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隨著數位化時代來臨，專業證照已成提升競爭力的重要途徑。為強化學生資訊應用能力，聖約翰科技大學舉辦「Microsoft Office Specialist（MOS）Word 認證班」，邀請易天國際有限公司蔡易樺、陳韋綸老師授課，吸引學生參與。課程幫助學生精進 Word 操作技能，順利取得微軟國際證照，為未來就業奠定基礎。 現今企業對員工資訊素養要求提高，文書處理能力已成職場必備技能。本次 MOS Word 認證班，讓學生快速掌握Word核心操作，包括：格式設定、文件管理、圖表與範本應用等關鍵技巧。課程涵蓋MOS國際認證考試範圍，並結合理論與實務，幫助學生應用於學術報告、專案製作及職場需求。學校提供考試輔導與模擬測驗，提高考取率。 工業管理系主任彭慶懷表示，隨著AI教育時代來臨，職場對智慧資訊與數據管理的應用愈發重視，學生具備資訊能力已成為職場不可或缺的優勢。希望透過 MOS Word 認證班，幫助學生取得國際證照，提升文書處理與數據應用能力，增強職場競爭力。學校亦將持續開設 MOS Word 認證班，並導入進階數據分析與資料視覺化課程，培養學生在數位時代的綜合應用能力。 「取得國際證照讓履歷更具亮點，增強我的求職信心。」順利通過MOS Word認證的工管一誠許淳淳同學說，過去雖然使用過 Word，但對許多進階功能不熟悉。透過密集訓練，讓她瞭解格式設定、快速排版及目錄製作等技巧，對製作報告與簡報非常實用。 工管三甲邱琪勻同學認為這場課程內容充實，不僅強化文書處理能力，也讓她更有系統地學習專業排版與文件整理，對未來職場非常有幫助，尤其是行政管理或文書相關領域的學生，更應參與證照課程。能在畢業前取得MOS國際證照，是重要成就，也提升求職競爭力。
SAN FRANCISCO and SUZHOU, China, June 30, 2025 /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, cardiovascular and metabolic, ophthalmology, and other major diseases, held its Oncology R&D Day, unveiling its forward-looking strategy centered on dual innovation in next-generation immuno-oncology (IO) and antibody-drug conjugate (ADC) technologies. This strategic focus aims to redefine the standards of cancer treatment and propel Innovent toward becoming a global, premier biopharmaceutical leader. The event drew over 500 participants, including leading oncology key opinion leaders (KOLs), principal investigators, analysts, and global investors, signaling strong engagement with Innovent's transformative vision for the future of oncology. Keynote speech "Over the past decade, Innovent has been at the forefront of China's biopharmaceutical evolution—pioneering the PD-1 immunotherapy era and building China's leading oncology brand, with over 3 million cancer patients treated with our therapies," said Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent. "We are entering a new chapter focused on global innovation, powered by a robust pipeline and dual innovation of next-generation IO and next-generation ADC. Our recent presence at the 2025 ASCO with eight oral presentations highlights the strength and global competitiveness of our R&D. But this is only the beginning. With a clear vision to advance at least five pipeline assets into MRCT Phase 3 by 2030, we are committed to delivering innovative, high-quality, and accessible cancer treatments to patients worldwide." Dual Innovation to Unlock the Future of Oncology: Next-gen IO + Next-gen ADC At the core of Innovent's oncology strategy lies the dual engines of next-generation immunotherapy (IO) and next-generation antibody-drug conjugates (ADC), supported by deep insights in cancer biology and differentiated technology platforms. Dual Innovations of IO+ADC "We are harnessing deep cancer biology insights, advanced antibody and protein engineering, and differentiated ADC linker-payload technologies to develop broader-spectrum, more potent, and less toxic therapies aimed at transforming the oncology treatment paradigm," said Dr. Zhou Hui, SVP of Innovent Oncology R&D. "Our strategy is designed to target some of the toughest challenges in cancer care, including drug resistance, cold tumors, and improve the efficacy of current IO treatment, while bringing new hope to patients worldwide." Keynote speech Global R&D Roadmap: a Clear, Stepwise Development Strategy Innovent's pipeline is guided by a rational, phased IO+ADC combination strategy designed to address tumor heterogeneity and immune escape, evolving through three stages: Next-gen IO + Chemotherapy: to redefine the IO cornerstone Next-gen IO + mAb-ADC / bispecific ADC: to cover expansive tumor types and treatment lines Next-gen IO + Dual-Payload ADC (dpADC): to unlock full potential of IO+ ADC synergy, and reshape cancer treatment Development Strategy Currently its oncology pipeline features nearly 10 next-generation molecules in global development, with multi-regional trials actively underway in the U.S., EU, and Asia. The company also continues to invest in global R&D infrastructure, supported by R&D hubs in Shanghai and San Francisco and antibody and ADC manufacturing capacity exceeding 140,000L. Global Innovation Innovent is rapidly expanding its global innovation footprint, with a 2030 goal to advance at least five pipeline assets into global MRCT Phase 3 trials. Key potential candidates includes: IBI343: innovative CLDN18.2 ADC with site-specific conjugation and a TOPO1 inhibitor payload, demonstrating significant survival benefits in both GC and PDAC IBI363: PD-1/IL-2α-bias fusion protein as next-gen IO to redefine cancer treatment and expand the boundaries of IO responsiveness IBI3009: DLL3 ADC in collaboration with Roche IBI3003: tri-specific T-cell engager targeting BCMA/GPRC5D/CD3 for multiple myeloma IBI3001: EGFR/B7H3 ADC with two synergetic targets covering multiple potential indications IBI3020: CEACAM5 dual-payload ADC as globally the first to enter clinical phase IBI363: Next-Gen IO Redefining Cancer Immunotherapy IBI363 is a global first-in-class PD-1/IL-2α-bias fusion protein, featuring a differentiated molecular design and a dual immune activation mechanism. Emerging clinical data strongly support its mechanism of action in reinvigorating and expanding tumor-specific T cells (TSTs). Next-gen IO IBI363 At ASCO 2025, IBI363 demonstrated breakthrough potential in three hard-to-treat tumor types, with a long tailing effect in prolonged survival benefits: Immune-resistant NSCLC (squamous & Adeno): boosted response rate and extended PFS reflects strong immune activation; median overall survival (mOS) up to 17.5 months in 1.5 mg dose cohorts, 12-month OS rate exceeding 70% for 3 mg dose cohorts, and benefit observed even in PD-L1 low expressers Later-line CRC (3L+): mOS of 16.1 months in monotherapy and only 17.8% OS events occurred in combination with bevacizumab with 9.4 months follow-up, outperforming historical benchmarks Immune-resistant melanoma (mucosal/acral subtypes): confirmed overall response rate (cORR) 23%, median duration of response (mDoR) 14 months, and median OS 14.7 months, showing unprecedented positive response and a long-lasting immunologic tailing effect Development Strategy With two Breakthrough Therapy Designations from the NMPA CDE, two Fast Track Designations from the FDA, IBI363 is advancing rapidly toward registrational development. The first head-to-head trial vs. pembrolizumab in mucosal and acral melanoma was initiated. Meanwhile, IBI363 is in preparation for registrational trails in IO-treated squamous NSCLC, and third-line MSS colorectal cancer. Additional trails for first-line and other solid tumors also under exploration in ongoing PoC studies. Near-term Catalyst High-Potency, Low-toxicity ADC Platforms Synergizing with IO for Broad Indication Coverage ADC Platforms Innovent is rapidly advancing its next-gen ADC pipeline, including: IBI343 (CLDN18.2 ADC): first in PDAC to demonstrate long-term survival benefits (mOS 12.1 months in 2L) IBI3001 (EGFR/B7H3 ADC): dual-targeted ADC with broad