Investment Rating - The report maintains a "Buy" rating for 康方生物 (9926 HK) with a target price of HKD 115, indicating a potential upside of 16.3% from the current price of HKD 98.90 [7]. Core Insights - 康方生物's application for the PD-L1 positive NSCLC indication for its drug 依沃西 has been approved in mainland China earlier than expected, just 9 months after submission [1]. - The initial overall survival (OS) interim analysis from the HARMONi-2 study shows a hazard ratio (HR) of 0.777, indicating a 22.3% reduction in the risk of death, although it has not yet reached statistical significance [1]. - The report expresses optimism regarding the overseas development of 依沃西, particularly the ongoing HARMONi-7 study, which is expected to have a higher probability of achieving significant results due to a larger sample size and a focus on patients with higher PD-L1 expression [1]. Summary by Sections Approval and Clinical Data - The approval of 依沃西 for PD-L1 positive NSCLC in mainland China reflects regulatory confidence in the clinical benefits observed [1]. - The interim analysis of the HARMONi-2 study is based on a sample size of 398, with a low alpha allocation value of 0.0001, suggesting that the results may improve as more data matures [1][2]. Market Potential - The report forecasts peak sales of 61 billion RMB in mainland China and 5.7 billion USD overseas for 依沃西, highlighting its significant commercial potential [1]. - The upcoming data readout from the global Phase III HARMONi study for 2L EGFR+ NSCLC is anticipated to be a key event for investors [1]. Pipeline Developments - The report notes that the first clinical-stage antibody-drug conjugate (ADC) targeting HER3 has commenced enrollment in Australia, and a second ADC targeting TROP-2/Nectin-4 has received FDA clinical approval [1].

Core Viewpoint - The communication meeting held by Kangfang Biotech was prompted by a significant stock price drop of its overseas partner Summit Therapeutics, following the release of preliminary overall survival (OS) data for its dual-target antibody Ivosidenib, which led to market volatility and investor concerns about clinical data interpretation [1][4][5]. Group 1: Clinical Data and Market Reaction - The initial OS data for Ivosidenib was based on immature data and should be interpreted cautiously, as it was a mid-term analysis required by the National Medical Products Administration [2][10]. - The market had high expectations for Ivosidenib, especially after its previous clinical data showed significant efficacy compared to Keytruda (K drug), with a median progression-free survival (mPFS) of 11.14 months versus 5.82 months for K drug, and a hazard ratio (HR) of 0.51, indicating a 49% reduction in disease progression or death risk [3][4]. - Following the release of the OS data, Summit Therapeutics' stock fell by 36%, reflecting the market's reaction to the perceived overvaluation based on previous expectations [4][9]. Group 2: Company Strategy and Future Outlook - Kangfang Biotech's chairman emphasized that the OS data was not the primary endpoint of the study, and the focus should remain on the primary endpoint of progression-free survival (PFS) and the trend in OS [6][7]. - The company aims to provide innovative treatment options for lung cancer patients, marking a significant milestone for both Kangfang Biotech and the Chinese innovative drug industry [8][9]. - Kangfang Biotech is committed to advancing its clinical research in alignment with global standards, with confidence in the success of its ongoing studies, including the HARMONi-7 trial in the U.S. [11].

Group 1 - Southbound funds net bought Hong Kong stocks worth 2.03 billion HKD on April 28, with significant purchases in the Tracker Fund (20.43 billion HKD) and China Enterprises (12.51 billion HKD) [1] - Continuous net selling of Xiaomi for 8 days totaling 5.11 billion HKD, and net selling of SMIC for 5 days totaling 1.18 billion HKD [3] - Goldman Sachs raised its forecast for southbound fund inflows to 110 billion USD from 75 billion USD, with 78 billion USD net inflow year-to-date, representing 75% of last year's total inflow [4] Group 2 - Kangfang Biopharma's stock dropped nearly 12% despite receiving approval for its bispecific antibody drug for treating PD-L1 positive non-small cell lung cancer [5] - Alibaba and Tencent experienced slight declines of 0.35% and 0.27% respectively, with Tencent purchasing GPU resources worth approximately 2 billion CNY from ByteDance [5][6]

