{"id":20194,"date":"2025-03-19T19:54:59","date_gmt":"2025-03-19T19:54:59","guid":{"rendered":"https:\/\/www.hotelsalepage.com\/feed\/cision-pr-newswire\/henlius-receives-orphan-drug-designation-for-innovative-anti-her2-mab-hlx22-in-the-u-s-for-gastric-cancer-2\/"},"modified":"2025-03-19T19:54:59","modified_gmt":"2025-03-19T19:54:59","slug":"henlius-receives-orphan-drug-designation-for-innovative-anti-her2-mab-hlx22-in-the-u-s-for-gastric-cancer-2","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=20194","title":{"rendered":"Henlius Receives Orphan Drug Designation for Innovative Anti-HER2 mAb HLX22 in the U.S. for Gastric Cancer"},"content":{"rendered":"

SHANGHAI<\/span><\/span>, March 19, 2025<\/span><\/span> \/PRNewswire\/ — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S.\u00a0Food and Drug Administration\u00a0(FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company’s innovative\u00a0anti-HER2 monoclonal antibody\u00a0(mAb) for the treatment of gastric cancer.\u00a0<\/p>\n

Receiving an Orphan Drug Designation for HLX22 recognizes its potential to treat patients with gastric cancer and marks another milestone for HLX22, following the initiation of its multicenter phase 3 clinical trials in multiple countries and regions worldwide, and signifies a crucial step forward in its global presence.<\/p>\n

Until now, gastric cancer still constitutes a major global health problem. A<\/span>ccording to\u00a0GLOBOCAN 2022, there were around 1 million new cases and over 660 thousand new deaths of gastric cancer in 2022 globally. Gastric cancer is often diagnosed at an advanced stage, with a poor prognosis and a 5-year relative survival rate of only 6%.\u00a0Despite significant advancements in targeted therapies, such as anti-HER2 agents, and immune checkpoint inhibitors (anti-PD-1\/PD-L1 mAbs) for gastric cancer treatment in recent years, the disease’s high molecular heterogeneity leads to markedly varied responses to chemotherapy, targeted therapy, and immunotherapy across different subtypes.<\/p>\n

HLX22, an innovative anti-HER2 mAb, can bind to HER2 extracellular subdomain IV at a binding site different from that of trastuzumab via differentiated molecular design and mechanism of action, which allows simultaneous binding of HLX22 and trastuzumab to HER2 dimers (HER2 homodimer and HER2\/EGFR heterodimer) on tumour cell surface, thereby promoting the internalization and HER2 dimer degradation. The phase 2 clinical data on the combination of HLX22 and HANQUYOU (trastuzumab, trade name: HERCESSI\u2122 in the U.S., Zercepac\u00ae<\/sup>\u00a0in Europe<\/span>) demonstrate that the addition of HLX22 to trastuzumab\u00a0plus chemotherapy significantly improves survival and anti-tumour efficacy in first-line treatment of HER2-positive gastric\/gastroesophageal junction cancer (GC\/GEJC) patients, with manageable safety profiles\uff0cexpected to redefine the first-line standard treatment for advanced gastric cancer. At present, the Investigational New Drug (IND) applications for HLX22-GC-301, a phase 3 clinical study aims to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line treatment of patients with HER2-positive metastatic GC\/GEJC have been approved in China<\/span>, the U.S, Japan<\/span> and Australia<\/span>, etc. This international study has been initiated in multiple countries and regions worldwide and has completed its first patient dosing globally.\u00a0<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n

SHANGHAI<\/span><\/span>, March 19, 2025<\/span><\/span> \/PRNewswire\/ — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S.\u00a0Food and Drug Administration\u00a0(FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company’s innovative\u00a0anti-HER2 monoclonal antibody\u00a0(mAb) for the treatment of gastric cancer.\u00a0<\/p>\n

Receiving an Orphan Drug Designation for HLX22 recognizes its potential to treat patients with gastric cancer and marks another milestone for HLX22, following the initiation of its multicenter phase 3 clinical trials in multiple countries and regions worldwide, and signifies a crucial step forward in its global presence.<\/p>\n

Until now, gastric cancer still constitutes a major global health problem. A<\/span>ccording to\u00a0GLOBOCAN 2022, there were around 1 million new cases and over 660 thousand new deaths of gastric cancer in 2022 globally. Gastric cancer is often diagnosed at an advanced stage, with a poor prognosis and a 5-year relative survival rate of only 6%.\u00a0Despite significant advancements in targeted therapies, such as anti-HER2 agents, and immune checkpoint inhibitors (anti-PD-1\/PD-L1 mAbs) for gastric cancer treatment in recent years, the disease’s high molecular heterogeneity leads to markedly varied responses to chemotherapy, targeted therapy, and immunotherapy across different subtypes.<\/p>\n

HLX22, an innovative anti-HER2 mAb, can bind to HER2 extracellular subdomain IV at a binding site different from that of trastuzumab via differentiated molecular design and mechanism of action, which allows simultaneous binding of HLX22 and trastuzumab to HER2 dimers (HER2 homodimer and HER2\/EGFR heterodimer) on tumour cell surface, thereby promoting the internalization and HER2 dimer degradation. The phase 2 clinical data on the combination of HLX22 and HANQUYOU (trastuzumab, trade name: HERCESSI\u2122 in the U.S., Zercepac\u00ae<\/sup>\u00a0in Europe<\/span>) demonstrate that the addition of HLX22 to trastuzumab\u00a0plus chemotherapy significantly improves survival and anti-tumour efficacy in first-line treatment of HER2-positive gastric\/gastroesophageal junction cancer (GC\/GEJC) patients, with manageable safety profiles\uff0cexpected to redefine the first-line standard treatment for advanced gastric cancer. At present, the Investigational New Drug (IND) applications for HLX22-GC-301, a phase 3 clinical study aims to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line treatment of patients with HER2-positive metastatic GC\/GEJC have been approved in China<\/span>, the U.S, Japan<\/span> and Australia<\/span>, etc. This international study has been initiated in multiple countries and regions worldwide and has completed its first patient dosing globally.\u00a0<\/p>\n

<\/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-20194","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\/20194","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=20194"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/20194\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=20194"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20194"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20194"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}