第 44届摩根大通全球医疗健康年会 即将开幕 。我们基于大会公开参会名单与 JPM 活动 日程 信息，对 全部的约 530家 参会主体做了结构化归 类，并结合投行前瞻与一线披露，尝试回答两个更 投资级的问题：第一，哪些赛道正在从讲逻辑转向交答卷。第二，在同一赛道里，什么样的公 司更容易获得跨周期的确定性溢价。 以下文章来源于AI医疗观察 ，作者关注AI医疗的 AI医疗观察 . 响应《关于深入实施"人工智能+"行动的意见》，推动AI在医疗领域的应用，本账号发布权威资讯 | Pacific Time | Grand Balliroom | Colonial Room | California West | California East | Elizabethan A/B | Georgian | Union Square | Elizabethan C | Elizabethan D | Pacific | PRIVATE TRACK | PRIVATE TRACK | Pacific | NOT FOR PROFIT | | --- | --- | --- | --- | --- | --- | --- | ...

Core Insights - The new National Medical Insurance Drug List will take effect on January 1, 2026, allowing innovative drugs with high clinical value to enter the reimbursement system, significantly reducing the financial burden on patients [1] - The inclusion of the BTK inhibitor, Obutinib, for first-line treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) marks a significant advancement in the treatment landscape, transitioning from second-line to first-line therapy [1][3] - The entry of Obutinib into the National Medical Insurance system signifies recognition of this treatment pathway and positions domestic innovative drugs on par with international competitors [3] Industry Overview - CLL primarily affects the elderly, with a median onset age of 65 in China, and its incidence is rising due to an aging population and improved diagnostic capabilities [2] - Despite a lower incidence rate compared to Western countries, the rapid increase in CLL cases in China presents challenges in treatment accessibility and patient compliance [3] - The introduction of targeted therapies, particularly BTK inhibitors, has revolutionized CLL treatment, moving towards a "chemotherapy-free era" [2][4] Market Dynamics - The global market for BTK inhibitors has reached significant scale, with combined sales of five products totaling approximately $11.1 billion in 2022 [4] - New-generation BTK inhibitors are designed to enhance efficacy and safety, addressing the quality of life for patients requiring long-term treatment [4][5] - Obutinib has shown promising clinical results, with an objective response rate of about 93% and a complete response rate of 21.3% in relapsed/refractory CLL/SLL patients [5][6] Future Directions - The successful integration of BTK inhibitors into first-line treatment protocols is supported by major clinical guidelines, indicating a shift towards more effective treatment strategies [6] - Ongoing research is exploring combination therapies, such as Obutinib with new BCL2 inhibitors, aiming for deeper remission and potentially limited-duration treatments [6]

