Acetic Acid, Glacial

近期，华鲁集团旗下新华制药自主研发的1类创新药物LXH-2103注射液，正式获得国家药品监督管理局颁发的《药物临床试验批准通知书》，获准开展术后中至重度疼痛临床试验！ 美迪西助力 美迪西作为新华制药的合作伙伴，为LXH-2103注射液提供了全套非临床研究服务（包含药效、药代、安评），凭借高效的项目管理与合规的数据支持，助推该药物快速完成IND申报。  临床刚需 · 镇痛破局  术后疼痛临床挑战突出，新型镇痛药物亟待突围 术后疼痛是外科常见的急性伤害性疼痛，分为躯体痛和内脏痛。若干预不及时，易转为慢性或神经病理性疼痛，加重身心负担。有效镇痛可阻断疼痛信号，抑制术后应激反应，降低肺部感染、血栓等并发症风险，改善患者恢复状态，有效缩短康复与住院周期。 当前临床主流镇痛方案多依赖传统阿片类药物，但该类药物代谢受CYP2D6基因多态性影响显著，不同基因型患者药效强弱、不良反应发生风险差异较大，存在镇痛不足或呼吸抑制、恶心呕吐等安全隐患。  机制创新 · 镇痛新解  新型镇痛药LXH-2103，破解CYP2D6基因多态性影响 LXH-2103是新华制药研发的针对术后中至重度疼痛的1类创新药，是一种新型镇痛药，旨在解决传统阿片类药物（如氢可酮、可待因、曲马多）因CYP2D6基因多态性导致的个体间疗效和安全性差异问题。研究显示，LXH-2103具有偏向性μ阿片受体（MOR）激动剂的特性，这使其在规避CYP2D6基因多态性影响的同时，具备显著的镇痛潜力和安全性优势，有望填补国内术后强效精准镇痛创新药的市场空白。 目前，新华制药已布局20余个精麻类仿制药批件。1类新药LXH-2103获批临床，标志着新华制药在精麻产品领域实现从跟跑到领跑，体现了其在疼痛领域的创新布局，以及面向临床未竟需求持续攻坚的竞争力。  平台赋能 · 技术助力   美迪西一站式临床前平台，助力镇痛创新药研发提速 在LXH-2103注射液的临床前研发中，美迪西充分发挥一站式生物医药临床前研发平台优势，药效、药代、毒理多部门高效协同、无缝衔接，针对药物结构特性与精麻类药物研发难点，定制专属研发方案，高效完成全套临床前研究。 针对该精麻类药物药理相关异常症状、药理作用与可逆毒性行为表现重叠、NOAEL判定难度大等特点，美迪西毒理团队基于耐受性动态优化剂量方案，避免因较多动物死亡导致数据缺失。团队通过清晰界定"药理作用"与"毒性反应"，构建了多重证据链以支持安全性评价，确保了申报资料的合规性与科学性。 在镇痛领域，美迪西已建立了急性疼痛、炎症性疼痛和神经性疼痛的模型，并开发了多种诱导与临床疼痛综合征相关的各种疼痛表型的常用方法，以及评估疼痛的主要行为测试方法。主要模型包括热板试验、醋酸扭体试验、福尔马林致痛模型、完全弗氏佐剂致痛模型、胶原诱导的关节炎模型、手术切口疼痛模型、坐骨神经分支选择性损伤模型、糖尿病神经痛模型和化疗痛模型等，能够全方位满足创新镇痛药物的临床前研发需求。 MEDICILON 美迪西祝贺新华制药LXH-2103注射液获批临床，期待该产品在临床阶段进展顺利，早日为术后疼痛患者带来安全、无依赖性的镇痛新选择。未来，美迪西将持续精进临床前研发服务能力，赋能更多创新药物加速从Target到IND，聚力推动全球原创新药创新发展！ 关于新华制药 新华制药是新中国第一家化学合成制药企业，是全球重要的解热镇痛药生产和出口基地，国内重要的心脑血管类、抗感染类、神经系统类、甾体激素类药物等生产企业。拥有化学原料药、医药制剂、医药中间体、医药商业四大业务板块，5个产业园区，13家子公司。化学原料药年生产能力5万吨，医药中间体50万吨，固体制剂320亿片(粒)，注射剂15亿支。拥有阿司匹林、布洛芬、左旋多巴、乙氧苯柳胺、三苯双脒、马蔺子素、吡哌酸等26个市场占有率第一或独家品种，年出口额近4亿美元，与罗氏、拜耳、默克、百利高等200多家知名跨国企业建立了长期战略合作关系。企业总资产90.69亿元，为全国制药工业百强企业、原料药出口五强企业、制剂出口十强企业。新华制药是H股、A股上市公司，新华牌商标被国家商务部和山东省列为重点培育和发展的出口品牌。 新华制药是国家高新技术企业、国家火炬计划重点高新技术企业、国家火炬计划生物医药产业基地骨干企业，拥有国家级企业技术中心，建有院士工作站、博士后工作站、泰山产业人才岗位、泰山学者岗位、硕士联合培养点、山东省技师工作站等6大人才平台。近年来,新华制药加大了校企合作力度，与中国医学科学院、清华大学、山东大学、沈阳药科大学、青岛科技大学等建立了全面战略合作关系。先后建成药物化学研究中心、药物制剂研究中心等6个中心，研究领域涵盖消化系统类、疼痛控制类、心脑血管类、抗代谢类、神经系统类、营养健康类、激素类等12个方向，加大研发投入，布局新产品100余个。累计37个产品46个规格通过一致性评价，拥有国家一类新药文号8个，二类新药文号21个，获得授权专利266项，是三星级“中国专利山东明星企业”(最高级)。 关于美迪西 美迪西（股票代码：688202.SH）成立于2004年，专注于为全球制药企业、研究机构及科研工作者提供全方位的临床前新药研发服务。公司构建了覆盖药物发现、药学研究至临床前研究的一站式综合研发平台，并在ADC、核酸、多肽、CGT、PROTAC、抗体等前沿领域搭建了服务平台。公司建立了符合国际规范的质量体系，已获得中国NMPA、美国FDA、欧盟OECD等GLP认证以及AAALAC国际认证。目前，公司在国内外拥有约9.2万平方米研发实验室。至2026年6月底，公司已为全球超2000家客户提供药物研发服务，参与研发完成的新药项目已有691件IND获批临床，携手国内外合作伙伴共同推动药物创新突破。美迪西将继续立足全球，聚力创新，为人类健康贡献力量！欢迎访问公司官网 www.medicilon.com.cn 了解更多详情。 Novel Analgesic Breakthrough: Xinhua Pharmaceutical’s Class 1 Drug LXH-2103 Secures Clinical Approval with Medicilon’s Preclinical Support Shandong Xinhua Pharmaceutical Co., Ltd., the core subsidiary of Shandong Hualu Holdings Co., Ltd., has obtained official clinical trial approval from the National Medical Products Administration (NMPA) for LXH-2103 Injection, its self-developed Class 1 innovative drug. The candidate is approved for clinical research in the treatment of moderate to severe postoperative pain, marking a key milestone in the company’s pain therapy innovation pipeline. As a trusted strategic partner of Xinhua Pharmaceutical, Medicilon delivered high-quality preclinical research services for LXH-2103 