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复宏汉霖携多款重磅创新生物药产品亮相BIO 2022

发布时间:2022-06-20 作者: 来源: 浏览量:

内容来源于:复宏汉霖

美国太平洋标准时间6月13日-16日,2022美国生物技术大会暨展览会(2022 Biotechnology Innovation Organization International Convention,“BIO 2022”)在美国加利福尼亚州圣迭戈举行,吸引了逾3000位参展商以及众多全球行业领导者和顶级研究学者。复宏汉霖携多款创新研发成果亮相此次大会,在圣迭戈展览中心(San Diego Convention Center)5107展台为参会嘉宾带来精彩展示。

此次BIO 2022大会期间,复宏汉霖吸引了众多参会嘉宾及组织机构前来参观展台,并开展和参与了90多场会面,与来自全球的生物制药公司和医药公司共同探讨了在生物制品治疗、技术平台、肿瘤免疫联合疗法等方面合作共赢的潜在机遇。复宏汉霖多元化的产品管线和国际化布局令人瞩目,特别是近期公司首个创新产品H药 汉斯状®(斯鲁利单抗)以优异临床结果入选2022年美国临床肿瘤学会(ASCO)年会,成为首个在一线肺癌领域做口头报告的国产抗PD-1单抗。此外,公司于大会首日宣布与Organon公司达成授权合作,授予其对复宏汉霖自主开发的帕妥珠单抗生物类似药HLX11和地舒单抗生物类似药HLX14两款产品在除中国以外全球范围内进行独家商业化的权益,全面覆盖美国、欧盟、日本等主流生物药市场和众多新兴市场。

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复宏汉霖立足患者需求,致力于凭借强大的产品研发、前沿的生产与质量体系及卓越的商业化能力,携手价值链上的伙伴积极布局拓展全球生物药市场,为全球患者提供可负担的高品质生物药。研发方面,公司协同中美两地创新中心及全球产品开发团队,持续加码创新,夯实丰富的多元化产品管线,已累计在全球范围内获得超过70项临床试验批准,并同步在中国、欧盟、美国和澳大利亚等国家和地区开展20多项临床试验。生产方面,公司严格遵照按照国际药品生产质量管理规范(GMP)标准进行生产和质量管控,现有商业化产能共计48000L,管线内产品均由公司自主生产,积累了从临床到商业化各阶段产品的丰富生产经验。商业化方面,公司搭建了超过800人的自主商业化团队负责汉曲优®(曲妥珠单抗)和H药 汉斯状®(斯鲁利单抗)等核心肿瘤产品的商业化推广,同时前瞻性地开展了国际商业化布局,积极开拓海外市场,并与Abbott, Accord, Cipla, Eurofarma, Organon, Jacobson Medical, KG Bio, FARMA DE COLOMBIA和Mabxience等国际制药企业达成战略商业化合作,产品对外授权覆盖欧美主流生物药市场和新兴市场。

未来,复宏汉霖将继续聚焦临床和市场未被满足的需求,开发更多安全性高、疗效好的、患者可负担的创新生物药产品,持续强化研发、生产及商业化的全球运营体系,探索更多国际化合作可能,全面加速国际化进程,惠及全球更多患者群体。

关于 美国生物技术大会暨展览会

美国生物技术大会暨展览会(BIO International Convention)是全球最大的生物技术行业盛会,聚集了来自全球的业内领先生物制药公司、投资商及合作商,并有诸多合作活动在大会期间举行。大会由美国生物技术创新组织机构(Biotechnology Innovation Organization,以下简称“BIO”) 主办,是代表生物技术公司、学术机构和相关机构的全球最大生物技术行业协会,其成员覆盖美国和其他30个国家。BIO致力于为生物技术行业提供更多行业交流、合作机遇机会。

关于复宏汉霖

复宏汉霖(2696.HK)是一家国际化的创新生物制药公司,致力于为全球患者提供可负担的高品质生物药,产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域,已在中国上市5款产品,在欧洲上市1款产品,13项适应症获批,2个上市注册申请获得中国药监局受理。自2010年成立以来,复宏汉霖已建成一体化生物制药平台,高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心,按照国际药品生产质量管理规范(GMP)标准进行生产和质量管控,不断夯实一体化综合生产平台,其中,佛山徐汇基地已获得中国和欧盟药品GMP认证,松江基地(一)也已获得中国GMP认证。


