Core Viewpoint - Kangfang Biopharma presented the final overall survival (OS) results of the HARMONi-A study at the 2025 SITC, demonstrating a statistically significant benefit of Ivonescimab in patients with EGFR TKI-resistant non-small cell lung cancer (NSCLC) [1][2][4] Summary by Sections Event - Kangfang Biopharma released the final OS results of the HARMONi-A study, showing a median follow-up of 32.5 months with an OS of 16.8 months for the Ivonescimab group compared to 14.1 months for the control group, achieving an OS hazard ratio (HR) of 0.74 (P=0.019) [1][2] Analysis - The overall data met expectations, with the OS benefit reaching statistical significance. The HARMONi-A study is the first to achieve both progression-free survival (PFS) and OS benefits in this indication, with previous analyses also showing significant PFS results [1][4] - The OS benefit was consistent across subgroups, including patients with and without brain metastases and those with specific EGFR mutations [3] Clinical Development - The HARMONi-A study is the first Phase III trial to show significant clinical benefits in both PFS and OS for EGFR TKI-resistant NSCLC, highlighting the breakthrough potential of Ivonescimab [4] - Global clinical trials for Ivonescimab are accelerating, with new studies initiated for various cancers, including colorectal cancer and NSCLC [5][6] Future Milestones - Upcoming milestones include the submission of a Biologics License Application (BLA) for Ivonescimab in late 2025, along with updates on ongoing clinical trials and new indications [7][8][9] Financial Projections - The company forecasts 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% [9]

Core Viewpoint - CITIC Securities reports that Kangfang Biopharma (09926) has multiple products and indications in its pipeline that are expected to be approved for market entry, indicating a strong long-term sustainable development capability [1] Group 1: Pipeline and Product Development - Kangfang Biopharma's research pipeline is expanding, with a rich reserve of early-stage products [1] - The approval of Iwosimab for market entry contributes to the company's sales growth, while the sales revenue from its products is increasing year by year [1] - The company is rated as "Buy" due to the excellent efficacy of its innovative drug products and the broad market potential [1] Group 2: Clinical Trial Results - At the 2025 SITC, Kangfang Biopharma presented the final overall survival (OS) results of the HARMONi-A trial, showing a median follow-up time of 32.5 months, with an OS hazard ratio (OSHR) of 0.74 (0.58-0.95) (P=0.019) for the Iwosimab treatment group compared to the control group [1] - This trial is noted as the first to achieve clinically meaningful and statistically significant benefits in both progression-free survival (PFS) and OS for an immunotherapy in patients with EGFR TKI-pretreated non-small cell lung cancer (NSCLC) [1] Group 3: Future Focus Areas - Future attention can be directed towards the final OS results update for Iwosimab in the domestic HARMONi-2 trial and the submission of the BLA application in the U.S. [2] - Ongoing global clinical trials for AK104 targeting first-line gastric cancer, second-line IO-resistant hepatocellular carcinoma, and PD-L1 negative NSCLC are also noteworthy [2] - The advancement of AK132 (Claudin18.2/CD47), AK137 (CD73/LAG3) into Phase II clinical trials, and the IND application for AK150 (ILT2/ILT4/CSF1R) are significant developments [2]

Core Viewpoint - CITIC Securities reports that Kangfang Biopharma (09926) has multiple products and indications in its pipeline nearing approval, with a continuously expanding R&D pipeline and a strong early-stage pipeline, indicating long-term sustainable development capability [1] Group 1: Product Pipeline and R&D - Kangfang Biopharma is expected to present final overall survival (OS) results for HARMONi-A at the 2025 SITC, with a median follow-up of 32.5 months showing an OS hazard ratio (OSHR) of 0.74 (0.58-0.95) (P=0.019) [1] - The company has achieved significant clinical and statistical benefits in its Phase III clinical trial for an immunotherapy that targets EGFR TKI-treated non-small cell lung cancer (NSCLC) [1] Group 2: Sales Performance - The approval of the drug Iwosimab has contributed to incremental sales for the company, while the sales of the drug Kantan have shown stable growth, leading to an annual increase in product sales revenue [1] Group 3: Future Focus Areas - Future attention can be directed towards the final OS results update for Iwosimab in the domestic HARMONi-2 trial, the submission of the BLA application in the U.S., and the overseas mPFS analysis for HARMONi-32026 in the second half of 2026 [2] - Ongoing global clinical trials for AK104 targeting first-line gastric cancer, second-line IO-resistant hepatocellular carcinoma, and PD-L1 negative NSCLC are also noteworthy [2] - The advancement of AK132 (Claudin18.2/CD47), AK137 (CD73/LAG3) into Phase II clinical trials, and the IND application for AK150 (ILT2/ILT4/CSF1R) are significant developments [2]