potential in solid tumors IBI3020 (CEACAM5 dual payload ADC): designed for high efficacy and low toxicity in treatment-resistant tumors These programs leverage proprietary payloads and linkers, optimized for lower toxicity and high potency, and are poised to synergize with Innovent's IO agents to address broader and deeper indications. Innovent Academy: R&D Engine to Drive Global Innovation Innovent Academy is the company's discovery engine for driving global innovation. The Academy continues to expand its platforms in IO, ADC, T-cell engagers, and cytokines, firmly establishing its leadership in next-gen oncology discovery and translational science to generate 6–8 novel molecules per year. Keynote speech Specifically, for next-gen IO and next-gen ADC dual upgradation, Innovent Academy focuses on: diversified antitumor mechanisms to integrate TME modulation and optimize IO efficacy; dual targeting approaches to overcome tumor heterogeneity and drug resistance. R&D Strategy This framework allows Innovent to systematically escalate efficacy and broaden tumor applicability, laying the foundation for first-in-class and best-in-class combination regimens for cancer treatments. Catalyzing China's Role in Global Oncology Innovation Leading oncology KOLs and principal investigators (PIs) delivered keynote speeches, reflecting on a pivotal moment for China's biotech industry. They emphasized that China's innovation, which is driven by rising translational capabilities, expanding global talent pools, and patient-centric trial execution, has entered a "Deepseek" moment, one where Chinese-discovered drugs can lead global standards, not just follow them. "What we're witnessing is a profound shift," said one keynote speaker. "Innovent's next-generation IO programs like IBI363, with a clear global-first design, and ADC platforms targeting previously untreatable populations, show that Chinese biotech is poised to influence—not just participate in—the next global oncology paradigm." The enthusiastic response from investors and KOLs underscores growing confidence in China-originated oncology innovation and reaffirms Innovent's position as it enters a new era of global innovation with a vision to become a global premier biopharmaceutical leader. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 16 products in the market. It has 2 new drug applications (NDA) under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn. Statement: 1) Innovent does not recommend the use of any unapproved drug (s)/indication (s). 2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. 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.
隨著技術的飛速發展，商業、工業及汽車等領域對耐高溫積體電路（IC）的需求持續攀升 。 高溫環境會嚴重制約積體電路的性能、可靠性和安全性，亟需透過創新技術手段攻克相關技術難題。 安森美提供適用於高功率的設計技術以應對這些挑戰，以下將介紹高溫設計的優勢。 高溫設計的優勢 能夠在高溫下工作的積體電路具有多種優勢。 它們可以在汽車和航空航太等環境溫度超過 150°C 的苛刻環境中可靠運行。 這些設計通常非常穩健，包括溫度保護電路，不易發生熱失控和其他溫度引起的故障，從而提高了系統的整體可靠性。 透過耐受更高的溫度，這些電路可以減少或消除對複雜冷卻系統的需求，從而提供更簡單、更具成本效益的解決方案。 ▷熱管理 熱管理對電子系統的設計和運行至關重要，可確保性能和可靠性。 可利用散熱器、液體冷卻和改善空氣流通等方法加強散熱來降低結溫。 然而，這些方法也會增加電子模組的重量、尺寸和成本。 在大功率應用中，如功率開關和電動引擎等零組件需要主動冷卻。 使用標溫較高的冷卻劑可以減少對大型散熱器的需求，從而提高效率，但同時也要求元件能夠承受更高的溫度。 碳化矽（SiC）功率開關適用於這些條件。 在高溫條件下工作並靠近功率電晶體安裝的預驅動器是必不可少的，尤其是在汽車應用中，因為它們可以共享發動機冷卻迴路。 無需特殊冷卻即可在較高環境溫度下工作的電路在各產業都具有巨大的潛力。 電源管理對於感測器等低功耗應用也至關重要，儘管這些應用的功率不高，但熱管理仍然具有挑戰性。 這是因為感測器尺寸超小、塑膠外殼、無法添加散熱片等因素導致散熱不佳。 額外的熱管理會大大增加電子模組的成本、尺寸和重量。 在這種情況下，從裸片到環境的熱阻可達每瓦數十到數百℃。 驅動感測器執行器和處理感測器數據可能需要一定的功率，這會使裸片溫度比環境溫度高出數十℃。 這就需要能夠承受高溫的IC來實現沒有這些熱管理措施的應用。 另一個例子是由汽車電池直接供電的車用IC。 這可能是 12V 電池，或越來越常見的 48V 電池。 