Core Insights - The Hong Kong Innovative Drug ETF (159567) closed down 0.46% on October 20, with a trading volume of 907 million yuan [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of October 17, 2024, the fund's shares totaled 8.134 billion, with a total size of 6.968 billion yuan, reflecting a significant increase in both shares and size compared to the previous year [1] Fund Performance - The fund has seen a remarkable increase of 1957.27% in shares and 1744.35% in size since December 31, 2023 [1] - The fund's cumulative trading amount over the last 20 trading days reached 27.487 billion yuan, with an average daily trading amount of 1.374 billion yuan [1] - Year-to-date, the cumulative trading amount is 224.063 billion yuan, averaging 1.173 billion yuan per day over 191 trading days [1] Fund Management - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 71.34% during the management period [2] - The fund's top holdings include companies such as Innovent Biologics, WuXi Biologics, BeiGene, and others, with significant percentages of the portfolio allocated to these stocks [2]

Group 1: Top Net Buy Companies - The top net buy company is Pop Mart (9992.HK) with a net buy amount of 30.56 billion CNY and a change in holdings of 11,095,857 shares[8] - Xiaomi Group (1810.HK) follows with a net buy amount of 29.88 billion CNY and a change in holdings of 65,019,122 shares[8] - China Mobile (0941.HK) ranks third with a net buy amount of 23.84 billion CNY and a change in holdings of 27,952,291 shares[8] Group 2: Top Net Sell Companies - The top net sell company is SMIC (0981.HK) with a net sell amount of -63.04 billion CNY and a change in holdings of -91,228,489 shares[9] - Alibaba (9988.HK) follows with a net sell amount of -40.16 billion CNY and a change in holdings of -26,011,949 shares[9] - Tencent Holdings (0700.HK) ranks third with a net sell amount of -27.79 billion CNY and a change in holdings of -4,569,909 shares[9] Group 3: Industry Distribution - The report highlights significant net buying in the consumer discretionary sector, particularly in companies like Pop Mart and Meituan[11] - The technology sector shows notable net selling, with companies like SMIC and Tencent experiencing substantial outflows[11] - Financial services also see mixed activity, with both buying and selling observed in major banks like ICBC and CMB[11]

Investment Rating - The industry investment rating is "Outperform the Market" and is maintained [2][47]. Core Insights - The report highlights that the medical device procurement is gradually reflecting principles of "stabilizing clinical needs, ensuring quality, preventing collusion, and countering price wars" [6][30]. - The report suggests that the recent adjustments in procurement rules indicate a shift towards a more moderate approach, focusing on clinical needs and product quality rather than solely on low prices [6][30]. - The report emphasizes the potential for long-term development in the domestic medical device industry as procurement becomes more reasonable [6][30]. Summary by Sections Industry Overview - The closing index for the medical and biological sector is 8583.87, with a 52-week high of 9323.49 and a low of 6764.34 [2]. Market Performance - During the week of October 13-17, 2025, the A-share medical and biological sector fell by 2.48%, underperforming the CSI 300 index by 0.26 percentage points but outperforming the ChiNext index by 3.23 percentage points [7][36]. - The Hang Seng Healthcare Index decreased by 5.85%, underperforming the Hang Seng Index by 1.88 percentage points [7][36]. Industry Opinions and Investment Recommendations 1. **Innovative Drugs**: The innovative drug sector is experiencing adjustments, with a recommendation to maintain or increase positions based on long-term industry development logic. Key companies to watch include Innovent Biologics, 3SBio, and others [8][21]. 2. **Medical Devices**: The report notes that the National Medical Insurance Administration's recent procurement documents aim to optimize price differences and control "anchor points," indicating a move away from simply selecting the lowest bid [8][29]. 3. **Research Services**: The report expresses optimism about investment opportunities in the research services sector, particularly for companies with strong competitive advantages [26]. Sector Valuation - As of October 17, 2025, the overall valuation of the medical sector (TTM) is 30.03, a decrease of 0.84 from the previous week. The sector's valuation premium over the CSI 300 index is 123.96%, down by 4.90 percentage points [43].

