Golimumab

GUANGZHOU, China and HYDERABAD, India, March 27, 2025 /PRNewswire/ -- Bio-Thera Solutions (688177:SH; "Bio-Thera"), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY| NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as "Dr. Reddy's"), announce today they have reached commercialization and license agreements for BAT2206, a proposed Stelara® biosimilar, and BAT2506, a proposed Simponi® biosimilar. Continue Reading Bio-Thera and Dr. Reddy’s Execute Exclusive Commercialization Agreement for BAT2206, a Proposed Stelara® Biosimilar, and BAT2506, a Proposed Simponi® Biosimilar, for Southeast Asia Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206 and BAT2506. Dr. Reddy's will be responsible for seeking regulatory approvals as well as commercialization in the licensed territories in Southeast Asia, including Cambodia, Indonesia, Malaysia, Philippines, Thailand, Vietnam. In addition, Dr. Reddy's will also receive the exclusive commercial rights to BAT2206 in Colombia. "This is our first partnership focused solely on Southeast Asia and Dr. Reddy's is the perfect partner to help bring BAT2206 and BAT2506 to patients in the region", said Dr. Shengfeng Li, CEO of Bio-Thera. "Bio-Thera believes in the health and welfare of patients around the world and this collaboration with Dr. Reddy's demonstrates our commitment to the patients in Southeast Asia." M.V. Ramana, CEO – Branded Markets (India & Emerging Markets), Dr. Reddy's, said: "Our partnership with Bio-Thera enables us to further expand our biosimilars offerings in the emerging markets. With our well-established commercial strengths in these markets, we look forward to addressing the unmet needs of patients with access to affordable medicines." About BAT2206 (ustekinumab) BAT2206 is a proposed biosimilar to Jansen'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. In the EU, Stelara® is currently approved for the treatment of 1) moderate to severe plaque psoriasis in adults and children above the age of 6 years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, 2) active psoriatic arthritis, alone or combined with methotrexate, in adults, when the condition has not improved enough with other treatments called disease-modifying anti-rheumatic drugs (DMARDs), 3) moderately to severely active Crohn's disease in adults whose condition has not improved enough with other treatments for Crohn's disease or who cannot receive such treatments, 4) moderately to severely active ulcerative colitis in adults whose condition has not improved enough with other treatments for ulcerative colitis or who cannot receive such treatments. About BAT2 5 06 ( 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. 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 antibody-drug conjugates (ADCs). For more information, please visit or follow us on X ( @bio_thera_sol) and WeChat (Bio-Thera). About Dr. Reddy's: Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of 'Good Health Can't Wait', we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: . Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management's current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers', products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2024. The company assumes no obligation to update any information contained herein. Bio-Thera Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to BAT2206, 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. Stelara® and Simponi® is a registered trademark of Johnson & Johnson QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. TOFIDENCETM is a trademark of Biogen MA Inc. Avzivi® is a registered trademark of Sandoz AG POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. For further information: Bio-Thera Contact: Bert E. Thomas IV Phone: +1.410.627.1734 Email: [email protected] Dr. Reddy's Contacts: Usha Iyer Head of Corporate Communications [email protected] Richa Periwal Head of Investor Relations [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

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”。公司今日宣布已与Dr. Reddy’s就BAT2206（一款参照喜达诺®乌司奴单抗开发的生物类似药）和BAT2506（一款参照欣普尼®戈利木单抗开发的生物类似药）签署在东南亚市场的授权许可及商业化协议。 根据协议条款，Dr. Reddy’s拥有BAT2206和BAT2506在柬埔寨、印度尼西亚、马来西亚、菲律宾、泰国等东南亚市场的独家分销权及销售权，并负责BAT2206和BAT2506在这些国家的注册及商业化销售。此外，Dr. Reddy’s也将拥有BAT2206在哥伦比亚市场的独家的商业化权利；百奥泰将负责BAT2206和BAT2506的研发、生产以及商业化供应。目前，BAT2206上市许可申请在中国NMPA、美国FDA以及欧洲EMA审评中。BAT2506上市许可申请也正在中国NMPA以及欧洲EMA的审评中。 Dr. Reddy’s CEO，M.V. Ramana表示：“此次与百奥泰合作将进一步扩大我们生物类似药在新兴市场的布局。我们在新兴市场已有成熟的商业化网络，期待为患者提供可负担的优质药物以满足尚未被满足的医疗需求。” 百奥泰创始人及总经理李胜峰博士表示：“公司非常重视东南亚等新兴市场的开拓，我们相信公司与Dr. Reddy’s 就BAT2206和BAT2506的合作将加速公司产品进入全球新兴市场，惠及全球更多患者， 进一步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BAT2506 BAT2506注射液是百奥泰根据中国NMPA、美国FDA、欧洲EMA生物类似药相关指导原则开发的戈利木单抗生物类似药。戈利木单抗是靶向TNF-α的抗体，能够以高亲和力特异性地结合可溶性及跨膜的人TNF-α，阻断TNF-α与其受体TNFR结合，从而抑制TNF-α的活性。 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（欧美商品名：TOFIDENCE®）和贝伐珠单抗（欧美商品名：Avzivi®）已在中美欧三个全球主要市场获批上市。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）。 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. TOFIDENCE®是渤健的注册商标 6. Avzivi®是山德士的注册商标 7. 欣普尼®是强生公司的注册商标 8. 喜达诺®是强生公司的注册商标 关于Dr. Reddy's Dr. Reddy’s Laboratories Ltd.（BSE: 500124，NSE: DRREDDY，NYSE: RDY，NSEIFSC: DRREDDY）是一家总部位于印度海德拉巴的全球性制药企业。公司创立于1984年，始终致力于提供可负担的创新药物。秉持"健康不容等待"的理念，我们提供包括原料药、仿制药、品牌仿制药、生物类似药和非处方药在内的多元化产品组合。重点治疗领域涵盖消化系统、心血管、糖尿病、肿瘤、疼痛管理和皮肤科。主要市场包括美国、印度、俄罗斯及独联体国家、中国、巴西和欧洲。作为一家凭借深厚科研积淀屡创行业先河的企业，我们持续前瞻布局，投资前瞻性业务。作为可持续发展与ESG实践的先行者，我们早在2004年就发布了首份可持续发展报告。当前，我们的ESG目标致力于在以下领域树立行业标杆：环境管理、患者用药可及性与可负担性、多元共融以及企业治理。更多信息，请访问www.drreddys.com. 百奥泰前瞻性声明 本新闻稿包含了BAT2206、BAT2506或百奥泰及其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。 Dr. Reddy's免责声明 本新闻稿可能包含前瞻性陈述，这些陈述基于管理层当前的观点和假设，涉及已知或未知的风险和不确定性，可能导致实际结果、业绩或事件与陈述明示或暗示的内容存在重大差异。除上下文明确表明前瞻性的表述外，词语"可能"、"将"、"应"、"预期"、"计划"、"打算"、"预计"、"相信"、"估计"、"预测"、"潜在"或"继续"及类似表述均属前瞻性陈述标识。实际结果、业绩或事件可能因以下因素（包括但不限于）与陈述产生重大差异：(i) 宏观经济环境，如金融市场表现、信用违约、汇率、利率、续保率及承保损失事件发生频率/严重程度；(ii) 死亡率与发病率水平及趋势变化；(iii) 竞争程度变化及一般竞争因素；(iv) 法律法规及央行/政府政策变动；(v) 收购或重组影响（含相关整合问题）；(vi) 因自然灾害、流行病（包括冠状病毒/COVID-19）等广泛疫情导致本行业及客户产品服务所处市场的经济下行风险；(vii) 美国证监会公开备案文件中载明的其他风险与不确定性（包括截至2024年3月31日的20-F年报"风险因素"和"前瞻性陈述"章节所列内容）。公司无义务更新本文所含任何信息。