A Randomized, Multicenter, Double-Masked, Saline-Controlled Trial to Evaluate Corneal Endothelial Cell Density in Subjects With Dry Eye Disease Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months.

开始日期2024-07-31

申办/合作机构

Bausch & Lomb, Inc.

NCT06346340 / Active, not recruiting临床4期

A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy

开始日期2024-04-30

申办/合作机构

Bausch & Lomb, Inc.

NCT06309953 / Completed临床4期

An Open-Label, Multicenter, Phase 4 Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease

开始日期2024-02-28

申办/合作机构

Bausch & Lomb, Inc.

100 项与全氟己基辛烷相关的临床结果

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100 项与全氟己基辛烷相关的专利（医药）

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项与全氟己基辛烷相关的文献（医药）

2024-09-01·Cornea

Long-Term Safety and Efficacy of Perfluorohexyloctane Ophthalmic Solution for the Treatment of Patients With Dry Eye Disease: The KALAHARI Study

Article

作者: Vittitow, Jason L ; Krösser, Sonja ; Korenfeld, Michael S ; Segal, Bruce A ; Protzko, Eugene E

Purpose::

The aim of this study was to assess the long-term safety and efficacy of perfluorohexyloctane (PFHO) ophthalmic drop (formerly NOV03) for treatment of dry eye disease (DED).

Methods::

KALAHARI was a phase 3, multicenter, single-arm, open-label extension study in patients aged 18 years or older with DED associated with Meibomian gland dysfunction who completed the randomized, double-masked, hypotonic saline-controlled GOBI study. Patients instilled 1 drop of PFHO (MIEBO, Bausch + Lomb) 4 times daily in both eyes for 52 weeks. Safety assessments included adverse events, best-corrected visual acuity, slit-lamp biomicroscopy, intraocular pressure, and dilated fundoscopy. Efficacy end points included change from GOBI study baseline in total corneal fluorescein staining and eye dryness score (0–100 visual analog scale).

Results::

Overall, 208 patients from GOBI (PFHO [n = 97]; saline [n = 111]) were rolled over into KALAHARI. Twenty-nine patients (13.9%) had ≥1 ocular adverse event, with most being mild or moderate in severity; the most common ocular adverse events were vitreous detachment (1.9%), allergic conjunctivitis (1.4%), blurred vision (1.4%), and increased lacrimation (1.4%). Other safety end points were unremarkable. For patients continuing PFHO from GOBI, improvements in total corneal fluorescein staining and visual analog scale dryness scores observed in GOBI were maintained throughout KALAHARI. Patients treated with saline in GOBI and switched to PFHO in KALAHARI showed improvements in total corneal fluorescein staining and visual analog scale scores by week 4 that were maintained for the rest of the study.

Conclusions::

PFHO was safe and well tolerated and maintained efficacy for improving signs and symptoms of DED in this year-long study of patients with DED associated with Meibomian gland dysfunction.

2024-08-27·Cureus Journal of Medical Science

Efficacy and Safety of Perfluorohexyloctane in Evaporative Dry Eye Disease Associated With Meibomian Gland Dysfunction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Review

作者: Freitas, Marcos A A ; Mora-Paez, Denisse J ; Guedes, Jaime ; Souza, Maria Eduarda C ; Freitas, Marcos A A ; Fontes, Bruno M ; Fontes, Bruno M ; Hespanhol, Larissa C ; Faneli, Adriano Cypriano ; Balieiro, Caroline C A ; Melo, Hosanna S S

Meibomian gland dysfunction (MGD) is the primary cause of evaporative dry eye disease (DED), which negatively affects the physical and mental quality of life of patients. We performed a meta-analysis of randomized controlled trials (RCTs) comparing perfluorohexyloctane to placebo for MGD in order to identify the best course of treatment for DED in these patients. We followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guideline recommendations and prospectively registered the study in PROSPERO (CRD42023442172). The PubMed, Cochrane, and Embase databases were searched for RCTs comparing perfluorohexyloctane to placebo on patients with DED associated with MGD. The statistical analysis was carried out using the "R" software. The mean difference (MD) with 95% CIs was computed using a random-effects model, and p < 0.05 was regarded as statistically significant. The study included 1,814 patients from four RCTs, of whom 972 (53.5%) received perfluorohexyloctane. Patients treated with perfluorohexyloctane had significantly lower total corneal fluorescein staining (tCFS) score (MD -1.09; 95% CI -1.37 to -0.82; p < 0.001; I² = 0%), eye distress Visual Analogue Scale (VAS) (MD -9.69; 95% CI -12.01 to -7.36; p < 0.01; I² = 0%), Ocular Surface Disease Index (OSDI) (MD -5.79; 95% CI -8.22 to -3.36 p < 0.01; I² = 0%), and Eye Burning/Stinging Score (VAS) (MD, -7.16; 95% CI -9.55 to -4.80 p < 0.01; I² = 0%). The meta-analysis results indicate that perfluorohexyloctane was effective and safe in treating evaporative dry eye, reducing tCFS, eye discomfort, OSDI, and burning sensation, despite the included studies only assessing short-term effects and excluding certain patient groups.

2024-04-01·Drugs

Perfluorohexyloctane Ophthalmic Solution: A Review in Dry Eye Disease

Review

作者: Zhuang-Yan, Amy ; Syed, Yahiya Y

Perfluorohexyloctane ophthalmic solution (Miebo^®) is a single-entity, water-, steroid- and preservative-free, first-in-class semifluorinated alkane that is approved in the USA for the treatment of the signs and symptoms of dry eye disease (DED). DED is often linked with meibomian gland dysfunction (MGD), which causes an excessive evaporation of tears. Perfluorohexyloctane ophthalmic solution stabilizes the lipid layer of the tear film and inhibits tear evaporation by forming a monolayer at the air-liquid interface. In the phase III GOBI and MOJAVE trials in adults with DED associated with MGD, one drop of perfluorohexyloctane ophthalmic solution instilled in each eye four times daily over 8 weeks resulted in statistically significant and clinically meaningful improvements in the signs and symptoms of DED compared with hypotonic saline (0.6%). The agent was generally well tolerated, with most ocular adverse events being mild or moderate in severity. The efficacy and tolerability of perfluorohexyloctane ophthalmic solution was sustained for up to 52 weeks in an extension study (KALAHARI). As the first and currently the only prescription treatment approved in the USA directly addressing the pathophysiology of excessive tear evaporation, perfluorohexyloctane ophthalmic solution is a valuable emerging option for the management of DED.

