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首個(gè)在東南亞國(guó)家成功獲批上市的國(guó)產(chǎn)抗PD-1單抗璃锻；

H藥首次在海外成功獲批上市，是繼漢曲優(yōu)?之后公司”國(guó)際化戰(zhàn)略”又一重大成果省瓜；

攜手KGbio等合作伙伴，開拓超過70個(gè)國(guó)家和地區(qū)

2023年12月28日赤巢，復(fù)宏漢霖（2696.HK）宣布彤笼，公司商業(yè)合作伙伴PT Kalbe Genexine Biologics（KGbio）附屬公司PT Kalbio Global Medika收到藥品注冊(cè)批件，復(fù)宏漢霖自主研發(fā)和生產(chǎn)的抗PD-1單抗H藥 漢斯?fàn)?（斯魯利單抗）獲得印度尼西亞食品藥品監(jiān)督管理局（BPOM）批準(zhǔn)用于治療廣泛期小細(xì)胞肺癌（ES-SCLC）仁热，商品名為Zerpidio?榜揖。這是H藥首次在海外市場(chǎng)成功獲批上市，也是國(guó)產(chǎn)抗PD-1單抗首次在東南亞國(guó)家成功獲批上市抗蠢。目前举哟，復(fù)宏漢霖正與KGbio就H藥在22個(gè)國(guó)家的開發(fā)和商業(yè)化進(jìn)行合作，此次獲批將有助于雙方攜手將H藥帶給更多印尼的患者物蝙。

肺癌是全球最常見的惡性腫瘤之一炎滞。據(jù)GLOBOCAN數(shù)據(jù)顯示，2020年印度尼西亞肺癌新發(fā)病例近3.5萬例诬乞，肺癌死亡病例近3.1萬例册赛，位居該國(guó)癌癥死亡人數(shù)榜首[1]。小細(xì)胞肺癌（SCLC）約占肺癌總數(shù)的15%[2]震嫉，是肺癌中侵襲性最強(qiáng)的亞型森瘪，分為局限期小細(xì)胞肺癌（LS-SCLC）和ES-SCLC。其中約30%-40%的患者確診時(shí)處于局限期票堵，多數(shù)患者在確診時(shí)已處于廣泛期[3]扼睬，臨床病情惡化快，總體預(yù)后不良悴势。過去20年补搅，依托泊苷聯(lián)合卡鉑或順鉑的化療方案長(zhǎng)期作為ES-SCLC患者的標(biāo)準(zhǔn)一線治療，但中位OS（總生存期）不到1年泞霹，并且絕大多數(shù)化療患者在一年內(nèi)復(fù)發(fā)[4]舱闪。

免疫檢查點(diǎn)抑制劑的出現(xiàn)為SCLC領(lǐng)域的治療帶來新希望，H藥 漢斯?fàn)?為復(fù)宏漢霖自主研發(fā)的重組人源化抗PD-1單抗注射液俱菜，也是全球首個(gè)且目前唯一獲批一線治療SCLC的抗PD-1單抗阶务。自2022年3月獲批上市以來，H藥已在中國(guó)獲批用于治療微衛(wèi)星高度不穩(wěn)定（MSI-H）實(shí)體瘤恕琅、鱗狀非小細(xì)胞肺癌忧龙、ES-SCLC和食管鱗狀細(xì)胞癌，惠及逾5萬名患者。2022年渣雁，H藥治療SCLC相繼獲得美國(guó)食品和藥品監(jiān)督管理局（FDA）和歐盟委員會(huì)（EC）授予的孤兒藥資格認(rèn)定驮肄，有助于H藥在美國(guó)和歐洲的研發(fā)、注冊(cè)及商業(yè)化等方面享受一定的政策支持支读。H藥一線治療ES-SCLC的歐盟上市許可申請(qǐng)（MAA）已于2023年3月獲得歐洲藥品管理局 (EMA) 受理厦碎。此外，公司穩(wěn)步推進(jìn)H藥對(duì)比一線標(biāo)準(zhǔn)治療阿替利珠單抗用于治療ES-SCLC的頭對(duì)頭美國(guó)橋接試驗(yàn)扇雕，以進(jìn)一步支持H藥在美國(guó)的上市申報(bào)拓售。

