{"id":18923,"date":"2023-05-10T23:25:00","date_gmt":"2023-05-10T15:25:00","guid":{"rendered":"https:\/\/flcube.com\/?p=18923"},"modified":"2024-12-19T23:30:00","modified_gmt":"2024-12-19T15:30:00","slug":"jiangsu-nhwa-pharmaceutical-receives-nmpa-approval-for-olinvyk-oliceridine-injection","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=18923","title":{"rendered":"Jiangsu Nhwa Pharmaceutical Receives NMPA Approval for Olinvyk (Oliceridine) Injection"},"content":{"rendered":"\n<p>Jiangsu Nhwa Pharmaceutical Co., Ltd. (<a href=\"https:\/\/www.google.com\/finance\/quote\/002262:SHE\">SHE: 002262<\/a>), a China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its Olinvyk (oliceridine; TRV130) injection. The approved indication is for adult patients requiring management of acute pain severe enough to necessitate an intravenous opioid analgesic, where alternative treatments have proven inadequate.<\/p>\n\n\n\n<p><strong>Olinvyk&#8217;s Development and Commercial Rights Acquired by Nhwa<\/strong><br>Olinvyk was originally discovered by US-based Trevena Inc., (Nasdaq: TRVN). Nhwa acquired the development and commercial rights to the drug in China through a licensing deal in 2018. The approval filing was supported by data from two bridging trials conducted in China and also utilized US clinical data from Trevena.<\/p>\n\n\n\n<p><strong>Financial Implications and Milestone Payments<\/strong><br>This week&#8217;s market approval triggers a USD 3 million milestone payment to Trevena from Nhwa. Additionally, Trevena is set to receive a further USD 15 million upon the first commercial sale of the drug and another potential USD 10 million payout if certain sales milestones are achieved. Nhwa has previously paid over USD 11 million in upfront and two milestone payments to Trevena.<\/p>\n\n\n\n<p><strong>Olinvyk&#8217;s Unique Mechanism and Advantages<\/strong><br>Olinvyk is a first-in-class G-protein biased \u00b5-opioid receptor agonist, offering similar efficacy to morphine but with significantly reduced beta-arrestin 2 recruitment and receptor internalization. This results in fewer adverse effects, including respiratory depression and constipation. Trevena received approval for Olinvyk in the US in 2020, where it is available in 1 mg\/1 mL and 2 mg\/2 mL single-dose vials, and a 30 mg\/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg, with doses greater than 3 mg not to be administered.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Nhwa Pharmaceutical Co., Ltd. (SHE: 002262), a China-based pharmaceutical company, has announced that it&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","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}},"categories":[7,11],"tags":[87,1472,25,15,1471],"class_list":["post-18923","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-chronic-disease","tag-nhwa-pharmaceutical","tag-potential-first-in-class","tag-product-approvals","tag-she-002262"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Jiangsu Nhwa Pharmaceutical Receives NMPA Approval for Olinvyk (Oliceridine) Injection - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Nhwa Pharmaceutical Co., Ltd. (SHE: 002262), a China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its Olinvyk (oliceridine; TRV130) injection. The approved indication is for adult patients requiring management of acute pain severe enough to necessitate an intravenous opioid analgesic, where alternative treatments have proven inadequate.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=18923\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Jiangsu Nhwa Pharmaceutical Receives NMPA Approval for Olinvyk (Oliceridine) Injection\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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