Apraglutide

– Tom McCourt to Retire from CEO Post After 17 Years at Ironwood and Four Decades of Distinguished Industry Leadership Bringing Transformational Medicines to Patients – BOSTON--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases, today announced that its Board of Directors appointed Chief Commercial Officer Tammi Gaskins as Chief Executive Officer and a member of the Board of Directors, effective January 1, 2027. On that date Chief Executive Officer Tom McCourt will retire from his current role and will remain a member of the Board of Directors. “The Board of Directors selected Tammi Gaskins to be Ironwood’s next CEO because she is a proven leader with a deep understanding of the business, culture and late-stage pipeline. Tammi was instrumental in driving the turnaround of LINZESS ® this year, returning it to blockbuster status and growth. She is uniquely positioned to build upon the strong momentum Ironwood has delivered so far in 2026, and to lead the company through its next phase of growth,” said Julie McHugh, Chair of the Ironwood Board of Directors. Tammi has been a leader in Ironwood’s commercial organization since joining the company in 2020 playing a critical role establishing LINZESS as the number one prescribed brand in the U.S. for the treatment of patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). She has also led commercial development efforts for apraglutide, a potential best-in-class, once-weekly GLP-2 analog in Phase 3 development for the treatment of adults with short bowel syndrome with intestinal failure (SBS-IF). Prior to joining Ironwood, Tammi held commercial leadership roles of increasing responsibilities during a 20-year tenure at AstraZeneca. “It is an honor to be named Ironwood’s next CEO, and I would like to thank Tom and the Board of Directors for their leadership and support,” said Gaskins. “I am excited to continue working with our talented team to bring innovation to patients living with GI and rare diseases. This has been a turnaround year for Ironwood as we have worked to maximize the value of LINZESS and strengthen our balance sheet while advancing the confirmatory STARS-2 clinical trial of apraglutide in SBS-IF. With each step we are shaping Ironwood for the future, working to bring treatment advancements to patients and creating value for shareholders. I look forward to helping Ironwood continue to grow as we extend this momentum into 2027 and beyond.” “The Board would like to thank Tom for his steady leadership over the last 17 years. From the first approval and launch of LINZESS to the acquisition of VectivBio and progress of the apraglutide program, Tom has made an indelible mark on Ironwood. We wish him well in his retirement and look forward to continuing our collaboration with him on