{"id":23001,"date":"2023-10-27T11:47:00","date_gmt":"2023-10-27T11:47:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4251017_CN51017_0"},"modified":"2023-10-27T11:47:00","modified_gmt":"2023-10-27T11:47:00","slug":"henlius-deepens-collaboration-with-intas-to-bring-henlius-novel-anti-pd-1-mab-serplulimab-to-europe-and-india","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=23001","title":{"rendered":"Henlius Deepens Collaboration with Intas to bring Henlius&#8217; Novel anti-PD-1 mAb Serplulimab to Europe and India"},"content":{"rendered":"\n<ul type=\"disc\">\n<li>The footprint of serplulimab now includes <span class=\"xn-location\">the United States<\/span>, <span class=\"xn-location\">Europe<\/span>, <span class=\"xn-location\">Southeast Asia<\/span>, MENA, and India&nbsp;<\/li>\n<li>Intas to develop and commercialise serplulimab in <span class=\"xn-location\">Europe<\/span> and <span class=\"xn-location\">India<\/span>; Henlius to receive \u20ac42 million upfront payment, double-digit royalties and up to \u20ac143 million in regulatory and commercial milestone payments&nbsp;<\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">SHANGHAI<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Oct. 27, 2023<\/span><\/span> \/PRNewswire\/ &#8212; Shanghai Henlius Biotech, Inc. (2696.HK) has entered into an exclusive license agreement with Intas Pharmaceuticals Limited (&quot;Intas&quot;) for the development and commercialisation in <span class=\"xn-location\">Europe<\/span> and <span class=\"xn-location\">India<\/span> for several indications including ES-SCLC, and specific formulation of HANSIZHUANG (serplulimab injection), Henlius&#8217; novel anti-PD-1 mAb. In <span class=\"xn-chron\">June 2018<\/span>, Henlius and Accord Healthcare Ltd., a subsidiary of Intas, entered into a license agreement, under which Henlius granted Accord exclusive commercialisation rights of HLX02 (trastuzumab for injection, trade name in <span class=\"xn-location\">China<\/span>: HANQUYOU; trade name in <span class=\"xn-location\">Europe<\/span>: Zercepac<sup>&reg;<\/sup>; trade names in <span class=\"xn-location\">Australia<\/span>: Tuzucip<sup>&reg;<\/sup>\/Trastucip<sup>&reg;<\/sup>) in certain countries and regions in <span class=\"xn-location\">Europe<\/span>, the <span class=\"xn-location\">Middle East<\/span>, <span class=\"xn-location\">North Africa<\/span>, and the Commonwealth of Independent States. In 2021, Henlius granted Intas the exclusive rights to develop and commercialize HLX02 in <span class=\"xn-location\">the United States<\/span> (U.S.) and <span class=\"xn-location\">Canada<\/span>.<\/p>\n<p>This collaboration marks a deepening of the strategic partnership between the two companies and opens up new development opportunities for serplulimab&#8217;s global layout. Under the terms of the agreement, Henlius will be responsible for clinical development, manufacturing and supply upon launch and will receive a \u20ac42 million upfront payment, up to \u20ac43 million in regulatory milestones, up to \u20ac100 million in commercial sales milestones, and double-digit royalties on net profit from Intas in the licensed territory.<\/p>\n<p>&quot;With superior efficacy and data quality, HANSIZHUANG (serplulimab) has become the world&#8217;s first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer, and has been approved for 4 indications in <span class=\"xn-location\">China<\/span>, benefiting over 40,000 Chinese patients. Its marketing application has been validated by the European Medicines Agency (EMA) in <span class=\"xn-chron\">March 2023<\/span>,&quot; said <span class=\"xn-person\">Jason Zhu<\/span>, Executive Director, Chief Executive Officer, and Chief Financial Officer of Henlius. &quot;By continuously partnering with Intas, we hope to accelerate serplulimab&#8217;s wider accessibility globally and contribute to the improvement of patient outcomes.&quot;<\/p>\n<p><span class=\"xn-person\">Ping Cao<\/span>, Senior Vice President and Chief Business Development Officer of Henlius, said, &quot;Henlius and Intas first entered into a collaboration in 2018. Over the past 5 years, we have worked closely together and expanded the internationalisation of HANQUYOU (Zercepac<sup>&reg;<\/sup>&nbsp;in <span class=\"xn-location\">Europe<\/span>), which has been successfully approved in 40+ overseas countries, benefiting patients in <span class=\"xn-location\">Europe<\/span> and MENA. Building on the successful collaboration, we look forward to working with Intas to accelerate the launch of serplulimab in <span class=\"xn-location\">Europe<\/span> and <span class=\"xn-location\">India<\/span>, and to continue our mission to offering high-quality and affordable biologics to patients around the world.