11月7日上午在第七届进博会上,复宏汉霖(2696.HK)与沙特阿拉伯知名的Fakeeh家族旗下专注于医疗保健的子公司AL-TIRYAQ AL-KHALAWI Medical Company(下称“SVAX”)公司达成战略合作。双方将于沙特阿拉伯设立合资公司,并整合复宏汉霖领先的生物药研发及生产能力与SVAX的本地注册、市场准入和商业化优势资源,推动复宏汉霖多款产品的全球注册与商业化,共同提升先进生物药在中东北非土耳其地区(MENAT)的可及性,以惠及更多患者。
上海市商务委员会对外经济合作处处长沈未来女士,上海市浦东新区科技和经济委员会总工程师凌钢先生,复星国际联席首席执行官陈启宇先生,复星医药董事长吴以芳先生,复星医药执行总裁、复宏汉霖董事长张文杰先生,Fakeeh家族企业董事长Ammar Fakeeh先生,SVAX创始人兼董事总经理Mazen M. Hassanain教授等出席战略合作签约仪式。
根据协议,双方将在沙特阿拉伯分别设立商业化和生产合资公司,并在MENAT地区就复宏汉霖的一系列产品,包括阿达木单抗汉达远®(HLX03)、贝伐珠单抗汉贝泰®(HLX04),进行合作开发,开展本地注册、生产及商业化。另外,此次合作框架中的首批项目亦包括共同投资开发复宏汉霖自研的帕博利珠单抗生物类似药HLX17,共同推动该产品的全球注册上市。
复星医药执行总裁
复宏汉霖董事长
张文杰
与SVAX的合作是复宏汉霖全球化蓝图的重要组成部分,这将加速我们在关键市场的业务布局,进一步提升公司的国际竞争力。我们期待这一合作能够为双方的创新发展注入新动力,促进高品质生物药的研发和生产,为中东、北非及土耳其地区的患者提供更多可负担的治疗选择,共同为全球健康事业贡献力量。
复宏汉霖首席执行官
朱俊
我们很高兴与SVAX达成合作,这不仅是对我们全球战略的有力补充,也是我们践行‘以患者为中心’承诺的重要一步。SVAX在创新和提升区域医疗保健水平方面的热忱,与我们的愿景高度契合。此次合作有望结合SVAX在MENAT地区的深厚资源和本土经验,与复宏汉霖的全球视野和创新能力,加速生物医药创新成果转化落地,促进优质生物药造福全球更多患者。
Fakeeh家族企业董事长
Ammar Fakeeh
我们很荣幸能与复宏汉霖建立这一战略合作伙伴关系,其在生物制药创新方面的卓越表现完美契合了我们提升MENAT区域医疗保健水平的使命。通过强强联手,我们致力于提高对优质关键生物药的可及性,并为沙特及更广泛区域的医疗保健生态系统高质量发展夯实基础。此次合作是为患者提供先进疗法的重要一步,充分体现了我们对健康、创新和可持续影响的坚定承诺。
SVAX创始人兼董事总经理
Mazen M. Hassanain
非常高兴与复宏汉霖建立这一战略合作伙伴关系,复宏汉霖以高质量和创新生物药而闻名。通过结合SVAX在药政、市场推广、销售和本地生产方面的知识和经验,以及复宏汉霖在生物药开发和全球供应方面的技术积累,双方致力于为MENAT区域带来前沿疗法,造福更多患者。此次合作将助力提升高效用药可及性,与我们推动沙特阿拉伯乃至更广泛区域医疗保健水平发展的愿景相一致。我们期待与复宏汉霖携手并进,共同推动MENAT区域的增长、创新和医疗可及性。
作为一家国际化的创新生物制药公司,复宏汉霖致力于为全球患者提供可负担的创新生物药,产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域。公司不断提升研产销一体化平台的开发及运营效率,通过多维提升产品可及性等举措,推动核心产品的商业化增长,实现持续的高质量盈利。公司前瞻性布局了一个多元化、高质量的产品管线,涵盖50多个分子,已有6款产品在中国上市,3款产品在国际市场获批上市,24项适应症获批,惠及逾67万名患者。其中,汉曲优®(曲妥珠单抗)已在全球49个国家和地区获批,为获批上市国家和地区最多的国产单抗生物类似药,累计惠及超过21.5万名乳腺癌和胃癌患者。公司与国际合作伙伴紧密合作,加速推进公司产品在全球的上市注册进程,广泛覆盖亚洲、欧洲、拉丁美洲、北美洲和大洋洲,共同推动中国生物医药创新与全球化发展。
MENAT地区是全球医药市场的重要组成部分,随着当地医疗需求的不断增长和政府政策的支持,该区域生物医药产业正迎来快速发展。2024年6月,汉曲优®成功发货沙特,成为首个登陆中东市场的国产单抗生物药。复宏汉霖与SVAX的强强联手不仅将促进双方管线布局和业务版图,更将助力提升新兴市场的医药创新能力。展望未来,复宏汉霖将持续践行提升国际竞争力,为全球临床需求和生物医药创新发展贡献更多力量。
关于SVAX
SVAX是一家总部位于沙特阿拉伯的先锋企业,致力于沙特本土化生物制造,并确保该地区疫苗和生物制剂的稳定、高质量供应。SVAX成立旨在加强国家卫生安全,积极支持该地区对抗传染病大流行的准备。响应沙特2030愿景和沙特国家生物技术战略等战略方针,SVAX通过聘用高技能的本土科学家和专业人员,引领生物制造行业本土化发展。
SVAX以其作为沙特阿拉伯及更广泛中东和北非地区(MENA)关键生物制剂的本地开发商和生产商而闻名。公司通过创新、制造和咨询服务三大战略业务板块运营。其创新工作聚焦于生物制剂和疫苗的先进研发,推动创新和合作,将前沿疗法推向市场。在生产方面,SVAX正建立 最先进的技术和设施,以生产符合全球标准的疫苗和生物制剂。同时,SVAX通过其咨询服务提供专家咨询,支持并加快该地区生物技术产业的发展。
通过这些举措,SVAX独特地定位于推动生物制造的转型变革,确保该地区的发展保持韧性、创新,并为未来的医疗挑战做好准备。
