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 ...

Investment Rating - The investment rating for the pharmaceutical industry is "Positive" (maintained) [3] Core Viewpoints - The report emphasizes that the fourth quarter is expected to see a rebound in innovative drugs, driven by a concentration of business development (BD) activities and upcoming events such as the ESMO conference and medical insurance negotiations [4][16] - The Chinese pharmaceutical industry has completed a transition from old to new growth drivers, with innovative drugs significantly opening new growth avenues for Chinese pharmaceutical companies [16][35] - The report suggests that the demand for healthcare will continue to rise due to an aging population, and the payment side is also expected to grow steadily, supported by the development of a multi-tiered payment system [35] Summary by Sections 1. BD + ESMO - The number of license-out transactions in China has been increasing, with 135 transactions occurring from January 1, 2025, to October 17, 2025, totaling $10.2996 billion [8][9] - The report highlights that the international pharmaceutical industry recognizes the value of Chinese innovative drug assets, which are characterized by high quality and low cost [8][9] - The ESMO conference will showcase 23 studies led by Chinese scholars, indicating a significant increase in international recognition of Chinese innovation [12][13] 2. Industry Perspective - The report maintains that innovative drugs will remain the main focus for the year, with attention on manufacturing, overseas expansion, and aging-related consumption [16][35] - The pharmaceutical index has shown a decline of 2.48% in the past week, but an increase of 18.85% year-to-date, indicating a mixed performance [16] - The report lists several companies to watch, including innovative drug manufacturers and those involved in the supply chain [38]

Market Overview - The Hang Seng Index fell by 1.61%, down 415 points, closing at 25,472 points, while the Hang Seng Tech Index dropped by 2.81%. The early trading volume in the Hong Kong market was HKD 153.2 billion [1] Energy Sector - Gas stocks rose, with Zhongyu Energy (03633) increasing by over 10%. This surge is attributed to the early initiation of winter heating in Gansu and other regions due to continuous temperature drops, leading to increased natural gas demand [1] Biotechnology Sector - Newly listed stock Xuan Zhu Bio-B (02575) surged over 13%, reaching a new high, and is up more than 190% from its IPO price. Yimai Sunshine (02522) rose over 4% following the global launch of its medical imaging model product AIR. The performance of medical stocks varied, with Yaojie Ankang-B (02617.HK) up over 21%, Baize Medical (02609) up over 5%, while Kangfang Biotech (09926) fell by 2%. Kangning Jereh Pharma-B (09966) increased by over 13% after announcing a share buyback plan, with market attention on significant data from the ESMO conference [2] Precious Metals Sector - Laopu Gold (06181) rose over 4%, benefiting from increased channel expansion and upgrades, with institutions indicating that rising gold prices favor its high-end brand positioning [3] Hospitality Sector - Wanda Hotel Development (00169) increased by over 10% after completing a sale and announcing a special dividend of HKD 0.462 per share to be paid next month [4] Digital Assets Sector - Delin Holdings (01709) rose over 3% after entering a strategic cooperation agreement with Antalpha to promote business in the digital asset sector [5] Telecommunications Sector - Changfei Optical Fiber and Cable (06869) fell over 6%, having dropped 40% from its September peak due to declining fiber optic prices and shareholder sell-offs. Cryptocurrency-related stocks collectively declined, with Bitcoin experiencing significant volatility and a recent incident in the US stablecoin market. Mi Strategy (02440) fell by 4.36%, and OSL Group (00863) dropped by 3.99% [6] Semiconductor Sector - Chip stocks continued to decline, with SMIC (00981) down over 5% and Huahong (01347) down over 3%, as US export controls accelerate domestic semiconductor replacements [6]

| 公司名称 | 成交金额 | 净买入额 | | --- | --- | --- | | 阿里巴巴-W(09988) | 48.16 亿元 | +5.75 亿元 | | 小米集团-W(01810) | 39.95 亿元 | +10.20 亿元 | | 中芯国际(00981) | 35.00 亿元 | +5390.90 万元 | | 腾讯控股(00700) | 30.20 亿元 | -2.35 亿元 | | 华虹半导体(01347) | 21.48 亿元 | -1195.71 万元 | | 泡泡玛特(09992) | 20.81 亿元 | +2.85 亿元 | | 紫金黄金国际(02259) | 19.49 亿元 | +17.38 亿元 | | 中兴通讯(00763) | 16.86 亿元 | +1.56 亿元 | | 药捷安康-B(02617) | 16.79 亿元 | +3899.32 万元 | | 巨子生物(02367) | 16.39 亿元 | +4.24 亿元 | 深港通（南向）十大活跃成交公司 | 公司名称 | 成交金额 | 净买入额 | | --- | --- | --- | | 小米集团-W(0 ...

