一款创新药要从中国走向全球市场，就必须叩开美国食品药品监督管理局（FDA）的大门。正因为这 样，AK112的海外研究进展和数据都格外受关注。 HARMONi是一项全球多中心、随机、双盲、安慰剂对照Ⅲ期研究，用于评估经三代EGFR-TKI治疗后 疾病进展的患者接受依沃西单抗联合化疗方案的疗效与安全性。该研究共随机入组438例患者（各组219 例），其中273例来自中国，165例（38%）来自北美和欧洲。中位年龄62岁，24.7%的患者在入组时存 在脑转移。 今年5月，Summit公布HARMONi的顶线结果，这是依沃西单抗的首个全球Ⅲ期临床数据披露。结果显 示，AK112在主要终点PFS上取得统计学显著且具有临床意义的改善，风险比（HR）为0.52；在另一主 要终点OS（总生存期）上则显示出积极趋势，但未达到统计学显著获益，风险比为0.79（p=0.057）。 OS被认为是FDA批准药物的主要指标之一，这一结果意味着AK112的上市预期延后，Summit和康方生 物股价重挫。 《每日经济新闻》记者注意到，此次Summit更新公布了HARMONi研究更长随访时间的临床研究数据， PFS和OS结果较今年5月公布的数 ...

Group 1 - Citic Lyon maintains "outperform" rating for Kangfang Biotech with a target price of HKD 177, citing excellent treatment performance from the global Phase III clinical study of Ivoris monoclonal antibody [1] - Goldman Sachs maintains "buy" rating for Meituan with a target price of HKD 144, expecting continued leadership in local services as the instant retail market expands [1] - Jianyin International maintains "outperform" rating for BYD, lowering the target price to HKD 115.7 due to a stock split, while highlighting the company's strong supply chain capabilities [1] Group 2 - Dongfang Caifu maintains "accumulate" rating for Pop Mart, noting strong performance in H1 2025 and potential for growth through IP exploration and global store expansion [2] - Goldman Sachs maintains "buy" rating for Ping An Insurance, raising the H-share target price to HKD 61, anticipating profit margin advantages from recent product repricing [3] - Goldman Sachs upgrades Luoyang Molybdenum to "buy" with a target price increase to HKD 10.8, driven by a 38% increase in regular profit due to rising copper and rare metal prices [4] Group 3 - Jefferies maintains "buy" rating for MicroPort with a target price increase to HKD 35, citing strong visibility in order growth and manageable competition in the domestic market [4] - Citic Securities maintains "buy" rating for Li Auto with a target price of HKD 151, expecting quarterly improvements in automotive business due to sales channel adjustments and new model launches [5] - CMB International upgrades UBTECH to "buy" with a target price increase to HKD 140, driven by strong orders for humanoid robots and rapid capacity expansion [6]

Core Viewpoint - CITIC Securities maintains a target price of HKD 177 for CanSino Biologics (09926) and a "outperform" rating following the positive trends observed in the global Phase III Harmoni study data for ivonescimab in treating second-line EGFR+ non-small cell lung cancer (NSCLC) [1] Group 1 - The Harmoni study data shows an improvement in overall survival (OS) risk trend from 0.79 to 0.78 [1] - The risk ratios reported for North America and Asia subgroups are 0.7 and 0.76, respectively, indicating strong performance [1] - The next key catalyst to watch is the results from the Phase III head-to-head clinical trial of Harmoni-6 versus tislelizumab, which will be presented at the 2025 European Society for Medical Oncology (ESMO) [1]

Core Viewpoint - Citic Securities maintains a target price of HKD 177 for Kangfang Biopharma (09926) and a "outperform" rating, following the positive trends observed in the global Phase III Harmoni study data for ivonescimab in treating second-line EGFR+ non-small cell lung cancer (NSCLC) [1] Group 1 - The Harmoni study showed an improvement in overall survival (OS) risk trend from 0.79 to 0.78, with risk ratios reported at 0.7 for North America and 0.76 for Asia, indicating strong performance [1] - The next anticipated catalyst is the presentation of results from the Harmoni-6 head-to-head Phase III trial against tislelizumab at the 2025 European Society for Medical Oncology (ESMO) [1]

