed by Bio-Thera. Golimumab, a human monoclonal antibody, inhibits the biological activity of tumor necrosis factor alpha (TNF-alpha). Originator product Simponi® is approved in the U.S. for moderate to severe rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis and moderate to severely active UC, and carries a Boxed Warning for Serious Infection and Malignancy. In 2023 worldwide sales of Simponi® (for subcutaneous injection) and Simponi Aria® (for intravenous infusion) totaled approximately $3.2 billion, representing a compelling opportunity for Accord BioPharma to broaden patient access to biologics and build scale in immunology, a high-demand therapeutic area. "Our U.S. portfolio of biosimilars continues to rapidly expand at multiple levels across the drug development and commercialization cycle," said Chrys Kokino, U.S. President of Accord. "In addition to developing and marketing our own biosimilar products, we're strategically collaborating with select partners around the world to bring more biosimilars to the U.S. market as swiftly as possible." "The U.S. biologics market is predicted to grow rapidly in the coming years. Biosimilars can play a transformative role in creating unique opportunities for stakeholders across the healthcare value chain," said Binish Chudgar, Executive Chairman and Managing Director of Intas Pharmaceuticals. "This agreement reaffirms our commitment to improving the patient experience." "Accord is a leading biosimilar company in the United States, and we are pleased to establish this commercial partnership with Accord for BAT2506," said Dr. Shengfeng Li, CEO of Bio-Thera. "This partnership will expand Bio-Thera's efforts to bring more immunology biosimilars to patients in the USA." Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2506, while Accord will have exclusive rights to commercialize the product in the U.S. About Accord BioPharma Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access to a number of biologic medicines, that in the past may not have been considered for patients due to their high costs. Accord BioPharma looks forward to providing one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com. About BAT2506 BAT2506 is a biosimilar candidate to Simponi® (golimumab). Binding of golimumab to TNF-α results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers. About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including four approved products: QLETLI® and BETAGRIN® (Bevifibatide Citrate Injection) in China, and TOFIDENCE/ BAT1806 and Avzivi® / Pobevcy® in the US, EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs. For more information, please visit . References: Simponi® (golimumab) Full Prescribing Information. Accessed January 2025. All trademarks, logos and brand names are the property of their respective owners. Contact: [email protected] SOURCE Accord BioPharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

GUANGZHOU, China, Feb. 10, 2025 /PRNewswire/ -- Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced the company has reached an exclusive commercialization and license agreement with Intas Pharmaceuticals for BAT2506, a golimumab biosimilar, for the United States of America. Continue Reading Bio-Thera Solutions Announces Exclusive Commercialization and License Agreement with Intas Pharmaceuticals for BAT2506, a Proposed Biosimilar Referencing Simponi® (golimumab), in the United States of America BAT2506 is a proposed golimumab biosimilar developed by Bio-Thera. Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-a), a pro-inflammatory molecule. Binding of golimumab to TNF-a results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers. The reference medicine golimumab has been approved in the United States and Europe for several indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2506. Intas Pharmaceuticals, through its US-specialty division Accord BioPharma, will be responsible for commercializing the product in the United States of America. Bio-Thera will receive an upfront payment of $21 million USD, as well as further development and commercial milestones of up to $143.5 million USD. "Accord BioPharma is a leading biosimilar company in the United States, and we are pleased to establish this commercial partnership with Accord for BAT2506," said Dr. Shengfeng Li, CEO of Bio-Thera. "This partnership will expand Bio-Thera's efforts to bring more immunology biosimilars to patients in USA." "Our exclusive commercialization agreement with Bio-Thera strengthens our biosimilar pipeline, a vital component of our U.S. growth strategy," said Chrys Kokino, U.S. President of Accord. "We're investing heavily in biosimilars through external partnerships plus our own clinical efforts, because we believe in their vast potential to drive patient- and provider-centric solutions. Bio-Thera's global experience makes them an excellent partner." About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including four approved products: QLETLI® and BETAGRIN® (Bevifibatide Citrate Injection) in China, and TOFIDENCE™/ BAT1806 and Avzivi® / Pobevcy® in the US, EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs. For more information, please visit or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera). About Intas Pharmaceuticals Intas Pharmaceuticals is a pioneer in biosimilars, having developed and launched one of the highest numbers of indigenous biosimilars in India. Intas Pharmaceuticals has a rich history of making quality biosimilars accessible to the masses. Being the most affordable treatment option, Intas' products like Neukine (filgrastim), Pegasta (Pegfilgrastim), Mabtas (rituximab), Razumab (ranibizumab) and Bevatas (bevacizumab) have transformed the management of their respective therapies. Eleftha is the latest testament to Intas' Biosimilar for Billions philosophy, fulfilling its commitment to provide quality cancer care to the masses. Intas' biosimilars are manufactured at Intas Pharmaceuticals' state of the art European Union- Good Manufacturing Practices (EU-GMP) certified biotechnology plant located near Ahmedabad, Gujarat. For more information, visit us at . About Accord BioPharma, Inc. Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access to a number of biologic medicines, that in the past may not have been considered for patients due to their high costs. Accord BioPharma looks forward to providing one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com. Bio-Thera Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to BAT2506, or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise. 1. Simponi® is a registered trademark of Johnson & Johnson 2. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. 3. TOFIDENCE™ is a trademark of Biogen MA Inc. 4. Avzivi® is a registered trademark of Sandoz AG 5. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. 6. BETAGRIN® is a registered trademark of Bio-Thera Solutions, Ltd. Contact Bert E. Thomas IV Phone: +1.410.627.1734 Email: [email protected] SOURCE Bio-Thera Solutions, Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED