Core Viewpoint - Kolon Biotech Inc. (06990) shares rose nearly 5%, currently up 3.42% at 436 HKD, with a trading volume of 88.67 million HKD, following the announcement of multiple clinical research results at the ESMO conference held in Berlin from October 17 to 21, 2025 [1] Group 1: Clinical Research Results - The company's core product SKB264 was selected for two oral presentations at ESMO, demonstrating BIC potential in the treatment of EGFRm NSCLC in the 2L+ setting, with good safety profile; the indication was approved for market in October [1] - SKB264 showed significantly better results than chemotherapy for HR+/HER2- BC in the 2L+ treatment, with expectations for approval in 2026 [1] - Clinical data for the core product A166 indicated that it surpassed T-DM1 in the treatment of HER2+ BC in the 2L+ setting, with this indication also approved for market in October [1]

Core Viewpoint - Keren Biotechnology-B (06990) has seen a stock increase of nearly 5%, currently trading at 436 HKD with a transaction volume of 88.67 million HKD, following the announcement of multiple clinical research results at the ESMO conference in Berlin from October 17 to 21, 2025 [1] Group 1: Clinical Research Results - The company's core product SKB264 was selected for two oral presentations at ESMO, demonstrating BIC potential in the treatment of EGFRm NSCLC in the 2L+ setting, with good safety profile; the indication was approved for market in October [1] - SKB264 showed significantly better results than chemotherapy for HR+/HER2- BC in the 2L+ treatment, with expectations for approval in 2026 [1] - Clinical data for the core product A166 was announced, showing that it outperformed T-DM1 in the treatment of HER2+ BC in the 2L+ setting, with this indication also approved for market in October [1]

Summary of Key Points from Conference Call Records Industry Overview - The conference call discusses advancements in the oncology sector, particularly focusing on various innovative drugs and their clinical trial results across different cancer types. Key Companies and Their Findings 1. 康方生物 (Kangfang Biopharma) - PD-L1 combined with chemotherapy in squamous cell lung cancer achieved a PFS of 11.1 months with an HR of 0.6, indicating a competitive market advantage over previous data from China National Pharmaceutical Group [1][3] 2. 科伦博泰 (Kolex Biotech) - CHOICE DTC for cervical cancer in second and third-line treatment showed a PFS of 6.1 months, considered the best data currently available. The PD-1 combination showed a 6-month PFS rate of 65.7% [1][4][5] 3. 恒瑞 (Hengrui) - KRAS G12D inhibitor in second-line KRAS mutant lung cancer patients reported a PFS of 5.6 months and an OS of 13.7 months, with preliminary data indicating good results but requiring larger sample validation [1][6] 4. 百利天恒 (Baili Tianheng) - HER2 ADC in hormone-positive, HER2-negative breast cancer achieved a PFS of 15.2 months, significantly outperforming similar products. In HER2-positive breast cancer, PFS reached 18 months, surpassing Dato-DXd study results [1][15] 5. 乐普 (Lepu) - TFADC in second-line pancreatic cancer patients reported a PFS of 5.8 months and an OS of 13 months, indicating good efficacy [1][10] 6. 进方 (Jinfang) - KRAS G12D inhibitor in pancreatic cancer showed a PFS of 5.5 months among patients who had received second-line treatment or higher, demonstrating promising efficacy in a challenging treatment area [1][11][12] 7. YEN Company - B73 ADC data indicated a PFS of over 8 months in patients who had previously received Lutetium-177 treatment, showcasing good therapeutic effects [9] 8. Pimasma and F2 Alpha - Data from the ASCO GU meeting showed a 12-month RPFS of 60% for Pimasma and F2 Alpha dual antibody ADC, indicating strong treatment performance [8] Additional Insights - The conference highlighted the competitive landscape of innovative oncology drugs, with several companies demonstrating significant advancements in PFS across various cancer types, including lung, cervical, prostate, and breast cancers [7][16] - The data presented suggests a trend towards improved treatment outcomes with new combinations and targeted therapies, emphasizing the importance of ongoing clinical trials for validation and further development [1][3][4][5][6][7][10][15]