the Board,” said McHugh. Tom joined Ironwood as its first Chief Commercial Officer helping to shape the clinical pro LINZESS to enable its commercial success. Building the commercial organization from the ground up, Tom and the team collaborated closely with multiple LINZESS partners over the years to grow it into a blockbuster brand. After becoming CEO in 2021, he led the effort to acquire VectivBio bringing apraglutide to Ironwood’s late-stage pipeline. Before Ironwood, Tom made significant contributions to the commercial and drug development efforts for several market-leading brands at Merck, Astra Merck, AstraZeneca, Novartis and Amgen. “Working with Tammi closely for several years, I’ve seen first-hand the impact of her business acumen, her passion for Ironwood’s culture and, most importantly, her relentless commitment to bringing better GI medicines to patients. I have every confidence that she will be a strong successor to lead Ironwood into the future,” said McCourt. “I’m grateful for the honor of leading this company, for all of the Ironwood colleagues who shared this journey with me, and for the differences in patients’ lives we have made by working together.” About Ironwood Pharmaceuticals Ironwood Pharmaceuticals (Nasdaq: IRWD) is a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases. Ironwood is advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for short bowel syndrome patients who are dependent on parenteral support. In addition, Ironwood has been a pioneer in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for the treatment of irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Building upon our history of innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of diseases and address significant unmet needs. Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, with a site in Basel, Switzerland. We routinely post information that may be important to investors on our website at . In addition, follow us on X and on LinkedIn . About LINZESS (Linaclotide) LINZESS ® is the #1 prescribed brand in the U.S. for the treatment of patients with irritable bowel syndrome with constipation (“IBS-C”) or chronic idiopathic constipation (“CIC”), based on IQVIA data. LINZESS is a once-daily capsule that helps relieve the abdominal pain and constipation associated with IBS-C in adults and pediatric patients 7 years of age and older. LINZESS has also been shown to relieve constipation, infrequent stools, hard stools, straining and incomplete evacuation associated with CIC in adult patients. LINZESS relieves constipation in children and adolescents aged 2 to 17 years with functional constipation. LINZESS is not a laxative; it is the first medicine approved by the FDA in a class called GC-C agonists. LINZESS contains a peptide called