1月7日，亚盛医药-B(06855)宣布，公司原创新一代BTK靶向蛋白降解剂APG-3288的新药临床申请(IND)已获美国FDA许可，将开展其治疗复发/难治B细胞恶 性肿瘤的临床研究。这标志着公司在靶向蛋白降解领域的研发成果正式进入临床阶段，是亚盛医药全球创新管线的又一重大布局。 得益于这一消息利好，亚盛医药当日股价出现明显涨势：开盘后便一路走高，当日最大涨幅接近10%，二级市场的积极反馈显示出投资者对于公司在研创新 管线及内在价值的充分认可。 智通财经APP了解到，亚盛医药此次披露的这项研究是一项全球多中心、开放性的I期临床研究，旨在评估APG-3288治疗复发/难治性血液系统恶性肿瘤患者 的安全性、耐受性、PK特征及初步疗效。 通常来说，BTK是B细胞受体(BCR)信号通路中的关键激酶，在B细胞的活化、增殖和存活中发挥核心作用。BTK异常激活被认为与多种B细胞恶性肿瘤的发 生和进展密切相关，包括多种B细胞淋巴瘤(弥漫大B细胞淋巴瘤、套细胞淋巴瘤、滤泡性淋巴瘤等)、慢性淋巴细胞白血病(CLL)、以及华氏巨球蛋白血症 (WM)等。除肿瘤适应症外，BTK在B细胞受体(BCR)信号转导及先天免疫细胞Fc受体信号 ...

（来源：E药资本界） 2025年，中国医药健康产业正式迈入"创新深化+全球突围"双轮驱动的关键阶段。以小核酸、 PROTAC、CGT为代表的新兴疗法从临床验证加速迈向商业化兑现，ADC、双抗、TCE等前沿技术引领 创新药疗法升级；国产高端医疗设备与外周介入器械在中高端市场实现关键突破，国产替代进程持续提 速。 产业变革浪潮中，头部券商的深度研判成为穿透行业迷雾、把握核心机遇的重要指引。 2025年度中国券商十大医药技术研报汇聚来自华福证券、西南证券、国金证券、中信建投证券、国盛证 券、兴业证券、天风证券（维权）、平安证券、开源证券、东吴证券医药首席分析师精选的重磅报告， 覆盖技术迭代、产业趋势、全球化布局等核心议题。 这些报告不仅解码了技术突破的核心逻辑与商业化落地的关键节点，更精准捕捉了行业价值重构的新范 式，为产业从业者、投资者及行业观察者提供了兼具深度与前瞻性的权威参考。 接下来，让我们聚焦十大券商研报的核心精华，共探医药产业创新与增长的核心密码。 01 华福证券研究所副所长、医药首席分析师陈铁林 《小核酸行业深度：技术平台和适应症不断验证，迎来销售和临床密集兑现期》 ▲图为华福证券研究所副所长、医药首 ...

Core Insights - Haichuang Pharmaceutical achieved significant revenue growth in the first three quarters of 2025, with a reported revenue of 23.35 million yuan, representing a year-on-year increase of 21,180.28% [1] - The company reported a net loss attributable to shareholders of 99.15 million yuan, a substantial reduction from a loss of 154 million yuan in the same period last year [1] - The approval and commercialization of the first-class new drug, Dihenzalutamide, in May 2025 marked a pivotal moment for the company, indicating a successful transition from the investment phase to the return phase [1][2] Revenue Growth and Market Strategy - The significant revenue increase is attributed to the successful market launch of Dihenzalutamide, which has become a key revenue driver for the company [1] - Haichuang Pharmaceutical employs a dual-track model of "self-operated + CSO (Contract Sales Organization)" and a four-wheel drive strategy encompassing "medical-market-access-sales" to rapidly capture market opportunities [2] - The company has established an efficient sales network covering over 500 hospitals and 240 DTP pharmacies across 30 provinces, laying a solid foundation for the rapid growth of new drug sales [2] Product Development and Clinical Trials - Dihenzalutamide has been included in the 2025 edition of the CSCO Prostate Cancer Diagnosis and Treatment Guidelines, enhancing its market recognition [2] - The product is undergoing preliminary review for inclusion in the national medical insurance directory, which, if successful, will significantly improve drug accessibility and accelerate market penetration [2] - In the metabolic disease sector, the company is advancing its key product HP515, which targets obesity and metabolic-associated fatty liver disease (MASH), with promising results from Phase I clinical trials [3] Future Prospects - The development path for HP515 focuses on three main areas: combination therapy with GLP-1 for MASH, combination therapy for obesity, and exploring its use with the company's own oral small molecule GLP-1 receptor agonist [3] - The company is expected to continue expanding its revenue scale and gradually reduce net profit losses as new drugs progress through commercialization [3] - With its innovative technology and forward-looking pipeline, Haichuang Pharmaceutical is positioned to secure a significant place in the biopharmaceutical sector [3]

