IL-12Rβ1

The U.S. Food and Drug Administration (FDA) has accepted Bio-Thera's Biologics License Applications (BLA) for BAT2206 as an interchangeable biosimilar to reference product Stelara® The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for BAT2206 as a biosimilar to reference product Stelara® The BAT2206 BLA and MAA are based on a robust analytical, non-clinical and clinical data package comparing BAT2206 to the reference product Stelara® GUANGZHOU, China, July 24, 2024 /PRNewswire/ -- Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the FDA has accepted the BLA for BAT2206, a proposed interchangeable biosimilar to Stelara® (ustekinumab) seeking a commercial license in the United States of America. In addition, Bio-Thera also announced that the EMA has accepted the MAA for BAT2206 seeking a commercial license in the European Union (EU). A Biologics License Application seeking approval for BAT2206 is also currently under review by the China National Medicinal Product Administration (NMPA). "The acceptance of both the FDA BLA and the EMA MAA for BAT2206 marks a milestone for Bio-Thera as it is the first ustekinumab biosimilar developed by a Chinese company to be submitted to the FDA or EMA for approval," said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions. "Bio-Thera is committed to helping patients around the world in need of affordable therapeutics like ustekinumab by developing BAT2206 for the global markets." This BLA/MAA for BAT2206 is based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of BAT2206 was conducted and supports biosimilarity with the reference product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of BAT2206 with both the EU and US reference ustekinumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared BAT2206 with ustekinumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with Moderate to Severe Plaque Psoriasis. About BAT2206 (ustekinumab) BAT2206 is a proposed biosimilar to Stelara® which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 from binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn's disease and ulcerative colitis, among many other autoimmune diseases. In the United States, Stelara® is a currently approved treatment for adult patients with 1) moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy, 2) active psoriatic arthritis (PsA), 3) moderately to severely active Crohn's disease (CD), 4) moderately to severely active ulcerative colitis. In pediatric patients 6 years and older Stelara® is currently approved for the treatment of 1) moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy and 2) active psoriatic arthritis (PsA). 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 three approved products: QLETLI® in China, and TOFIDENCE™/ BAT1806 in the US, EU and China, and Avzivi® / Pobevcy® in the US 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 antibody-drug conjugates (ADCs). For more information, please visit or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera). Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to BAT2206 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. Stelara® is a registered trademark of Johnson & Johnson Corporation QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. TOFIDENCE™ is a trademark of Biogen Avzivi® is a registered trademark of Sandoz AG POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. Contact Bio-Thera Solutions, Ltd.: Bert E. Thomas IV +1.410.627.1734 [email protected] SOURCE Bio-Thera Solutions, Ltd

The clinical comparative study met its primary endpoint and showed similar efficacy and comparable safety profile in patients with moderate to severe plaque psoriasis GUANGZHOU, China, Nov. 29, 2023 /PRNewswire/ -- Bio-Thera Solutions, Ltd. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, today announced results from the Phase 3 study of BAT2206, a proposed biosimilar referencing Stelara® (ustekinumab). The primary endpoint of this study was improvement from baseline in Psoriasis Area and Severity Index (PASI) score to Week 12, demonstrating BAT2206 is highly similar with Stelara® in patients with moderate to severe plaque psoriasis. Continue Reading In the US, Stelara® is currently approved for the treatment of patients 6 years or older with active psoriatic arthritis (PsA), the treatment of patients 6 years or older with moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy, the treatment of moderately to severely active Crohn's disease (CD) in adults, and the treatment of moderately to severely active ulcerative colitis (UC) in adults. Bio-Thera Solutions Announces Positive Results from Phase 3 Study of BAT2206, a Proposed Biosimilar Referencing Stelara® Post this The BAT2206 clinical trial was a global, multicenter, randomized, double-blind, parallel-arm, Phase 3 study designed to compare the efficacy, safety, immunogenicity and PK of BAT2206 with Stelara® in 556 patients with moderate to severe plaque psoriasis. More information regarding the BAT2206 Phase 3 clinical trial, including inclusion and exclusion criteria and primary and secondary outcome measures, can be found here: Results of the study will be presented in a future medical meeting or publication. "We are pleased to report on our fourth proposed biosimilar with positive Phase 3 study results. These results demonstrate the potential of our proposed ustekinumab biosimilar to be a safe and effective treatment," said Shengfeng Li, Ph.D., chief executive officer at Bio-Thera Solutions. "Bio-Thera is committed to increasing patient access to innovative medicines through the development of high-quality biosimilars." "I'm very pleased to have participated in the successful global Phase 3 study of BAT2206," commented professor Min Zheng, leading investigator for global phase 3 study of BAT2206. "BAT2206 will provide a new affordable treatment option for global patients in need. Congratulations to Bio-Thera Solutions." Bio-Thera entered into a commercialization and license agreement with Hikma for BAT2206 in August 2021. Developed by Bio-Thera, BAT2206 will be commercialized by Hikma in the United States of America. About BAT2206 (ustekinumab) BAT2206 is a proposed biosimilar to Janssen's Stelara® which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 from binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn's disease and ulcerative colitis, among many other autoimmune diseases. 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 three approved products, QLETLI®, POBEVCY® and BAT1806 in China and one approved product, TOFIDENCETM (BAT1806), in the USA. 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 follow us on LinkedIn, X (@bio_thera_sol) and WeChat (Bio-Thera). Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to BAT2206 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 those associated with 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. Stelara® is a registered trademark of Johnson & Johnson Corporation QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. TOFIDENCETM is a trademark of Biogen, Inc. SOURCE Bio-Thera Solutions, Ltd

