复星医药子公司复宏汉霖地舒单抗生物近似药HLX14获欧洲药品处罚局东说念主用药品委员会积极见地

2025年7月28日，复星医药子公司复宏汉霖(2696.HK)告示，欧洲药品处罚局(EMA)东说念主用药品委员会(CHMP)已发布保举公司自主设备的PROLIA/XGEVA(地舒单抗)在研生物近似药HLX14取得上市许可的积极见地,涵盖原研居品在欧盟已获批的一说念稳当症，障翳骨质疏松症、骨关联事件的严防及骨巨细胞瘤扶直等范围。这次获CHMP积极见地，记号着HLX14距离在欧洲终了可及性更进一步。

CHMP提出批准HLX14用于骨质疏松症及扶直骨折高风险的绝经后妇女及男性的骨质疏松症，骨折高风险的前哨腺癌男性因激素洗劫导致的骨质流失，骨折高风险成年患者因恒久全身糖皮质激素扶直导致的骨质流失，严防累及骨骼的晚期恶性肿瘤成东说念主的骨关联事件，以及扶直不行手术切除或手术切除后可能导致严重功能松懈的骨巨细胞瘤患者，包括成东说念主和骨骼发育练习的青少年患者。

复宏汉霖首席商务发展官兼高档副总裁

曹平默示

HLX14取得CHMP积极见地，彰显了咱们在生物近似药设备中的高质料表率与执续冲破。咱们将接续积极反映环球患者对优质可包袱生物药的需求，加速推动更多居品参预更多市集，以造福更锐利的患者群体。

这次EMA的积极见地主如果基于对HLX14一系列磋议数据的审查，包括分析雷同性磋议及临床比对磋议。这些数据齐解释了HLX14与原研居品在质料、安全性和有用性方面的雷同。复宏汉霖亦于本月取得比利时联邦药品和保健居品处罚局(Federal Agency for Medicines and Health Products)签发的GMP文凭，障翳包括HLX14在内的两款居品关联产线，记号着HLX14关联坐褥线已适合欧盟GMP表率。

复宏汉霖于2022年与organon达成授权许可和供应和谐，授予其对包括HLX14在内的两款在研生物近似药在除中国除外的环球区域进行独家交易化的职权，条约障翳欧盟、好意思国、加拿大等市集。此前，HLX14上市央求已取得加拿大Health Canada、好意思国FDA等多个监管机构的受理。

异日，复宏汉霖将执续以高质料表率推动环球化布局，联袂和谐伙伴加速后续注册和交易化程度，造福更多患者，进一步沉着公司在环球生物制药范围的抽象竞争力和品牌影响力。

对于复宏汉霖

复宏汉霖(2696.HK)是一家海外化的翻壮盛物制药公司，勉力于为环球患者提供可包袱的高品性生物药，居品障翳肿瘤、本身免疫疾病、眼科疾病等范围，已有6款居品在中国获批上市，4款居品在海外获批上市，5个上市央求离别获中国药监局、好意思国FDA和欧盟EMA受理。自2010年诞生以来，复宏汉霖已建成一体化生物制药平台，高效及翻新的自主中枢智商消亡研发、坐褥及交易运营全产业链。公司已莳植完善高效的环球翻新中心，按照海外药品坐褥质料处罚表率(GMP)表率进行坐褥和质料管控，不停夯实一体化抽象坐褥平台，其中，公司交易化坐褥基地已接踵取得中国、欧盟和好意思国GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质料的居品管线，涵盖约50个分子，并全面推动基于自有抗PD-1单抗H药汉斯状的肿瘤免疫纠合疗法。斥逐现在，公司已获批上市居品包括国内首个生物近似药汉利康(利妥昔单抗)、自主研发的中好意思欧三地获批单抗生物近似药汉曲优(曲妥珠单抗，好意思国商品名：HERCESSI，欧洲商品名：Zercepac)、汉达远(阿达木单抗)、汉贝泰(贝伐珠单抗)、环球首个获批一线扶直小细胞肺癌的抗PD-1单抗汉斯状(斯鲁利单抗，欧洲商品名：Hetronifly)以及汉奈佳(奈拉替尼)。公司亦同步就19个居品在环球范围内开展30多项临床进修，对外授权全面障翳西洋主流生物药市集和广宽新兴市集。

CHMP Recommends EU Approval of Henlius’Denosumab Biosimilar HLX14

Shanghai,China,July28,2025–Shanghai Henlius Biotech,Inc.(2696.HK)announced today that the European Medicines Agency’s(EMA)Committee for Medicinal Products for Human Use(CHMP)has adopted a positive opinion for HLX14,the company’s independently developed investigational denosumab biosimilar referencing Prolia/Xgeva(denosumab).The positive opinion covers all approved indications of the reference products in the EU,including osteoporosis,prevention of skeletal-related events,and treatment of giant cell tumour of bone.This marks an important step towards patient access to HLX14in Europe.

The CHMP recommends that HLX14be approved for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures,treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures,treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture,prevention of skeletal related events in adults with advanced malignancies involving bone,and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Ping Cao,Chief Business Development Officer and Senior Vice President of Henlius,said,"The positive CHMP recommendation on HLX14demonstrates our high standards and continued breakthroughs in biosimilar development.We will continue to actively respond to global patients’needs for high-quality and affordable biologics,and accelerate the advancement of more products into more markets to benefit a broader patient population."

The CHMP's positive opinion is mainly based on a series of head-to-head studies,including comparative quality analytical studies and clinical studies.These data prove that HLX14is similar to the reference denosumab in terms of quality,safety and efficacy.This month,Henlius received a GMP certificate issued by the Federal Agency for Medicines and Health Products in Belgium,covering production lines for HLX14and another product,indicating that the HLX14-related production lines meet the EU GMP standards.

In 2022,Henlius entered into a license and supply agreement with organon,granting organon the exclusive commercialization rights to two biosimilar candidates,including HLX11.The agreement covers markets such as the United States,the European Union,and Canada.An exception to the agreement is China.Prior to this positive opinion,marketing applications for HLX14had already been accepted by Health Canada,the US FDA and other regulatory authorities.

Looking ahead,Henlius will continue to uphold high standards to advance its global footprint,work closely with partners to accelerate registrations and commercialisation,benefit more patients,and further strengthen the company's competitiveness and brand influence in the global biopharmaceutical industry.

About Henlius Henlius(2696.HK)is a global biopharmaceutical company with the vision to offer high-quality,affordable and innovative biologic medicines for patients worldwide with a focus on oncology,autoimmune diseases and ophthalmic diseases.Up to date,6products have been launched in China,4have been approved for marketing in overseas markets,and5marketing applications have been accepted for review in China,the U.S.and the EU,respectively.Since its inception in2010,Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including RD,manufacturing and commercialization.It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China,the EU and U.S.GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering about50molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG(anti-PD-1mAb)as the backbone.To date,the company's launched products include HANLIKANG(rituximab),the first China-developed biosimilar,HANQUYOU(trastuzumab,trade name:HERCESSI in the U.S.,Zercepac in Europe),a China-developed mAb biosimilar approved in China,Europe and U.S.,HANDAYUAN(adalimumab),HANBEITAI(bevacizumab),HANSIZHUANG(serplulimab,trade name:Hetronifly in Europe),the world’s first anti-PD-1mAb for the first-line treatment of SCLC,and HANNAIJIA(neratinib).What’s more,Henlius has conducted over30clinical studies for19products,expanding its presence in major markets as well as emerging markets.

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