Group 1: Gold Market Analysis - Recent surge in gold prices, with London gold reaching nearly $3580 per ounce on September 3, 2025, after a four-month period of high volatility [12][10] - Under neutral assumptions, the gold price midpoint for the second half of the year is projected at $3627 per ounce, with an optimistic scenario suggesting a rise to $3816 per ounce [12][10] - Key drivers for the recent price increase include a shift in investment from long-term US and European bonds to gold due to concerns over debt risks, particularly in Europe [12][11] Group 2: International Beauty Market Trends - The global beauty market is expected to grow at a rate of 4.5% in 2024, down from 8% in 2023, with significant regional disparities [13][13] - The European market outperformed the global average with a 7.5% year-on-year growth, while the North Asia market saw a decline of 2% [13][13] - Major international beauty brands are adapting to the competitive landscape in China by embracing new online channels and local partnerships, leading to a slight recovery in market performance [13][13] Group 3: Fourth Paradigm Company Overview - The company is projected to achieve revenues of 68.52 billion, 88.19 billion, and 112.26 billion yuan from 2025 to 2027, with year-on-year growth rates of 30%, 29%, and 27% respectively [17][17] - The company is expected to turn a profit by 2025, with net profits forecasted at 0.55 billion, 2.83 billion, and 5.68 billion yuan for the same period [17][17] - The company's strategy focuses on standardization, which is anticipated to drive rapid industry expansion and maintain long-term competitiveness [14][14]

Core Insights - The global multi-center phase III clinical study HARMONi for AK112 (Evosinib) has successfully met its primary endpoint of progression-free survival (PFS) [1][2] - Evosinib is the world's first PD-1/VEGF dual antibody, showing potential to replace Merck's PD-1 drug, Pembrolizumab, based on its superior PFS results in previous studies [1][2] - The study included 438 patients, with a significant portion (38%) from North America and Europe, indicating a diverse patient demographic [2] Group 1 - The HARMONi study demonstrated a statistically significant improvement in PFS with a hazard ratio (HR) of 0.52, while the overall survival (OS) showed a positive trend but did not reach statistical significance with an HR of 0.79 (p=0.057) [2] - The updated data from Summit Therapeutics revealed an improved OS HR of 0.78 (95% CI: 0.62–0.98, p=0.0332) after a median follow-up of 13.7 months, indicating a notable enhancement in survival outcomes [3] - The results from the international HARMONi study align with the domestic HARMONi-A study, showcasing consistent clinical performance in both PFS and OS, highlighting Evosinib's global market potential [4] Group 2 - The chairman of the company expressed strong confidence in AK112 despite the stock price fluctuations, emphasizing the importance of clinical validation in the development of dual antibodies [2][3] - The study's findings underscore the therapeutic advantages of Evosinib, including rapid efficacy and effective disease control, as well as a favorable immune therapy tail effect [4] - The data from the North American cohort showed significant survival benefits, with the control group having a median OS of 14.0 months and an HR of 0.70, further supporting the drug's efficacy [3]

Core Viewpoint - The report emphasizes the sustained high growth in the innovative pharmaceutical and medical device sectors, recommending continued investment in these areas [1]. Investment Highlights - The report maintains a recommendation for innovative pharmaceuticals and medical devices, highlighting the potential for value re-evaluation in the Pharma sector, with specific buy ratings for companies such as 恒瑞医药, 翰森制药, 三生制药, and 华东医药 [2]. - It continues to recommend Biopharma/Biotech companies that are gradually realizing their innovative pipelines and entering a performance growth phase, with buy ratings for 科伦博泰生物, 信达生物, 康方生物, 新诺威, 映恩生物, 京新药业, 微芯生物, 特宝生物, 我武生物, and 来凯医药 [2]. - The report also suggests investment in CXO and upstream pharmaceutical companies benefiting from innovation and recovery, maintaining buy ratings for 百普赛斯, 药明康德, 药明合联, 泰格医药, and 美诺华 [2]. - It recommends leading medical device companies expected to recover, with buy ratings for 微创医疗, 联影医疗, and 惠泰医疗 [2]. Market Performance - In the first week of September 2025, the A-share pharmaceutical sector outperformed the broader market, with the SW pharmaceutical and biotech index rising by 1.4% while the Shanghai Composite Index fell by 1.2% [3]. - Within the biopharmaceutical sector, the chemical preparations segment saw a notable increase of 4.5%, while biological products and medical services rose by 1.9% and 1.7%, respectively [3]. - The top-performing stocks included 海辰药业 (+28.7%), 长春高新 (+24.2%), and 百花医药 (+21.3%), while the worst performers were 舒泰神 (-24.0%), 广生堂 (-15.8%), and 塞力医疗 (-15.6%) [3]. - In the Hong Kong market, the healthcare sector also outperformed, with the Hang Seng Healthcare index rising by 7.0% and the biotech index by 7.3%, compared to a 1.4% increase in the Hang Seng Index [3]. - The top gainers in the Hong Kong market were 三叶草生物-B (+99%), 圣诺医药-B (+62%), and 加科思-B (+41%), while the biggest losers included 美中嘉和 (-11%), 科笛-B (-9%), and 思路迪医药股份 (-6%) [3]. - In the US market, the healthcare sector performed in line with the broader market, with the S&P Healthcare Select Sector Index increasing by 0.3%, matching the S&P 500's performance [4]. - The top gainers in the US healthcare sector included 德康医疗 (+7%), 生物基因 (+6%), and 环球健康服务 (+5%), while the largest declines were seen in KENVUE (-10%), REVVITY (-4%), and MOLINA HEALTHCARE (-3%) [4].

