{"id":16948,"date":"2023-03-18T00:00:00","date_gmt":"2023-03-18T00:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4045531_CN45531_0"},"modified":"2023-03-18T00:00:00","modified_gmt":"2023-03-18T00:00:00","slug":"keymed-biosciences-announces-2022-annual-results-efficiently-promotes-clinical-progress-proactively-develops-global-strategic-collaboration","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=16948","title":{"rendered":"Keymed Biosciences Announces 2022 Annual Results: Efficiently Promotes Clinical Progress &amp; Proactively Develops Global Strategic Collaboration"},"content":{"rendered":"<p><span class=\"legendSpanClass\"><span class=\"xn-location\">CHENGDU, China<\/span>, March 18, 2023 \/PRNewswire\/ &#8212; Keymed Biosciences Inc. (HKEX: 02162) announced its 2022 annual results. Focused on unmet clinical needs, the Company continued to efficiently develop innovative and differentiated pipelines, proactively carry out global strategic collaboration and accelerate its commercialization progress in 2022.<\/span><\/p>\n<p><b><i><u>Development&nbsp;of&nbsp;Innovative and Differentiated Pipelines <\/u><\/i><\/b><\/p>\n<p><b><u>Core Product CM310 (IL-4R\u03b1 antibody):<\/u><\/b><\/p>\n<ul type=\"disc\">\n<li>Initiated <b>Phase III registrational clinical <\/b><b>trial<\/b>&nbsp;for adults with moderate to severe AD in 2022 Q1;&nbsp;Completed the patient enrollment in 2022 November;<b> The Company<\/b> <b>plans to complete this trial and submit the NDA for this indication in 2023.<\/b><\/li>\n<li>Released Phase II clinical data for the treatment of CRSwNP in end of <span class=\"xn-chron\">March 2022<\/span>: co-primary efficacy endpoints are fully achieved with positive results; Initiated <b>Phase III trial<\/b> in 2022 H2.<\/li>\n<li>Received <b>Breakthrough therapy designation (BTD) <\/b>from the CDE for the treatment of moderate to severe AD in <span class=\"xn-chron\">June 2022<\/span>.<\/li>\n<li>Obtained the CDE IND approval for the treatment of AR in <span class=\"xn-chron\">July 2022<\/span>.<\/li>\n<li>Obtained the FDA IND approval for the treatment of AD&nbsp;in <span class=\"xn-chron\">August 2022<\/span>.<\/li>\n<li>Initiated <b>Phase II\/III pivotal clinical <\/b><b>trial <\/b>for moderate to severe asthma in <span class=\"xn-chron\">March 2023<\/span>, led by CSPC.<\/li>\n<\/ul>\n<p><b><u>Core Product CM326 (TSLP antibody)<\/u><\/b><u>:<\/u><\/p>\n<ul type=\"disc\">\n<li>Initiated Phase Ib\/IIa clinical trial for patients with moderate to severe AD in 2022 H1; Simultaneously initiated Phase II clinical trial for adults with moderate to severe AD in 2022 H2.<\/li>\n<li>Initiated Phase Ib\/IIa clinical trial for patients with CRSwNP in 2022 H2; Completed the patient enrollment in <span class=\"xn-chron\">February 2023<\/span>.<\/li>\n<\/ul>\n<p><b><u>Core Product CMG901 (Claudin 18.2 ADC):<\/u><\/b><\/p>\n<ul type=\"disc\">\n<li>Completed the patients enrollment of Phase Ia dose-escalation clinical trial in subjects with solid tumor by 2022 H1; Initiated Phase Ib dose-expansion clinic trial in 2022 Q2 and patient enrollment for this trial is ongoing.<\/li>\n<li>Received <b>Orphan-drug Designation &amp; Fast Track Designation<\/b> for the treatment of unresectable or metastatic gastric and gastroesophageal junction cancer from the FDA in <span class=\"xn-chron\">April 2022<\/span>.<\/li>\n<li>Received <b>Breakthrough therapy designation (BTD)<\/b> for the treatment of Claudin 18.2-positive advanced gastric cancer from the CDE in <span class=\"xn-chron\">September 2022<\/span>.