公司报告 | 公司专题研究 百济神州（688235） 证券研究报告 CDK4 抑制剂展现出优异早期疗效信号，后续将进入 注册临床研究阶段 CDK4 抑制剂 BGB-43395 具有更优抑制效力。目前 CDK4i 领域 FIC 的药物是 进入 III 期临床的辉瑞的 PF-07220060，在 MCF-7 增殖实验中，BGB-43395 的抑制细胞增殖效力IC₅₀为126 nM，比PF-07220060 更强（后者为544 nM）， 活性提升 4.3 倍，展现出卓越疗效。 后续随访时间延长，整体响应率有望大幅提升 从辉瑞披露的数据可以看到，CDK4 抑制剂 Atirmociclib 的中位起效时间是 3.6M。所以对同靶点药物，百济神州的 CDK4i 来说，3 个月的中位随访时 间还未到中位起效时间。过往数据提示 CDK4/6i 的应答率随时间延长逐 步提升，在 9 个月时达到最高应答概率。BGB-43395 在 3 个月的评估时间 看到 240mg、400mg、600mg BID 联用组 SD+PR 为 67%(8/12)，83%（5/6）， 75%（6/8），趋势较好。 盈利预测与投资评级 我们预计 202 ...

内容概要：利尿药是一类能促进体内电解质和水分排出而增加尿量的药物。主要通过影响肾脏滤过、重 吸收和再分泌功能而发挥利尿作用。利尿剂在临床上常用于治疗心、肾、肝脏等疾病所引起的水肿，亦 用于高血压等非水肿性疾病的治疗。目前，我国心血管疾病的防治形势非常严峻，患者数量逐渐增多， 据《中国心血管健康与疾病报告2023》，中国CVD现患人数达3.3亿，其中心力衰竭（HF）890万、高 血压2.45亿。除此之外，随着老龄化人口的攀升，我国高血压、心衰、肾衰和肝硬化患者数量将不断增 加。利尿剂作为治疗高血压和心衰的重要药物，应用需求持续攀升，用药规模持续增长，2024年中国利 尿剂市场规模达42.2亿元，同比增长11%。医院端为利尿剂主要销售渠道，占比超过85%。2024年医院 端利尿剂销售规模为36.3亿元，同比增长13%，药店端为5.9亿元。我国利尿剂市场厂商数量众多，市场 竞争较为激烈，总体竞争格局较分散，同时本地药企品牌近几年已经牢牢占据了国内主要市场。2024年 前十家企业累计占据50%的市场份额，其余中小企业占据剩下的50%的市场份额。知名度较高，市场份 额较大的国内企业有桂林南药、天津力生制造、南京海辰药业 ...

康缘药业（600557）公告，公司近日收到国家药品监督管理局签发的1类化学新药KYS2301凝胶的《药 物临床试验批准通知书》。KYS2301是一种新型的趋化因子受体8(CCR8)特异性抑制剂，适用于特应性 皮炎。该药物为全球首个针对CCR8靶点的多肽抑制剂，累计研发投入约4493万元。特应性皮炎是一种 常见的慢性复发性炎症性皮肤病，2019年全球患者人数已达到6.49亿人，预计2030年将进一步增至7.55 亿人。目前，全球尚无针对CCR8靶点的多肽药物上市，KYS2301具有良好的市场前景。公司在收到临 床试验通知书后，需完成I-III期临床试验并整合申报资料申报产品上市。 ...

Core Insights - Vorasidenib, the world's first dual-target IDH inhibitor, has been approved for clinical use in Beijing to treat patients with IDH-mutant diffuse gliomas, enhancing treatment options for this patient group [1][2] - The drug is designed to penetrate the blood-brain barrier and specifically targets IDH1 and IDH2 mutations, marking a significant breakthrough in the treatment of low-grade gliomas [2] - Vorasidenib's introduction in Beijing is facilitated by an innovative policy that accelerates the approval of urgently needed imported drugs, significantly reducing patient wait times for new therapies [3] Group 1 - Vorasidenib is now available in designated medical institutions in Beijing, with initial treatments taking place at major hospitals [1] - The drug addresses the high mortality and recurrence rates associated with IDH-mutant diffuse gliomas, where over 90% of patients experience recurrence despite current treatment options [1] - The median age of onset for patients with IDH-mutant diffuse gliomas is around 40 years, with many facing significant physical and psychological challenges post-surgery [1] Group 2 - Vorasidenib has received approvals in multiple countries, including the US, Canada, Australia, and others, with its introduction in Beijing being part of a broader strategy to enhance access to innovative treatments [3] - The 2024 NCCN guidelines and the Chinese Anti-Cancer Association's updated guidelines now recommend IDH inhibitors for postoperative adjuvant therapy in patients with IDH-mutant gliomas [2] - The inclusion of Vorasidenib in the Beijing Universal Health Insurance special drug list enhances patient access to this treatment, improving their overall treatment experience [3]