&quot;<\/p>\n<p><span class=\"xn-person\">Binish Chudgar<\/span>, Vice-Chairman &amp; Managing Director, Intas Pharmaceuticals Ltd., said, &quot;We are excited to reinforce our long-standing partnership with Henlius. This collaboration will further bolster Intas&#8217; global oncology portfolio, underlining our commitment to delivering innovative healthcare solutions worldwide. The forthcoming launch of serplulimab in <span class=\"xn-location\">Europe<\/span> and <span class=\"xn-location\">India<\/span> will mark a crucial landmark in our mission to enable access to advanced biologics, ensuring patients across the world receive the high-quality treatments they deserve.&quot;<\/p>\n<p><span class=\"xn-person\">Paul Tredwell<\/span>, Executive Vice President of EMENA., Accord, said, &quot;I am delighted to strengthen our partnership with Henlius. The launch of serplulimab will further solidify Accord as a leader in providing specialty medicines. This marks our second novel launch in just two years, adding to our existing platform of supplying up to 25% of chemotherapy medicines in our region, exemplifying our commitment to innovation and growth and our mission to improve access to value-based medicines for patients.&quot;<\/p>\n<p>The company&#8217;s first innovative product, HANSIZHUANG (serplulimab), was approved in <span class=\"xn-location\">China<\/span> in <span class=\"xn-chron\">March 2022<\/span>. At present, HANSIZHUANG has been approved for 4 indications in <span class=\"xn-location\">China<\/span> including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). With its breakthrough efficacy and differentiation advantages in the relevant treatment fields, HANSIZHUANG has earned wide recognitions and its pivotal clinical research results have been published in leading medical journals such as&nbsp;<i>the Journal of the American Medical Association (JAMA)<\/i>&nbsp;and&nbsp;<i>Nature Medicine<\/i>. 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., enrolling more than 3,600 subjects globally. And the proportion of Caucasians is over 30% in two multi-regional clinical trials (MRCTs). Its global clinical trial data will further support marketing applications in global markets and lay a foundation for clinical applications all over the world in the future.<\/p>\n<p>In 2022, serplulimab 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 it to benefit from certain policy support for research and development, registration, and commercialisation in the U.S. and <span class=\"xn-location\">Europe<\/span>. The EMA has validated the application for serplulimab and it is expected to be approved in the first half of 2024. The company is also steadily advancing the bridging head-to-head trial in the U.S. to compare serplulimab 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.<\/p>\n<p>In the meantime, Henlius pro-actively advances the commercialisation of HANSIZHUANG in overseas markets at high speed. Henlius granted KGbio exclusive rights to develop and commercialize HANSIZHUANG in 10 ASEAN member countries and 12 MENA countries. Furthermore, Henlius and Fosun Pharma have entered into an exclusive license agreement for HANSIZHUANG in the U.S. HANSIZHUANG&#8217;s coverage footprint now includes the U.S., <span class=\"xn-location\">Europe<\/span>, <span class=\"xn-location\">Southeast Asia<\/span>, MENA, and <span class=\"xn-location\">India<\/span>.<\/p>\n<p>In the future, Henlius will join hands with its international partners to make full use of their respective resources and advantages to actively promote the development and commercialisation of HANSIZHUANG globally, to enable it to cover a wider range of countries and regions and to provide more therapeutic choices for more patients.<\/p>\n<p><b>About HANSIZHUANG (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. Up to date, 4 indications are approved for marketing in <span class=\"xn-location\">China<\/span>, 1 marketing application is under review in the EU, and more than 10 clinical trials are ongoing across the world.<\/p>\n<p>HANSIZHUANG was launched in <span class=\"xn-chron\">March 2022<\/span> and has been approved by the 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). Its marketing applications of the first-line treatment for ES-SCLC are under review by the EMA. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial approvals in <span class=\"xn-location\">China<\/span>, the U.S., the EU and other countries and regions to initiate more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications. As of now, the company has enrolled more than 3,600 subjects in <span class=\"xn-location\">China<\/span>, the U.S., <span class=\"xn-location\">Turkey<\/span>, <span class=\"xn-location\">Poland<\/span>, <span class=\"xn-location\">Georgia<\/span> and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The results of 3 pivotal trials of HANSIZHUANG were published in the&nbsp;<i>Journal of the American Medical Association<\/i>&nbsp;(<i>JAMA<\/i>), Nature Medicine and the British Journal of