Company Dynamics - On October 19, the company presented impressive interim analysis data from the HARMONi-6 trial at The Lancet & ESMO [1] - The company revised the HARMONi-3 trial protocol to conduct independent statistical analyses based on histological types [2] Clinical Trial Results - The interim analysis of HARMONi-6 showed a median progression-free survival (mPFS) of 11.1 months compared to 6.9 months, with a hazard ratio (HR) of 0.60 (P<0.0001), indicating a significant improvement [1] - The absolute difference in mPFS between the two groups was 4.24 months, with consistent results across subgroups regardless of PD-L1 expression or liver metastasis [1] - Treatment-related serious adverse events (SAE) were reported at 32.3% for the experimental group versus 30.2% for the control group, with no overall survival (OS) data available yet [1] HARMONi-3 Trial Updates - The HARMONi-3 trial will be divided into two parts: sq-NSCLC (600 patients) and nsq-NSCLC (1000 patients), with separate statistical analyses planned [2] - Enrollment for sq-NSCLC is expected to complete in the first half of 2026, with OS analysis anticipated around the same time [2] - The nsq-NSCLC group aims to complete enrollment in the second half of 2026, with PFS event numbers expected in the first half of 2027 [2] Expansion of Clinical Indications - The company plans to initiate a global multi-regional clinical trial (HARMONi-GI3) for AK112 in colorectal cancer, based on promising II phase data [2] - The trial will compare AK112 combined with chemotherapy against bevacizumab combined with chemotherapy, with an enrollment target of 600 patients [2] Earnings Forecast and Valuation - The company maintains its earnings per share (EPS) forecasts for 2025 and 2026 at 0.09 CNY and 0.59 CNY, respectively [2] - The target price has been adjusted down by 18.2% to 184.00 HKD, reflecting a 50.1% upside potential [3]

来源：新浪基金 10月21日，港股通创新药板块震荡回暖，100%创新药研发标的——港股通创新药ETF（520880）午后 稳定涨势，场内收涨1.21%终结两连跌。成份股荣昌生物、云顶新耀涨超4%，权重股石药集团、翰森制 药跌1%有所拖累。 【创新药"新势力"——港股通创新药ETF（520880）：纯正创新药，聚焦真龙头，港股高弹性】 港股通创新药ETF（520880）被动跟踪恒生港股通创新药精选指数，该指数完全不含CXO，100%布局 创新药研发类公司，超7成仓位押注大市值创新药龙头，是精准表征创新药硬核力量的纯正创新药指 数。场外投资者可关注其联接基金：025221。 | | | 港股通创新药ETF (520880)标的指数 前十成份股权重高达71.63%,龙头优势显著 | | | --- | --- | --- | --- | | 代码 | 简称 | 权重(%) | 总市值(亿港元) | | 6160.HK | 三济神州 | 10.47 | 3.304 | | 1177.HK | 中国生物制药 | 10.01 | 1,527 | | 1093.HK | 石药集团 | 9.58 | 1,080 | | 18 ...

Market Performance - The Hang Seng Index (HSI) closed at 25,859, up 2.4% for the day and 28.9% year-to-date[2] - The KOSPI index showed significant growth, closing at 3,815, with a 1.8% increase for the day and a remarkable 59.0% year-to-date[2] - The MSCI China index increased by 2.3% for the day and 33.2% year-to-date, indicating strong market performance[2] Commodity Prices - Gold prices rose to $4,356 per ounce, reflecting a 2.5% increase for the day and a substantial 66.0% increase year-to-date[3] - Brent Crude oil prices decreased to $61 per barrel, down 0.6% for the day and down 15.1% year-to-date[3] - The Baltic Dry Index (BDI) surged to 2,046, showing a remarkable 105.2% increase year-to-date[3] Economic Indicators - China's GDP growth moderated to 4.8% year-on-year in Q3 2025, down from 5.2% in Q2 2025, with a required growth of 4.2-4.5% in Q4 to meet the annual target of 4.9-5%[6][7] - Retail sales growth in China slowed to 3.0% year-on-year in September, the lowest since November 2024, down from 3.4% in August[14] - The US Initial Jobless Claims for the week ending October 23 are expected to be 226,000, slightly higher than the consensus of 218,000[4] Corporate Updates - China Mobile reported a 1.4% year-on-year increase in Q3 earnings to RMB 31.1 billion, with service revenue rising by 0.8% to RMB 216.2 billion[10][11] - Akeso Inc. presented positive Phase III study results for its drug AK112, showing a progression-free survival hazard ratio of 0.60 in the treatment of sqNSCLC[26][29]

