复宏汉霖汉曲优®(曲妥珠单抗)获美国FDA核准上市

颁布发表时候:2024-04-26 信息来厉于: 阅读量:

方面来源:复宏汉霖


  • 汉曲优®(美国商品名:HERCESSI™,欧洲商品名:Zercepac®)是在中国、欧盟、美国获批的“中国籍”单抗生物近似药;


  • 汉曲优®现已在环球40余个国度和地域获批上市,惠及逾18万患者;


  • 复宏汉霖加快速度環球国际设计,令高思想道德微生物药受惠環球国际人群


2024年4月26日,复宏汉霖(2696.HK)颁布发表,公司商务协作火伴Accord BioPharma Inc.(Intas美国子公司,“Accord”)于克日收到美国食物药品监视办理局(FDA)告诉,由复宏汉霖自立研发、出产的曲妥珠单抗生物近似药HERCESSI™(HLX02,中国商品名:汉曲优®,欧洲商品名:Zercepac®)获美国核准上市,用于帮助医治人表皮成长因子受体-2(HER2)过抒发的乳腺癌、HER2过抒发的转移性乳腺癌,和HER2过抒发的转移性胃腺癌或胃食管交壤腺癌。汉曲优®是在中国、欧盟、美国获批的“中国籍”单抗生物近似药,此前已于2020年7月及8月前后取得欧盟委员会与中国国度药监局(NMPA)核准上市。

复宏汉霖执行监事、总裁执行官兼总裁财政性官 朱俊师长体育教师

汉曲优®是复宏汉霖严酷根据中国、欧盟和美国等生物近似药律例自立研发的曲妥珠单抗,也是公司首个经由进程FDA核准在美国展开贸易化的产物。以患者为中间的初心差遣咱们不时摸索优良高效、更可承担和可及的医治挑选,而果断鞭策汉曲优®在环球40余个市场获批上市,恰是复宏汉霖对患者关心的实在回应。咱们等候将更多的北美患者归入咱们惠及的规模,让他们可以或许或许以更具性价比的体例取得高品德的生物药。

Intas副张总长兼张总总司理 Binish Chudgar师长美术教师

Intas即将上市FDA批准微生物体是药是机构美利坚共和国分院的各项关键性总建筑面积成绩排名,而这仅仅只是都是个抵达点。大家只望也需要虽然搭配极为面面俱到的微生物体是药结合,为知足客户和整形业务展现给方的必备,并助力器美利坚共和国整形系统软件完全大大俭节。大家的经营理念和初忠一致阵列让整形双倍可承受,而仅仅获准那必然将助力大家完全此种经营理念,为治疗历程中碰触的很多关头有什么好处相干方展现给大多付出,抓好他俩也需要虽然虽然拿得必备的口服药。


Accord美利坚共和国大总裁 Chrys Kokino师长英语教师

科学研究在法国整个市场拥有核定的第一款生态学是药HERCESSI,代表会了Accord在做患儿用药治疗因缘上迈向的关头一大步。乳房癌和直肠癌是最难见的肝癌复发范本之1,而肝癌复发治疗不时伴跟随艰巨的资金支付,是以有需注意为患儿提供给更好地资金经济实惠的治疗挑选到,打比方生态学是药。

秉心而行,以国.际思想品德受益更好糖尿病患者

乳腺癌是环球第二多发肿瘤[1]。据美国癌症协会数据显现,2024年美国乳腺癌新病发例估计将跨越37万例,位居该国癌症病发率第一,并显现逐年增加的态势[2]。此中,HER2过抒发的乳腺癌约占乳腺癌总数的15%-20%[2]。另外一方面,胃癌患者的HER2过抒发比率约为12%-23%[3]。曲妥珠单抗恰是医治HER2阳性乳腺癌和胃癌的基石类药物。自2020年7月及8月前后于欧盟和中国获批上市以来,汉曲优®(美国商品名:HERCESSI™, 欧洲商品名:Zercepac®)今朝已成功于英国、法国、德国、瑞士、澳大利亚、芬兰、西班牙、阿根廷、沙特阿拉伯、泰国等跨越40个国度和地域获批上市,笼盖亚洲、欧洲、拉丁美洲、北美洲和大洋洲,并进入中国、英国、法国和德国等多个国度的医保目次。停止今朝,汉曲优®(美国商品名:HERCESSI™, 欧洲商品名:Zercepac®)已惠及逾18万名患者。

这次FDA核准首要基于复宏汉霖递交的周全的阐发成果、临床前及临床研讨数据。自2015年以来,复宏汉霖针对汉曲优®(美国商品名:HERCESSI™, 欧洲商品名:Zercepac®)展开了一系列的头仇家比对研讨,包含品德对照研讨、临床I期和国际多中间临床III期研讨等。这些数据充实证实了汉曲优®(美国商品名:HERCESSI™, 欧洲商品名:Zercepac®)与原研曲妥珠单抗在品德、宁静性和有用性方面高度近似。

