Group 1 - The core point of the article is that Kangfang Biopharma has received Orphan Drug Designation from the FDA for its new generation anti-CD47 humanized IgG4 monoclonal antibody, Lefalimab (AK117), for the treatment of acute myeloid leukemia (AML) [1] Group 2 - The Orphan Drug Designation is significant as it provides certain benefits, including tax credits for clinical trial costs and market exclusivity for seven years upon approval [1] - The designation highlights the potential of Lefalimab in addressing unmet medical needs in the treatment of AML, a condition with limited effective therapies [1] - This development may enhance Kangfang Biopharma's position in the oncology market and attract potential investors interested in innovative cancer therapies [1]

Core Insights - The article highlights the changes in the Hong Kong Stock Connect holdings, with notable increases and decreases in ownership percentages for various companies [1][2]. Group 1: Increased Holdings - Heng Rui Medicine (01276) saw the largest increase in ownership percentage, rising by 1.49% to a total of 13.84% [2]. - Kanglong Chemical (03759) experienced a 1.35% increase, bringing its ownership to 60.51% [2]. - Zhaoyan New Drug (06127) increased by 1.27%, reaching a holding of 43.70% [2]. - Other companies with significant increases include Junshi Biosciences (01877) at +1.24% (59.08%) and China Pacific Insurance (02601) at +1.20% (44.16%) [2]. Group 2: Decreased Holdings - Shandong Molong (00568) had the largest decrease, with a drop of 1.99% to 57.67% [2]. - Yisou Technology (02550) decreased by 0.99%, now holding 37.95% [2]. - Nanjing Panda Electronics (00553) saw a reduction of 0.98%, bringing its ownership to 42.65% [2]. - Other notable decreases include Kailai Ying (06821) at -0.95% (43.35%) and Meizhong Jiahe (02453) at -0.95% (32.06%) [2]. Group 3: Five-Day Changes - In the last five trading days, China Merchants Energy (01138) had the highest increase in ownership, up by 6.19% to 65.63% [3]. - Shandong Molong (00568) also saw a significant increase of 3.74% [3]. - Other companies with notable increases include Zhongchu Innovation (03931) at +3.62% (10.35%) and Youbao Online (02429) at +3.33% (17.38%) [3]. Group 4: Twenty-Day Changes - Over the past twenty days, Anjiren Food (02648) experienced the largest increase, up by 12.29% to 20.54% [4]. - China Merchants Energy (01138) also saw a significant increase of 9.07% [4]. - Other companies with notable increases include Yimai Sunshine (02522) at +7.70% (43.02%) and Lens Technology (06613) at +7.56% (13.64%) [4].

Core Viewpoint - On September 15, the Hang Seng Index rose by 0.22%, closing at 26,446.56 points, with a net inflow of 14.473 billion HKD through the southbound trading channel [1] Group 1: Market Activity - The total trading amount for the southbound trading on September 15 was 156.251 billion HKD, with a net buying amount of 14.473 billion HKD [1] - The Shanghai Stock Exchange's southbound trading accounted for 95.161 billion HKD, with a net buying of 6.968 billion HKD, while the Shenzhen Stock Exchange's southbound trading amounted to 61.089 billion HKD, with a net buying of 7.505 billion HKD [1] Group 2: Active Stocks - Alibaba-W was the most actively traded stock on the Shanghai Stock Exchange southbound trading, with a trading amount of 7.960 billion HKD and a net buying of 2.890 billion HKD, closing with a price increase of 2.32% [2] - In the Shenzhen Stock Exchange southbound trading, Alibaba-W also led with a trading amount of 5.047 billion HKD and a net buying of 2.395 billion HKD, maintaining the same closing price increase of 2.32% [2] - The stock with the highest net selling was Xiaomi Group-W, with a net selling amount of 724 million HKD, while its closing price increased by 1.90% [1][2]

