{"id":60195,"date":"2026-06-09T19:18:00","date_gmt":"2026-06-09T12:18:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=60195"},"modified":"2026-06-09T19:18:00","modified_gmt":"2026-06-09T12:18:00","slug":"kelun-biotech-partner-windward-bio-announces-first-patients-dosed-in-phase-2-sirius-copd-study-of-skb378-win378","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=60195","title":{"rendered":"Kelun-Biotech Partner Windward Bio Announces First Patients Dosed in Phase 2 SIRIUS COPD Study of SKB378\/WIN378"},"content":{"rendered":"<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2650617\/logo_kelun_Biotech_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"\/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul type=\"disc\">\n<li><i>COPD study initiation expands SKB378\/WIN378 development into a second major respiratory disease<\/i><\/li>\n<li><i>SKB378\/WIN378 is currently being evaluated in the Phase 2\/3 POLARIS asthma study, with initial Phase 2 data expected in the second half of 2026<\/i><\/li>\n<li><i>SKB378\/WIN378 has the potential to be the first-to-market,<\/i> <i>ultra long-acting anti-TSLP antibody for asthma and COPD, <\/i><i>with Phase 3 initiation in asthma planned for Q4 2026<\/i><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\">CHENGDU, China<\/span>, <span class=\"legendSpanClass\">June 9, 2026<\/span> \/PRNewswire\/ &#8212; Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (&#8220;Kelun-Biotech&#8221; or the &#8220;Company&#8221;) today announced that\u00a0its partner Windward Bio has dosed the first patients in the Phase 2 SIRIUS study of SKB378\/WIN378 (also known as HBM9378) in patients with chronic obstructive pulmonary disease (COPD).<\/p>\n<div class=\"PRN_ImbeddedAssetReference\">\n<\/div>\n<p>COPD is a progressive, irreversible lung disease and the third leading cause of death worldwide. Driven by immune-mediated airway inflammation and persistent airflow obstruction, the disease makes even routine daily activities a struggle. Its defining feature is exacerbations \u2014 sudden, severe flare-ups that lead to emergency room visits, hospitalizations, and lasting declines in lung function. Despite currently available inhaled background therapies, more than 3 million patients with moderate-to-severe COPD remain at high risk of recurrent exacerbations, underscoring an urgent need for better treatment options.<\/p>\n<p>SIRIUS is a global, Phase 2 randomized, double-blind, placebo-controlled, dose-finding study. It is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SKB378\/WIN378 in patients with moderate-to-severe COPD.<\/p>\n<p>SKB378\/WIN378 started as a co-development project jointly conducted by the Company and Harbour BioMed, with both parties equally sharing global rights.<\/p>\n<p><b>About SKB378\/WIN378 (also known as HBM9378)<\/b><\/p>\n<p>SKB378\/WIN378\u00a0is a next-generation, fully human monoclonal antibody that potently inhibits the TSLP ligand. This clinically validated target plays a key role in the development and progression of a wide array of immunological diseases, including asthma and COPD. SKB378\/WIN378 has been engineered to achieve half-life extension (HLE) and silenced\u00a0effector function. It has been studied in a Phase 1 trial, which confirmed an extended half-life suitable for twice-yearly dosing, demonstrated a low rate of antidrug antibodies, and was safe and well tolerated up to the highest dose tested. SKB378\/WIN378 is administered subcutaneously. Windward Bio licensed the global rights (excluding\u00a0Greater China\u00a0and several Southeast and West Asian countries) for SKB378\/WIN378 from Kelun-Biotech and Harbour BioMed (also known as HBM9378). WIN378 is currently being evaluated in the POLARIS Phase 2\/3 asthma study with initial readouts expected in the second half of 2026. WIN378 is also being evaluated in the SIRIUS Phase 2 COPD study. The first Phase 3 study of WIN378 in asthma is expected to begin in the fourth quarter of 2026.<\/p>\n<p><b>About Kelun-Biotech\u00a0<\/b><\/p>\n<p>Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&amp;D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world&#8217;s leading proprietary ADC and novel DC platforms, OptiDC\u2122, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit <a href=\"https:\/\/en.kelun-biotech.com\/\" target=\"_blank\" rel=\"nofollow\">https:\/\/en.kelun-biotech.com\/<\/a>.\u00a0<\/p>\n<p><b>About Windward Bio <\/b><\/p>\n<p>Windward Bio is a clinical-stage biotechnology company with deep discovery, development, and commercialization expertise committed to transforming the treatment of people living with serious immunological conditions. Its lead program is WIN378, a potential best-in-disease, ultra long-acting anti-TSLP monoclonal antibody currently in a Phase 2\/3 trial for asthma and in a Phase 2 study for COPD. The pipeline also includes WIN027, a clinical-stage, long-acting anti-TSLPxIL-13 bispecific with broad therapeutic potential across immunological diseases, which is currently in Phase 1. The company is building a discovery pipeline of long-acting bispecific antibodies, targeting validated biology in respiratory and dermatological conditions.