据了解，ACT001是由尚德药缘开发的全新机制的1类创新药，从发现到临床前开发经历了8年，临床试 验又经历了8年。已在全球开展了10多项多个适应症的探索性I-II期临床试验，全球有400多位患者参与 了ACT001的正式临床试验。 借力引进肿瘤创新药ACT001，亿帆医药（002019）在创新药方面，出现了从"自主研发为主"转向"整合 社会研发资源"的新模式。值得一提的是，公司在1月7日披露的机构调研中还表示，未来将持续推进更 多系列项目的讨论与落地，丰富管线，加快商业化步伐。 近日，亿帆医药全资子公司合肥亿帆生物制药有限公司与天津尚德药缘科技股份有限公司及其关联方签 订一系列独家协议，获得后者自主研发的1类创新药ACT001(活性成分：二甲胺基含笑内酯富马酸盐— 水合物)在特定区域和适应症上的独家开发、生产及商业化权利。 为此，亿帆制药需支付1亿元人民币的首付款，并承诺在交易对方于2027年6月30日前成功实现境外IPO 时，作为基石投资者出资1亿元，或在该条件未达成但就III期临床试验主要及其他关键终点获益趋势达 成一致时支付5000万元里程碑款。此外，未来产品上市后，亿帆制药还需根据净销售额向尚德药缘支 ...

近期，中国国家药品监督管理局药品审评中心（CDE）宣布将上海海和药物研究开发股份有限公司的甲 磺酸瑞索利塞（CYH33）纳入"儿童抗肿瘤药物研发鼓励试点计划（星光计划）"试点项目。这不仅让海 和药物在小分子创新药领域的硬实力再度引发行业关注，也让华丽家族在生物医药赛道的布局蓝图更具 想象空间。 从研发管线的多维开花到商业化进程的稳步推进，海和药物的价值正在被市场看见。目前创新药行业正 处在结构性调整的关键期，有核心技术、临床价值明确且具备商业化能力的企业，更容易在激烈竞争中 站稳脚跟。凭借对小分子创新药领域的持续深耕与突破，海和药物正全面推进"研发-临床-商业化-国际 化"的全链条贯通。接下来，随着临床试验推进、海外市场拓展以及更多管线产品的落地，海和药物有 望在创新药赛道持续发力，这将会为华丽家族的产业升级与价值增长注入强劲动力。不过行业本身存在 研发不确定性、市场竞争等客观因素，其后续表现仍需结合临床数据、商业化进度等多方面动态观察。 作为"星光计划"启动后第7个入围的创新药，CYH33 面向的适应症为具有严重临床表现、需要系统治疗 的PIK3CA相关过度生长谱（PROS）和PIK3CA相关脉管畸形（PR ...

Investment Rating - The report maintains a "Buy" rating for the company [2][6]. Core Insights - The approval of the CSF-1R inhibitor, Pimitinib, by the Chinese regulatory authority marks the beginning of a new commercialization journey for the company. This drug is the first self-developed new drug and will be commercialized by Merck [6]. - Pimitinib has shown best-in-class overall response rates (ORR) in clinical trials, with a significant increase from 54% to 76.2% in ORR during a median follow-up of 14.3 months [6]. - The company has multiple ongoing pipeline projects, including the approval of IND for the oral KRAS G12D inhibitor and the completion of the first patient dosing in a clinical trial for the FGFR2/3 inhibitor [6]. Financial Data and Profit Forecast - Revenue projections for the company are as follows: - 2023: 19 million - 2024: 504 million - 2025E: 612 million - 2026E: 756 million - 2027E: 627 million - The net profit attributable to ordinary shareholders is expected to be: - 2023: -432 million - 2024: 28 million - 2025E: 63 million - 2026E: 151 million - 2027E: 133 million - The projected earnings per share (EPS) are: - 2023: -0.67 - 2024: 0.04 - 2025E: 0.09 - 2026E: 0.22 - 2027E: 0.20 [3][7].

Core Insights - The collaboration between Fosun Pharma and Pfizer marks a significant milestone in the competitive landscape of GLP-1 therapies, highlighting Fosun's innovative capabilities in small molecule drug development [3][8][10] Group 1: Transaction Details - On December 9, Fosun Pharma announced a licensing agreement with Pfizer for its orally administered small molecule GLP-1 receptor agonist YP05002, granting Pfizer global rights for development, production, and commercialization [4][5] - Fosun Pharma will receive an upfront payment of up to $150 million, with potential milestone payments totaling up to $1.935 billion, along with tiered royalties post-approval [4][5] Group 2: Market Context - The GLP-1 market is experiencing intense competition, with major pharmaceutical companies actively pursuing next-generation therapies. Sales of existing GLP-1 products like semaglutide and tirzepatide have reached $25.462 billion and $24.837 billion respectively in the first three quarters of the year, indicating a strong market demand [6][7] - The collaboration signifies Fosun Pharma's recognition in the global market, as it aligns with the trend of multinational corporations seeking innovative GLP-1 solutions [5][6] Group 3: Strategic Implications - Fosun Pharma's chairman emphasized that this partnership is a key step in the company's strategy for innovation and internationalization, aiming to address unmet clinical needs in obesity and metabolic diseases [5][8] - The deal is part of a broader trend where Fosun Pharma has secured multiple business development transactions in 2023, totaling approximately $4 billion, showcasing its diverse research capabilities [9][10]

