内容概况：近年来，靶向蛋白质降解技术在中国取得了显著的发展。作为新一代药物研发的重要方向， 该技术通过特异性降解致病蛋白，为治疗癌症、神经退行性疾病和自身免疫性疾病等提供了新的策略。 2024年，中国靶向蛋白质降解行业市场规模约为1.02亿元，同比增长112.50%。随着人口老龄化和慢性 疾病的增加，市场对新型药物的需求不断攀升。靶向蛋白质降解技术作为一种前沿的治疗手段，能够满 足部分未被满足的临床需求，因此受到市场的广泛关注。 相关上市企业：海创药业（688302）、开拓药业（09939）、恒瑞医药（600276）、诺诚健华 （688428）、百济神州（688235）、药明康德（603259） 相关企业：成都先导药物开发股份有限公司、键凯科技股份有限公司、卫星化学股份有限公司、金发科 技股份有限公司、浙江东方基因生物制品股份有限公、广州万孚生物技术股份有限公司、山东思扬生物 科技有限公司、海创药业股份有限公司、苏州开拓药业股份有限公司、上海海和药物研究开发股份有限 公司、百济神州有限公司 关键词：靶向蛋白质降解、靶向蛋白质降解市场规模、靶向蛋白质降解行业现状、靶向蛋白质降解发展 趋势 一、行业概述 靶向蛋白 ...

Core Viewpoint - Yuan Dong Bio is focusing on innovation-driven development in the biopharmaceutical sector, with a comprehensive industrial layout in chemical raw materials, high-end chemical drugs, and biological drugs [1] Summary by Relevant Sections Innovation Drug Development - The company has over 80 ongoing research projects, with innovative drug projects accounting for 24.4% of the total, including small molecule new drugs, biological drugs, and modified new drugs [1] - In the small molecule new drug category, the drug "Yoglitin Tablets" has achieved the expected goals in its Phase III clinical trial, while EP-0108 capsules, EP-0146 tablets, and EP-0186 tablets have received clinical trial approvals [1] - In the biological drug sector, the anesthetic and analgesic drug EP-9001A monoclonal antibody has completed Phase Ib clinical trials, and the ADC innovative drug YLSH003 has submitted an IND and received clinical approval [1] - Several modified new drugs, such as oral solution of chloral hydrate and extended-release oxycodone tablets, have been submitted for production, with multiple distinctive modified new drugs entering clinical stages [1] Strategic Investments and Collaborations - The company is actively tracking global cutting-edge technologies and accelerating its innovation transformation through strategic investments, external introductions, and collaborative development [1] - Following the acquisition of shares in Shanghai Chaoyang, the company's indirect shareholding increased from 11.36% to 30.68%, and it plans to further increase its stake to achieve controlling interest, raising its indirect ownership to 51.48% [1] - This strategic control over Shanghai Chaoyang will enhance the company's pipeline in frontier technology areas such as molecular glue, PROTAC (proteolysis-targeting chimeras), and DAC (drug-antibody conjugates), strengthening its R&D capabilities in innovative drugs [1]

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 ...

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]

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]

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]