{"id":17596,"date":"2025-02-05T21:44:24","date_gmt":"2025-02-05T14:44:24","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=17596"},"modified":"2025-02-05T21:44:24","modified_gmt":"2025-02-05T14:44:24","slug":"serplulimab-approved-in-the-eu-for-first-line-treatment-of-extensive-stage-small-cell-lung-cancer-es-sclc","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=17596","title":{"rendered":"Serplulimab Approved in the EU for First-Line Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC)"},"content":{"rendered":"<ul type=\"disc\">\n<li><b>Serplulimab is the world&#8217;s first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC<\/b><\/li>\n<li><b>Serplulimab is the first and only anti-PD-1 mAb approved in the European Union (EU) for the treatment of ES-SCLC<\/b><\/li>\n<li><b>Serplulimab has now been approved in <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Europe<\/span>, and several Southeast Asian countries, benefiting over 90,000 patients<\/b><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">SHANGHAI<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Feb. 5, 2025<\/span><\/span> \/PRNewswire\/ &#8212;\u00a0Shanghai Henlius Biotech, Inc. (2696.HK) announced that its anti-PD-1 mAb, HANSIZHUANG (serplulimab, marketed as Hetronifly<sup>\u00ae<\/sup>\u00a0in <span class=\"xn-location\">Europe<\/span>),\u00a0has been officially approved by the European Commission (EC) for use in combination with carboplatin and etoposide as a first-line treatment of adult patients with\u00a0ES-SCLC. This approval establishes serplulimab as the first and only anti-PD-1 mAb approved in the EU\u00a0for the treatment of ES-SCLC.<\/p>\n<p>Serplulimab is the world&#8217;s first anti-PD-1 mAb approved for first-line treatment of ES-SCLC. Underpinned by clinical needs, Henlius has carried out a differentiated and multi-dimensional layout of serplulimab in the fields of lung cancer and gastrointestinal cancer. To date, more than 4,800 subjects have been enrolled worldwide for clinical trials of serplulimab. In 2023, Henlius entered into a collaboration with Intas Pharmaceuticals, granting Intas exclusive rights to develop and commercialise serplulimab in over 50 countries across <span class=\"xn-location\">Europe<\/span> and <span class=\"xn-location\">India<\/span>. This latest approval covers all 27 EU member states as well as the European Economic Area countries, including <span class=\"xn-location\">Norway<\/span>, <span class=\"xn-location\">Iceland<\/span>, and <span class=\"xn-location\">Liechtenstein<\/span>. Commercialisation in <span class=\"xn-location\">Europe<\/span> will be led by Intas&#8217; subsidiary, Accord Healthcare Ltd (&#8220;Accord&#8221;).<\/p>\n<p>Dr. <span class=\"xn-person\">Jason Zhu<\/span>, Executive Director and Chief Executive Officer of Henlius, stated: &#8220;The approval of serplulimab in the EU represents another significant step forward in our mission to benefit patients worldwide. This milestone not only underscores our leadership in innovative drug development and global strategy, but also brings new hope to ES-SCLC patients in <span class=\"xn-location\">Europe<\/span> and beyond. Moving forward, we will continue to collaborate with our partners to enhance the accessibility of advanced therapies and work together to make a meaningful difference in patients&#8217;\u00a0lives.&#8221;<\/p>\n<p><b>Breakthrough Innovation to Address Unmet Clinical Needs<\/b><\/p>\n<p>Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases.<sup>[1] <\/sup>Small cell lung cancer (SCLC), which accounts for 15% to 20% of all lung cancers, is characterised by high malignancy, early metastasis, rapid progression, and poor prognosis. Among SCLC patients, approximately 30% to 40% are diagnosed at a limited stage, while the remaining cases are in extensive stage. In the EU, the prevalence of SCLC ranges from 1 to 5 per 10,000 people.<sup>[2]<\/sup>\u00a0In <span class=\"xn-chron\">December 2022<\/span>, serplulimab received orphan drug designation from the EC for the treatment of SCLC. The orphan-drug designation granted by the EC\u00a0is beneficial for\u00a0serplulimab\u00a0to enjoy certain policy supports in the R&amp;D, registration and commercialisation in the treatment of SCLC\u00a0in the EU. In <span class=\"xn-chron\">September 2024<\/span>, the European Medicines Agency&#8217;s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Hetronifly<sup>\u00ae<\/sup>\u00a0for approval in the EU.