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Mediti700wireless和i700是全球牙醫的首選掃描儀 Medit的掃描儀屢獲殊榮，繼續推動牙科技術創新 韓國首爾和加州長灘2023年6月6日 /美通社/ -- Institute of Digital Dentistry(iDD)進行的一項最新全球問卷調查表明，Medit(Medit)i700 wireless和i700是牙科領域排名前兩位的口內掃描儀。此外，Mediti600也在該研究中排在前四。這項開創性的研究共有109個不同國家的1072名受訪者參加，範圍遍布全球四分之三以上的地區。 Medit 該研究旨在探討牙科行業口內掃描儀的用戶體驗。參與者被要求從速度、售後支持、可及性、價格和整體質量等幾個方面對不同的掃描儀進行評估。結果顯示，Mediti700 wireless和i700成為了全球牙科專業人士的首選，同時Mediti600也獲得了廣泛的認可。 Medit的全球KOL之一金東煥(Donghwan Kim)博士在評價Medit掃描儀的性能時表示："Mediti700 wireless和i700真正改變了我們臨床的操作方法。這些掃描儀不僅速度超快、易於使用、整體品質卓越，而且提供可靠的支持和有競爭力的價格。此外，Medit Link軟件平台提供的各種免費應用程序也能幫助提高效率並簡化工作流程。" Mediti700 wireless和i700採用先進的掃描技術，可實現精準而詳細的數字化印模。這些功能有助於準確診斷和簡化治療方案。 i700 wireless的無線功能和i700的有線連接為牙科專業人員提供了靈活性和便利性。 作為牙科技術的全球領導者，Medit繼續將創新和客戶滿意度放在首位。通過開發最前沿的解決方案，滿足了全球牙科專業人員不斷變化的需求。 Medit首席執行官GB Ko表示："我們的目標是為牙科醫生提供可靠、準確的用戶友好型掃描儀，以提升他們的工作流程並改善患者的治療效果。我們很高興我們的掃描儀在這項研究中獲得了認可，這也展示了我們追求卓越牙科技術的決心。" 欲了解有關Mediti700 wireless、Mediti700、Mediti600和Medit提供的其他先進牙科解決方案的更多信息，請訪問www.medit.com。 完整的調研報告可在此處獲取：[https://www.sciencedirect.com/science/article/pii/S0020653923000680?fbclid=PAAaYdwTWkajf4Yw_cHvdKuDt8Q37LxOF3Mz978BIyk9Ofavd5pTfgoGz_Ty8] Medit
美國羅克維爾和中國蘇州2023年6月6日 /美通社/ -- 信達生物製藥集團（香港聯交所股票代碼：01801），一家致力於研發、生產和銷售腫瘤、自身免疫、代謝、眼科等重大疾病領域創新藥物的生物製藥公司，在2023年美國臨床腫瘤學會（ASCO）年會上首次公佈了IBI351（GFH925，KRASG12C抑制劑）單藥治療晚期結直腸癌患者的初步研究結果。 IBI351單藥治療在具有KRASG12C突變的晚期結直腸癌患者中的安全性和有效性：來自兩項臨床I期研究的匯總分析 摘要編號：3586 IBI351是一種特異性共價不可逆的KRASG12C 抑制劑。本次報道的數據是基於兩項正在進行的臨床研究的匯總結果（NCT05005234, NCT05497336）。截至2023年2月16日，共有54例晚期結直腸癌受試者納入分析（其中700mg QD劑量組3例，450mg BID劑量組4例，600mg BID劑量組46例，750mg BID劑量組1例）。研究結果顯示： 600mg BID劑量組中共有42例受試者接受了至少一次腫瘤評估，客觀緩解率（ORR）為42.9%（18/42），確認的客觀緩解率（cORR）為31.0%（13/42），疾病控制率（DCR）為88.1%（37/42）。其中共有23例受試者既往接受了2線及以上的系統性治療。ORR為65.2%（15/23），cORR為43.5%（10/23），DCR為87.0%（20/23）。 中位緩解持續時間（DoR）尚未達到（中位隨訪時間為5.5個月）。3個月DoR率為85.7%。截至數據分析日，92.3%的確認緩解的受試者仍在持續治療中。 安全性方面，截至數據分析日，總體耐受性良好。共有87.0%（47/54）的受試者發生藥物相關不良事件（TRAE），大部分為1-2級，最常見的TRAE為貧血、白細胞計數降低、瘙癢、丙氨酸氨基轉移酶升高、中性粒細胞計數降低、天門冬氨酸氨基轉移酶升高、血膽紅素升高和乏力。18.5%的受試者發生3級TRAE，無4級和5級的TRAE以及導致治療終止的TRAE發生。 IBI351單藥在攜帶KRASG12C 突變的晚期結直腸癌患者中展示出良好的安全性、耐受性及初步的療效信號。該藥物已分別於2023年1月和2023年5月被CDE納入突破性治療品種，擬用於治療至少接受過一種系統性治療的KRAS G12C突變型的晚期非小細胞肺癌（NSCLC）患者和至少接受過兩種系統性治療的KRASG12C突變型的晚期結直腸癌（CRC）患者。 浙江大學醫學院附屬第二醫院丁克峰教授表示：「中國人群KRASG12C的突變頻率在結直腸癌約占2.5%。KRASG12C突變的晚期結直腸癌患者較KRAS野生型患者預後更差，現有的治療手段非常有限，化療治療效果欠佳，目前國內無針對該靶點的藥物上市，臨床上亟需新的治療手段。IBI351是一種特異性共價不可逆的KRASG12C抑制劑。初步數據顯示IBI351單藥在KRASG12C 突變的晚期結直腸癌患者中展示出了良好的安全性和令人鼓舞的療效。我們期待該研究有更多的積極持續的結果更新。」 信達生物製藥集團高級副總裁周輝博士表示：「我們很高興能夠在今年ASCO年會上分享IBI351在晚期結直腸癌中的臨床開發項目進展。作為一款高效的KRASG12C口服抑制劑，IBI351已經在多種晚期實體瘤中展現出令人鼓舞的療效和安全性信號，並且已獲得CDE對非小細胞肺癌和結直腸癌兩項適應症的突破性療法認定。本次ASCO報道的數據顯示，IBI351單藥治療在晚期結直腸癌後線治療中初步顯示出優異的療效和良好的安全性，我們將在後續的臨床試驗中做進一步的驗證，並探索IBI351單藥或聯合治療在晚期結直腸癌患者中的療效和安全性。」 關於結直腸癌 結直腸癌（Colorectal carcinoma, CRC）是嚴重危害人類健康的常見惡性腫瘤。根據國際癌症研究機構統計，2020年全球新髮結直腸癌癌病例約為193萬，死亡人數約93萬[1]。過去30年我國CRC發病人數及死亡人數持續增加，2015年新發病例37.6萬，死亡病例19.1萬，並且在未來25年我國CRC新發病例和死亡病例將延續增長趨勢，是我國面臨的重大公共衛生問題。KRASG12C是一種特定的KRAS亞突變，導致KRAS處於一個持續GTP結合活化狀態。在西方人群中，約3%結直腸癌患者存在KRASG12C突變，在我國約2.5%結直腸癌患者存在KRASG12C突變[2]。 關於IBI351（GFH925,KRASG12C抑制劑） 作為一款高效口服新分子實體化合物，IBI351通過共價不可逆修飾KRASG12C蛋白突變體半胱氨酸殘基，有效抑制該蛋白介導的GTP/GDP交換從而下調KRAS蛋白活化水平；臨床前半胱氨酸選擇性測試，也顯示了IBI351對於該突變位點的高選擇性抑制效力。此外，IBI351抑制KRAS蛋白後可進而抑制下游信號傳導通路，有效誘導腫瘤細胞凋亡及細胞週期阻滯，達到抗腫瘤效果。 2021年9月，信達生物與勁方醫藥宣佈達成全球獨家授權協議，信達生物作為獨家合作夥伴獲得GFH925（信達生物研發代號：IBI351）在中國（包括中國大陸、香港、澳門及台灣）的開發和商業化權利，並擁有全球開發和商業化權益的選擇權。 關於信達生物 「始於信，達於行」，開發出老百姓用得起的高質量生物藥，是信達生物的理想和目標。信達生物成立於2011年，致力於開發、生產和銷售腫瘤、自身免疫、代謝、眼科等重大疾病領域的創新藥物。