{"id":8359,"date":"2024-09-04T14:50:40","date_gmt":"2024-09-04T07:50:40","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=8359"},"modified":"2024-09-04T14:50:40","modified_gmt":"2024-09-04T07:50:40","slug":"hkbu-develops-chinese-medicine-for-ulcerative-colitis-approved-by-national-medical-products-administration-for-clinical-trial","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=8359","title":{"rendered":"HKBU develops Chinese medicine for ulcerative colitis approved by National Medical Products Administration for clinical trial"},"content":{"rendered":"

HONG KONG<\/span><\/span>, Sept. 4, 2024<\/span><\/span> \/PRNewswire\/ — The Centre for Chinese Herbal Medicine Drug Development (CDD) at\u00a0Hong Kong Baptist University<\/span> (HKBU) has achieved a significant milestone in developing a novel Chinese herbal formulation for ulcerative colitis\u00a0remission maintenance. Following a submission of Investigational New Drug application for CDD-2103 to\u00a0the National Medical Products Administration (NMPA) in mid-June\u00a0this year, CDD has received in late August its authorisation\u00a0for clinical trial.<\/p>\n

\n

<\/a>
(From right) Ms Emily Au, Assistant Director (Research and Development); Dr Tan Hor Yue, Assistant Professor; and Mr Duan Zhigang, Senior Regulatory Affairs Manager of CDD at HKBU, introduce the development of the novel Chinese herbal formulation for ulcerative colitis remission maintenance.<\/span><\/p>\n<\/div>\n

CDD plans to commence\u00a0a Phase II clinical trial for this new\u00a0drug in the Mainland next year to verify\u00a0its\u00a0effectiveness and safety as a treatment for remission maintenance for ulcerative colitis.<\/p>\n

Developed\u00a0based on traditional Chinese medicine\u00a0formulation <\/p>\n

Ulcerative colitis, a form of inflammatory bowel disease,\u00a0is becoming increasingly prevalent. It has a rising morbidity particularly in China<\/span> and other Asian countries. Its main symptoms include\u00a0diarrhea, rectal bleeding and abdominal cramps, resulting in a reduced quality of life for patients. Ulcerative colitis\u00a0can be broadly divided into active and remission stages. Currently the main treatment\u00a0objectives of the disease are to relieve symptoms, sustain the remission period, and reduce recurrence. Existing treatment options for ulcerative colitis cannot completely maintain remission, nor prevent its recurrence.<\/p>\n

In search of more effective ways to relieve\u00a0ulcerative colitis,\u00a0the research team developed a Chinese herbal formulation CDD-2103, with nine Chinese herbal medicines including Codonopsis Radix (dang shen) and Curcumae Longae Rhizoma (jiang huang), based on years of clinical experience. CDD-2103 is formulated for to maintain remission in ulcerative colitis patients who exhibit symptoms of spleen deficiency and internal accumulation of damp heat.<\/p>\n

According to a\u00a0clinical study conducted in Hong Kong\u00a0by the research team, patients who used CDD-2103 in a decoction format demonstrated good tolerability with no adverse effects reported. The research team has developed the CDD-2103 granule\u00a0in accordance with NMPA’s stringent quality control standards, and completed a series of basic experimental studies including preclinical pharmaceutical, pharmacology and non-clinical safety evaluations. Results of the preclinical studies showed that CDD-2103 suppressed the progression of colitis by improving\u00a0the tolerogenic immune microenvironment, which is achieved by mediating\u00a0the differentiation of\u00a0regulatory T cells\u00a0and reducing the number of inflammatory macrophages in the colon, as well as strengthening the\u00a0tight junction proteins in the mucosal barriers.\u00a0The research findings have been published in a number of\u00a0scientific journals\u00a0including\u00a0Journal of Advanced Research, Phytomedicine\u00a0and Journal of Ethnopharmacology.<\/p>\n

Professor Bian Zhaoxiang, Associate Vice-President (Clinical Chinese Medicine) and Director of CDD at HKBU, said: “We are delighted that CDD-2103 has obtained approval to carry out a Phase II clinical trial in the Mainland. The Centre is\u00a0optimistic that it can\u00a0improve patients’ quality of life. CDD-2103 is a novel Chinese herbal formulation developed based on\u00a0the modified ancient formulations combined with modern technology.\u00a0Obtaining clinical trial approval from NMPA\u00a0for this new drug is one of the important milestones of the Centre, which is\u00a0also a recognition of\u00a0the efforts of the research\u00a0team in the development of novel Chinese herbal\u00a0drugs.” \u00a0<\/p>\n

Phase II trial focuses on safety and effectiveness<\/p>\n

CDD will\u00a0launch a randomised, double-blind, and placebo-controlled clinical trial in the Mainland in 2025 to evaluate the drug’s safety and effectiveness\u00a0in\u00a0ulcerative colitis\u00a0patients in remission.<\/p>\n

Dr Tan Hor Yue<\/span>, Assistant Professor of CDD stated: “It is anticipated that the larger scales of clinical trials will be completed in\u00a0the next five years in order to confirm CDD-2103’s\u00a0therapeutic effect\u00a0and safety in\u00a0treating ulcerative colitis. After collecting sufficient data regarding the drug’s safety and efficacy,\u00a0the Centre will submit an application\u00a0for NMPA’s new drug approval, with the objective of obtaining\u00a0authorisation for the sales\u00a0of CDD-2103 in the market”.<\/p>\n

CDD, located in the Hong Kong Science Park, is\u00a0funded by the Innovation and Technology Commission’s InnoHK initiative. It\u00a0is the only centre focusing on the research and development of Chinese\u00a0herbal\u00a0medicines\u00a0at a local university. Since its establishment in 2020, CDD has been focusing on innovative Chinese medicine research for gastrointestinal and immune-related diseases such as chronic constipation and ulcerative colitis.<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n