<\/p>\n<p>The approval of serplulimab by the EC is primarily based on data from the ASTRUM-005 study, a randomized, double-blind, placebo-controlled international multi-centre Phase 3 study evaluating the efficacy and safety event profile of serplulimab in combination with chemotherapy versus placebo with chemotherapy as a first-line treatment for ES-SCLC. The study has set up a total of 128 sites across countries including <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Poland<\/span>, <span class=\"xn-location\">Turkey<\/span>, and <span class=\"xn-location\">Georgia<\/span>, enrolling 585 subjects, of whom around 31.5% were Caucasians.\u00a0Results from ASTRUM-005 were first presented orally at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and later published in the\u00a0<i>Journal of the American Medical Association<\/i>\u00a0(<i>JAMA<\/i>), making it the first SCLC immunotherapy study to publish on\u00a0<i>JAMA<\/i>. Based on ASTRUM-005, serplulimab has been approved in <span class=\"xn-location\">China<\/span>, Southeast Asian countries, and the EU for the first-line treatment of ES-SCLC, establishing it as the world&#8217;s first anti-PD-1 mAb approved for the indication. Additionally, Henlius is conducting a head-to-head bridging trial in the U.S. comparing serplulimab with atezolizumab, the current standard of care, to further support its U.S. regulatory submission.<\/p>\n<p><b>Global Expansion to Benefit More Patients<\/b><\/p>\n<p>Henlius&#8217; commitment to stringent quality standards has been instrumental in achieving EC approval for serplulimab. In 2023, Henlius&#8217; manufacturing facilities and production lines of serplulimab successfully passed EU GMP inspections, ensuring a stable and high-quality supply of serplulimab for the European market. Henlius operates three facilities in Shanghai\u2014Xuhui Facility, Songjiang First Plant, and Songjiang Second Plant\u2014with a total commercial capacity of 48,000 litres, ensuring consistent global supply to regions including <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Europe<\/span>, <span class=\"xn-location\">Latin America<\/span>, the <span class=\"xn-location\">Middle East<\/span>, <span class=\"xn-location\">North America<\/span>, and\u00a0Southeast Asia. The company has implemented a comprehensive quality management system in line with international standards, covering the entire product continuum ranging from R&amp;D to material management, product manufacturing, quality control, product supply management and post-marketing surveillance. The company&#8217;s facilities and quality systems have been audited and certified by regulatory authorities including the National Medical Products Agency (NMPA), European Medicines Agency (EMA), United States Food and Drug Administration (FDA), and international business partners.<\/p>\n<p>Henlius has established a robust global presence through partnerships with Accord, KGbio, and Fosun Pharma, extending its reach to over 70 countries and regions, including the U.S., <span class=\"xn-location\">Europe<\/span>, <span class=\"xn-location\">Southeast Asia<\/span>, and emerging markets. Looking ahead, Henlius will continue to work closely with its partners to expand the availability of serplulimab to more countries and regions, providing broader treatment options to patients worldwide.<\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody>\n<tr>\n<td class=\"prnpr2 prnpl2 prnvab prnsbtb0 prnrbrb0 prnsbbb0 prnsblb0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Reference<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.\u00a0CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322\/caac.21834<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[2] Dingemans AC, Fr\u00fch M, Ardizzoni A, et al. Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up\u2606.\u00a0Ann Oncol. 2021;32(7):839-853. doi:10.1016\/j.annonc.2021.03.207<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p><b>About Serplulimab<\/b><\/p>\n<p>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 <span class=\"xn-location\">China<\/span>, the EU and several SEA countries. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. Up to date, HANSIZHUANG has been approved by the National Medicinal Products Administration (NMPA) for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Serplulimab was granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in <span class=\"xn-location\">the United States<\/span> to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.