linaclotide that activates the GC-C receptor in the intestine. Activation of GC-C is thought to result in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established. In the United States, Ironwood and AbbVie co-develop and co-commercialize LINZESS for the treatment of IBS-C in adults and pediatric patients 7 years of age and older, CIC in adults and functional constipation (FC) in pediatric patients 2 years of age and older. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood’s partner, Astellas, markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C or CIC. Ironwood also has partnered with Grand Life Sciences for development and commercialization of LINZESS in China, and with AbbVie for development and commercialization of linaclotide in all other territories worldwide. LINZESS Important Safety Information INDICATIONS AND USAGE LINZESS® (linaclotide) is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older, chronic idiopathic constipation (CIC) in adults, and functional constipation (FC) in pediatric patients 2 years of age and older. IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE LINZESS is contraindicated in patients less than 2 years of age; in nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. Contraindications LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration. LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Warnings and Precautions Risk of Serious Dehydration in Pediatric Patients Less Than 2 Years of Age LINZESS is contraindicated in patients less than 2 years of age. In neonatal mice, linaclotide increased fluid secretion as a consequence of age-dependent elevated guanylate cyclase (GC-C) agonism, which was associated with increased mortality within the first 24 hours due to dehydration. There was no age-dependent trend in GC-C intestinal expression in a clinical study of children 2 to less than 18 years of age; however, there are insufficient data available on GC-C intestinal expression in children less than 2 years of age to assess the risk of developing diarrhea and its potentially serious consequences in these patients. Diarrhea In adults, diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of adult patients with IBS-C or CIC treated with LINZESS 145 mcg or 290 mcg once daily, and in <1% of adult patients with CIC treated with LINZESS 72 mcg once daily. In pediatric patients, diarrhea was also the most common adverse reaction in clinical trials of patients 7 to 17 years of age with IBS-C and 6 to 17 years of age with FC treated with LINZESS. In two double-blind trials, diarrhea was reported in 4% of pediatric patients 6 to 17 years of age with FC treated with LINZESS 72 mcg once daily, and 7% and 8% of pediatric patients 7 to 17 years of age with IBS-C treated with LINZESS 145 mcg and 290 mcg once daily, respectively. In clinical trials, severe diarrhea was reported in one pediatric patient with FC treated with LINZESS 72 mcg once daily and in one pediatric patient with IBS-C treated with LINZESS at a dose higher than the recommended 145 mcg once daily dosage for IBS-C. