{"id":1297,"date":"2022-06-29T08:09:52","date_gmt":"2022-06-29T12:09:52","guid":{"rendered":"http:\/\/herpescureadvocacy.com\/2022\/06\/29\/possible-herpes-keratitis-cure-takes-another-step-bdgene-of-china-applies-for-orphan-drug-designation-at-the-fda\/"},"modified":"2022-06-29T08:22:03","modified_gmt":"2022-06-29T12:22:03","slug":"possible-herpes-keratitis-cure-takes-another-step-bdgene-of-china-applies-for-orphan-drug-designation-at-the-fda","status":"publish","type":"post","link":"https:\/\/herpescureadvocacy.com\/2022\/06\/29\/possible-herpes-keratitis-cure-takes-another-step-bdgene-of-china-applies-for-orphan-drug-designation-at-the-fda\/","title":{"rendered":"Possible herpes keratitis cure takes another step: BDGene of China applies for Orphan Drug Designation at the FDA"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" width=\"750\" height=\"500\" data-attachment-id=\"1296\" data-permalink=\"https:\/\/herpescureadvocacy.com\/2022\/06\/29\/possible-herpes-keratitis-cure-takes-another-step-bdgene-of-china-applies-for-orphan-drug-designation-at-the-fda\/pexels-photo-4033148\/\" data-orig-file=\"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/06\/pexels-photo-4033148.jpg?fit=1880%2C1253&amp;ssl=1\" data-orig-size=\"1880,1253\" data-comments-opened=\"1\" data-image-meta=\"{&quot;aperture&quot;:&quot;0&quot;,&quot;credit&quot;:&quot;&quot;,&quot;camera&quot;:&quot;&quot;,&quot;caption&quot;:&quot;&quot;,&quot;created_timestamp&quot;:&quot;0&quot;,&quot;copyright&quot;:&quot;&quot;,&quot;focal_length&quot;:&quot;0&quot;,&quot;iso&quot;:&quot;0&quot;,&quot;shutter_speed&quot;:&quot;0&quot;,&quot;title&quot;:&quot;&quot;,&quot;orientation&quot;:&quot;1&quot;}\" data-image-title=\"pexels-photo-4033148\" data-image-description=\"\" data-image-caption=\"\" data-large-file=\"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/06\/pexels-photo-4033148.jpg?fit=750%2C500&amp;ssl=1\" src=\"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/06\/pexels-photo-4033148.jpg?resize=750%2C500&#038;ssl=1\" alt=\"\" class=\"wp-image-1296\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Chinese company BDGene from Shanghai continues to lead in the global race for a herpes keratitis cure. The highly anticipated treatment, BD111 has reached a big milestone as it applied for Orphan Drug designation from the US FDA. Previously, BD111 has received international attention for its progress with a gene editing cure for herpes keratitis. We <a href=\"https:\/\/herpescureadvocacy.com\/2022\/01\/16\/hope-for-herpes-keratitis-cure-in-china-study-results-expected-in-2022\/\">reported on its progress<\/a> &#8211; which it has published in the top international academic journals <a href=\"https:\/\/www.nature.com\/articles\/s41587-020-00781-8\">Nature Biotechnology<\/a> and Nature Biomedical Engineering. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">BD Gene has (in collaboration with the Eye and ENT Hospital of Fudan University) carried out 3 cases of IIT human clinical trials, and has reported pre-clinical results where study subjects were cleared of the virus. The potential to change the landscape for Herpes treatment has patient advocates very excited.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Orphan drugs, also known as rare disease drugs, refer to drugs used for the prevention, treatment and diagnosis of rare diseases. The orphan drug designation granted by the FDA applies to drugs and biologics for rare diseases that affect less than 200,000 people in the United States each year, and provides policy support for related products. Therefore, obtaining orphan drug designation is of great advantage for manufacturers bringing new medicines to market. <\/p>\n\n\n\n<h1 class=\"wp-block-heading\">Possible herpes cure takes another important step<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">According to the U.S. FDA Orphan Drug Act, new drugs that have obtained orphan drug qualification allows for a series of advantages for BDGene including quicker, easier processes to get to market in the US. Supports include tax credit for clinical research expenses, Exemption of NDA\/BLA application fees, access to special R&amp;D funds, special approval channels, exemption from the declaration of some clinical data, and a seven-year market exclusivity period after the drug is approved. Orphan Drug Designation can also bring investment as the company continues to lead the market. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">About Herpes Keratitis: Herpes virus keratitis is caused by herpes simplex virus (HSV-1) infection and is the most common infectious blindness disease. Current first-line antiviral drugs can only inhibit viral replication by interfering with viral DNA synthesis. These drugs can inhibit HSV-1 DNA replication, but cannot clear the latent viral genome in the cornea and trigeminal ganglion, which leads to the disease. Repeated attacks can lead to blindness in severe cases.