<\/p>\n<p>The results of 4\u00a0pivotal trials of HANSIZHUANG were published in the\u00a0<i>Journal of the American Medical Association<\/i>\u00a0(<i>JAMA<\/i>),\u00a0<i>Nature Medicine<\/i>,\u00a0<i>Cancer Cell<\/i>\u00a0and\u00a0<i>British Journal of Cancer<\/i>, respectively. Furthermore, HANSIZHUANG was respectively recommended\u00a0by the\u00a0<i>CSCO Guidelines for Small Cell Lung Cancer<\/i>, the\u00a0<i>CSCO Guidelines for Non-Small Cell Lung Cancer<\/i>, the\u00a0<i>CSCO Guidelines for Esophageal Cancer<\/i>,\u00a0the\u00a0<i>CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor<\/i>, the\u00a0<i>China Guidelines for Radiotherapy of Esophageal Cancer<\/i>,\u00a0and other definitive guides, providing valuable references for clinical diagnosis and treatment of\u00a0tumours.<\/p>\n<p><b>About Henlius<\/b><\/p>\n<p>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.\u00a0Up to date, 6 products have been launched in <span class=\"xn-location\">China<\/span>, 4 have been approved for marketing in overseas markets, and 4 marketing applications have been accepted for review in <span class=\"xn-location\">China<\/span>, 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&amp;D, manufacturing and commercialization. It has established global innovation centre and <span class=\"xn-location\">Shanghai<\/span>-based commercial manufacturing facilities certificated by <span class=\"xn-location\">China<\/span>, the EU and U.S. GMP.<\/p>\n<p>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 the backbone.\u00a0To date, the company&#8217;s launched products include HANLIKANG (rituximab), the first <span class=\"xn-location\">China<\/span>-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI\u2122 in the U.S., Zercepac<sup>\u00ae<\/sup>\u00a0in <span class=\"xn-location\">Europe<\/span>), a <span class=\"xn-location\">China<\/span>-developed mAb biosimilar approved in <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Europe<\/span> and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab),\u00a0HANSIZHUANG, the world&#8217;s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib).\u00a0What&#8217;s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.<\/p>","protected":false},"excerpt":{"rendered":"<p><!-- wp:html --><\/p>\n<ul type=\"disc\">\n<li><b>Serplulimab is the world&#8217;s first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC<\/b><\/li>\n<li><b>Serplulimab is the first and only anti-PD-1 mAb approved in the European Union (EU) for the treatment of ES-SCLC<\/b><\/li>\n<li><b>Serplulimab has now been approved in <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Europe<\/span>, and several Southeast Asian countries, benefiting over 90,000 patients<\/b><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">SHANGHAI<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Feb. 5, 2025<\/span><\/span> \/PRNewswire\/ &#8212;\u00a0Shanghai Henlius Biotech, Inc. (2696.HK) announced that its anti-PD-1 mAb, HANSIZHUANG (serplulimab, marketed as Hetronifly<sup>\u00ae<\/sup>\u00a0in <span class=\"xn-location\">Europe<\/span>),\u00a0has been officially approved by the European Commission (EC) for use in combination with carboplatin and etoposide as a first-line treatment of adult patients with\u00a0ES-SCLC. This approval establishes serplulimab as the first and only anti-PD-1 mAb approved in the EU\u00a0for the treatment of ES-SCLC.<\/p>\n<p>Serplulimab is the world&#8217;s first anti-PD-1 mAb approved for first-line treatment of ES-SCLC. Underpinned by clinical needs, Henlius has carried out a differentiated and multi-dimensional layout of serplulimab in the fields of lung cancer and gastrointestinal cancer. To date, more than 4,800 subjects have been enrolled worldwide for clinical trials of serplulimab. In 2023, Henlius entered into a collaboration with Intas Pharmaceuticals, granting Intas exclusive rights to develop and commercialise serplulimab in over 50 countries across <span class=\"xn-location\">Europe<\/span> and <span class=\"xn-location\">India<\/span>. This latest approval covers all 27 EU member states as well as the European Economic Area countries, including <span class=\"xn-location\">Norway<\/span>, <span class=\"xn-location\">Iceland<\/span>, and <span class=\"xn-location\">Liechtenstein<\/span>. Commercialisation in <span class=\"xn-location\">Europe<\/span> will be led by Intas&#8217; subsidiary, Accord Healthcare Ltd (&#8220;Accord&#8221;).