Bupivacaine/Meloxicam

Ventoux Bio July 22, 2026 Dupuytren's Information, Events We have now studied VEN-201 in human Dupuytren’s tissue from several individual donors, and the early results are genuinely encouraging. Across these samples, VEN-201 has shown consistent signs of acting on the biological processes that drive the disease, exactly the direction we hoped to see. What gives us particular confidence is that consistency. Seeing the same direction of effect across tissue from different people, despite the natural variation from one person to the next, is an important early signal that we may be engaging the true drivers of the disease rather than seeing a one-off result. It is still early, and there is real work ahead before this reaches patients, but this is the kind of human-anchored evidence that strengthens our conviction and helps open doors with research and funding partners. Out of respect for the scientific process, we are sharing these findings at a high level for now, with more detail to follow as the work matures. Our focus now is to build on these findings: studying additional donor tissue to further test what we are seeing, deepening our understanding of how VEN-201 works, and advancing the preparation needed to move toward a first clinical study. Each of these steps brings us closer to testing VEN-201 in patients, and each one depends on continued support. This is the question closest to my own heart and the one I receive the most from fellow patients. Our current estimate is roughly 18 months to a first clinical study, and reaching that milestone depends heavily on funding. Here is the honest part. Dupuytren’s affects millions of people, yet it has long been underfunded for how common and life-altering it is, and today’s climate is especially hard for early-stage research. Many investors now wait to commit until a therapy is already being tested in humans, which leaves promising pre-clinical programs like ours in a real gap. We are pushing hard to reach that in-human stage, and it is truly within sight. That final stretch is where community support matters most. Any and all help, whether you run with me, donate, or invest, moves us from promising science into the clinic and closer to the day patients can join a study. There are three ways to be part of this, whichever fits you best: Run with Me. This October I am running the 25k at the Lake Hodges Trail Festival in San Diego and I would love for you to join our team and run with me. Our team name is the Dupuytren’s & Ledderhose Run Collective, more info below. Donate. If you would rather cheer from the sidelines (near or far), every dollar donated does directly to our Dupuytren’s research at Ventoux Biosciences. Please donate and / or share with fellow patients impacted by this disease. Invest. We have a crowdfunding campaign now open and anyone can invest. WeFunder is a regulated investment crowdfunding platform where everyday investors can invest in Ventoux and receive equity, an ownership stake in the company, rather than making a donation. Investment minimum is $100. Company News Dupuytren's Information Events Johnny Randel is a senior finance executive who has more than 30 years of experience in financial institutions including over 17 in private equity. Mr. Randel recently retired as the Chief Financial Officer (“CFO”) of StepStone Group. Inc (Nasdaq: STEP), a global private markets specialist firm delivering tailored investment solutions, advisory services, and impactful, data-driven insights to the world’s investors with $678B of capital responsibility. Mr. Randel spent over 13 years leading the corporate and investment finance and accounting teams and was the CFO for the lead up and execution of the company’s initial public offering in 2020. Previously, Mr. Randel held the role of Chief Financial Officer and Chief Operating Officer at Citigroup Private Equity overseeing financial and operational activities for the company and its coinvestment, mezzanine, and fund of fund investment programs. Mr. Randel also held a previous role as Assistant Treasurer within Citigroup Inc.’s Treasury department where he managed rating agency relationships and fixed income client relations. Mr. Randel also held various finance roles supporting corporate finance and strategy over the course of his career. Mr. Randel received his B.G.S. from the University of Kansas and MBA from the University of Southern California. Mr. Cravets is an industry leader in biostatistics with extensive experience in program design and analysis. He currently serves as the Senior Vice President of Biometrics at Gossamer Bio. Prior to joining Gossamer Bio, Mr. Cravets was Vice President of Biometrics at Heron Therapeutics Inc. from 2016 to 2018, where he played a key role in the late-stage development programs for Zynrelef for the treatment post-surgical pain and Cinvanti for the prevention of chemotherapy induced nausea and vomiting. Before joining Heron, Mr. Cravets was Executive Director of Biometrics at Receptos Inc. from 2014 to 2016, where he built the biostatistics and data management functions while contributing to mid- and late-stage development programs for ozanimod (Zeposia) in multiple sclerosis (MS) and inflammatory bowel diseases (IBD). Before joining