{"id":730188,"date":"2023-02-09T09:00:16","date_gmt":"2023-02-09T14:00:16","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\/"},"modified":"2023-02-09T09:00:16","modified_gmt":"2023-02-09T14:00:16","slug":"bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\/","title":{"rendered":"Bellerophon Therapeutics Receives IND Clearance from China NMPA to Conduct Phase 3 Clinical Trial in China for INOpulse\u00ae in Fibrotic Interstitial Lung Disease"},"content":{"rendered":"<h2>\nChina NPMA accepts the use of Moderate to Vigorous Physical Activity (MVPA) as the primary endpoint<br \/>\n<\/h2>\n<div class=\"mw_release\">\n<p align=\"justify\">WARREN, N.J., Feb.  09, 2023  (GLOBE NEWSWIRE) &#8212; Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (\u201cBellerophon\u201d or the \u201cCompany\u201d), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced clearance of its Investigational New Drug (IND) application from the Center for Drug Evaluation of China\u2019s National Medical Products Administration (NMPA) to conduct a Phase 3 clinical trial to support the registration of INOpulse\u00ae for the treatment of fibrotic interstitial lung disease (fILD) in China. The study will utilize Moderate to Vigorous Physical Activity (MVPA) as the primary endpoint and be conducted in collaboration with Bellerophon\u2019s regional partner, Baylor BioSciences, a life sciences company dedicated to the development and commercialization of innovative medical products for Greater China.<\/p>\n<p align=\"justify\">\u201cWe are delighted to expand our clinical program with the aim of bringing INOpulse to patients in need in Greater China,\u201d said Peter Fernandes, Bellerophon\u2019s Chief Executive Officer. \u201cINOpulse has the potential to become the first therapy to treat an fILD population that includes patients at low-, intermediate- and high-risk of pulmonary hypertension. This IND clearance further underscores the potential of INOpulse to improve activities of daily living and quality of life in patients with fILD, and supports the use of our novel primary endpoint, MVPA, which we are also utilizing in our ongoing Phase 3 REBUILD study in the U.S.\u201d<\/p>\n<p align=\"justify\">\u201cWe are excited to continue strengthening our partnership with Baylor BioSciences,\u201d said Naseem Amin, Chairman of Bellerophon Therapeutics. \u201cINOpulse has significant potential in treating various diseases associated with pulmonary hypertension and the clearance of this IND brings us one step closer to a new treatment option for the underserved fILD patient community in Greater China.\u201d<\/p>\n<p align=\"justify\">\n        <strong>About Bellerophon<\/strong>\n      <\/p>\n<p align=\"justify\">Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The Company is currently developing multiple product candidates under its INOpulse\u00ae program, a proprietary pulsatile nitric oxide delivery system. For more information, please visit www.bellerophon.com.<\/p>\n<p align=\"justify\">\n        <strong>Forward-looking Statements<\/strong>\n      <\/p>\n<p align=\"justify\">Any statements in this press release about Bellerophon\u2019s future expectations, plans, and prospects, including statements about the clinical development of its product candidates, regulatory actions with respect to the Company\u2019s clinical trials and expectations regarding the sufficiency of the Company\u2019s cash balance to fund clinical trials, operating expenses and capital expenditures, and other statements containing the words \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccontinue,\u201d \u201ccontemplate,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201cshould,\u201d \u201ctarget,\u201d \u201cwill,\u201d \u201cwould,\u201d and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks and uncertainties relating to INOpulse\u00ae, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary or interim results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, the FDA\u2019s substantial discretion in the approval process, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the \u201cRisk Factors\u201d section of the Company\u2019s most recent Annual Report on Form 10-K and in subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent Bellerophon\u2019s views only as of the date of this release and should not be relied upon as representing the Company\u2019s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.