Open label randomized study to evaluate the in vivo efficacies of Artemether-lumefantrine and Dihydroartemisinin-piperaquine in the treatment of uncomplicated Plasmodium falciparum malaria in children 6 months to 10 years of age in western Kenya

开始日期2026-12-01

申办/合作机构

Program for Appropriate Technology in Health

PACTR202602775567145

/ Recruiting临床3期IIT

A Phase 3, Observer-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, and Immunogenicity of MenFive Meningococcal Conjugate Vaccine A, C, Y, W, X, (Serum Institute of India), in Pregnant Women and their Infants

开始日期2026-03-25

申办/合作机构

Program for Appropriate Technology in Health

NCT07439185

/ Not yet recruitingN/AIIT

Impact of a Cricket and Black Soldier Fly Larvae-Fortified Cracker on the Gut Microbiome and Iron Status in Malagasy Schoolchildren

The purpose of this study is to determine the health impacts of consistent consumption of insect-fortified crackers among school-aged children in Madagascar.
Specifically, in this RCT, the investigators will assess whether the insect-fortified crackers can improve the health status of Malagasy school children. The investigators' objectives are to: (1) Assess changes in gut microbiome composition that occur after 6 and 14 weeks of cracker consumption through 16S rRNA sequencing. (2) Assess changes in intestinal and systemic inflammation after 6 and 14 weeks of cracker consumption through quantification of fecal calprotectin, lactoferrin, myeloperoxidase (MPO), and alpha-1-antitrypsin (AAT) and circulating pro-inflammatory cytokines. (3) Assess changes in iron status after 14 weeks of cracker consumption through quantification of hemoglobin (Hb), inflammation-adjusted serum ferritin, and soluble transferrin receptor (sTfR).

开始日期2026-02-01

申办/合作机构

Cornell University

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100 项与 Program for Appropriate Technology in Health 相关的临床结果

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0 项与 Program for Appropriate Technology in Health 相关的专利（医药）

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项与 Program for Appropriate Technology in Health 相关的文献（医药）

2026-05-01·LANCET

Substantial increases in cervical cancer inequalities worldwide without enhanced human papillomavirus vaccination and screening efforts: a global modelling study

Article

作者: Gingras, Guillaume ; Drolet, Mélanie ; Bénard, Élodie ; Brisson, Marc ; Bruni, Laia ; Chamberland, Éléonore ; Laprise, Jean-François ; Ndiaye, Cathy ; Barnabas, Ruanne V ; Sabourin, Andrée-Anne

BACKGROUND:

To reduce worldwide inequalities, WHO made a call for action to eliminate cervical cancer by vaccinating 90% of girls, screening 70% of women, and treating 90% of pre-cancers and cancers. Low-income countries and lower-middle-income countries (LMICs) are far from reaching the WHO elimination targets compared with high-income countries (HICs). Using mathematical modelling, we aimed to examine the following questions: (1) Are we on the path to cervical cancer elimination in LMICs and HICs? (2) What is the potential evolution of inequalities in cervical cancer between LMICs and HICs under current screening and vaccination coverage? And (3) what would be the potential impact of enhanced prevention strategies (ie, human papillomavirus [HPV] vaccination and screening) on inequalities and cervical cancer elimination?

METHODS:

We used the HPV-ADVISE model to project the age-standardised cervical cancer incidence in 67 LMICs and 42 HICs for different HPV vaccination and screening scenarios. For the status quo scenario (of HPV vaccination and screening), we modelled the vaccine used, the start year of vaccination, vaccination coverage, and the target population for each country, and current screening coverage in LMICs and HICs. We examined five enhanced prevention strategies for LMICs: (1) status quo for all countries using the nine-valent vaccine; (2) reaching 90% vaccination coverage for girls-only routine vaccination; (3) reaching the WHO vaccination, screening, and treatment elimination targets; (4) adding routine vaccination for boys with 90% coverage (ie, universal routine vaccination) and multi-age-cohort vaccination; and (5) reaching the WHO elimination targets combined with universal routine and multi-age-cohort vaccination. Inequalities were measured as the age-standardised cervical cancer incidence (ASR) ratio between LMICs and HICs (RR_LMIC/HIC=ASR_LMICs/ASR_HICs).

FINDINGS:

Under the status quo, the model projected that cervical cancer incidence in LMICs would decrease by only 23% while HICs would reach elimination by 2048 (age-standardised cervical cancer incidence LMIC/HIC=3 in 2022 and 12 in 2105). Reaching 90% vaccination coverage among girls in LMICs would reduce these inequalities (RR_LMIC/HIC=2 in 2105) and lead to elimination in LMICs outside sub-Saharan Africa. To reach equality between LMICs and HICs and elimination in all LMIC regions, LMICs would need to reach the WHO elimination targets and introduce universal vaccination and multi-age-cohort vaccination.

INTERPRETATION:

Worldwide inequalities in cervical cancer have been projected to increase dramatically without enhanced HPV prevention strategies. Reaching WHO vaccination and screening elimination targets or introducing universal vaccination with high coverage is necessary to eliminate cervical cancer in LMICs, which would substantially attenuate worldwide inequalities.

FUNDING:

Canada Research Chairs Program, Canadian Institute of Health Research, and Fonds de recherche du Québec through the research centre grant for the CHU de Québec-Université Laval Research Center.