HONG KONG<\/span><\/span>, Sept. 4, 2024<\/span><\/span> \/PRNewswire\/ — The Centre for Chinese Herbal Medicine Drug Development (CDD) at\u00a0Hong Kong Baptist University<\/span> (HKBU) has achieved a significant milestone in developing a novel Chinese herbal formulation for ulcerative colitis\u00a0remission maintenance. Following a submission of Investigational New Drug application for CDD-2103 to\u00a0the National Medical Products Administration (NMPA) in mid-June\u00a0this year, CDD has received in late August its authorisation\u00a0for clinical trial.<\/p>\n

\n

<\/a>
(From right) Ms Emily Au, Assistant Director (Research and Development); Dr Tan Hor Yue, Assistant Professor; and Mr Duan Zhigang, Senior Regulatory Affairs Manager of CDD at HKBU, introduce the development of the novel Chinese herbal formulation for ulcerative colitis remission maintenance.<\/span><\/p>\n<\/div>\n

CDD plans to commence\u00a0a Phase II clinical trial for this new\u00a0drug in the Mainland next year to verify\u00a0its\u00a0effectiveness and safety as a treatment for remission maintenance for ulcerative colitis.<\/p>\n

Developed\u00a0based on traditional Chinese medicine\u00a0formulation <\/p>\n

Ulcerative colitis, a form of inflammatory bowel disease,\u00a0is becoming increasingly prevalent. It has a rising morbidity particularly in China<\/span> and other Asian countries. Its main symptoms include\u00a0diarrhea, rectal bleeding and abdominal cramps, resulting in a reduced quality of life for patients. Ulcerative colitis\u00a0can be broadly divided into active and remission stages. Currently the main treatment\u00a0objectives of the disease are to relieve symptoms, sustain the remission period, and reduce recurrence. Existing treatment options for ulcerative colitis cannot completely maintain remission, nor prevent its recurrence.<\/p>\n

In search of more effective ways to relieve\u00a0ulcerative colitis,\u00a0the research team developed a Chinese herbal formulation CDD-2103, with nine Chinese herbal medicines including Codonopsis Radix (dang shen) and Curcumae Longae Rhizoma (jiang huang), based on years of clinical experience. CDD-2103 is formulated for to maintain remission in ulcerative colitis patients who exhibit symptoms of spleen deficiency and internal accumulation of damp heat.<\/p>\n

According to a\u00a0clinical study conducted in Hong Kong\u00a0by the research team, patients who used CDD-2103 in a decoction format demonstrated good tolerability with no adverse effects reported. The research team has developed the CDD-2103 granule\u00a0in accordance with NMPA’s stringent quality control standards, and completed a series of basic experimental studies including preclinical pharmaceutical, pharmacology and non-clinical safety evaluations. Results of the preclinical studies showed that CDD-2103 suppressed the progression of colitis by improving\u00a0the tolerogenic immune microenvironment, which is achieved by mediating\u00a0the differentiation of\u00a0regulatory T cells\u00a0and reducing the number of inflammatory macrophages in the colon, as well as strengthening the\u00a0tight junction proteins in the mucosal barriers.\u00a0The research findings have been published in a number of\u00a0scientific journals\u00a0including\u00a0Journal of Advanced Research, Phytomedicine\u00a0and Journal of Ethnopharmacology.<\/p>\n

Professor Bian Zhaoxiang, Associate Vice-President (Clinical Chinese Medicine) and Director of CDD at HKBU, said: “We are delighted that CDD-2103 has obtained approval to carry out a Phase II clinical trial in the Mainland. The Centre is\u00a0optimistic that it can\u00a0improve patients’ quality of life. CDD-2103 is a novel Chinese herbal formulation developed based on\u00a0the modified ancient formulations combined with modern technology.\u00a0Obtaining clinical trial approval from NMPA\u00a0for this new drug is one of the important milestones of the Centre, which is\u00a0also a recognition of\u00a0the efforts of the research\u00a0team in the development of novel Chinese herbal\u00a0drugs.” \u00a0<\/p>\n

Phase II trial focuses on safety and effectiveness<\/p>\n

CDD will\u00a0launch a randomised, double-blind, and placebo-controlled clinical trial in the Mainland in 2025 to evaluate the drug’s safety and effectiveness\u00a0in\u00a0ulcerative colitis\u00a0patients in remission.<\/p>\n

Dr Tan Hor Yue<\/span>, Assistant Professor of CDD stated: “It is anticipated that the larger scales of clinical trials will be completed in\u00a0the next five years in order to confirm CDD-2103’s\u00a0therapeutic effect\u00a0and safety in\u00a0treating ulcerative colitis. After collecting sufficient data regarding the drug’s safety and efficacy,\u00a0the Centre will submit an application\u00a0for NMPA’s new drug approval, with the objective of obtaining\u00a0authorisation for the sales\u00a0of CDD-2103 in the market”.<\/p>\n

CDD, located in the Hong Kong Science Park, is\u00a0funded by the Innovation and Technology Commission’s InnoHK initiative. It\u00a0is the only centre focusing on the research and development of Chinese\u00a0herbal\u00a0medicines\u00a0at a local university. Since its establishment in 2020, CDD has been focusing on innovative Chinese medicine research for gastrointestinal and immune-related diseases such as chronic constipation and ulcerative colitis.<\/p>\n

<\/p>\n","protected":false},"author":0,"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-8359","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/8359","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"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=8359"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/8359\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=8359"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=8359"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=8359"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}