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项与全氟己基辛烷相关的新闻（医药）

2024-11-22

·米内网

10亿眼科明星药集采止跌！TOP20洗牌，康弘、兴齐……国产品牌突围，恒瑞、信达新药来袭

精彩内容近期，眼科用药市场波澜再起。成都康弘药业集团的玻璃酸钠滴眼液、苏州乐珠制药的盐酸氮䓬斯汀滴眼液等4个产品同日获批。今年以来，眼科用药已有20个品种（133个受理号）获批上市。米内网数据显示，眼科用药在近年中国公立医疗机构终端销售规模均超过100亿元，2024年上半年同比下滑6.21%。5个国采品种中仅玻璃酸钠滴眼液正增长，从TOP20来看，康柏西普眼用注射液领跑，康弘、兴齐等国产品牌突围。眼科用药有52个品种（270个受理号）报产在审，辰欣佛都药业、扬州中宝药业等企业冲击首仿，5个新药亮眼。 4个眼科用药同日获批，兴齐、齐鲁、万汉制药领跑过评榜 11月以来眼科用药获批情况来源：米内网中国申报进度（MED）数据库 11月21日，国家药监局官网显示，华熙生物科技的玻璃酸钠滴眼液、成都康弘药业集团的玻璃酸钠滴眼液、苏州乐珠制药的盐酸氮䓬斯汀滴眼液和地夸磷索钠滴眼液同日获批，视同过评。在此之前，妥布霉素滴眼液第2家过评企业诞生，苏州乐珠制药和浙江莎普爱思药业均以仿制4类报产同日获批，视同过评。今年以来，眼科用药已有20个品种（133个受理号）获批上市，数量超过2023年全年。过评企业数10家及以上的眼科用药来源：米内网中国申报进度（MED）数据库截至目前，眼科用药有24个品种（256个品规）过评，7个品种有10家及以上企业过评，其中，玻璃酸钠滴眼液（41家）最为火热，其次是盐酸莫西沙星滴眼液（40家）、地夸磷索钠滴眼液（30家）。 8个品种独家过评，分别为成都普什制药的氯化钠滴眼液、沈阳兴齐眼药的环孢素滴眼液(Ⅱ)、四川禾亿制药的盐酸利多卡因眼用凝胶、兆科(广州)眼科药物的贝美素噻吗洛尔滴眼液、Maxmind的拉坦前列素滴眼液、汇禹远和(海南)药业的复方托吡卡胺滴眼液、山东绅联药业的盐酸环喷托酯滴眼液、苏州欧康维视生物的盐酸西替利嗪滴眼液，其中，山东绅联药业的盐酸环喷托酯滴眼液和苏州欧康维视生物的盐酸西替利嗪滴眼液均在今年获批。过评5个及以上眼科用药的集团来源：米内网中国申报进度（MED）数据库从集团过评品种数来看，沈阳兴齐眼药、齐鲁制药、中山万汉制药领跑，各有8个；远大健康、成都普什制药、欧康维视生物各有6个；扬子江药业、众生药业、莎普爱思药业、苏州乐珠制药等6家各有5个。 10亿明星药集采止跌！TOP20洗牌，康弘、兴齐……国产品牌突围米内网数据显示，近年中国公立医疗机构终端眼科用药（化学药+生物药）销售规模均超过100亿元，2024年上半年同比下滑6.21%，眼部血管病变治疗药、抗感染药、抗炎药是3大畅销小类。2024年上半年中国公立医疗机构终端眼科用药TOP5集团来源：米内网中国公立医疗机构药品终端竞争格局从集团格局来看，诺华集团、康弘药业、参天制药、沈阳兴齐眼药、拜耳位居前五，其中，康弘药业和沈阳兴齐眼药两家国内药企逆势上扬，销售额增速分别为25.74%和4.82%。 