双特异性抗体
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荣昌生物(09995) - 海外监管公告 - 2025年年度报告
2026-03-29 10:14
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並表明概不就因本公告全部或任何部份內容而產生或因依賴該等 內容而引致的任何損失承擔任何責任。 RemeGen Co., Ltd.* 榮 昌 生 物 製 藥( 煙 台 )股 份 有 限 公 司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:9995) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條由榮昌生物製藥 (煙台)股份有限公司(「本公司」)作出。 茲載列本公司於上海證券交易所網站刊登公告如下,僅供參閱。 承董事會命 榮昌生物製藥(煙台)股份有限公司 董事長兼執行董事 王威東先生 中國煙台 2026年3月27日 於本公告日期,董事會成員包括執行董事王威東先生、房健民博士、林健先生及 溫慶凱先生;非執行董事王荔強博士及蘇曉迪博士;及獨立非執行董事郝先經先 生、陳雲金先生及黃國濱先生。 * 僅供識別 荣昌生物制药(烟台)股份有限公司 2025 年年度报告 公司代码:688331 公司简称:荣昌生物 荣昌生物制药(烟台)股份有限公司 2025 年年度报告 1 / 2 ...
这种辅助疗法可显著延长肿瘤患者生存期,顶刊背后中国创新药力量爆发
第一财经· 2026-03-06 12:59
Core Viewpoint - A new preoperative adjuvant therapy significantly extends survival time for patients with intrahepatic cholangiocarcinoma, highlighting China's innovative drug development capabilities in the medical field [3][4][5]. Group 1: Research Findings - The study conducted by the team at Fudan University Zhongshan Hospital demonstrated that patients receiving three cycles of GEMOX chemotherapy combined with targeted drug Lenvatinib and immunotherapy drug Toripalimab had a median survival time of 18 months, compared to 8.7 months in the control group [4]. - The median recurrence-free survival for patients in the treatment group was 15.4 months, significantly better than the control group's 9.7 months, with a 31% reduction in recurrence risk [4][5]. - This research is the first multicenter, randomized controlled trial exploring neoadjuvant therapy for intrahepatic cholangiocarcinoma, filling an international gap and showcasing China's leading position in liver cancer treatment [5]. Group 2: Drug Development and Innovation - The PD-1 inhibitors used in the studies are original drugs developed by Chinese biopharmaceutical companies, with Camrelizumab from Heng Rui Medicine and Toripalimab from Junshi Biosciences, both included in medical insurance [6]. - In 2025, China is expected to see a surge in innovative pharmaceutical achievements, with a record 76 innovative drugs approved by the National Medical Products Administration, over 80% of which are domestically developed [6]. - The Chinese biopharmaceutical industry is recognized as a key indicator of national technological innovation and comprehensive strength, with significant advancements in tumor immunotherapy and other cutting-edge fields [6][7]. Group 3: Industry Challenges and Recommendations - Despite the progress, there is a call for enhancing original innovation capabilities to produce more globally influential results and to strengthen intellectual property protection [7]. - Recommendations include direct inclusion of innovative drugs in medical institution drug directories without hospital admission thresholds, ensuring efficient application of insurance-covered innovative drugs [7].
维立志博-B(09887) - 自愿公告 - 维利信TM(PD-L1/4-1BB双特异性抗体奥帕替...
2026-03-06 08:30
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責,對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明,並 明 確 表 示,概 不 對 因 本 公 告 全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 Nanjing Leads Biolabs Co., Ltd. (於 中 華 人 民 共 和 國 成 立 的 股 份 有 限 公 司) (股 份 代 號:9887) 自願公告 維 利 信™(PD-L1/4-1BB雙 特 異 性 抗 體 奧 帕 替 蘇 米 單 抗,LBL-024) 於一線食管鱗狀細胞癌II期試驗的首例患者入組 本公告由南京 維 立志博生物科技股份有限公司(「本公司」,連 同 其 附 屬 公 司 統 稱「本集團」)自 願 作 出,以 告 知 本 公 司 股 東 及 潛 在 投 資 者 有 關 本 公 司 的 最 新 業 務 發 展 情 況。 本 公 司 欣 然 宣 布,評 價 維 利 信™(PD-L1/4-1BB雙 特 異 性 抗 體 奧 帕 替 蘇 米 單 抗, LBL-024)用於治療一線食管鱗狀細胞癌的II期 臨 床 研 究 首 ...