2018年10月31日，信達生物製藥在香港聯合交易所有限公司主板上市，股票代碼：01801。 自成立以來，公司憑借創新成果和國際化的運營模式在眾多生物製藥公司中脫穎而出。建立起了一條包括35個新藥品種的產品鏈，覆蓋腫瘤、自身免疫、代謝、眼科等多個疾病領域，其中7個品種入選國家「重大新藥創製」專項。公司已有 8個產品獲得批准上市，它們分別是信迪利單抗注射液（達伯舒®），貝伐珠單抗注射液（達攸同®），阿達木單抗注射液（蘇立信®），利妥昔單抗注射液（達伯華®），佩米替尼片（達伯坦®），奧雷巴替尼片（耐立克®）， 雷莫西尤單抗注射液（希冉擇®），塞普替尼膠囊（睿妥®），3個品種在NMPA審評中，6個新藥分子進入III期或關鍵性臨床研究，另外還有18個新藥品種已進入臨床研究。 信達生物已組建了一支具有國際先進水平的高端生物藥開發、產業化人才團隊，包括眾多海歸專家，並與禮來、羅氏、賽諾菲、Adimab、Incyte和MD Anderson 癌症中心等國際合作方達成28項戰略合作。 信達生物在不斷自研創新藥物、謀求自身發展的同時，秉承經濟建設以人民為中心的發展思想。多年來，始終心懷科學善念，堅守「以患者為中心」，心繫患者並關注患者家庭，積極履行社會責任。公司陸續發起、參與了多項藥品公益援助項目，讓越來越多的患者能夠得益於生命科學的進步，用得上、用得起高質量的生物藥。至2023年3月，信達生物患者援助項目已惠及16余萬普通患者，藥物捐贈總價值數億元。 信達生物希望和大家一起努力，提高中國生物製藥產業的發展水平，以滿足百姓用藥可及性和人民對生命健康美好願望的追求。 詳情請訪問公司網站：www.innoventbio.com或公司領英賬號www.linkedin.com/company/innovent-biologics/。 聲明：信達不推薦任何未獲批的藥品/適應症使用。 前瞻性聲明 本新聞稿所發佈的信息中可能會包含某些前瞻性表述。這些表述本質上具有相當風險和不確定性。在使用「預期」、「相信」、「預測」、「期望」、「打算」及其他類似詞語進行表述時，凡與本公司有關的，均屬於前瞻性表述。本公司並無義務不斷地更新這些預測性陳述。 這些前瞻性表述是基於本公司管理層在做出表述時對未來事務的現有看法、假設、期望、估計、預測和理解。這些表述並非對未來發展的保證，會受到風險、不確性及其他因素的影響，有些是超出本公司的控制範圍，難以預計。因此，受我們的業務、競爭環境、政治、經濟、法律和社會情況的未來變化及發展的影響，實際結果可能會與前瞻性表述所含資料有較大差別。 本公司、本公司董事及僱員代理概不承擔 (a) 更正或更新本網站所載前瞻性表述的任何義務;及 (b) 若因任何前瞻性表述不能實現或變成不正確而引致的任何責任。 參考文獻 [1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID: 33538338. [2] LOONG H H, Du N, CHENG C, et al. KRAS G12C mutations in Asia: a landscape analysis of 11,951 Chinese tumor samples[J]. Transl Lung Cancer Res, 2020,9(5): 1759-1769.
Dentists Worldwide Choose Medit i700 wireless and Medit i700 as Preferred Scanners Medit Continues to Drive Innovation in Dental Technology with Award-Winning Scanners SEOUL, South Korea and LONG BEACH, Calif., June 6, 2023 /PRNewswire/ -- A recent transnational questionnaire study conducted by the Institute of Digital Dentistry(iDD) has recognized the Medit i700 wireless and Medit i700 as the top two intraoral scanners in dentistry. Furthermore, the study ranked the Medit i600 among the top four scanners. This groundbreaking research involved 1,072 respondents from 109 different countries and spanned over three quarters. Medit The objective of the study was to explore the user experience of intraoral scanners in dentistry. Participants were asked to evaluate various scanners based on multiple factors, including speed, support system, accessibility, price, and overall quality. The results revealed that the Medit i700 wireless and Medit i700 emerged as the best preferred choices among dental professionals worldwide, with the Medit i600 also receiving significant recognition. Dr. Donghwan Kim, one of key opinion leaders of Medit, commented on the performance of Medit scanners: "The Medit i700 wireless and Medit i700 have truly transformed our practice. These scanners provide exceptional speed, reliable support, ease of accessibility, competitive pricing, and overall excellent quality. Additionally, the Medit Link software platform offers a wide range of free apps that enhance productivity and streamline workflows." The Medit i700 wireless and Medit i700 incorporate advanced scanning technology that enables precise and detailed digital impressions. These features contribute to accurate diagnoses and streamlined treatment planning. The wireless functionality of the i700 wireless and the seamless wired connectivity of the i700 provide flexibility and convenience for dental professionals. Medit, as a global leader in dental technology, continues to prioritize innovation and customer satisfaction. By developing