2026-03-01·SEXUALLY TRANSMITTED INFECTIONS

Preferences for pre-exposure prophylaxis service package among men who have sex with men in Australia: a discrete choice experiment

Article

作者: Tieosapjaroen, Warittha ; Green, Kimberly E ; Cassell, Michael ; Zhang, Lei ; Chan, Curtis ; Murphy, Dean ; Schmidt, Heather-Marie A ; Phanuphak, Nittaya ; Ong, Jason J ; Tang, Weiming ; Fraser, Doug ; Bavinton, Benjamin Robert

Objectives:

Pre-exposure prophylaxis (PrEP) usage remains below the Australian 75% coverage target. This study identified preferences for PrEP services shared among subgroups of men who have sex with men (MSM) living in Australia and explored heterogeneity preferences across different age groups and countries of birth.

Methods:

MSM aged>18 years with no prior HIV diagnosis and residing in Australia completed an online discrete choice experiment between May and November 2022. The attributes included type of PrEP, service location, service cost, PrEP side effects, visit frequency and additional services. Participants were recruited through dating apps, Facebook and local MSM community organisations. We used a latent class model (LCM) to explore subgroups with similar preferences for PrEP programmes and a random parameters logit model with interactions to explore heterogeneity preferences.

Results:

Overall, 1894 MSM participated, with a mean age of 40 (±12) years. The LCM identified four groups of MSM who shared similar preferences for PrEP services: ‘Long-acting oral or injectable PrEP from community clinics’ (22% of participants), ‘Daily oral PrEP from pharmacies’ (5%), ‘Long-acting oral PrEP from pharmacies’ (52%) and ‘injectable PrEP from the hospital’ (22%). The group preferring injectable PrEP (22%) preferred accessing PrEP services at hospitals offering sexually transmitted infection testing every 6 months, with a willingness to pay a small fee ($A25). They were willing to endure mild pain at the injection site as a side effect of injectable PrEP. Compared with Australian-born, overseas-born MSM preferred PrEP services offering injectable PrEP. Compared with younger MSM, MSM over 30 years old preferred services offering daily PrEP.

Conclusions:

There is a growing demand for alternatives to oral daily PrEP, with a significant group preferring services including long-acting oral or injectable PrEP and willing to pay a small fee to access it. The majority preferred decentralising access to PrEP through pharmacies. Diverse preferences for PrEP service delivery signify tailored PrEP implementation initiatives to increase PrEP coverage among underserviced populations.

2025-10-01·VACCINE

Immunogenicity and safety of a meningococcal a conjugate vaccine administered with routine EPI vaccines in African infants and toddlers

Article

作者: Plikaytis, Brian ; Parulekar, Varsha ; Haidara, Fadima Cheick ; Kulkarni, Prasad S ; Hodgson, Abraham ; Preziosi, Marie-Pierre ; Marchetti, Elisa ; Martellet, Lionel ; Carlone, George ; Tapia, Milagritos D ; Bangre, Oscar ; Enwere, Godwin C ; Montomoli, Emanuele ; Borrow, Ray ; LaForce, F Marc ; Ansah, Nana Akosua ; Stanzani, Valerio ; Ansah, Patrick Odum ; Makadi, Marie-Françoise ; Tang, Yuxiao ; Chaumont, Julie ; Sow, Samba O ; Viviani, Simonetta

In 2010, a Meningococcal group A (MenA) conjugate vaccine (PsA-TT) was WHO prequalified and introduced in preventive campaigns in 1-29 year-olds across the African Meningitis Belt. An extension of the indication to infants and toddlers in the Expanded Programme on Immunization (EPI) was pursued for the protection of new birth cohorts. Between 2008 and 2012, a Phase 2 randomized controlled trial was conducted in Ghana to assess the safety and immunogenicity of different PsA-TT formulations (10 μg, 5 μg or 2.5 μg of MenA polysaccharide) given as one or two doses with EPI vaccines at 14-18 weeks, 9-12 months, and 12-18 months of age (Study A). Between 2012 and 2013, a subsequent Phase 3 randomized controlled trial was conducted in Mali to assess the 10 μg and 5 μg formulations given as one or two doses with EPI vaccines at 9-12 and 15-18 months of age (Study B). Immunogenicity was assessed using a serum bactericidal antibody assay using rabbit complement (rSBA). Non-inferiority of the 5 μg and 2.5 μg PsA-TT formulations to the 10 μg formulation was demonstrated in Study A with ≥93 % seroconversion in MenA rSBA 28 days after each dose. Non-inferiority of the 5 μg to the 10 μg was demonstrated in Study B in terms of seroconversion in MenA rSBA at 28 days (≥97 %) when given as two doses at 9-12 and 15-18 months and as a single dose at 9-12 months. Non-inferiority with respect to most EPI antigens was demonstrated in pairwise comparisons across both studies. Adverse events and serious adverse events reported in either study following vaccinations were similar across vaccine groups. Results of both trials showed that the vaccine was safe and immunogenic when co-administered with the EPI, paving the way for a WHO recommendation for the 5 μg PsA-TT to be included in the EPI as a single dose at 9-18 months of age. PsA-TT-004, registered International Standard Randomized Controlled Trial Number: ISRCTN82484612; PsA-TT-007, International registration number: PACTR201110000328305.