Core Insights - On September 15, 2025, Alibaba-W (09988), Pop Mart (09992), and Yaojie Ankang-B (02617) were the top three stocks by trading volume in the Southbound Stock Connect, with trading amounts of 79.60 billion, 29.45 billion, and 26.94 billion respectively [1] - In the Shenzhen-Hong Kong Stock Connect, Alibaba-W (09988), Xiaomi Group-W (01810), and Tencent Holdings (00700) led the trading volume, with amounts of 50.47 billion, 25.76 billion, and 18.75 billion respectively [1] Southbound Stock Connect - Top Active Companies - Alibaba-W (09988) had a trading amount of 79.60 billion with a net buying amount of +28.90 billion [2] - Pop Mart (09992) recorded a trading amount of 29.45 billion with a net selling amount of -3.25 billion [2] - Yaojie Ankang-B (02617) had a trading amount of 26.94 billion with a net selling amount of -1.39 billion [2] - Other notable companies included Brainstorm Aurora-B (06681) with a trading amount of 26.34 billion and a net buying amount of +2.66 billion [2] - Tencent Holdings (00700) had a trading amount of 23.45 billion with a net selling amount of -2.21 billion [2] Shenzhen-Hong Kong Stock Connect - Top Active Companies - Alibaba-W (09988) led with a trading amount of 50.47 billion and a net buying amount of +23.95 billion [2] - Xiaomi Group-W (01810) had a trading amount of 25.76 billion with a net buying amount of +457.14 million [2] - Tencent Holdings (00700) recorded a trading amount of 18.75 billion with a net buying amount of +26.27 million [2] - Pop Mart (09992) had a trading amount of 18.72 billion with a net selling amount of -1.27 billion [2] - Other significant companies included Meituan-W (03690) with a trading amount of 15.29 billion and a net buying amount of +3.88 billion [2]

Core Insights - The top three companies by Hong Kong Stock Connect holding ratios are China Telecom (00728) at 72.04%, Green Power Environmental (01330) at 69.16%, and China Shenhua (01088) at 67.97% [1] - Alibaba-W (09988), Horizon Robotics-W (09660), and Ping An of China (02318) saw the largest increases in holding amounts over the last five trading days, with increases of +14.898 billion, +1.834 billion, and +1.420 billion respectively [1] - The companies with the largest decreases in holding amounts over the last five trading days include Pop Mart (09992) with a decrease of -2.561 billion, Xiaomi Group-W (01810) with -2.531 billion, and Kangfang Biotech (09926) with -0.911 billion [2] Group 1: Top Holding Ratios - China Telecom (00728) has a holding ratio of 72.04% with 10 billion shares [1] - Green Power Environmental (01330) has a holding ratio of 69.16% with 280 million shares [1] - China Shenhua (01088) has a holding ratio of 67.97% with 2.296 billion shares [1] Group 2: Recent Increases in Holdings - Alibaba-W (09988) increased its holdings by +14.898 billion, adding 98.598 million shares [1] - Horizon Robotics-W (09660) increased its holdings by +1.834 billion, adding 17.948 million shares [1] - Ping An of China (02318) increased its holdings by +1.420 billion, adding 24.8703 million shares [1] Group 3: Recent Decreases in Holdings - Pop Mart (09992) decreased its holdings by -2.561 billion, reducing 9.2515 million shares [2] - Xiaomi Group-W (01810) decreased its holdings by -2.531 billion, reducing 45.9018 million shares [2] - Kangfang Biotech (09926) decreased its holdings by -0.911 billion, reducing 6.7244 million shares [2]

Group 1 - Alibaba-W (09988), Laopu Gold (06181), and China Pacific Insurance (02601) ranked the top three in net inflow of southbound funds, with net inflows of 4.484 billion, 463 million, and 456 million respectively [1][2] - Pop Mart (09992), Kangfang Biotech (09926), and Xiaomi Group-W (01810) ranked the top three in net outflow of southbound funds, with net outflows of -1.721 billion, -908 million, and -438 million respectively [1][2] - In terms of net inflow ratio, Tehai International (09658), Swire Properties B (00087), and Modern Dairy (01117) led the market with ratios of 60.71%, 57.33%, and 54.43% respectively [1][2] Group 2 - The top ten stocks by net inflow included Alibaba-W (09988) with 4.484 billion and a closing price of 142.800 (+0.63%), Laopu Gold (06181) with 463 million and a closing price of 755.000 (-7.59%), and China Pacific Insurance (02601) with 456 million and a closing price of 32.200 (+2.81%) [2] - The top ten stocks by net outflow included Pop Mart (09992) with -1.721 billion and a closing price of 275.200 (-4.51%), Kangfang Biotech (09926) with -908 million and a closing price of 133.500 (-4.71%), and Xiaomi Group-W (01810) with -438 million and a closing price of 54.950 (-2.22%) [2] - The top three stocks by net outflow ratio were Zhongjiao Holdings (00839) with -69.56%, Qingdao Bank (03866) with -60.56%, and Canggang Railway (02169) with -56.33% [3]

