Core Viewpoint - The Hong Kong Innovative Drug ETF (159567) has shown a slight increase in performance, with a closing rise of 0.79% and a trading volume of 849 million yuan on February 6, 2024 [1]. Group 1: Fund Overview - The Hong Kong Innovative Drug ETF (159567) was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1]. - As of February 5, 2024, the fund's total shares stood at 10.244 billion, with a total size of 7.906 billion yuan, reflecting a 2.36% decrease in shares and a 0.13% increase in size since December 31, 2023 [1]. Group 2: Liquidity and Trading Activity - Over the last 20 trading days, the cumulative trading amount for the ETF reached 21.573 billion yuan, with an average daily trading amount of 1.079 billion yuan [1]. - Since the beginning of the year, the ETF has recorded a cumulative trading amount of 29.237 billion yuan over 25 trading days, averaging 1.169 billion yuan per day [1]. Group 3: Fund Management - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 56.50% during the management period [1]. Group 4: Top Holdings - The top holdings of the Hong Kong Innovative Drug ETF (159567) include: - CSPC Pharmaceutical Group (10.44% holding, 108 million shares, market value of 825 million yuan) [2] - BeiGene (9.91% holding, 4.8299 million shares, market value of 782 million yuan) [2] - CanSino Biologics (9.72% holding, 7.52 million shares, market value of 768 million yuan) [2] - China Biologic Products (9.66% holding, 13.7 million shares, market value of 763 million yuan) [2] - Innovent Biologics (9.53% holding, 10.9295 million shares, market value of 753 million yuan) [2] - Other notable holdings include 3SBio, Hansoh Pharmaceutical, and Kelun-Biotech [2].

Investment Rating - The report provides an "Outperform" rating for multiple companies in the healthcare sector, including BeiGene, JD Health, WuXi Biologics, and others, indicating a positive outlook for these stocks [1]. Core Insights - The macro and industry environment is improving due to the resolution of policy uncertainties, the release of significant clinical data, and a resurgence in global M&A activity, leading to a notable increase in investor sentiment towards innovative drugs for 2026 [4][11]. - In oncology, the PD-1/VEGF dual antibody approach is transitioning from "mechanism validation" to "clinical and industrial resonance," with multiple global Phase III trials underway, expected to catalyze approvals and data releases within the year [5][17]. - The metabolic sector is seeing growth in the cash-pay market for GLP-1 drugs, driven by limited insurance coverage and high out-of-pocket costs, prompting companies to enhance accessibility through direct sales and pricing adjustments [6][25]. - In the autoimmune space, there is a growing concentration risk among major products from multinational corporations (MNCs), with new antibody platforms expected to yield significant data in 2026, potentially leading to new business development opportunities [7]. - The central nervous system (CNS) investment focus remains on advancing Aβ monoclonal antibody treatments, with key data expected to open up early intervention market opportunities [9]. Summary by Sections Oncology - The PD-1/VEGF dual antibody's clinical and industrial certainty is strengthening, with major companies conducting multiple global Phase III trials across high-value indications [17]. - The Pan-RAS precision therapy is entering a realization phase, with key Phase III data expected in 2026 for pancreatic cancer and NSCLC [22]. Metabolic - The cash-pay market for GLP-1 drugs is expanding due to limited insurance coverage, with companies like Eli Lilly and Novo Nordisk adopting different direct-to-consumer strategies to enhance accessibility [25][26]. - Small nucleic acid therapies are expected to upgrade treatment paradigms, showing competitive data in weight loss and safety profiles when combined with GLP-1 [30]. Autoimmune - MNCs are increasingly reliant on a few blockbuster products, with structural opportunities arising from new antibody platforms expected to report data in 2026 [7]. - The trend towards oral formulations in autoimmune diseases is gaining traction, offering advantages in adherence and competitive differentiation [7]. CNS - The focus in CNS remains on Aβ monoclonal antibody treatments, with advancements expected to shift treatment towards earlier intervention populations [9]. - New delivery methods, such as systemic administration of small nucleic acids, are being explored as complementary approaches [9].