复宏汉霖前瞻性布局了一个多元化、高质量的产品管线,涵盖20多种创新单克隆抗体,并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。继国内首个生物类似药汉利康®(利妥昔单抗)、中国首个自主研发的中欧双批单抗药物汉曲优®(曲妥珠单抗,欧洲商品名:Zercepac®)、汉达远®(阿达木单抗)和汉贝泰®(贝伐珠单抗)相继获批上市,创新产品汉斯状®(斯鲁利单抗)已获批用于治疗微卫星高度不稳定(MSI-H)实体瘤,其鳞状非小细胞肺癌和广泛期小细胞肺癌两项适应症的上市注册申请也正在审评中。公司亦同步就12个产品、10个免疫联合治疗方案在全球范围内开展20多项临床试验,对外授权全面覆盖欧美主流生物药市场和众多新兴市场。


Henlius Attends BIO 2022


From June 13-16, 2022, the 2022 Biotechnology Innovation Organization International Convention (“BIO 2022”) was held in San Diego, California, USA. The conference attracted more than 3,000 exhibitors, as well as many global industry leaders and top research scholars. At the San Diego Convention Center’s booth 5107, Henlius showcased a wide range of innovative research and development accomplishments for conference attendees.

 

During the conference, Henlius ended with more than 90 meetings with national and international partners and multiple possible leads for in-licensing, research collaboration, or commercial right out-licensing conducted at the Henlius’ booth throughout the four-day exhibition. These discussions focused on advancing new approaches to science, including therapeutic biologics, technology platforms, immuno-oncology target combinations, and building robust partnerships to accelerate innovation. Henlius’ diversified product pipeline and international presence was attractive to attendees. Most impressive is Henlius' leading innovative product, HANSIZHUANG (serplulimab), which was the first China-based company developed anti-PD-1 mAb to be orally presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting for the first-line treatment of lung cancer. Subsequently, Henlius announced on the first day of BIO 2022 that it had entered into a license and supply agreement with Organon LLC for the exclusive global commercialization of Henlius independently developed HLX11 (Pertuzumab biosimilar) and HLX14 (Denosumab biosimilar) in ex-China countries, including mature markets such as the United States, the European Union and Japan, as well as emerging markets.

 

Having the goals of providing innovation and affordability for patient centric unmet medical needs, Henlius has actively expanded the global markets by leveraging its strong product development, manufacturing and quality systems, and commercialization capabilities, as well as collaborating with capable partnerships to accelerate these goals. Synergising its innovation centres in China and the US and global product development teams, the company continues to build on the momentum to expand an even more diversified innovation product pipeline and has conducted more than 20 clinical trials in China, the EU, the US, Australia, etc. with more than 70 clinical trial approvals worldwide. In terms of manufacturing, the company strictly follows the International Good Manufacturing Practice (GMP) standards for production and quality control. It has a total commercial manufacturing capacity of 48,000L currently, and all the products in the pipeline are produced in-house, accumulating vertically integrating production experience and capabilities from clinical stages to commercialized products. In terms of commercialization, Henlius has built a top tier in-house commercial team of over 800 sales force for the commercialization of the company's core oncology products such as HANQUYOU (trastuzumab biosimilar, Zercepac® in Europe) and HANSIZHUANG. In addition, Henlius has actively collaborated with global partners such as Abbott, Accord, Cipla, Eurofarma, Organon, Jacobson Medical, KG Bio, FARMA DE COLOMBIA, and Mabxience to expand the global presence of bring innovative medicines and affordability to patients both in major and emerging markets.

 

Looking forward, Henlius will maintain its focus on unmet medical and market needs; develop more high-quality, affordable and innovative biologics; advance its global R&D, production, and commercialization capabilities; expand international collaborations, and accelerate building a global presence to benefit patients worldwide.

About BIO International Convention

BIO International Convention is the world’s largest gathering of the biotechnology industry along with industry-leading investor and partnering meetings held around the world. It is produced by BIO (Biotechnology Innovation Organization), which is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO works towards enriching the industry with networking, partnering and education opportunities.

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, 1 in Europe, 13 indications approved worldwide, and 2 New Drug Applications (NDAs) accepted for review in China. 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 centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP.


Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) 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, trade name in Europe: Zercepac®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors and its NDA for the treatment of squamous non-small cell lung cancer and extensive small-cell lung cancer (ES-SCLC) are under review. What's more, Henlius has conducted over 20 clinical studies for 12 products and 10 combination therapies.