Injection, encompassing PK, PD and Tox. Backed by rigorous project management and fully compliant, scientifically validated data packages, Medicilon substantially accelerated the candidate’s IND submission and successful clinical approval. Addressing Unmet Clinical Needs: Overcoming Key Bottlenecks in Postoperative Pain Management Postoperative pain is a common acute nociceptive condition following surgical procedures, categorized into somatic and visceral pain. Without timely and standardized clinical intervention, acute postoperative pain may progress to intractable chronic pain or neuropathic pain, imposing severe physical discomfort and psychological burden on patients. Precision analgesia effectively blocks pain signal transmission, mitigates postoperative stress responses, reduces the risk of common complications such as pulmonary infection and thrombosis, improves overall patient recovery outcomes, and shortens both rehabilitation duration and hospital stay. Current mainstream clinical analgesic regimens rely heavily on conventional opioid drugs. However, the metabolic profiles of these agents are highly susceptible to CYP2D6 genetic polymorphism. Patients with distinct genotypes exhibit significant heterogeneity in therapeutic efficacy and adverse reaction susceptibility, leading to prevalent clinical risks including inadequate pain relief, respiratory depression, nausea and vomiting. Mechanistic Innovation Resolves Genetic Variability Barriers LXH-2103 Injection is an original Class 1 innovative analgesic independently developed by Xinhua Pharmaceutical for moderate to severe postoperative pain. Designed to tackle the clinical limitations of classic opioids including codeine, hydrocodone and tramadol, the candidate effectively addresses inconsistent efficacy and safety risks stemming from CYP2D6 genetic polymorphism across patient populations. Preclinical research confirms that LXH-2103 acts as a biased μ-opioid receptor (MOR) agonist. This differentiated pharmacological profile enables the drug to bypass CYP2D6 metabolism-related individual differences, while delivering robust analgesic potency and improved safety margins. As a first-in-class candidate targeting precise postoperative analgesia, it is poised to fill a critical gap in China’s innovative analgesic market. Xinhua Pharmaceutical currently holds over 20 product approvals for psychotropic and narcotic drugs. The clinical clearance of LXH-2103 signifies the company’s transformative upgrade from industry follower to technological leader in the psychotropic and narcotic drug sector. It underscores Xinhua’s forward-looking innovation layout in pain management and its robust R&D strength to tackle unmet clinical medical demands. Medicilon’s Integrated Preclinical Platform Accelerates Innovative Analgesic R&D During the preclinical development of LXH-2103 Injection, Medicilon fully leveraged its one-stop integrated preclinical R&D platform. Cross-functional teams covering PD, PK and Tox collaborated efficiently and seamlessly. Tailored R&D strategies were formulated to adapt to the compound’s unique structural properties and resolve core technical challenges