关注四大催化剂 出品 | 妙投APP 作者 | 张贝贝 编辑 | 丁萍 头图 | 视觉中国 昔日的"药茅"恒瑞医药，已很久没有像样的行情了。 虽然2025年9月以来，对外授权的BD交易"祛魅"，创新药板块出现回调；但今年随着药企有高质量大额BD 交易落地，以及多家药企业绩预告扭亏或减亏，核心产品临床数据有积极进展等情况下，资本市场有所回 暖。 （妙投注：BD交易，指的是通过将自主研发的潜力项目授权给其他药企（主要是跨国药企），为企业带来 首付款、里程碑收入等，改善业绩预期） （资料来源：Choice数据） BD交易带动业绩高增 的逻辑，出现"裂痕" （资料来源：Choice数据） 然而，资本市场"暖风"却绕过了昔日的"药茅"。 当荣昌生物、歌礼制药等同行今年以来股价录得两位数涨幅时，恒瑞医药却走出了罕见的"十一连阴"，年 内涨跌幅陷负值区间。 那么，恒瑞医药，到底怎么了？资本市场暖风何时能吹到？ 自2024年起，BD交易成为恒瑞业绩增长的重要驱动因素，但因为相关收入确认节奏滞后，市场开始担忧 BD模式对业绩的拉动是否具备持续性，从而使BD交易逻辑出现松动。 凭 借 着 2023 年 10 月 一 起 BD 交 ...

Group 1 - Kangfang Biotech's AK112 has been proposed for inclusion as a breakthrough therapy for advanced biliary cancer, marking the fifth time it has received such recognition from CDE, offering new hope for patients with poor prognosis [1] - Hengrui Medicine has submitted new indication applications for its drugs, demonstrating the trend of integrating systemic and local treatments in solid tumor therapy, particularly in liver cancer [2] - Innovent Biologics expects a revenue increase of approximately 134% in 2025, projecting around 2.37 billion yuan, with a turnaround to a net profit of about 630 million yuan, driven by sustained commercialization and global business development [3] Group 2 - Roche's 2025 financial report indicates total revenue of approximately 74.37 billion USD, with pharmaceutical business revenue reaching about 57.63 billion USD, reflecting a 9% year-on-year growth [4] - Fosun Pharma has secured commercialization rights for VGX-3100, a therapeutic DNA drug targeting HPV, which is expected to complement existing preventive vaccines and address a significant market for infected individuals [5]

本报记者 张晓玉 作为我国药品监管体系的重要配套法规，新《条例》从药品研制、生产、经营到使用和监管全链条作出 系统性优化，尤其强化了对中药、儿童用药、罕见病用药等领域的规范管理。 多位受访专家对记者表示，此次修订将为创新药产业注入强劲政策动能。 近日，新修订的《中华人民共和国药品管理法实施条例》（以下简称"新《条例》"）正式公布，自2026 年5月15日起施行。 长期以来，儿童用药和罕见病用药因患者基数小、研发回报低而陷入"无人愿做"的困境。新《条例》对 此开出"精准药方"，对儿童用药品新品种、采用新剂型或者新规格的儿童用药品、增加儿童适应症的药 品，符合条件的，给予不超过2年的市场独占期。对符合条件的罕见病治疗用药品，药品上市许可持有 人承诺保障药品供应的，给予不超过7年的市场独占期。 胡麒牧表示，这是国际通行的激励机制，独占期不是垄断，而是对高风险投入的合理补偿，有助于撬动 社会资本投向"冷门但刚需"领域。 新药上市周期缩短 2020年发布实施的《药品注册管理办法》，首次设立突破性治疗药物、附条件批准、优先审评审批和特 别审批这4个药品上市加快通道，新《条例》进一步将这4条通道写入法条。国家药监局数据显示 ...