Core Viewpoint - Kangfang Biopharma/Summit presented updated data from the HARMONi study at the 2025 WCLC, showing improved overall survival (OS) with a hazard ratio (HR) of 0.78 (P=0.0332), indicating a significant trend of survival benefit compared to previous analyses [1][2] Group 1: Study Overview - The HARMONi study is a global, multicenter, randomized, double-blind, placebo-controlled Phase III trial assessing the efficacy and safety of Ivonescimab in patients with disease progression after third-generation EGFR-TKI treatment [2] - A total of 438 patients were randomized (219 per group), with a median follow-up of 22.3 months, showing a significant improvement in progression-free survival (PFS) for the Ivonescimab group (HR=0.52, P<0.001) [3] Group 2: Efficacy Results - The median OS for the Ivonescimab group was 16.8 months compared to 14.0 months for the placebo group (HR 0.79, P=0.0570) [3] - Objective response rates were 44.7% for the Ivonescimab group versus 34.2% for the placebo group, with intracranial PFS also showing improvement [3] Group 3: Safety Profile - The Ivonescimab group demonstrated good safety and tolerability, with treatment-related adverse events (TRAEs) of grade ≥3 occurring in 50.0% of patients compared to 42.2% in the placebo group [4] - The most common TRAEs were laboratory abnormalities, with no new safety signals identified [4] Group 4: Follow-Up and Trends - Extended follow-up showed further improvement in OS, particularly in North American patients, with a median OS of 17 months compared to 14 months for the control group (HR=0.84) [5] - The study indicated that patients with brain metastases had better PFS outcomes compared to those without [5] Group 5: Comparative Analysis - The HARMONi study results align with the HARMONi-A study, demonstrating consistent efficacy trends across different regions, highlighting the global market potential of Ivonescimab [6] - Both studies achieved significant clinical endpoints, confirming the drug's rapid efficacy and favorable safety profile [6] Group 6: Future Outlook - Future focus will be on the results of ongoing Phase III trials, particularly HARMONi-3 and HARMONi-7, which will be critical for the drug's commercialization prospects [7] - The company has initiated multiple Phase III studies across various cancer types, indicating a robust pipeline and potential for sustained growth [7] Group 7: Financial Projections - The company projects revenues of 34.42 billion, 51.49 billion, and 76.28 billion for 2025, 2026, and 2027, respectively, with corresponding growth rates of 62.04%, 49.62%, and 48.14% [8] - The company is expected to achieve profitability by 2026, supported by a rich pipeline of products nearing approval [8]

Market Overview - On September 12, the Hang Seng Index rose by 1.16%, closing at 26,388.16 points, with a net inflow of HKD 7.331 billion through the southbound trading channel [2] - The total trading volume for the southbound trading on that day was HKD 157.992 billion, with a net buying amount of HKD 7.331 billion [2] Southbound Trading Details - The Shanghai Stock Exchange's southbound trading had a total transaction amount of HKD 97.259 billion, with a net selling of HKD 1.487 billion; while the Shenzhen Stock Exchange's southbound trading had a transaction amount of HKD 60.733 billion, with a net buying of HKD 8.818 billion [2] - The most actively traded stock in the Shanghai southbound trading was Alibaba-W, with a transaction amount of HKD 87.744 billion and a net buying of HKD 2.076 billion, closing with a price increase of 5.44% [2] - In the Shenzhen southbound trading, Alibaba-W also led with a transaction amount of HKD 63.889 billion and a net buying of HKD 2.304 billion, maintaining the same closing price increase of 5.44% [3] Active Stocks Summary - The top ten actively traded stocks in the southbound trading included Alibaba-W, Meituan-W, and SMIC, with transaction amounts of HKD 87.744 billion, HKD 50.99 billion, and HKD 37.02 billion respectively [2] - Meituan-W had the highest net selling amount of HKD 1.635 billion, closing flat [2] - Other notable stocks included Tencent Holdings and Xiaomi Group, with transaction amounts of HKD 32.17 billion and HKD 23.17 billion respectively, and Tencent saw a net buying of HKD 0.744 billion [3] Additional Stock Performance - The stock performance of various companies showed that 8 out of the top ten stocks had net buying, with Alibaba-W leading at HKD 2.304 billion [3] - The stock of Sanofi had the highest net selling amount of HKD 0.295 billion, while its closing price increased by 1.81% [4]