<\/li>\n<li>Presented Phase Ia clinical data in subjects with advanced solid tumor at the 2023 ASCO GI in January 2023:&nbsp;The results showed that CMG901 was <b>well-tolerated with a favorable safety profile<\/b>; Preliminary efficacy results demonstrated that in the 8 Claudin 18.2-positive gastric\/GEJ cancer patients receiving CMG901, <b>Objective response rate (ORR) and disease control rate (DCR) were 75.0% and 100%<\/b>, respectively, with <b>ORR of 100%<\/b> in the 2.6, 3.0, and 3.4 mg\/kg cohorts.<\/li>\n<li>In <span class=\"xn-chron\">February 2023<\/span>, KYM Biosciences Inc. (a non-wholly owned subsidiary owned by Keymed with 70% shares) entered a global exclusive license agreement with AstraZeneca AB, who will be responsible for the research, development, manufacture, and commercialization of&nbsp;CMG901 globally. Under the terms of the agreement, KYM Biosciences will receive an upfront payment of&nbsp;<b><span class=\"xn-money\">$63m<\/span><\/b>&nbsp;on&nbsp;transaction closing and additional development and sales-related milestone payments of up to&nbsp;<b><span class=\"xn-money\">$1.1bn<\/span><\/b>&nbsp;as well as tiered royalties up to low double-digits.<\/li>\n<\/ul>\n<p><b><u>Core Product CM313 (CD38 antibody):<\/u><\/b><\/p>\n<ul type=\"disc\">\n<li>Proceeding Phase Ia does-escalation clinical trial for RRMM in 2022; Initiated dose expansion clinical trial in the late stage of 2022 Q1.<\/li>\n<li>Obtained IND approval for the treatment of SLE in <span class=\"xn-location\">China<\/span> in <span class=\"xn-chron\">April 2022<\/span>; completed the first patient dosing in <span class=\"xn-chron\">October 2022<\/span>; Phase Ib\/IIa clinical trial is ongoing.<\/li>\n<\/ul>\n<p><b><u>Core Product CM338 (MASP-2 antibody):<\/u><\/b><\/p>\n<ul type=\"disc\">\n<li>Completed CM338 Phase I clinical trial with healthy volunteers in <span class=\"xn-chron\">November 2022<\/span>.<\/li>\n<li>Initiated CM338 Phase II clinical trial for the treatment of IgAN in <span class=\"xn-chron\">March 2023<\/span>.<\/li>\n<\/ul>\n<p><b><i>Other Assets<\/i><\/b><\/p>\n<p><b><u>CM355 (CD20xCD3):<\/u><\/b><\/p>\n<ul type=\"disc\">\n<li>Completed the first patient dosing in <span class=\"xn-chron\">January 2022<\/span>; Phase I dose-escalation trial is ongoing.<\/li>\n<\/ul>\n<p><b><u>CM336 (BCMAxCD3):<\/u><\/b><\/p>\n<ul type=\"disc\">\n<li>Completed the first patient dosing in <span class=\"xn-chron\">September 2022<\/span>; Phase I dose-escalation trial is ongoing.<\/li>\n<\/ul>\n<p><b><u>CM350 (GPC3xCD3):<\/u><\/b><\/p>\n<ul type=\"disc\">\n<li>Obtained IND approval in <span class=\"xn-location\">China<\/span> for the treatment of solid tumor in <span class=\"xn-chron\">January 2022<\/span>; Completed the first patient dosing in <span class=\"xn-chron\">May 2022<\/span>; Phase I dose-escalation trial is ongoing.<\/li>\n<\/ul>\n<p><b><u>CM369 (CCR8 antibody):<\/u><\/b><\/p>\n<ul type=\"disc\">\n<li>Obtained IND approval in <span class=\"xn-location\">China<\/span> for the treatment of advanced solid tumor in <span class=\"xn-chron\">August 2022<\/span>; Completed the first patient dosing in <span class=\"xn-chron\">January 2023<\/span>; Phase I dose-escalation trial is ongoing.<\/li>\n<\/ul>\n<p><b><i><u>Enlarged Team of Talents &amp; Expanded Manufacturing Capabilities<\/u><\/i><\/b>&nbsp;<\/p>\n<ul type=\"disc\">\n<li>The Company has built a stable core team and continuously recruit talents to match its growing demand for R&amp;D, clinical trial, manufacture, operation and commercialization. By <span class=\"xn-chron\">December 31th<\/span> 2022, the Company has a total of <b>613 employees<\/b>, including <b>over <\/b><b>240 employees<\/b>&nbsp;in clinical development and operations, and <b>more than 230 employees<\/b> in production and quality control, with<b> a year-over-year increase of 189%<\/b>.