6月12日，CDE官网显示，山东诺禾康药业有限公司提交的4类仿制化药乌帕替尼缓释片上市申请已获受理。 乌帕替尼是由艾伯维（AbbVie）公司自主研发的新一代选择性和可逆性JAK1抑制剂。乌帕替尼口服缓释片于2019年8月16日获FDA批准上市，商品名为 RINVOQ，同年12月，在欧盟获EMA批准上市。 乌帕替尼缓释片自2019年上市以来销售额呈现爆发性增长。从上市初期的0.47亿美元迅速攀升至2020年的7.31亿美元，并在2021年突破16亿美元大关。2022 年销售额达到25.22亿美元。2023年，乌帕替尼在全球的销售额已达到约27亿美元。 根据IQVIA和EvaluatePharma的报告，乌帕替尼的全球市场需求在快速增长。预计到2026年，乌帕替尼的年销售额将接近80亿美元。 作为目前全球医学界最有前景的靶点之一，据摩熵医药数据库显示，JAK抑制剂在全国医院（全终端）累计销售额达24.9亿元，市场规模迅速攀升，由2019 年的0.56亿元增长至2023年的8.5亿元，复合年增长率达97.28%。乌帕替尼缓释片是其中的TOP3产品。 | 受理品种目录浏览 | 在审品种目录浏览 | | | | | | ...

Summary of Brepicitinib Investor Call Company and Industry - **Company**: Regan and Privyant - **Industry**: Pharmaceutical, specifically focusing on autoimmune diseases, particularly dermatomyositis (DM) Core Points and Arguments 1. **Brepicitinib Overview**: Brepicitinib is a dual selective Tyk2/JAK1 inhibitor, representing a new generation of treatments for inflammatory diseases, with potential to set a new standard of care for patients with high unmet medical needs, particularly in DM and other autoimmune conditions [4][5][6] 2. **Clinical Trials**: The VALOR study aims to improve treatment for over 40,000 patients with DM, with results expected in the second half of the year. The study is the largest DM trial ever conducted, enrolling 241 patients globally [4][22][45] 3. **Patient Burden**: DM is characterized by severe muscle weakness and debilitating skin conditions, leading to a high burden on patients. Current treatments, primarily high-dose steroids, are inadequate and carry significant side effects [10][12][14][16] 4. **Market Opportunity**: There is a significant commercial opportunity in DM, with several competitor programs in late-stage development, but brepicitinib is the only oral treatment in this space [49][50][51] 5. **Regulatory Engagement**: The company has had productive engagement with the FDA and plans to submit a New Drug Application (NDA) if the study results are positive [46] Important but Overlooked Content 1. **Steroid Burden**: The high use of steroids among DM patients leads to adverse health impacts, highlighting the need for new therapies that can reduce this burden while effectively treating the disease [14][15][40] 2. **Study Design**: The VALOR trial includes a strict steroid taper protocol to manage placebo response and demonstrate the drug's efficacy. A high success rate of 98% was achieved in tapering patients off steroids [40][41][86] 3. **Endpoints**: The primary endpoint of the study is the Total Improvement Score (TIS), which measures improvement rather than disease activity. This is crucial for understanding the drug's impact on patient quality of life [27][28][33] 4. **Patient Demographics**: The trial population is heavily treated, with many patients on multiple therapies, indicating a high level of disease severity and the need for effective new treatments [38][39] Conclusion - The upcoming results from the VALOR study are critical for establishing brepicitinib as a viable treatment option for DM, with the potential to significantly improve patient outcomes and address a substantial market need in the autoimmune disease space [44][58]