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated. Common Adverse Reactions (incidence ≥2% and greater than placebo) In adult patients with IBS-C or CIC: diarrhea, abdominal pain, flatulence and abdominal distension. In pediatric patients 7 to 17 years of age with IBS-C and 6 to 17 years of age with FC: diarrhea. Please see full Prescribing Information including Boxed Warning: LINZESS® and CONSTELLA® are registered trademarks of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release are the property of their respective owners. All rights reserved. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about Ironwood’s ability to execute on its mission; Ironwood’s strategy, business, financial position and operations; Ironwood’s ability to drive growth and profitability; the commercial potential of LINZESS; the leadership transition, including its planned effective date and the anticipated benefits of the transition; and the potential of apraglutide to become a best-in-class treatment for adults with SBS-IF. These forward-looking statements speak only as of the date of this press release, and Ironwood undertakes no obligation to update these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Applicable risks and uncertainties include those related to the effectiveness of development and commercialization efforts by us and our partners; preclinical and clinical development, manufacturing and formulation development of linaclotide, apraglutide, and our other product candidates; the risk of uncertainty relating to pricing and reimbursement policies in the U.S., which, if not favorable for our products, could hinder or prevent our products’ commercial success; the risk that clinical programs and studies, including for apraglutide, may not progress or develop as anticipated, including that studies are delayed or discontinued for any reason, such as safety, tolerability, enrollment, manufacturing, economic or other reasons; the risk that findings from our completed nonclinical studies and clinical trials may not be replicated in later trials and earlier-stage clinical trials may not be predictive of the results we may obtain in later-stage clinical trials or of the likelihood of regulatory approval; the risk that apraglutide will not be approved by the FDA or other regulatory agencies; the risk of competition or that new products may emerge that provide different or better alternatives for treatment of the conditions that our products are approved to treat; the risk that