项与 Program for Appropriate Technology in Health 相关的新闻（医药）

2026-09-18

·微信

领取|学习生物制药CMC必看的23本书籍！

各位爱学习的粉丝们，平台小编团队给大家整理汇总了学习生物制药CMC比较好的一些书籍！话不多说！以下是书籍目录：（中文名仅供参考）点击图片放大可以看的更清楚哦领取方式：关注微信公众号：法迈医讯；扫码添加小编小草老师微信备注领取“CMC书籍”可免费获取！直播-体内CAR-T治疗药品CMC关键难点突破与注册申报实战主办单位中国化工企业管理协会医药化工委员会各有关单位随着全球生物医药产业进入细胞与基因治疗时代，体内CAR-T技术以其革命性的治疗潜力和便捷化的临床应用，正成为引领下一代肿瘤免疫治疗的关键方向。然而，机遇与挑战并存。从实验室研究走向产业化落地，从概念验证推进到成功注册上市，CMC（化学、生产和控制）环节的诸多关键难点与日益严格的全球监管要求，构成了产品成功商业化必须跨越的核心壁垒。为系统解析体内CAR-T药品开发的全链条挑战，深度聚焦从工艺开发、质量研究到注册申报的实战落地，本次研讨会应需而生。我们旨在搭建一个高浓度、强实战的交流平台，特邀资深专家团，结合多年一线实战经验与最新案例，为您逐一拆解：为此我们将于2025年10月25日至26日在线上举办“体内CAR-T治疗药品CMC关键难点突破与注册申报实战落地培训班”，详细通知如下，请各单位积极选派人员参加。会议安排会议地点：线上直播会议时间：2025年10月25日-26日会议时间安排上午09:00-12:00 下午13:30-16:30 会议内容第一天：聚焦工艺与质量——从早期开发到控制策略模块一：体内CAR-T新药工艺开发策略与核心难点突破 1.从概念到CMC：新产品工艺开发顶层设计 1)早期研发（R&D）与CMC工艺开发的衔接与转化策略 2)平台化工艺开发理念在体内CAR-T中的应用与优势 3)关键质量属性（CQA）前瞻性识别对工艺开发的指导 2.工艺核心难点深度剖析与解决方案 1)载体递送系统（LNP、病毒载体等）的筛选与优化：如何平衡效率、特异性与安全性 2)体内细胞转导/转染效率和体内活化扩增可控性的工艺优化 3)规模化与数字化生产挑战：从临床前到商业化的工艺放大策略，关键工艺参数（CPP）的界定与监控 3.突破路径：QbD（质量源于设计）的实战应用 1)设计空间（Design Space）的建立与验证 2)控制策略（Control Strategy）的制定：如何将工艺参数与产品质量动态关联模块二：体内CAR-T新产品分析方法开发与质量研究策略 1.新产品分析控制策略搭建 1)关键质量属性（CQA）的特殊挑战与识别： potency（效力）纯度、安全性指标的确立 2)表征研究（Characterization）深入：载体结构完整性、CAR表达水平与功能的深度分析（如NGS、质谱应用） 1.前沿分析技术（AT）应用与方法开发 1)体内分布与持久性：新型生物发光成像（BLI）PCR等技术的应用与验证难点 2)痕量杂质检测：工艺残留物（如宿主细胞DNA/蛋白、载体相关杂质）的超高灵敏度方法开发（LOD/LOQ设定） 3)免疫原性风险评价：抗药抗体（ADA）检测方法开发及细胞因子释放综合征（CRS）的体外预测模型 2.质量控制（QC）方法验证与标准品建立 1)方法验证实战：符合ICH Q2(R1)要求的设计与执行（特异性、精密度、准确度、线性等） 2)参考品/标准品的建立、标定与质量控制模块三：体内CAR-T药品生产控制、合规与稳定性 1.GMP生产与合规性管理 1)生产环境控制：基于风险的洁净等级划分（对比NMPA，FDA，EMA要求） 2)交叉污染防控：一次性技术应用与共线生产的风险评估（FMEA案例） 3)数据完整性保障：电子记录（MES/LIMS）实施要点与审计追踪管理 2.稳定性研究与包装设计 1)新产品稳定性研究策略：加速试验与长期试验设计，指示稳定性（指示稳定性）考察点的选择 2)包材相容性研究：可提取物和浸出物（E&L）研究设计 3)冷链物流管理：运输验证策略与风险控制互动答疑第二天：聚焦注册申报——从策略制定到实战应对模块四：国内外注册法规动态与申报策略制定 1.全球法规格局最新解读 1)NMPA《体内基因治疗产品临床试验技术指导原则》（2024）核心变化与影响 2)FDA《体内CAR-T治疗产品申报指南（草案）》及EMA ATMP法规关键要求对比 2.