近日，新修订的《中华人民共和国药品管理法实施条例》（以下简称"新《条例》"）正式公布，自2026 年5月15日起施行。 作为我国药品监管体系的重要配套法规，新《条例》从药品研制、生产、经营到使用和监管全链条作出 系统性优化，尤其强化了对中药、儿童用药、罕见病用药等领域的规范管理。 多位受访专家对记者表示，此次修订将为创新药产业注入强劲政策动能。 新药上市周期缩短 2020年发布实施的《药品注册管理办法》，首次设立突破性治疗药物、附条件批准、优先审评审批和特 别审批这4个药品上市加快通道，新《条例》进一步将这4条通道写入法条。国家药监局数据显示，截至 2025年12月份，已有395个品种纳入突破性治疗药物程序，158个通过附条件批准上市，508个品种进入 优先审评通道。创新药平均审评时限较2018年缩短25%。 "这相当于把过去'试点性'的审评改革成果制度化、法治化。"中国企业联合会特约研究员胡麒牧对《证 券日报》记者表示，企业可以更稳定地规划研发管线，投资者也能获得更清晰的政策预期。 以恒瑞医药为例，其自主研发的PD-1抑制剂卡瑞利珠单抗已通过优先审评获批多个适应症；百济神州 的泽布替尼凭借突破性疗法认定加速 ...

Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. is recognized as a leading player in China's biopharmaceutical industry, transitioning from generic drugs to innovative drugs, with its strategic movements indicating the development direction of the entire Chinese pharmaceutical industry [1] Group 1: Strategic Overview - Hengrui has undergone a painful transformation over the past five years, successfully navigating the challenges posed by the National Drug Centralized Procurement (VBP), with 2023 revenue reaching 22.82 billion yuan, a year-on-year increase of 7.26%, and net profit of 4.30 billion yuan, up 10.14% [2] - The company is expected to accelerate growth in 2024 and 2025, with projected revenue of 27.99 billion yuan in 2024, a significant year-on-year increase of 22.63%, and innovative drug revenue surpassing 60% by mid-2025 [2] Group 2: Investment Logic Reconstruction - The core investment logic for Hengrui is restructured around four dimensions: the clearance of existing risks and realization of innovation, global competitiveness of the ADC platform, explosive potential of chronic disease pipelines, and iterative internationalization models [4] - The ADC pipeline, led by SHR-A1811, has established a competitive edge against imported drugs and validated its underlying technology platform (HRMAP) through extensive external licensing [4] Group 3: Financial Deep Dive - Hengrui's financial reports show a clear V-shaped recovery trend, with 2023 revenue of 22.82 billion yuan and innovative drug revenue reaching 10.64 billion yuan, a year-on-year increase of 22.1% [6] - By 2025, the company anticipates revenue of 33.65 billion yuan, with net profit projected between 6 to 7 billion yuan, reflecting a growth rate of approximately 29% [6] - Operating cash flow surged by 504.12% to 7.644 billion yuan in 2023, indicating strong cash generation capabilities [10] Group 4: Oncology Pipeline Insights - Hengrui's oncology pipeline has shifted from a "Me-too/Me-better" strategy to a "Best-in-Class" and "First-in-Class" approach, with the ADC platform becoming a new cornerstone [12] - SHR-A1811 is positioned as a strategic asset, directly competing with DS-8201, and has received breakthrough therapy designations for multiple indications [14] Group 5: Non-Oncology Growth Areas - Hengrui's deep layout in non-oncology fields serves as a stabilizer for its performance and a second growth curve, particularly in metabolic diseases, cardiovascular, and autoimmune areas [23] - The company is actively participating in the GLP-1 market, with HRS9531 showing potential for superior efficacy in weight loss and diabetes management [24] Group 6: Globalization Strategy 2.0 - Hengrui's internationalization strategy has evolved from simple export to a more integrated approach involving NewCo and licensing-out models, allowing for risk isolation and capital leverage [33] - The NewCo model enables Hengrui to finance high-risk clinical developments through partnerships with top-tier venture capital, mitigating cash flow strain [34] Group 7: Policy Environment and Market Access - The impact of the VBP has diminished, with Hengrui's main generic products now serving as cash cows to support innovative drug development [41] - Successful negotiations in the National Reimbursement Drug List (NRDL) for innovative drugs are expected to catalyze growth, despite average price reductions of around 60% [42]