2024年上半年中国公立医疗机构终端眼科用药产品TOP20来源：米内网中国公立医疗机构药品终端竞争格局产品TOP20中，13个产品销售额超过1亿元，康柏西普眼用注射液是超10亿元的重磅品种，右旋糖酐羟丙甲纤维素滴眼液为新上榜产品。从在销企业数来看，妥布霉素滴眼液最多，有21家；其次是玻璃酸钠滴眼液和左氧氟沙星滴眼液均超过10家。目前，眼科用药已有5个产品纳入国采，左氧氟沙星滴眼液（第三批）、玻璃酸钠滴眼液（第四批）、地夸磷索钠滴眼液（第九批）均在产品TOP20之列。5个集采产品中仅有玻璃酸钠滴眼液正增长，4个产品均有下滑，地夸磷索钠滴眼液跌幅最大。近年中国公立医疗机构终端玻璃酸钠滴眼液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局玻璃酸钠滴眼液在中国公立医疗机构终端销售额峰值超过10亿元，受集采影响连续下滑后，2023年止跌回升，2024年上半年同比增长近5%，是眼科用药TOP3产品。该产品目前有54家企业拥有生产批文，参天制药、URSAPHARM、成都普什制药的市场份额位居前三。 2024年上半年中国公立医疗机构终端眼科用药品牌TOP20来源：米内网中国公立医疗机构药品终端竞争格局品牌TOP20中，成都康弘生物的康柏西普眼用注射液、诺华的雷珠单抗注射液、拜耳的阿柏西普眼内注射溶液位居前三，爱尔康的右旋糖酐羟丙甲纤维素滴眼液和沈阳兴齐眼药的加替沙星眼用凝胶则是新上榜品牌。 4个品牌增速超过20%，其中，成都康弘生物的康柏西普眼用注射液、沈阳兴齐眼药的环孢素滴眼液(Ⅱ)、珠海亿胜生物制药的牛碱性成纤维细胞生长因子滴眼液3个均是独家产品。从品牌数量来看，诺华最多，有4个上榜；参天制药和沈阳兴齐眼药各有2个上榜。辰欣、兆科……冲击首仿，恒瑞、信达新药来袭 11月22日，CDE官网显示，江苏福邦药业的玻璃酸钠滴眼液以仿制4类报产在审。在此之前，辰欣佛都药业的盐酸奥布卡因滴眼液、深圳市宇健生物医药|中山万汉制药的地夸磷索钠滴眼液同日报产在审。截至目前，眼科用药有52个品种（270个受理号）报产在审，地夸磷索钠滴眼液最火，有27家企业，其次是玻璃酸钠滴眼液，有20家。从企业数量来看，14家企业有5个及以上产品报产在审，其中，莎普爱思药业和宁波视方医药科技各有7个，沈阳兴齐眼药、兆科药业、石家庄格瑞药业等8家各有6个。国内无仿制药获批且报产在审的眼科用药来源：米内网中国申报进度（MED）数据库曲伏噻吗滴眼液、氟比洛芬钠滴眼液、盐酸依匹斯汀滴眼液等眼科用药国内暂无仿制药获批，辰欣佛都药业、扬州中宝药业、兆科(广州)眼科药物等企业有望拿下首仿。眼科用药新药报产在审情况来源：米内网中国申报进度（MED）数据库此外，信达生物制药(苏州)的替妥尤单抗注射液、山东博安生物技术的阿柏西普眼内注射溶液等5个眼科用药新药报产在审，其中，成都盛迪医药的SHR8058滴眼液为化药1类新药。资料来源：国家药监局官网、米内网数据库等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准一致性评价医药出海