Core Viewpoint - Kangfang Biopharma's drug Iwosimab (PD-1/VEGF dual antibody) has shown significant improvement in progression-free survival (PFS) compared to Tislelizumab in a Phase III clinical trial for advanced squamous non-small cell lung cancer (sq-NSCLC) [1][2] Group 1: Clinical Trial Results - The HARMONi-6 study demonstrated that Iwosimab combined with chemotherapy significantly extends PFS, achieving a median PFS of 11.14 months compared to 6.90 months for Tislelizumab, with a hazard ratio of 0.60 (P<0.0001), resulting in an absolute difference of 4.24 months [1] - The new indication application for Iwosimab in treating sq-NSCLC based on the HARMONi-6 study results has been accepted for review by the National Medical Products Administration (NMPA) [1] Group 2: Drug Approvals and Pipeline - Iwosimab has been included in the national medical insurance drug list, with 13 Phase III clinical trials currently in progress, covering various cancers including lung cancer and cholangiocarcinoma [2] - Iwosimab has received approval for two indications in China, with the first being for EGFR-mutant locally advanced or metastatic non-squamous NSCLC after EGFR-TKI treatment, and the second for PD-L1 positive locally advanced or metastatic NSCLC [2] Group 3: Other Drug Developments - Cardunili has received approval for a new indication in first-line treatment of cervical cancer, with approximately 10 Phase III or registration clinical trials actively advancing [3] - Cardunili is pursuing around 20 indications through combination therapies, with three indications currently approved in China [3]

Core Viewpoint - Kangfang Biopharma (09926) announced that its drug Iwosimab (PD-1/VEGF dual antibody) combined with chemotherapy achieved the primary endpoint of progression-free survival (PFS) in a Phase III clinical study for advanced squamous non-small cell lung cancer (sq-NSCLC), outperforming the comparator drug Tislelizumab combined with chemotherapy [1] Group 1: Clinical Research and Results - The HARMONi-6 study demonstrated that Iwosimab combined with chemotherapy significantly extended PFS compared to Tislelizumab combined with chemotherapy, with a median PFS of 11.14 months for Iwosimab versus 6.90 months for Tislelizumab (HR=0.60, P<0.0001), resulting in an absolute difference of 4.24 months [1] - Based on the positive results from the HARMONi-6 study, the supplemental new drug application (sNDA) for Iwosimab combined with chemotherapy for sq-NSCLC was accepted by the National Medical Products Administration (NMPA) in July 2025 and is currently under review [1] Group 2: Drug Approvals and Pipeline - Iwosimab has been included in the National Medical Insurance Drug List, with 13 Phase III clinical studies ongoing, covering various cancers including lung cancer, cholangiocarcinoma, and head and neck squamous cell carcinoma [2] - Iwosimab has received approval for two indications in China, with the first being for locally advanced or metastatic non-squamous NSCLC after progression on EGFR-TKI therapy, which has been successfully included in insurance; the second indication for PD-L1 positive locally advanced or metastatic NSCLC is expected to receive NMPA approval in April 2025 [2] - The drug Kadunili has also received approval for a new indication in first-line treatment of cervical cancer, with approximately 10 Phase III or registration clinical trials actively progressing [2]

Core Viewpoint - The A-share and Hong Kong stock markets have experienced significant gains, with the Hong Kong Stock Connect Innovative Drug ETF (159570) seeing a nearly 2% increase and a trading volume approaching 2 billion yuan, indicating strong investor interest and liquidity in the innovative drug sector [1][3]. Group 1: Market Performance - The Hong Kong Stock Connect Innovative Drug ETF (159570) has a current scale exceeding 21 billion yuan, leading its peers in both scale and liquidity [1]. - As of October 20, the ETF has seen a net inflow of over 1.7 billion yuan in the past 20 days [1]. - Major stocks within the ETF, such as Innovent Biologics, CanSino Biologics, and 3SBio, have shown positive performance, with increases exceeding 2% [3]. Group 2: Business Development (BD) Trends - The innovative drug sector continues to thrive, with five business development (BD) deals totaling $4.266 billion reported over two days [3]. - Notable transactions include Hansoh Pharmaceutical with a total deal amount of $1.53 billion and Prigen with $1.64 billion [3]. - The total number of license-out transactions in China from January 1 to October 17, 2025, reached 135, with upfront payments totaling $4.976 billion and total deal amounts reaching $102.996 billion, reflecting strong international interest in Chinese innovative drug assets [5]. Group 3: Upcoming Catalysts - The fourth quarter is expected to see an acceleration in BD activities, with a focus on data from the ESMO conference [5]. - Chinese scholars are leading 23 LBA studies at the 2025 ESMO, showcasing various innovative drugs and highlighting China's growing influence in the global pharmaceutical landscape [7]. - The anticipated release of clinical data from the ESMO conference may lead to a revaluation of Chinese innovative drug pipelines and their corresponding stocks [7]. Group 4: Global Pricing Dynamics - Recent agreements between Pfizer and AstraZeneca with the U.S. government on Most Favored Nation (MFN) pricing have exceeded expectations, potentially impacting global sales forecasts for innovative drugs [8][9]. - Pfizer's agreements cover aspects such as pricing for existing and new drugs, direct sales, and tariff exemptions, which could enhance the market potential for innovative drugs [9][10]. - If MFN pricing trends continue, the peak global sales forecast for innovative drugs, including those licensed out from China, may significantly increase [10].