healthcare reform and other governmental and private payor initiatives may have an adverse effect upon or prevent our products’ or product candidates’ commercial success; the efficacy, safety and tolerability of linaclotide and our product candidates; the risk that the commercial and therapeutic opportunities for LINZESS, apraglutide or our other product candidates are not as we expect; decisions by regulatory and judicial authorities; the risk we may never get additional patent protection for linaclotide, apraglutide and other product candidates, that patents for linaclotide, apraglutide or other products may not provide adequate protection from competition, or that we are not able to successfully protect such patents; the risk that we are unable to manage our expenses or cash use, or are unable to commercialize our products as expected; the risk that the development of apraglutide is not successful or that any of our product candidates does not receive regulatory approval or is not successfully commercialized; outcomes in legal proceedings to protect or enforce the patents relating to our products and product candidates, including abbreviated new drug application litigation; the risk that financial and operating results may differ from our projections; developments in the intellectual property landscape; challenges from and rights of competitors or potential competitors; the risk that our planned investments do not have the anticipated effect on our company revenues; developments in accounting guidance or practice; Ironwood’s or AbbVie’s accounting practices, including reporting and settlement practices as between Ironwood and AbbVie; the risk that our indebtedness could adversely affect our financial condition or restrict our future operations; and the risks listed under the heading “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2025, and in our subsequent Securities and Exchange Commission filings. Contacts Investors and Media: Chris Stamm Vice President, Investor Relations and Communications cstamm@ironwoodpharma.com Investors: Precision AQ Stephanie Ascher Stephanie.Ascher@precisionaq.com

2026年9月23-24日，由中国生化制药工业协会主办、创志科技（江苏）股份有限公司与创志生命科技（江苏）有限公司联合主办的“重组蛋白药物分会场”在江苏南京顺利召开。该分会场设置专家报告环节，旨在为参会者打造全方位了解重组蛋白药物最新研究成果及行业动态的交流平台。众多在此领域极具影响力的专家学者和企业家受邀出席，围绕重组蛋白药物的研发热点、质量控制、工艺开发、适应症拓展、临床验证及市场现状等关键议题，共呈现 20 余场精彩报告。 分会场致辞 温州医科大学科技处处长、中生药协重组药物专业委员会副主任委员王晓杰在致辞中指出，重组蛋白药物是生物药产业的重要基石，从胰岛素、干扰素、生长激素，到凝血因子、重组人白蛋白和各类细胞因子，重组蛋白技术不断把“实验室里的科学发现”变成“临床上用得上的治疗药物”。她表示近年来表达系统不断拓展，下游工艺走向连续化、数字化、智能化，质量研究走向可表征、可控制、可追溯，产业边界也在与ADC、疫苗、细胞基因治疗、AI制药深度融合。但她也指出，重组蛋白药物仍面临高难度品种表达量低、翻译后修饰复杂、高端纯化介质和核心装备依赖进口、出海注册和商业化能力仍需锤炼等挑战。本次分会场把“科学前沿—工艺装备—质量监管—产业转化”放在同一张议程里，紧扣政策、贴合产业、聚焦实战。 创志科技（江苏）股份有限公司副总经理徐兵在致辞中指出，重组蛋白是生物药产业的源头与根基，生长激素、胰岛素以及当前热门的单抗、双抗、ADC、罕见病蛋白药物，底层均依托重组蛋白技术。