<\/p>\n<p>Dr. <span class=\"xn-person\">Jason Zhu<\/span>, Executive Director and Chief Executive Officer of Henlius, stated: &#8220;The approval of serplulimab in the EU represents another significant step forward in our mission to benefit patients worldwide. This milestone not only underscores our leadership in innovative drug development and global strategy, but also brings new hope to ES-SCLC patients in <span class=\"xn-location\">Europe<\/span> and beyond. Moving forward, we will continue to collaborate with our partners to enhance the accessibility of advanced therapies and work together to make a meaningful difference in patients&#8217;\u00a0lives.&#8221;<\/p>\n<p><b>Breakthrough Innovation to Address Unmet Clinical Needs<\/b><\/p>\n<p>Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases.<sup>[1] <\/sup>Small cell lung cancer (SCLC), which accounts for 15% to 20% of all lung cancers, is characterised by high malignancy, early metastasis, rapid progression, and poor prognosis. Among SCLC patients, approximately 30% to 40% are diagnosed at a limited stage, while the remaining cases are in extensive stage. In the EU, the prevalence of SCLC ranges from 1 to 5 per 10,000 people.<sup>[2]<\/sup>\u00a0In <span class=\"xn-chron\">December 2022<\/span>, serplulimab received orphan drug designation from the EC for the treatment of SCLC. The orphan-drug designation granted by the EC\u00a0is beneficial for\u00a0serplulimab\u00a0to enjoy certain policy supports in the R&amp;D, registration and commercialisation in the treatment of SCLC\u00a0in the EU. In <span class=\"xn-chron\">September 2024<\/span>, the European Medicines Agency&#8217;s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Hetronifly<sup>\u00ae<\/sup>\u00a0for approval in the EU.<\/p>\n<p>The approval of serplulimab by the EC is primarily based on data from the ASTRUM-005 study, a randomized, double-blind, placebo-controlled international multi-centre Phase 3 study evaluating the efficacy and safety event profile of serplulimab in combination with chemotherapy versus placebo with chemotherapy as a first-line treatment for ES-SCLC. The study has set up a total of 128 sites across countries including <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Poland<\/span>, <span class=\"xn-location\">Turkey<\/span>, and <span class=\"xn-location\">Georgia<\/span>, enrolling 585 subjects, of whom around 31.5% were Caucasians.\u00a0Results from ASTRUM-005 were first presented orally at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and later published in the\u00a0<i>Journal of the American Medical Association<\/i>\u00a0(<i>JAMA<\/i>), making it the first SCLC immunotherapy study to publish on\u00a0<i>JAMA<\/i>. Based on ASTRUM-005, serplulimab has been approved in <span class=\"xn-location\">China<\/span>, Southeast Asian countries, and the EU for the first-line treatment of ES-SCLC, establishing it as the world&#8217;s first anti-PD-1 mAb approved for the indication. Additionally, Henlius is conducting a head-to-head bridging trial in the U.S. comparing serplulimab with atezolizumab, the current standard of care, to further support its U.S. regulatory submission.<\/p>\n<p><b>Global Expansion to Benefit More Patients<\/b><\/p>\n<p>Henlius&#8217; commitment to stringent quality standards has been instrumental in achieving EC approval for serplulimab. In 2023, Henlius&#8217; manufacturing facilities and production lines of serplulimab successfully passed EU GMP inspections, ensuring a stable and high-quality supply of serplulimab for the European market. Henlius operates three facilities in Shanghai\u2014Xuhui Facility, Songjiang First Plant, and Songjiang Second Plant\u2014with a total commercial capacity of 48,000 litres, ensuring consistent global supply to regions including <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Europe<\/span>, <span class=\"xn-location\">Latin America<\/span>, the <span class=\"xn-location\">Middle East<\/span>, <span class=\"xn-location\">North America<\/span>, and\u00a0Southeast Asia. The company has implemented a comprehensive quality management system in line with international standards, covering the entire product continuum ranging from R&amp;D to material management, product manufacturing, quality control, product supply management and post-marketing surveillance. The company&#8217;s facilities and quality systems have been audited and certified by regulatory authorities including the National Medical Products Agency (NMPA), European Medicines Agency (EMA), United States Food and Drug Administration (FDA), and international business partners.