Major Events - Yunzhisheng (09678) secured a regional medical cooperation contract worth over 20 million [1] - Kelun-Biotech (06990) received breakthrough therapy designation from NMPA for TROP2 ADC drug in combination with pembrolizumab for treating PD-L1 positive locally advanced or metastatic non-small cell lung cancer [1] - InSilico Medicine (03696) entered into an 8.88 billion USD multi-year collaboration for anti-tumor drug development with Sihuiya [1] - Hutchison China MediTech (00013) is conducting a Phase III study on surufatinib combined with camrelizumab for first-line treatment of pancreatic ductal adenocarcinoma [1] - Ascletis Pharma-B (01672) announced FDA approval for IND of ASC30 in a 13-week Phase II study in diabetic patients [1] - Foryou Medical (01696) received quality standard inspection approval for its reauthorized injectable botulinum toxin from the Chinese National Medical Products Administration [1] - CanSino Biologics (06185) obtained clinical trial approval in China for its 24-valent pneumococcal polysaccharide conjugate vaccine [1] - Stone Group (02005) received drug production registration approval for perindopril and amlodipine tablets [1] - Sunny Optical Technology (02382) proposed to spin off its automotive optical business for independent listing on the Hong Kong Stock Exchange [1] - Dongyang Sunshine Pharmaceutical (06887) completed the first patient enrollment for HECN30227 in China [1] - Haitong International's subsidiary plans to sell 100% equity of Guohua Machinery for 342 million [1] - Yuexiu Property (00123) subsidiary intends to sell 73.74% actual equity in Hangzhou Yueyun [1] - CIMC Group (02039) subsidiary CIMC Shilianda plans to introduce strategic investors through capital increase and transfer of a small number of old shares [1] Operating Performance - Chifeng Jilong Gold Mining (06693) expects annual net profit attributable to shareholders to be approximately 3 billion to 3.2 billion, an increase of about 70% to 81% year-on-year [2] - Corning Hospital (02120) anticipates outpatient visits to reach approximately 720,200 in 2025, a year-on-year increase of 29% [2] - Seres (09927) reported total vehicle sales of 63,700 units in December, a year-on-year increase of 53.54% [2] - Xiehe New Energy (00182) reported an equity power generation of 790.32 GWh in December [2] - Country Garden (02007) reported contract sales amounting to approximately 2.69 billion attributable to shareholders in December [2]

Core Viewpoint - The company, Hutchison China MediTech Limited (和黄医药), has initiated the Phase III portion of a clinical trial for surufatinib in combination with camrelizumab, nab-paclitaxel, and gemcitabine for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) patients in China, with the first patient receiving treatment on December 30, 2025 [1]. Group 1 - The study is a multicenter, randomized, open-label, positive-controlled Phase II/III clinical trial aimed at evaluating the efficacy and safety of the S+C+AG regimen compared to the AG regimen in adult patients with metastatic pancreatic cancer who have not previously received systemic anti-tumor therapy [2]. - The Phase II portion of the study included 62 patients, with plans to enroll approximately 400 additional patients in the Phase III portion [2]. - The primary endpoint of the Phase III portion is overall survival (OS), while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), quality of life, and safety [2]. Group 2 - Results from the Phase II portion were recently presented at the 2025 European Society for Medical Oncology (ESMO) Asia Congress, showing a median PFS of 8.15 months as of the data cutoff on July 24, 2025 [3]. - The S+C+AG group had a median PFS of 7.20 months compared to 5.52 months for the AG group, indicating a 50.1% reduction in the risk of disease progression or death (HR 0.499, p=0.0407) [3]. - Other key efficacy endpoints showed similar benefits, with an ORR of 67.7% versus 41.9% (p=0.0430) and a DCR of 93.5% versus 71.0% (p=0.0149) [3]. - Although overall survival data is not yet mature, a positive trend has been observed, with 9 events in the S+C+AG group and 15 events in the AG group [3]. - The treatment demonstrated manageable safety characteristics, with 80.6% of patients in the S+C+AG group experiencing grade 3 or higher treatment-emergent adverse events (TEAEs), compared to 61.3% in the AG group [3].