Core Viewpoint - The approval of the new indication for Ivosidenib (依沃西单抗) by Kangfang Biopharma (康方生物) did not positively impact the company's stock price, which fell by 11.83% on April 28 due to concerns over the overall survival (OS) data, which showed clinical benefits compared to Keytruda (K药) but lacked statistical significance [1][4][6]. Summary by Sections Drug Approval and Clinical Data - Ivosidenib received approval for a second indication as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 positivity (TPS≥1%) and negative for EGFR and ALK mutations [4]. - The approval was based on positive results from the AK112-303/HARMONi-2 clinical trial, which demonstrated a median progression-free survival (PFS) of 11.14 months for Ivosidenib compared to 5.82 months for Keytruda, with a hazard ratio (HR) of 0.51, indicating a 49% reduction in the risk of disease progression or death [4][5]. Overall Survival Analysis - A mid-term analysis at 39% maturity showed that Ivosidenib reduced the risk of death by 22.3% compared to Keytruda, although this result did not achieve statistical significance [6][8]. - The total survival data is considered the gold standard for evaluating the efficacy of cancer therapies, and there are differing opinions on the interpretation of these results [6][9]. Market Reaction and Future Prospects - The market's reaction to the OS data has been viewed as misaligned with the essence of the clinical findings, according to Kangfang's chairman, Xia Yu [6][8]. - The ongoing competition with Keytruda is significant, as lung cancer remains the most prevalent and deadly cancer type in China, with Ivosidenib's performance in clinical trials being closely monitored [9][10]. Upcoming Research - The HARMONi-7 study, conducted by Summit, will further evaluate Ivosidenib against Keytruda in patients with high PD-L1 expression, with a focus on achieving statistically significant benefits in overall survival [10]. - This study is crucial for determining whether Ivosidenib can genuinely challenge Keytruda's dominant position in the market [10].

Group 1 - Northbound capital recorded a net purchase of 20.3 billion HKD in the Hong Kong stock market on April 28, with the Shanghai-Hong Kong Stock Connect seeing a net purchase of 23.43 billion HKD and the Shenzhen-Hong Kong Stock Connect experiencing a net sale of 3.13 billion HKD [1] - The stocks with the highest net purchases included the Tracker Fund of Hong Kong (02800), Hang Seng China Enterprises (02828), and CanSino Biologics (09926) [1] - The stocks with the highest net sales were Alibaba-W (09988), Tencent (00700), and Xiaomi Group-W (01810) [1] Group 2 - CanSino Biologics (09926) received a net purchase of 7.79 billion HKD, with a report indicating positive results from its clinical trial for the dual-specific antibody AK112 in treating advanced squamous non-small cell lung cancer [5] - Meituan-W (03690) saw a net purchase of 5.56 billion HKD, with analysts noting that the company does not face risks of ADR delisting and has stable revenue sources [5] - China Shenhua (01088) had a net purchase of 5.17 billion HKD, with analysts highlighting its strong cash flow supporting high dividend payouts despite pressure from falling coal prices [6] Group 3 - The Tracker Fund of Hong Kong (02800) and Hang Seng China Enterprises (02828) received net purchases of 20.43 billion HKD and 12.5 billion HKD, respectively, indicating increased investor confidence [4] - Tencent (00700) and Alibaba-W (09988) faced net sales of 5.97 billion HKD and 14.24 billion HKD, respectively, amid concerns regarding the ongoing US-China trade tensions [6] - China Mobile (00941) received a net purchase of 1.13 billion HKD, while Xiaomi Group-W (01810) and SMIC (00981) experienced net sales of 2.56 billion HKD and 1.36 billion HKD, respectively [6]

南向资金今日净买入20.3亿元。港股通（沪）方面，康方生物、盈富基金分别获净买入11.38亿港元、 10.29亿港元；阿里巴巴-W净卖出额居首，金额为8.84亿港元；港股通（深）方面，恒生中国企业、盈 富基金分别获净买入12.51亿港元、10.14亿港元；阿里巴巴-W净卖出额居首，金额为5.41亿港元。 ...