Investment Rating - The report does not explicitly state an investment rating for the industry [1] Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 2.4% from November 3 to November 7, 2025, underperforming compared to the Wind All A index (0.63%) and the CSI 300 index (0.82%) [2][7] - The rise in flu activity was noted, with the percentage of flu-like illness (ILI) cases reported at 4.7% in the week of October 27 to November 2, 2025, indicating an increase compared to previous weeks and years [2][10] - The final overall survival (OS) results from the HARMONi-A study of Ivosidenib combined with chemotherapy for EGFR-mutant non-small cell lung cancer showed a significant improvement in OS, with a median OS of 16.8 months versus 14.1 months for the control group [2][10] Weekly Market Review - The pharmaceutical and biotechnology sector's performance was down 2.4%, with notable declines in medical research outsourcing (-4.93%), chemical preparations (-4.42%), and other biological products (-4.33%) [7][8] - The leading gainers included Hezhi China (61.1%), Wanze Shares (30.3%), and Fuxiang Pharmaceutical (23.3%), while Changshan Pharmaceutical (-20%), Yifang Bio-U (-17.8%), and Guangshengtang (-15.3%) were the biggest losers [10] Industry News and Key Company Announcements - On November 7, 2025, the final OS analysis of the HARMONi-A study was presented, showing significant results for Ivosidenib in combination with chemotherapy [10][12] - According to data from the Chinese Center for Disease Control, flu-like illness percentages in southern provinces increased to 4.6%, while northern provinces reported 5.1%, both higher than the previous week [10][12] - BeiGene reported a total revenue of $1.412 billion for Q3 2025, a 41% year-on-year increase, driven by a 51% growth in global sales of its product [12][14] - Metsera announced a merger agreement with Pfizer, with an estimated total transaction value of approximately $9 billion [12][14]

Core Viewpoint - The introduction of the commercial insurance innovative drug directory is expected to address the accessibility and affordability issues of high-priced innovative drugs by guiding market forces [1][3]. Group 1: Policy Changes - The National Medical Insurance Administration organized a 5-day negotiation for the medical insurance drug directory and commercial insurance innovative drug directory, with 120 domestic and foreign companies participating [2]. - The new directory is set to be released in early December and will officially take effect on January 1 of the following year [2]. Group 2: Market Opportunities - The commercial insurance innovative drug directory aims to open market space for high-cost or rare disease medications, particularly for rare disease treatments and high-value innovative drugs [3]. - Notably, five CAR-T drugs have been submitted for approval, which could significantly benefit patients due to their high annual treatment costs [3]. Group 3: Drug Submission Strategies - The introduction of the "dual directory" submission allows companies to choose between submitting for both the basic medical insurance directory and the innovative drug directory, providing more strategic options [4]. - For example, BMS's O drug (Nivolumab) opted for dual submission after previous failures, while competitors like Merck's K drug (Pembrolizumab) have not submitted any applications [4]. Group 4: Competitive Landscape - Domestic innovative drugs are becoming major competitors to imported drugs, with examples like the TROP2 ADC drug Gosituzumab (Gilead) and its domestic counterpart [5]. - The increasing support for innovative drugs from the government and the diversification of the medical insurance payment system are expected to create new market demand for innovative drugs [5]. Group 5: Investment Recommendations - The medical insurance bureau is encouraging the high-quality development of innovative drugs, indicating a warming trend in payment policies [6]. - Relevant investment targets include companies such as Heng Rui Medicine, Kelun Pharmaceutical, and others that are actively transitioning towards innovation [6].