<\/p>\n<p>Henlius has established a robust global presence through partnerships with Accord, KGbio, and Fosun Pharma, extending its reach to over 70 countries and regions, including the U.S., <span class=\"xn-location\">Europe<\/span>, <span class=\"xn-location\">Southeast Asia<\/span>, and emerging markets. Looking ahead, Henlius will continue to work closely with its partners to expand the availability of serplulimab to more countries and regions, providing broader treatment options to patients worldwide.<\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody>\n<tr>\n<td class=\"prnpr2 prnpl2 prnvab prnsbtb0 prnrbrb0 prnsbbb0 prnsblb0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Reference<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.\u00a0CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322\/caac.21834<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">[2] Dingemans AC, Fr\u00fch M, Ardizzoni A, et al. Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up\u2606.\u00a0Ann Oncol. 2021;32(7):839-853. doi:10.1016\/j.annonc.2021.03.207<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p><b>About Serplulimab<\/b><\/p>\n<p>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 <span class=\"xn-location\">China<\/span>, the EU and several SEA countries. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. Up to date, HANSIZHUANG has been approved by the National Medicinal Products Administration (NMPA) for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Serplulimab was granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in <span class=\"xn-location\">the United States<\/span> to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.<\/p>\n<p>The results of 4\u00a0pivotal trials of HANSIZHUANG were published in the\u00a0<i>Journal of the American Medical Association<\/i>\u00a0(<i>JAMA<\/i>),\u00a0<i>Nature Medicine<\/i>,\u00a0<i>Cancer Cell<\/i>\u00a0and\u00a0<i>British Journal of Cancer<\/i>, respectively. Furthermore, HANSIZHUANG was respectively recommended\u00a0by the\u00a0<i>CSCO Guidelines for Small Cell Lung Cancer<\/i>, the\u00a0<i>CSCO Guidelines for Non-Small Cell Lung Cancer<\/i>, the\u00a0<i>CSCO Guidelines for Esophageal Cancer<\/i>,\u00a0the\u00a0<i>CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor<\/i>, the\u00a0<i>China Guidelines for Radiotherapy of Esophageal Cancer<\/i>,\u00a0and other definitive guides, providing valuable references for clinical diagnosis and treatment of\u00a0tumours.<\/p>\n<p><b>About Henlius<\/b><\/p>\n<p>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.\u00a0Up to date, 6 products have been launched in <span class=\"xn-location\">China<\/span>, 4 have been approved for marketing in overseas markets, and 4 marketing applications have been accepted for review in <span class=\"xn-location\">China<\/span>, 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&amp;D, manufacturing and commercialization. It has established global innovation centre and <span class=\"xn-location\">Shanghai<\/span>-based commercial manufacturing facilities certificated by <span class=\"xn-location\">China<\/span>, the EU and U.S. GMP.<\/p>\n<p>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 the backbone.\u00a0To date, the company&#8217;s launched products include HANLIKANG (rituximab), the first <span class=\"xn-location\">China<\/span>-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI\u2122 in the U.S., Zercepac<sup>\u00ae<\/sup>\u00a0in <span class=\"xn-location\">Europe<\/span>), a <span class=\"xn-location\">China<\/span>-developed mAb biosimilar approved in <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Europe<\/span> and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab),\u00a0HANSIZHUANG, the world&#8217;s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib).\u00a0What&#8217;s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.<\/p>\n<p><!-- \/wp:html --><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-17596","post","type-post","status-publish","format-standard","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/17596","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=17596"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/17596\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=17596"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17596"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17596"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}