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">About BD111: CRISPR-based gene editing technology can directly degrade the viral genome, providing the possibility of fundamentally curing the disease. BD111 gene editing drugs get rid of the drawbacks of traditional related drugs that need to be repeatedly administered, and only need to be injected once. The drug uses the original delivery technology of VLP to transduce the CRISPR gene editing tool to directly target and cut the HSV-1 genome, so as to achieve the purpose of removing the HSV-1 virus genome, thereby realizing the treatment of herpes virus keratitis. The characteristics of the BD111 drug are: (1) Cas9 mRNA is delivered, and the gene enzyme stays in the body for a short time, which can reduce the risk of immune response and gene editing off-target; (2) It cuts the viral genome and does not need to change anyone&#8217;s genes, not detected to off-target effects on the human genome.<\/p>\n\n\n","protected":false},"excerpt":{"rendered":"<p>Chinese company BDGene from Shanghai continues to lead in the global race for a herpes keratitis cure. The highly anticipated treatment, BD111 has reached a big milestone as it applied<a class=\"more-link\" href=\"https:\/\/herpescureadvocacy.com\/2022\/06\/29\/possible-herpes-keratitis-cure-takes-another-step-bdgene-of-china-applies-for-orphan-drug-designation-at-the-fda\/\">Continue reading <span class=\"screen-reader-text\">&#8220;Possible herpes keratitis cure takes another step: BDGene of China applies for Orphan Drug Designation at the FDA&#8221;<\/span><\/a><\/p>\n","protected":false},"author":205069572,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"{title}\n\n{excerpt}\n\n{url}","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"_wpas_customize_per_network":false,"jetpack_post_was_ever_published":false},"categories":[1],"tags":[],"class_list":["post-1297","post","type-post","status-publish","format-standard","hentry","category-uncategorized","entry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Possible herpes keratitis cure takes another step: BDGene of China applies for Orphan Drug Designation at the FDA - Herpes Cure Advocacy<\/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:\/\/herpescureadvocacy.com\/2022\/06\/29\/possible-herpes-keratitis-cure-takes-another-step-bdgene-of-china-applies-for-orphan-drug-designation-at-the-fda\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Possible herpes keratitis cure takes another step: BDGene of China applies for Orphan Drug Designation at the FDA - Herpes Cure Advocacy\" \/>\n<meta property=\"og:description\" content=\"Chinese company BDGene from Shanghai continues to lead in the global race for a herpes keratitis cure. 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BDgene now has approval to run Phase 3 trials (held in China) on their gene therapy cure for HSV-1 keratitis. The gene editing treatment for viral keratitis (BD111), developed based on BDmRNA delivery patent technology, has completed 3 human clinical\u2026","rel":"","context":"Similar post","block_context":{"text":"Similar post","link":""},"img":{"alt_text":"shallow focus photography of human eyes","src":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/05\/pexels-photo-834783.jpeg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/05\/pexels-photo-834783.jpeg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/05\/pexels-photo-834783.jpeg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/05\/pexels-photo-834783.jpeg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/05\/pexels-photo-834783.jpeg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/05\/pexels-photo-834783.jpeg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":1018,"url":"https:\/\/herpescureadvocacy.com\/2022\/03\/17\/herpes-cure-pipeline-2-0-2\/","url_meta":{"origin":1297,"position":1},"title":"Herpes Cure Pipeline 2.0","author":"Patient Advocate","date":"March 17, 2022","format":false,"excerpt":"Pipeline for a Herpes Cure We track the timelines for preclinical and clinical study, formulation updates, and go-to market strategies with research teams globally. 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What is the timeline for a Herpes Cure? When will there be a herpes cure? There have always been companies working towards better treatments, vaccines, and cures for HSV-1 and HSV-2, and many have failed. But recently two events changed the possible\u2026","rel":"","context":"In \"Advocacy\"","block_context":{"text":"Advocacy","link":"https:\/\/herpescureadvocacy.com\/tag\/advocacy\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/05\/winter-view.