cutting-edge solutions, the company addresses the evolving needs of dental professionals worldwide. "We aim to provide dental practitioners with reliable, accurate, and user-friendly scanners that enhance their workflows and improve patient outcomes," said GB Ko, the CEO at Medit. "We are thrilled that our scanners have been recognized in this study, validating our commitment to excellence in dental technology." For more information about the Medit i700 wireless, Medit i700, Medit i600, and other advanced dental solutions offered by Medit, please visit www.medit.com. The full Scientific Research Report can be accessed here: [https://www.sciencedirect.com/science/article/pii/S0020653923000680?fbclid=PAAaYdwTWkajf4Yw_cHvdKuDt8Q37LxOF3Mz978BIyk9Ofavd5pTfgoGz_Ty8] Medit
ROCKVILLE, Md. and SUZHOU, China, June 6, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, announced the preliminary data of IBI351 (GFH925, KRASG12C inhibitor) is presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Efficacy and safety of IBI351 monotherapy in metastatic colorectal cancer harboring KRASG12C mutation: preliminary results from a pooled analysis of two Phase 1 studies Abstract #: 3586 IBI351 is a novel, irreversible covalent inhibitor of KRASG12C mutation. Data presented in ASCO 2023 was from a pooled analysis of two Phase 1 studies (NCT05005234, NCT05497336). As of data cutoff date(Feb 16, 2023), a total of 54 metastatic colorectal cancer patients were included for analysis (including 3 subjects at 700mg QD, 4 subjects at 450mg BID, 46 subjects at 600mg BID and 1 subjects at 750mg BID). The study results were as follows: Of 42 evaluable subjects at 600mg BID, ORR was 42.9% (18/42), confirmed ORR was 31.0% (13/42), DCR was 88.1% (37/42). A total of 23 subjects at 600mg BID received ≥2 lines of systematic anticancer therapy prior to enrollment. ORR was 65.2% (15/23), confirmed ORR was 43.5% (10/23), DCR was 87.0% (20/23). The median duration of response (DoR) was not reached yet, with a median follow-up of 5.5 months. The 3-month DoR rate was 85.7%. As data cutoff, 92.3% of the confirmed responders were remained on treatment. As data cutoff, IBI351 was well tolerated. Treatment-related adverse events (TRAEs) occurred in 87.0% (47/54) subjects and the majority of the TRAEs were grade 1-2. The most common TRAEs were anemia, white blood cell count decreased, pruritus, alanine aminotransferase increased, neutrophil count decreased, aspartate aminotransferase increased, blood bilirubin increased and asthenia. About 18.5% subjects reporting grade 3 TRAEs. There were no grade 4-5 TRAEs or TRAEs led to treatment discontinuation. Favorable safety and tolerability and promising antitumor activity of IBI351 monotherapy were observed in advanced colorectal cancer harboring KRASG12C mutation. IBI351 has received NMPA Breakthrough Designation as monotherapy for previous treated advanced non-small cell lung cancer (NSCLC) and colorectal carcinoma in Jan 2023 and May 2023, respectively. Professor Kefeng Ding from the Second Affiliated Hospital Zhejiang University School of Medicine, stated: "KRASG12C mutation occurs in about 2.5% of colorectal cancer in China. The prognosis of advanced colorectal carcinoma patients with KRASG12C mutation is worse than KRAS wild type patients with limited therapeutic options. Currently, there are no approved drugs targeting KRASG12C available on the market in China. IBI351 is