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 主要内容由来于： 浏览量：

信息源于：复宏汉霖



美利坚共和国的时期6月5日-8日，2023美利坚共和国的微动物系统多而暨展品会（2023 BIO International Convention，“BIO 2023”）在美利坚共和国的麻省波士顿开展。复宏汉霖携许多不断创新创新成效二次现身旨在多而，在波士顿国际展会中（Boston Convention & Exhibition Center）1635呈现台为出席会议客人创造火爆呈现，深深吸引了许多出席会议客人及结构企业前去瞻仰，与发源中国的微动物制药厂我司和医疗器械我司共同体论述了在微动物产品中药治疗、系统app、肺部肿瘤免疫性联席中医疗法等部分合作的互赢的存在创业机会。


 


复宏汉霖顶尖商业成长官曹平表示法："做全世界生态学国药各个领域偏重要的网站之1，BIO 2023洽谈会为让你们公司提高了贵重的成功的人，以进的一步增加让你们公司的数据网络，并与全世界生态学国药平台打造沟通。我司BIO 2023洽谈会期间里，复宏汉霖组织开展和参与到了100多局交谈，与未知联合同伴论述了外商许可和产品的入选的成功的人，令朋友对复宏汉霖出现更紧入的了解，并领会到重视复宏汉霖的历史使命感和使用价值观念。让你们公司我期待共话更大牢固树立重复战略目标的联合同伴，之间持续推进业进一步，将可负担重的好的生态学药我们对全世界糖尿病患者。”
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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）。


未来发展，复宏汉霖将依然专注临床护理和行业市场未被满足需要的需求分析，发掘大多安全的高朝、治疗作用好的、女性可额外负担的自主创新生物制品药物品，不断增幅生产方式研发、生产方式及行业化的全国在运营体系建设，探秘大多国际联盟级化企业合作有可能，推进改革速度国际联盟级化守护进程，劳有所得全国大多女性消费群。

关于美国生物技术大会暨展览会

美利坚共和国微微微微生物体体新技能会暨展馆会(BIO International Convention)是各国较大 的微微微微生物体体新技能制造业博览会，群聚了是来自于各国的制造业内更优微微微微生物体体制药厂集团、加盟商及联合商，并有遭受联合运动在会这段时间拉开帷幕。会由美利坚共和国微微微微生物体体新技能创新性结构部门(Biotechnology Innovation Organization，之下英文缩写“BIO”) 协办，是是微微微微生物体体新技能集团、科研部门和相应部门的各国较大 微微微微生物体体新技能制造业协会会员，其成员英文合并美利坚共和国和另外的30个国度。BIO专业专注于为微微微微生物体体新技能制造业供给其他制造业讨论、联合契机机。


关于复宏汉霖

复宏汉霖（2696.HK）一家国家联盟化的的技术创新发展生态学制品技术药厂工司，全力于为世界患儿具备可压力的高物品品质生态学制品技术药，物品包裹淋巴肿瘤、人体免疫检测疫情、眼科医生疫情等层面，已在大发售5款物品，在国家联盟发售1款物品，18项适应环境症应用，3个发售单位申请差别获全国大食药监局、欧美FDA和欧洲经济共同体国家EMA审批。自20五年成立单位后，复宏汉霖已建设成合一化生态学制品技术药厂APP，有效化及的技术创新发展的数字化核心内容水平贯彻产品开发、生孩子及商业区产品运营全领域链。工司已成立完整有效化的世界的技术创新发展咨询中心，采用国家联盟消毒产品生孩子服务质量水平工作管理条件（GMP）条件来生孩子和服务质量水平防范，逐渐扎实合一化宗合生孩子APP，但其中，佛山徐汇基底已换取全国大和欧洲经济共同体国家GMP认正，松江基底（一）也已换取全国大GMP认正。


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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