Bevacizumab biosimilar (Bio-Thera Solutions)

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 ” 。公司今日宣布近期已与 World Medicine 就 BAT2206 （一款参照喜达诺 ® 乌司奴单抗开发的生物类似药）签署授权许可及商业化协议。 根据协议条款， World Medicine 将拥有 BAT2206 在土耳其市场的独家分销权及销售权，并负责 BAT2206 在土耳其的引进、注册及销售；百奥泰将负责 BAT2206 的研发、生产以及商业化供应 。目前， BAT2206 上市许可申请已获中国 NMPA 、美国 FDA 以及欧洲 EMA 受理。 World Medicine 董事长 Ruşen Kalender 表示： “ 自成立以来， World Medicine 一直致力于通过广泛的产品组合改善人们的生活，我们与百奥泰达成合作是践行这一承诺的必然结果。通过这次合作，我们在提供可持续的医疗解决方案方面迈出了重要的一步，提高乌司奴单抗等重要药物在土耳其的可及性。” 百奥泰创始人及总经理李胜峰博士表示：“我们很高兴能与 World Medicine 达成在土耳其市场的合作。我们期待与 World Medicine 共同将 BAT2206 引进土耳其，提高生物制剂的可及性。” 关于 BAT2206 BAT2206 是百奥泰根据中国 NMPA 、美国 FDA 、欧洲 EMA 生物类似药相关指导原则开发的乌司奴单抗注射液，乌司奴单抗是一款靶向白细胞介素 IL-12 和 IL-23 共有的 p40 亚基的全人源单克隆抗体。 IL-12 和 IL-23 是天然产生的细胞因子，能够参与炎症和免疫应答过程，可以与 p40 亚基以高亲和力特异性地结合，阻断其与细胞表面受体结合，从而破坏 IL-12 和 IL-23 介导的信号传导和细胞因子的效应。 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。作为新一代抗体药物研发的领导者，百奥泰已推动多款候选药物进入后期临床试验，其中格乐立 ® （阿达木单抗）、普贝希 ® （贝伐珠单抗）、施瑞立 ® （托珠单抗）、贝塔宁 ® （枸橼酸倍维巴肽）已在中国获批上市。 TOFIDENCE™ （托珠单抗）和 Avzivi® （贝伐珠单抗）已实现中美欧三地获批上市。公司现有 20 多款在研产品处于不同临床研究阶段， 其中肿瘤领域主要聚焦后 PD-1 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 www.bio-thera.com ，或关注我们的推特（ @bio_thera_sol ）和微信公众号（百奥泰）。 1. 格乐立 ® 是百奥泰的注册商标 2. 普贝希 ® 是百奥泰的注册商标 3. 施瑞立 ® 是百奥泰的注册商标 4. 贝塔宁 ® 是百奥泰的注册商标 5. TOFIDENCETM 是渤健的注册商标 6. Avzivi® 是山德士的注册商标 关于 World Medicine İlaç Sanayi ve Ticaret A.Ş. （ World Medicine ） World Medicine 于 2011 年在土耳其成立，以可持续的质量标准和创新疗法为动力，致力于在全球范围提供可及和有效的药品，从而提高人们的生活质量。 World Medicine 连续三年蝉联土耳其药品出口第一，产品出口至 50 多个国家。通过持续投资，公司将把土耳其打造为主要生产中心和总部基地。公司业务涉及多个治疗领域，包括眼科、神经科、内分泌科、心脏科、风湿病科、消化科、泌尿科和肺科，拥有 500 多种产品组成的多样化产品组合。 World Medicine 将继续努力在开展业务的市场中成为值得信赖的合作伙伴和领先的制药公司。 更多信息，请访问： www.worldmedicine.com.tr/en/ 或关注 X (@ worldmedicinetr ) 和 领英 ( in/worldmedicineturkiye ) 。 百奥泰前瞻性声明 本新闻稿包含了 BAT2206 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 January 14, 2025 I Bio-Thera Solutions, Ltd. today announced the publication of the Phase I clinical study results for BAT4406F , an ADCC-enhanced fully humanized anti-CD20 monoclonal antibody in Chinese patients with neuromyelitis optica spectrum disorders (NMOSD) in the journal CNS Neuroscience & Therapeutics. Neuromyelitis optica spectrum disorder (NMOSD) is a rare immune-mediated central nervous system (CNS) inflammatory demyelinating disease with high recurrence and disability, primarily characterized by severe optic neuritis (ON) and longitudinally extensive transverse myelitis (LETM). ON might result in a decrease in visual acuity, visual field defects, and even blindness. Spinal cord inflammation will also cause paralysis and bladder rectal damage. B-cell depletion therapy by monoclonal antibody (mAb) against CD20 can reduce the recurrence of NMOSD and slow the progression of neurological dysfunction and has a significant therapeutic effect. BAT4406F, a Class 1 innovative drugs developed by Bio-Thera, is a glycosylation-optimized fully anti-CD20 