2024-10-02

·novaliq

Novaliq and Laboratoires Théa Announce Partnership and EU Approval for Vevizye (Ciclosporin 0.1% Eye Drops Solution)

Heidelberg, Germany, Cambridge, MA, USA, and CLERMONT-FERRAND, France, October 2, 2024 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, and Laboratoires Théa (Théa), the leading independent eye care group in Europe, announce European Commission approval of Vevizye® (ciclosporin 0.1% eye drops solution) in Europe and the closing of a partnership under which Théa has acquired the rights to commercialise the product in Europe and selected countries in the Middle East and North Africa (MENA). Vevizye® is based on Novaliq’s proprietary EyeSol® technology and the only water-free ciclosporin 0.1% eye drops solution approved in the European Union for the treatment of moderate to severe dry eye disease (keratoconjunctivitis sicca) in adult patients which has not improved despite treatment with tear substitutes. “Our partnership with Novaliq highlights our dedication to delivering innovative treatments to all patients.”, stated Jean-Frédéric Chibret, President of the Théa Group. “We are looking forward to launching Vevizye® to complement our range of non-preserved treatments for dry eye, a disease that has substantial impacts on the quality of life of many patients.” Dry eye disease (DED) is one of the most common ocular surface disorders, affecting approximately 15 million diagnosed patients in the five largest European countries(1) and is difficult to treat(2). In Europe, there is a need for additional prescription treatments intended for adults suffering from moderate to severe dry eye disease. “We are thrilled to partner with Théa, the leading ophthalmic pharmaceutical company in Europe, to bring Vevizye® to patients. Théa’s focus on innovation, its leading commercial capabilities and the strong track record in Europe makes them the perfect partner for Novaliq” said Christian Roesky, Ph.D., Chief Executive Officer Novaliq. About ESSENCE 1(3) & ESSENCE 2(4) clinical studies The efficacy of Vevizye® for the treatment of dry eye disease was demonstrated by two randomised, multicentre, double-masked, vehicle-controlled studies (ESSENCE-1(3) and ESSENCE-2(4)). The change from baseline in total corneal fluorescein staining (tCFS) score at Day 29 was the primary endpoint in both trials. At Day 29, a statistically significant reduction in tCFS favouring Vevizye® was observed in both studies. Up to 71.6% of patients responded within four weeks with a clinically improvement in total corneal fluorescein staining. All other key secondary ocular surface sign endpoints (tCFS at Day 15, conjunctival staining at Day 29 and central corneal staining at Day 29) showed statistically significant effects favouring Vevizye® in both studies. Continued improvement under therapy in both signs and symptoms of DED were demonstrated over a period of up to 56 weeks.(5) About VEVIZYE® The product was approved by the US Food and Drug Administration (FDA) in May 2023 as VEVYE®. In the European Union (EU) the eligibility to the centralised procedure under Article 3(2)(b) of Regulation (EC) No 726/2004 was based on the “interest of patients”. Vevizye® is indicated for the treatment of moderate to severe dry eye disease (keratoconjunctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes. Vevizye® is approved in all 27 EU member states. Full European Summary of Product Characteristics for Vevizye® is available from the EMA website at www.ema.europa.eu . At time of publication of this press release, the full SPCs have not been yet published online. Additional regulatory applications are under review in several countries, including China, Australia, and New Zealand. About Novaliq Novaliq is a private biopharmaceutical company focusing on the development of first- and best-in-class ocular therapeutics. Novaliq developed EyeSol®, a novel drug category of water-free topical eye medicines. Two FDA-approved EyeSol® medicinal products for dry eye disease – Miebo® and Vevye® – are on the market in the US and are beginning to revolutionize patient care. The Novaliq R&D pipeline provides multiple development opportunities in ophthalmology and retina therapies. Novaliq is headquartered in Heidelberg, Germany and has an office in Cambridge, MA, USA. The long-term single shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More on www.novaliq.com. About Laboratoires Théa Théa is the leading independent European pharmaceutical company specialized in the research, development, and commercialization of eye care products. Based in Clermont-Ferrand, France, this family-owned and run company comprises more than 2,000 collaborators and has expanded by opening more than 35 affiliates and offices in Europe, North Africa, North and South America, and the Middle East. Its products are available in 75 countries. In 2023, Théa’s turnover reached €923 million. More on www.laboratoires-thea.com. Recommended Readings Global Data. Dry Eye Syndrome: Seven-Market Drug Forecast and Market Analysis Update | December 2022 Jones et al. TFOS DEWSII Management and Therapy Report. The Ocular Surface. 2017; 15 (3): 575-628 Sheppard et al. A Water-free 0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease: Results of the Randomized Phase 2B/3 ESSENCE Study. Cornea. 2021 Oct 1;40(10):1290-1297 Akpek et al. Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease The ESSENCE-2 Randomized Clinical Trial. JAMA Ophthalmology. 2023; 141(5):459-466 Wirta et. al. Long-Term Safety and Efficacy of a Water-Free Cyclosporine 0.1% Ophthalmic Solution for Treatment of Dry Eye Disease: ESSENCE-2 OLE. Cornea. 2024 May 21.