Cancer, respectively. Furthermore, HASIZHUANG was 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 <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><b>About Intas<br \/><\/b><\/p>\n<p>Intas is one of the leading multinational pharmaceutical formulation development, manufacturing, and marketing companies in the world. The company has set up a network of subsidiaries under the name Accord for marketing and selling in the highly regulated markets of EU, US, <span class=\"xn-location\">Canada<\/span>, <span class=\"xn-location\">South Africa<\/span>, <span class=\"xn-location\">Australia<\/span>, <span class=\"xn-location\">Asia Pacific<\/span>, CIS and MENA regions. Intas is present in 85+ countries worldwide with more than 69% of its revenue coming from global business, particularly the highly regulated markets of the EU and the US.<\/p>\n<p>Currently ranked 6th&nbsp;(As per IQVIA TSA <span class=\"xn-chron\">AUGUST 2023<\/span> MAT) in the Indian pharmaceutical market, it is also the largest privately owned Indian generic pharmaceutical company. While Intas has established leadership in key therapeutic segments like CNS, Cardiovascular, Diabetology, Plasma Therapy, Cell and Gene Therapy, Gastroenterology, Urology and Oncology in <span class=\"xn-location\">India<\/span>, the company is known for its range of products in Oncology and other hospital-based therapeutic segments in the EU and US.<\/p>\n<p>Intas&#8217; success and growth are a direct influence of Intas&#8217; extensive R&amp;D and manufacturing capabilities. Intas operates sixteen formulation manufacturing facilities, of which eleven are in <span class=\"xn-location\">India<\/span>, and the rest in the U.K., <span class=\"xn-location\">Greece<\/span>, and <span class=\"xn-location\">Mexico<\/span>. Between them, the facilities are accredited by top global regulators such as the US FDA, EMA, MHRA, TGA, and others. Every year, the company invests 6-7% of its revenues in R&amp;D. Currently, Intas has over 10,000 product registrations worldwide and a strategic pipeline of 300+ high-value FTF\/FTM, Biosimilars and NDDS products.<\/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. Up to date, 5 products have been launched in <span class=\"xn-location\">China<\/span>, 1 has been approved for marketing in overseas markets, 19 indications are approved worldwide, and 2 marketing applications have been accepted for review in 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 centers and <span class=\"xn-location\">Shanghai<\/span>-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including <span class=\"xn-person\">Xuhui Plant<\/span> certificated by <span class=\"xn-location\">China<\/span> and the EU GMP and Songjiang First Plant certificated by China GMP.<\/p>\n<p>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 <span class=\"xn-location\">China<\/span>-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in <span class=\"xn-location\">Europe<\/span>: Zercepac<sup>&reg;<\/sup>; trade names in <span class=\"xn-location\">Australia<\/span>: Tuzucip<sup>&reg;<\/sup>&nbsp;and Trastucip<sup>&reg;<\/sup>), the first <span class=\"xn-location\">China<\/span>-developed mAb biosimilar approved both in <span class=\"xn-location\">China<\/span> and <span class=\"xn-location\">Europe<\/span>, 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&#8217;s first anti-PD-1 mAb for the first-line treatment of SCLC. What&#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","protected":false},"excerpt":{"rendered":"<p>The footprint of serplulimab now includes the United States, Europe, Southeast Asia, MENA, and India&nbsp; Intas to develop and commercialise serplulimab in Europe and India; Henlius to receive \u20ac42 million upfront payment, double-digit royalties and up to \u20ac143 million in regulatory and commercial milestone payments&nbsp; SHANGHAI, Oct. 27, 2023 \/PRNewswire\/ &#8212; Shanghai Henlius Biotech, Inc. [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-23001","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Henlius Deepens Collaboration with Intas to bring Henlius&#039; Novel anti-PD-1 mAb Serplulimab to Europe and India - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=23001\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Henlius Deepens Collaboration with Intas to bring Henlius&#039; Novel anti-PD-1 mAb Serplulimab to Europe and India - My Blog\" \/>\n<meta property=\"og:description\" content=\"The footprint of serplulimab now includes the United States, Europe, Southeast Asia, MENA, and India&nbsp; Intas to develop and commercialise serplulimab in Europe and India; Henlius to receive \u20ac42 million upfront payment, double-digit royalties and up to \u20ac143 million in regulatory and commercial milestone payments&nbsp; SHANGHAI, Oct. 27, 2023 \/PRNewswire\/ &#8212; Shanghai Henlius Biotech, Inc. 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