Receptos, Mr. Cravets was the head of biostatistics at Ardea Biosciences from 2011-2014, building the biostatistics function while also making significant contributions to the designs and analyses of late-stage studies of lesinurad (Zurampic) for the treatment of gout. From 2003-2011 Mr. Cravets served in roles of increasing responsibility in the biostatistics group at Biogen Idec Inc., contributing to the successful regulatory approvals of rituximab (Rituxan) in both rheumatoid arthritis (RA) and chronic lymphocytic leukemia (CLL). From 1996 to 2003, Mr. Cravets was in the biostatistics group at Amgen, Inc., working on multiple products across various neurology, rheumatology, cardiovascular, and bone disease indications. Mr. Cravets began his career in the pharmaceutical products division of Abbott Laboratories in 1994 after completing his master’s degree in statistics at the University of Michigan and his bachelor’s degree in mathematics at UCLA. Dr. Satish is a trained biotechnologist with several years of experience in cell and molecular biology. Dr. Satish’s interest has been in skin research with a special focus on skin inflammation, infection, and fibrosis. The other arm of Dr. Satish’s research has been to study the molecular determinants of palmar fascial disease, Dupuytren’s contracture. Her long-term interest has been to develop therapeutic agents to help alleviate the pain and distress of patients with Dupuytren’s. Her studies on Dupuytren’s disease were funded by a private donor, which moved the research forward to study this disease in an animal model, which was not feasible earlier. Dr. Satish’s research on Dupuytren has identified small molecules that can be used as a target to intervene with the progression and development of the disease. Dr. Satish received her Ph.D. from a prestigious institute in India and did her post-doctoral training at the University of Pittsburgh. Currently, Dr. Satish serves as a faculty at the Division of Asthma Research, Cincinnati Children’s Hospital; named as the top hospital in the US. At Cincinnati Children’s, Dr. Satish researches Atopic Dermatitis, a chronic inflammatory skin disease affecting children and adults. Dr. Satish has published over 50 articles in peer-reviewed journals, review articles and book chapters. Dr. Denkler is an accomplished, board certified plastic surgeon with expertise in aesthetic and reconstructive surgery. Dr. Denkler is a clinical professor of plastic surgery at UCSF and has a private practice in Marin County. He is internationally renowned for his use of multiple approaches in treating the debilitating and disabling effects of palmar fibromatosis (Dupuytren disease). Dr. Denkler is an expert in needle aponeurotomy (NA), a minimally invasive procedure that uses subcutaneous needles to release the contracture as well as use of subcutaneous injection of collagenase. He has treated over 10,000 Dupuytren’s fingers, authored >35 publications and book chapters, presented internationally and domestically and is often cited for expert opinion in national and international news discussing Dupuytren’s. HIs pioneering investigational work documenting the safety of epinephrine with local anesthesia contributed to the origination of “wide-awake hand surgery”. Dr. Denkler trained at prestigious medical institutions in the United States and Europe. He attended Baylor College of Medicine in Houston, Texas, followed by residency training in plastic and reconstructive surgery with the Cronin, Bauer, and Biggs group, also in Houston. Additionally, Dr. Denkler completed a hand surgery fellowship with Dr. Eugene Kilgore in San Francisco and one year of fellowship training in craniofacial surgery with Dr. Paul Tessier in Paris, France. Daiva Bajorunas MD is an endocrinologist with more than 25 years of experience in the biopharmaceutical industry. She has a strong interest in advancing therapeutic options for conditions of significant unmet medical need. For the past decade, Daiva has been engaged as a consultant to the pharmaceutical industry, currently as Founder and Principal, DBMD Consulting, and previously as Chief Medical Officer / Chief Scientific Officer for Vault Bioventures. She has provided her expertise to enhance large, mid-size and small pharmaceutical company product development, clinical/regulatory, and life cycle strategies for both drugs and devices, including oral, transdermal, injectable and inhalative delivery systems, working across multiple therapeutic areas and geographies. She has considerable experience chairing Data Safety Monitoring Boards. In the past she held various R&D positions of increasing responsibility at Rhone-Poulenc Rorer, BMS, Aventis (acquired by Sanofi), and Kos Pharmaceuticals (acquired by Abbott). Before she joined industry, she held academic appointments at Memorial Sloan-Kettering Cancer Center and Cornell University Medical College (CUMC), and was Director of Clinical Care, Endocrinology Service, Memorial Hospital (MH), New York, NY. Daiva received her MD degree at the University of Michigan Medical School, did her residency training at St. Vincent’s Hospital & Medical Center in NY, her metabolism fellowship at Stanford University Medical Center, CA and her endocrinology fellowship at MH/CUMC, NY.

