H药汉斯状®领衔，复宏汉霖携创新研发成果连续五年参展BIO International Convention

发布时间:2023-06-12 方面的来缘于： 浏览量：

文章来源于：复宏汉霖



荷兰时候6月5日-8日，2023荷兰怪物方法交流会暨展品会（2023 BIO International Convention，“BIO 2023”）在荷兰麻省波士顿叁加。复宏汉霖携好些款企业创新产品研发优秀成果再揭幕本次交流会，在波士顿展览机构（Boston Convention & Exhibition Center）1635展台模型为与会人员者男主持人造成 美妙呈现，吸引了了有很多与会人员者男主持人及阻止厂家前往观光，与出自于世界各国的怪物药厂厂家和生物材质医药厂家按份共有论述了在怪物材质方法、方法机构、淋巴肿瘤免疫检测携手中医疗法等角度合作方式互利共赢的存在机遇与挑战。


 


复宏汉霖顶尖商进展官曹平表述："算作各国生态学技术健康安全领域业最沉要的服务平台之六，BIO 2023洽谈会为.我展示了付出的时间，以进每一步拉大.我的网咯，并与各国生态学技术健康安全街道办事处加入关联。为此BIO 2023洽谈会这段时间内，复宏汉霖做和陆续参与了100每局会谈，与内在的媒体合作协议小粉丝探究了一般品牌授权和产品设备入选的时间，令人们对复宏汉霖自从有了更感触颇深入的详细了解，并感触颇深认可复宏汉霖的神圣职责和社会个人价值观念。.我充满期待联手一些本着同样愿景是什么的媒体合作协议小粉丝，相互统筹推进业突飞猛进，将可经济负担的高质量生态学技术药给人以各国病号。”
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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。H药 汉斯状®（斯鲁利单抗）是全球首个用于治疗小细胞肺癌（SCLC）的抗PD-1单抗，该产品治疗SCLC已获得美国FDA和欧盟EC的孤儿药资格认定。2023年3月，H药联合化疗一线治疗ES-SCLC的上市许可申请（MAA）获得EMA受理。此外，公司在美国启动了一项H药对比一线标准治疗阿替利珠单抗的头对头桥接试验，并计划于2024年在美国递交上市申请，有望惠及全球更广泛的肿瘤患者群体。公司另一款抗肿瘤核心产品汉曲优®（曲妥珠单抗）是中国首个自主研发的中欧双批单抗药物。作为国产生物药“出海”代表，汉曲优®在英国、法国、德国、瑞士、澳大利亚、新加坡、阿根廷、沙特阿拉伯等30多个国家获批上市，同时，汉曲优®的上市许可申请已获得美国FDA受理，有望进一步覆盖欧美主流生物药市场。


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100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30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48000升。公司商业化生产基地及配套的质量管理体系已获得中国和欧盟药品生产质量管理规范（GMP）认证，可为公司已上市产品提供商业化生产，并已实现中国和欧盟市场常态化供应，强力支撑产品在全球的持续放量。商业化方面，公司搭建了超过1000人的自主商业化团队负责汉曲优®和H药 汉斯状®等核心肿瘤产品在中国市场的商业化推广，同时前瞻性地布局海外市场，积极与Abbott, Accord Healthcare, Getz Pharma, Eurofarma, Organon和银河集团官网 医药等国际制药企业达成战略商业化合作，产品对外授权覆盖美国、欧盟、日本等主流生物药市场和新兴市场。凭借在全球合作增长方面的卓越表现和优秀的品牌声誉，复宏汉霖在Global Generics & Biosimilars Awards 2022（GGB Awards，2022全球仿制药与生物类似药奖）榜单中斩获 “Business Development of the Year”（年度商务拓展奖）。


未来的发展，复宏汉霖将仍然聚焦点临床试验和市场上未被供需的供需，激发非常多安全保障高朝、有效时间好的、用户可负担重的企业创新生物工程药产品设备，坚持加强科研开发、生产销售及服务业化的亚洲运营服务制度，不断探索非常多國际上化达成合作可能会，全面、明确加快國际上化进度，谋福利亚洲非常多用户群体心理。

关于美国生物技术大会暨展览会

国外海洋生物制品制品体工程医药科技性技艺性大时会暨展览厅会(BIO International Convention)是全.球最多的海洋生物制品制品体工程医药科技性技艺性相应互联网职业中博览会，聚众了来全.球的互联网职业中内进取海洋生物制品制品体工程医药科技性药厂企业、融资商及相互合作方式协议商，并有越来越多相互合作方式协议活跃在大时会前三天如期举行。大时会由国外海洋生物制品制品体工程医药科技性技艺性特色化组织开展中介企业(Biotechnology Innovation Organization，接下来缩写“BIO”) 主办方，是代表人海洋生物制品制品体工程医药科技性技艺性企业、学术界中介企业和相应中介企业的全.球最多海洋生物制品制品体工程医药科技性技艺性相应互联网协会会员，其员工涉及国外和一些30个欧洲国家。BIO强院于为海洋生物制品制品体工程医药科技性技艺性相应互联网职业中展示越来越多相应互联网职业中座谈会、相互合作方式协议机遇与挑战可能。