human mAb of IgG1 subclass with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) effect. In preclinical studies, BAT4406F has showed stronger B-cell depletion activity than the marketed anti-CD20 monoclonal antibodies including rituximab. In this first-in-human, open-label, dose-escalation Phase I clinical study of BAT4406F injection in Chinese NMOSD patients, the overall objective was to assess the tolerability, safety, pharmacokinetics (PK), pharmacodynamics, and immunogenicity of BAT4406F in NMOSD patients. The efficacy of BAT4406F in NMOSD was also preliminarily explored (ClinicalTrials.gov identifier: NCT04146285 ). Five fixed dose groups ranging from 20 mg to 750 mg were set. Fifteen eligible patients were enrolled in this trial and administered with a single intravenous infusion of BAT4406F followed by a 6-month observation period. No subjects experienced DLT at the studied doses. BAT4406F injection has shown favorable safety, with most of the adverse events (AE) of CTCAE Grade 1 or 2 in severity, and no Grade ≥3 adverse drug reactions (ADR) or serious adverse reactions occurred in any subjects. With the dose increase of BAT4406F, C max , AUC 0-t and AUC 0-inf showed an increasing trend, whereas the CL, l Z , and V d decreased. The mean elimination half-life (T 1/2 ) ranged from 9.0-16.4 days. PK profile of BAT4406F was generally nonlinear. BAT4406F led to a rapid and significant B-cell depletion in all dose groups. Single dose of BAT4406F administration maintains B lymphocyte at a low level, and the duration of B lymphocyte suppression and depletion depends on the dose. During the observation period, 13 (86.7%) subjects remained relapse free and 2 (13.3%) subjects relapsed. On day 180 postdose, 100 mg, 500 mg, and 750 mg groups had decreased expanded disability status scale (EDSS) scores compared to baseline. Three subjects were antidrug antibody (ADA) positive and all were neutralizing antibody (NAb)-negative. No obvious effects of ADA positivity on PK, safety, pharmacodynamics, or efficacy were observed. In this study, BAT4406F was well tolerated and showed an expected pharmacodynamic effect of significant and long-term depletion of CD19 + B lymphocytes. BAT4406F also demonstrated preliminary evidence of activity as a NMOSD maintenance treatment. Based on this Phase I study, a Phase II/III multicenter, randomized, double-blind, placebo-controlled trial of BAT4406F in Chinese NMOSD patients is currently undergoing ( NCT06044350 ). 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 www.bio-thera.com/en/ or follow us on Twitter ( @bio_thera_sol ) and WeChat (Bio-Thera). 1. QLETLI ® is a registered trademark of Bio-Thera Solutions, Ltd. 2. POBEVCY ® is a registered trademark of Bio-Thera Solutions, Ltd. 3. BETAGRIN ® is a registered trademark of Bio-Thera Solutions, Ltd. 4. Avzivi ® is a registered trademark of Sandoz AG SOURCE: Bio-Thera Solutions