<\/li>\n<li>In addition to the headquarters in <span class=\"xn-location\">Chengdu<\/span>, the Company has set offices in <span class=\"xn-location\">Shanghai<\/span>, <span class=\"xn-location\">Beijing<\/span>, <span class=\"xn-location\">Wuhan<\/span>, <span class=\"xn-location\">Guangzhou<\/span>, <span class=\"xn-location\">Nanjing<\/span>, <span class=\"xn-location\">Jinan<\/span>.<\/li>\n<li>The construction of the first phase of commercial-scale facility has been completed by the end of 2022, which will provide <b>16,000L <\/b>of manufacturing capacity. The design of all facilities is in compliance with the requirements of cGMP of the NMPA and FDA.<\/li>\n<\/ul>\n<p><b><i><u>Financial Data &amp; Capital Market Performanc<\/u><\/i><\/b><b><i><u>e <\/u><\/i><\/b><\/p>\n<ul type=\"disc\">\n<li>As of <span class=\"xn-chron\">December 31, 2022<\/span>, the Company&#8217;s R&amp;D investment amounted<b> <span class=\"xn-money\">RMB 500 million<\/span><\/b>, a <b>year-over-year increase of 42%<\/b>; Income amounted <b><span class=\"xn-money\">RMB 100 million<\/span><\/b>, which comes from the out-licensing revenue of CM326 from CSPC; The Company holds a total of <b><span class=\"xn-money\">RMB 3.17 billion<\/span><\/b> in cash and cash equivalents, time deposits and bank wealth management, which can fully support the Company&#8217;s future development.<\/li>\n<li>In <span class=\"xn-chron\">March 2022<\/span>, Keymed Bio (2162.HK) was included as eligible stocks of the Shenzhen-Hong Kong Stock Connect. In <span class=\"xn-chron\">Aug 2022<\/span>, Keymed got listed in FTSE Global Small Cap Index ex US; In <span class=\"xn-chron\">Nov 2022<\/span>, Keymed got listed in MSCI China Small Cap Index.<\/li>\n<\/ul>\n<p><b>About Keymed Biosciences Inc. <\/b><\/p>\n<p>Keymed Biosciences Inc. (Stock Code: 02162 HK) focuses on the urgent unmet clinical needs, and is committed to providing high-quality, affordable, innovative therapies for patients in <span class=\"xn-location\">China<\/span> and overseas. Keymed was founded by medical and scientific experts from world-renowned universities who have strong experience in the transformation of scientific and technological achievements to commercialization at home and abroad. The core leadership team includes the inventors of the first PD-1 antibody drugs that were pioneered and approved in <span class=\"xn-location\">the United States<\/span> and <span class=\"xn-location\">China<\/span>. The Company was listed on the main board of Hong Kong Stock Exchange on <span class=\"xn-chron\">July 8, 2021<\/span>.<\/p>\n<p>For more information, please visit <a href=\"http:\/\/www.Keymedbio.com\" rel=\"nofollow\">www.Keymedbio.com<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>CHENGDU, China, March 18, 2023 \/PRNewswire\/ &#8212; Keymed Biosciences Inc. (HKEX: 02162) announced its 2022 annual results. Focused on unmet clinical needs, the Company continued to efficiently develop innovative and differentiated pipelines, proactively carry out global strategic collaboration and accelerate its commercialization progress in 2022. Development&nbsp;of&nbsp;Innovative and Differentiated Pipelines Core Product CM310 (IL-4R\u03b1 antibody): Initiated [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-16948","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Keymed Biosciences Announces 2022 Annual Results: Efficiently Promotes Clinical Progress &amp; Proactively Develops Global Strategic Collaboration - My Blog<\/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:\/\/transmediavictoria.net.au\/?p=16948\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Keymed Biosciences Announces 2022 Annual Results: Efficiently Promotes Clinical Progress &amp; Proactively Develops Global Strategic Collaboration - My Blog\" \/>\n<meta property=\"og:description\" content=\"CHENGDU, China, March 18, 2023 \/PRNewswire\/ &#8212; Keymed Biosciences Inc. 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