Investment Rating - The industry rating is "Positive" for the next 12 months, expecting a growth rate exceeding 10% relative to the CSI 300 index [67][79]. Core Insights - The report highlights the impressive research outcomes of Chinese pharmaceutical companies showcased at the 2025 World Lung Cancer Conference (WCLC), emphasizing the strength of innovation in the sector. It also notes that Heng Rui has further advanced its overseas licensing strategy through the NewCo model [9][67]. - The report suggests continuous monitoring of the R&D progress of Chinese pharmaceutical companies, particularly in innovative drugs and related industrial chains, benefiting from optimized procurement rules in the pharmaceutical and medical device sectors, as well as the recovery of traditional Chinese medicine and medical services due to domestic demand [9][67]. Industry News - Bai Li Tian Heng's dual-target ADC for EGFR/HER3 has shown promising results at WCLC, with a 100% overall response rate in a study involving 154 patients [18]. - BeiGene presented the latest findings from its RATIONALE studies at WCLC, demonstrating significant survival benefits for its drug in treating non-small cell lung cancer [19]. - Kangfang Biotech updated data from its HARMONi study, showing improved overall survival rates, particularly in North America [20]. Company Announcements - Heng Rui Pharma signed a licensing agreement with Braveheart Bio for the HRS-1893 project, with an upfront payment of $65 million and potential milestone payments totaling up to $1.013 billion [35]. - The new drug application for KN026 by CSPC has been accepted by the National Medical Products Administration (NMPA) [39]. - Junshi Biosciences reported positive results from its Phase III clinical trial for an anti-IL-17A monoclonal antibody [40]. Market Review - The Shanghai Composite Index rose by 2.91%, while the Shenzhen Component Index increased by 7.11%. The pharmaceutical and biological sector saw a 1.76% increase, with most sub-sectors showing positive performance [53][57]. - As of September 11, 2025, the TTM P/E ratio for the pharmaceutical and biological industry was 31.56, with a valuation premium of 148% relative to the CSI 300 [57]. Weekly Strategy - The report recommends focusing on investment opportunities in innovative drugs and medical devices, as well as sectors benefiting from domestic demand recovery, while maintaining a "Positive" industry rating [67].

Group 1 - On September 12, 2025, Alibaba-W (09988), Meituan-W (03690), and SMIC (00981) were the top three companies by trading volume in the Southbound Stock Connect, with transaction amounts of 87.74 billion, 50.99 billion, and 37.02 billion respectively [1] - In the Southbound Stock Connect for Shenzhen-Hong Kong, Alibaba-W (09988), Tencent Holdings (00700), and Xiaomi Group-W (01810) led the trading volume, with transaction amounts of 63.89 billion, 32.17 billion, and 23.17 billion respectively [1] Group 2 - In the Southbound Stock Connect (Hong Kong), the top active trading companies included: - Alibaba-W (09988) with a net buy of +20.76 billion - Tencent Holdings (00700) with a net buy of +1.85 billion - Meituan-W (03690) with a net sell of -16.35 billion [2] - In the Southbound Stock Connect (Shenzhen), the top active trading companies included: - Alibaba-W (09988) with a net buy of +23.04 billion - Tencent Holdings (00700) with a net buy of +7.44 billion - Meituan-W (03690) with a net sell of -46.59 million [2]