Summary of the Conference Call for 诺诚健华 Company and Industry Overview - The conference call focuses on 诺诚健华 (Nuo Cheng Jian Hua) and its drug 奥布替尼 (Obutinib) for the treatment of systemic lupus erythematosus (SLE), a chronic autoimmune disease affecting over 8 million patients globally, with more than 1 million in China [2][3]. Key Points and Arguments Clinical Trial Results - The IIb clinical trial results for 奥布替尼 show a significant SL4 response rate at week 48 of 57.1% in the 75 mg QD group compared to 34.4% in the placebo group (p<0.05), indicating substantial efficacy in treating SLE [2][5]. - In a subgroup of patients with more severe disease (baseline steroid dose ≥10 mg/day or baseline urine protein ≥1 g/24 hours), the 75 mg QD group demonstrated even greater efficacy, with differences of 30% and 36% compared to the placebo group [5][8]. - 奥布替尼 exhibited good safety and tolerability, with no new safety signals identified, aligning with the BTK inhibition mechanism and SLE disease biology [2][6]. Steroid Reduction - The treatment group showed a significant reduction in glucocorticoid use, with 71.1% of patients successfully reducing their steroid dose to below 7.5 mg/day compared to 43.6% in the placebo group, highlighting the potential to minimize long-term steroid-related side effects [2][6]. Future Clinical Trials - 诺诚健华 plans to initiate a Phase III clinical trial with 484 patients, focusing on the same efficacy endpoints as the IIb trial, expected to start patient enrollment in Q1 2026 [2][7]. - The trial design aligns with international standards, incorporating mandatory steroid reduction protocols to meet the higher requirements set by the CDE for SLE drug trials [4][9]. Market Potential and Commercialization - 奥布替尼 is the first BTK inhibitor to enter Phase III trials for SLE, presenting a significant market opportunity, especially given the limited availability of new small molecule drugs in the past 20 years [3][8]. - The company plans to establish its own commercialization team post-approval and has synergistic effects with other T2 inhibitors to support market promotion [4][10]. Regulatory Landscape - The CDE has tightened clinical requirements for SLE drugs, necessitating lower steroid doses and more rigorous trial designs. 诺诚健华's Phase III study aims to meet these stringent standards to ensure data consistency with global results [9][10]. International Collaboration - 诺诚健华 has partnered with Xenios to advance overseas market opportunities, focusing on SLE and multiple sclerosis (MS) projects, with expectations for the IIb results to inform future international development strategies [12][13]. Additional Important Information - 奥布替尼's mechanism of action shows high selectivity for BTK, with significant inhibition in preclinical models, supporting its development as an effective SLE treatment [3][8]. - The drug's oral formulation offers advantages in convenience and compliance, avoiding issues associated with large molecule biologics [8]. This summary encapsulates the critical insights from the conference call regarding 诺诚健华's developments in SLE treatment with 奥布替尼, highlighting its clinical efficacy, safety profile, market potential, and strategic plans for future trials and commercialization.

生物医药高科技公司诺诚健华（上交所代码：688428；香港联交所代码：09969）12月14日宣布，公司 自主研发的新型BTK抑制剂奥布替尼在治疗系统性红斑狼疮（SLE）的IIb期临床研究中达到主要终点， 同时获得国家药品监督管理局（NMPA）药品审评中心（CDE）批准开展III期注册临床试验。 临床IIb期结果展示，在接受治疗48周的患者中，奥布替尼展现了卓越的有效性以及良好的耐受性和安 全性。本次研究共入组187例患者，按1:1:1随机分成三组，即口服奥布替尼每天一次75毫克和50毫克两 个剂量组，以及一个安慰剂组。 本次研究的主要终点是第48周时的SLE反应指数-4（SRI-4）应答率。第48周时，每天一次75毫克奥布替 尼剂量组的SRI-4应答率显著高于安慰剂组（57.1% vs. 34.4%），具有统计学意义（p＜0.05），达到主 要终点。此外，每天一次75毫克奥布替尼剂量组的疗效优于每天一次50毫克剂量组，这表明疗效呈剂量 依赖性的改善趋势。 奥布替尼显示出良好的耐受性和安全性，安全性特征与BTK抑制剂的作用机制和SLE的疾病生物学相一 致。 第48周时，每天一次75毫克奥布替尼剂量组的SRI- ...

本次研究的主要终点是第48周时的SLE反应指数-4（SRI-4）应答率。第48周时，每天一次75毫克奥布替 尼剂量组的SRI-4应答率显著高于安慰剂组（57.1%vs.34.4%），具有统计学意义（p＜0.05），达到主要 终点。此外，每天一次75毫克奥布替尼剂量组的疗效优于每天一次50毫克剂量组，这表明疗效呈剂量依 赖性的改善趋势。 登录新浪财经APP 搜索【信披】查看更多考评等级 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 诺诚健华医药有限公司（以下简称"公司"）自主研发的BTK抑制剂奥布替尼治疗系统性红斑狼疮（以下 简称"SLE"）的IIb期临床研究达到主要终点，并获国家药品监督管理局（NMPA）药品审评中心 （CDE）批准开展III期注册性临床试验。公司将尽快启动该临床研究，现将主要情况公告如下： 一、奥布替尼临床试验进展情况 近日，公司自主研发的BTK抑制剂奥布替尼治疗SLE的IIb期临床研究达到主要终点，并获CDE批准开展 III期注册性临床试验。该III期研究将评估每日一次（QD）75毫克的给药方案，该方 ...

