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开拓药业(09939) - 自愿公告 - GT20029凝胶治疗痤疮中国II期临床试验达到主要终点
2025-08-11 22:05
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之內容概不負責,對其準確 性或完整性亦不發表任何聲明,並明確表示概不就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。 ( 股份代號 : 9939) 自願公告 GT20029 凝膠治療痤瘡中國 I I 期臨床試驗達到主要終點 本公告由開拓藥業有限公司*(「本公司」,連同其附屬公司統稱「本集團」)自願 刊發,以知會本公司股東及潛在投資者有關本集團的最新進展。 茲提述本公司日期為 2024 年 6 月 17 日的自願公告,內容有關 GT20029 凝膠治療痤 瘡的中國 II 期臨床試驗(「該項 II 期臨床試驗」),其已於 2024 年 6 月 17 日完成首 例受試者入組。 本公司董事(「董事」)會(「董事會」)欣然宣佈,其自主研發的新型靶向雄激素 受體(「AR」)的蛋白降解嵌合體(「PROTAC」)化合物 GT20029 治療痤瘡的 該項 II 期臨床試驗讀出頂線數據。數據顯示,該項 II 期臨床試驗成功達到主要研究終 點,結果具有統計學顯著性及臨床意義,且有效性、安全性和藥代動力學特徵均表現 出色,並確定 III 期臨床 ...
药石科技:目前TPD、ADC、多肽的相关的分子砌块订单增长很快
Zheng Quan Ri Bao Wang· 2025-08-11 07:41
Core Insights - The company announced a rapid growth in orders for TPD, ADC, and peptide-related molecular building blocks, indicating a sustained demand in the new drug market [1] - In the TPD field, the company has built a large linker library with over 1,000 novel CRBN ligand structures, attracting inquiries from clients [1] - Due to space limitations, the current number of personnel in related business areas is limited, but new facilities will be operational by early next year, adding 300-400 fume hoods to enhance ADC and TPD-related operations [1] - The company aims to continuously enhance its influence in PROTAC, ADC, peptides, and non-natural amino acids [1]
抗肿瘤创新药企「先声再明」获太平医疗健康基金投资
Sou Hu Cai Jing· 2025-06-24 06:33
Core Insights - Taiping Medical Health Fund has completed an investment in Hainan Xiansheng Zaiming Pharmaceutical Co., Ltd., a subsidiary of Xiansheng Pharmaceutical Group, which is a leading domestic pharmaceutical company focused on innovative anti-tumor drugs [1] - The investment aims to enhance Xiansheng Zaiming's innovative capabilities and support its participation in international competition and collaboration in tumor immunotherapy [1] - Xiansheng Zaiming has developed several advanced research and development platforms, including protein engineering, T cell engagers, NK cell engagers, ADCs, PROTACs, and AI-assisted molecular design [1] Company Developments - Xiansheng Zaiming has achieved compliance with GMP standards in both China and the United States for its independent production capabilities [1] - The company has four core innovative drugs, namely Kexaila®, Envida®, Endu®, and Enlitai®, which are already commercialized and cover various solid tumor treatments [1] - Kexaila® and Enlitai® are expected to enter the national medical insurance catalog in 2024, following Endu® [1] Strategic Partnerships - Following the investment, Xiansheng Zaiming announced a strategic partnership with Next Cure, Inc. to co-develop a new ADC drug, SIM0505, targeting the CDH6 antigen for solid tumor treatment [3] - The potential development phase of SIM0505 could yield up to $745 million in related payments, including upfront, development, and sales milestone payments, along with tiered royalties based on net sales outside Greater China [3] - Previously, Xiansheng Zaiming entered a licensing option agreement with AbbVie for SIM0500, a tri-specific antibody, with a total value of up to $1.055 billion [6]
Arvinas Reports First Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-05-01 11:00
Core Insights - Arvinas, Inc. reported positive topline results from the Phase 3 VERITAC-2 trial, supporting global regulatory filings for vepdegestrant, a PROTAC treatment for metastatic breast cancer [1][6][30] - The company announced a workforce reduction of approximately one-third to extend its cash runway into the second half of 2028 [5][11][30] - Revenue for Q1 2025 was $188.8 million, a significant increase from $25.3 million in Q1 2024, primarily due to the Vepdegestrant collaboration with Pfizer [21][39] Company Developments - Vepdegestrant is positioned as a competitive monotherapy for metastatic breast cancer in the second-line ESR1 mutant setting, with plans for regulatory submission [2][24] - The company has removed two Phase 3 combination trials from its development plan, focusing instead on maximizing patient benefit and shareholder value [2][11] - Arvinas presented first-in-human data for ARV-102, showing significant LRRK2 degradation, and plans to continue its clinical trials [5][10][27] Financial Performance - As of March 31, 2025, cash, cash equivalents, and marketable securities totaled $954.3 million, down from $1,039.4 million at the end of 2024 [15] - Research and development expenses for Q1 2025 were $90.8 million, an increase from $84.3 million in Q1 2024, driven by external expenses [16][18] - General and administrative expenses rose to $26.6 million in Q1 2025 from $24.3 million in Q1 2024, primarily due to increased professional fees [19][20] Upcoming Milestones - The company plans to present detailed results from the VERITAC-2 trial at the 2025 ASCO Annual Meeting and submit a new drug application to the FDA in the second half of 2025 [17][30] - Arvinas aims to initiate a first-in-human Phase 1 trial for ARV-806 in patients with solid tumors harboring KRAS G12D mutations in the second half of 2025 [13][31] - Continued recruitment for the Phase 1 clinical trial of ARV-102 in patients with non-Hodgkin lymphoma is expected, with initial data presentation planned for the second half of 2025 [10][31]