Core Insights - The Hong Kong Innovative Drug ETF (159567) closed with a gain of 2.42% on October 16, with a trading volume of 1.486 billion 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 15, 2024, the fund's shares reached 8.213 billion, with a total size of 7.102 billion yuan, reflecting a significant increase of 1977.25% in shares and 1779.88% in size compared to December 31, 2023 [1] Fund Performance - The current fund manager, Ma Jun, has achieved a return of 68.94% since taking over the fund on January 3, 2024 [2] - The ETF'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] Trading Activity - Over the last 20 trading days, the ETF recorded a cumulative trading amount of 30.962 billion yuan, averaging 1.548 billion yuan per day [1] - Since the beginning of the year, the ETF has seen a total trading amount of 222.219 billion yuan over 189 trading days, averaging 1.176 billion yuan per day [1]

Core Insights - The Hong Kong stock market saw a net inflow of 15.822 billion HKD from northbound trading on October 16, with the Shanghai-Hong Kong Stock Connect contributing 8.672 billion HKD and the Shenzhen-Hong Kong Stock Connect contributing 7.15 billion HKD [1] Group 1: Stock Performance - The most net bought stocks included Zijin Mining International (02259), Xiaomi Group-W (01810), and Alibaba-W (09988) [1] - The most net sold stocks included SMIC (00981), GigaDevice Semiconductor (02367), and Tencent (00700) [1] Group 2: Detailed Stock Transactions - Alibaba-W had a net inflow of 2.696 billion HKD, with total transactions amounting to 4.816 billion HKD [2] - Xiaomi Group-W recorded a net inflow of 2.508 billion HKD, with total transactions of 3.995 billion HKD [2] - SMIC had a net outflow of 539.09 million HKD, with total transactions of 3.5 billion HKD [2] - Tencent experienced a net outflow of 235 million HKD, with total transactions of 3.02 billion HKD [2] - Zijin Mining International received a net inflow of 1.738 billion HKD, following its inclusion in the Stock Connect list [4] Group 3: Company-Specific News - Zijin Mining International is expected to achieve a compound annual growth rate of approximately 20% in production from 2025 to 2027, increasing total output from 45 tons to 65 tons, leading to a 30% compound annual growth rate in profits [4] - Xiaomi Group's stock price has been volatile due to various news events, with expectations of a decline in gross profit margin in the second half of the year [5] - Alibaba's stock received a boost from the launch of the Tmall Double 11 shopping festival and an upgrade in capital expenditure forecasts by Goldman Sachs [5] - Kangfang Biopharma (09926) received a net inflow of 6.02 billion HKD following the acceptance of its clinical research results for a new drug in a top medical journal [6] - Pop Mart (09992) saw a net inflow of 4.7 billion HKD, with expectations of strong sales growth from new IPs [7]

Group 1 - The innovative drug sector is leading the market, with Kangfang Biotech and 3SBio both rising over 8%, contributing to a 3.5% increase in the Hang Seng Innovative Drug ETF (159316) [1] - The Hang Seng Innovative Drug ETF has attracted a total of 849 million in capital over the past 20 days, bringing its latest scale to 2.961 billion [1] - The ETF is the only one tracking the Hang Seng Hong Kong Stock Connect Innovative Drug Index, which has recently been updated to exclude CXO, achieving a "100% purity" in innovative drug representation [1] Group 2 - The innovative drug sector is experiencing a significant upward trend, with attention on domestic innovative drug companies participating in the upcoming ESMO conference in Berlin from October 17 to 21, 2025 [1] - Companies to watch include Kangfang Biotech, Kelun-Biotech, Hengrui Medicine, Rongchang Biotech, Junshi Biosciences, and Jinfang Medicine, particularly for new data releases in dual antibodies and ADC technologies [1] - Huafu Securities expresses optimism about the innovative drug industry, predicting a transformative growth over the next 5-10 years driven by overseas business development, continuous data catalysts, and new product sales expansion [1]