9月18日国家发布的医药工业发展“十五五”规划，专门将重组蛋白、抗体类药物列为重点扶持赛道，并明确提出补齐高端生物装备、高密度培养、连续纯化、智能制造的产业短板。这意味着未来五年，重组蛋白不仅是科研热点，更是国家重点布局、必须实现自主可控的核心产业。本次分会场紧扣政策、贴合产业、聚焦实战，开设得非常及时且富有价值。 分会场报告 顾宁 中国科学院院士、南京大学医学院教授 报告题目：基于磁性微纳材料的医药新技术探索 顾宁院士指出在纳米材料、药物、器件与仪器、信息技术等多学科交叉支撑下，血管纳米技术有望成为未来实现血管疾病精准诊疗的重要路径。顾院士系统介绍了高性能磁性微纳材料及仪器的研发进展，以及其在医学先进诊疗技术中的应用探索，重点分享了磁性纳米材料在疾病诊断、治疗及药物递送方面的最新研究成果，为重组蛋白药物的新剂型开发与精准诊疗提供了新思路。 主持人：邢新会 清华大学深圳国际研究生院生物医药与健康工程研究院主持工作副院长、中生药协重组药物专业委员会副主任委员 华子春 南京大学生命科学学院教授、江苏省重组蛋白质制造工程实验室主任、河南医药大学学术副校长 报告题目：基于蛋白A的抗体纯化技术：过去、现在与趋势 华子春教授指出蛋白A亲和层析是抗体纯化的核心步骤，一步即可达到90%以上纯度、去除98%以上杂质，是抗体捕获的“唯一选择”。华教授表示天然蛋白A存在空间位阻大、碱清洗易脱落等局限，工程化改造需围绕微型化、提高碱稳定性、提高洗脱pH等方向展开。他还表示，全球蛋白A专利的竞争焦点已从“能不能结合抗体”转向“能不能形成稳定、耐清洗、低泄漏、可长期工业使用的蛋白A纯化介质”。针对传统改造中多性能指标相互制约、试错周期长的核心挑战，华教授重点介绍了AI驱动的蛋白A工程化改造新范式，通过数据驱动、AI序列生成与多维度预测筛选，兼顾多个关键性能优化，大幅减少实验试错成本，加速高性能蛋白A的获取。 杨代常 武汉禾元生物科技股份有限公司董事长兼首席科学家、中生药协血浆蛋白专业委员会副主任委员 报告题目：水稻生物制造技术平台与重组蛋白药物拓展 杨代常董事长指出现有重组蛋白表达体系各有局限，植物分子医药技术历经数十年发展，已有多个产品进入临床或获批上市。杨总表示水稻胚乳是理想的生物制造体系，具有免疫原性低、纯化工艺简单、可大规模种植等优势，光合作用可取代人体献血与高能耗发酵。他重点介绍了水稻胚乳细胞蛋白质表达平台（OryzHiExp）等四大核心技术平台，通过基因编辑、人工启动子及ER应激缓解等策略，表达量已提升至40-50 g/kg糙米。杨总表示奥福民®重组人白蛋白注射液（水稻）已于2025年7月获批上市，分子结构与人白蛋白完全一致，纯度达99.9999%，杜绝血源性疾病风险，有望将我国从人血白蛋白最大进口国变为出口国。 王晓杰 温州医科大学科技处处长、中生药协重组药物专业委员会副主任委员 报告题目：细胞生长因子与眼疾病 王晓杰教授表示人体内含有100多种细胞生长因子，是再生、代谢等生命活动的“执行者”，FGFs/FGFRs在眼球中广泛表达，与眼发育和眼疾病演进密切相关。王教授指出眼科药物已成为投资蓝海，预计到2030年中国眼科药物市场规模将突破1000亿元。重点介绍了院士团队开发的FGF2滴眼剂已成为临床角膜溃疡修复的首选药，以及温州医科大学第一个一类新药临床批文KGF-2滴眼液的研发进展。王教授还表示，J002滴眼液（FGF10）作为治疗干眼的1类新药已获临床批件，通过促进泪液分泌、眼表细胞修复和改善炎症微环境三重机制治疗干眼，为干眼治疗开辟了新路径。 主持人：黄志锋 温州医科大学二级教授、安徽医科大学学术副校长 中生药协重组药物专业委员会委员 徐兵 创志科技（江苏）股份有限公司副总经理 报告题目：装备如何成为重组蛋白产业化桥梁 徐总在报告中指出全球重组蛋白药物市场已超1700亿美元，年复合增速约8%。报告深入剖析了工艺放大与批次一致性、全链条协同与合规能力不足、复合型人才短缺三大产业化瓶颈，提出全链工艺设备赋能体系。重点介绍了发酵设备、均质机、分离设备等核心装备的技术要点，以及数字化与智能化赋能路径，强调通过装备系统打通产业化最后一公里，助力客户跨越“死亡之谷”。 刘思安 温州医科大学附属眼视光医院，温州医科大学临床大数据研究院博士后 报告题目：人工智能赋能医疗健康和新药开发 刘思安博士指出，医疗AI面临多模态数据整合难、患者隐私保护难、高性价比算力不足等难题，而生成式AI与合成数据为解决数据稀缺和隐私问题提供了新路径。他表示，团队2018年首次在医疗领域应用“预训练-迁移学习AI框架”，实现眼底疾病和肺炎的智能分类；基于CT影像的新冠肺炎AI系统可精准诊断和预测重症，数据集和代码已开源，下载量超350万次。他还介绍了基于视网膜图像筛查全身疾病的系统、MetaGP生成式基础模型及MINIM自改进生成式基础模型，并指出基于常规临床数据的全生命周期生物钟首次在同一框架下同步刻画儿童发育与成人衰老，AI驱动全周期新药研发有望大幅降低成本、缩短周期并提升成功率。 陈炳良 信达生物制药有限公司首席科学家、信达国清院副院长 报告题目：全球生物医药产业的浪潮与中国产业的发展 陈炳良博士的报告围绕全球生物医药产业的浪潮与中国产业的发展展开。陈博士指出生物药和先进疗法掀起了药物开发的技术创新浪潮，生物药市场增速显著高于化学药，CGT、双特异性抗体、ADC等新兴领域增长潜力巨大。他表示细胞治疗、RNA药物、基因治疗、基因编辑药物等新技术蓬勃发展，人工智能有望深刻改变新药研发范式；中国生物药产业的“黄金十年”得益于监管政策、支付体系、资本市场三大改革，创新药出海交易持续攀升。他还介绍了信达生物坚持源头创新的发展实践，公司已成长为拥有最多上市单抗产品的中国药企之一，核心产品惠及众多患者，并积极布局肿瘤与综合产品管线，目标成为国际一流的生物制药公司。 张翀 清华大学化工系教授、探微书院副院长、中生药协重组药物专业委员会委员 报告题目：毕赤酵母底盘细胞基因组精准导航创构 张翀教授指出毕赤酵母是重组蛋白工业生产的重要工业底盘，但其基因组调控网络复杂，高效分泌合成路径的重构长期依赖低效试错，开发周期长、产量提升有限。他提出“基因组导航”策略，通过高通量基因型-表型关联数据的系统生成与精准解析，驱动底盘靶点挖掘与重构。张教授表示其团队依托数字液滴微反应器单细胞分选、全基因组CRISPR混合干扰文库及菌种自动化创制三大技术平台，系统绘制毕赤酵母蛋白分泌相关功能基因图谱，并通过多靶点协同重构实现重组蛋白表达水平的大幅提升。报告还展示了上述技术的实际应用案例，并探讨了基因组导航与人工智能建模融合的未来方向，为工业底盘细胞高效开发提供了新范式。 