临床结果上市批准

2024-09-13

·药渡

医药一哥杀回来了！创新药收入直指503亿

9月8日，“医药一哥”恒瑞医药发布了《2024年员工持股计划》。公告显示，参加该持股计划的员工总人数预计不超过1203人（其中，董监高不超过18人，大部分为公司核心管理人员、骨干员工），本员工持股计划拟受让公司回购股份的数量不超过1220万股（含预留份额），受让价格为21.20元/股。而截至9月9日收盘，恒瑞医药股价为44.55元，按此计算折扣率达52.41%，意味着员工能以半价购入股票，优惠颇大。值得一提的是解锁条件，其中业绩考核指标包括3项：创新药销售收入、新分子实体IND获批数量、创新药申报并获得受理的NDA申请数量（包含新适应症），设定100%、90%、0%三个解锁比例。其中，“创新药销售收入”是最为关键的指标，若不能100%解锁，则无法实施该员工持股计划。而“创新药收入（亿元，含税）”的100%解锁条件是：2024年超过130亿元，2024-2025年累计超过295亿元、2024-2026年累计超过503亿元。这意味着，2025年、2026年创新药收入要分别超过165亿元、208亿元，相当于每年增速超过26%，足见恒瑞医药的雄心，能否如愿达标呢？恒瑞医药员工持股计划业绩考核指标图片来源：公司公告 01 已获批17款创新药，冲击130亿大关恒瑞医药在这个节点推出员工持股计划，有其“底气”所在。过去的2021、2022年，恒瑞均实现总营收和归母净利润同比双双下滑，但在2023年迎来了业绩拐点。尤其今年上半年，恒瑞交出了靓丽的成绩单：实现总营收同比增长21.78%至136.01亿元，归母净利润同比增长48.67%至34.32亿元。这是由于，今年上半年公司创新药收入达66.12亿元（含税，不含对外许可收入），虽然面临竞争加剧、产品降价及准入难等因素影响，仍然实现了同比增长33%，同时，公司在报告期内将收到的Merck Healthcare 1.6亿欧元对外许可首付款确认为收入，进一步推动经营业绩指标增长。据2024年半年报显示，恒瑞医药共有16款创新药在国内获批上市（14款自研，2款合作引进），其中富马酸泰吉利定在今年1月获批。报告期内，瑞维鲁胺、达尔西利、恒格列净等产品凭借纳入医保和进院数量的增加，实现收入快速增长；尚未纳入医保的阿得贝利单抗，借助多地普惠性惠民保进一步扩大收入；海曲泊帕凭借口服给药优势实现收入持续稳定增长；卡瑞利珠单抗、吡咯替尼、阿帕替尼等上市较早的创新药，随着新适应症的不断获批，也贡献了一定的销售增量。另外，今年上半年，国产首个PARP抑制剂氟唑帕利的第3个适应症（用于晚期卵巢癌一线含铂化疗后维持治疗）与脯氨酸恒格列净的第2个适应症（与盐酸二甲双胍和磷酸瑞格列汀联合使用治疗2型糖尿病）获批上市；氟唑帕利单药/联合阿帕替尼治疗伴有BRCA1/2突变的转移性HER2阴性乳腺癌，已处于上市申请阶段。不久前，恒瑞医药还迎来了在自免领域的首个创新药——夫那奇珠单抗，于8月27日获NMPA批准上市，用于治疗适合接受系统治疗或光疗的中重度斑块状银屑病的成人患者，打破了外资药企在IL-17A单抗领域的长期垄断局面。目前，全球已有3个IL-17A抗体药物获批上市，其中2023年诺华Cosentyx（司库奇尤单抗）和礼来Taltz（依奇珠单抗）全球销售额合计高达约77.4亿美元。可见，夫那奇珠单抗是潜在大单品，获批的首个适应症银屑病在我国约有700多万患者，其中中重度银屑病患者占比高达57.3%，估算有近400万人。此外，夫那奇珠单抗还开展了银屑病关节炎、成人活动性强直性脊柱炎、儿童及青少年中重度慢性斑块状银屑病等临床研究，其中成人活动性强直性脊柱炎已在NDA阶段。可以预见，随着已上市创新药持续拓展新适应症和新获批创新药的增量，恒瑞医药今年创新药收入大概率能超过130亿元。 02 业绩新引擎除已上市创新药外，已处于临床后期的在研创新药，也是助推恒瑞医药完成业绩考核指标的“新引擎”。据2024年中报显示，截至7月31日，恒瑞共有9款创新药处于NDA阶段，包括法米替尼联合卡瑞利珠单抗治疗复发转移性宫颈癌、HR20013预防化疗后恶心呕吐、HRX0701（复方）和HR20031（三方）治疗2型糖尿病、夫那奇珠单抗治疗成人活动性强直性脊柱炎、艾玛昔替尼和SHR-1209均针对3项适应症、SHR8058治疗睑板腺功能障碍相关干眼病、SHR8028（环孢素滴眼液）治疗干眼病（角结膜干燥症）。艾玛昔替尼（SHR0302）、瑞卡西单抗（SHR-1209）是备受关注的潜在大单品。