MENLO PARK, Calif.--(BUSINESS WIRE)-- Synthekine Inc., an engineered cytokine therapeutics company, today announced that two poster presentations showcasing its next series of oncology programs will be delivered at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023 taking place in Orlando, FL from April 14-19, 2023. "We are excited to present on two programs from our maturing oncology pipeline at AACR 2023,” said Debanjan Ray, chief executive officer of Synthekine. “We are introducing the clinical trial design for our orthogonal IL-2 and CD19 CAR-T combination therapy, STK-009 + SYNCAR-001. This unique combination pioneers new ground in the field of cytokine supported cell therapy, and is our second oncology program to enter clinical studies, behind STK-012, our alpha/beta-biased IL-2 partial agonist.” Ray continued, “We are also introducing STK-026, our IL-12 partial agonist program, which is currently in IND-enabling studies and shows promise as a potent immunotherapy for the treatment of cancer. Systemically administered wild-type IL-12 has been shown to cause significant toxicity. Our approach with STK-026 leverages Synthekine’s expertise in structural biology, immunology, and protein engineering to bias IL-12 activity and expand the therapeutic index.” Details are as follows and available on the AACR online itinerary planner: Title: Trial in Progress: A Phase 1 Study to Evaluate the Safety and Tolerability of a Combination Autologous CD19 CAR T Cell Therapy (SYNCAR-001) and Orthogonal IL-2 (STK-009) in Subjects With Relapsed or Refractory CD19+ Hematologic Malignancies (NCT05665062) Session Title: Phase I Clinical Trials in Progress Session Date & Time: Monday Apr 17, 2023 1:30 PM - 5:00 PM ET Location: Poster Section 46 Poster Board Number: 13 Abstract Number: CT125 Summary: A first-in-human, open-label, dose escalation study of combination SYNCAR-001 + STK-009 in adults with relapsed or refractory (r/r) CD19+ hematologic malignancies (NCT05665062). The objectives of this study are to evaluate the safety, preliminary efficacy, pharmacokinetics, immunogenicity, and pharmacodynamics of SYNCAR-001 + STK-009. Recruitment in the Phase 1 study is underway. Title: Novel IL-12 Partial Agonist For Cancer Immunotherapy Avoids NK-cell Mediated Toxicity Session Title: Immunomodulatory Agents and Interventions 2 Session Date & Time: Monday Apr 17, 2023 9:00 AM - 12:30 PM ET Location: Poster Section 24 Poster Board Number: 5 Abstract Number: 1833 Summary: A novel human IL-12 partial agonist (STK-026) has been designed to more selectively engage antigen activated T-cells and to reduce stimulation of NK cells. In preclinical models, a mouse surrogate of STK-026 retained anti-tumor efficacy without induction of severe toxicities and spike in NK cell activation associated with wild-type mouse IL-12 treatment. Similarly, STK-026 avoided NK hyperactivation on human cells. These data suggest IL-12 partial agonists may represent a novel immunotherapy approach to maintain efficacy while avoiding classical toxicity associated with IL-12 therapy. Copies of the posters will be available on Synthekine’s website following presentation at the meeting. About Synthekine Synthekine is harnessing the potential of cytokine therapeutics to develop selective immunotherapies designed to improve the treatment paradigm of cancer and inflammatory disease. Using insights on cytokine structure and function, the company engineers therapeutics designed to unlock the full efficacy potential of cytokines while avoiding their associated toxicities. Synthekine is applying principles of cytokine partial agonism and immunological specificity across multiple protein engineering platforms to create a broad and deep pipeline of product candidates. These novel immunotherapies include modified cytokines, cytokine-enhanced cell therapies and surrogate cytokine agonists. For more information, visit , and follow us on Twitter @synthekine and LinkedIn.