a novel, irreversible covalent inhibitor of KRASG12C mutation. The preliminary data shows favorable safety and promising activity of IBI351 monotherapy in KRASG12C mutated advanced colorectal cancer. We look forward to more positive clinical data from this study. " Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present our clinical development results of IBI351 in advanced colorectal cancer at the 2023 ASCO. As a highly effective oral inhibitor of KRASG12C, IBI351 has shown encouraging efficacy and safety signals in a variety of advanced solid tumors and has received Breakthrough Designation by CDE for NSCLC and colorectal cancer. The data reported at ASCO 2023 showed that IBI351 monotherapy has excellent efficacy and safety in previously treated advanced colorectal carcinoma. We look forward to obtaining more data from the ongoing clinical trials, and further explore the efficacy and safety of IBI351 as monotherapy or combination therapy in patients with advanced colorectal carcinoma. " About Colorectal Carcinoma (CRC) According to GLOBOCAN 2020 report, there were about 1.93 million new cases of colorectal cancer worldwide in 2020, and caused about 930,000 deaths[1]. In the past 30 years, the number of CRC cases and deaths has continued to increase. In 2015, there were 376,000 new cases and 191,000 deaths, and the new CRC cases and deaths will continue to increase in the next 25 years, which is a major public health problem in China. KRASG12C is a specific KRAS mutation subtype that causes KRAS to be in a state of sustained GTP-binding activation. KRASG12C mutation is present in about 3% of colorectal cancer patients in the Western population and 2.5% of Chinese colorectal cancer patients[2]. About IBI351 (GFH925,KRASG12C Inhibitor) Discovered by GenFleet Therapeutics, GFH925 (Innovent R&D code: IBI351) is a novel, orally active, potent KRASG12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRASG12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of IBI351 towards G12C. Subsequently, IBI351 effectively inhibits the downstream signal pathway to induce tumor cells' apoptosis and cell cycle arrest. In September 2021, Innovent and GenFleet Therapeutics entered into an exclusive license agreement for the development and commercialization of IBI351 in China (including mainland China, Hong Kong, Macau and Taiwan) with additional option-in rights for global development and commercialization. About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 35 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include: TYVYT® (sintilimab injection), BYVASDA®(bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA®(rituximab biosimilar injection), Pemazyre®(pemigatinib oral inhibitor), olverembatinib (BCR ABL TKI), Cyramza® (ramucirumab) and Retsevmo®(selpercatinib). An additional 3 assets are under NMPA NDA review, 6 assets are in Phase 3 or pivotal clinical trials, and 18 more molecules are in clinical studies. Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/. Disclaimer: Innovent does not recommend any off-label usage. Note:TYVYT® (sintilimab injection) is not an approved product in the United States. BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.TYVYT® (sintilimab injection, Innovent) BYVASDA® (bevacizumab biosimilar injection, Innovent)HALPRYZA® (rituximab biosimilar injection, Innovent)SULINNO® (adalimumab biosimilar injection, Innovent)Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.CYRAMZA® (ramucirumab, Eli Lilly). CYRAMZA® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.Retsevmo®(selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. Reference [1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID: 33538338. [2] LOONG H H, Du N, CHENG C, et al. KRAS G12C mutations in Asia: a landscape analysis of 11,951 Chinese tumor samples[J]. Transl Lung Cancer Res, 2020,9(5): 1759-1769.