新产品申报路径选择策略 1)中美/中欧双报策略：时间节点规划、资料要求差异与沟通协调 2)突破性治疗、孤儿药、优先审评等加速通道的申请条件与策略模块五：注册申报资料（CTD）撰写实战与发补应对 1.CTD模块三大核心难点撰写 1)质量部分：如何清晰且有说服力地呈现新产品工艺、质量研究与控制策略 2)质量总体概述：如何提炼精华，突出产品优势和控制策略合理性 3)非临床 4)临床：与CMC部分的衔接与数据支持 2.发补（CRL）应对与沟通 1)常见CMC发补问题深度解析 2)发补回复策略：数据补充、逻辑论证与沟通技巧模块六：注册沟通会议与监管核查准备 1.高效注册沟通 1)Pre-IND、Pre-NDA会议：会议资料准备、问题清单设计及会议模拟 2)与监管机构建立良好沟通渠道的策略 2.应对监管核查 1)核查重点领域：生产工艺、质量控制、数据管理系统 2)模拟核查实战：基于案例的角色扮演与问题应答策略 • 互动答疑：学员提问，专家解答主讲老师专家介绍：张长风博士：上药集团生物治疗注册总监。师从“CART之父”Carl June院士，深度参与Kymriah（全球首款CART）等产品在FDA的申报工作，回国后作为总负责人斩获国内首个基因敲除CART产品的IND批件，并数次与CDE、中检院等药政监管部门联合举办细胞治疗中美政策研讨会。张博士迄今已在Nature Medicine, Blood, JCI-insight等国际权威期刊发表多篇论文，并组织开展多项临床研究，治疗白血病、骨髓瘤等各类癌症患者400余人。协会特聘专家。程玉博士：医药工程高级工程师，曾在多家生物医药企业从事质量研究和管理工作，10余年疫苗、重组蛋白、TCR-T细胞、CAR-T细胞等从研发、临床到上市分析方法开发、QC和QA经验，主导过多个产品的检测方法的开发与验证，参与多个产品的注册申报工作，并推动几个产品成功申报IND。在医药期刊发表SCI论文3篇，授权发明专利3项，授权实用新型专利7项。有0-1团队成功搭建经验，有丰富的GLP、GMP体系建设经验。协会特聘专家。袁歆：浙江霍德生物质量副总裁，质量受权人。此前担任传奇生物中国区质量负责人、亘喜生物质量副总裁、星奕昂生物质量副总裁，曾先后在Baxter、药明生物、PATH、Abbott、Fresenius-kabi等国内外知名药企和机构从事药品研发与生产质量管理工作，拥有30年细胞、单抗、疫苗、化药相关研发、生产和质量管理经验；多次在国内细胞治疗公司产业化初期成功搭建质量团队、并建立全面符合国内外相关法规要求的研发、生产和质量管理体系，作为质量负责人先后完成IND临床阶段多个项目产品的放行。协会特聘专家。郑老师：近25年的国内外注册事务工作经验。曾任多家跨国药企和国内大型制药企业注册负责人和副总裁。带领团队负责过多个CAR-T的注册工作，包括临床申请和上巿申请。对创新产品的注册策略和项目执行有着非常丰富实战经验。同时也是多个行业协会的工作组的核心成员。协会特聘专家。报名咨询详情咨询扫描下方二维码联系小草老师备注：体内CAR-T治疗药品欢迎加入1476+人的中国生物制药行业千人通讯录精品推荐限时领取|生物制药从业人员的全套资料大礼包！免费领取|制药资料补给站！领取|书籍-生物制药工艺验证限时领取|EBMT/EHA嵌合抗原受体T细胞免疫疗法细胞手册限时领取|细胞和基因治疗干货资料汇总！！！限时领取|药厂 SOP 汇总限时领取|药品制造手册--生产和工艺限时领取|EMA制剂成品生产指南（中英文2017完整版）免费领取|双节大礼包:制药企业从业人员231个实用文件干货 | 领取制药人必备的全套资料包限时领取|学习生物制药CMC必看的23本书籍！干货|PDA全套资料合辑欢迎关注法迈新媒体 >>>> 公众号推荐更多，更及时的干货内容，请加我们的微信公众号：法迈制药，诚邀业内人士及机构向我们投稿。投稿邮箱:bellama@pharmanews.cn 【免责声明】文章为网络整理，不代表“法迈制药”立场。如因作品内容、版权等存在问题，请于本文刊发30日内联系法迈医讯进行删除或洽谈版权使用事宜。法迈制药作为法迈新媒体微信公众号矩阵之一，法迈新媒体是国内一家面向制药行业供应链综合服务平台，致力于服务全球制药行业从业人员。以创新的互网+模式服务于行业用户，形成以“资源整合，知识共享”为核心，微信公众号矩阵、社群矩阵为分支的新媒体模式，力争打造国内活跃和具影响力的专业化平台！