在電路內部，IC 訊號處理的電壓可能僅需 1.2V，而從汽車電池到 IC 的線性穩壓器消耗了大部分功耗。 對於小負載來說，增加一個帶有外部線圈的DC-DC轉換器以提高效率既不實際也不經濟。 如果線性穩壓器可以在高溫下工作，則能夠節省模組的成本和重量。 ▷過溫保護 過溫保護或熱關斷（Thermal Shutdown，TSD）對積體電路至關重要，可防止 IC 及其外部元件損壞，確保可靠性和安全性。 環境溫度過高、功耗過大、熱管理不善或故障導致過載等因素都可能觸發過溫保護。 當IC的結溫超過預設閾值時，熱關斷機制就會啟動，自動關閉IC的高功耗部分或整個晶片，以防止溫度進一步升高及造成損壞。 一旦IC冷卻到安全溫度，它可以自動重新啟動之前關閉的部分或整個IC，在確保保護的同時最大限度地減少停機時間。 這種機制對於維持IC的可靠性和使用壽命至關重要，可保護IC免受外部故障、過載或溫度波動的影響。 有功能安全要求的產品也需要 TSD。 也可使用具有功率降額功能的熱監測或熱預警。 TSD 應當保護IC免受熱失控的影響，以形成一個正反饋。 迴圈熱失控發生在IC產生的熱量超過其散熱能力時，導致溫度不可控地上升。 高溫會增加結和亞閾值洩漏，降低 MOS 電晶體的性能，並提高功率耗散。 如果缺乏 TSD 的保護，這一迴圈將持續到 IC 過熱，可能導致故障、壽命縮短或安全隱憂，包括火災或爆炸。 TSD 級別的設置通常略高於最高工作溫度，以便偶爾出現溫度偏差時，不會造成不必要的關機，但也要足夠低，以便有效控制和關閉功率耗散部分。 例如，如果最高工作溫度為 165°C，考慮到 TSD 電路的製造容差，TSD 級別可設置在 170°C 至 185°C 之間。 正確設置這一閾值對於平衡電子設計中的性能和安全性至關重要。 TSD 電路及其所有由該機制控制的相關模組，必須設計為能夠在最大 TSD 溫度以及額外的安全裕度範圍內可靠工作。 這個安全裕度考慮了晶元上的溫度梯度，即功率元件與溫度感測器之間的溫差。 根據佈局的不同以及使用的功率元件和感測器的數量，感測器可以放置在功率元件內部、旁邊或更遠的位置。 此外，裕量還考慮了從溫度上升到感測器檢測到過熱並關閉受影響的功率電晶體之間的延遲所導致的溫度上升。 這確保了即使在極端過熱情況下，保護功能仍然能夠保持有效運作。 因此，TSD 電路必須在比IC其餘部分更高的溫度下保持工作狀態，即超過最大工作結溫。 圖 1. 保護電路的工作溫度範圍 ▷功耗 - 性能 - 面積 對IC進行改良，需要在功耗、性能和面積（PPA）這三個指標之間做出權衡。 例如，提高性能會導致更高的功耗或更大的尺寸。 相反，降低功耗可能會限制性能或需要更多的面積來添加節能元件。 提高最大工作溫度可以擴大功耗空間，從而為性能提升或面積改善提供更多餘地。 設計能在更高溫度下可靠工作的IC實際上是一種性能的提升，因為它延長了使用壽命並降低了故障率。 減少對大量冷卻解決方案的需求可以降低系統的整體成本、複雜性和重量，從而實現更加緊湊和經濟高效的設計。 高溫工作能力使得在功耗、性能和面積之間進行的權衡更容易，同時也有助於提升整體的 PPA（功耗 - 性能 - 面積）評分。 結語 安森美（onsemi）Treo 平臺提供了一個專為高溫運行而設計的全面生態系統。 包括先進的技術、元件模型和嚴格的認證流程。 Treo 中的所有 IP 都經過精心設計，可在高達 175°C 的寬溫度範圍內工作。 該平臺具有熱監測和熱關斷電路功能，確保性能可靠。 熱監測和熱關斷保護所需的模組經過設計和驗證，最高溫度可達 200°C。 此外，安森美 Treo 平臺還有助於開發出能夠在惡劣的環境條件下工作的高性價比解決方案。 它還提供了優化熱管理的機會，從而設計出高性能、高可靠性的產品。 ### 關於安森美（onsemi） 安森美（onsemi， 納斯達克股票代號：ON）致力推動顛覆性創新，打造更美好的未來。 公司關注汽車和工業終端市場的大趨勢，加速推動汽車功能電子化和汽車安全、可持續電網、工業自動化以及5G和雲基礎設施等細分領域的變革創新。 安森美提供高度差異化的創新產品組合以及智能電源和智能感知技術，以解決全球最複雜的挑戰，引領創造更安全、更清潔、更智能的世界。 安森美名列《財富》美國500強，也被納入納斯達克100指數和標普500指數。 瞭解更多關於安森美的資訊，請訪問：http://www.onsemi.com。 onsemi和onsemi圖示是Semiconductor Components Industries， LLC的註冊商標。 所有本文中出現的其它品牌和產品名稱分別為其相應持有人的註冊商標或商標。 雖然公司在本新聞稿提及其網站，但此稿並不包含其網站中有關的資訊。
SHANGHAI and CHICAGO, June 5, 2025 /PRNewswire/ -- The 2025 ASCO Annual Meeting is taking place in Chicago, US, from May 30 to June 3. Duality Bio (HKEX: 9606.HK) presented the preliminary data of two clinical trials, HER3 ADC candidate DB-1310 and B7H3 ADC candidate DB-1311/BNT324, which is being jointly developed with BioNTech, in Oral/Rapid Oral presentations. B7H3 ADC candidate DB-1311/BNT324: Data from the ongoing Phase 1/2 clinical trial (NCT05914116) in patients with heavily pre-treated castration-resistant prostate cancer (CRPC) were presented during an oral session on BNT324/DB-1311, an B7H3-targeted ADC candidate. Dr. Andrew Parsonson delivering the rapid oral presentation at the ASCO 2025 meeting in Chicago, USA. The data indicated early clinical activity and a manageable safety profile with low discontinuation rates. Most common adverse events were gastrointestinal and hematologic toxicities. In the 52 efficacy evaluable patients with heavily pretreated CRPC based on RCIST v1.1, the confirmed objective response rate (cORR) was 30.8%, DCR was 90.4%. Among 68 evaluable patients, the 6-month rPFS rate was 69.8%. Similar outcomes were observed across both dose levels (6 mg/kg or 9 mg/kg). Outcomes appeared better in earlier treatment lines and in patients who received one prior NHT, while antitumor activity was also observed in later lines and regardless of type of prior treatment or metastatic site. The clinical trial is currently enrolling post Lu-177 CRPC (Cohort 11) and taxane-naïve CRPC (Cohort 12). As the incidence