在基线疾病活动度BILAG ≥1A 或≥2B的亚组患者中，每天一次 75 毫克奥布替尼剂量组相较于安慰剂 组，SRI-4 应答率提高了 35%。在基线疾病活动度 BILAG ≥1A 或 ≥2B 且临床SLEDAI-2K评分 ≥4 的亚 组患者中，每天一次75毫克奥布替尼剂量组的SRI-4应答率较安慰剂组提高 43%。 诺诚健华联合创始人、董事长兼CEO崔霁松博士说："系统性红斑狼疮存在巨大的未被满足的临床需 求，患者往往需要长期甚至终身服药，极大影响他们的生活质量。非常高兴看到奥布替尼在治疗SLE的 IIb期研究中达到主要终点，展示优异疗效，并获批开展III期注册临床试验。我们将加速推进临床开 发，为SLE等自身免疫性疾病患者带来更好的治疗选择。" 本次研究的主要终点是第48周时的SLE反应指数-4（SRI-4）应答率。第48周时，每天一次75毫克奥布替 尼剂量组的SRI-4应答率显著高于安慰剂组（57.1% vs. 34.4%），具有统计学意义（p<0.05），达到主 要终点。此外，每天一次75毫克奥布替尼剂量组的疗效优于每天一次50毫克剂量组，这表明疗效呈剂量 依赖性的改善趋势。 SLE是一种全身性自身免 ...

Core Viewpoint - The approval of the III phase clinical trial for Obutinib in treating systemic lupus erythematosus (SLE) marks a significant advancement for the company, supported by strong data from the IIb phase trial demonstrating efficacy and safety [1][2][3] Group 1: Clinical Trial Results - The III phase trial will evaluate a daily dose of 75 mg of Obutinib, building on solid data from the IIb phase trial [1] - In the IIb trial, 187 SLE patients were randomized into three groups, with the 75 mg dose showing a significant SLE response index-4 (SRI-4) response rate of 57.1% compared to 34.4% in the placebo group at 48 weeks (p < 0.05) [1] - The 75 mg dose also demonstrated a dose-dependent efficacy trend, with significant improvements in SRI-6 and British Isles Lupus Assessment Group (BILAG) response rates compared to the placebo group (p < 0.05) [1] Group 2: Subgroup Analysis - In patients with baseline BILAG ≥ 1A or ≥ 2B, the SRI-4 response rate for the 75 mg dose improved by 35% compared to the placebo group [2] - Among patients with baseline BILAG ≥ 1A or ≥ 2B and clinical SLEDAI-2K scores ≥ 4, the SRI-4 response rate increased by 43% for the 75 mg dose compared to the placebo [2] Group 3: Future Development Plans - The company aims to accelerate the clinical development of Obutinib, which is a selective, irreversible oral BTK inhibitor with potential best-in-class advantages [3] - The III phase trial is expected to enroll the first patient in Q1 2026, with ongoing trials for immune thrombocytopenic purpura (ITP) and multiple sclerosis (MS) also in progress [3] - Obutinib has already gained significant clinical recognition and market penetration in the hematological malignancies sector, having been included in China's National Reimbursement Drug List (NRDL) [4]