2026-09-08

·动脉网

通过Bio Farma与MCRI合作开发的新生儿轮状病毒疫苗Bio-RV获得印尼国家药品和食品监督管理局（BPOM）的市场营销授权Bio-RV, a Neonatal Rotavirus Vaccine Developed Through Bio Farma–MCRI Collaboration, Receives Marketing Authorization from BPOM

Jakarta (ANTARA) - PT Bio Farma (Persero), together with Murdoch Children’s Research Institute (MCRI), has marked an important milestone in efforts to strengthen the protection of children against rotavirus disease following the issuance of marketing authorization for Bio-RV, a neonatal rotavirus vaccine, by the Indonesian Food and Drug Authority (BPOM).. 雅加达（安塔拉通讯社）——印度尼西亚食品药品监督管理局（BPOM）批准新生儿轮状病毒疫苗Bio-RV的上市许可后，印尼国有制药公司PT Bio Farma（Persero）与默多克儿童研究所（MCRI）共同标志着在加强儿童免受轮状病毒疾病侵害的保护方面取得了重要里程碑。Bio Farma officially received marketing authorization for Bio-RV on September 2, 2026. This regulatory milestone follows an extensive journey encompassing research, process development, preclinical and clinical studies, technology transfer, regulatory submission, and manufacturing preparation involving various national and international institutions.. Bio Farma于2026年9月2日正式获得Bio-RV的上市许可。这一监管里程碑标志着历经广泛历程的成果，该历程涵盖研究、工艺开发、临床前和临床研究、技术转移、监管申报以及制造准备，涉及众多国内外机构。The marketing authorization confirms that Bio-RV has undergone BPOM’s evaluation of its safety, efficacy, and quality in accordance with applicable regulatory standards and requirements. For Bio Farma and MCRI, this achievement shows how collaboration among research institutions, academia, industry, and global partners can translate into biotechnology innovation with the potential to deliver tangible public health benefits.. 该上市许可确认，Bio-RV 已根据适用的监管标准和要求，通过了印度尼西亚食品药品监督管理局（BPOM）对其安全性、有效性和质量的评估。对于印尼生物法玛公司（Bio Farma）和月球城研究所以及合作伙伴而言，这一成就彰显了研究机构、学术界、产业界和全球伙伴之间的合作如何转化为具有带来切实公共卫生效益潜力的生物技术创新。Bio-RV is a naturally attenuated live rotavirus vaccine administered orally. The vaccine is intended to prevent gastroenteritis, or acute diarrhea, caused by rotavirus infection. It is administered in a three-dose schedule: the first dose at 0–5 days of age, the second at 8–10 weeks, and the third at 12–14 weeks. Bio-RV 是一种口服的自然减毒活轮状病毒疫苗。该疫苗旨在预防由轮状病毒感染引起的胃肠炎（即急性腹泻）。该疫苗采用三剂接种程序：第一剂在出生后 0–5 天接种，第二剂在 8–10 周龄接种，第三剂在 12–14 周龄接种。These characteristics allow vaccination to begin during the neonatal period, establishing protection against rotavirus disease from the earliest stage of an infant’s life, at a time when families are in contact with their local health services. 这些特性使得在新生儿期即可开始接种疫苗，从而在婴儿生命的最早阶段建立对轮状病毒疾病的防护，此时家庭正与当地卫生服务机构保持接触。Bio-RV is particularly relevant as rotavirus remains one of the leading causes of severe diarrhea among infants and young children. Citing data from the Indonesia Rotavirus Surveillance Network for 2001–2017, the Indonesian Ministry of Health reported that rotavirus accounted for approximately 41–58 percent of diarrhoeal cases among children under five requiring hospitalization. 轮状病毒疫苗（Bio-RV）尤其重要，因为轮状病毒仍然是导致婴儿和幼儿严重腹泻的主要原因之一。印度尼西亚卫生部引用2001–2017年印度尼西亚轮状病毒监测网络的数据报告称，在需要住院治疗的五岁以下儿童腹泻病例中，轮状病毒约占41%至58%。Recurrent diarrhea may also impair nutrient absorption and increase the risk of growth disorders in children.. 复发性腹泻还可能损害营养吸收，并增加儿童生长障碍的风险。Bio Farma President Director Shadiq Akasya said that obtaining marketing authorization for Bio-RV reflects the company’s commitment to delivering vaccine innovations that address public health needs while strengthening Indonesia’s national capabilities in vaccine development. Bio Farma 总裁董事 Shadiq Akasya 表示，获得 Bio-RV 的上市许可反映了公司致力于提供满足公共卫生需求的疫苗创新，同时加强印度尼西亚在疫苗开发方面的国家能力。“Bio-RV is not simply about introducing a new vaccine. Behind this achievement lies an extensive journey of scientific advancement, process development, preclinical and clinical studies, technology transfer, regulatory submission, and manufacturing preparation. This entire process has been made possible through collaboration among researchers, academia, industry, and global partners,” Shadiq said.. “Bio-RV 并不仅仅是引入一种新疫苗。这一成就的背后，是一段漫长的历程，涵盖了科学进步、工艺开发、临床前和临床研究、技术转让、监管申报以及生产准备。整个过程的实现得益于研究人员、学术界、产业界和全球合作伙伴之间的协作。”沙迪克说。According to Shadiq, Bio-RV’s neonatal dosing schedule provides an opportunity to establish protection against rotavirus from the earliest stage of life. 据Shadiq称，Bio-RV的新生儿剂量方案提供了从生命最早阶段建立对轮状病毒防护的机会。“What we aim to deliver is protection for Indonesian children as early as possible, while ensuring that Indonesia has the capacity to independently safeguard the continuity of vaccine supply. This forms part of Bio Farma’s contribution to strengthening national health resilience and sovereignty,” he added.. “我们的目标是在尽可能早的阶段为印尼儿童提供保护，同时确保印尼具备独立保障疫苗供应连续性的能力。这是生物法尔马公司为加强国家卫生韧性和主权所作贡献的一部分。”他补充道。