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2024-05-22

产品速递 | 汉达远?在中国获批四项新增顺应症

2024年5月22日，，， ，，，， ，复宏汉霖（2696.HK）宣布，，， ，，，， ，公司自主开发的汉达远?（阿达木单抗注射液）增补申请获国家药品监视治理局（NMPA）批准，，， ，，，， ，用于多枢纽型幼年特发性枢纽炎、儿童斑块状银屑病、克罗恩病和儿童克罗恩病四项顺应症，，， ，，，， ，为成人和儿童自身免疫疾病患者提供更多治疗选择 。。。。。。。 。此前，，， ，，，， ，该产品已在海内获批治疗类风湿枢纽炎、强直性脊柱炎、银屑病和葡萄膜炎，，， ，，，， ，阻止现在，，， ，，，， ，汉达远?已获批原研阿达木单抗在海内上市的所有八项顺应症 。。。。。。。 。


据预计，，， ，，，， ，全球约有7.6%-9.4%的人群患有种种类型的自身免疫性疾病[1] 。。。。。。。 。TNF-α（肿瘤坏死因子-α）在多种自身免疫疾病的发病历程中具有要害性的作用 [2]，，， ，，，， ，现已证实，，， ，，，， ，类风湿性枢纽炎、银屑病、克罗恩病、强直性脊柱炎等多种自身免疫性疾病与TNF-α亲近相关 。。。。。。。 。阿达木单抗作为全人源化抗TNF-α单抗，，， ，，，， ，通过与TNF-α的特异性团结，，， ，，，， ，降低 TNF-α 激活的免疫应答，，， ，，，， ，从而有用镌汰炎症反应，，， ，，，， ，对多种自身免疫疾病起到有用长期的控制 。。。。。。。 。依附在自免疾病领域优异的疗效和清静性，，， ，，，， ，阿达木单抗已经获得《美国风湿病学会 (ACR)类风湿枢纽炎诊疗指南》、《美国皮肤病学会-国家银屑病基金会(AAD-NFP)银屑病指南》等多个全球权威自免类诊疗指南的推荐 。。。。。。。 。


汉达远?是复宏汉霖凭证《生物类似药研发与评价手艺指导原则（试行）》自主开发的单抗生物类似药，，， ，，，， ，也是公司首款治疗自身免疫疾病的产品 。。。。。。。 。公司针对汉达远?与原研阿达木单抗开展了多项头对头比对研究，，， ，，，， ，包括药学比对研究、非临床比对研究和临床比对研究，，， ，，，， ，研究效果证实汉达远?在质量、清静性和有用性等方面与原研药高度相似 。。。。。。。 。2020年12月，，， ，，，， ，汉达远?获国家药监局批准上市，，， ，，，， ，用于治疗类风湿枢纽炎、强直性脊柱炎和银屑病 。。。。。。。 。2021年4月，，， ，，，， ，汉达远?获批非熏染性葡萄膜炎顺应症，，， ，，，， ，为眼科治疗带来更多用药选择 。。。。。。。 。此次新增获批四项顺应症，，， ，，，， ，将治疗领域进一步拓展至消化科和儿科 。。。。。。。 。


别的，，， ，，，， ，复宏汉霖起劲携手商业相助同伴一连拓展海内外市场 。。。。。。。 。汉达远?在海内的商业销售由人生就是搏(ZLKS)集团唯一官方网站医药隶属公司江苏万邦认真 。。。。。。。 。阻止现在，，， ，，，， ，汉达远?已正式纳入国家医保目录，，， ，，，， ，并完成了29个省份的招标挂网和所有省份医保准入，，， ，，，， ，累计惠及约8万名中国患者 。。。。。。。 。围绕汉达远?建设了海内首个针对自身免疫患者的全病程关爱平台“达恩之家”，，， ，，，， ，以期实现患者从就诊到康复的全病程治理，，， ，，，， ，并率先与“国家皮肤与免疫疾病临床医学研究中心”相助推出了“ASSC强直性脊柱炎规范化诊疗项目”，，， ，，，， ，一连为海内患者带来更多获益 。。。。。。。 。2022年，，， ，，，， ，公司与Getz Pharma 就汉达远?告竣商业化授权相助，，， ，，，， ，笼罩巴基斯坦、菲律宾、肯尼亚等亚非欧11个新兴市场国家，，， ，，，， ，为全球更多国家和地区的病患带来可肩负的优质治疗选择 。。。。。。。 。


未来，，， ，，，， ，复宏汉霖将继续以患者为中心，，， ，，，， ，围绕未被知足的临床需求，，， ，，，， ，一连深耕肿瘤、自身免疫疾病、眼科疾病等领域，，， ，，，， ，依托研产销一体化平台，，， ，，，， ，一直带来质高价优的治疗选择，，， ，，，， ，并一连提高优质药物的可及性，，， ，，，， ，造福更多自身免疫性疾病患者 。。。。。。。 。


参考文献

[1] Cooper G S, Bynum M L K, Somers E C. Recent insights in the epidemiology of autoimmune diseases: improved prevalence estimates and understanding of clustering of diseases[J]. Journal of autoimmunity, 2009, 33(3-4): 197-207.
[2] Silva L C R, Ortigosa L C M, Benard G. Anti-TNF-α agents in the treatment of immune-mediated inflammatory diseases: mechanisms of action and pitfalls[J]. Immunotherapy, 2010, 2(6): 817-833.


