复宏汉霖H药汉斯状于印度尼西亚获批上市_新闻动态_新闻及媒体资源

复宏汉霖H药汉斯状于印度尼西亚获批上市

颁布功夫:2023-12-28 内容起源于：浏览量：

20231229163113_4329

内容起源：复宏汉霖

首个在东南亚国度成功获批上市的国产抗PD-1单抗；；；
H药初次在外洋成功获批上市，是继汉曲优^{^®}之后公司”国际化战术”又一重大成就；；；
携手KGbio等合作同伴，启发超过70个国度和地域

2023年12月28日，复宏汉霖（2696.HK）颁发，公司贸易合作同伴PT Kalbe Genexine Biologics（KGbio）从属公司PT Kalbio Global Medika收到药品注册批件，复宏汉霖自主研发和出产的抗PD-1单抗H药汉斯状^{^®}（斯鲁利单抗）获得印度尼西亚食品药品监督治理局（BPOM）核准用于医治宽泛期小细胞肺癌（ES-SCLC），商品名为Zerpidio^{^®}。。这是H药初次在外洋市场成功获批上市，也是国产抗PD-1单抗初次在东南亚国度成功获批上市。。目前，复宏汉霖正与KGbio就H药在22个国度的开发和贸易化进行合作，这次获批将有助于双方携手将H药带给更多印尼的患者。。

肺癌是全球最常见的恶性肿瘤之一。。据GLOBOCAN数据显示，2020年印度尼西亚肺癌新发病例近3.5万例，肺癌殒命病例近3.1万例，位居该国癌症殒命人数榜首^[1]。。小细胞肺癌（SCLC）约占肺癌总数的15%^[2]，是肺癌中侵袭性最强的亚型，分为局期限小细胞肺癌（LS-SCLC）和ES-SCLC。。其中约30%-40%的患者确诊时处于局期限，无数患者在确诊时已处于宽泛期^[3]，临床病情恶化快，总体预后不良。。从前20年，依附泊苷结合卡铂或顺铂的化疗规划持久作为ES-SCLC患者的尺度一线医治，但中位OS（总生计期）不到1年，并且绝大无数化疗患者在一年内复发^[4]。。

免疫查抄点克制剂的出现为SCLC领域的医治带来新但愿，H药汉斯状^{^®}为复宏汉霖自主研发的重组人源化抗PD-1单抗注射液，也是全球首个且目前唯一获批一线医治SCLC的抗PD-1单抗。。自2022年3月获批上市以来，H药已在中国获批用于医治微卫星高度不不变（MSI-H）实体瘤、、、鳞状非小细胞肺癌、、、ES-SCLC和食管鳞状细胞癌，惠及逾5万名患者。。2022年，H药医治SCLC相继获得美国食品和药品监督治理局（FDA）和欧盟委员会（EC）授予的孤儿药资格认定，有助于H药在美国和欧洲的研发、、、注册及贸易化等方面享受肯定的政策支持。。H药一线医治ES-SCLC的欧盟上市许可申请（MAA）已于2023年3月获得欧洲药品治理局 (EMA) 受理。。此外，公司稳步推动H药对比一线尺度医治阿替利珠单抗用于医治ES-SCLC的头仇家美国桥接试验，以进一步支持H药在美国的上市申报。。

凭借突破性疗效和差距化优势，H药展示出了壮大的市场竞争力，获得了业内宽泛认可，其多项关键性临床钻研了局颁发于《美国医学会杂志》（JAMA）、、、Nature Medicine等国际驰名期刊。。复宏汉霖积极推动H药与公司其他产品的协同以及与创新疗法的结合，在全球同步发展十余项肿瘤免疫结合疗法临床试验，宽泛覆盖肺癌、、、食管癌和胃癌等适应症，全面覆盖肺癌一线医治，全球累计入组患者超3600人。。

2019年，复宏汉霖与KGbio就H药签定独家许可和谈，授予其H药在东盟十国的部门适应症及疗法的独家开发和贸易化权势。。2023年8月，公司进一步扩大与KGbio的合作，授予其在沙特阿拉伯、、、阿联酋、、、埃及、、、卡塔尔、、、约旦、、、摩洛哥等12个中东和北非地域（MENA）国度针对H药蕴含ES-SCLC在内的两项适应症进行独家开发和贸易化的权利。。将来，复宏汉霖也将携手KGbio和其它合作同伴持续推动H药在更多国度的获批上市过程。。

【参考文件】

[1]Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and MortalityWorldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249.