矢志不渝,以最高规范践行汉霖品德

汉曲优®(美国的货物名:HERCESSI™, 南美洲货物名:Zercepac®)一再拿得國际势利巨子国家药监局企业的死不承认,也致力于复宏汉霖坚持下去对物品德量的严酷申请。2024年,汉曲优®(韩国的商品是名:HERCESSI™, 欧式的商品是名:Zercepac®)相干出产园地和举措措施接管并顺遂经由进程美国FDA的核准前查抄(Pre-license Inspection, PLI)。这是继中国和欧盟药品出产物德办理规范(GMP)认证后复宏汉霖再获国际承认,成为经由进程中国、欧盟、美国GMP认证的自立研发和出产抗体药物的生物制药企业。


复宏汉霖如今也变成了组建买套适用香港國际品质管理规范的品质办证好控制系統,笼盖从项目新产品研发到原辅料办证好、代谢物主产、品质放肆、代谢物供求链办证好和代谢物开卖后跟踪定位的全小命定期。平台岩土工程师徐汇基底、松江基底(一)及松江基底(二)五个主产基底,现阶段纺织品纺织品国际货运化总产值已达48,000升,提交寰球代谢物意识化供求,周密笼盖中、东北亚、法国其他国家及拉丁北美洲。至今,平台纺织品纺织品国际货运化主产基底及配合的品质办证好控制系統己经由历程我我国食国家药监局局、法国其他国家医疗药品办证好局(EMA)、韩国食食国家药监局局(FDA)、欧洲共同体委员会品质受权人(QP)和平台香港國际纺织品纺织品国际货运协同合作火伴停此的好多项逐户查对及审计局,选取中、欧洲共同体委员会和韩国GMP认证服务。


环绕汉曲优®,复宏汉霖前瞻性地展开了国际贸易化规划,主动开辟海内市场,联袂环球贸易协作火伴Accord、Abbott、Eurofarma和Elea等国际一流的生物制药企业,周全规划美国、加拿大、欧洲和浩繁新兴国度市场,笼盖环球约100个国度和地域。跟着汉曲优®不时拓展到更广漠市场,复宏汉霖将加快为环球患者供给可承担的高品德生物药。

【参看论文】
[1] Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2020). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: //gco.iarc.who.int/today, accessed [29 January 2024] [2] American Cancer Society. Cancer Facts and Figures 2024. Atlanta: American Cancer Society; 2024.

[3] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastric Cancer V.3.2023

对于复宏汉霖

复宏汉霖(2696.HK)是一种家国外化的标新立义怪物医药业品牌,奋斗于为环宇患有市场机制可承担连带责任的高道德怪物药,有机物笼盖良性肿瘤、原本免疫细胞病、眼科整形病等本质特征,已在我国的什么时候挂牌销售5款有机物,在国外什么时候挂牌销售2款有机物,19项趋利避害症获准,6个什么时候挂牌销售申请离别时获我国的中药饮片监督管理局和欧洲共同体EMA审理。自2012年创立十八大以来,复宏汉霖已竣工内置式化怪物医药业APP,快速及标新立义的自强主焦点才行贯串新产品研发、主产及易货商贸销售经营全财产权链。品牌已创立好看快速的环宇标新立义其中,据国外中药饮片出有机物德代办管理规范化(GMP)管理规范化关闭程序主产和道德防范,经常压实内置式化网络综合主产APP,此中,品牌易货商贸化主产集地已接踵争取我国的、欧洲共同体和加拿大GMP身份验证。


复宏汉霖前瞻性规划了一个多元化、高品德的产物管线,涵盖50多个份子,并周全推动基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫结合疗法。继国际首个生物近似药汉利康®(利妥昔单抗)、自立研发的中美欧三地获批单抗生物近似药汉曲优®(曲妥珠单抗,美国商品名:HERCESSI™,欧洲商品名:Zercepac®)、汉达远®(阿达木单抗)和汉贝泰®(贝伐珠单抗)接踵获批上市,立异产物汉斯状®(斯鲁利单抗)已获批用于医治微卫星高度不不变(MSI-H)实体瘤、鳞状非小细胞肺癌、普遍期小细胞肺癌和食管鳞状细胞癌,并成为环球首个获批一线医治小细胞肺癌的抗PD-1单抗。公司亦同步就16个产物在环球规模内展开30多项临床实验,对外受权周全笼盖西欧支流生物药市场和浩繁新兴市场。


Henlius Trastuzumab Receives FDA Approval in the United States


  • HLX02 (trastuzumab-strf, trade name: HANQUYOU in China, HERCESSI™ in the U.S. and Zercepac® in Europe) is a China-developed mAb biosimilar approved in China, Europe, and U.S.


  • HLX02 was approved in more than 40 countries and regions around the world, benefiting more than 180,000 patients


  • Henlius accelerates global expansion, delivering high-quality biologics to patients worldwide


Shanghai, China, April 26, 2024 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the company's business partner, Accord BioPharma Inc. (the U.S. specialty division of Intas Pharmaceuticals, Ltd.), has received approval from the United States Food and Drug Administration (FDA) for HERCESSI™ (HLX02, trastuzumab-strf, biosimilar to Herceptin® trade name: HANQUYOU in China and Zercepac® in Europe), a trastuzumab biosimilar self-developed and -manufactured by Henlius. The product has been approved in the United States (U.S.) for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. HLX02 is a China-developed monoclonal antibody (mAb) biosimilar approved in China, the European Union (EU) and U.S., with previous approvals for commercialisation by the European Commission (EC) and National Medical Products Administration (NMPA) in July 2020 and August 2020, respectively.