ROCKVILLE, Md. and SUZHOU, China, June 6, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and IASO Biotechnology ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, today jointly announced that the updated data from Phase 1b/2 study of Equecabtagene Autoleucel (Innovent R&D code: IBI326, IASO Bio R&D code: CT103A), a fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma (RRMM), was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 2-6, 2023. Poster Presentation Overview Presentation Title: CT103A, a novel fully human BCMA-targeting CAR-T therapy, in patients with relapsed/refractory multiple myeloma: updated long-term follow-up results of phase 1b/2 study (FUMANBA-1) Session Title：Hematologic Malignancies—Plasma Cell Dyscrasia Abstract Code: ASCO-8025 Session date and Time: Monday, June 5, 2023, at 8:00 AM - 10:00 AM CDT Venue: McCormick Place, Chicago, Illinois, United States + Online The updated data showed long-term follow-up efficacy and safety of the Phase 1b/2 study (FUMANBA-1) conducted in 14 centers in China. This study enrolled RRMM patients who received ≥ 3 lines of prior therapies containing at least a proteasome inhibitor and an immunomodulatory agent and were refractory to their last line of treatment (ChiCTR1800018137, NCT05066646). As of the data cutoff date of September 9th, 2022, a total of 103 patients received CT103A at 1.0×106 CAR-T cells/kg with the median follow-up of 13.8 months (range 0.4, 27.2) and median prior four lines of therapy (range 3,23). Among the 103 patients, 68.9% (71/103) had high-risk cytogenetic abnormalities per mSMART 3.0, 12.6%（13/103）had extramedullary multiple myeloma (EMM), and 11.7%（12/103）had received prior CAR-T therapy. Equecabtagene Autoleucel showed deepening and durable efficacy: Among the 101 evaluable patients, the overall response rate (ORR) was 96.0% (97/101), with 91.1% (92/101) of those patients achieving very good partial response (VGPR) or deeper responses, and the stringent complete response/ complete response (sCR/CR) rate was 74.3% (75/101). The median time to response(mTTR) was 16 days (range 11-179). The median duration of response (DOR) and median progression free survival (PFS) have not been reached. The 12-month PFS rate was 78.8% (95% CI: 68.6–85.97). 95.0% (96/101) of patients achieved minimal residual disease (MRD) negativity, and all CR/sCR patients achieved MRD negativity. 82.4% (95%CI: 70.90-89.72%) of patients achieved sustained MRD negativity over 12 months and the median duration of MRD negativity was not reached. In 89 patients without prior CAR-T therapy, ORR was 98.9% (88/89), including 78.7% (70/89) of patients reaching CR/sCR. Of the 63 patients with ≥ 12 months follow-up (including patients that withdrew early), ORR was 98.4% (62/93）and 87.3%（55/63）reached sCR/CR. Of the 12 patients with prior CAR-T therapy, 75% (9/12) achieved response, and 5 patients achieved sCR (including 4 patients that sustained sCR for over 18 months post-infusion). Equecabtagene