来源：市场资讯 （来源：医药笔记） 2025年12月2日，和美药业港股IPO申请获得受理，招股书正式公开。 和美药业成立于2002年，致力于研发针对自身免疫病和肿瘤的小分子创新药，研发管线包括7款创新 药，首发管线为PDE4B抑制剂Mufemilast（已经获批上市），后续管线还有TNFα抑制剂Hemay007、 IgE/PDE4抑制剂Hemay808、EGFR/HER2抑制剂Hemay022等。 Mufemilast为首款国产PDE4B抑制剂，具有治疗多种自身免疫病的潜力。除了PDE4B抑制剂外，和美药 业还有多款治疗自免、肿瘤的差异化小分子新药，期待其后续临床进展。 | 中國已上市的PDE4抑制劑 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 品牌名稱 | 國際非專利藥 名(INN) | 公司 | 靶點 | 避魔症 | 國家藥監局 首次批准日期 | 醫療保險 | 图量 | 價格(人民 带元) | | 舒坦明。 | 克立硼羅軟膏 | Anacor Pharmaceutic | PDE4 | 特應性皮炎 ...

Financial Performance - In the first nine months of 2025, the company achieved revenue of CNY 3.624 billion, a year-on-year increase of 6.23% [1] - Net profit attributable to the parent company was CNY 1.033 billion, up 6.08% year-on-year [1] - Revenue breakdown: - Traditional Chinese medicine: CNY 1.138 billion, up 8.72% [1] - Chemical drugs: CNY 441 million, down 14.21% [1] - Biological drugs: CNY 2.040 billion, up 11.36% [1] R&D Progress - KH902-R10 (high-dose Conbercept for diabetic macular edema) is in Phase II clinical trials [2] - Gene therapy products KH631 and KH658 (for neovascular age-related macular degeneration) are in Phase II in China and Phase I in the U.S. [2] - KH617 (for advanced solid tumors) is in Phase II [2] - Antibody-drug conjugate KH815 (for various advanced solid tumors) is in Phase I in China and Australia [2] - Traditional Chinese medicine KH110 (for Alzheimer's disease) is in Phase III [2] - Small molecule innovation drug KH607 (for depression) is in Phase II [2] Market Insights - The global market for nAMD drugs is expected to become more competitive, with anti-VEGF drugs remaining mainstream [3] - The U.S. market holds a significant share, with China ranking second in terms of market size [3] - The company aims to leverage its product lineup to meet diverse clinical needs in the ophthalmology sector [3] Future Plans - The company will focus on chronic diseases, including cardiovascular, central nervous system, metabolic, and oncology areas for innovative R&D [4] - Plans to expand the pipeline in oncology with antibody conjugates and small molecule drugs [5] - The company anticipates a revenue and net profit growth of 5%-15% for 2025 compared to 2024 [4] Competitive Landscape - Conbercept is currently a leader in the domestic anti-VEGF market [4] - The company plans to enhance its product line with high-concentration Conbercept expected to be approved by 2028 [7] - The company is committed to optimizing drug delivery methods and addressing unmet clinical needs through innovative research [4]

Group 1 - The core viewpoint is that He Yu-B (02256) is a leader in small molecule innovative drugs, with projected revenues of RMB 650 million, 680 million, and 730 million for 2025-2027, and net profits of RMB 97 million, 111 million, and 142 million respectively, leading to a target price of HKD 22.06, indicating a potential upside of 48.5% from the current price [1] Group 2 - Global BIC product Pimiatin has shown excellent data at ESMO, with an overall response rate (ORR) of 76.2% in the III phase MANEUVER study for patients with giant cell tumor of the tendon sheath, and a significant improvement in joint activity by 23.9% compared to baseline [2] - The NDA for Pimiatin has been submitted domestically, and the FDA NDA submission is progressing, expected to be submitted in Q4 2025 [2] - Pimiatin is also advancing in a II phase study for treating chronic graft-versus-host disease [2] Group 3 - The development of innovative drugs is accelerating, with the oral PD-L1 inhibitor ABSK043 and the KRASG12C inhibitor from Ailis receiving IND approval for treating KRASG12C mutated non-small cell lung cancer (NSCLC) patients [3] - The single-agent treatment of Ipagotin for advanced hepatocellular carcinoma (HCC) has commenced, with the first patient dosed in June 2025, targeting a population with poor prognosis due to FGF19 overexpression [3] - A novel targeted therapy approach for HCC is being developed, with a II phase study showing an ORR of ≥50% and a progression-free survival (PFS) of ≥7 months when combined with Atezolizumab [3]