<\/p>\n<p>\n        <strong>Contacts:<\/strong>\n      <\/p>\n<p>LifeSci Advisors:<\/p>\n<p>Brian Ritchie<\/p>\n<p>(212) 915-2578<\/p>\n<p>britchie@lifesciadvisors.com<\/p>\n<p>      <img decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODc0NTg0NiM1NDAwMjI4IzIwMTE0NzU=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/OGFjZDgyYTctZWQ0ZC00YzAyLWI2YjMtNzcxNWE2ZWVlNzJhLTEwMjMwNDg=\/tiny\/Bellerophon-Therapeutics-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China NPMA accepts the use of Moderate to Vigorous Physical Activity (MVPA) as the primary endpoint WARREN, N.J., Feb. 09, 2023 (GLOBE NEWSWIRE) &#8212; Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (\u201cBellerophon\u201d or the \u201cCompany\u201d), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced clearance of its Investigational New Drug (IND) application from the Center for Drug Evaluation of China\u2019s National Medical Products Administration (NMPA) to conduct a Phase 3 clinical trial to support the registration of INOpulse\u00ae for the treatment of fibrotic interstitial lung disease (fILD) in China. The study will utilize Moderate to Vigorous Physical Activity (MVPA) as the primary endpoint and be conducted in collaboration with Bellerophon\u2019s regional partner, Baylor BioSciences, a life sciences company &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Bellerophon Therapeutics Receives IND Clearance from China NMPA to Conduct Phase 3 Clinical Trial in China for INOpulse\u00ae in Fibrotic Interstitial Lung Disease&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-730188","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Bellerophon Therapeutics Receives IND Clearance from China NMPA to Conduct Phase 3 Clinical Trial in China for INOpulse\u00ae in Fibrotic Interstitial Lung Disease - Market Newsdesk<\/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:\/\/www.marketnewsdesk.com\/index.php\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bellerophon Therapeutics Receives IND Clearance from China NMPA to Conduct Phase 3 Clinical Trial in China for INOpulse\u00ae in Fibrotic Interstitial Lung Disease - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"China NPMA accepts the use of Moderate to Vigorous Physical Activity (MVPA) as the primary endpoint WARREN, N.J., Feb. 09, 2023 (GLOBE NEWSWIRE) &#8212; Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (\u201cBellerophon\u201d or the \u201cCompany\u201d), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced clearance of its Investigational New Drug (IND) application from the Center for Drug Evaluation of China\u2019s National Medical Products Administration (NMPA) to conduct a Phase 3 clinical trial to support the registration of INOpulse\u00ae for the treatment of fibrotic interstitial lung disease (fILD) in China. The study will utilize Moderate to Vigorous Physical Activity (MVPA) as the primary endpoint and be conducted in collaboration with Bellerophon\u2019s regional partner, Baylor BioSciences, a life sciences company &hellip; Continue reading &quot;Bellerophon Therapeutics Receives IND Clearance from China NMPA to Conduct Phase 3 Clinical Trial in China for INOpulse\u00ae in Fibrotic Interstitial Lung Disease&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2023-02-09T14:00:16+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODc0NTg0NiM1NDAwMjI4IzIwMTE0NzU=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Bellerophon Therapeutics Receives IND Clearance from China NMPA to Conduct Phase 3 Clinical Trial in China for INOpulse\u00ae in Fibrotic Interstitial Lung Disease\",\"datePublished\":\"2023-02-09T14:00:16+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\\\/\"},\"wordCount\":672,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODc0NTg0NiM1NDAwMjI4IzIwMTE0NzU=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\\\/\",\"name\":\"Bellerophon Therapeutics Receives IND Clearance from China NMPA to Conduct Phase 3 Clinical Trial in China for INOpulse\u00ae in Fibrotic Interstitial Lung Disease - 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(Nasdaq: BLPH) (\u201cBellerophon\u201d or the \u201cCompany\u201d), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced clearance of its Investigational New Drug (IND) application from the Center for Drug Evaluation of China\u2019s National Medical Products Administration (NMPA) to conduct a Phase 3 clinical trial to support the registration of INOpulse\u00ae for the treatment of fibrotic interstitial lung disease (fILD) in China. The study will utilize Moderate to Vigorous Physical Activity (MVPA) as the primary endpoint and be conducted in collaboration with Bellerophon\u2019s regional partner, Baylor BioSciences, a life sciences company &hellip; Continue reading \"Bellerophon Therapeutics Receives IND Clearance from China NMPA to Conduct Phase 3 Clinical Trial in China for INOpulse\u00ae in Fibrotic Interstitial Lung Disease\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\/","og_site_name":"Market Newsdesk","article_published_time":"2023-02-09T14:00:16+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODc0NTg0NiM1NDAwMjI4IzIwMTE0NzU=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Bellerophon Therapeutics Receives IND Clearance from China NMPA to Conduct Phase 3 Clinical Trial in China for INOpulse\u00ae in Fibrotic Interstitial Lung Disease","datePublished":"2023-02-09T14:00:16+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\/"},"wordCount":672,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODc0NTg0NiM1NDAwMjI4IzIwMTE0NzU=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/bellerophon-therapeutics-receives-ind-clearance-from-china-nmpa-to-conduct-phase-3-clinical-trial-in-china-for-inopulse-in-fibrotic-interstitial-lung-disease\/","name":"Bellerophon Therapeutics Receives IND Clearance from China NMPA to Conduct Phase 3 Clinical Trial in China for INOpulse\u00ae in Fibrotic Interstitial Lung Disease - 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