Autoleucel demonstrated a favorable and manageable safety profile: Among the 103 patients, 93.2% (96/103) experienced cytokine release syndrome (CRS). The majority experienced grade 1~2 CRS, with only one experiencing ≥ grade 3 CRS. The median time to CRS onset was 6 days (range 1, 13) after infusion, and the median duration of CRS was 5 days (range 2, 30). Only two patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS), including one grade 1 and one grade 2 ICANS. All patients with CRS or ICANS have recovered. The most common ≥ grade 3 treatment-related AEs were still hematologic. Equecabtagene Autoleucel demonstrated robust expansion and prolonged persistence and low immunogenicity: Equecabtagene Autoleucel in peripheral blood reached the peak at a median of 12 days post-infusion, with a median Cmax of 87570.6 copies/ug DNA. Equecabtagene Autoleucel was still detectable in 50% (28/56) and 40% (4/10) of the patients who completed 12-month and 24-month follow-ups after infusion. Only 19.4% (20/103) of the subjects were anti-drug antibody (ADA)-positive after Equecabtagene Autoleucel infusion. "Multiple myeloma (MM) is the second most prevalent hematological malignancy. While current major drug therapies such as proteasome inhibitors (PIs), immunomodulators (IMiDs) and monoclonal antibodies (mAbs) have significantly improved MM treatments in the past two decades, it is still an incurable disease. The updated data from our ongoing clinical study of Equecabtagene Autoleucel presented at ASCO demonstrated that treatment with our a BCMA-targeted CAR-T therapy was effective and well-tolerated for a longer period of time,"said principal investigators Prof. Lugui Qiu，MD，from the Chinese Academy of Medical Science Hematology Hospital, and Prof. Chunrui Li, MD, PhD, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology." In comparison to the clinical data released at the EHA 2022 Congress, we're excited that our updated study data show that with the number of subjects receiving Equecabtagene Autoleucel increasing from 79 to 103, and the median follow-up time from 9.0 months to 13.8 months, Equecabtagene Autoleucel's efficacy further improved: the sCR/CR rate increased from 68.4% to 74.3%. It is more worth mentioning that the sCR/CR rate reached 87.3% in the subjects naïve to BCMA-targeted CAR-T therapies and followed up for at least 12 months. These results are encouraging and entails an opportunity to advance Equecabtagene Autoleucel to earlier lines of treatment to benefit more MM patients." About Multiple Myeloma (MM) Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For multiple myeloma patients, common first-line drug treatments include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. While treatment may result in remission, most patients will inevitably enter the relapsed or refractory stage as there's currently no cure. As a result, there is a significant unmet need for patients with relapsed/refractory multiple myeloma. In the United States, MM accounts for nearly 2% of all cancer cases, and more than 2% of cancer-related deaths. According to Frost & Sullivan, the number of new MM cases in the United States rose from 30,300 in 2016 to 32,300 in 2020 and is expected to increase to 37,800 by 2025. Additionally, the total number of patients diagnosed with MM increased from 132,200 in 2016 to 144,900 in 2020 and is expected to rise to 162,300 by 2025. In China, the number of