rate of prostate cancer is increasing[1],1 there is a high unmet need for new effective therapies for patients with heavily pretreated CRPC[1]. The DB-1311/BNT324 program received Fast Track Designation by the U.S. Food & Drug Administration ("FDA") for the treatment of patients with advanced/unresectable or metastatic CRPC that has progressed on or after standard systemic regimens in 2024. HER3 ADC DB-1310： Data from the first-in-human Phase I/IIa study (NCT05785741) presented by Professor Aaron E. Lisberg of the University of California, Los Angeles (UCLA), demonstrated that DB-1310 showed encouraging efficacy and a manageable safety profile in patients with advanced solid tumors who had failed standard treatments. Dr. Aaron E. Lisberg delivering the oral presentation at the ASCO 2025 meeting in Chicago, USA. Among 123 efficacy evaluable patients, the unconfirmed objective response rate (uORR) was 31%, and the disease control rate (DCR) reached 84%. Notably, efficacy was particularly striking in the key subgroup of patients with EGFR-mutated non-small cell lung cancer (NSCLC) (n=46) where uORR reached 44%, DCR was 91%, median progression-free survival (mPFS) was 7.0 months, and median overall survival (mOS) was 18.9 months. The uORR reached an impressive 66.7% at the 5.5 mg/kg Q3W dose level (n=12). In addition, DB-1310 was well-tolerated with a manageable safety profile. The most common treatment-related adverse events (TRAEs) were Grade 1-2 hematological and gastrointestinal events with a low treatment-related discontinuation rate of 3.5%. These positive results support the continued development of DB-1310 in advanced solid tumors, particularly in patients with EGFR-mutated NSCLC. The company is advancing its global development program, including exploring DB-1310 as a monotherapy in additional tumor types, as well as exploring DB-1310 in combination with EGFR TKIs and HER2-targeted therapies. About DualityBio Duality Biotherapeutics is a clinical-stage biotech company dedicated to the discovery and development of next-generation ADC to treat cancer and autoimmune diseases. DualityBio has successfully built several cutting-edge ADC technology platforms with global intellectual property rights. Leveraging a robust pipeline, DualityBio is conducting multiple global clinical trials across 17 countries, has enrolled over 2,000 patients for multiple clinical-stage ADC candidates. Additionally, DualityBio have established strategic collaborations with global MNCs and leading biotech innovators. As a global ADC powerhouse, DualityBio is developing candidates including bispecific ADCs, novel-payload ADCs, and autoimmune ADCs. For more information, please visit www.dualitybiologics.com. [1]. Sherman RL et al. Cancer 2025;131(9):e35833; 2. Narayan V et al. Clin Genitourin Cancer 2024;22(6):102188;
SAN FRANCISCO and SUZHOU, China, June 3, 2025 /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, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, updated the Phase 1 study results of IBI343, a novel anti-CLDN18.2 ADC, for the treatment of advanced pancreatic cancer at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. With extended follow-up and more mature data on progression-free survival (PFS) and overall survival (OS), IBI343 has demonstrated promising therapeutic efficacy in patients with CLDN18.2-positive advanced pancreatic cancer. These encouraging results suggest the potential of IBI343 in this challenging-to-treat malignancy. Supported by these