憑借突破性療效和差異化優(yōu)勢(shì)，H藥展現(xiàn)出了強(qiáng)大的市場(chǎng)競(jìng)爭(zhēng)力镶奉，獲得了業(yè)內(nèi)廣泛認(rèn)可础淤，其多項(xiàng)關(guān)鍵性臨床研究結(jié)果發(fā)表于《美國(guó)醫(yī)學(xué)會(huì)雜志》（JAMA）、Nature Medicine等國(guó)際知名期刊哨苛。復(fù)宏漢霖積極推進(jìn)H藥與公司其他產(chǎn)品的協(xié)同以及與創(chuàng)新療法的聯(lián)合鸽凶，在全球同步開展十余項(xiàng)腫瘤免疫聯(lián)合療法臨床試驗(yàn)，廣泛覆蓋肺癌建峭、食管癌和胃癌等適應(yīng)癥玻侥，全面覆蓋肺癌一線治療，全球累計(jì)入組患者超3600人亿蒸。

2019年凑兰，復(fù)宏漢霖與KGbio就H藥簽訂獨(dú)家許可協(xié)議，授予其H藥在東盟十國(guó)的部分適應(yīng)癥及療法的獨(dú)家開發(fā)和商業(yè)化權(quán)利边锁。2023年8月姑食，公司進(jìn)一步擴(kuò)大與KGbio的合作，授予其在沙特阿拉伯乾哆、阿聯(lián)酋道竖、埃及、卡塔爾翩愧、約旦汰浊、摩洛哥等12個(gè)中東和北非地區(qū)（MENA）國(guó)家針對(duì)H藥包括ES-SCLC在內(nèi)的兩項(xiàng)適應(yīng)癥進(jìn)行獨(dú)家開發(fā)和商業(yè)化的權(quán)益。未來坑箭，復(fù)宏漢霖也將攜手KGbio和其它合作伙伴持續(xù)推動(dòng)H藥在更多國(guó)家的獲批上市進(jìn)程丐作。

【參考文獻(xiàn)】

[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.

關(guān)于H藥 漢斯?fàn)?

H藥 漢斯?fàn)?為重組人源化抗PD-1單抗注射液（通用名：斯魯利單抗注射液），是全球首個(gè)獲批一線治療小細(xì)胞肺癌的抗PD-1單抗些玖，已在中國(guó)和印度尼西亞獲批上市俗衍。截至目前粥萍，H藥已有4項(xiàng)適應(yīng)癥獲批上市步垢，2項(xiàng)適應(yīng)癥上市申請(qǐng)分別在中國(guó)和歐盟獲受理，10余項(xiàng)臨床試驗(yàn)同步在全球開展。

2022年3月易解，H藥正式于中國(guó)獲批上市撰钥，目前可用于治療微衛(wèi)星高度不穩(wěn)定（MSI-H）實(shí)體瘤、鱗狀非小細(xì)胞肺癌（sqNSCLC）腥椒、廣泛期小細(xì)胞肺癌（ES-SCLC）及食管鱗狀細(xì)胞癌（ESCC）阿宅。H藥聯(lián)合化療一線治療非鱗狀非小細(xì)胞肺癌（nsNSCLC）和一線治療廣泛期小細(xì)胞肺癌（ES-SCLC）的上市申請(qǐng)也分別獲得中國(guó)NMPA和歐盟EMA受理。聚焦肺癌和消化道腫瘤笼蛛，復(fù)宏漢霖積極推進(jìn)H藥與公司其他產(chǎn)品的協(xié)同以及與創(chuàng)新療法的聯(lián)合洒放，在全球同步開展10余項(xiàng)腫瘤免疫聯(lián)合療法臨床試驗(yàn)，于中國(guó)滨砍、美國(guó)往湿、土耳其、波蘭惋戏、格魯吉亞等國(guó)家和地區(qū)累計(jì)入組超3600人领追。H藥的3項(xiàng)關(guān)鍵性臨床研究結(jié)果分別發(fā)表于知名期刊《美國(guó)醫(yī)學(xué)會(huì)雜志》（JAMA）、《自然-醫(yī)學(xué)》（Nature Medicine）和British Journal of Cancer响逢。此外绒窑，H藥還榮獲《CSCO 小細(xì)胞肺癌診療指南》、《CSCO非小細(xì)胞肺癌診療指南》舔亭、《CSCO 食管癌診療指南》些膨、《CSCO結(jié)直腸癌診療指南》、《CSCO免疫檢查點(diǎn)抑制劑臨床應(yīng)用指南》和《中國(guó)食管癌放射治療指南》等多部權(quán)威指南推薦畦洞，為腫瘤臨床診療提供重要參考晴消。海外方面，H藥治療SCLC也已獲得美國(guó)FDA和歐盟EC的孤兒藥資格認(rèn)定铡捉，并在美國(guó)啟動(dòng)了一項(xiàng)H藥對(duì)比一線標(biāo)準(zhǔn)治療阿替利珠單抗的頭對(duì)頭橋接試驗(yàn)战决。