艾玛昔替尼是新一代高选择性JAK1抑制剂，可用于治疗多种免疫炎症性疾病，目前已在国内递交了4项上市申请，包括成人和12岁及以上青少年中度至重度特应性皮炎、强直性脊柱炎、中重度活动性类风湿关节炎、成人斑秃，其中前3项适应症有望于2025年上半年获批上市。不仅如此，艾玛昔替尼还开展了针对银屑病关节炎、溃疡性结肠炎、活动性放射学阴性中轴型脊柱关节炎和轻中度特应性皮炎的Ⅲ期临床。值得一提的是，JAK抑制剂领域诞生了不少“重磅炸弹”，2023年诺华/Incyte的芦可替尼、艾伯维的乌帕替尼销售额分别达43亿美元、39.7亿美元。目前，恒瑞医药已针对SHR0302相关项目累计投入研发费用约10亿元，足见其重视程度。瑞卡西单抗是PCSK9抑制剂，该类药物有着比传统他汀类更高效（降脂作用更强）、更安全的优势，目前已提交3项适应症的上市申请，包括单药治疗原发性高胆固醇血症和混合型高脂血症、联合（降脂药）治疗血脂控制不佳的原发性高胆固醇血症和混合型高脂血症、单药治疗杂合子家族性高胆固醇血症。据公开数据显示，目前我国有接近1亿人患有高胆固醇血症，超过4亿人群患有血脂异常，患者人数相当庞大，市场规模超过200亿元。根据弗若斯特沙利文预计，2030年中国PCSK9抑制剂市场规模可达90亿元。不过，PCSK9药物市场竞争激烈，国内已有4款获批，包括安进的依洛尤单抗、再生元/赛诺菲的阿利西尤单抗、信达生物的托莱西单抗，以及诺华的PCSK9 siRNA药物Inclisiran（英克司兰钠）；另外，康方生物的伊努西单抗、君实生物的昂戈瑞西单抗，也已提交上市申请。尤其Inclisiran具备一年只需注射两针的超长效优势，今年上半年全球销售额同比增长135%至3.33亿美元，接近2023年全年水平，放量速度迅猛。恒瑞医药能否杀出重围？ 03 下一张王牌 3年创新药收入累计超过503亿元，恒瑞医药的“底气”不仅在于已获批17款创新药，更在于持续高额的研发投入，打造了丰富的产品管线，投身下一个贡献业绩增量的王牌产品。今年上半年，恒瑞医药累计投入研发38.6亿元，其中费用化研发投入30.38亿元，同比增长30.3%，研发投入占公司总营收的比重达到22.26%。随着快速推进创新药临床试验，上半年有诸多研发管线取得进展，共有2项上市申请获NMPA受理，10项临床推进至III期，20项临床推进至II期，19项临床推进至I期。今年上半年进入III期临床的管线，包括SHR-A1904（Claudin 18.2 ADC）、PD-L1抑制剂阿得贝利单抗、SHR-A1921（TROP2 ADC）、SHR-8068（CTLA-4单抗）、GLP-1/GIP双受体激动剂HRS9531、IL-4R单抗SHR-1819等，主要集中在抗肿瘤、自免和代谢等容易诞生大药的疾病领域。 2024年上半年研发管线进展情况（部分）图片来源：恒瑞医药2024年半年报 Claudin 18.2 ADC是ADC领域的热门赛道，目前共有4款国产药物达成海外授权合作，潜在总交易额合计超40亿美元，其中恒瑞在去年10月以超14亿欧元将SHR-A1904、HRS-1167（PARP1抑制剂）授予德国默克，并于今年上半年收到后者支付的1.6亿欧元首付款。 TROP2 ADC也是深受跨国制药巨头青睐的领域，目前全球仅吉利德的Trodelvy获批上市，该药2023年销售额近11亿美元。 HRS9531正在开展用于超重或肥胖的Ⅲ期临床，而减重领域是巨头必争的“当红炸子鸡”。今年5月，恒瑞将包括HRS9531在内的HRS-7535、HRS-4729等3款GLP-1类创新药，以总交易额60亿美元授予美国Hercules公司。 SHR-1819所在的IL-4R单抗领域，更是诞生了年销售额超110亿美元的度普利尤单抗，该药今年上半年销售额达约66.6亿美元，超越阿达木单抗、强生的乌司奴单抗，成为了新一代自免“药王”。 04 结语世上无难事，只要肯登攀。3年创新药收入累计超过503亿元，足见恒瑞医药的“雄心”。上一个有如此雄心壮志的创新药企是信达生物，立下了5年内“实现产品销售收入突破200亿元”、“获批产品数超过15款”的目标。究竟两家药企能否如愿达标，交由时间来检验。参考资料 1.各家公司的财报、公告、官微 2.华源证券、国投证券研报一年长高11厘米！诺和诺德长效生长激素国内申报上市《生物安全法案》通过引波澜：CXO板块集体受挫，药明康德跌超10% 偶联不止ADC，浅谈新型偶联药物——AOC

