攻坚阿尔茨海默病！美迪西助力恒瑞医药SHR-3201注射液获批临床

近日，恒瑞医药子公司北京盛迪医药有限公司收到国家药品监督管理局核准签发关于SHR-3201注射液的《药物临床试验批准通知书》，适应症为阿尔茨海默病（AD）。

美迪西助力

美迪西作为恒瑞医药的战略合作伙伴，为SHR-3201注射液提供了符合GLP规范的非人灵长类毒理试验，支持NMPA、FDA、OECD临床试验申报，助力该创新药顺利进入临床阶段。

AD药物?需求迫切 

攻克阿尔茨海默病，临床治疗亟待突破性创新

AD是一种进行性神经认知疾病，会逐渐侵蚀患者的记忆、判断力、认知、学习能力，是老年人群痴呆症的首要病因。AD可影响患者的情绪、思维和行为，以及整体人格特质、性情和自我认知，造成严重的家庭和社会负担。当前临床治疗手段有限，全球对于阿尔茨海默病全新治疗药物存在巨大的未满足临床需求。

靶向清除?AD新解 

SHR-3201注射液，源头创新破局阿尔茨海默病

SHR-3201注射液是恒瑞医药自主研发治疗阿尔茨海默病的药物，可清除患者脑内的疾病生物标志物，延缓患者认知衰退。经查询，国内外尚无同类药物获批上市。

SHR-3201的获批，进一步完善恒瑞医药在神经退行性疾病领域的管线布局，印证企业源头创新战略落地成效与新药研发硬实力。

平台赋能?技术助力 

美迪西一站式助力中枢神经创新药临床前研发

中枢神经系统创新药物研发面临血脑屏障穿透难、药效评价复杂、安全性要求高等多重挑战。美迪西能够为中枢神经系统创新药提供体系化、全球化合规的药效、药代、安评等临床前解决方案，核心能力如下：

国际规范质量体系：已获中国NMPA、美国FDA、欧盟OECD等GLP认证及AAALAC国际认证。

实验动物资源：拥有非人灵长类、犬、大小鼠、兔、豚鼠、小型猪等实验动物，可满足多种毒理评价需求。

60+种中枢神经系统疾病模型：包括抑郁症、惊厥、镇静-催眠-焦虑、帕金森病、疼痛、痴呆、精神分裂症等

助力药物类型：可为小分子、多肽、抗体、ADC、PDC、核酸、细胞治疗、疫苗等药物类型，LNP、AAV、溶瘤病毒等基因递送与病毒载体产品提供全面系统的评价服务。

给药途径：涵盖PO、IV等常见途径，以及吸入、鞘内、眼科、皮肤、舌下等特色给药方式。

NAMs替代毒理：布局NAMs新型替代毒理评估技术，提供更前沿、高效的毒理研究选择。

灵活服务模式：可提供单项试验，或一站式毒理方案设计、试验实施、数据分析及IND申报资料支持。

美迪西祝贺恒瑞医药SHR-3201注射液进入临床试验，期待该产品在临床阶段进展顺利，早日为阿尔茨海默病患者带来全新的治疗选择。未来，美迪西将持续精进一站式生物医药临床前研发服务平台，赋能更多创新药物加速从Target到IND！

关于恒瑞医药

恒瑞医药（股票代码：600276.SH，01276.HK）创立于1970年，分别于2000年、2025年在上海证券交易所和香港联合交易所挂牌上市，成为“A+H”两地上市企业。作为一家专注研发、生产及推广高品质药物的创新驱动型国际化制药企业，恒瑞医药在五十多年的发展历程中，始终坚持“以患者为中心”的初心，聚焦肿瘤、代谢和心血管疾病、免疫和呼吸系统疾病以及神经科学等领域，持续攻坚药物研发，为了攻克疾病、改善生活质量和延长生命，公司不断拓展可能的疆域，致力于运用科技的力量造福全球患者。

恒瑞医药连续8年上榜美国《制药经理人》杂志公布的全球制药企业TOP50榜单；国际知名咨询机构Citeline发布全球TOP25管线规模制药公司榜单，恒瑞连续5年上榜，自研管线数量位居全球第二。

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/AOC、小核酸、多 (环)肽、TPD, RIPTAC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，公司在上海和Boston拥有约 9.2 万平方米研发实验室。至 2026 年 6 月末，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临床批件。美迪西将继续携手国内外合作伙伴共同推动药物创新，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。

Breaking New Ground in Alzheimer’s Disease! Medicilon Supports Hengrui Pharma’s SHR-3201 Injection to Secure Clinical Trial Approval

Beijing Shengdi Pharmaceutical Co., Ltd., a subsidiary of Hengrui Pharma, recently received the 《Drug Clinical Trial Approval Notice》for SHR-3201 Injection issued by China’s NMPA, for the indication of Alzheimer’s disease (AD).