首个缓释溶液通用名2026年7月3日，中国生物制药（01177.HK）发布自愿公告，其附属公司北京泰德制药自主研发的国家2.2类新药——盐酸罗哌卡因缓释溶液，已正式向CDE递交新药上市申请并获得受理，用于成人术后长效镇痛。从2024年IND到2026年NDA，短短两年时间，泰德制药以惊人的研发速度，将这款全球首创的罗哌卡因长效镇痛新药推向了上市门槛。 一、何为“切口内涂布给药”？一次给药，72小时持续镇痛 术后疼痛管理，长期面临一个核心矛盾：单次局麻药镇痛时间太短（通常仅6-8小时），而术后疼痛高峰期可持续72小时。临床上常需反复给药或借助镇痛泵，不仅增加医护工作量，也带来全身暴露量升高、阿片类药物依赖等风险。 盐酸罗哌卡因缓释溶液（研发代号：TRD303）正是针对这一临床痛点而生。该产品依托泰德制药自主知识产权的脂质靶向注射剂技术平台开发而成。其核心机制在于：药物在给药部位接触体液后发生相变，原位形成药物储库，从而实现长达72小时的持续缓慢释药。 在给药方式上，该产品采用创新的切口内涂布给药方案——于伤口缝合前涂布给药，操作简便，可有效缩短医护操作时间。与多点浸润的传统给药方式相比，这一方案可显著降低全身暴露量，安全性优势突出。 国外参考药品为Heron公司的Zynrelef(布比卡因和美洛昔康)缓释溶液。2025年销售3800万美元，增长49% 二、全球首创，何以“首创”？ 放眼全球，术后长效局麻药领域并非空白。恒瑞医药的布比卡因脂质体注射液（商品名：艾恒平）已于2022年底在中国获批上市，是国内首个超长效局麻药，同样可实现72小时镇痛。2025年销售7亿元。 年售7亿，恒瑞布比卡因脂质体放量超预期 但泰德这款产品的“首创”在于两个维度： 其一，活性成分的选择。 盐酸罗哌卡因是首个纯左旋体长效酰胺类局麻药物，与同为酰胺类的布比卡因相比，心脏毒性更低、运动与感觉阻滞分离效应更显著。这意味着在同等镇痛效果下，罗哌卡因对患者心血管系统的安全性更高，且更倾向于阻滞感觉神经（镇痛）而保留运动功能，对术后早期下床活动更为友好。 其二，剂型与给药路径的创新。 布比卡因脂质体采用DepoFoam多囊脂质体技术；而泰德的产品依托脂质靶向注射剂技术平台，采用切口内涂布这一全新给药路径。从剂型上看，该产品为涂剂（规格10mL:320mg），而非传统注射液。这一“涂布”而非“注射”的方案，既是技术创新，也是临床便利性的重大提升。 因此，“全球首款采用切口内涂布给药的罗哌卡因长效镇痛新药”这一称号，恰如其分。 三、两年从IND到NDA，泰德的“速度与激情” 从研发历程来看，泰德制药在这款产品上的推进速度堪称惊人： 2024年4月22日，盐酸罗哌卡因缓释溶液首次提交IND申请（受理号CXHL2400407），于2024年7月5日获批临床。 2024年至2025年，密集开展临床试验。据药智数据显示，TRD303溶液共登记了6项临床试验： I期（CTR20242831）：体表肿物切除术术后镇痛，入组75例，已完成； II期（CTR20244973、CTR20244966）：腹部手术与髋关节置换术后镇痛，各入组144例，已完成； III期（CTR20254316、CTR20253306）：腹部手术入组333例、髋关节置换术入组315例，均已完成。 