维立志博-B(09887):维利信™于复发性或转移性三阴性乳腺癌IB/II期试验的首例患者用药
智通财经网· 2026-02-10 08:46
Core Viewpoint - The announcement highlights the successful administration of the first patient in a Phase Ib/II clinical trial for the treatment of recurrent or metastatic triple-negative breast cancer (TNBC) using the bispecific antibody, Opalizumab (LBL-024), which targets PD-L1 and 4-1BB [1] Group 1: Clinical Trial and Drug Development - The Phase Ib/II clinical trial is an open-label, multicenter study led by Professor Yin Yongmei from Jiangsu Provincial People's Hospital, aiming to evaluate the efficacy and safety of Opalizumab alone or in combination with albumin-bound paclitaxel for TNBC patients [1] - Opalizumab is the first bispecific antibody targeting both PD-L1 and 4-1BB, showing potential as a leading therapy for advanced pulmonary neuroendocrine carcinoma and demonstrating promising clinical activity in various indications [1][2] - The drug has received several regulatory designations, including Breakthrough Therapy Designation (BTD) from the NMPA in October 2024 and Orphan Drug Designation from the FDA in November 2024 for neuroendocrine carcinoma [2] Group 2: Market Need and Cancer Statistics - Cancer remains a leading cause of morbidity and mortality globally, with breast cancer being the second most common cancer, accounting for approximately 2.3 million new cases annually [3] - In China, the incidence of breast cancer continues to rise, with an estimated 360,000 new cases and 75,000 deaths each year, highlighting the urgent need for effective treatments, particularly for TNBC, which represents 15% to 20% of all breast cancer cases [3] - TNBC is characterized by high malignancy, recurrence rates, and poor prognosis, indicating a significant unmet clinical need for more effective treatment options beyond standard chemotherapy [3]
维立志博-B(09887) - 自愿公告 - 维利信TM(PD-L1/4-1BB双特异性抗体奥帕替苏...
2026-02-10 08:30
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責,對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明,並 明 確 表 示,概 不 對 因 本 公 告 全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 Nanjing Leads Biolabs Co., Ltd. 南 京 維 立志博生物科技股份有限公司 (於 中 華 人 民 共 和 國 成 立 的 股 份 有 限 公 司) (股 份 代 號:9887) 維 利 信™是一種同時靶向PD-L1與4-1BB的 雙 特 異 性 抗 體,為 針 對 肺 外 神 經 內 分泌癌的全球首款達到註冊臨床階段的靶向4-1BB受 體 的 療 法。於 非 小 細 胞 肺 癌、小 細 胞 肺 癌 及 肺 外 神 經 內 分 泌 癌 這3種適應症的II期 或 註 冊 臨 床 試 驗 中, 維 利 信™展 現 出 同 類 第 一 或 同 類 最 佳 臨 床 活 性 潛 力。維 利 信™亦有望成為治療 晚 期 肺 外 神 經 內 分 泌 癌 的 首 款 獲 批 藥 物。憑 藉 我 們 自 主 研 發 並 具 有 知 識 產 ...
阿斯利康(AZN.US)双抗1类新药在中国获批临床
智通财经网· 2026-02-06 07:11
Core Insights - AstraZeneca's new drug AZD1163 has been approved for clinical trials in China, targeting rheumatoid arthritis treatment [1] - AZD1163 is a novel bispecific antibody that inhibits the activity of PAD2 and PAD4 enzymes, which are responsible for protein citrullination in rheumatoid arthritis patients [1] Group 1: Drug Approval and Mechanism - The approval of AZD1163 by the China National Medical Products Administration (NMPA) marks a significant step in developing a treatment for rheumatoid arthritis [1] - The drug targets the citrullination process that activates T cells and leads to the production of pathogenic anti-citrullinated protein antibodies (ACPAs), which are associated with worse prognosis in rheumatoid arthritis patients [1] Group 2: Clinical Trial Data - The 2025 ACR annual meeting presented pharmacokinetic data showing that AZD1163 has a dose-proportional increase in exposure, with a maximum concentration observed on day 10 after subcutaneous administration [2] - The estimated bioavailability of AZD1163 via subcutaneous injection is 65%, with an average systemic clearance rate of 0.15 L/day and a half-life of 38 days [2] - The drug demonstrated significant and dose-dependent inhibition of PAD2/4 activity, with a maximum inhibition rate exceeding 95%, confirming target engagement [2] - A low incidence of anti-drug antibodies (ADA) at 6.7% and few adverse events indicate good tolerability of AZD1163 in healthy volunteers [2] - AstraZeneca is conducting a Phase 2 clinical trial for AZD1163 in rheumatoid arthritis patients, following its approval for clinical research in China [2]
康方生物入选“2026全球产业重塑关键药物”榜单
Nan Fang Du Shi Bao· 2026-01-29 11:47