财报医药出海申请上市

100 项与全氟己基辛烷相关的药物交易

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研发状态

批准上市

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适应症	国家/地区	公司	日期
干眼综合征	美国	Bausch & Lomb, Inc.	2023-05-18

未上市

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适应症	最高研发状态	国家/地区	公司	日期
干眼症	申请上市	中国	成都盛迪医药有限公司	2023-02-01
睑板腺功能障碍	临床3期	美国	Bausch & Lomb, Inc.	2020-07-20

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04139798 (GOBI, CTgov)	临床3期	干眼综合征 \| 睑板腺功能障碍	599	NOV03 (NOV03 4 Times Daily (QID))	憲鹽願夢鬱淵鬱鬱壓鬱(憲鹽範鹹製夢艱製淵餘) = 淵觸艱遞製餘簾憲鹽繭選窪繭簾簾願淵糧願窪 (淵構醖襯壓鹹積艱餘顧, 蓋繭醖鹽選範醖網糧鏇 ~ 製築遞顧鹽鏇繭積鏇顧) 更多	-	2024-10-23
				Placebo (Placebo 4 Times Daily (QID))	憲鹽願夢鬱淵鬱鬱壓鬱(憲鹽範鹹製夢艱製淵餘) = 艱遞遞願簾衊齋簾艱襯選窪繭簾簾願淵糧願窪 (淵構醖襯壓鹹積艱餘顧, 鏇鹽醖醖願鏇壓餘製製 ~ 鑰鏇選遞簾積範膚鹹選) 更多
NCT04567329 (MOJAVE Study \| GOBI, CTgov)	临床3期	干眼综合征 \| 睑板腺功能障碍	620	NOV03 (NOV03)	積蓋鬱鏇廠鹹顧積鹹築(鹽糧鏇夢遞餘醖範衊糧) = 繭餘積壓鏇糧選壓窪鬱醖構範淵餘積餘糧糧鑰 (齋鏇膚衊憲夢顧獵獵簾, 廠鬱鏇製顧鬱構網廠衊 ~ 鹹構範鬱積鏇窪網選衊) 更多	-	2024-08-19
				Saline Solution (Saline Solution)	積蓋鬱鏇廠鹹顧積鹹築(鹽糧鏇夢遞餘醖範衊糧) = 淵築艱遞選獵簾範顧觸醖構範淵餘積餘糧糧鑰 (齋鏇膚衊憲夢顧獵獵簾, 艱膚糧襯壓鏇艱衊構簾 ~ 艱製衊壓構顧獵製艱觸) 更多
NCT04140227 (KALAHARI, Pubmed \| Cornea)	临床3期	干眼综合征	208	Perfluorohexyloctane (PFHO) ophthalmic drop	襯獵鹽窪製襯積壓壓製(簾顧廠鏇廠襯築衊齋觸) = 1.4% 選簾觸糧獵鏇築淵衊鑰 (觸範觸鬱鑰獵顧艱蓋鬱 ) 更多	积极	2023-11-03
NCT04567329 (MOJAVE Study, Pubmed \| Am J Ophthalmol)	临床3期	睑板腺功能障碍	620	NOV03	築網蓋遞膚襯齋構醖鏇(鏇築鑰鹹範網膚襯齋襯) = 鑰醖壓範壓壓範醖獵廠蓋鏇鏇鑰壓簾網顧鬱顧 (醖鹽願積淵醖鬱構積襯 ) 更多	积极	2023-08-01
				Saline	築網蓋遞膚襯齋構醖鏇(鏇築鑰鹹範網膚襯齋襯) = 製獵顧選鏇鏇鹹簾範選蓋鏇鏇鑰壓簾網顧鬱顧 (醖鹽願積淵醖鬱構積襯 ) 更多
MOJAVE (FDA) 人工标引	N/A	干眼综合征	1,217	MIEBO (GOBI)	餘範範選顧齋壓鬱繭繭(積觸憲醖憲餘膚網憲觸) = 齋醖製糧壓淵壓繭觸糧獵觸鏇鏇夢衊鹹遞膚選 (遞鬱網積顧遞壓憲醖齋, 2.1) 更多	积极	2023-05-18
				Saline (GOBI)	餘範範選顧齋壓鬱繭繭(積觸憲醖憲餘膚網憲觸) = 廠繭繭築築獵繭襯選糧獵觸鏇鏇夢衊鹹遞膚選 (遞鬱網積顧遞壓憲醖齋, 2.2) 更多
NCT04567329 (GOBI, PRNewswire) 人工标引	临床3期	干眼综合征 \| 睑板腺功能障碍	-	NOV03	繭齋廠淵鑰獵鹽淵構顧(壓願壓膚鬱蓋糧夢艱鹽) = 遞蓋艱築蓋窪顧衊蓋夢齋鏇壓選襯築糧醖顧鏇 (齋艱繭廠廠鑰網艱鬱衊 )	积极	2021-09-30
				Placebo	-
NCT03333057 (CTgov)	临床2期	干眼综合征	336	NOV03 (NOV03 2 Times Daily (BID))	鬱鹹壓鹽鬱窪醖齋廠襯(構獵鬱餘簾壓積廠構蓋) = 繭願範艱遞網獵積餘鏇選廠膚願蓋壓範鏇獵觸 (遞獵襯壓鏇鏇積鹹夢窪, 顧蓋餘鏇築齋網蓋蓋淵 ~ 淵觸廠製鏇鬱鑰衊鹽選) 更多	-	2021-05-24
				NOV03 (NOV03 4 Times Daily (QID))	鬱鹹壓鹽鬱窪醖齋廠襯(構獵鬱餘簾壓積廠構蓋) = 齋夢膚築窪艱憲壓獵鹽選廠膚願蓋壓範鏇獵觸 (遞獵襯壓鏇鏇積鹹夢窪, 鹽壓鏇衊遞獵衊簾鏇獵 ~ 構鏇築糧壓繭膚壓製遞) 更多
NCT04139798 (GOBI, Corporate Publications) 人工标引	临床3期	干眼综合征	597	NOV03	窪醖築鏇鹽繭積衊廠鬱(繭糧遞餘壓簾鏇鏇窪網): P-Value = <0.001 更多	积极	2021-04-13
				Placebo
ARVO2017	N/A	撕裂	4	Perfluorohexyloctane	鹹遞顧齋齋憲廠遞獵鬱(餘壓鬱襯製鹽簾願願鏇) = 艱壓遞積窪製蓋襯顧構繭醖窪糧範齋鑰衊膚衊 (窪製蓋鏇簾糧鹽範顧築 )	-	2017-06-01
ARVO2003	N/A	肌张力过低	19	Perfluorohexyloctane (F6H8)	遞醖夢鏇餘壓簾簾鑰範(製範鏇網積糧憲蓋壓餘) = 廠觸艱網繭顧簾餘網鹽憲鹹選鹹範膚鬱醖鹽範 (夢膚鏇淵鹽顧願簾選廠 ) 更多	-	2003-05-01