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/05\/winter-view.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/05\/winter-view.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/05\/winter-view.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/05\/winter-view.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/05\/winter-view.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":4361,"url":"https:\/\/herpescureadvocacy.com\/2024\/08\/18\/news-from-herpes-cure-advocacy\/","url_meta":{"origin":1297,"position":3},"title":"News from Herpes Cure Advocacy","author":"Patient Advocate","date":"August 18, 2024","format":false,"excerpt":"There is momentum in the field of new herpes diagnostics and therapies. Advocates, experts and patient advocates continue to urge public health stakeholders to advance new vaccines into clinical trials urgently. Evidence continues to grow around herpes impact on brain health - several new studies are below. Can infections cause\u2026","rel":"","context":"In &quot;Advocacy&quot;","block_context":{"text":"Advocacy","link":"https:\/\/herpescureadvocacy.com\/category\/advocacy\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/07\/Screenshot-2023-07-15-103920.png?fit=1200%2C794&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/07\/Screenshot-2023-07-15-103920.png?fit=1200%2C794&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/07\/Screenshot-2023-07-15-103920.png?fit=1200%2C794&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/07\/Screenshot-2023-07-15-103920.png?fit=1200%2C794&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/07\/Screenshot-2023-07-15-103920.png?fit=1200%2C794&ssl=1&resize=1050%2C600 3x"},"classes":[]},{"id":5,"url":"https:\/\/herpescureadvocacy.com\/2021\/04\/18\/herpes-cure-vaccine-research\/","url_meta":{"origin":1297,"position":4},"title":"Latest Herpes Cure Research Projects","author":"Patient Advocate","date":"April 18, 2021","format":false,"excerpt":"Updated as of 4\/18\/21. These are herpes cure research projects, of which we are aware, that are either in clinical trials currently or have expressed intent. For the latest timelines, news, videos, and dialogue on Herpes (HSV) cure research projects please join the Herpes Cure Research Reddit group. 1. The\u2026","rel":"","context":"Similar post","block_context":{"text":"Similar post","link":""},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/04\/img_5393.jpg?fit=1100%2C832&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/04\/img_5393.jpg?fit=1100%2C832&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/04\/img_5393.jpg?fit=1100%2C832&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/04\/img_5393.jpg?fit=1100%2C832&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/04\/img_5393.jpg?fit=1100%2C832&ssl=1&resize=1050%2C600 3x"},"classes":[]},{"id":2155,"url":"https:\/\/herpescureadvocacy.com\/2023\/04\/08\/latest-updates-on-herpes-cure-treatment-and-prevention\/","url_meta":{"origin":1297,"position":5},"title":"Latest Updates on Herpes Cure Treatment and Prevention","author":"Patient Advocate","date":"April 8, 2023","format":false,"excerpt":"Herpes Cure Advocacy News HHS Listening Sessions: Two listening sessions were held this past week in an effort to gather insights for an addendum to the HHS 2020 STI Strategic Plan. Both patients and providers spoke with OIDP, NIH, and CDC stakeholders about their experiences and ideas for how to\u2026","rel":"","context":"Similar post","block_context":{"text":"Similar post","link":""},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/04\/Website-Headers.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/04\/Website-Headers.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/04\/Website-Headers.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/04\/Website-Headers.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/04\/Website-Headers.png?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/04\/Website-Headers.png?resize=1400%2C800&ssl=1 4x"},"classes":[]}],"_links":{"self":[{"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/posts\/1297","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/users\/205069572"}],"replies":[{"embeddable":true,"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/comments?post=1297"}],"version-history":[{"count":2,"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/posts\/1297\/revisions"}],"predecessor-version":[{"id":1299,"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/posts\/1297\/revisions\/1299"}],"wp:attachment":[{"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/media?parent=1297"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/categories?post=1297"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/tags?post=1297"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}