Core Viewpoint - The approval of Enasidenib capsules (brand name: Beimingna) by the Macao Drug Regulatory Authority marks a significant milestone for the company in treating ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients [1] Group 1: Product Development and Approvals - Enasidenib is a new generation ALK inhibitor developed jointly by the company and its subsidiary Xcovery [1] - The drug received approval for second-line indications from the National Medical Products Administration of China in November 2020 [1] - In March 2022, the first-line indication was approved, followed by the approval for clinical trials of postoperative adjuvant therapy in April 2022, with ongoing Phase III clinical research [1] Group 2: Market Access and Insurance Inclusion - Enasidenib was included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2023) with an agreement valid until December 31, 2025 [1] - The first-line indication is expected to receive approval from the U.S. Food and Drug Administration in December 2024 [1] Group 3: Competitive Landscape - As of the announcement date, other ALK inhibitors available in Macao include Crizotinib, Ceritinib, Alectinib, Brigatinib, and Lorlatinib [1]

▪ 截至 2025 年 3 月 21 日，正在进行中的 EVER001 的 1b/2a 期临床研究收集到了更多患者的更长期数据，其中低剂量组 11 位患者随访至 52 周，高剂量组分别有 16 位和 12 位患者完成了 24 周和 36 周治疗，并有 7 位患者随访至 52 周。 ▪ 当前数据显示， EVER001 在原发性膜性肾病的患者中有效且耐受性良好。这些结果支持 EVER001 具有治疗以蛋白尿为特征的自身 免疫性肾小球疾病的潜力。 ▪ 抗 -PLA2R 自身抗体最小二乘法 (LS) 几何平均值水平，在 12 周时低剂量组和高剂量组分别下降 62.2% 和 87.3% ，在 24 周时两组的降幅 均增至 93% 以上。 ▪ 24 小时蛋白尿 LS 几何平均值，在 24 周时低剂量组和高剂量组分别下降 57.0% 和 67.6% ， 36 周时降幅分别增至 76.7% 和 80.6% ，并维 持到第 52 周。 ▪ EVER001 安全性和耐受性良好，与此前观察结果一致。不良事件多数为轻到中度，且为短暂性，未观察到其他 BTK 抑制剂常见的 一些有临床意义的不良事件。 ▪ 在问答环节中，斯坦福大学医学教 ...

郝倩/发自挪威克里斯蒂安松 千百年以来，挪威北极峡湾孕育着一种独特的冷水海藻，当地人一直有收割此类海藻的传统，以往只是 主要用来作为动物饲料，剩下些残渣再用来培沃土壤。如今，随着科技的发展，这种挪威峡湾随处可见 的冷水海藻焕发了新的生命力，成为农业生物制剂的重要成分，销往全球各地，他们是怎么做到的呢？ 百年前当地人只是觉得海藻有营养，可以用来做牲畜饲料，剩下的残余用来沤肥。包括Algea以前的生 产工艺，也是单纯的烘干和研磨，这样的产品适合做饲料，其营养物质却无法被土壤直接吸收。 邦迪坦言，过去20年生物工程、数据科学等领域的发展，才让萃取泡叶藻活性物质成为可能。在传统的 烘干，研磨之后，Algea增加了溶解提取活性素的工艺，每天都有数以百吨计的海藻被制成液态和固态 两种可溶性肥料。 我前几日走访了北极圈边缘的挪威克里斯蒂安松（Kristiansund），实地考察了当地企业Algea的海藻采 收与加工的全过程。该公司始建于1937年，原为一家挪威当地家族企业，后为先正达集团收购，其生产 的海藻提取物已经成为先正达生物制剂产品的核心原材料。近年来，生物制剂已成为最"热门"农业科技 创新领域之一。 — 科技解锁冷 ...