2025年10月至2026年3月，多次提交补充申请（CXHB2500289、CXHB2600090、CXHB2600091），均快速获批临床。 2026年7月3日，正式提交NDA并获得受理（受理号CXHS2600094-CXHS2600097）。 从首次IND到NDA受理，全程仅约26个月。这一速度在2.2类改良型新药中堪称高效，背后是泰德制药在长效镇痛制剂领域深厚的技术积累与高效的临床执行力。 超越合作伙伴南京清普改良新药QP001（美洛昔康注射液Ⅱ）32个月的最快纪录（2021.1-2023.9），中国生物制药学到真招了，青出于蓝而胜于蓝 中国生物制药交易一项镇痛改良制剂 尤其值得关注的是，两项III期临床试验合计入组648例患者，规模之大在术后镇痛领域并不多见。大样本量不仅为审评提供了充分的统计学支撑，也反映出泰德对该产品临床价值的充分信心。四、疗效显著优于阳性对照，数据说话 中国生物制药公告披露，两项关键III期注册临床研究结果显示： 在单侧髋关节置换术（躯体疼痛模型）与腹部手术（躯体/内脏混合型疼痛模型）中，单次给药即可实现长达72小时的持续镇痛； 显著减少患者补救镇痛药物的使用剂量与频次； 镇痛疗效显著优于阳性对照药； 总体安全性良好。 药代动力学研究进一步显示，该药物具有吸收延迟、血药峰浓度更低、峰浓度平台期更长、全身暴露量更低且消除过程平缓的缓释特征。这些特征从药代动力学角度印证了其在延长镇痛时长、提升安全性与改善用药依从性方面的临床价值。 五、镇痛版图再下一城 在镇痛领域，中国生物制药已形成层次清晰的布局： 已上市品种：得百安等成熟产品构筑了坚实的商业化基础； 本次申报的盐酸罗哌卡因缓释溶液：填补了术后长效非阿片类镇痛的产品空白，与现有品种形成差异化互补； 在研管线：还包括TRD205（AT2R拮抗剂，用于慢性神经病理性疼痛，II期数据计划2026年读出）和TRD208（全球首创非阿片类多靶点多模式镇痛创新药，已完成I期首例入组）。 从急性术后镇痛到慢性疼痛管理，从局部麻醉药到新型靶点药物，中国生物制药在镇痛领域的布局正日趋完善。 六、市场前景：长效局麻药的“黄金时代” 全球术后疼痛管理市场规模在2026年预计达452.9亿美元，并以5.72%的年复合增长率持续扩大。其中，缓释局部麻醉剂市场正经历变革性增长——布比卡因脂质体注射液2025年全球市场规模约3.77亿美元，预计2032年将增长至8.75亿美元，年复合增长率达12.78%。 在中国市场，术后镇痛需求同样旺盛。恒瑞医药的布比卡因脂质体（艾恒平）2022年上市后快速放量，2025年销售超过7亿元，验证了超长效局麻药的临床与商业价值。泰德此次以罗哌卡因这一差异化活性成分切入，有望凭借其更低的心脏毒性优势和创新的涂布给药方式，在长效局麻药市场中占据独特的生态位。 免责声明：本报告仅供参考，不构成投资建议© 2026 医药专利 版权所有 📌 关注"医药专利"，深度解读最新医药资讯、技术、专利、药政