new MM cases rose from 18,900 in 2016 to 21,100 in 2020 and is expected to increase to 24,500 by 2025. The total number of patients diagnosed with MM in China increased from 69,800 in 2016 to 113,800 in 2020 and is expected to rise to 182,200 by 2025. About Equecabtagene Autoleucel Equecabtagene Autoleucel is an innovative fully-human anti- BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully-human scFv, CD8a hinge and transmembrane, and 4-1BB-mediated co-stimulation and CD3ζ activation domains. Based on rigorous screening and comprehensive in vivo and in vitro evaluation, Equecabtagene Autoleucel is proven to have potent and rapid anti-myeloma activity and outstanding safety, efficacy, and persistence results. Equecabtagene Autoleucel received New Drug Application (NDA) acceptance from China's National Medical Products Administration (NMPA) for the treatment of RRMM and obtained the U.S. FDA IND approval. The company also received Breakthrough Therapy Designation (BTD) from the NMPA in February 2021 and Orphan Drug Designation (ODD) in February 2022 and Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations in February 2023 from the FDA. In addition to multiple myeloma, NMPA has accepted its IND application for the new extended indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). Innovent and IASO Bio are jointly developing Equecabtagene Autoleucel for the treatment of RRMM in mainland China. About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 35 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include: TYVYT® (sintilimab injection), BYVASDA® (bevacizumab injection), SULINNO® (adalimumab injection), HALPRYZA® (rituximab injection), Pemazyre® (pemigatinib oral inhibitor), olverembatinib(BCR ABL TKI), Cyramza® (ramucirumab) and Retsevmo® (selpercatinib). An additional 3 assets are under NMPA NDA review, 6 assets are in Phase III or pivotal clinical trials, and 18 more molecules are in clinical studies. Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. Disclaimer: Innovent does not recommend any off-label usage. Note: TYVYT® (sintilimab injection) is not an approved product in the United States. BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States. TYVYT® (sintilimab injection, Innovent) BYVASDA® (bevacizumab biosimilar injection, Innovent) HALPRYZA® (rituximab biosimilar injection, Innovent) SULINNO® (adalimumab biosimilar injection, Innovent) Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan. CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Retsevmo® (selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. About IASO Biotechnology IASO Bio is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases. Leveraging its proprietary fully human antibody discovery platform (IMARS), high-throughput chimeric antigen receptor T-cell (CAR-T) drug screening platform, and proprietary manufacturing processes, IASO Bio is developing a rich clinical-stage pipeline of multiple autologous and allogeneic CAR-T and biologics product candidates. This pipeline includes a diversified portfolio of over 10 novel products, including IASO's leading asset, Equecabtagene Autoleucel (CT103A), a fully human BCMA CAR-T injection. In addition to Equecabtagene Autoleucel, the company's pipeline includes the fully developed in-house human CD19/CD22 dual-targeted CAR-T cell therapy which has received two IND clearances for treating relapsed/refractory B-cell non-Hodgkin's