[2]Eskandar A, Ahmed A, Daughtey M, et al. Racial and sex differences in presentation and outcomes of small cell lung cancer in the United States: 1973 to 2010[J].Chest, 2015,147(4): e164-e165.

[3]Klautke G , Sauer R, Fietkau R .Combined Treatment Modality in Small Cell Lung Cancer[J]. Strahlentherapie Und Onkologie, 2008, 184(2):61-66.

[4]Puglisi M , Dolly S , Faria A , et al. Treatment options for small cell lung cancer – do we have more choice?[J].Br J Cancer, 2010, 102(4):629-638.

关于H药汉斯状^®

H药汉斯状^{^®}为重组人源化抗PD-1单抗注射液（通用名：斯鲁利单抗注射液），是全球首个获批一线医治小细胞肺癌的抗PD-1单抗，已在中国和印度尼西亚获批上市。。截至目前，H药已有4项适应症获批上市，2项适应症上市申请别离在中国和欧盟获受理，10余项临床试验同步在全球发展。。

2022年3月，H药正式于中国获批上市，目前可用于医治微卫星高度不不变（MSI-H）实体瘤、、、鳞状非小细胞肺癌（sqNSCLC）、、、宽泛期小细胞肺癌（ES-SCLC）及食管鳞状细胞癌（ESCC）。。H药结合化疗一线医治非鳞状非小细胞肺癌（nsNSCLC）和一线医治宽泛期小细胞肺癌（ES-SCLC）的上市申请也别离获得中国NMPA和欧盟EMA受理。。聚焦肺癌和消化道肿瘤，复宏汉霖积极推动H药与公司其他产品的协同以及与创新疗法的结合，在全球同步发展10余项肿瘤免疫结合疗法临床试验，于中国、、、美国、、、土耳其、、、波兰、、、格鲁吉亚等国度和地域累计入组超3600人。。H药的3项关键性临床钻研了局别离颁发于驰名期刊《美国医学会杂志》（JAMA）、、、《天然-医学》（Nature Medicine）和British Journal of Cancer。。此外，H药还荣获《CSCO 小细胞肺癌诊疗指南》、、、《CSCO非小细胞肺癌诊疗指南》、、、《CSCO 食管癌诊疗指南》、、、《CSCO结直肠癌诊疗指南》、、、《CSCO免疫查抄点克制剂临床利用指南》和《中国食管癌放射医治指南》等多部权威指南推荐，为肿瘤临床诊疗提供重要参考。�Ｍ庋蠓矫�，H药医治SCLC也已获得美国FDA和欧盟EC的孤儿药资格认定，并在美国启动了一项H药对比一线尺度医治阿替利珠单抗的头仇家桥接试验。。

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职守的高品质生物药，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，在国际上市2款产品，19项适应症获批，3个上市申请别离获中国药监局、、、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，高效及创新的自主主题能力贯通研发、、、出产及贸易运营全产业链。。公司已成立美满高效的全球创新中心，依照国际药品出产质量治理规范（GMP）尺度进行出产和质量管控，不休夯实一体化综合出产平台，其中，上海徐汇基地和松江基地（一）均已获得中国和欧盟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，并全面推动基于自有抗PD-1单抗H药汉斯状^{^®}的肿瘤免疫结合疗法。。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）已获批用于医治微卫星高度不不变（MSI-H）实体瘤、、、鳞状非小细胞肺癌、、、宽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医治小细胞肺癌的抗PD-1单抗。。公司亦同步就16个产品在全球领域内发展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。。

HANSIZHUANG Sets Sail in Indonesia Market

The 1^st?China anti-PD-1 monoclonal antibody successfully approved in Southeast Asia -?
The 1^st?overseas approval of HANSIZHUANG, highlighting another major milestone of Henlius’ global strategy after HANQUYOU -
Along with KGbio and other partners?to develop and launch HANSIZHUANG in?over 70 countries -?

Shanghai, China, December 28, 2023 - Shanghai Henlius Biotech, Inc. (2696.HK) announces that recently, PT Kalbio Global Medika, the subsidiary of Henlius' partner PT Kalbe Genexine Biologics (KGbio), has received the relevant registration certificates issued by Indonesia’s National Agency for Drug and Food Control (Indonesian: Badan Pengawas Obat and Makanan, the “BPOM”) for the approval of Henlius’ self-developed and manufactured anti-PD-1 mAb HANSIZHUANG (serplulimab) in Indonesia under the trade name Zerpidio^{^®} for the treatment of extensive stage small cell lung cancer (ES-SCLC). This is the first time HANSIZHUANG has been successfully approved for marketing in an overseas market, and it has become the first China anti-PD-1 mAb successfully approved for marketing in Southeast Asia. Currently, Henlius is joining hands with KGbio?for the development and commercialisation?in 22 countries, and the approval is expected to bring HANSIZHUANG to more patients in Indonesia.