in psychotropic and narcotic drug development, enabling the efficient and high-quality completion of the entire preclinical research program. R&D of psychotropic and narcotic drugs presents unique technical challenges, including overlapping phenotypic manifestations of pharmacological effects and reversible toxic responses, as well as high difficulty in NOAEL determination. To overcome these hurdles, Medicilon’s toxicology team dynamically optimized dosage regimens based on real-time animal tolerance, preventing data loss caused by excessive animal mortality. By establishing clear differentiation criteria between pharmacological effects and toxicological reactions, the team built a comprehensive multi-evidence safety evaluation system, ensuring full compliance and scientific rigor of all IND application data and documents. Focused on analgesic drug innovation, Medicilon has established a complete, validated preclinical evaluation system covering acute pain, inflammatory pain and neuropathic pain, alongside mature induction protocols and behavioral testing methodologies for diverse clinical pain phenotypes. The company’s full-spectrum pain model portfolio includes hot-plate test, acetic acid writhing test, formalin-induced pain model, complete Freund’s adjuvant-induced pain model, collagen-induced arthritis model, surgical incision pain model, spared nerve injury model, diabetic neuropathic pain model and chemotherapy-induced pain model. This comprehensive system fully supports end-to-end preclinical R&D for novel analgesic candidates. MEDICILON Medicilon congratulates Xinhua Pharmaceutical on the successful clinical approval of LXH-2103 Injection. We look forward to smooth and progressive clinical development, expecting this innovative candidate to provide a safer postoperative analgesic alternative with lower addiction potential for global patients. Moving forward, Medicilon will continue to optimize and upgrade its full-process preclinical R&D services, empower more innovative drug candidates to advance rapidly from target discovery to IND approval. About Medicilon From its inception in 2004, Shanghai Medicilon Inc. (SHA: 688202)has been committed to providing comprehensive R&D services to pharmaceutical companies, research institutions, and any organizations working in the preclinical space. Medicilon has built an integrated one-stop R&D platform covering drug discovery, CMC and preclinical studies, and has established service platforms in cutting-edge fields such as ADC, nucleic acids, peptides, CGT, PROTAC, and antibodies. Medicilon has established a quality system in compliance with international standards and has obtained GLP certifications from China's NMPA, the US FDA, the EU OECD,as well as AAALAC accreditation. Currently, Medicilon has nearly 92,000 square meters of R&D laboratories. By the end of June 2026, Medicilon has provided drug development services to over 2,000 clients worldwide, and has been involved in the research and development of 691 new drugs projects that have been approved for clinical trials with IND applications. For more information, please visit the company's official website at www.medicilon.com.