相关事件 格隆汇2月6日丨科伦博泰生物-B(06990.HK)发布公告，近日，公司靶向人滋养细胞表面抗原2(TROP2) 的抗体偶联药物(ADC)芦康沙妥珠单抗(sac-TMT，亦称SKB264/MK-2870)(佳泰莱®)的一项新增适应症 上市申请已获中国国家药品监督管理局(NMPA)批准，用于治疗既往接受过内分泌治疗且在晚期疾病阶 段接受过至少一线化疗的不可切除或转移性的激素受体阳性(HR+)且人类表皮生长因子受体2阴性 (HER2-)(免疫组织化学(IHC)0、IHC1+或IHC2+/原位杂交(ISH)-)乳腺癌(BC)成人患者。此次获批的至少 经一线化疗治疗HR+/HER2-BC是芦康沙妥珠单抗(sac-TMT)在中国上市的第四项适应症。 科伦博泰生物-B(06990.HK)：核心产品TROP2ADC芦康沙妥珠单抗(sac-TMT)获国家药监局批准第四项 适应症上市，用于治疗2L+HR+/HER2-乳腺癌 科伦博泰生物-B(06990.HK)与华润科伦续签2026年研发相 关物资框架协议 本次获批基于OptiTROP-Breast02 3期临床研究的积极结果，该研究已在2025年欧洲肿瘤内科学会 (E ...

OptiTROP-Breast02研究评估芦康沙妥珠单抗(sac-TMT)单药对比研究者选择化疗用于治疗不可切除或转 移性的HR+/HER2-BC患者的有效性和安全性。本项3期研究入组患者中，95.7%的患者入组时存在内脏 转移，75.9%的患者存在肝转移;52.9%的患者入组时HER2表达为0(IHC0)，47.1%的患者入组时HER2为 低表达(IHC1+或IHC2+/ISH-);所有患者既往接受过CDK4/6抑制剂和紫杉烷类药物治疗。在晚期或转移 性阶段，56.6%的患者既往接受过≥2线化疗方案治疗。结果显示，芦康沙妥珠单抗(sac-TMT)组盲态独 立评审委员会(BIRC)评估的无进展生存期(PFS)相较于化疗组显示出具有显著统计学意义和临床意义的 改善(8.3个月vs.4.1个月;风险比(HR)，0.35;95%置信区间(CI)：0.26-0.48;p<0.0001);在预先设定的各亚组 中均观察到一致的PFS获益，包括HER2表达为0及HER2低表达、晚期或转移性阶段接受化疗线数、基 线有无内脏转移、基线肝转移、既往CDK4/6抑制剂治疗时长。BIRC评估的PFS结果显示，HER2表达为 0和HE ...

目前，芦康沙妥珠单抗(sac-TMT)联合╱不联合帕博利珠单抗(可瑞达2)用于治疗既往接受过内分泌治疗 但未接受过化疗的HR+/HER2-BC患者的全球(NCT06312176)和中国(NCT07071337)的3期临床研究均已 启动。 本次获批基于OptiTROP-Breast023期临床研究的积极结果，该研究已在2025年欧洲肿瘤内科学会 (ESMO)大会入选最新突破性摘要(LBA)并以口头报告的形式发布。 科伦博泰生物-B(06990)发布公告，近日，本公司靶向人滋养细胞表面抗原2(TROP2)的抗体偶联药物 (ADC)芦康沙妥珠单抗(sac-TMT，亦称SKB264/MK-2870)(佳泰莱)的一项新增适应症上市申请已获中国 国家药品监督管理局(NMPA)批准，用于治疗既往接受过内分泌治疗且在晚期疾病阶段接受过至少一线 化疗的不可切除或转移性的激素受体阳性(HR+)且人类表皮生长因子受体2阴性(HER2-)(免疫组织化学 (IHC)0、IHC1+或IHC2+/原位杂交(ISH)-)乳腺癌(BC)成人患者。此次获批的至少经一线化疗治疗 HR+/HER2-BC是芦康沙妥珠单抗(sac-TMT)在中国上市的 ...