Group 1: Market Performance - The Hong Kong Innovative Drug Selected ETF (520690) increased by 0.22%, with the latest price at 0.89 yuan as of October 29, 2025 [3] - The ETF recorded a turnover of 4.25% during the trading session, with a total transaction value of 21.78 million yuan [3] - Over the past year, the average daily transaction volume of the ETF was 120 million yuan [3] Group 2: Clinical Data and Industry Insights - Grail presented initial data from its multi-cancer early detection product Galleri at the 2025 ESMO annual meeting, showing a positive predictive value of 61.6% and a specificity of 99.6% [3] - Among the detected new cancers, 69.3% were in stages I-III, with a tissue origin accuracy of 91.7% [3] - Guosen Securities views this data as a significant milestone in the multi-cancer early detection field, suggesting Galleri could enhance existing screening systems [3] Group 3: Company Earnings and Trends - Over 280 pharmaceutical and biotech companies, including Heng Rui Pharmaceutical and WuXi AppTec, reported strong Q3 results, driven by advancements in R&D pipelines and new drug launches [3] - The overall industry is exhibiting a positive trend characterized by "innovation as a foundation and overseas expansion" [3] Group 4: CDMO Sector Performance - Lonza, a leading overseas CDMO, reported strong Q3 results, maintaining a revenue growth forecast of 20-21% for the year, with core EBITDA margins between 30-31% [4] - Medpace has seen consecutive growth in new orders for two quarters, indicating a recovering financing environment for U.S. small and mid-sized biotech firms [4] - WuXi AppTec exceeded Q3 performance expectations and raised its full-year guidance, further confirming the positive outlook for the CXO industry [4] Group 5: ETF Size and Inflows - The latest size of the Hong Kong Innovative Drug Selected ETF reached 512 million yuan, marking a new high since its inception [4] - The ETF's share count also hit a record high of 574 million shares [4] - In the past five days, the ETF experienced continuous net inflows, with a peak single-day net inflow of 31.48 million yuan, totaling 82.81 million yuan in net inflows [4]

Core Insights - The Hong Kong Innovative Drug ETF (159567) closed down 1.32% with a trading volume of 588 million yuan on October 28, 2024 [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of October 27, 2024, the fund's latest share count was 8.177 billion shares, with a total size of 6.823 billion yuan, reflecting a significant increase in both share count and size compared to the previous year [1] Fund Performance - The fund's share count increased by 1968.15% and its size increased by 1706.06% from December 31, 2023, when it had 395 million shares and a size of 378 million yuan [1] - The fund has recorded a total trading amount of 22.001 billion yuan over the last 20 trading days, averaging 1.1 billion yuan per day [1] - Year-to-date, the cumulative trading amount is 229.668 billion yuan, with an average daily trading amount of 1.166 billion yuan [1] Fund Management - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 66.90% during the management period [2] - The top holdings of the fund include companies such as BeiGene, CanSino Biologics, Innovent Biologics, and others, with significant percentages of the portfolio allocated to these stocks [2] - The largest holding is BeiGene, accounting for 10.62% of the portfolio, followed by CanSino Biologics at 10.55% and Innovent Biologics at 10.21% [2]

Group 1 - The core focus of several fund managers in Q3 has been on PCB leading stocks, particularly East Mountain Precision, with notable increases in holdings by prominent funds [2][3] - The fund "Yongying Technology Smart Select" has shown significant performance, with a year-to-date return exceeding 200%, and has heavily invested in the PCB sector and optical module leaders [3][5] - Fund managers have expressed confidence in the A-share market, highlighting the potential for further asset allocation towards equity due to favorable domestic fiscal and monetary policies [10][11] Group 2 - Fund managers have adjusted their portfolios, with some reducing holdings in optical module leaders while increasing investments in the robotics industry [6][7] - The "Yongying Technology Smart Select" fund has seen its net asset value growth rate approach 100%, leading to a substantial increase in fund size from 11.66 billion to 115.21 billion [12] - There is a growing interest in Hong Kong stocks, with funds increasing their positions in companies like Alibaba and various biotech firms, reflecting a dual focus on technology and recovery sectors [9]

Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical and biotechnology industry [1] Core Insights - The report highlights significant advancements in innovative drugs, particularly in the context of recent clinical trial results presented at the 2025 ESMO conference, showcasing the potential for new treatment options in various cancer types [12][19] - The report emphasizes the emergence of domestic drugs that have achieved notable efficacy in treating conditions such as NSCLC and HER2-positive breast cancer, indicating a shift in the competitive landscape [13][17] Summary by Sections 1. New Drug Developments - **2L EGFR Mutant NSCLC**: The drug Lukanosumab (sac-TMT) is the first to demonstrate both overall survival (OS) and progression-free survival (PFS) benefits in patients with TKI-resistant NSCLC, with mPFS of 8.3 months compared to 4.3 months for chemotherapy [13][14] - **HER2 Positive Breast Cancer**: The drug Ruikang Trastuzumab shows longer mPFS of 30.6 months compared to 8.3 months for the chemotherapy combination, indicating a promising new option for patients [17][18] - **T-Bren for Breast Cancer**: Early data from the T-Bren trial shows a clinical overall response rate (cORR) of 82.2% in HER2-positive patients, with mPFS of 18.0 months [19][20] - **2L HER2 Positive Gastric Cancer**: Anniotuzumab combined with chemotherapy shows significant improvements in mPFS (7.1 months vs 2.7 months) and mOS (19.6 months vs 11.5 months), suggesting a potential shift in treatment paradigms [21][24] 2. Market Performance - The pharmaceutical and biotechnology sector saw a 0.58% increase in October, underperforming the CSI 300 index by 2.67 percentage points, ranking 25th among 31 sub-industries [25][30] - The medical research outsourcing sector experienced the highest growth, up 5.47%, while other bioproduct sectors faced declines [30][34]

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].

Core Viewpoint - The pharmaceutical sector is experiencing fluctuations, with a notable increase in the Medical Innovation ETF and several key stocks, indicating a positive trend in the market despite recent adjustments [1][2]. Group 1: Market Performance - As of October 24, the Medical Innovation ETF (516820.SH) rose by 0.26%, with significant gains in constituent stocks such as Kanglong Chemical (300759) up 3.34%, Xingqi Eye Medicine (300573) up 2.35%, and WuXi AppTec (603259) up 1.77% [1]. - Over the past five trading days, there have been net inflows into the Medical Innovation ETF for four days, totaling 14.06 million yuan, with an average daily net inflow of 2.81 million yuan [1]. Group 2: Upcoming Events and Innovations - The European Society for Medical Oncology (ESMO) conference in mid to late October 2025 will showcase research results from several domestic innovative drugs, including clinical trials from Kangfang Bio, Kelun Biotech, and others [1]. - The increasing competitiveness of domestic innovative drugs in global clinical data and progress is strengthening the trend of these drugs entering international markets [1]. Group 3: Industry Trends and Outlook - Historically, the fourth quarter is a peak period for business development (BD) activities, with major deals expected from companies like Kangfang Bio and Kelun Biotech [2]. - Despite recent market adjustments, the outlook for innovative drug companies remains positive, with multiple catalysts expected, including ESMO data and continued performance improvements in quarterly reports [2]. - The long-term trend for innovative drugs is upward, driven by both international expansion and domestic revenue growth, with the potential for significant market opportunities despite short-term disturbances [2].

Group 1: Sac-TMT in NSCLC Treatment - Sac-TMT has established a new benchmark for treating EGFR mutation-resistant NSCLC, showing significant improvements in PFS and OS compared to platinum-based chemotherapy in the III phase OptiTROP-Lung04 study, with median PFS of 8.3 months vs. 4.2 months (HR=0.49) and median OS of NR vs. 17.4 months (HR=0.60) [1] - The treatment demonstrated consistent OS and PFS benefits across all predefined key subgroups, including a notable OS HR of 0.59 in patients previously treated with third-generation EGFR therapies [1] - The application for market approval for this indication was granted in October, and Sac-TMT showed lower incidences of oral mucositis, ocular toxicity, and interstitial lung disease compared to competitor Dato-DXd, although it had a higher incidence of hematological toxicity [1] Group 2: ADC Product Matrix in Breast Cancer - Sac-TMT has also made significant progress in treating second-line and above HR+/HER2- breast cancer, with its market application recently accepted by CDE, while HER2 ADC, Dato-DXd, was approved for 2L+ HER2-positive breast cancer [2] - In the OptiTROP-Breast02 study, Sac-TMT achieved statistically significant PFS improvement with a median of 8.3 months vs. 4.1 months (HR 0.35) and preliminary OS HR of 0.33, showing benefits across all predefined subgroups [2] - The KL166-III-06 study indicated that Dato-DXd significantly outperformed T-DM1, extending median PFS to 11.1 months vs. 4.4 months (HR 0.39) [2] Group 3: Revenue Forecast and Target Price Adjustment - Based on regulatory approval progress, the company has a more optimistic outlook for sales of Sac-TMT and Dato-DXd, raising revenue forecasts for 2025-2027 by 0-5% and adjusting peak sales estimates to 6.4 billion and 1.1 billion RMB respectively [3] - The DCF target price has increased to 549 HKD, maintaining a buy rating, reflecting confidence in the global value of the ADC product matrix driven by clinical data [3]