 

Mr. Jason Zhu, Executive Director, Chief Executive Officer and Chief Financial Officer of Henlius remarked, “Henlius independently developed HLX02 in accordance with the NMPA, the European Medicines Agency (EMA), the FDA and other international biosimilar guidelines. It is Henlius’ first FDA-approved product. Our patient-centered approach has led us to unwaveringly explore high-quality, effective, affordable and accessible treatment options, and our determination to promote HLX02 in more than 40 markets around the world is Henlius' response to patients' concerns. We look forward to reaching more patients in North America and providing them with more cost-effective access to high-quality biologics.”

 

“Our first FDA-approved biosimilar is an important achievement for our U.S. specialty business, but we’re just getting started. We aspire to deliver one of the deepest portfolios of biosimilars to patients and providers alike, and to help the U.S. health system achieve significant savings,” said Binish Chudgar, vice chairman and managing director, Intas Pharmaceuticals. “Our vision to make affordable medicines available forms the bedrock of the company, and this work advances that vision to provide value and promote access for all the key stakeholders we engage along the treatment journey.”  


“The approval of HERCESSI - our first biosimilar to be approved in the U.S. - marks an important milestone for Accord BioPharma in our efforts to improve access for patients," said Chrys Kokino, U.S. president of Accord. “Because breast and gastric cancers are among the most common types of cancer and cancer can have a high-cost burden for patients, there is a need to provide these patients with additional treatment options that may be more affordable, such as biosimilars.”


HLX02 to benefit global patients

Breast cancer is the second most diagnosed cancer [1]. According to the American Cancer Society, over 370,000 new cases of breast cancer will be diagnosed in the U.S. in 2024, ranking first in the country's cancer incidence rates and showing year-over-year growth [2]. About 15% to 20% of breast tumors are HER2-positive breast cancers [2]. On the other hand, the reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23% [3]. Trastuzumab has long been a cornerstone of therapy for the treatment of HER2-positive breast and gastric cancers. Since its approval in the EU and China in July and August 2020, HLX02 (trade name: HANQUYOU in China, HERCESSI™ in the U.S., Zercepac® in Europe) has been successfully approved in more than 40 countries and regions, including the United Kingdom, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia, and Thailand, covering Asia, Europe, Latin America, North America, and Oceania, and it is reimbursed nationally in countries and regions including China, the United Kingdom (UK), France and Germany. To date, HLX02 has benefited more than 180,000 patients.

 

HLX02 (trade name: HANQUYOU in China, HERCESSI™ in the U.S., Zercepac® in Europe) was granted approval by the FDA based on a comprehensive package of analytical, pre-clinical and clinical study data submitted by Henlius. Since 2015, Henlius has conducted a series of head-to-head studies for HLX02, including comparative quality analytical studies, a phase 1 PK similarity study and a global multicentre phase 3 clinical study. The data indicates that HLX02 is highly similar to reference trastuzumab in terms of quality, safety, and efficacy.


Henlius Quality in line with highest quality standards

HLX02 (trade name: trade name: HANQUYOU in China, HERCESSI™ in the U.S., Zercepac® in Europe) has received recognition from global regulatory authorities for its longstanding commitment to maintaining manufacturing systems that comply with the highest quality standards. In 2023, the manufacturing site and facility where HLX02 is manufactured underwent and successfully passed the Pre-License Inspection (PLI) by the FDA. The success of the FDA PLI, as well as the previous GMP certifications from China and EU regulatory agencies, make Henlius a biopharmaceutical company GMP-certificated by China, the EU and U.S. for the manufacturing of self-developed antibody drugs.

 

Henlius has established a quality management system in accordance with the highest quality standards. The system covers the entire product life cycle from research and development to material management, product manufacturing, quality control, product supply management and product post-marketing surveillance. The company has built 3 manufacturing facilities, namely Xuhui Facility, Songjiang First Plant and Songjiang Second Plant. The current total commercial production capacity has reached 48,000 liters and maintains stable supply in China, Southeast Asia, Europe, and Latin America. The company's commercial production facilities and supporting quality management system have passed on-site inspections and audits conducted by the NMPA, the EMA, the FDA, the EU Qualified Person, as well as Henlius’ international business partners, and have been GMP-certificated by China, the EU and U.S. regulatory agencies.

 

Henlius has aggressively pursued international commercialization of HLX02 and is actively collaborating with global partners such as Accord, Abbott, Eurofarma, and Elea to bring its therapeutics to patients in the U.S., Canada, Europe, and other emerging markets, covering about 100 countries and regions. As the product expands into more countries, Henlius will accelerate the delivery of high-quality, affordable, and innovative medicines to patients worldwide.

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, 5 products have been launched in China, 2 have been approved for marketing in overseas markets, 19 indications are approved worldwide, and 6 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, 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 over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.    






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