lymphoma (r/r B-NHL) and relapsed/refractory acute B-lymphoblastic leukemia (r/r B-ALL). CD19/CD22 is currently in Phase I clinical trials for r/r B-NHL. It was also granted ODD by the FDA in October 2021. In the approximately 20 patients dosed to date in the investigator-initiated trial, there were no ICANS, or immune effector cell-associated neurotoxicity syndrome, of any grade observed in any patient, and a grade 3 cytokine release syndrome (CRS) rate of less than 5%, with the remainder of patients experiencing no CRS or less than grade 3. Leveraging its strong management team, innovative product pipeline, integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China and around the world. For more information, please visit www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics. Innovent's Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics, Inc. ("Innovent" or "Company") , are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.
SINGAPORE, June 6, 2023 /PRNewswire/ -- Ahead of Asia Tech x Singapore (ATxSG), the region's most influential technology event, Mrs. Josephine Teo, Singapore's Minister for Communications and Information launched Singapore's Digital Connectivity Blueprint (DCB) that sets the direction for the next bound of Singapore's digital connectivity. Architecting Singapore's Digital Future Developed in consultation with the Advisory Panel on Digital Infrastructure, co-chaired by Dr. Janil Puthucheary, Singapore's Senior Minister of State, Ministry of Communications and Information, and Mr. Irving Tan, Executive Vice President of Global Operations at Western Digital, and other industry partners, the Blueprint outlines our strategic priorities and moves into new frontiers to stay ahead of the curve. Singapore will continue to invest ahead of demand, and holistically plan for the entire digital infrastructure stack – hard infrastructure, physical-digital infrastructure and soft infrastructure, to ensure that our digital infrastructure is future ready. Singapore is committed to stay ahead by growing our digital connectivity to create better lives and exciting opportunities for our people and enterprises. Singapore will double down on the following strategic priorities: Provide capacity to enable submarine cable landings to double within the next ten years. Build seamless end-to-end 10 Gbps domestic connectivity within the next five years. Ensure world-class resilience and security for our digital infrastructure. Pioneer a roadmap for growth of new Green Data Centres and push the sustainability envelope. Drive greater adoption of the Singapore Digital Utility Stack, to expand the benefits of seamless digital transactions. In addition, Singapore will make moves in more nascent and frontier areas to reap future opportunities: Advance the vision of a Quantum-safe Singapore within the next ten years. Put in place foundations for pervasive autonomy. "Green software", to mitigate intensified compute by building the nascent ecosystem for sustainable software. Enable innovative solutions in key industries with Low Earth Orbit satellite services. The Blueprint serves as a strong foundation upon which Singapore can realise better opportunities, stronger trust and empowered communities. For media queries, please reach out to:Email: aung_thi_ha@imda.gov.sg Hill+Knowlton StrategiesEmail: HKATxSG@hkstrategies.com
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