Bio-RV originated from the RV3-BB vaccine candidate, based on a neonatal rotavirus strain developed by MCRI. The collaboration then progressed through clinical research and further development to prepare for Bio-RV production in Indonesia. Bio-RV 源于 RV3-BB 疫苗候选株，该候选株基于默多克儿童研究所（MCRI）开发的一种新生儿轮状病毒株。随后，双方通过临床研究和进一步开发推进合作，为在印度尼西亚生产 Bio-RV 做好准备。Human rotavirus was first identified in 1973 by MCRI Professor Ruth Bishop and Professor Ian Holmes from the University of Melbourne. Soon after, MCRI’s Professors Bishop and Barnes established a collaboration with UGM’s Professor Yati Soenarto, who was the first to confirm that rotavirus was the most common cause of diarrheal death and hospitalization in children in Indonesia. 人类轮状病毒于1973年由默多克儿童研究所（MCRI）的露丝·毕晓普教授和墨尔本大学的伊恩·霍尔姆斯教授首次发现。不久之后，MCRI的毕晓普教授和巴恩斯教授与印度尼西亚加查马达大学（UGM）的亚蒂·苏纳托教授建立了合作关系。亚蒂·苏纳托教授率先证实，轮状病毒是印度尼西亚儿童腹泻死亡和住院的最常见原因。In 1982, Professor Bishop identified RV3, an unusual rotavirus strain that infected newborn babies without causing disease and appeared to protect them from subsequent severe rotavirus diarrhea. . 1982年，Bishop教授鉴定出RV3，这是一种不寻常的轮状病毒株，可感染新生儿但不致病，并似乎能保护他们免受后续严重轮状病毒腹泻的影响。Building on this discovery, MCRI Professor Julie Bines led the development of RV3-BB as a live oral neonatal vaccine, taking it from a promising naturally occurring strain through clinical development in Australia, New Zealand and Indonesia. This work provided the foundation for Bio Farma’s Bio-RV vaccine. 在此发现的基础上，默多克儿童研究所（MCRI）的朱莉·拜恩斯教授领导了RV3-BB作为口服活体新生儿疫苗的研发工作，推动该疫苗从一种具有前景的自然毒株逐步完成在澳大利亚、新西兰和印度尼西亚的临床开发。这项工作为印尼生物法玛公司（Bio Farma）的Bio-RV疫苗奠定了基础。The close 50-year collaboration between the teams at UGM and. UGM 团队之间长达 50 年的紧密合作。MCRI has been pivotal to the clinical development of MCRI’s original RV3-BB vaccine and Bio Farma’s Bio-RV. The MCRI RV3-BB vaccine development was made possible through grants from the Gates Foundation and the Australian National Health and Medical Research Council. MCRI also acknowledges the Australian Government's enduring support for global health through the Department of Foreign Affairs and Trade.. 默多克儿童研究所（MCRI）在MCRI原创的RV3-BB疫苗以及印尼生物法玛公司（Bio Farma）的Bio-RV疫苗的临床开发中发挥了关键作用。MCRI RV3-BB疫苗的开发得益于盖茨基金会和澳大利亚国家健康与医学研究委员会提供的资助。MCRI还感谢澳大利亚政府通过外交贸易部对全球卫生事业提供的持续支持。Several partners have also supported the collaboration between Bio Farma and MCRI, including Universitas Gadjah Mada (UGM), Universitas Airlangga through the Airlangga Integrated Research Clinic (AIRC), and PATH at various stages of development. 多个合作伙伴也支持了Bio Farma与MCRI之间的合作，包括加查马达大学（UGM）、通过艾尔朗加综合研究诊所（AIRC）参与的艾尔朗加大学，以及PATH，在发展的各个阶段提供了支持。This collaboration has not only delivered a new vaccine but also strengthened Bio Farma’s capabilities to build Indonesia’s vaccine innovation ecosystem through cooperation among global research institutions, national academic institutions, and industry. Developing domestic capabilities across the Bio-RV development and manufacturing processes is expected to strengthen vaccine availability, reduce reliance on imported products, and support the sustainability of Indonesia’s National Immunization Program.. 此次合作不仅带来了一款新型疫苗，还通过全球研究机构、国家学术机构与产业界之间的协作，增强了印尼生物法玛公司（Bio Farma）构建印尼疫苗创新生态系统的能力。预计在本土建立涵盖Bio-RV研发和生产全流程的能力，将有助于提升疫苗供应稳定性，减少对进口产品的依赖，并支持印尼国家免疫计划的可持续发展。As part of the Danantara Indonesia ecosystem, Bio Farma remains committed to transforming national strategic assets and capabilities into tangible benefits for society while upholding good corporate governance, professionalism, and integrity. The development of Bio-RV represents a concrete contribution to improving quality of life through health innovation while strengthening Indonesia’s capabilities and competitiveness in the vaccine and life sciences industries.. 作为印尼Danantara生态系统的一部分，Bio Farma始终致力于将国家战略性资产和能力转化为社会的切实福祉，同时坚守良好的公司治理、专业精神和诚信原则。Bio-RV的研发是通过健康创新改善生活质量的实质性贡献，同时也增强了印尼在疫苗和生命科学产业的能力与竞争力。This initiative aligns with Danantara’s purpose, “Transforming National Assets into Prosperity with Integrity,” particularly through efforts to improve quality of life and build a stronger Indonesia supported by robust national healthcare industry capabilities. 这一倡议与达纳特拉的宗旨“以诚信将国家资产转化为繁荣”相契合，特别是通过改善生活质量，并依托强大的国家医疗健康产业能力，建设一个更强大的印度尼西亚。This achievement also reflects Bio Farma’s spirit of “Advancing Hope, Shaping the Future,” by turning hope into reality through health protection, science, innovation, and collaboration, while helping shape the future of healthcare in Indonesia and around the world. 这一成就也体现了印尼生物制药公司（Bio Farma）“推进希望，塑造未来”的精神，通过健康保护、科学、创新和合作将希望变为现实，同时助力塑造印度尼西亚乃至全球医疗保健的未来。Reporter: PR Wire 记者：PR WireEditor: PR Wire 编辑：PR WireCopyright © ANTARA 2026 版权所有 © ANTARA 2026

