{"id":47229,"date":"2022-08-12T08:01:41","date_gmt":"2022-08-12T06:01:41","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\/"},"modified":"2022-08-12T08:01:41","modified_gmt":"2022-08-12T06:01:41","slug":"innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\/","title":{"rendered":"InnoCare Announces Acceptance of Supplemental New Drug Application for Orelabrutinib in Relapsed or Refractory Marginal Zone Lymphoma in China"},"content":{"rendered":"
\n

BEIJING–(BUSINESS WIRE)–InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a supplemental New Drug Application (sNDA) for Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of patients with relapsed or refractory Marginal Zone Lymphoma (R\/R MZL).\n<\/p>\n

\nProfessor Jun Zhu of the Beijing Cancer Hospital said, “As the principal investigator, I am happy to see the treatment of R\/R MZL patients with orelabrutinib reached the preset primary endpoint and showed sustainable efficacy at the dose of 150 mg QD. Orelabrutinib was well tolerated with a safety profile in the patients with MZL. So far, no BTK inhibitor has ever been approved for treating patients with R\/R MZL in China, and we do hope that orelabrutinib can fill the gap in this therapeutic area. ”\n<\/p>\n

\nDr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said: ” MZL is a common type of non-Hodgkin’s lymphoma (NHL), accounting for about 7-10% of all NHL1<\/sup>. The incidence is higher in the elderly population, especially those over 80 years old. Current treatment options for R\/R MZL are quite limited. Orelabrutinib is expected to be the first BTK inhibitor to be approved for R\/R MZL in China. We hope orelabrutinib will benefit MZL patients who are in urgent need of innovative treatment as soon as possible.”\n<\/p>\n

\nOn December 25, 2020, orelabrutinib received approval from NMPA in two indications: the treatment of patients with relapsed\/refractory chronic lymphocytic leukemia (CLL) \/small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed\/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list. In March 2022, the NMPA accepted a supplemental New Drug Application for orelabrutinib for the treatment of patients with relapsed or refractory Waldenstr\u00f6m\u2019s Macroglobulinemia.\n<\/p>\n

\nAbout Marginal Zone Lymphoma<\/b>\n<\/p>\n

\nMarginal zone lymphoma (MZL) is a common B-cell non-Hodgkin’s lymphoma (B-NHL), accounting for about 7-10% of all NHLs. Its incidence rate ranked third after diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). According to WHO classification, MZL can be divided into three subtypes: extranodal MZL (EMZL) of mucosa-associated lymphoid tissue (MALT), nodal MZL (NMZL), and splenic MZL (SMZL). Although MZL is an indolent lymphoma, it is still an incurable malignant tumor based on the existing treatment options, and the prognosis of R\/R MZL patients is even worse. At present, there is no consensus standard of care in clinical practice, and the therapies for R\/R MZL patients are limited. As no effective targeted drug has been approved for the treatment of R\/R MZL in China, there is an urgent unmet medical need for patients with R\/R MZL.\n<\/p>\n

\nAbout Orelabrutinib<\/b>\n<\/p>\n

\nOrelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.\n<\/p>\n

\nOn Dec. 25 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed\/refractory chronic lymphocytic leukemia (CLL) \/small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed\/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients.\n<\/p>\n

\nIn addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies.\n<\/p>\n

\nOrelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r\/r MCL by U.S. Food and Drug Administration (FDA).\n<\/p>\n

\nIn addition, orelabrutinib is also being evaluated in global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE, Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in China.\n<\/p>\n

\nAbout InnoCare<\/b>\n<\/p>\n

\nInnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and\/or best-in-class drugs for the treatment of cancer and autoimmune diseases. We strategically focus on liquid cancer, solid tumors, and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong and the United States.\n<\/p>\n

\n1<\/sup> Cerhan JR, Habermann TM. Epidemiology of Marginal Zone Lymphoma. Ann Lymphoma. 2021 Mar;5:1. doi: 10.21037\/aol-20-28. Epub 2021 Mar 30. PMID: 33829216; PMCID: PMC8020862.\n<\/p>\n

\nThandra KC, Barsouk A, Saginala K, Padala SA, Barsouk A, Rawla P. Epidemiology of Non-Hodgkin’s Lymphoma. Med Sci (Basel). 2021 Jan 30;9(1):5. doi: 10.3390\/medsci9010005. PMID: 33573146; PMCID: PMC7930980.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nMedia<\/b>
Chunhua Lu
\n
86-10-66609879
\n
chunhua.lu@innocarepharma.com<\/a>\n<\/p>\n

\nInvestors<\/b>
86-10-66609999
\n
ir@innocarepharma.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