Group 1 - The company has approved a special report on the storage and actual use of raised funds for the first half of 2025, ensuring compliance with relevant regulations [7][17][46] - The total amount raised from the public offering was RMB 1,062,699,200, with a net amount of RMB 995,113,315 after deducting issuance costs [7][25] - As of June 30, 2025, the company has used RMB 871,447,067.89 of the raised funds, with a remaining balance of RMB 147,244,678.39 [8][9] Group 2 - The company has adjusted the investment projects related to the raised funds, specifically suspending further development of the HP501 project due to market competition [27][31] - The remaining funds from the "Innovative Drug R&D Project" will be redirected to ongoing projects HP518 and HP537 [27][30] - The adjustments are aimed at improving the efficiency of fund usage and aligning with the company's long-term strategic goals [31][33] Group 3 - The company has decided to cancel its supervisory board, with its functions being transferred to the audit committee of the board of directors [48][69] - Amendments to the company's articles of association have been proposed to align with the new Company Law and improve governance [49][80] - The company has also revised several internal governance documents to enhance management efficiency and compliance with updated regulations [81]

Core Viewpoint - Haichuang Pharmaceutical Co., Ltd. plans to adjust certain sub-projects within its "Innovative Drug R&D Project" to enhance the efficiency of fundraising usage while maintaining the total investment amount for the project [1][2] Fundraising Overview - The company issued 24,760,000 shares at a price of RMB 42.92 per share, raising a total of RMB 1,062.70 million, with a net amount of RMB 995.91 million after deducting issuance costs [1] - The funds are managed in a dedicated account as per regulatory requirements [1] Project Adjustments - The first adjustment of fundraising amounts was made on June 7, 2022, due to the net amount being lower than initially planned [2] - A second adjustment was approved on April 4, 2024, to further optimize the allocation of funds for the "Innovative Drug R&D Project" and the "R&D Production Base Construction Project" [2] Current Fund Usage - As of June 30, 2025, the cumulative investment in the projects has reached RMB 99.51 million, with the R&D production base construction project exceeding its planned investment due to interest income from cash management [3][5] Sub-Project Adjustments - The company has decided to suspend the further development of the HP501 sub-project, a small molecule chemical innovative drug, due to increased competition in the market [6] - Remaining funds of RMB 121.73 million will be redirected to ongoing projects HP518 and HP537 [6] Ongoing Projects - HP518 is the first oral AR PROTAC drug in clinical trials in China, with a completed Phase I study and ongoing Phase II trials [7][8] - HP537 has received approval for clinical trials in China and the U.S. [8] Rationale for Adjustments - The decision to adjust sub-projects is based on market competition and the company's strategic planning to enhance fundraising efficiency [6][9] Impact of Adjustments - The adjustments are expected to improve overall R&D efficiency and resource allocation without significantly impacting the company's current operating performance [9] Decision-Making Process - The adjustments were approved by the company's board and supervisory committee and will be submitted for shareholder approval [9][10]

Group 1 - The company, Hai Chuang Pharmaceutical Co., Ltd., has made adjustments to its fundraising investment projects due to the net amount raised being lower than initially planned, aiming to enhance the efficiency of fund utilization [2][4] - The total amount raised from the initial public offering was RMB 106,269.92 million, with a net amount of RMB 99,511.33 million after deducting issuance costs [1][2] - The first adjustment to the fundraising projects was made in June 2022, followed by a second adjustment in April 2024, which included changes to the amounts allocated to specific projects [2][4] Group 2 - The company has decided to suspend the further development of the HP501 subproject under the "Innovative Drug R&D Project" due to increased competition in the market for URAT1 target products [5][6] - The remaining funds from the "Innovative Drug R&D Project" will be redirected to ongoing projects HP518 and HP537, with a total of RMB 12,172.60 million remaining for these projects as of June 30, 2025 [4][5] - The company is focusing on the development of PROTAC technology, which is considered revolutionary in the biopharmaceutical field, and aims to advance the clinical progress of its projects [5][6] Group 3 - The company has received regulatory approvals for its core product HC-1119, which is aimed at treating prostate cancer, and has multiple products in various stages of clinical research [5][6] - The clinical trial for HP518 has completed its Phase I study in China, and the Phase II trial is currently enrolling participants, with positive safety and efficacy signals reported [6][7] - The adjustments made to the fundraising projects are aligned with the company's long-term strategic goals and are not expected to significantly impact current operating performance [7][8] Group 4 - The decision to adjust the fundraising projects was approved by the company's board of directors and supervisory board, and will be submitted for shareholder approval [8] - The sponsor, CITIC Securities, has confirmed that the decision-making and approval processes comply with relevant regulations [8]