Market Review - The A-share market experienced a style switch with a mixed index performance, as technology stocks led the decline while small-cap stocks showed active performance. The Shanghai Composite Index broke through 4000 points before retreating, with an average daily trading volume of 2.33 trillion yuan, up from 1.80 trillion yuan the previous week [4][5]. Hard Technology - The global semiconductor expansion driven by AI continues, with Q2 2025 global semiconductor equipment sales reaching 33.1 billion USD, a 23% year-on-year increase. In September, Japan's semiconductor equipment sales reached 424.6 billion yen, up 14.9% year-on-year [14][15]. - Domestic semiconductor equipment manufacturers saw significant revenue growth in Q3 2025, with an average year-on-year increase of 35%. This reflects strong order fulfillment from last year's orders and progress in downstream wafer fabs [25][26]. Healthcare - Chinese innovative drug companies showcased significant achievements at the 2025 ESMO conference, with 33 companies presenting research results and 35 studies selected for oral presentations. Chinese companies accounted for 15.3% of the total abstracts presented [28][29]. - The value of patent licensing transactions for Chinese innovative drugs exceeded 100.7 billion USD in the first three quarters of 2025, marking a 170% year-on-year increase, indicating accelerated globalization of Chinese innovative drugs [32][33]. High-end Manufacturing - The tungsten price has significantly increased, reflecting supply-side policy tightening and recovering downstream demand. The average price of domestic black tungsten concentrate reached 299,000 yuan per ton, up 109.8% from the beginning of the year [38][39]. - The excavator industry in China has shown a continuous recovery, with sales reaching 174,000 units in the first nine months of 2025, a year-on-year increase of 18.1%. Both domestic and export markets experienced double-digit growth [42][43]. Consumer Sector - Cross-border e-commerce has emerged as a new highlight in China's foreign trade, with a rich midstream ecosystem involving merchants, platforms, and service providers. The development is driven by domestic "push" factors and overseas "pull" factors, leading to a comprehensive export era for platforms, factories, and sellers [5][6].

Core Viewpoint - The innovation drug sector in China is experiencing significant growth, driven by policy support, innovation upgrades, and normalization of overseas business development, indicating a period of high prosperity for the industry [5]. Group 1: Market Performance - As of October 27, 2025, the Shanghai Stock Exchange Sci-Tech Innovation Board Innovation Drug Index rose by 2.50%, with notable increases in constituent stocks such as Ailis (up 5.76%) and ZhiXiang JinTai (up 5.63%) [1]. - The Huatai-PineBridge Innovation Drug ETF (589120) increased by 2.67%, with a latest price of 0.89 yuan, and has seen a cumulative increase of 1.06% since the beginning of October [1]. - The ETF recorded a turnover rate of 4.12% and a trading volume of 15.2063 million yuan, with an average daily trading volume of 24.6571 million yuan over the past year [1]. Group 2: Financial Performance - WuXi AppTec reported a net profit of 3.515 billion yuan for Q3 2025, a year-on-year increase of 53.27%, and a total net profit of 12.076 billion yuan for the first three quarters, up 84.84% year-on-year [3]. - The growth in profits is attributed to the company's focus on the CRDMO business model, increased operational efficiency, and gains from the sale of shares in WuXi XDC Cayman Inc. [3]. Group 3: Industry Developments - The 2025 European Society for Medical Oncology (ESMO) annual meeting showcased significant breakthroughs in Chinese innovative drug research, with multiple clinical data points reaching international leading levels [4]. - Notable presentations included CanSino Biologics' results on the efficacy of Ivosidenib in advanced squamous non-small cell lung cancer and Rongchang Biologics' RC48-C016 study in HER2+ urothelial carcinoma, which achieved significant benefits in progression-free survival (PFS) and overall survival (OS) [4]. - The Federal Reserve's initiation of a rate-cutting cycle is expected to benefit innovative assets, particularly in the pharmaceutical sector, as historical trends show that innovative assets tend to outperform during such periods [4].

Investment Rating - The report maintains an "Overweight" investment rating for the pharmaceutical and biotechnology industry [1]. Core Insights - The report highlights that the 2025 ESMO conference showcased significant advancements from Chinese innovative drug companies, marking a shift from being followers to leaders in the global market [19][22]. - The A-share pharmaceutical index has shown a year-to-date increase of 19.54%, with a weekly increase of 0.58%, while the Hang Seng Biotechnology Index has surged by 81.15% year-to-date [9]. - Key sub-sectors showing positive performance include medical services (+3.94%), pharmaceutical commerce (+2.27%), and medical devices (+0.89%), while chemical pharmaceuticals and traditional Chinese medicine experienced declines [9]. Summary by Sections Industry Trends - The report notes that the Chinese pharmaceutical sector is entering a harvest period, with a significant increase in the number and quality of research presented at the ESMO conference [16][19]. - The report emphasizes the successful approval of innovative drugs, such as Boehringer Ingelheim's treatment for pulmonary fibrosis and Novartis' drug for polymyalgia rheumatica, which have achieved significant clinical milestones [4]. Research and Development Progress - The report details several groundbreaking studies that have the potential to change existing treatment paradigms, including studies on innovative drugs and ADCs (antibody-drug conjugates) [4][22]. - Specific companies are highlighted for their promising research pipelines, including Innovent Biologics, Rongchang Biologics, and others, which have made significant contributions to the field [12][22]. Market Performance - The report provides a detailed analysis of stock performance within the pharmaceutical sector, noting that certain stocks, such as Teva Pharmaceutical and ST Rong Control, have seen significant weekly gains [9][11]. - The report suggests a ranking of favored sub-sectors for investment, with innovative drugs, research services, and CXO services at the top of the list [10][12]. Recommendations - The report recommends specific companies for investment based on their performance and potential, including Hengrui Medicine, WuXi AppTec, and others across various sub-sectors [11][12].