Core Viewpoint - Suzhou Zejing Biopharmaceutical Co., Ltd. announced that its self-developed drug, JAK inhibitor Jikaxitinib (brand name: Zepuping), has received approval for marketing in China, targeting specific types of myelofibrosis in adult patients [1][2][3] Drug Basic Information - Drug Name: Jikaxitinib - Dosage Form: Tablet - Specification: 50mg - Marketing Authorization Holder: Suzhou Zejing Biopharmaceutical Co., Ltd. - Indications: For adult patients with intermediate or high-risk primary myelofibrosis (PMF), secondary myelofibrosis due to polycythemia vera (PPV-MF), and secondary myelofibrosis due to primary thrombocythemia (PET-MF), treating disease-related splenomegaly or symptoms [1][2] Drug Mechanism and Clinical Trials - Jikaxitinib is a novel JAK inhibitor that works by inhibiting the activity of JAK1, JAK2, JAK3, and TYK2, blocking the JAK-STAT signaling pathway to reduce inflammation and splenomegaly [2] - The approval is based on a Phase III clinical trial showing that 72.3% of patients had a ≥35% reduction in spleen volume after 24 weeks of treatment [3] - Other clinical trials indicated good safety and tolerability profiles for Jikaxitinib in the target patient population [3] Market Potential and Competitive Landscape - The annual incidence of myelofibrosis in China is approximately 60,000 new patients, with a total patient population exceeding 200,000 [5] - The market size for myelofibrosis drugs in China was 1.73 billion yuan in 2020, projected to grow to 2.93 billion yuan by 2025 and 3.30 billion yuan by 2030 [5] - Currently, the only approved targeted drug for treating intermediate and high-risk myelofibrosis in China is the imported drug Ruxolitinib, which had a global sales figure of approximately 4.9 billion USD in 2024 [5] Regulatory and Clinical Guidelines - Jikaxitinib has been included in the 2024 CSCO guidelines as a first-line treatment for myelofibrosis-related anemia and is recommended for second-line and advanced treatment [4] - The drug is also undergoing clinical trials for other immune-inflammatory diseases, including atopic dermatitis and ankylosing spondylitis [4]

医药 本周医药板块上涨 1.27%，百济 BTK PROTAC 启动头对头 3 期临 床 证券研究报告 | 行业周报 2025 年 05 月 19 日 | 股票 | 股票 | 投资 | EPS （元） | | PE | | | --- | --- | --- | --- | --- | --- | --- | | 代码 | 名称 | 评级 | 2025E | 2026E | 2025E | 2026E | | 002755.SZ | 奥赛康 | 买入 | 0.2 | 0.28 | 87.7 | 62.64 | | 01952.HK | 云顶新耀 | 买入 | -0.94 | 0.58 | - | - | | 600079.SH | 人福医药 | 增持 | 1.59 | 1.86 | 12.83 | 10.97 | | 688192.SH | 迪哲医药 | 增持 | -1.33 | -0.08 | - | - | | 688315.SH | 诺禾致源 | 买入 | 0.53 | 0.62 | 26.51 | 22.66 | | 688321.SH | 微芯生物 | 增持 | 0.05 | 0.23 | 349. ...

5月13日晚间，泽璟制药(688266)发布公告称，已收到国家药品监督管理局核准签发的《受理通知 书》，公司递交的盐酸吉卡昔替尼片治疗重度斑秃的新药上市申请(NDA)获得受理。这是盐酸吉卡昔替 尼片第二个申请新药上市的适应症。 盐酸吉卡昔替尼(曾用名：盐酸杰克替尼)是一种新型的JAK抑制剂，对JAK激酶的四个亚型JAK1、 JAK2、JAK3和TYK2都有显著的抑制作用。吉卡昔替尼能够有效抑制炎症和抑制T细胞过度激活，亦能 显著增加真皮层的厚度和促进毛囊再生，增加毛囊密度。 目前，我国尚无国产JAK抑制剂类药物获批用于治疗重度斑秃，泽璟制药若能成功获批，将填补这一空 白。同时，盐酸吉卡昔替尼片治疗中、高危骨髓纤维化适应症的NDA申请也正在国家药监局审批过程 中。 除已提交上市申请的适应症外，泽璟制药还在积极开展盐酸吉卡昔替尼片用于多个免疫炎症性疾病的临 床研究。其中，治疗重度斑秃的III期临床试验、治疗特发性肺纤维化的II期临床试验已取得成功；针对 中重度特应性皮炎(III期)、强直性脊柱炎(III期)等自身免疫性疾病的临床试验正在进行；用于治疗12岁 及以上青少年和成人非节段型白癜风患者的II/III期临床 ...

智通财经5月13日电，泽璟制药(688266.SH)公告称，公司收到国家药品监督管理局核准签发的《受理通 知书》，公司递交的盐酸吉卡昔替尼片治疗重度斑秃的新药上市申请（NDA）获得受理。这是盐酸吉 卡昔替尼片第二个申请新药上市的适应症。盐酸吉卡昔替尼是一种新型的JAK抑制剂，对JAK激酶的四 个亚型JAK1、JAK2、JAK3和TYK2都有显著的抑制作用。本次获得NDA受理的适应症是用于治疗重度 斑秃，是盐酸吉卡昔替尼片第二个申请新药上市的适应症。在我国，目前尚无国产JAK抑制剂类药物获 批用于治疗重度斑秃。 泽璟制药：盐酸吉卡昔替尼片治疗重度斑秃的新药上市申请获得受理 ...