2026-09-03

·圭特RNA

mRNA 动态 | 行业简报

m R N A 行业动态行业简报 2026.9.3 · 总第 3期临床进展 × 产业动态 × 前沿文献 | 每周更新在mRNA技术加速迭代、临床转化不断推进的当下，及时掌握行业动态，是洞察技术趋势与把握发展机遇的重要基础。本期聚焦BioNTech猴痘mRNA疫苗首次人体数据登顶、Intismeran里程碑后的数据细节与商业化节奏，以及国内"AI+mRNA"与递送系统平台的价值兑现，与您共同了解行业最新成果，探索mRNA技术未来的发展方向。 01临床与管线进展 01BioNTech猴痘mRNA疫苗BNT166a首次人体I期数据登陆《柳叶刀·感染病学》：安全耐受、全剂量水平诱导强免疫应答由南安普顿大学医院牵头、在英国三处NIHR临床研究设施及美国两个中心开展的国际首次人体试验结果显示，BioNTech猴痘mRNA候选疫苗BNT166a在健康成人中总体安全且耐受性良好，并在所有剂量水平、无论既往有无正痘病毒疫苗接种史（48名未接种者+16名已接种者，共64名受试者）的受试者中，均诱导出可识别并对抗病毒的强抗体应答，部分证据提示对人类疫情中出现过的不同临床毒株可能具有保护潜力。研究论文已发表于《柳叶刀·感染病学》（The Lancet Infectious Diseases）。大多数不良反应为轻中度、一过性；候选疫苗现正推进至更大规模确证性试验。结合本周石药集团SYS6037获FDA批准进入美国临床，猴痘mRNA疫苗正形成"中国IND出海+国际人体数据落地"的双线竞速格局。来源：NIHR Southampton CRF；The Lancet Infectious Diseases（2026.9） 02Intismeran里程碑后续：III期关键数据细节与商业化节奏披露，Moderna目标2027年上市围绕全球首个III期阳性的个体化mRNA肿瘤疫苗，更多关键数据与商业化细节于本周披露：INTerpath-001研究共纳入1,137例IIB–IV期高危黑色素瘤术后患者，中期分析同时达到无复发生存（RFS）与无远处转移生存（DMFS）双终点；此前IIb期5年随访显示，联合帕博利珠单抗治疗使复发或死亡风险降低49%、远处转移或死亡风险降低59%（治疗18个月时联合组约79%未复发 vs 单药组62%）。商业化方面，Moderna已着手与监管沟通BLA申报，力争2027年上市；位于马萨诸塞州Marlborough的个性化生产设施目前"从穿刺到穿刺"周期约42天，年产能可扩至数万剂个性化剂量。管线拓展上，肺癌III期（含I期单药）、肾癌与膀胱癌II期推进中，胰腺癌、胃癌等探索性研究亦在布局；CEO Bancel称现有版本是"Intismeran历史上最差的一版"——基于III期患者数据的算法迭代仍在继续。该消息8月19日曾推动Moderna股价单日盘中涨超176%，市值自约250亿美元升至近700亿美元。来源：Merck/Moderna公告；无癌家园（2026.9.3）；21世纪经济报道（2026.9.2）；The a16z Show（2026.9.2） 02国内/外产业动态 01英矽智能×元码智药达成合作：共建"下一代mRNA AI原生研发引擎"，布局环状mRNA与靶向递送 9月2日，英矽智能宣布与下一代RNA创新药研发企业元码智药达成研发合作，双方将围绕AI新抗原预测与序列设计、环状mRNA（circRNA）、靶向递送、自动化实验及智能制造，共建下一代mRNA AI原生研发引擎，探索个体化肿瘤疫苗及相关创新疗法。英矽智能联合CEO任峰表示，Intismeran的III期阳性"证明了肿瘤疫苗这一分子形式是可行的"，希望以Pharma.AI结合元码智药的下一代RNA平台，推动AI药物研发向新模态拓展；元码智药CEO曾贤称，下一代mRNA肿瘤疫苗是对预测、设计、分子形态、靶向递送和个体化生产流程的系统性重构，双方将共建端到端闭环。同期，晶泰科技亦披露其与长江生命科技的AI癌症疫苗平台合作（聚焦p53等难靶）以及与尧唐生物共建AI驱动的mRNA干湿实验闭环筛选平台——"AI+新一代RNA"的产业组合正在密集成形。