主持人：华子春 南京大学生命科学学院教授 江苏省重组蛋白质制造工程实验室主任 河南医药大学学术副校长 王征 上海宝济药业股份有限公司总经理 报告题目：IgG降解酶的开发及临床应用 王征总经理指出急重症自身免疫性疾病存在巨大未满足临床需求，急性期组织损伤不可逆，现有疗法无法快速阻断疾病进展。王总表示KJ103作为全球首款低免疫原性IgG降解酶，可在给药后迅速高效裂解循环IgG，重复给药可维持低IgG状态，并可深入组织清除沉积IgG及免疫复合物，是唯一同时覆盖血管内、组织沉积IgG及BCR的方案。他介绍，KJ103提出“三击”治疗策略，作为第一击即时阻断损害，在肾移植脱敏、抗GBM病、吉兰-巴雷综合征、AAV基因治疗等领域均展现显著疗效，首个适应症已报产，多个适应症进入临床II/III期并获突破性疗法认证。 吴息凤 浙江大学数智健康研究院院长 报告题目：数智赋能健康长寿的前沿研究 吴息凤教授在报告中指出慢性病是我国居民首要健康威胁，但管理面临诊疗精准化不足、数据孤岛等问题。她介绍了团队打造的“健康浙江百万人群队列”，融合自然、高危、专病三类人群，实现基因、影像、环境、临床等多模态数据整合。依托队列大数据与AI技术，团队建成多种癌症风险预测模型，搭建多维衰老评估体系，并证实健康生活方式可抵消六成以上短寿基因的负面影响。她还介绍了数智技术在个性化保险风控、5G慢性病管理平台等方面的应用实践，推动健康管理从“以疾病为中心”转向“以健康为中心”。 阳成成 楚天源创生物技术（长沙）有限公司首席产品经理 报告题目：下游纯化设备创新及连续化生产设计 阳成成经理在报告中指出传统超滤设计中泵同时承担切向流动力与过膜压力，导致剪切力大、温升高、能耗大等问题叠加。他表示，增压式超滤通过将“切向流动力”与“过膜压力”解耦，取消PCV阀，从根本上消除节流导致的高剪切、高热量和压力波动，显著降低热功率、温升和能耗，提升TMP控制精度。他还介绍，连续化生产设计可显著促进生物制药规模化产业化，在线配液系统实现多缓冲液配置，连续流层析可节省填料和缓冲液、减少人工、提升产能，基于DCS的整线集成可实现设备、配方和数据的集中管理，助力生物制药实现自动化、数字化、智能化生产。 主持人：曹春阳 中国科学院上海有机化学研究所研究员 中生药协重组药物专业委员会委员 石峰 山东省食品药品检验研究院生物检测室主任、中国生化制药工业协会糖类药物专业委员会委员 报告题目：重组蛋白药物关键质量属性及检验技术研究进展 石峰主任介绍，重组蛋白药物因表达体系与药物类型不同，面临差异化的质量挑战，CQA的关键性取决于其对安全性和有效性的影响。他表示，质谱技术是结构解析的核心工具，在完整质量测定、肽图分析、二硫键连接分析、糖基化位点定位等方面发挥重要作用；CE-MS联用为电荷变异体分析提供了有力手段，但结构归属仍需多层级证据支持。他还介绍了HCP检测的动态范围问题及主成分共价固定的前处理思路，并系统梳理了外源因子检测技术和免疫原性风险评估策略，为重组蛋白药物的质量控制提供了系统性技术方案。 马丽强 智享生物（苏州）股份有限公司制剂研究副总监 报告题目：生物药冻干制剂开发及案例分享 马总表示冻干是一个传质与传热耦合的过程，关键温度和传热传质参数是工艺开发的核心。他表示，基于QbD理念的冻干工艺开发需经过处方及特性分析、初步设计、特性分析、放大确认四个步骤。他还分享了冻干制剂评估、外观“爬壁”、底部轻微萎缩、复溶时间长、装量研究等实际案例，并介绍了喷雾干燥、超临界反溶剂、温敏凝胶等差异化制剂平台的探索，为生物药冻干制剂的开发提供了实用参考。 杜亚楠 清华大学生物医学工程学院副院长 报告题目：微组织工程革新细胞智造和再生医学 杜亚楠教授在报告中指出细胞微环境是影响细胞命运的关键“生态系统”，团队聚焦再生与病理微环境，揭示了细胞外基质异常交联重塑组织生物力学特性、干扰细胞功能的机制，并验证了相关干预方法缓解肝纤维化的潜力。他表示，团队通过微组织工程技术打造了高效的干细胞“超级工厂”，大幅降低空间、人力与时间成本，相关3D微载体和规模化制造工艺赋能国内首款干细胞药品获批上市，实现了我国干细胞药物领域零的突破。他还展望了数据驱动的人工智能技术在细胞制造中的应用前景，为细胞智造和再生医学的智能化发展勾勒了新蓝图。 主持人：惠琦 温州医科大学新药开发中心主任 中生药协重组药物专业委员会委员 主持人：章金刚 原军事医学科学院免疫学教研室主任 野战输血研究所学委会主任 中生药协血浆蛋白专业委员会主任委员 主持人：陆益红 江苏省药品监督检验研究院生物技术药品检验室主任 李盈淳 正大天晴药业集团研究院总监、生物药物开发研究中心负责人 报告题目：注射用重组人凝血因子VIIa-N01的药学开发 李盈淳总监介绍的重组人凝血因子VIIa-N01（安启新®）已于2025年6月获批上市，用于凝血因子VIII或IX抑制物阳性的先天性血友病患者出血治疗。该产品蛋白结构复杂，包含12对二硫键、多种翻译后修饰及多个降解和氧化位点，工艺开发难度大。团队采用CHO细胞高效表达，优化培养工艺获得稳定高效表达产物，创新性采用离子交换层析替代亲和层析，降低了HCP、HCD等工艺杂质，一步获得95%以上纯度；同时优化制剂处方，有效降低原液振摇引发的稳定性风险。他还介绍了安启新®与诺其®全面的头对头质量相似性研究，涵盖Gla修饰、甲硫氨酸氧化、糖基化修饰、唾液酸含量等方面，证明产品安全、有效、质量可控。 翁勤洁 浙江大学药学院副院长，浙江大学台州研究院常务副院长 报告题目：靶向天然免疫的炎症性肠病靶点发现及治疗抗体开发 翁教授指出超过40%的IBD患者对生物制剂原发性无应答，天然免疫在生物制剂疗效不足中发挥重要调控作用。翁教授表示其团队通过单细胞测序发现疗效不足样本中中性粒细胞显著增多，开发了中性粒细胞异质性预测算法Neuspectrum，并预测出靶点X可作为TNF-α单抗药物PNR的潜在干预靶点。他还介绍了基于靶点X设计单抗M02及双特异性抗体B02的研发进展，M02可有效缓解PNR小鼠结肠炎，B02体外活性显著且可逆转小鼠PNR模型结肠炎，为克服生物制剂疗效不足提供了新策略。 刘金毅 北京三元基因药业股份有限公司研发医学总负责人 报告题目：全长人胶原蛋白高效表达与应用 刘总表示全球胶原蛋白市场规模持续增长，重组胶原渗透率快速提升，核心驱动为低致敏性和透皮效率优势。他指出公司采用哺乳动物细胞表达系统，成功研制出全球首个且唯一与人胶原蛋白基因序列100%一致的全长重组胶原蛋白，实现100%三螺旋结构覆盖，具备完整生物整合与生理功能，并利用AlphaFold进行空间结构模拟和AI辅助表达系统改造。他还介绍了该产品在医美填充、软骨修复等领域的广泛应用前景，以及基于胶原蛋白的器官芯片、类器官等组织工程产品布局，展现了从美学修复到组织器官再生的全生态开发潜力。 