Group 1 - The core viewpoint of the article highlights a significant increase in Hong Kong pharmaceutical stocks, with notable gains in specific companies [1] Group 2 - Yongtai Bio surged by 14.94% [1] - Rongchang Bio increased by 5.14% [1] - Other companies such as Kangfang Bio and WuXi AppTec also experienced upward movement [1]

Group 1 - The market sentiment regarding US credit risk has eased, and Trump's tariff exemptions on certain products have boosted market confidence, leading to a significant rise in Hong Kong stocks, with the Hang Seng Tech Index opening up by 3.9% [1] - The Hong Kong pharmaceutical sector has rebounded, with AI medical concepts remaining active. Leading stocks include MicroPort, Crystal International, and JD Health, while the Hong Kong Medical ETF focusing on AI medical + CXO gained nearly 2% [1] - The 2025 European Society for Medical Oncology (ESMO) annual meeting commenced on October 17, showcasing multiple Chinese innovative drug data, with clinical data in PD1-PLUS bispecific antibodies and ADCs reaching international leading levels, potentially boosting opportunities for innovative drugs to enter overseas markets [1] Group 2 - Guotai Junan Securities indicated that the recent intensive business development (BD) activities have alleviated market concerns, and the logic for Chinese innovative drugs to expand overseas remains unchanged, with expectations for continued active BD transactions as the year-end approaches [1]

Core Insights - 康方生物's HARMONi-6/AK112–306 study results were prominently presented at the ESMO 2025 and published in The Lancet, demonstrating the efficacy of Ivoris combined with chemotherapy compared to Tarelizumab combined with chemotherapy for advanced sq-NSCLC [1][2] Study Overview - HARMONi-6/AK112–306 is a randomized, controlled, multi-center Phase III clinical trial assessing Ivoris combined with chemotherapy versus Tarelizumab combined with chemotherapy as first-line treatment for advanced sq-NSCLC, with the primary endpoint being progression-free survival (PFS) evaluated by IRRC based on RECIST v1.1 [1][3] - The study enrolled 532 participants, with a balanced baseline, and 92.3% of subjects being in stage IV; the characteristics of squamous cell carcinoma were consistent with real-world patient distribution, with approximately 63% being central squamous cell carcinoma [1][3] Efficacy Results - The study achieved a significant positive result for the primary endpoint of PFS, with Ivoris showing a marked improvement over the control group, resulting in a PFS hazard ratio (HR) of 0.60 (p<0.0001) [1][2] - The median PFS for the Ivoris group was 11.14 months compared to 6.9 months for the control group, indicating an absolute improvement of 4.24 months in PFS [1][2] Subgroup Analysis - In the PD-L1 negative population (TPS ≤ 1%), the median PFS was 9.9 months versus 5.7 months, with a PFS HR of 0.55 [2] - In the PD-L1 positive population (TPS ≥ 1%), the median PFS was 12.6 months versus 8.6 months, with a PFS HR of 0.66 [2] - The PFS HR for patients with liver metastases was 0.53, while for those without liver metastases, it was 0.64; for patients with three or more baseline metastatic sites, the PFS HR was 0.46 [2] Safety Profile - The overall safety profile of the Ivoris group was favorable, with no new safety signals identified; the incidence of treatment-related serious adverse events and grade 3 or higher bleeding events was similar to the control group [2] Regulatory Status - The new indication application for Ivoris combined with chemotherapy for first-line treatment of sq-NSCLC has been accepted by the CDE and is currently under review, potentially offering hope to more patients [2]

Core Insights - The clinical trial results of HARMONi-6 / AK112-306 were prominently presented by Professor Lu Shun at the ESMO 2025 and published in The Lancet, demonstrating the efficacy of Ivosidenib combined with chemotherapy for advanced sq-NSCLC [1][2] Group 1: Clinical Trial Overview - HARMONi-6 / AK112-306 is a randomized, controlled, multi-center Phase III clinical trial assessing Ivosidenib combined with chemotherapy versus Toripalimab combined with chemotherapy as first-line treatment for advanced sq-NSCLC [1][2] - The study enrolled 532 participants, with 92.3% of subjects in clinical stage IV, and the characteristics of squamous cell carcinoma were consistent with real-world patient distribution [1][2] Group 2: Key Findings - Ivosidenib combined with chemotherapy achieved a significant improvement in progression-free survival (PFS) compared to Toripalimab, with a hazard ratio (HR) of 0.60 and a p-value of <0.0001 [1] - The median PFS for the Ivosidenib group was 11.14 months, while the control group had a median PFS of 6.9 months, resulting in an absolute improvement of 4.24 months [1] Group 3: Subgroup Analysis - Significant benefits of Ivosidenib were observed across various subgroups, including those with different PD-L1 expression levels and liver metastasis status [1] - In the PD-L1 negative population, the median PFS was 9.9 months versus 5.7 months (HR = 0.55) [1] - In the PD-L1 positive population, the median PFS was 12.6 months versus 8.6 months (HR = 0.66) [1] Group 4: Safety Profile - The overall safety profile of the Ivosidenib group was favorable, with no new safety signals identified, and the incidence of treatment-related serious adverse events was similar to the control group [1]

