首个在东南亚国度收效获批上市的国产抗PD-1单抗；焱火体育和杜康

H药初度在国际收效获批上市，是继汉曲优®之后公司”国际化政策”又一要紧后果；

联袂KGbio等诱惑伙伴，开拓逾越70个国度和地区

2023年12月28日，复宏汉霖（2696.HK）布告，公司生意诱惑伙伴PT Kalbe Genexine Biologics（KGbio）附庸公司PT Kalbio Global Medika收到药品注册批件，复宏汉霖自主研发和分娩的抗PD-1单抗H药 汉斯状®（斯鲁利单抗）取得印度尼西亚食物药品监督措置局（BPOM）批准用于调治庸碌期小细胞肺癌（ES-SCLC），商品名为Zerpidio®。这是H药初度在国际阛阓收效获批上市，亦然国产抗PD-1单抗初度在东南亚国度收效获批上市。现在，复宏汉霖正与KGbio就H药在22个国度的开发和生意化进行诱惑，这次获批将有助于两边联袂将H药带给更多印尼的患者。

肺癌是公共最常见的恶性肿瘤之一。据GLOBOCAN数据深化，2020年印度尼西亚肺癌新发病例近3.5万例，肺癌牺牲病例近3.1万例，位居该国癌症牺牲东谈主数榜首[1]。小细胞肺癌（SCLC）约占肺癌总额的15%[2]，是肺癌中侵袭性最强的亚型，分为局限期小细胞肺癌（LS-SCLC）和ES-SCLC。其中约30%-40%的患者确诊时处于局限期，大量患者在确诊时已处于庸碌期[3]，临床病情恶化快，总体预后不良。当年20年，依托泊苷斡旋卡铂或顺铂的化疗决策长期行为ES-SCLC患者的轨范一线调治，但中位OS（总生活期）不到1年，况兼绝大大量化疗患者在一年内复发[4]。

免疫搜检点阻扰剂的出现为SCLC规模的调治带来新但愿(000876)，H药 汉斯状®为复宏汉霖自主研发的重组东谈主源化抗PD-1单抗打针液，亦然公共首个且现在唯独获批一线调治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调治微卫星高度不巩固（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药调治SCLC接踵取得好意思国食物和药品监督措置局（FDA）和欧盟委员会（EC）授予的孤儿药经验认定，有助于H药在好意思国和欧洲的研发、注册及生意化等方面享受一定的政策复古。H药一线调治ES-SCLC的欧盟上市许可请求（MAA）已于2023年3月取得欧洲药品措置局 (EMA) 受理。此外，公司稳步激动H药对比一线轨范调治阿替利珠单抗用于调治ES-SCLC的头敌人好意思国桥接磨真金不怕火，以进一步复古H药在好意思国的上市申诉。

凭借冲突性疗效和各异化上风，H药展现出了广博的阛阓竞争力，取得了业内庸碌认同，其多项要害性临床照看完毕发表于《好意思国医学会杂志》（JAMA）、Nature Medicine等国际著名期刊。复宏汉霖积极激动H药与公司其他居品的协同以及与篡改疗法的斡旋，在公共同步开展十余项肿瘤免疫斡旋疗法临床磨真金不怕火，庸碌秘籍肺癌、食管癌和胃癌等符合症，全面秘籍肺癌一线调治，公共累计入组患者超3600东谈主。

2019年，复宏汉霖与KGbio就H药坚硬独家许可公约，授予其H药在东盟十国的部分符合症及疗法的独家开发和生意化职权。2023年8月，公司进一步扩大与KGbio的诱惑，授予其在沙特阿拉伯、阿联酋、埃及、卡塔尔、约旦、摩洛哥等12个中东和北非地区（MENA）国度针对H药包括ES-SCLC在内的两项符合症进行独家开发和生意化的权益。异日，复宏汉霖也将联袂KGbio和其它诱惑伙伴握续推动H药在更多国度的获批上市进度。

【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.

对于H药 汉斯状®

H药 汉斯状®为重组东谈主源化抗PD-1单抗打针液（通用名：斯鲁利单抗打针液），是公共首个获批一线调治小细胞肺癌的抗PD-1单抗，已在中国和印度尼西亚获批上市。狂放现在，H药已有4项符合症获批上市，2项符合症上市请求分歧在中国和欧盟获受理，10余项临床磨真金不怕火同步在公共开展。

2022年3月，H药厚爱于中国获批上市，现在可用于调治微卫星高度不巩固（MSI-H）实体瘤、鳞状非小细胞肺癌（sqNSCLC）、庸碌期小细胞肺癌（ES-SCLC）及食管鳞状细胞癌（ESCC）。H药斡旋化疗一线调治非鳞状非小细胞肺癌（nsNSCLC）和一线调治庸碌期小细胞肺癌（ES-SCLC）的上市请求也分歧取得中国NMPA和欧盟EMA受理。聚焦肺癌和消化谈肿瘤，复宏汉霖积极激动H药与公司其他居品的协同以及与篡改疗法的斡旋，在公共同步开展10余项肿瘤免疫斡旋疗法临床磨真金不怕火，于中国、好意思国、土耳其、波兰、格鲁吉亚等国度和地区累计入组超3600东谈主。H药的3项要害性临床照看完毕分歧发表于著名期刊《好意思国医学会杂志》（JAMA）、《当然-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免疫搜检点阻扰剂临床欺骗指南》和《中国食管癌辐照调治指南》等多部泰斗指南推选，为肿瘤临床诊疗提供热切参考。国际方面，H药调治SCLC也已取得好意思国FDA和欧盟EC的孤儿药经验认定，并在好意思国初始了一项H药对比一线轨范调治阿替利珠单抗的头敌人桥接磨真金不怕火。

对于复宏汉霖

复宏汉霖（2696.HK）是一家国际化的篡改生物制药公司，勤恳于为公共患者提供可背负的高品性生物药，居品秘籍肿瘤、本人免疫疾病、眼科疾病等规模，已在中国上市5款居品，在国际上市2款居品，19项符合症获批，3个上市请求分歧获中国药监局、好意思国FDA和欧盟EMA受理。自2010年建立以来，复宏汉霖已建成一体化生物制药平台，高效及篡改的自主中枢能力结合研发、分娩及生意运营全产业链。公司已设备完善高效的公共篡改中心，按照国际药品分娩质料措置范例（GMP）轨范进行分娩和质料管控，不停夯实一体化玄虚分娩平台，其中，上海徐汇基地和松江基地（一）均已取得中国和欧盟GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质料的居品管线，涵盖20多种篡改单克隆抗体，并全面激动基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫斡旋疗法。继国内首个生物同样药汉利康®（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）接踵获批上市，篡改居品汉斯状®（斯鲁利单抗）已获批用于调治微卫星高度不巩固（MSI-H）实体瘤、鳞状非小细胞肺癌、庸碌期小细胞肺癌和食管鳞状细胞癌，并成为公共首个获批一线调治小细胞肺癌的抗PD-1单抗。公司亦同步就16个居品在公共范围内开展30多项临床磨真金不怕火，对外授权全面秘籍西洋主流生物药阛阓和盛大新兴阛阓。

HANSIZHUANG Sets Sail in Indonesia Market

The 1st China anti-PD-1 monoclonal antibody successfully approved in Southeast Asia - 

The 1st 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.

皇冠体育hg86a

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.

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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)焱火体育和杜康, 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.

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