Group 1 - The core viewpoint is that He Yu-B (02256) is a leading player in small molecule innovative drugs, with projected revenues of RMB 650 million, 680 million, and 730 million for 2025-2027, and net profits of RMB 97 million, 111 million, and 142 million respectively, leading to a target price of HKD 22.06, indicating a potential upside of 48.5% from the current price [1] Group 2 - Global BIC product Pimiatin has shown excellent data at ESMO, with an overall response rate (ORR) of 76.2% in the III phase MANEUVER study for patients with giant cell tumor of the tendon sheath, and a significant improvement in joint activity by 23.9% compared to baseline [2] - The NDA for Pimiatin has been submitted domestically, and the FDA NDA submission is progressing, expected to be submitted in Q4 2025 [2] - Pimiatin is also advancing in a Phase II study for treating chronic graft-versus-host disease [2] Group 3 - The development of innovative drugs is accelerating, with the oral PD-L1 inhibitor ABSK043 and the KRASG12C inhibitor from Ailis receiving IND approval for treating KRASG12C mutated non-small cell lung cancer (NSCLC) patients [3] - The single-agent treatment of Ipagotini for advanced hepatocellular carcinoma (HCC) is underway, with the first patient dosed in June 2025, targeting a population with poor prognosis due to FGF19 overexpression [3] - A novel targeted therapy approach for HCC is being developed, with a Phase II study showing an ORR of ≥50% and a progression-free survival (PFS) of ≥7 months when combined with Atezolizumab [3]

Market Performance - The pharmaceutical and biotechnology index rose by 0.35% from October 20 to October 24, underperforming the Shanghai Composite Index by 0.36 percentage points, marking five consecutive weeks of underperformance [1] - The innovative drug index (BK1106) saw a slight increase of 0.03%, ending a four-week decline [1] - The Hang Seng Healthcare Index fell by 0.77%, although the decline was less severe than the previous week, indicating a continued downward trend [1] - The Hong Kong innovative drug ETF (513120) decreased by 2.82%, failing to capitalize on positive news from the ESMO conference and significant business development transactions by Innovent Biologics [1] IPO Developments - Jiangxi Biological Products Research Institute Co., Ltd. has submitted a new application for listing on the Hong Kong Stock Exchange, following a failed attempt in April 2023 [2] - Jiangxi Biological is the largest provider and exporter of human tetanus antitoxin (TAT) in China, holding a global market share of 36.6% and a domestic market share of 65.8% in 2024 [2] - The company's revenue is relatively low, projected at 221 million yuan in 2024 and 99.7 million yuan in the first half of 2025, primarily due to the low price of TAT, which averages 3.6 yuan per unit for exports, about 30% of the domestic price [2] Clinical Trials - From October 20 to October 26, the National Medical Products Administration disclosed 95 new clinical trial registrations, with 30 of these being innovative drugs in Phase II or higher, mainly in oncology, cardiovascular, and dermatology fields [6] Drug Approvals - Three small molecule innovative drugs were approved last week, including a PDE4B inhibitor for idiopathic pulmonary fibrosis (IPF), marking the first successful approval for IPF treatment in nearly a decade [9] - The drug, developed by Boehringer Ingelheim, achieved its primary endpoint in Phase III trials and was approved in both the U.S. and China within two weeks [9] - Other approved drugs include a first-line treatment for advanced non-small cell lung cancer (NSCLC) and a new oral hypoglycemic agent for type 2 diabetes [10][11] Company Performance - Huahao Zhongtian Pharmaceutical-B has seen a cumulative decline of over 33% in the past two weeks, attributed to low trading volumes and a general downturn in the innovative drug sector [12] - The company reported a revenue of 14.78 million yuan in the first half of the year, a decrease of 55.36% year-on-year, with a net loss of 54.04 million yuan, slightly improved from the previous year's loss [12]

Group 1 - The company is set to achieve its first commercial product with the development of small molecule therapies, focusing on FIC and BIC, and is expanding into non-tumor and macromolecule fields [1] - The company expects to transition from long-term losses to profitability in 2024 through external licensing agreements [1] - Pimitinib, a BIC CSF-1R inhibitor, has submitted an NDA application in China and is expected to launch in 2026, marking the company's first commercial product [1] Group 2 - Pimitinib has shown best-in-class ORR and significant safety advantages in key Phase III trials for TGCT, with the NMPA accepting its application for market approval [1] - The company has established exclusive commercialization cooperation with Merck for Pimitinib in several regions, reflecting confidence in the product's commercial potential [1] - The company is advancing I/II phase clinical trials for ABSK061, a selective FGFR2/3 inhibitor, with the first patient expected to be enrolled by June 2025 [2] Group 3 - The company is developing ABSK043, a PD-L1 small molecule inhibitor, which is currently the fastest progressing oral PD-L1 inhibitor globally, showing good safety and anti-tumor activity [2] - The company has initiated three II phase clinical trials for ABSK043 in combination therapies for various types of NSCLC and gastric cancer [2] - The company has a target price of 21.68 RMB, indicating a potential 41% upside from its market value as of September 17, 2025 [3]