Lung cancer (LC) is one of the most common malignancies around the world. According to GLOBOCAN 2020, there were near 35,000 new LC cases and 31,000 new deaths in 2020 worldwide, and LC is still the leading cause of cancer death^[1]. SCLC is the most aggressive subtype of lung cancer, accounting for around 15% of all lung cancer cases ^[2]. The SCLC breaks down into limited stage small cell lung cancer (LS-SCLC) and ES-SCLC. Around?30%–40% patients are?in limited stage?and most patients?are in extensive stage when diagnosed^?[3]. Their clinical condition deteriorates rapidly, and the overall prognosis is poor. In the past 20 years, chemotherapy such as etoposide combined carboplatin/cisplatin was still the standards of care for ES-SCLC, but almost all patients in extensive stage relapse within one year^[4], with a median overall survival (OS) of only 10 to 11 months.

The advent of immune checkpoint inhibitors has brought new hope to patients with SCLC. The company's first innovative product, HANSIZHUANG (serplulimab), was approved in China in March 2022 and became the world's first anti-PD-1 mAb for the first-line treatment of SCLC. At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, and esophageal squamous cell carcinoma (ESCC), benefiting over 50,000 Chinese patients.?In 2022, HANSIZHUANG was successively granted orphan drug designations by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of SCLC, which will enable HANSIZHUANG to benefit from certain policy support for research and development, registration, and commercialisation in the United States (U.S.) and European Union. The European Medicines Agency (EMA) has validated the application for HANSIZHUANG. The company is also steadily advancing the bridging head-to-head trial in the U.S. to compare HANSIZHUANG to standard-of-care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC to propel the product towards U.S. market approval.

With its breakthrough efficacy and differentiation advantages in the relevant treatment fields, HANSIZHUANG has earned wide recognition and its pivotal clinical research results have been published in leading medical journals such as the Journal of the American Medical Association(JAMA) and Nature Medicine. Its synergy with in-house products of the company and innovative therapies are being actively promoted and over 10 clinical trials on immuno-oncology combination therapies are in progress in a wide variety of indications, such as lung cancer, esophageal carcinoma, gastric cancer, etc., covering the full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 3,600 subjects globally.

In 2019, Henlius reached a collaboration agreement with KGbio, upon which KGbio is granted exclusive rights to develop and commercialize HANSIZHUANG in certain therapies in 10 ASEAN member countries. In 2023, the collaboration has been further expanded to 12 Middle East and North African (MENA) countries for two indications of HANSIZHUANG including ES-SCLC, covering a total of 22 emerging market countries. In the future, Henlius will work closely with KGbio and other global partners to promote approval of HANSIZHUANG in more countries.

About HANSIZHUANG

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in China and Indonesia. Up to date, 4 indications are approved for marketing, 2 marketing applications are under review in China and the EU, and more than 10 clinical trials are ongoing across the world.

HANSIZHUANG was approved in China in March 2022 and has been approved by the National Medicinal Products Administration (NMPA) for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). The marketing applications of the first-line treatment for non-squamous non-small cell lung cancer (nsNSCLC) and ES-SCLC are under review by the NMPA and the European Medicines Agency (EMA), respectively. Focus on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. The company has initiated more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with? more than 3,600 subjects enrolled in China, the U.S., Turkey, Poland, Georgia and other countries and regions. The results of 3 pivotal trials of HANSIZHUANG were published in the?Journal of the American Medical Association?(JAMA),?Nature Medicine, and the?British Journal of Cancer, respectively. Furthermore, HANSIZHUANG was respectively recommended?by the?CSCO Guidelines for Small Cell Lung Cancer, the?CSCO Guidelines for Non-Small Cell Lung Cancer, the?CSCO Guidelines for Esophageal Cancer,?the?CSCO Guidelines for Colorectal Cancer,?the?CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor,?the?China Guidelines for Radiotherapy of Esophageal Cancer,?and other definitive guides, providing valuable references for clinical diagnosis and treatment of?tumours. On the other hand, serplulimab was granted orphan drug designations by the U.S. FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.

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 has been approved for marketing in overseas markets, 19 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 Facility and Songjiang First Plant, both certificated by China and the EU 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), 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.