证 券 研 究 报 告 苑东生物（688513）2025 年三季报点评 强推（维持） 主业经营持续改善，创新药进展顺利 目标价：82.5 元 事项： ❖ 公司发布 2025 年三季报，单三季度收入 3.65 亿元（-1.55%），归母净利润 8359 万元（+18.52%，含股权激励费用)，扣非净利润 6919 万元（+27.85%，含股权 激励费用）。受益于新品放量以及仿制药研发投入管控，利润端明显超出预期。 评论： ❖ 创新转型提速，核心管线加速推进 1）战略控股超阳药业，强化创新引擎：公司持续看好上海超阳药业创新药管 线及创新药团队的发展，在第三季度内战略增资上海超阳药业，现已完成对上 海超阳药业的控股（持股 51.48%），将其核心在研管线纳入公司创新体系，显 著增强了在分子胶、PROTAC 等前沿技术平台的研发实力。 2）超阳管线快速推进，潜力逐步验证：控股后的超阳药业管线进展顺利，核 心产品 HP-001（分子胶）la 期临床安全性良好，并已在不同剂量组观察到患 者症状改善，展现出"Best-in-Class"潜力：lb/lla 期临床已启动。HP-002（BTK PROTAC）、CY007 等管 ...

Summary of Arvinas FY Conference Call (November 11, 2025) Company Overview - **Company**: Arvinas (NasdaqGS:ARVN) - **Industry**: Biotechnology, specifically focused on protein degrader technology Key Points and Arguments Protein Degrader Technology - Arvinas is recognized as a pioneer in protein degrader technology, with a focus on developing degraders for specific targets such as androgen and estrogen receptors [4][3] - The company is on the verge of potentially having the first PROTAC (Proteolysis Targeting Chimera) approved, with a PDUFA date set for June 6 for vepdegestrant, targeting estrogen receptor-positive second-line breast cancer [4][5] Pipeline Development - Arvinas has three drugs currently in clinical trials and plans to introduce two more drugs into the clinic next year [5] - The company has partnered with Novartis for an androgen receptor degrader, which is currently in three Phase 2 studies [4] Vepdegestrant Commercialization - The process for finding a third party to commercialize vepdegestrant is ongoing, with multiple interested parties [7] - The company views vepdegestrant as a financial asset and is open to the best bid, regardless of whether the buyer intends to further develop the drug [7][8] LRRK2 Target Validation - LRRK2 is considered a well-validated target for neurodegenerative diseases, particularly Parkinson's disease, with genetic variants linked to the disease [9][10] - The company aims to achieve a 50% reduction in LRRK2 levels in the cerebrospinal fluid (CSF) to restore physiological levels, with current results showing a 75% knockdown in healthy volunteers [17][14] Clinical Trials and Future Studies - Ongoing studies in Parkinson's disease aim to confirm the 75% reduction in LRRK2 levels in patients, with results expected in the first quarter of next year [19][20] - A Phase 1b study in progressive supranuclear palsy (PSP) is planned, with the potential to start a registration-quality Phase 2 study based on the results of the Phase 1b [24][26] ARV-102 and Differentiation - ARV-102 is positioned as a differentiated approach compared to classical inhibitors, demonstrating higher target engagement and pathway engagement in preclinical models [12][13] - The drug has shown significant brain penetration and effective degradation of LRRK2 in preclinical studies [14][15] ARV-393 and Hematological Cancers - ARV-393 targets BCL6, a promising but previously undruggable target in hematological cancers, with plans to combine it with bispecific antibodies for enhanced efficacy [28][29] - The company is observing responses in B cell malignancies and is also enrolling patients with T cell malignancies [28] KRAS G12D Degrader - The KRAS G12D degrader is in Phase 1 trials, with Arvinas claiming it is 25-40 times more potent than competitors' inhibitors [36][37] - The degrader is expected to overcome resistance mechanisms that inhibit traditional therapies [37] New Programs - Arvinas announced two new programs targeting SBMA (spinal and bulbar muscular atrophy) and HPK1, with plans to start clinical studies next year [42][43] - The SBMA program focuses on degrading the androgen receptor, while the HPK1 program aims to enhance immune response against solid tumors [43][44] Additional Insights - The company is closely monitoring competitor studies, particularly Biogen's LUMA study, to inform its development strategies [27] - Arvinas emphasizes a biotech-friendly development path, aiming for rapid advancement in clinical trials and potential accelerated approvals [24][26] This summary encapsulates the key insights and developments discussed during the Arvinas FY Conference Call, highlighting the company's innovative approaches and strategic plans in the biotechnology sector.