Core Viewpoint - Kangfang Biopharma (09926.HK) announced significant results from the HARMONi-6/AK112–306 study, which were presented by Professor Lu Shun at the ESMO 2025 and published in The Lancet, indicating a strong clinical benefit of Ivoris combined with chemotherapy over Tarelizumab combined with chemotherapy for advanced sq-NSCLC [1] Group 1: Study Overview - HARMONi-6/AK112–306 is a randomized, controlled, multi-center Phase III clinical trial assessing Ivoris combined with chemotherapy versus Tarelizumab combined with chemotherapy as first-line treatment for advanced sq-NSCLC [1] - The primary endpoint of the study is progression-free survival (PFS) evaluated by IRRC based on RECIST v1.1, with key secondary endpoints including overall survival (OS) [1] - A total of 532 subjects were enrolled in the HARMONi-6 study, with baseline characteristics balanced between the two groups, and 92.3% of subjects being classified as stage IV [1] Group 2: Study Results - The trial results demonstrated that Ivoris combined with chemotherapy achieved the primary endpoint of PFS, showing a decisive positive outcome with significant statistical and clinical benefits [1] - The Ivoris group significantly extended patient PFS compared to the control group, aligning with real-world patient distribution, where approximately 63% of cases were central squamous cell carcinoma [1]

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 之 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，概不就因本公告全部 或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 Akeso, Inc. 康 方 生 物 科 技（ 開 曼 ）有 限 公 司 （於 開 曼 群 島 註 冊 成 立 的 有 限 公 司） 康方生物科技（ 開曼 ）有限公司（「本公司」，連同其附屬公司統稱「本集團」）自願刊 發，以告知本公司股東及潛在投資者有關本集團最新業務發展的資料。 本公 司董事會（「董事會」）欣然 宣布，HARMONi-6 / AK112 – 306 的研 究結果 由主要 研究、上海市胸科醫院腫瘤科主任陸舜教授在2025歐洲腫瘤內科學會(ESMO)的主 席論壇上重磅發布，並在國際頂級醫學期刊《柳葉刀》（ THE LANCET ）主刊同步發 表。 HARMONi-6 / AK112 – 306（ CTR20231272 / NCT 05840016 ）是一項評估依沃西聯合化療 對比替雷利珠聯合化療一線治療晚期sq-NSCL ...

- The report focuses on Hong Kong pharmaceutical indices and ETFs, highlighting the significant tracking scale of indices such as Guozheng Hong Kong Stock Connect Innovative Drugs and Hong Kong Innovative Drugs, with tracking ETF scales of 341.3 billion yuan and 226.4 billion yuan respectively [1][6][7] - Since August 2025, Guozheng Hong Kong Stock Connect Innovative Drugs and Hong Kong Innovative Drugs indices have seen net inflows of 145.1 billion yuan and 81.5 billion yuan respectively, ranking among the top two in terms of net inflows [7][10] - Seven indices focus on the innovative drug sector, with one compiled by Guozheng Index, two by China Securities Index, and four by Hang Seng Index. Indices compiled by the same company show similar compilation schemes and performance, while differences exist between companies. Year-to-date (YTD) returns show China Securities > Guozheng ≈ Hang Seng [7][12] - The industry distribution of indices varies: Guozheng and Hang Seng indices have a higher proportion of pharmaceutical industry, while China Securities indices have a higher proportion of biotechnology and life sciences tools and services [7][13] - Guozheng Hong Kong Stock Connect Innovative Drugs index experienced short-term deviation in September due to individual constituent stock adjustments during the sample adjustment period, but the deviation was corrected within two trading days, and the subsequent operation returned to normal [7][14]