Group 1: Index and Market Trends - The Hang Seng Hong Kong Stock Connect Innovative Drug Index will be revised to exclude CXO companies, focusing solely on innovative drug firms, achieving a 100% purity in its index composition [1] - This adjustment is expected to increase the weight of Hong Kong innovative drug companies in the index, better reflecting the core trends and valuation logic of the innovative drug industry [1] Group 2: Company Developments - Heng Rui Medicine received approval from the National Medical Products Administration for its innovative drug SHR0302 for treating severe alopecia areata, marking a significant advancement in domestic JAK1 inhibitors [2] - The approval addresses a substantial patient population in China, with approximately 3.49 million alopecia areata patients reported in 2021, highlighting the unmet medical need in this area [2] - Huiyu Pharmaceutical's TCE tri-antibody drug HY05350 has received clinical trial approval for treating advanced solid tumors, showcasing the company's capabilities in innovative drug development [3] - Han Yu Pharmaceutical expects a net profit of 142 to 162 million yuan for the first half of 2025, driven by strong global market demand and successful product approvals, indicating a recovery from previous losses [4] - The company's performance is significantly influenced by a few products in overseas markets, raising questions about future sustainability [4]

Summary of Aurinia Pharmaceuticals (AUPH) Conference Call Company Overview - **Company**: Aurinia Pharmaceuticals - **Product**: Aretinirecept (previously referred to as AUR200) - **Focus**: Development of treatments for autoimmune diseases Key Points from the Conference Call Phase One Study Results - Aretinirecept is a dual BAF and APRIL inhibitor designed to modulate immune responses in autoimmune diseases [3][4] - The Phase one study involved 61 healthy subjects with a standard single ascending dose design [7] - Doses tested: 5 mg, 25 mg, 75 mg, 150 mg, 225 mg, and 300 mg [7] - Aretinirecept was well tolerated with no treatment-related grade three or higher adverse events [7][9] - Injection site reactions occurred in 24% of subjects receiving Aretinirecept compared to 13% for placebo [9] - Significant reductions in immunoglobulins were observed: IgA (up to 76%), IgM (up to 67%), and IgG (up to 43%) [6] Pharmacokinetics and Pharmacodynamics - Aretinirecept demonstrated a half-life of 6 to 8 days after a single dose [9] - Mean reductions from baseline to day 28 for immunoglobulins were: IgA (48%), IgM (55%), and IgG (20%) [10] - The drug's pharmacodynamic effects support the potential for once-monthly dosing [10] Future Plans - Aurinia plans to initiate further clinical studies in at least two autoimmune diseases in the second half of the year [13][16] - Specific details on future studies and indications were not disclosed for competitive reasons [13][16] Competitive Landscape - The BAF and APRIL inhibitor space is becoming increasingly competitive, with many potential targets identified [24] - Aurinia is focusing on a range of B cell-mediated autoimmune diseases, with an internal review identifying over 20 potential targets [24] Intellectual Property and Development Strategy - Aurinia continues to file for intellectual property related to Aretinirecept, although specific details on the IP life were not disclosed [20] - The company intends to conduct further studies independently without seeking external funding [21] Safety and Administration - No dose-dependent effects were observed for upper respiratory infections or back pain, which were mild and transient [30] - Future formulations are expected to allow for self-administration at home via prefilled syringes or auto-injectors [32] Additional Insights - The study's design included a higher number of patients in the 150 mg dose group to better understand pharmacodynamic impacts [25][26] - Aretinirecept's binding affinity is significantly higher than that of competitor drugs, indicating a potential advantage in efficacy [5][6] This summary encapsulates the key findings and strategic directions discussed during the conference call, highlighting Aurinia Pharmaceuticals' advancements and future plans in the autoimmune disease treatment landscape.

Group 1 - The stock of Yaojie Ankang-B (02617) rose over 10%, reaching a new high of 30.7 HKD, which is an increase of over 130% from the IPO price of 13.15 HKD [1] - As of the report, the stock was up 8.83% at 30.2 HKD, with a trading volume of 24.18 million HKD and a market capitalization that briefly exceeded 12 billion HKD [1] - Yaojie Ankang announced that its self-developed multi-target kinase inhibitor, TT-00420, received Fast Track designation from the FDA for the treatment of metastatic castration-resistant prostate cancer [1] Group 2 - According to Frost & Sullivan, the global CCA drug market is expected to reach 2 billion USD by 2024, with a compound annual growth rate (CAGR) of 16.2% from 2019 to 2024 [2] - The market is projected to grow to 3.2 billion USD by 2027, with a CAGR of 17.1% from 2024 to 2027, and further increase to 4.6 billion USD by 2030, with a CAGR of 12.8% from 2027 to 2030 [2] - The company is a leader in the niche industry, with Tinengotinib being the first and only FGFR inhibitor entering the registration clinical stage for treating recurrent or refractory cholangiocarcinoma patients [2]