来源：英矽智能公告；上海市浦东新区政府网（2026.9.2）；21世纪经济报道 02康希诺披露mRNA平台细节：ISL-3C-LNP授权磐如生物收益超1亿元，"预防+治疗"双线管线成型康希诺生物9月3日披露8月投资者关系活动记录表，首次系统性阐述其mRNA技术平台布局：公司已建成从序列设计、递送系统到工艺放大的全链条自主能力，并开发新一代三组分LNP递送系统（ISL-3C-LNP）——基于可离子化甾醇脂质（ISL）构建，相较传统四组分系统细胞免疫应答更强、安全性更优（降低全身不良反应与肝毒性），已授权磐如生物用于前列腺癌mRNA治疗性疫苗全球开发，协议总收益超1亿元，递送系统商业价值率先兑现。管线上，"预防+治疗"双线推进：与马来西亚NIBM合作的多价流感mRNA疫苗处于临床前；治疗领域胶质母细胞瘤、横纹肌肉瘤（已获批IIT）、宫颈癌等mRNA治疗性疫苗与InVivo CAR疗法在研，并与德普世生物合作开发消化道实体瘤个性化疫苗。公司同时建成个性化/中试临床/商业化（年产能1亿剂）三级产线，中试产线已通过阿斯利康、PATH现场审计。来源：康希诺投资者关系活动记录表（2026.9.3）；东方财富 0319家A股疫苗企业半年考：行业承压之下，肿瘤mRNA疫苗被视为新风口新浪财经9月2日盘点显示，19家A股疫苗企业上半年11家营收下滑，行业整体承压（渠道去库存、应收账款高企）；而mRNA癌症疫苗正被视为行业新变量。据中信建投证券研报，截至2026年年中，国内已有20–30家企业布局肿瘤mRNA疫苗，整体处于I–II期临床及更早阶段：恒瑞医药双线布局（现货型RGL-232临床I期、个性化新抗原疫苗RGL-270临床II期）；云顶新耀以端到端mRNA平台布局个性化EVM16与现货型EVM14；康方生物打造"疫苗+IO双抗"协同（AK154）；石药集团布局通用型现货疫苗SYS6026；百克生物参股传信生物、安科生物参股合肥阿法纳生物切入赛道。中邮证券指出，个性化路线实现精准医疗、通用路线有望现货化，两条技术路线的产业化竞赛已在国内展开。来源：新浪财经（2026.9.2）；中信建投证券研报；中邮证券研报 03前沿文献速递 01mRNA-1010获批后的流感疫苗新格局：迈向"流感+新冠+RSV"组合呼吸道疫苗 2026年8月18日｜Vaccines（雅典大学团队）配合mFLUSIVA（mRNA-1010）获批上市热点，该综述系统梳理了mRNA-1010从临床开发到获批的完整历程，指出mRNA平台在流感疫苗快速迭代上的固有优势——无需鸡胚培养、序列可快速更新以匹配流行株。文章进一步提出，mRNA-1010的意义超出季节性流感本身：它为下一代呼吸道组合疫苗（同时覆盖流感、SARS-CoV-2与RSV）提供了技术与监管路径的参照，展示了mRNA疫苗技术在呼吸道传染病预防领域的更宏观图景。来源：Vaccines 2026;14(8):709（PMID: 42646726） 02ARV-2001临床前开发：皮内递送mRNA-LNP，治疗HPV-16阳性宫颈高级别鳞状上皮内病变 2026年8月19日｜Vaccines报道了治疗性mRNA-LNP免疫疗法ARV-2001的临床前开发：该候选针对HPV-16阳性的宫颈高级别鳞状上皮内病变（HSIL），采用皮内给药路线编码HPV-16 E6/E7抗原，旨在诱导特异性细胞免疫清除病变组织，为物理切除/消融之外的药物治疗选项提供概念验证。研究涵盖免疫原性评价与局部给药的耐受性数据，展示了mRNA治疗性疫苗在"癌前病变可逆窗口期"的差异化定位——不依赖冷链注射系统、可通过皮内途径实现免疫激活，为HPV相关疾病的干预窗口前移提供了新工具。来源：Vaccines 2026;14(8):714（PMID: 42646731） 03浆细胞样树突状细胞（pDC）是mRNA疫苗应答的"隐藏引擎"：新机制为佐剂优化指路 2026年8月21日｜EBioMedicine（瑞士团队）一项临床前小鼠研究揭示了浆细胞样树突状细胞（pDC）在BNT162b2 mRNA疫苗应答中的关键作用：pDC通过同时调控固有与适应性免疫通路、促进CD8+ T细胞活化，对mRNA疫苗诱导的体液免疫与CD8+ T细胞记忆应答发挥功能性支撑。这一发现修正了"mRNA疫苗免疫主要依赖髓系DC"的既有认知，提示pDC活性可作为预测疫苗应答强度与优化佐剂/组分设计的新的介入节点，对肿瘤mRNA疫苗与增强针策略的免疫学优化具有直接参考价值。来源：EBioMedicine 2026;131:106432（PMID: 42628376） — 行业简报 · mRNA行业动态 — 本简报内容基于公开信息整理，仅供参考，不构成任何投资建议或医疗建议。如需引用请注明原始出处 · 下期简报敬请期待

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