关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化的立异生物制药公司，，， ，，，， ，致力于为全球患者提供可肩负的高品质生物药，，， ，，，， ，产品笼罩肿瘤、自身免疫疾病、眼科疾病等领域，，， ，，，， ，已在中国上市5款产品，，， ，，，， ，在国际上市2款产品，，， ，，，， ，23项顺应症获批，，， ，，，， ，2个上市申请划分获中国药监局和欧盟EMA受理 。。。。。。。 。自2010年建设以来，，， ，，，， ，复宏汉霖已建成一体化生物制药平台，，， ，，，， ，高效及立异的自主焦点能力贯串研发、生产及商业运营全工业链 。。。。。。。 。公司已建设完善高效的全球立异中心，，， ，，，， ，凭证国际药品生产质量治理规范（GMP）标准举行生产和质量管控，，， ，，，， ，一直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 。。。。。。。 。


复宏汉霖前瞻性结构了一个多元化、高质量的产品管线，，， ，，，， ，涵盖50多个分子，，， ，，，， ，并周全推进基于自有抗PD-1单抗H药汉斯状?的肿瘤免疫团结疗法 。。。。。。。 。继海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）和汉贝泰?（贝伐珠单抗）相继获批上市，，， ，，，， ，立异产品汉斯状?（斯鲁利单抗）已获批用于治疗微卫星高度不稳固（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个产品在全球规模内开展30多项临床试验，，， ，，，， ，对外授权周全笼罩西欧主流生物药市场和众多新兴市场 。。。。。。。 。


The Supplemental Applications of HANDAYUAN(adalimumab injection)?for the New Indications Approved by the NMPA


Shanghai, China, May?22, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications of its independently developed adalimumab biosimilar HANDAYUAN for the four new indications of polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, Crohn’s disease and pediatric Crohn’s disease have been approved by the National Medical Products Administration (NMPA), providing more treatment options for adult and pediatric patients with autoimmune diseases in China. HANDAYUAN has previously been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. To date, HANDAYUAN has been approved for eight indications in China, covering all indications of originator adalimumab in China.


It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases [1]. TNF-α (tumor necrosis factor-α) plays a key role in the pathogenesis of a variety of autoimmune diseases [2]. It has been proven that many autoimmune diseases such as rheumatoid arthritis, psoriasis, Crohn’s disease and ankylosing spondylitis are closely related to TNF-α. Adalimumab, a fully humanized anti-TNF-α monoclonal antibody, can reduce the immune response activated by TNF-α through specific binding to TNF-α, thus effectively reducing the inflammatory response and providing effective and long-lasting control of a variety of autoimmune diseases. Adalimumab has received recommendations from many global authoritative clinical treatment guidelines for autoimmune diseases, including the American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis and the AAD-NPF Guidelines for the Treatment of Psoriasis with Biologics.


HANDAYUAN is a monoclonal antibody biosimilar developed by Henlius in accordance with the NMPA Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative) and is also Henlius’ first product approved for the treatment of autoimmune diseases.?On the other hand, HANDAYUAN has taken multiple head-to-head comparison studies to the originator adalimumab. Results from the pharmaceutical comparison studies, non-clinical studies and clinical studies showed that HANDAYUAN is highly similar to the originator adalimumab in terms of quality, safety, and efficacy.?In December 2020, HANDAYUAN was approved by the NMPA for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. In April 2021, HANDAYUAN was approved for the treatment of non-infectious uveitis, providing a new treatment option for ophthalmology. The addition of the four approved indications this time further expands the therapeutic area to the gastroenterology and pediatrics.


In addition, Henlius is also actively working with partners to expand domestic and overseas markets. Currently, the commercialization of HANDAYUAN in China is handled by Wanbang Pharma. Up to date, HANDAYUAN has been included in the national medical insurance catalogue. It has completed tendering process on the procurement platform in 29 provinces and is included into the medical insurance procurement platform in all provinces in Chinese mainland, benefiting about 80,000 Chinese patients. In respect of HANDAYUAN, we have established the first whole-course care platform “Da’en Home” targeted for autoimmune patients in China, with an aim to realise the whole-course management of patients from medical treatment to rehabilitation, and have launched the “ASSC Ankylosing Spondylitis Standardised Treatment Project” in collaboration with the National Clinical Research Centre for Skin and Immune Diseases, continuing to bring more benefits to Chinese patients. In 2022, Henlius entered into a collaboration with Getz Pharma to commercialize HANDAYUAN in 11 emerging markets in Asia, Africa and Europe, such as Pakistan, the Philippines, Kenya, etc., bringing affordable and high-quality therapeutic solutions to patients in more countries and regions around the world.


In the future, Henlius will continue to be patient-centered, address unmet clinical needs with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Based on its integrated industrial chain of R&D, manufacturing, and commercialization, Henlius will provide patients with more high-quality and affordable biological medicines, and at the same enhance the accessibility of its products, thus benefiting more autoimmune disease patients.

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, 23 indications are approved worldwide, and 2 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), the first 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.? ??

联系方法

媒体：PR@Henlius.com

投资者：IR@Henlius.com


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