Core Insights - The article highlights the inclusion of Ivonescimab, a PD-1/VEGF bispecific antibody developed by Kangfang Biopharma, in the FirstWord Pharma's "Spotlight On: The drugs that will shape 2026" list, marking it as the only drug from a Chinese innovative pharmaceutical company [1][2] Company Overview - Kangfang Biopharma, established in 2012 in Zhongshan, focuses on addressing unmet clinical needs through technological innovation and has developed over 50 innovative drug candidates targeting major diseases [4] - The company is the only pharmaceutical firm globally with two tumor immune bispecific antibody drugs, with seven new drugs already commercialized and four additional indications under review [4] Drug Development and Market Potential - Ivonescimab is set to receive approval from the National Medical Products Administration of China in May 2024 for treating locally advanced or metastatic non-small cell lung cancer (nsq-NSCLC) after progression on EGFR-TKI therapy [2] - The drug has been recognized for its clinical value and commercial potential, being included in the national medical insurance catalog in November 2024 [2] - The global development of Ivonescimab, in collaboration with Summit Therapeutics, positions it as a leader in the PD-(L)1/VEGF bispecific antibody space, with significant attention on its potential in broader clinical applications beyond second-line NSCLC [3] Industry Context - The trend of developing PD-(L)1/VEGF bispecific antibodies is largely driven by China, with clinical studies indicating enhanced efficacy in treating non-small cell lung cancer compared to PD-1 monotherapy [3] - The biopharmaceutical industry in Zhongshan is recognized as a key sector, with the city expanding its health base and establishing a comprehensive support system for biopharmaceutical innovation, including a 10 billion yuan angel fund [4][5]
维立志博-B再涨近6% TCE双抗LBL-034获FDA快速通道资格认定
Zhi Tong Cai Jing· 2026-01-29 03:09
Core Viewpoint - The company Valiant Bio-B (09887) has seen a significant stock increase of nearly 6%, currently trading at 62.2 HKD, with a transaction volume of 11.42 million HKD, following the announcement of its dual-specific antibody LBL-034 receiving Fast Track designation from the FDA for the treatment of relapsed/refractory multiple myeloma (RRMM) [1] Group 1 - Valiant Bio-B's LBL-034, developed using its proprietary TCE technology platform LeadsBody, has been granted Fast Track designation by the FDA [1] - This designation marks an important milestone in the international development of LBL-034, following its orphan drug designation received in October 2024 [1] - The recognition from international regulatory bodies further validates the clinical value and development strategy of LBL-034 [1] Group 2 - LBL-034 is a humanized dual-specific T-cell engager targeting GPRC5D and CD3 [1]
港股异动 | 维立志博-B(09887)再涨近6% TCE双抗LBL-034获FDA快速通道资格认定
智通财经网· 2026-01-29 03:06
Core Viewpoint - The company Valiant Pharmaceuticals-B (09887) has seen a significant stock increase of nearly 6%, currently trading at 62.2 HKD, with a transaction volume of 11.42 million HKD, following the announcement of its dual-specific antibody LBL-034 receiving Fast Track designation from the FDA for the treatment of relapsed/refractory multiple myeloma (RRMM) [1] Group 1 - Valiant Pharmaceuticals announced that its proprietary TCE technology platform LeadsBody has developed the dual-specific antibody LBL-034, which has received Fast Track designation from the FDA [1] - This designation is a significant milestone in the international development of LBL-034, following its orphan drug designation received in October 2024, indicating further recognition of its clinical value and development strategy by international regulatory authorities [1] - LBL-034 is a humanized dual-specific T-cell engager targeting GPRC5D and CD3 [1]
港股异动 | 先声药业(02096)高开近6% 与勃林格殷格翰就SIM0709订立独家授权许可协议
智通财经网· 2026-01-28 01:29
Core Viewpoint - The announcement of an exclusive licensing agreement between the company and Boehringer Ingelheim for the dual-specific antibody SIM0709 has positively impacted the company's stock price, reflecting investor confidence in its innovative capabilities in the autoimmune research field [1] Group 1: Licensing Agreement Details - The company’s subsidiary, Jiangsu Xiansheng, signed an exclusive licensing agreement with Boehringer Ingelheim on January 26, 2026, granting Boehringer global exclusive rights to SIM0709 outside Greater China [1] - The agreement includes an upfront payment of €42 million and potential milestone payments up to €1.016 billion based on development progress, regulatory approvals, and commercialization [1] - The company will also receive tiered royalties on net sales outside Greater China [1] Group 2: Product Information - SIM0709 is a long-acting humanized dual-specific antibody developed by the company’s proprietary multi-specific antibody platform [1] - The antibody targets TL1A and IL-23, which are key pathways involved in the onset and progression of inflammatory bowel disease [1] - Preclinical studies have shown that SIM0709 exhibits superior synergistic effects compared to the combination of two single agents in both in vitro and in vivo experiments [1]