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,已有6款产品在中国获批上市,3款产品在国际获批上市,24项适应症获批,4个上市申请分别获中国药监局、美国FDA和欧盟EMA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,公司商业化生产基地已相继获得中国、欧盟和美国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50多个分子,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。截至目前,公司已获批上市产品包括国内首个生物类似药汉利康®(利妥昔单抗)、自主研发的中美欧三地获批单抗生物类似药汉曲优®(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)、汉贝泰®(贝伐珠单抗)以及汉奈佳®(奈拉替尼),此外,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、广泛期小细胞肺癌和食管鳞状细胞癌,并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。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 and SVAX Forge Strategic Partnership in the MENAT Market
On the morning of November 7, at the 7th China International Import Expo (CIIE), Henlius (2696.HK) entered into a strategic collaboration with AL-TIRYAQ AL-KHALAWI Medical Company ("SVAX"), a subsidiary entity of Saudi Arabia's prominent family business group in the healthcare sector, the Fakeeh Family. The two parties will establish joint ventures in Saudi Arabia to integrate Henlius’ leading capabilities in the research, development, and manufacturing of biologics with SVAX's local expertise in registration, market access, and commercialization. The collaboration seeks to advance the global registration and commercialization of multiple Henlius products and enhance the accessibility of advanced biologics across the Middle East, North Africa, and Türkiye (MENAT) countries, and benefit more patients.
The signing ceremony was attended by Ms. Weilai Shen, Director of the Foreign Economic Cooperation Department of the Shanghai Municipal Commission of Commerce, Mr. Gang Ling, The Science and Economy Commission of the People's Government of Shanghai Pudong New Area, Mr. Qiyu Chen, Co-CEO of Fosun International, Mr. Yifang Wu, Chairman of Fosun Pharma, Mr. Wenjie Zhang, Executive President of Fosun Pharma and Chairman of Henlius, Mr. Ammar Fakeeh, Chairman of the Family Business, and Prof. Mazen M. Hassanain, Founder and Managing Director of SVAX.
According to the agreement, Henlius and SVAX will establish joint ventures for commercialization and manufacturing in Saudi Arabia and will collaborate on a series of Henlius products in the MENAT region, including HANDAYUAN (adalimumab, HLX03) and HANBEITAI (bevacizumab, HLX04), to conduct local commercial and manufacturing activities. In addition, the two parties will initially focus on jointly investing in the development of Henlius' investigational biosimilar of pembrolizumab, HLX17, to accelerate its global registration and commercialization.