Investment Rating - The report maintains a positive outlook on the pharmaceutical sector, indicating an "Overweight" rating for the industry, suggesting it is expected to outperform the overall market in the next six months [30]. Core Insights - The pharmaceutical sector saw a weekly increase of 0.6%, while the Shanghai Composite Index rose by 2.9% during the same period. The pharmaceutical index ranked 25th among 31 sub-industries [3][5]. - Notable collaborations include a strategic partnership between Innovent Biologics and Takeda Pharmaceutical, valued at up to $11.4 billion, which includes an upfront payment of $1.2 billion [4][13]. - Key clinical trial results presented at the 2025 ESMO conference highlighted significant advancements in cancer treatments, with several companies reporting promising outcomes in their respective studies [4][14][17]. Market Performance - The pharmaceutical sector's overall valuation stands at 30.4 times earnings, ranking 9th among 31 primary industries [7][5]. - Various sub-sectors showed mixed performance, with medical devices and medical consumables performing relatively well, while traditional Chinese medicine and chemical preparations faced declines [7][5]. Key Events - The report notes that 99 A-share pharmaceutical companies released their Q3 2025 earnings, with a total revenue of 94.15 billion yuan, reflecting a year-on-year growth of 1.3% [19][21]. - Significant clinical trial results from companies like Kintor Pharmaceutical and Zai Lab were highlighted, showcasing their innovative approaches to cancer treatment [14][17][18]. Company Recommendations - The report recommends focusing on innovative drug companies and those with improving performance in medical devices and CXO sectors, listing companies such as Hengrui Medicine, Changchun High-tech, and Mindray Medical as key investment targets [4][19].

Investment Rating - The report maintains a positive outlook on the pharmaceutical sector, indicating an "Overweight" rating for the industry, suggesting it is expected to outperform the overall market [32]. Core Insights - The report highlights that the Shenwan Pharmaceutical and Biological Index increased by 0.6% this week, while the Shanghai Composite Index rose by 2.9% and the Wind All A (excluding financials and petrochemicals) increased by 3.7% [4][6]. - The pharmaceutical sector's overall valuation stands at 30.4 times earnings, ranking 9th among 31 Shenwan primary industries [4][8]. - Significant collaborations and clinical trial results were reported, including a $11.4 billion global strategic partnership between Innovent Biologics and Takeda Pharmaceutical, which includes a $1.2 billion upfront payment [5][13]. - Key clinical trial results presented at the 2025 ESMO conference showed promising outcomes for several drugs, indicating advancements in treatment efficacy for various cancers [14][18][19]. Market Performance - The report details the performance of various sub-sectors within the pharmaceutical industry, with notable increases in medical devices (+0.2%), medical consumables (+1.7%), and medical research outsourcing (+5.5%), while traditional Chinese medicine and other biological products saw declines [4][8]. - The report also notes that 99 A-share pharmaceutical companies released their Q3 2025 earnings, with a total revenue of 94.15 billion yuan, reflecting a 1.3% year-on-year increase [20][22]. Key Events - The report mentions that Bairui Tianheng has passed the Hong Kong Stock Exchange hearing and is in the process of listing its H-shares [12]. - The report emphasizes the importance of the 2025 ESMO conference, where several companies presented significant clinical data, enhancing their market visibility and potential investment attractiveness [14][17][18]. Company Recommendations - The report recommends focusing on innovative drug sectors and companies with improving performance in medical devices and upstream sectors, including companies like Hengrui Medicine, Changchun High-tech, and Mindray Medical [5][20].