本次获批基于OptiTROP-Breast023期临床研究的积极结果，该研究已在2025年欧洲肿瘤内科学会 (ESMO)大会入选最新突破性摘要(LBA)并以口头报告的形式发布。 OptiTROP-Breast02研究评估芦康沙妥珠单抗(sac-TMT)单药对比研究者选择化疗用于治疗不可切除或转 移性的HR+/HER2-BC患者的有效性和安全性。本项3期研究入组患者中，95.7%的患者入组时存在内脏 转移，75.9%的患者存在肝转移;52.9%的患者入组时HER2表达为0(IHC0)，47.1%的患者入组时HER2为 低表达(IHC1+或IHC2+/ISH-);所有患者既往接受过CDK4/6抑制剂和紫杉烷类药物治疗。在晚期或转移 性阶段，56.6%的患者既往接受过≥2线化疗方案治疗。结果显示，芦康沙妥珠单抗(sac-TMT)组盲态独 立评审委员会(BIRC)评估的无进展生存期(PFS)相较于化疗组显示出具有显著统计学意义和临床意义的 改善(8.3个月vs.4.1个月;风险比(HR)，0.35;95%置信区间(CI)：0.26-0.48;p<0.0001);在预先设定的各亚组 中均观察到一致的PFS获益，包括HE ...

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四川科倫博泰生物醫藥股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 份 代 號：6990） 自願公告 核心產品TROP2 ADC蘆康沙妥珠單抗(sac-TMT) 獲 國 家 藥 品 監 督 管 理 局 批 准 第 四 項 適 應 症 上 市， 用於治療2L+ HR+/HER2-乳腺癌 四 川 科 倫 博 泰 生 物 醫 藥 股 份 有 限 公 司（「本公司」）董 事（「董 事」）董 事 會（「董 事 會」）欣 然 宣 佈，近 日，本 公 司 靶 向 人 滋 養 細 胞 表 面 抗 原2(TROP2)的抗體 偶聯藥物(ADC)蘆 康 沙 妥 珠 單 抗（sac-TMT，亦稱SKB264/MK-2870）（佳 泰 萊®） 的一項新增適應症上市申請 已獲中國國家藥品監督管理局(NMPA)批 准， 用於治療既往接受過內分泌治療且在晚期疾病階段接受過至少一線化療 的不可切除或轉移性的激素受體陽性(HR+)且人類表皮生長因子受體2陰 性（HER2-）（免 疫 組 織 化 ...

Group 1 - The Hong Kong stock market for innovative drug concept stocks has experienced a significant upward trend, with notable gains in several companies [1] - Nocare Pharma (09969.HK) has seen an increase of over 10%, while Genscript Biotech (01672.HK) has risen by more than 7% [1] - Other companies such as Kelun-Biotech (06990.HK), Sihuan Pharmaceutical (02096.HK), and WuXi AppTec (02359.HK) have also followed suit with upward movements in their stock prices [1]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2026年1月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 四川科倫博泰生物醫藥股份有限公司 (於中華人民共和國註冊成立的股份有限公司) 呈交日期: 2026年2月4日 | 2. 股份分類 | 普通股 | 股份類別 | 其他類別 (請註明) | | 於香港聯交所上市 (註1) | | 否 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | N/A | 說明 | 內資股 | | | | | | | | | 法定/註冊股份數目 | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 65,773,800 RMB | | | 1 RMB | | 65,773,800 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 65,773,800 RMB | | | 1 RMB | | 65,773,800 | | 3. 股份分類 | 普通股 ...

Group 1 - The core viewpoint is that innovative drugs are expected to show significant excess returns in 2025, driven by continuous BD overseas expansion, excellent clinical data, and policy support [1] - The CXO sector is anticipated to experience substantial growth due to the recovery in demand and improved investment environment in the global pharmaceutical industry [1] - The report emphasizes the importance of focusing on new technologies, particularly bispecific antibodies, small nucleic acid drugs, AI healthcare, and brain-computer interface innovations [3] Group 2 - Domestic supply and demand are relatively stable, with national health expenditure showing a year-on-year growth of 4.7% from January to November 2025, marking a positive turnaround after two years of decline [2] - The medical insurance fund's income and expenditure growth rates continue to decline, with total income of 2.63 trillion yuan (+2.9%) and expenditure of 2.11 trillion yuan (+0.5%) from January to November [2] - The report suggests that the commercialization of new drug forms is entering a critical phase, with significant clinical data supporting the application of B-cell depletion therapies in autoimmune diseases [3] Group 3 - Investment recommendations include focusing on innovative overseas expansion and new technology directions, with suggested stocks such as Mindray Medical, WuXi AppTec, and others [4] - The report highlights the potential for explosive growth in the global market for brain-computer interfaces, supported by policy incentives and technological breakthroughs [3]