Group 1 - The article emphasizes that macroeconomic factors and market trends have limited guidance for individual stock investments, except during critical turning points [1] - The upcoming Federal Reserve interest rate cuts and global geopolitical changes are identified as a key turning point, particularly benefiting the Hong Kong stock market [1] - The Hang Seng Index is expected to reach historical highs in the next three to five years, driven by the technology and innovative pharmaceutical sectors [1] Group 2 - Hong Kong stocks are highlighted as a mature market with significant growth potential, featuring competitive high-tech and innovative pharmaceutical companies such as Tencent, Alibaba, SMIC, Xiaomi, and others [1] - The decline in interest rates in Hong Kong, following the U.S. dollar's rate cuts, is anticipated to attract international capital back to the Hong Kong stock market [1] - The brokerage sector in Hong Kong is expected to benefit directly from the rising stock indices, making brokerage stocks worth noting in the short term [1]

Group 1 - The pharmaceutical sector has regained momentum, with A-shares in innovative drugs showing strong recovery, particularly the drug ETF (562050) which surged by 3.36%, reaching a record closing high [1] - The Hong Kong stock market saw even greater gains in innovative drugs, with the Hong Kong Stock Connect innovative drug ETF (520880) rising by 4.52%, also hitting a new closing high [1][3] - The innovative drug ETF (520880) currently covers 29 innovative drug concept stocks, all of which have shown positive performance, with notable increases in stocks like Sanofi and Kintor Pharmaceuticals [3] Group 2 - The innovative drug ETF (520880) will undergo a "purification" revision on September 8, 2023, removing CXO companies and focusing solely on innovative drug R&D firms, thus becoming a 100% pure innovative drug index [3] - As of September 3, 2023, the cumulative year-to-date increase for the index tracked by the innovative drug ETF (520880) reached 118.95%, leading among similar indices [3][4] - The Hang Seng Innovative Drug Select Index has shown significant fluctuations in past years, with a notable increase in 2023, indicating a potential upward trend in the innovative drug sector [5] Group 3 - Upcoming key academic conferences, including the World Lung Cancer Conference and the European Oncology Congress, are expected to catalyze further developments in the innovative drug sector [5] - The medical ETF has a total scale of 26.325 billion yuan, making it the largest medical ETF in the market [5]

Group 1 - In the first eight months of the year, 610 out of 644 comparable QDII funds saw an increase in net value, representing 94.7% of the total [1] - The innovative drug sector has rebounded, leading to significant gains for funds heavily invested in this area, with top performers including Huatai-PB Hong Kong Advantage Selected Mixed C and A, achieving returns of 133.73% and 133.56% respectively [1] - The top ten holdings of Huatai-PB Hong Kong Advantage Selected Mixed A/C include companies such as InnoCare Pharma, Kelun-Biotech, and Innovent Biologics [1] Group 2 - Ten QDII funds recorded gains exceeding 90%, with four from E Fund Management, including E Fund Global Pharmaceutical Industry Mixed Fund, all surpassing 94% [2] - The top ten holdings of these E Fund products include major players like Innovent Biologics and InnoCare Pharma [2] Group 3 - Funds such as GF CSI Hong Kong Innovative Drug ETF and Huatai-PB Hang Seng Innovative Drug ETF also performed well, with returns of 103.70% and 100.04% respectively [3] - The top ten holdings of the larger Huatai-PB Hang Seng Biotechnology ETF include companies like Innovent Biologics and WuXi Biologics [3] Group 4 - The bottom performers among QDII funds primarily tracked the FTSE Saudi Arabia Index, with several oil and gas funds and those tracking the S&P 500 healthcare index also underperforming [4]