Tocilizumab-bavi

百奥泰生物制药股份有限公司（上交所代码：688177）是一家位于中国广州，基于科学而创新的全球性生物制药企业，以下简称“百奥泰”或“公司”。公司今日宣布收到国家药品监督管理局核准签发的在研药品BAT4406F注射液新增微小病变肾病（MCD）/局灶节段性肾小球硬化（FSGS）适应症的《药物临床试验批准通知书》。微小病变肾病和局灶节段性肾小球硬化是原发性肾病综合征的两种常见病理类型，其发病机制尚未完全阐明，但足细胞损伤被认为是两者发病的共同关键因素。糖皮质激素是治疗MCD/FSGS的基础，但临床上多数患者存在经激素治疗后易复发、需要长期依赖激素等问题。BAT4406F为公司开发的新一代糖基优化的全人源抗 CD20 抗体，特异性与B 细胞及前体细胞表面的 CD20 分子结合，通过抗体 Fc 段，在补体、NK 自然杀伤性细胞、吞噬细胞等存在的情况下，诱发 ADCC、CDC（补体依赖的细胞毒性）等生物学效应从而达到清除 B 细胞的目的。目前，BAT4406F已获批临床试验的适应症为：视神经脊髓炎谱系疾病、微小病变肾病/局灶节段性肾小球硬化。近期，BAT4406F在视神经脊髓炎谱系疾病（NMOSD）适应症中的关键注册II/III期临床研究期中分析结果显示BAT4406F有效性达到了预设的统计准则，获得独立数据监查委员会（IDMC） “提前结束试验”的建议；经综合评估，公司决定提前结束该研究的受试者招募，积极推进研究后续工作。关于百奥泰百奥泰是一家位于中国广州，基于科学而创新的全球性生物制药企业。公司致力于开发新一代创新药和生物类似药，用于治疗肿瘤、自身免疫性疾病、心血管疾病、眼科以及其它危及人类生命或健康的疾病。作为抗体药物全球开发的领导者，百奥泰已推动多款药物获批上市，其中格乐立®（阿达木单抗）、贝塔宁®（枸橼酸倍维巴肽）已在中国获批上市；托珠单抗（美国商品名：TOFIDENCE™，中国商品名：施瑞立®）已在中美欧三个主要市场获批上市；贝伐珠单抗（欧美商品名：Avzivi®，中国商品名：普贝希®，巴西商品名：Bevyx®）已在中美欧巴西四地获批上市；乌司奴单抗（美国商品名：STARJEMZA®）已在美国获批。TOFIDENCE™成为第一个由中国药企研发、生产且获得美国FDA批准上市的单克隆抗体药物。公司另有多款候选药物进入后期临床试验，其中肿瘤领域主要聚焦PD-1后时代的肿瘤免疫治疗和抗体药物偶联体（ADC）靶向药物开发。百奥泰始终以患者的福祉作为首要核心价值，通过创新研发，为患者提供安全、有效、可负担的优质药物，以满足亟待解决的治疗需求。欲了解更多信息，请访问官网www.bio-thera.com，或关注我们的X（@bio_thera_sol）和微信公众号（百奥泰）。息，请访问官网AccordBioPharma.com。百奥泰前瞻性声明本新闻稿包含了BAT4406F或百奥泰及产品线相关的前瞻性声明。由于某些重要因素可能会影响公司的实际结果，特此提醒读者注意不要过分依赖该前瞻性声明。这些前瞻性语句包括但不限于包含意愿、将要、可能、潜在性、预测、计划、估计、预期等类似陈述。它们都应被视为百奥泰基于截至本新闻稿发布之日可获得的信息的合理假设，并不保证未来的表现或发展。由于多种因素，实际结果和事件可能与前瞻性声明中包含的信息存在重大差异，这些因素包括但不限于本产品可能不会获得受理或批准，以及药物研究、开发和商业化中固有的风险和不确定性，例如临床前和临床研究的风险和不确定性以及能否获得药政部门的批准。其他风险因素包括生产、分销、营销、竞争、知识产权、药物功效和安全性方面的风险和不确定性，国家及全球财务与医疗状况的变化，公司财务状况的变化以及适用法律法规的变化等。本新闻稿中包含的任何前瞻性声明仅针对截止于作出声明之日的情况。除非法律要求，否则百奥泰没有义务更新本新闻稿中包含的任何前瞻性声明，以反映本新闻稿发布之日以后的新信息和事件，公司观点的改变或其他情况。

GUANGZHOU, China I July 16, 2025 I Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi ® (golimumab).  The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is 16 th May 2026. The BLA was submitted by Bio-Thera’s US commercialization partner Accord BioPharma, who will be the MA holder if BAT2506 is approved by FDA.  Accord BioPharma filed the BLA with FDA on 16 th May 2025.  The BLA requests approval for all approved presentations and all currently approved indications for Simponi, including 1) moderately to severely active rheumatoid arthritis (RA) in adults, used with methotrexate, 2) active psoriatic arthritis (PsA) in adults, used alone or with methotrexate, 3) active ankylosing spondylitis (AS) in adults and 4) moderately to severely active ulcerative colitis (UC) in adults who depend on corticosteroids or haven’t responded well to or tolerated other treatments. The BLA also requests BAT2506 be declared interchangeable with Simponi. Bio-Thera and Intas entered into a license and commercialization agreement for BAT2506 in February 2025. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Accord BioPharma, the U.S. specialty division of Intas is responsible for the commercialization of BAT2506 in the United States. “The FDA’s acceptance of our BLA is a significant achievement that brings Bio-Thera closer to providing autoimmune patients in the USA with a high-quality, low-cost treatment option,” said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions. “Bio-Thera is committed to developing, manufacturing and commercializing biosimilars in the US and this marks the fourth FDA BLA that Bio-Thera has filed for a biosimilar.” The BLA submission is based on a comprehensive analytical, non-clinical, and clinical data package submitted to the FDA. Extensive analytical characterization between BAT2506 and US and EU Simponi ® was conducted on structural, physicochemical, and biological properties to support bio-similarity of BAT2506. A randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety, and immunogenicity of BAT2506 ® with both the US and EU Simponi ® in healthy volunteers. A multicenter, randomized, double-blind, parallel-arm, phase III study compared BAT2506 with EU Simponi ® for efficacy, safety, and immunogenicity in patients with active psoriatic arthritis. The totality of the evidence demonstrated that BAT2506 has similar efficacy, safety, immunogenicity, and quality as the reference product golimumab. About BAT2506 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. 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 five approved products: QLETLI ® (adalimumab) and BETAGRIN ® (bevifibatide citrate) Injection in China, STARJEMZA ® in the US, and BAT1806/TOFIDENCE TM (tocilizumab) and AVZIVI ® (bevacizumab-tnjn) in the US, a/k/a POBEVCY ® in 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 antibody-drug conjugates (ADCs). For more information, please visit www.bio-thera.com/en/ or follow us on X ( @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 www.intaspharma.com . 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. SOURCE: Bio-Thera Solutions