Group 1 - The core viewpoint of the article highlights the performance of the CSI Hong Kong-Shanghai Biotech Theme Index, which reflects the overall performance of listed companies in the biotech sector from mainland China and Hong Kong [1][3] - The CSI Hong Kong-Shanghai Biotech Theme Index has shown an increase of 0.82% over the past month, 12.93% over the past three months, and 12.21% year-to-date [1] - The index consists of 50 sample companies involved in biopharmaceuticals, pharmaceuticals, and biotech services, with a base date of December 28, 2018, set at 1000.0 points [1] Group 2 - The top ten weighted companies in the index include: Heng Rui Medicine (13.16%), BeiGene (10.43%), WuXi AppTec (8.41%), Mindray Medical (7.71%), WuXi Biologics (5.15%), Innovent Biologics (4.82%), CanSino Biologics (3.91%), Shanghai Pharmaceuticals (2.74%), China National Pharmaceutical Group (2.45%), and Shanghai RAAS Blood Products (1.83%) [1] - The market share of the index holdings is distributed as follows: Hong Kong Stock Exchange 41.72%, Shanghai Stock Exchange 35.62%, and Shenzhen Stock Exchange 22.66% [1] Group 3 - In terms of industry composition, biopharmaceuticals account for 43.26%, chemical drugs for 25.78%, pharmaceutical and biotech services for 21.39%, and medical devices for 9.57% [2] - The index samples are adjusted semi-annually, with adjustments occurring on the next trading day after the second Friday of June and December each year [2] - Special circumstances may lead to temporary adjustments to the index, including the removal of samples that are delisted or changes due to mergers, acquisitions, or other corporate actions [2]

Group 1 - Jianyin International raised the target price for Kangfang Biopharma (09926) by 33.3%, from HKD 90 to HKD 120, reflecting improved earnings forecasts and high potential for the company's lung cancer drugs in China and overseas [1] - Kangfang Biopharma's fundamentals are strong, with revenue forecasts for 2025, 2026, and 2027 increased to RMB 3.3 billion, RMB 5.3 billion, and RMB 9.6 billion respectively, and adjusted profit forecasts for 2025, 2026, and 2027 raised to RMB 121 million, RMB 1.2 billion, and RMB 3.9 billion respectively [1] - The approval of Ebdarokimab for moderate to severe plaque psoriasis in China is a significant milestone for Kangfang Biopharma [1] Group 2 - On April 23, Kangfang Biopharma announced that its drug AK112 met the target efficacy in a Phase 3 clinical trial for advanced squamous non-small cell lung cancer, showing superior efficacy compared to Tislelizumab [2] - The independent data monitoring committee confirmed that AK112's efficacy is significantly better than that of Tislelizumab, aligning with previously published Phase 3 clinical data [2] - AK112's performance indicates it outperforms Merck's well-known PD-1 biologic competitor, Keytruda [2]

Group 1 - The biotechnology stocks in the Hong Kong market mostly declined, with notable drops in several companies [1] - Kangfang Biotech (09926.HK) experienced a decline of over 12% [1] - Yunkang Group (02325.HK) fell by more than 6% [1] - Other companies such as Sillod Medical (01244.HK) and Zai Lab (09688.HK) also saw declines exceeding 4% [1]

看好依沃西生存获益潜力 在ITT人群中，依沃西组和帕博利珠组的mPFS为11.14vs5.82mo，PFS HR=0.51(P<0.0001);在39%成熟度 时进行的mOS的期中分析(α分配值仅0.0001)结果显示，依沃西对比帕博利珠单抗具有显著的临床生存获 益，HR=0.777，降低死亡风险22.3%。我们认为，依沃西已初步展现优异的生存获益潜力，考虑到本次 数据分析的成熟度较低、且α分配值较小，依沃西生存获益的统计学获益情况有待后续跟踪观察。 智通财经APP获悉，国泰海通发布研报称，维持康方生物(09926)"增持"评级。公司核心产品接连实现临 床突破，步入收获期维持2025-2027年收入预测37.28/59.28/78.00亿元，采用PS估值法，给予2025年28X PS，对应目标价123.72港元(原128.14港元)。 国泰海通主要观点如下： 依沃西一线治疗NSCLC适应症获批上市 据公司微信公众号披露4月25日，依沃西单药用于PD-L1阳性(TPS≥1%)NSCLC一线治疗适应症获NMPA 批准上市。依沃西为全球首个在头对头"药王"帕博利珠单抗的III期临床研究中获得显著阳性结果的药 物，为 ...