关于复宏汉霖

复宏汉霖（2696.HK）是家国.际化的革新海洋微生物工程药业新子公司，始终坚持于为欧洲女性供应可负荷的高高端海洋微生物工程药，厂品设备铺盖良性肿瘤、厂品免疫细胞疫情、骨科疫情等领域行业，已在国内 推出5款厂品设备，在国.际推出1款厂品设备，18项适宜症获准，3个推出子公司申请各是获国内 国家药监局局、意大利FDA和欧共体EMA核发。自20十多年子公司设立来说，复宏汉霖已建起集成化海洋微生物工程药业电商公司，优质及革新的自由目标业务能力环绕研制、出产及商业区运营推广全房产链。新子公司已确立改善优质的欧洲革新咨询中心，通过国.际保健药品出产重量菅理正规（GMP）规定进行出产和重量安全控制，迅速夯实基层基础集成化综合性出产电商公司，这里面，昆明徐汇幼儿园已领取国内 和欧共体GMP认可，松江幼儿园（一）也已领取国内 GMP认可。


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®，澳大利亚商品名：Tuzucip®和Trastucip®）、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、鳞状非小细胞肺癌和广泛期小细胞肺癌，成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，其食管鳞状细胞癌适应症的上市注册申请也正在审评中。公司亦同步就16个产品在全球范围内开展30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 Shines for Five Consecutive Years at BIO International Convention


From June 5-8, 2023, the 2023 BIO International Convention (“BIO 2023”) was held in Boston, Massachusetts, USA. At the Boston Convention & Exhibition Center’s booth 1635, Henlius showcased a wide range of innovative research and development accomplishments for conference attendees.


During the conference, Henlius engaged in in-depth discussions 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 interactions focused on advancing new approaches to science, including therapeutic biologics, technology platforms, immuno-oncology target combinations, and building robust partnerships to accelerate innovation.


“BIO 2023 provided Henlius with a remarkable platform to further expand our network and build potential relationships within the global biotech and pharma community. We concluded the conference with over 100 in-depth meetings for in-licensing, research collaboration, or commercial right out-licensing. We also promoted Henlius’ mission and values,” says Ping Cao, Chief Business Officer of Henlius. “Our business development strategies are driven by a shared vision of advancing patient care and forging strategic alliances that enable us to bring affordable and effective treatment solutions to more patients in need.”


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. One highlight was the global presence of HANSIZHUANG (serplulimab), the world's first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC). HANSIZHUANG was granted Orphan Drug Designations by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of SCLC. In March 2023, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for HANSIZHUANG for the first-line treatment of ES-SCLC. Patients have also been dosed in a head-to-head bridging trial of HANSIZHUANG versus first-line standard-of-care atezolizumab for ES-SCLC in the U.S. The company plans to submit a Biologics License Application (BLA) for HANSIZHUANG in the U.S. in 2024. Additionally, the company prides itself on its trastuzumab biosimilar HANQUYOU (trade name in Europe: Zercepac®, trade names in Australia: Tuzucip® and Trastucip®), the first China-developed mAb approved in both China and Europe. It is now approved in more than 30 countries, including China, the United Kingdom (UK), France, Germany, Switzerland, Australia, Singapore, Argentina, and Saudi Arabia. In February 2023, the Biologics License Application (BLA) for HANQUYOU has been accepted by the FDA, which will further expand the product's footprint in major markets of biologics in the U.S. and Europe.

  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 30 clinical trials in China, the EU, the US, Australia, etc. with more than 100 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 48,000 L. The company's commercial production facility and supporting quality management system have been certificated by China and the EU GMP. At present, a stable supply has been achieved in the Chinese and the EU markets, strongly supporting the continued expansion of the products globally. In terms of commercialization, Henlius has built a top-tier in-house commercial team of over 1000 sales forces for the local commercialization of the company's core oncology products such as HANQUYOU and HANSIZHUANG. In addition, Henlius has actively partnered with other global companies such as Abbott, Accord Healthcare, Getz Pharma, Eurofarma, Organon, and Fosun Pharma to expand into mature and emerging markets, including the U.S., EU, and Japan. In recognition of its remarkable global partnership growth and brand reputation, Henlius received the ‘Business Development of the Year’ award from Generics Bulletin in 2022.   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 has been approved for marketing in overseas markets, 18 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, the U.S., 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 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 for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®, 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, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. Its NDA for the treatment of esophageal squamous cell carcinoma (ESCC) is under review. 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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