Core Viewpoint - The company announced the initiation of a Phase III portion of a clinical trial for surufatinib in combination with camrelizumab, nab-paclitaxel, and gemcitabine for first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) patients in China, with the first patient receiving treatment on December 30, 2025 [1] Group 1: Clinical Trial Details - The study is a multicenter, randomized, open-label, positive-controlled Phase II/III clinical trial aimed at evaluating the efficacy and safety of the S+C+AG regimen compared to the AG regimen in adult metastatic pancreatic cancer patients who have not previously received systemic anti-tumor treatment [2] - The Phase II portion included 62 patients, with plans to enroll approximately 400 additional patients in the Phase III portion [2] - The primary endpoint for the Phase III portion is overall survival (OS), while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), quality of life, and safety [2] Group 2: Phase II Results - The results of the Phase II portion were recently presented at the 2025 ESMO Asia Congress, with a median PFS follow-up time of 8.15 months [3] - The median PFS for the S+C+AG group was 7.20 months, compared to 5.52 months for the AG group, indicating a 50.1% reduction in the risk of disease progression or death (stratified hazard ratio [HR] 0.499, log-rank test p=0.0407) [3] - Other key efficacy endpoints showed similar benefits, including ORR (67.7% vs. 41.9%, p=0.0430) and DCR (93.5% vs. 71.0%, p=0.0149) [3] - Although overall survival data is not yet mature, a positive trend has been observed, with 9 events in the S+C+AG group (N=31) and 15 events in the AG group (N=31) [3] - The treatment demonstrated manageable safety characteristics, with 80.6% of patients in the S+C+AG group experiencing grade 3 or higher treatment-emergent adverse events (TEAEs), compared to 61.3% in the AG group [3]

Core Viewpoint - Hutchison China MediTech Limited (HCM) has announced the initiation of a Phase III portion of a clinical study for surufatinib in combination with camrelizumab, nab-paclitaxel, and gemcitabine for first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) patients in China, with the first patient receiving treatment on December 30, 2025 [1] Group 1 - The clinical study is a Phase II/III trial focusing on the treatment of metastatic PDAC [1] - The combination therapy includes surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine [1] - The first patient has already commenced treatment as of December 30, 2025 [1]

Core Viewpoint - The study highlights the potential of AI-assisted molecular subtyping to enhance treatment efficacy in HR+/HER2- breast cancer, particularly for the newly identified subtypes SNF2 and SNF4 [4][22]. Group 1: Research Background - HR+/HER2- breast cancer accounts for approximately two-thirds of all breast cancer cases, with limited treatment options available after resistance to CDK4/6 inhibitors [3][4]. - The study published in Cancer Cell on December 4, 2025, by researchers from Fudan University, introduces a new approach to classify HR+/HER2- breast cancer into four subtypes using AI [3][4]. Group 2: AI Subtyping Methodology - The research team utilized multi-omics data and a similarity network fusion (SNF) algorithm to classify HR+/HER2- breast cancer into four new subtypes: SNF1, SNF2, SNF3, and SNF4 [8][11]. - An AI model was developed to predict these subtypes accurately from routine H&E stained pathology slides, making clinical application feasible without expensive multi-omics testing [11][21]. Group 3: LINUX Trial Design - The LINUX trial is a multi-center, randomized controlled Phase II study involving 105 HR+/HER2- advanced breast cancer patients who are resistant to CDK4/6 inhibitors [13][14]. - Patients were categorized based on their SNF subtype and randomly assigned to either a precision treatment group or a standard treatment group [13][14]. Group 4: Treatment Protocols - Treatment regimens were tailored to each subtype: - SNF1: Everolimus + endocrine therapy - SNF2: Camrelizumab + Famitinib + chemotherapy - SNF3: Olaparib + chemotherapy - SNF4: Apatinib + chemotherapy [14]. Group 5: Trial Results - The trial demonstrated significant efficacy, with objective response rates (ORR) for the precision treatment group compared to the control group as follows: - SNF1: 10% vs 0% - SNF2: 65% vs 30% - SNF3: 40% vs 30% - SNF4: 70% vs 20% [17]. - Notably, the probability of effective treatment for SNF2 and SNF4 was 86.7% and 97.6%, respectively, indicating successful patient selection for specific therapies [19]. Group 6: Safety and Clinical Implications - The safety profile of the precision treatment group was comparable to the standard treatment group, with a 37% incidence of grade 3-4 treatment-related adverse events [19]. - The LINUX trial results provide strong evidence for new treatment strategies in HR+/HER2- advanced breast cancer, particularly identifying SNF2 as an "immune hot tumor" type [22][24]. Group 7: Future Outlook - The success of the LINUX trial validates the feasibility of using low-cost pathology and AI for clinical precision subtyping and treatment guidance [21]. - This research paves the way for personalized treatment approaches in breast cancer, aiming for a "one patient, one plan" strategy in precision medicine [24].