BEIJING–(BUSINESS WIRE)–InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a supplemental New Drug Application (sNDA) for Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of patients with relapsed … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-47229","6":"format-standard","7":"category-industry"},"yoast_head":"\nInnoCare Announces Acceptance of Supplemental New Drug Application for Orelabrutinib in Relapsed or Refractory Marginal Zone Lymphoma in China - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"InnoCare Announces Acceptance of Supplemental New Drug Application for Orelabrutinib in Relapsed or Refractory Marginal Zone Lymphoma in China - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"BEIJING–(BUSINESS WIRE)–InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a supplemental New Drug Application (sNDA) for Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of patients with relapsed ... [Read more...]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pharma-trend.com\/en\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Trend\" \/>\n<meta property=\"article:published_time\" content=\"2022-08-12T06:01:41+00:00\" \/>\n<meta name=\"author\" content=\"Business Wire\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Business Wire\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\\\/\"},\"author\":{\"name\":\"Business Wire\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/person\\\/02d41342c7a74fa7f0032bb35ef0bb24\"},\"headline\":\"InnoCare Announces Acceptance of Supplemental New Drug Application for Orelabrutinib in Relapsed or Refractory Marginal Zone Lymphoma in China\",\"datePublished\":\"2022-08-12T06:01:41+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\\\/\"},\"wordCount\":769,\"publisher\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\"},\"articleSection\":[\"Industry\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\\\/\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\\\/\",\"name\":\"InnoCare Announces Acceptance of Supplemental New Drug Application for Orelabrutinib in Relapsed or Refractory Marginal Zone Lymphoma in China - Pharma Trend\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#website\"},\"datePublished\":\"2022-08-12T06:01:41+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/pharma-trend.com\\\/en\\\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"InnoCare Announces Acceptance of Supplemental New Drug Application for Orelabrutinib in Relapsed or Refractory Marginal Zone Lymphoma in China\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/\",\"name\":\"Pharma Trend\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\",\"name\":\"Pharma Trend\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"\",\"contentUrl\":\"\",\"caption\":\"Pharma Trend\"},\"image\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/person\\\/02d41342c7a74fa7f0032bb35ef0bb24\",\"name\":\"Business Wire\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"InnoCare Announces Acceptance of Supplemental New Drug Application for Orelabrutinib in Relapsed or Refractory Marginal Zone Lymphoma in China - Pharma Trend","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/pharma-trend.com\/en\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\/","og_locale":"en_US","og_type":"article","og_title":"InnoCare Announces Acceptance of Supplemental New Drug Application for Orelabrutinib in Relapsed or Refractory Marginal Zone Lymphoma in China - Pharma Trend","og_description":"BEIJING–(BUSINESS WIRE)–InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a supplemental New Drug Application (sNDA) for Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of patients with relapsed ... [Read more...]","og_url":"https:\/\/pharma-trend.com\/en\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\/","og_site_name":"Pharma Trend","article_published_time":"2022-08-12T06:01:41+00:00","author":"Business Wire","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Business Wire","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/pharma-trend.com\/en\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\/#article","isPartOf":{"@id":"https:\/\/pharma-trend.com\/en\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\/"},"author":{"name":"Business Wire","@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/person\/02d41342c7a74fa7f0032bb35ef0bb24"},"headline":"InnoCare Announces Acceptance of Supplemental New Drug Application for Orelabrutinib in Relapsed or Refractory Marginal Zone Lymphoma in China","datePublished":"2022-08-12T06:01:41+00:00","mainEntityOfPage":{"@id":"https:\/\/pharma-trend.com\/en\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\/"},"wordCount":769,"publisher":{"@id":"https:\/\/pharma-trend.com\/en\/#organization"},"articleSection":["Industry"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/pharma-trend.com\/en\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\/","url":"https:\/\/pharma-trend.com\/en\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\/","name":"InnoCare Announces Acceptance of Supplemental New Drug Application for Orelabrutinib in Relapsed or Refractory Marginal Zone Lymphoma in China - Pharma Trend","isPartOf":{"@id":"https:\/\/pharma-trend.com\/en\/#website"},"datePublished":"2022-08-12T06:01:41+00:00","breadcrumb":{"@id":"https:\/\/pharma-trend.com\/en\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/pharma-trend.com\/en\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/pharma-trend.com\/en\/innocare-announces-acceptance-of-supplemental-new-drug-application-for-orelabrutinib-in-relapsed-or-refractory-marginal-zone-lymphoma-in-china\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/pharma-trend.com\/en\/"},{"@type":"ListItem","position":2,"name":"InnoCare Announces Acceptance of Supplemental New Drug Application for Orelabrutinib in Relapsed or Refractory Marginal Zone Lymphoma in China"}]},{"@type":"WebSite","@id":"https:\/\/pharma-trend.com\/en\/#website","url":"https:\/\/pharma-trend.com\/en\/","name":"Pharma Trend","description":"","publisher":{"@id":"https:\/\/pharma-trend.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/pharma-trend.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/pharma-trend.com\/en\/#organization","name":"Pharma Trend","url":"https:\/\/pharma-trend.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/logo\/image\/","url":"","contentUrl":"","caption":"Pharma Trend"},"image":{"@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/person\/02d41342c7a74fa7f0032bb35ef0bb24","name":"Business Wire"}]}},"_links":{"self":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/posts\/47229","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/comments?post=47229"}],"version-history":[{"count":0,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/posts\/47229\/revisions"}],"wp:attachment":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/media?parent=47229"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/categories?post=47229"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/tags?post=47229"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}