<\/p>","protected":false},"excerpt":{"rendered":"<p><!-- wp:html --><\/p>\n<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2650617\/logo_kelun_Biotech_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"\/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul type=\"disc\">\n<li><i>COPD study initiation expands SKB378\/WIN378 development into a second major respiratory disease<\/i><\/li>\n<li><i>SKB378\/WIN378 is currently being evaluated in the Phase 2\/3 POLARIS asthma study, with initial Phase 2 data expected in the second half of 2026<\/i><\/li>\n<li><i>SKB378\/WIN378 has the potential to be the first-to-market,<\/i> <i>ultra long-acting anti-TSLP antibody for asthma and COPD, <\/i><i>with Phase 3 initiation in asthma planned for Q4 2026<\/i><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\">CHENGDU, China<\/span>, <span class=\"legendSpanClass\">June 9, 2026<\/span> \/PRNewswire\/ &#8212; Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (&#8220;Kelun-Biotech&#8221; or the &#8220;Company&#8221;) today announced that\u00a0its partner Windward Bio has dosed the first patients in the Phase 2 SIRIUS study of SKB378\/WIN378 (also known as HBM9378) in patients with chronic obstructive pulmonary disease (COPD).<\/p>\n<div class=\"PRN_ImbeddedAssetReference\">\n<\/div>\n<p>COPD is a progressive, irreversible lung disease and the third leading cause of death worldwide. Driven by immune-mediated airway inflammation and persistent airflow obstruction, the disease makes even routine daily activities a struggle. Its defining feature is exacerbations \u2014 sudden, severe flare-ups that lead to emergency room visits, hospitalizations, and lasting declines in lung function. Despite currently available inhaled background therapies, more than 3 million patients with moderate-to-severe COPD remain at high risk of recurrent exacerbations, underscoring an urgent need for better treatment options.<\/p>\n<p>SIRIUS is a global, Phase 2 randomized, double-blind, placebo-controlled, dose-finding study. It is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SKB378\/WIN378 in patients with moderate-to-severe COPD.<\/p>\n<p>SKB378\/WIN378 started as a co-development project jointly conducted by the Company and Harbour BioMed, with both parties equally sharing global rights.<\/p>\n<p><b>About SKB378\/WIN378 (also known as HBM9378)<\/b><\/p>\n<p>SKB378\/WIN378\u00a0is a next-generation, fully human monoclonal antibody that potently inhibits the TSLP ligand. This clinically validated target plays a key role in the development and progression of a wide array of immunological diseases, including asthma and COPD. SKB378\/WIN378 has been engineered to achieve half-life extension (HLE) and silenced\u00a0effector function. It has been studied in a Phase 1 trial, which confirmed an extended half-life suitable for twice-yearly dosing, demonstrated a low rate of antidrug antibodies, and was safe and well tolerated up to the highest dose tested. SKB378\/WIN378 is administered subcutaneously. Windward Bio licensed the global rights (excluding\u00a0Greater China\u00a0and several Southeast and West Asian countries) for SKB378\/WIN378 from Kelun-Biotech and Harbour BioMed (also known as HBM9378). WIN378 is currently being evaluated in the POLARIS Phase 2\/3 asthma study with initial readouts expected in the second half of 2026. WIN378 is also being evaluated in the SIRIUS Phase 2 COPD study. The first Phase 3 study of WIN378 in asthma is expected to begin in the fourth quarter of 2026.<\/p>\n<p><b>About Kelun-Biotech\u00a0<\/b><\/p>\n<p>Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&amp;D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world&#8217;s leading proprietary ADC and novel DC platforms, OptiDC\u2122, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit <a href=\"https:\/\/en.kelun-biotech.com\/\" target=\"_blank\" rel=\"nofollow\">https:\/\/en.kelun-biotech.com\/<\/a>.\u00a0<\/p>\n<p><b>About Windward Bio <\/b><\/p>\n<p>Windward Bio is a clinical-stage biotechnology company with deep discovery, development, and commercialization expertise committed to transforming the treatment of people living with serious immunological conditions. Its lead program is WIN378, a potential best-in-disease, ultra long-acting anti-TSLP monoclonal antibody currently in a Phase 2\/3 trial for asthma and in a Phase 2 study for COPD. The pipeline also includes WIN027, a clinical-stage, long-acting anti-TSLPxIL-13 bispecific with broad therapeutic potential across immunological diseases, which is currently in Phase 1. The company is building a discovery pipeline of long-acting bispecific antibodies, targeting validated biology in respiratory and dermatological conditions.<\/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-60195","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/60195","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=60195"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/60195\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=60195"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=60195"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=60195"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}