InnoCare Pharma Limited 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或 因依賴該等內容而引致的任何損失承擔任何責任。 諾誠健華醫藥有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股份代號：9969） 自願公告 奧布替尼治療系統性紅斑狼瘡的IIb期 臨床試驗取得積極結果並啟動III期臨床試驗 本公告乃由諾誠健華醫藥有限公司（「本公司」）自願作出，以告知本公司股東 及潛在投資者有關本公司的最新業務進展。 董事會（「董事會」）欣然宣佈，藥品審評中心(CDE)批准啟動奧布替尼治療系統 性紅斑狼瘡(SLE)的III期臨床試驗。在IIb期臨床試驗堅實數據的強力支持下，III 期研究將評估每日一次75毫克給藥的方案。 IIb期臨床結果展示，在接受治療48週的SLE患者中，奧布替尼展現了卓越的有 效性和良好的耐受性和安全性。本次研究共入組187例患者，按1:1:1隨機分成 三組，即奧布替尼每日一次75毫克和奧布替尼每日一次50毫克兩個劑量組，以 及一個安慰劑組 ...

奥布替尼在多项淋巴瘤研究中展现了良好的有效性和安全性，包括边缘区淋巴瘤（MZL）、套细胞淋 巴瘤（MCL）、慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）、原发中枢神经系统淋巴瘤 （PCNSL）和弥漫性大B细胞淋巴瘤（DLBCL）。主要研究数据如下： 口头报告 在预测新诊断的PCNSL对基于奥布替尼诱导方案治疗的缓解和生存方面，治疗中期脑脊液ctDNA和 MYD88清除优于PET-CT：一项前瞻性生物标志物研究（报告编号：59） 研究表明，奥布替尼联合利妥昔单抗和高剂量甲氨蝶呤在新诊断PCNSL治疗中展现了良好的有效和耐 受性。在治疗中期，脑脊液（CSF）中ctDNA和MYD88的早期清除相比PET-CT提供了更优越的预测和 预后价值。这些分子生物标志物能够实现实时风险分层，并能够指导早期治疗调整。将脑脊液ctDNA监 测纳入临床工作流程，有望改善PCNSL的反应预测和长期预后。 完成六个治疗周期后，总缓解率（ORR）为89.5%，完全缓解率（CRR）为78.9%。中位起效时间为2.6 个月，2年持续缓解率（DoR）为72.4%。中位随访时间为18.9个月；预估的2年无进展生存（PFS）率和 总生存 ...

Core Viewpoint - 诺诚健华 reported a revenue of 383.94 million yuan for Q3 2025, marking a year-on-year increase of 38.09%, but incurred a net loss of 34.32 million yuan [1][4] Financial Performance - Revenue for Q3 2025 was 383.89 million yuan, up 38.09% year-on-year, while total revenue for the first nine months reached 1.11 billion yuan, a 59.85% increase [3][4] - The company reported a net loss of 34.32 million yuan for Q3 2025, with a net loss of 72 million yuan for the first nine months, a 74.78% reduction compared to the previous year [4][6] - Gross margin improved to 88.8%, up from 86.0% year-on-year [3] Product Performance - The growth in revenue is primarily attributed to the sales of the core product, Acalabrutinib, which generated 1.01 billion yuan in sales for the first nine months, a 45.77% increase [4][7] - Acalabrutinib has been approved for four hematological indications in China and is the first BTK inhibitor approved for relapsed/refractory marginal zone lymphoma [4][5] Market Dynamics - Acalabrutinib's sales are expected to continue growing, with projected revenues of 2.41 billion yuan in 2021, 5.66 billion yuan in 2022, 6.71 billion yuan in 2023, and 10 billion yuan in 2024 [7] - The domestic BTK inhibitor market is becoming increasingly competitive, with five approved products, including Acalabrutinib and others from major pharmaceutical companies [8] - The patent for Ibrutinib, a competing product, will expire in December 2026, potentially leading to an influx of generic versions and intensifying market competition [8] Research and Development - R&D expenses totaled 226.35 million yuan in Q3 2025, accounting for 58.96% of revenue, a decrease from the previous year [3][4] - The company is expanding Acalabrutinib's indications, with ongoing clinical trials for multiple sclerosis and immune thrombocytopenic purpura [7][8]