刘伟 腾讯生命科学实验室AIDD技术负责人 报告题目：腾讯药物AI算法实践 刘伟博士表示腾讯AIDD在CASP14蛋白质结构预测、OC22催化剂挑战赛等国际赛事中取得世界级冠军成果，并构建了覆盖小分子与大分子药物发现的完整技术矩阵。小分子方面涵盖虚拟筛选、活性预测、分子设计优化、耐药性预测、ADMET成药性预测及逆合成路线设计；大分子方面包括抗体结构预测、抗体-抗原复合体预测、亲和力预测、人源化改造及成药性评估。他重点介绍了利用AI结构预测实现低成本抗体虚拟筛选的应用案例，AI方法筛选成功率是ELISA的4-6倍，平均每个hit筛选成本降低42.5%，并展示了抗体人源化改造在2024年Protein Design Competition中取得的优异成绩。 范开 重庆派金生物科技有限公司董事长、总经理，中生药协重组药物专业委员会委员 报告题目：GLP-2多肽治疗肠道疾病的临床价值与研发进展 范开董事长指出GLP-2是由肠道L细胞分泌的多肽激素，通过促进肠上皮增殖、增强屏障功能、改善营养吸收和调节肠道菌群，在肠道修复领域具有重要价值。他表示，GLP-2类似物在短肠综合征、化疗相关性腹泻等适应症中展现出良好前景，其中替度格鲁肽已上市，Apraglutide等长效类似物处于III期临床。他还介绍了新一代长效GLP-2类似物FT1的研发进展，该产品已获SBS和CID临床批件，并探索口服GLP-2类似物及在骨质疏松、抗精神病药物代谢异常、肝病、心血管疾病等肠外疾病中的应用潜力，为GLP-2多肽开辟了更广阔的治疗路径。 杨涛 通化安睿特生物制药股份有限公司常务副总 报告题目：重组人白蛋白注射液质量标准及药效学相关性研究 杨总表示重组人白蛋白在结构上与血浆来源人血白蛋白一致，但酵母表达会引入糖基化修饰，而肝脏新生的“有效白蛋白”是无修饰的单链蛋白，修饰会导致抗氧化、运载和长循环等功能降低。他表示，安睿特以“有效白蛋白”为核心质量要素建立QTPP和HCP标准，研究了各种修饰结构与FcRn亲和力、类酶活性的相关性，并据此建立更严格的质量标准，产品有效白蛋白含量显著高于人血白蛋白。他还介绍，安睿特rHA国内外已完成多项临床研究，III期结果显示疗效非劣于人血白蛋白，安全性良好，产品已在俄罗斯、吉尔吉斯斯坦、白俄罗斯获批上市，中国已进入上市申请阶段，生产基地设计年产量50吨，未来整体年产能将超100吨。 刘龙斌 杰华生物技术（青岛）有限公司创始人、董事长 报告题目：大分子药物的研发思路和开发策略 刘龙斌董事长在报告中指出大分子药物主要包括细胞因子、抗体及其衍生物、多肽类药物，具有作用机制清晰、临床效果确切等特点。他表示蛋白多肽药物通过序列优化等技术持续迭代，在半衰期、给药便利性和疗效方面不断改善，并以溶血栓药物、GLP-1多肽、促红素EPO和抗体药物的迭代历程为例加以说明。他还重点介绍了理性设计与高通量筛选两种主要新药发现技术，以及AI在靶点结构解析、分子对接与虚拟筛选、序列设计与成药性分析中的应用，并分享了杰华生物“三位一体”平台技术及乐复能的研发实践，展望了AI驱动大分子药物研发的未来方向。 王树民 佰诺创睿（温州）生物科技有限公司副董事长兼总经理 报告题目：重组成纤维细胞生长因子类药物工艺开发常见问题分析以及表征策略 王树民博士表示FGF家族高度保守、生物学活性广泛，但作为活性蛋白对温度、剪切力高度敏感，易变性、氧化或聚集失活。王博士表示工艺开发中常面临可溶性表达量低、包涵体复性效率低、澄清难、易聚合等问题，需通过高密度发酵、全程控温、低剪切搅拌等策略加以控制。王博士还系统介绍了基于QbD的工艺表征策略，包括CQA评估、CPP评估、CMA评估、缩小小样模型建立及DOE实验设计等，为生长因子类药物的工艺开发与质量控制提供了系统性方案。 同期展览 大会以会带展，各细分领域龙头企业同台亮相。会场内观点交锋、思想碰撞，会场外项目洽谈与合作交流高效务实。全方位展示生物药产业最新技术、科研成就与产业成果。 ✦ 左右滑动，查看更多 ✦ 最后，特别感谢“重组蛋白药物分会场”联合主办单位创志科技（江苏）股份有限公司与创志生命科技（江苏）有限公司的大力支持！ 同时，感谢江苏汉邦科技股份有限公司、东富龙科技集团股份有限公司、上海乐纯生物技术股份有限公司、沧州四星玻璃股份有限公司、楚天科技股份有限公司，以及各承办单位、协办单位、支持企业对本次大会的支持！ 协会近期活动 2026活动计划 2026 Annual Plan 关于协会： 中国生化制药工业协会（China Biochemical Pharmaceutical Industry Association），是由中华人民共和国原商业部组建（1991），中华人民共和国民政部登记注册。目前拥有单位会员近500余家，由副会长单位、常务理事单位、理事单位和普通会员单位组成。单位会员主要涵盖生化生物药品生产等多种经济类型的骨干企业（集团）及其相关设备、仪器企业。协会成立了由院士、科研院所、大专院校、研究机构及企业技术人才 600多位专家组成的专家库，其中院士专家 40 余位。 党的工作领导机关：中央社会工作部 独立社团法人资格的全国性非营利性行业社团组织，也是国内唯一的生化生物制药工业行业一级协会。 工作联系主要单位：国家药品监督管理局 中英文简称：中生药协 CBPIA 核心分支机构： ◆ 多肽专业委员会（2019年成立） ◆ 糖类药物专业委员会（2020年成立） ◆ 重组药物专业委员会（2023年成立） ◆ 血浆蛋白专业委员会（2025年成立） ◆ 核酸专业委员会（筹备中） ◆ 脂质专业委员会（筹备中） 生化药品概念： 生化药品是指从生物体分离、纯化以及用化学合成、微生物合成或现代技术所得到的用于预防、治疗和诊断疾病的物质。 两个基本特点： ◆ 生物体中的基本生化成分或类似物 ◆ 均具有生物活性或生理功能 生化药品主要来源于生物体的四类基本有机物质： ◆ 蛋白质类药物：主要包括蛋白质、酶、多肽、抗体、氨基酸及其衍生物、重组疫苗、血浆蛋白、先进治疗药品（CGT、干细胞、溶瘤病毒、类器官、外泌体）等； ◆ 糖类药物：主要包括多糖、寡糖、单糖等； ◆ 核酸药物：主要包括核苷、核苷酸、腺苷及其衍生物、反义寡核苷酸（ASO）、小干扰RNA（siRNA）、微小RNA（miRNA）、核酸适配体、mRNA等； ◆ 脂质药物：油脂（油、脂肪）和类脂（磷脂、固醇类）总称，主要包括不饱和脂肪酸、多烯酸乙酯、磷脂、胆固醇、胆酸、挥发油、天然色素及辅酶等。 入会咨询： 固定电话：010-67046276 电子邮箱：chinabpiahyb@163.com