Mr. Wenjie Zhang, Executive President of Fosun Pharma and Chairman of Henlius, stated, "Our collaboration with SVAX is a crucial step in Henlius’ global blueprint, strengthening our presence in key markets while enhancing our international competitiveness. Through this partnership, we aim to drive innovation and growth for both parties, advance the research and manufacturing of high-quality biologics, and deliver more affordable therapies to patients in MENAT countries, thereby contributing to the global healthcare initiative. "
Dr. Jason Zhu, CEO of Henlius, said, "We are delighted to collaborate with SVAX. This partnership not only complements our global strategy but also reaffirms our commitment to 'patient-centered' care. SVAX's dedication to innovation and improving regional healthcare closely aligns with Henlius' mission. Together, by combining SVAX's extensive resources and local expertise in MENAT with Henlius' global outlook and innovative capabilities, we are poised to bring more high-quality, innovative biologics to patients across the region and beyond."
Mr. Ammar Fakeeh, Chairman of the Family Business, stated, "We are honored to forge this strategic partnership with Henlius, whose excellence in biopharmaceutical innovation perfectly complements our mission to elevate healthcare in the MENAT region. By joining forces, we are enhancing access to essential, high-quality biologics and strengthening the foundations of a resilient healthcare ecosystem in Saudi Arabia and beyond. This collaboration represents an important step forward in delivering advanced therapies to patients, embodying our commitment to health, innovation, and sustainable impact."
Prof. Mazen Hassanain, Founder and Managing Director of SVAX, stated, "We at SVAX are delighted to enter this strategic partnership with Henlius, a company known for its commitment to high-quality and innovative biologic medicines. Combining our knowledge and experience in regulatory, marketing, sales, and local manufacturing with Henlius' expertise in biopharmaceutical development and global supply, we aim to bring cutting-edge therapies to the MENAT region and impact patients’ lives. This partnership aligns with our dedication to advancing healthcare in the Kingdom of Saudi Arabia and beyond, fostering an ecosystem where life-changing therapies are accessible to those who need them. Together with Henlius, we look forward to driving growth, innovation, and healthcare accessibility across the region."
As a global, innovative biopharmaceutical company, Henlius is dedicated to offering high-quality, affordable, and innovative biologic medicines for patients worldwide, focusing on oncology, autoimmune diseases, and ophthalmic diseases. Henlius continuously enhances the development and operational efficiency of its integrated R&D, production, and commercialization platform. Through various measures to improve product accessibility, the company drives the commercial growth of core products and achieves sustained high-quality profitability. Henlius has proactively built a diversified, high-quality product pipeline covering over 50 molecules. Six products have been launched in China, three have been approved for marketing in overseas markets, and 24 indications are approved worldwide, benefiting over 670,000 patients. Specifically, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S. and Zercepac® in Europe) has been approved in 49 countries and regions globally, making it the China-developed mAb biosimilar with the most marketing approvals and benefiting over 215,000 patients with breast and gastric cancer. Henlius collaborates with international partners to promote China's biopharmaceutical innovation and advance global development, with a presence across Asia, Europe, Latin America, North America, and Oceania.
The MENAT region represents a significant part of the global pharmaceutical market. With growing healthcare needs and supportive government policies, the biopharmaceutical industry in the area is witnessing a rapid transformation. In June 2024, Zercepac® successfully shipped to Saudi Arabia, becoming the first China-developed monoclonal antibody (mAb) to enter the Middle Eastern market. The strong tie between Henlius and SVAX will help achieve joint development for the two parties and foster pharmaceutical innovation in emerging markets. Henlius remains committed to enhancing its global competitiveness, meeting global clinical needs, and spurring biopharmaceutical innovation.
About SVAX
SVAX is a pioneering Saudi company with a mission to localizing biomanufacturing within Saudi Arabia and ensuring a steady, high-quality supply of vaccines and biologics for the region. Established to bolster national health security, SVAX actively supports the region's preparedness for pandemics against infectious diseases. Aligned with Saudi Vision 2030 and the Saudi National Biotechnology Strategy, the company is at the forefront of nationalizing the biomanufacturing sector by employing highly skilled Saudi scientists and professionals.
SVAX is distinguished as a local developer and manufacturer of essential biologics that serves Saudi Arabia and the broader MENAT region. The company operates through three strategic business segments: innovation, manufacturing, and advisory services. Its innovation efforts are focused on advanced R&D in biologics and vaccines, driving forward innovation and collaboration to bring cutting-edge therapies to market. In manufacturing, SVAX is establishing a state-of-the-art technologies and facilities to produce vaccines and biologics that meet global standards. Meanwhile, through its advisory services, SVAX offers expert consulting to support and accelerate the development of a strong biotech industry across the region.
Through these initiatives, SVAX is uniquely positioned to drive transformative change in biomanufacturing, ensuring that the region remains resilient, innovative, and prepared for future healthcare challenges.
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, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 4 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 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, 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) and HANNAIJIA (neratinib), 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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