robust clinical findings, IBI343 has been granted Breakthrough Therapy Designation (BTD) by China's National Medical Products Administration (NMPA). Concurrently, the Phase 1 clinical trial of IBI343 is also being conducted in the United States, where the drug candidate has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). Pancreatic cancer is one of the most aggressive malignancies worldwide. Most patients are diagnosed in the middle and late stages and often develop resistance to standard chemotherapy, resulting in a 5-year survival rate of less than 10%1. According to the GLOBOCAN 2022 statistics2, there are approximately 510,000 new cases and 467,000 deaths globally from pancreatic cancer each year, with China accounting for 120,000 new cases and 110,000 deaths annually. This Phase 1/1b study is a multi-regional, dose escalation and expansion clinical trial (NCT05458219). Preliminary data were presented at ASCO 2025 and ESMO Asia 2024 and the updated results from the study's dose-expansion cohort were presented at the 2025 ASCO as follows: As of March 14, 2025, a total of 83 patients with pancreatic cancer had received at least one dose of IBI343 with a median follow-up time of 11.1 months. As the data cutoff date, in patients with CLDN18.2 1+2+3+≥60% expression treated at the 6mg/kg dose (N=44), the confirmed overall objective response rate (cORR) was 22.7% and the disease control rate (DCR) was 81.8%. The median progression-free survival (mPFS) was 5.4 months, and the median overall survival (mOS) was 9.1 months. Among them, 17 patients had received only one line of prior treatment, achieving a mPFS of 5.4 months and a mOS of 12.1 months; and 18 patients had received two lines of prior treatment, the mPFS was 5.3 months and the mOS was 9.1 months. The updated safety results demonstrated the favorable safety profile of IBI343 with a consistently low rate of gastrointestinal toxicity and no new safety signals. 98.8% of the patients experienced treatment-emergent adverse events (TEAEs), with the most common TEAEs being anemia, neutrophil count decreased, and white blood cell count decreased. Notably, no ≥ grade 3 nausea and vomiting occurred. Professor Xianjun Yu from Fudan University Cancer Hospital, said, "Pancreatic cancer is one of the most malignant tumors of the digestive tract. Most patients are already in the advanced stage when diagnosed, and the 5-year survival rate is only about 10%1. Currently, chemotherapy is still the main first- and second-line treatment for advanced pancreatic cancer. The clinical options for second-line treatment are particularly limited, with a chemotherapy response rate of only 6-16%, median progression free survival of 2 to 5 months, and a median survival of approximately 6 to 9 months3, representing an urgent clinical need. With longer follow-up, the mature PFS and OS data from the latest IBI343 update demonstrate promising therapeutic potential, suggesting a breakthrough in this difficult-to-treat malignancy." Dr. Hui Zhou, Senior Vice President of Innovent, said, "We are pleased to present an oral update on IBI343's clinical data at this year's ASCO conference. With the unique Fc-silent antibody design, stable linker and potent TOPO1i payload, IBI343 is the first ADC candidate to show encouraging efficacy and a favorable safety profile in the treatment of advanced pancreatic cancer. We hope to continue advancing the clinical trials of IBI343 for pancreatic cancer patients. Innovent will leverage its unique