Group 1 - Arvinas and Pfizer submitted a New Drug Application (NDA) for Vepdegestrant, the first PROTAC drug to seek approval, targeting advanced or metastatic breast cancer patients with ESR1 mutations [1] - The approval of Vepdegestrant could fill a significant treatment gap in the breast cancer market, attracting substantial investment and enhancing the overall industry valuation [1] Group 2 - Beijing Tide Pharmaceutical's TDI01 has been proposed for inclusion as a breakthrough therapy for chronic graft-versus-host disease (cGVHD), indicating its potential in a complex treatment area [2] - TDI01 is a novel ROCK2 inhibitor, and its breakthrough designation could significantly enhance the company's valuation and attract investor interest, bolstering China's innovative drug competitiveness [2] Group 3 - Anke Biotech anticipates significant sales growth for its trastuzumab product, Ansaiting, projecting over 100 million yuan in revenue for 2024 [3] - The positive market performance of Ansaiting enhances Anke Biotech's position in the oncology sector, potentially attracting more investors and supporting future research and market expansion [3] Group 4 - Haiwang Bio announced the termination of its control change and stock issuance, indicating ongoing discussions with state-owned entities for potential equity cooperation [4] - The proactive approach to resource integration and business collaboration may create new growth opportunities for Haiwang Bio, positively influencing market perceptions of its long-term value [4] Group 5 - Green Valley Pharmaceutical has ceased production of its Alzheimer's drug, Ganluo Sodium Capsules, following concerns over its efficacy and safety [6] - The shutdown reflects significant operational adjustments for the company, potentially leading to investor concerns about its future prospects and market confidence [6]

Core Viewpoint - Company is undergoing an innovative transformation, focusing on chronic diseases, tumors, and immunology, with multiple products entering a harvest phase, maintaining a "buy" rating [1] Group 1: Business Segments - Company covers four major business segments: pharmaceutical manufacturing, pharmaceutical commerce, medical aesthetics, and industrial microbiology, optimizing product structure towards innovation [1] - Pharmaceutical manufacturing revenue is projected to reach 138.1 billion yuan in 2024, reflecting a year-on-year growth of 13.1% [2] - Medical aesthetics revenue is expected to recover gradually as new products are launched, despite a current decline of 4.9% [2] Group 2: Financial Performance - Company forecasts 2024 revenue of 419.1 billion yuan, a year-on-year increase of 3.2%, with a net profit of 35.1 billion yuan, up 23.7% [2] - Expected net profits for 2025, 2026, and 2027 are 40.61 billion yuan, 47.16 billion yuan, and 55.37 billion yuan respectively, with corresponding EPS of 2.32, 2.69, and 3.16 yuan [1] Group 3: Innovation Pipeline - Company is focusing on differentiated layouts in ADC and PROTAC technologies, with several products entering clinical stages [3] - The pipeline includes oral small molecule drugs for diabetes and obesity, with significant milestones expected in 2025 [3] Group 4: Market Sentiment - Recent ratings show 16 out of 17 institutions recommend a "buy" rating, with an average target price of 49.22 yuan [4]

Core Viewpoint - PROTAC drugs target and degrade pathogenic proteins, offering significant clinical value and potential as oral small molecule drugs, with ER PROTAC and AR PROTAC being the most advanced targets in clinical development [1][2]. Group 1: PROTAC Overview - PROTAC utilizes E3 ubiquitin ligase to ubiquitinate target proteins, leading to their degradation by the proteasome, which allows it to tackle "undruggable" targets and proteins that develop resistance mutations [2]. - PROTACs have high selectivity for targets and catalytic properties, enabling low-dose and low-frequency administration [2]. Group 2: ER PROTAC - The fastest progressing ER PROTAC is Arvinas' ARV-471, which has been licensed to Pfizer for over $2 billion and is expected to read out phase 3 clinical data in Q1 2025 [3]. - ARV-471 has shown excellent efficacy in phase 2 trials among patients who have previously used fulvestrant and chemotherapy, with further phase 3 trials planned in 2025 in combination with CDK4/6 inhibitors [3]. Group 3: AR PROTAC - BMS's BMS-986365 is the fastest progressing AR PROTAC, currently in phase 3 clinical trials, addressing issues of resistance and short survival in prostate cancer patients [4]. - Phase 2 clinical data for BMS-986365 showed clinical benefits in mCRPC patients with both AR LBD wild-type and mutant, with PSA50 rates of 27% and 55% respectively [4]. - Arvinas' ARV-766 has been licensed to Novartis for $1.16 billion, achieving a PSA50 of 43% in phase 2 trials among AR LBD mutant patients [4]. Group 4: Investment Focus - PROTAC drugs possess unique advantages and have been validated over 20 years of exploration, with the upcoming phase 3 data for ARV-471 expected to lead to significant breakthroughs in the field [6]. - Domestic pharmaceutical companies are actively engaging in PROTAC development, demonstrating international competitiveness and first-mover advantages [6].