Medicilon’s support

As a strategic partner of Hengrui Pharma, Medicilon conducted GLP-compliant non-human primate toxicology studies for SHR-3201 Injection. The study data supports clinical trial submissions to NMPA, FDA and OECD, helping this novel candidate advance smoothly into clinical development.

As a strategic partner of Hengrui Pharma, Medicilon conducted GLP-compliant non-human primate toxicology studies for SHR-3201 Injection. The study data supports clinical trial submissions to NMPA, FDA and OECD, helping this novel candidate advance smoothly into clinical development.

Unmet Medical Need for AD Therapies

Breakthrough innovation is urgently needed to tackle AD

AD is a progressive neurodegenerative disorder that gradually impairs patients’ memory, judgment, cognition and learning ability, and represents the leading cause of dementia among the elderly. AD can alter patients’ mood, thinking, behavior, personality, temperament and self-perception, imposing heavy burdens on families and society. Current therapeutic options remain limited worldwide, leaving a substantial unmet clinical need for novel treatments for Alzheimer’s disease.

Targeted Clearance: A Novel Approach to AD

SHR-3201 Injection: Original innovation to address AD

SHR-3201 Injection is an internally discovered AD therapeutic developed by Hengrui Pharma. It targets and removes disease-related biomarkers in the brain to slow cognitive decline. To date, no comparable therapies have been approved for marketing globally.

The clinical approval of SHR-3201 further expands Hengrui Pharma’s pipeline in neurodegenerative diseases. It also validates the successful execution of the company’s original innovation strategy and robust capabilities in new drug R&D.

Platform Capabilities Enabling Preclinical CNS Drug Discovery

Medicilon delivers end-to-end preclinical R&D support for novel central nervous system therapeutics

The development of CNS innovative drugs faces multiple hurdles, including poor blood-brain barrier penetration, complex pharmacodynamic assessment and stringent safety requirements. Medicilon offers systematic, globally compliant preclinical solutions covering pharmacodynamics, pharmacokinetics and safety evaluation for CNS drug candidates. Our core capabilities are outlined below:

- Globally recognized quality system: GLP certifications from NMPA (China), FDA (US), OECD, alongside AAALAC international accreditation.

- Diverse laboratory animal resources: Non-human primates, canines, mice, rats, rabbits, guinea pigs, minipigs and more to support varied toxicology evaluations.

- 60+ CNS disease models: Including depression, convulsion, sedation-hypnosis-anxiety, Parkinson’s disease, pain, dementia, schizophrenia, etc.

- Broad drug modality coverage: Comprehensive evaluation services for small molecules, peptides, antibodies, ADCs, PDCs, nucleic acids, cell therapies and vaccines; as well as gene delivery and viral vector products such as LNPs, AAVs and oncolytic viruses.

- Versatile administration routes: Standard routes including PO and IV, plus specialized routes such as inhalation, intrathecal, ophthalmic, dermal and sublingual delivery.

- NAMs for alternative toxicology: Invested in New Approach Methodologies (NAMs) to deliver advanced, efficient alternatives for toxicology assessment.

- Flexible service models: Standalone study services or full end-to-end packages including toxicology study design, experimental execution, data analysis and IND dossier support.

Medicilon congratulates Hengrui Pharma on the advancement of SHR-3201 Injection into clinical trials. We look forward to smooth clinical progress for this candidate, which may one day bring a new therapeutic option to patients living with Alzheimer’s disease. Moving forward, Medicilon will continue to refine its preclinical R&D service platform, empowering more innovative assets to accelerate their journey from Target to IND.

About Medicilon

Founded in 2004, Medicilon (Stock Code: 688202.SH) is dedicated to delivering comprehensive preclinical drug R&D services to pharmaceutical enterprises, research institutions, and scientific investigators worldwide. The company has established a one-stop integrated R&D platform encompassing drug discovery, pharmaceutical research, and preclinical research, and has developed service platforms in cutting-edge fields including ADC/AOC, RNAi, peptides (including macrocyclic peptides), TPD, and RIPTAC. The company has instituted a quality system compliant with international standards and has secured GLP certifications from China's NMPA, the U.S. FDA, and the EU's OECD, along with AAALAC International accreditation. At present, the company operates approximately 92,000 square meters of R&D laboratory space across Shanghai and Boston. As of the end of June 2026, the company has provided drug R&D services to over 2,000 clients globally and has supported 691 IND approvals. For more information, visit www.medicilon.com.