strengths in R&D innovation and clinical translation to develop a new generation of globally competitive oncology - focused innovative pipeline to benefit patients worldwide.." About IBI343（Anti-CLDN18.2 ADC） IBI343 is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. IBI343 binds to the CLDN18.2-expressing tumor cells, the CLDN18.2 dependent ADC internalization will occur and the drug is released resulting in DNA damage and eventually apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring cells, resulting in "bystander killing effect". As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in Phase 1 clinical studies. The therapeutic potential of IBI343 is currently being explored in tumor types such as gastric and pancreatic cancer. The Phase 3 trial of IBI343 for advanced gastric / gastroesophageal junction adenocarcinoma is now recruiting patients. The relevant indication has been included in China's NMPA breakthrough therapy list. IBI343's Phase 1 trial for advanced pancreatic ductal adenocarcinoma is enrolling patients in an multi-regional study. This indication has received Fast Track designation from the FDA and been included in the NMPA's BTD list. About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn. Statement: 1. Innovent Biologics does not recommend the use of unapproved drugs/indications. 2. Ramucirumab injection (Ciranza®), selpercatinib capsules (Ritu®) and pirtobrutinib tablets (Capra®) were developed by Eli Lilly and Company 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. References 1 Siegel RL, Miller KD, Fuchs HE, et al. Cancer statistics, 2022. CA Cancer J Clin. 2022;72:7-33. doi: 10.3322/caac.21708. 2 Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. 3 Jemal A, Bray F, Center MM, et al. Global cancer stastics. CA Cancer J Clin, 2011, 61(2): 69-90.
NANJING, China, June 1, 2025 /PRNewswire/ -- InxMed Co., Ltd, a clinical-stage biotechnological company, pioneering therapies to transform cancer treatment, released latest clinical data from a Phase Ib/II clinical trial (NCT06166836; NCT05379946) to evaluate the efficacy and safety of ifebemtinib (IN10018), an oral focal adhesion kinase (FAK) inhibitor in combination with garsorasib (D-1533), an oral KRAS G12C inhibitor, in KRAS G12C mutant solid tumors. The clinical data presented at the 2025 ASCO Annual Meeting (Abstract #8629 | Poster Board #109) included results from two cohorts: Durability follow-up data of the single-arm cohort in first-line KRAS G12C-mutant non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 expression, who received ifebemtinib + garsorasib treatment. A randomized cohort in previously treated KRAS G12C-mutant colorectal cancer (CRC) patients comparing ifebemtinib+ garsorasib versus garsorasib monotherapy. In NSCLC cohort, the combination of ifebemtinib and garsorasib, as a dual-oral, chemotherapy-free regimen, demonstrated compelling clinical benefit including high response rates and durable efficacy, regardless of PD-L1 expression, and in CRC cohort, the result showed clear add-on efficacy by ifebemtinib compared to KRAS inhibitor monotherapy. Key Highlights in First-line NSCLC: Dual-Oral Regimen Shows Durable Efficacy and Emerging Survival Benefit As of March 31, 2025, 33 first-line NSCLC patients, regardless of PD-L1 expression, were enrolled and received the combination of ifebemtinib and garsorasib, with a median follow-up of 16.0 months. Previously the company has reported an Objective Response rate (ORR) of 90.3% (data presented