Group 1 - The innovative drug sector experienced a rise, with notable increases in companies such as Zai Lab (up 3.8%), Sihuan Pharmaceutical, and 3SBio (both up over 3%), contributing to a 1.58% increase in the Hang Seng Innovative Drug ETF (159316) [1] - The ESMO conference is scheduled for October 17-21, 2025, where several Chinese innovative drug companies are expected to present positive data on core projects [1] - Hengrui Medicine has 46 studies included in the conference, covering various cancers and other diseases, with significant presentations across multiple formats [1] - CanSino Biologics reported that its Ivosidenib combined with chemotherapy showed a significant progression-free survival (PFS) advantage in treating sqNSCLC compared to SoCPD-1, reinforcing confidence in its efficacy [1] - BeiGene's RATIONALE-312 study demonstrated significant and durable overall survival (OS) improvements in a three-year follow-up without new safety signals [1] - The innovative drug sector has seen strong interest this year, with a net inflow of 984 million yuan into the Hang Seng Innovative Drug ETF over the past 20 days, reaching a record fund size of 3.359 billion yuan [1] Group 2 - The Hang Seng Innovative Drug ETF is the only ETF tracking the Hang Seng Hong Kong Stock Connect Innovative Drug Index, characterized by high elasticity and scarcity [2] - Industrial outlook for the innovative drug sector remains positive, with sustained policy support and increasing global competitiveness for Chinese innovative drugs, leading to continued commercialization and profitability [2]

Core Viewpoint - The report from CMB International maintains a target price of HKD 183 for Kangfang Biopharma (09926) and expresses a long-term bullish outlook with a "Buy" recommendation, highlighting the company's overseas development progress and upcoming catalysts in the next 1-2 years [1] Group 1: Company Performance - Kangfang Biopharma's overseas development is gaining momentum, with significant catalysts expected in the near future [1] - The report notes that Summit Therapeutics has recently announced an expansion of the overseas research scale for Ivosidenib [1] Group 2: Clinical Data - Ivosidenib's second head-to-head Phase III study has yielded strong positive data, showing that the median progression-free survival (PFS) is significantly better than other PD-1 monotherapy drugs [1] - The absolute improvement in PFS for Ivosidenib compared to PD-1 exceeds the improvement seen with traditional chemotherapy [1] Group 3: Sales Expectations - The report maintains an expectation of peak sales in mainland China at RMB 7.1 billion [1]

Core Viewpoint - The report from CMB International maintains a target price of HKD 183 for Kangfang Biotech (09926) and continues to recommend a "Buy" rating, expressing long-term confidence in the company due to its overseas development progress and upcoming catalysts in the next 1-2 years [1] Group 1 - The company is experiencing significant advancements in its overseas development, with a focus on expanding research efforts [1] - Summit Therapeutics has recently announced an expansion of the overseas research scale for Ivosidenib [1] - Ivosidenib's second head-to-head Phase III study has yielded strong positive data, showing a median progression-free survival (PFS) that significantly outperforms other PD-1 monotherapy drugs [1] Group 2 - The absolute improvement in PFS for Ivosidenib compared to PD-1 has exceeded the improvement seen with traditional chemotherapy [1] - The report maintains an expectation of peak sales in mainland China at RMB 7.1 billion [1]

Group 1 - The core viewpoint indicates that the innovative drug sector in Hong Kong is showing clear signs of bottoming out, supported by several factors [1] - BD (Business Development) transactions have started to recover since October, with historical data showing that transactions from October to January account for over 50% of the annual total, and transaction amounts can reach 60% to 70% of the yearly total [1] - Positive data from ESMO (European Society for Medical Oncology) has emerged, with several important clinical studies, such as AK112 and 3SB707, showing promising results, which is expected to catalyze further trading and stock price increases [1] - The valuation of innovative drugs has reached an absolute bottom, with some companies having little room for further decline [1] Group 2 - As of October 21, 2025, the National Securities Hong Kong Stock Connect Innovative Drug Index (987018) shows mixed performance among its constituent stocks, with notable gainers including CloudTop New Drug (01952) up 5.29% and Zai Lab (09688) up 1.80%, while major decliners include Juno Therapeutics-B (02617) down 6.82% [2] - The Hong Kong Innovative Drug ETF (159286) closely tracks the National Securities Hong Kong Stock Connect Innovative Drug Index and has seen a slight increase of 0.22%, with the latest price at 0.93 yuan [2] - As of September 30, 2025, the top ten weighted stocks in the National Securities Hong Kong Stock Connect Innovative Drug Index account for 71.83% of the index, including companies like BeiGene (06160) and Innovent Biologics (09926) [2]