Financial Data and Key Metrics Changes - As of the end of Q3 2025, the company had approximately $787.6 million in cash, cash equivalents, and marketable securities, down from $1.04 billion as of December 31, 2024 [31] - Revenue for Q3 2025 totaled $41.9 million, a decrease of $60.5 million compared to $102.4 million for Q3 2024, primarily due to the Novartis License agreement [31][32] - General and Administrative expenses were $21 million in Q3 2025, down from $75.8 million in the same period of 2024, mainly due to lease termination and reduced personnel costs [32] - Research and Development expenses were $64.7 million in Q3 2025, compared to $86.9 million in Q3 2024, driven by decreases in various programs [33] Business Line Data and Key Metrics Changes - The company reported significant progress in its clinical pipeline, including updates on ARV-102, ARV-393, and ARV-806, with multiple ongoing and planned clinical trials [12][14][27] - ARV-102 showed promising results in both healthy volunteers and Parkinson's disease patients, with significant reductions in LRRK2 protein levels [19][20][21] - ARV-393 demonstrated early responses in both B and T cell lymphomas, with ongoing dose escalation trials [25][26] Market Data and Key Metrics Changes - The company is focused on addressing significant unmet needs in oncology and neurology, with a deep pipeline of assets [13][14] - The FDA has issued a PDUFA action date of June 5, 2026, for the new drug application of vepdegestrant, with plans to have a commercialization partner in place before this date [15] Company Strategy and Development Direction - The company aims to deliver innovative and differentiated assets in areas of high unmet need, with a focus on progressing its early pipeline [37] - The strategic partnership with Pfizer for the commercialization of vepdegestrant is expected to enhance the company's market position [15] - The company is committed to maintaining a quarterly run rate spend below $75 million to manage expenses effectively [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for ARV-102 and its ability to address neurodegenerative diseases, with plans for a phase 1b trial in PSP [12][37] - The company anticipates a data-rich period with multiple readouts from early-stage clinical programs, reinforcing its belief in the promise of its pipeline [13][14] - Management highlighted the importance of cost reduction programs and strategic flexibility to navigate the evolving market landscape [34] Other Important Information - The company has authorized the repurchase of up to $100 million of its outstanding common stock, reflecting confidence in its long-term strategy [34] - The company expects to maintain its cash runway into the second half of 2028, allowing for continued investment in high-value assets [36] Q&A Session Summary Question: Updates on the BCL6 degrader program - Management expressed excitement about the BCL6 program and its differentiation from competitors, highlighting ongoing studies and expected data at the upcoming ASH meeting [45][48] Question: Signals to look for in the Parkinson's disease MAD phase one - Management indicated that the ongoing phase one study aims to generate biomarker-related data, with expectations for clinical efficacy data to follow [54][56] Question: Plans for ARV806 in KRAS amplified populations - The company is studying ARV806 in resistance settings and has seen promising early data in models of KRAS amplification [61][63] Question: Dosing cohorts for ARV393 - Management confirmed that they are not yet in the predicted efficacious range for ARV393 but are seeing significant responses at lower dose levels [129][139] Question: Evaluating combination strategies for ARV806 - The company has preclinically evaluated combinations with anti-EGFR inhibitors and believes this selective approach will provide advantages [89][91]

Core Insights - Targeted protein degradation technology has seen significant development in China, providing new strategies for treating diseases such as cancer, neurodegenerative diseases, and autoimmune diseases [1][8] - The market size for targeted protein degradation in China is projected to reach approximately 102 million yuan in 2024, reflecting a year-on-year growth of 112.50% [1][8] - The increasing demand for novel drugs is driven by an aging population and the rise of chronic diseases, highlighting the technology's potential to meet unmet clinical needs [1][8] Industry Overview - Targeted protein degradation involves hijacking cellular degradation mechanisms to specifically degrade target proteins, addressing diseases caused by protein accumulation or dysfunction [2][4] - The technology overcomes limitations of traditional small molecule inhibitors, enabling the targeting of "undruggable" proteins [2][4] Industry Development History - The industry has evolved over two decades, starting from basic research to global competition, with significant milestones including the introduction of PROTAC concepts and the establishment of early technology platforms [4][5] - Recent years have seen a surge in clinical trials and the establishment of a robust pipeline, with 35 clinical programs reported as of 2024 [4][5] Industry Value Chain - The upstream of the industry includes raw materials such as E3 ubiquitin ligase ligands and various production equipment [5][6] - The midstream focuses on research and development, while the downstream applications target oncology and neurodegenerative diseases [5][6] Key Companies and Performance - Leading companies in the PROTAC space include HaiChuang Pharmaceutical and KaiTou Pharmaceutical, with significant clinical advancements in prostate and breast cancer treatments [8][10] - Jiangsu Hengrui Medicine has adopted a "fast-follow + innovation" strategy, achieving a 22.63% increase in revenue in 2024 [10][11] Industry Trends - Continuous technological innovation is expected to break through core technical bottlenecks in PROTAC, molecular glue, and LYTAC/AUTAC technologies [12][13] - The market is expanding into rare disease applications, with targeted protein degradation strategies being developed for conditions like Alzheimer's disease [13] - The industry ecosystem is being restructured with deepening international collaborations, positioning China as a key player in global biopharmaceutical innovation [14]

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]