at ESMO 2024). The follow-up data were now summarized as follows: Median progression-free survival (mPFS): 22.3 months Median duration of response DOR (mDOR): 19.4 months Median overall survival (mOS): not yet reached, with a significant uplifting and flattening survival curve indicating durable benefit. Of note, the treatment demonstrated consistent efficacy regardless of PD-L1 expression status. Key Findings in Previously Treated CRC: Randomized Trial Validates Synergy with KRAS G12Ci As of Apr 21, 2025, 36 previously treated CRC patients were randomized 1:1 to receive the combination of ifebemtinib + garsorasib or garsorasib alone. All patients were radiologically evaluable and the antitumor responses were assessed and summarized as follows: ORR: 44.4% (combo) vs. 16.7% (mono) Disease control rate (DCR): 100.0% (combo) vs. 77.8% (mono) mPFS: 7.7 months (combo) vs. 4.0 months (mono) mOS: not yet reached in the combination arm; early separation observed in the survival curves "These results validate ifebemtinib as an ideal combination partner for RAS inhibitors in RAS-driven malignancies to boost efficacy of RASi significantly," said Dr. Zaiqi Wang, Chief Executive Officer of InxMed. "The unprecedented 19-month DOR and 22-month median PFS in front-line NSCLC in all comers and near doubling of response rate in CRC position this dual-oral regimen as a potential paradigm shift treatment in KRAS G12C-mutant cancers. Its favorable safety profile further supports the potential for a cytotoxic chemotherapy-free regimen in winning front-line in the future." InxMed has initiated a randomized Phase III pivotal trial in first-line KRAS G12C-mutant NSCLC. Additionally, the company is actively exploring combinations of ifebemtinib with other KRAS-targeted agents, including KRAS G12D inhibitors and multi-RAS inhibitors, supported by promising preclinical synergy data. About Ifebemtinib (IN10018) Ifebemtinib (IN10018) is a highly selective, orally administered, small molecule inhibitor against FAK, which has significant synergies with a broad spectrum of therapeutic modalities. Clinically, it has demonstrated therapeutic synergies with chemotherapy, targeted therapies, and immunotherapies. To date, over 600 patients have been treated with a favorable safety and tolerability profile. Ifebemtinib has been granted Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) and Fast-Track Designation from the U.S. Food and Drug Administration (FDA). A New Drug Application submission to the NMPA is planned for 2025. About InxMed Founded in 2018, InxMed is a clinical-stage biotech company dedicated to developing innovative therapies against resistance and metastasis in cancer. The company integrates deep insights in tumor biology with translational research capabilities to develop novel therapies targeting tumor defense mechanism. InxMed has built an efficient engine for clinical translational research driven by an in-depth understanding of disease biology. InxMed is conducting a registrational trial in platinum-resistant ovarian cancer and first-line NSCLC with KRAS G12C mutation in China, alongside multiple proof-of-concept studies in lung, colorectal, melanoma, and pancreatic cancers, with selected tumor types progressing toward pivotal trials. InxMed's pipeline includes several compounds targeting tumor defense mechanisms with highly differentiated therapeutic candidates. For more information, please visit en.inxmed.com.
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