關(guān)于復(fù)宏漢霖

復(fù)宏漢霖（2696.HK）是一家國(guó)際化的創(chuàng)新生物制藥公司，致力于為全球患者提供可負(fù)擔(dān)的高品質(zhì)生物藥劲徙，產(chǎn)品覆蓋腫瘤窘燎、自身免疫疾病、眼科疾病等領(lǐng)域秘挥，已在中國(guó)上市5款產(chǎn)品昂待，在國(guó)際上市2款產(chǎn)品，19項(xiàng)適應(yīng)癥獲批功缤，3個(gè)上市申請(qǐng)分別獲中國(guó)藥監(jiān)局呜唁、美國(guó)FDA和歐盟EMA受理。自2010年成立以來斜劳，復(fù)宏漢霖已建成一體化生物制藥平臺(tái)导盅，高效及創(chuàng)新的自主核心能力貫穿研發(fā)较幌、生產(chǎn)及商業(yè)運(yùn)營(yíng)全產(chǎn)業(yè)鏈。公司已建立完善高效的全球創(chuàng)新中心白翻，按照國(guó)際藥品生產(chǎn)質(zhì)量管理規(guī)范（GMP）標(biāo)準(zhǔn)進(jìn)行生產(chǎn)和質(zhì)量管控乍炉，不斷夯實(shí)一體化綜合生產(chǎn)平臺(tái)，其中滤馍，上海徐匯基地和松江基地（一）均已獲得中國(guó)和歐盟GMP認(rèn)證岛琼。

復(fù)宏漢霖前瞻性布局了一個(gè)多元化、高質(zhì)量的產(chǎn)品管線巢株，涵蓋20多種創(chuàng)新單克隆抗體槐瑞，并全面推進(jìn)基于自有抗PD-1單抗H藥漢斯?fàn)?的腫瘤免疫聯(lián)合療法。繼國(guó)內(nèi)首個(gè)生物類似藥漢利康?（利妥昔單抗）阁苞、中國(guó)首個(gè)自主研發(fā)的中歐雙批單抗藥物漢曲優(yōu)?（曲妥珠單抗随珠，歐洲商品名：Zercepac?，澳大利亞商品名：Tuzucip?和Trastucip?）猬错、漢達(dá)遠(yuǎn)?（阿達(dá)木單抗）和漢貝泰?（貝伐珠單抗）相繼獲批上市窗看，創(chuàng)新產(chǎn)品漢斯?fàn)?（斯魯利單抗）已獲批用于治療微衛(wèi)星高度不穩(wěn)定（MSI-H）實(shí)體瘤、鱗狀非小細(xì)胞肺癌倦炒、廣泛期小細(xì)胞肺癌和食管鱗狀細(xì)胞癌浴祥，并成為全球首個(gè)獲批一線治療小細(xì)胞肺癌的抗PD-1單抗。公司亦同步就16個(gè)產(chǎn)品在全球范圍內(nèi)開展30多項(xiàng)臨床試驗(yàn)毁兼，對(duì)外授權(quán)全面覆蓋歐美主流生物藥市場(chǎng)和眾多新興市場(chǎng)预蒜。

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.

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.