Group 1 - The stock of Sanofi Pharmaceutical (01530.HK) rose nearly 7% in early trading, with a current increase of 6.43%, priced at 29.46 HKD [2] - The trading volume reached 381 million HKD [2]

Core Viewpoint - The stock of 3SBio (01530) rose nearly 7% in early trading, driven by Pfizer's registration of two global Phase III clinical trials for the PD-1/VEGF dual antibody PF-08634404 (SSGJ-707) on Clinicaltrials.gov [1] Group 1: Clinical Trials and Developments - Pfizer registered two global Phase III clinical trials for PF-08634404, focusing on advanced non-small cell lung cancer (NSCLC) in comparison to Keytruda plus chemotherapy and metastatic colorectal cancer [1] - The clinical trials are expected to be rapidly initiated by Pfizer for NSCLC and other solid tumors, with exploration of PF-08634404 in monotherapy and combination therapy with other treatments, including ADCs [1] Group 2: Financial Aspects - In May, Pfizer secured the rights to 3SBio's PD-1/VEGF dual antibody with an upfront payment of $1.25 billion, milestone payments of up to $4.8 billion, and a double-digit percentage of sales [1] Group 3: Market Outlook - According to Zhongyou Securities, PF-08634404 is anticipated to become a cornerstone treatment in global oncology, highlighting its potential impact on the market [1]

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]

Group 1: Market Performance and Opportunities - The MSCI China Healthcare Index has increased by 58.6% year-to-date, outperforming the MSCI China Index which rose by 24.2% [1] - The recent slight pullback in the healthcare sector (10% decline in MSCI China Healthcare Index since October) presents a buying opportunity [1] - The recovery in capital market financing and the increase in overseas transactions for innovative drugs indicate a rebound in domestic innovative drug R&D demand [1] Group 2: Clinical Data and Drug Development - SKB264 is the only drug showing statistically significant overall survival (OS) in a Phase III trial for EGFR-TKI resistant NSCLC, with a hazard ratio (HR) of 0.56 compared to chemotherapy [2] - Ivonescimab demonstrated a median progression-free survival (mPFS) of 11.1 months in first-line sqNSCLC, outperforming the comparator at 6.9 months (HR=0.60) [2] - The uORR for drug 707 in first-line colorectal cancer reached 82.6%, with a cORR of 65.2%, indicating strong efficacy [2] Group 3: Strategic Collaborations and Future Outlook - The company suggests focusing on the clinical advancement of authorized pipelines overseas, as this has a higher certainty of success and can act as a catalyst for stock price increases [3] - The strategic collaboration between Innovent Biologics and Takeda for IBI363 involves shared global R&D costs and commercial rights, reflecting confidence in the drug and commitment to global strategy [3] - Pfizer is expected to announce overseas clinical plans for drug 707 within the year, with a focus on its combination with multiple ADC products [3]

Group 1 - The MSCI China Healthcare Index has increased by 58.6% since the beginning of 2025, outperforming the MSCI China Index by 24.2% [1] - The recent slight pullback in the healthcare sector (10% since October) presents a buying opportunity, driven by a recovery in capital market financing and an increase in the scale of innovative drug exports [1] - The CXO industry is expected to see performance recovery in the second half of 2025 due to the anticipated interest rate cuts in the U.S. [1] Group 2 - Significant clinical data was released at the ESMO conference, highlighting key drugs such as SKB264, which shows statistical significance in overall survival for NSCLC patients resistant to EGFR-TKI [2] - The mPFS for lvonescimab in first-line sqNSCLC was reported at 11.1 months, compared to 6.9 months for the control group [2] - The uORR for drug 707 from 三生制药 in first-line colorectal cancer reached 82.6%, indicating strong efficacy [2] Group 3 - The impact of business development (BD) on stock prices is diminishing, prompting a focus on the clinical advancement of authorized pipelines overseas [3] - 信达生物 has entered a global strategic partnership with Takeda for IBI363, sharing 40% of global R&D costs and U.S. commercial rights, reflecting confidence in the drug and commitment to globalization [3] - The company anticipates that clinical progress will serve as a catalyst for stock price increases, with most value realization dependent on successful commercialization rather than upfront payments from licensing deals [3]

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 an investment rating of "Outperform" with a rating of A [5] Core Insights - The report highlights the significant performance of domestic new drugs showcased at the ESMO 2025 conference, with several companies presenting excellent clinical data [3][21] - The report emphasizes the importance of academic conferences as key catalysts for the innovative drug sector, particularly mentioning ESMO, ASCO, and WCLC as critical events for Chinese pharmaceutical companies [20] Weekly New Drug Market Review - From October 20 to October 26, 2025, the top five gainers in the new drug sector were: - 欧康维视 (+8.87%) - 君圣泰 (+8.21%) - 诺思兰德 (+7.07%) - 友芝友 (+4.42%) - 海创药业 (+3.73%) - The top five losers were: - 康宁杰瑞 (-17.72%) - 北海康成 (-14.42%) - 创胜集团 (-14.29%) - 宜明昂科 (-13.40%) - 来凯医药 (-12.40%) [16][17] Recommended Focus Stocks - The report suggests focusing on several stocks with potential catalysts, including: 1. Products with high overseas volume certainty after MNC certification: - PD-1 upgraded product: 三生制药 - GLP-1 asset: 联邦制药 - ADC assets: 科伦博泰, 百利天恒 2. Potential heavyweights for overseas MNC authorization: - PD-1 upgraded products: 康方生物, 信达生物 - Breakthroughs in autoimmune fields: 益方生物, 中国抗体 - Innovative target ADC: 复宏汉霖, 石药集团 3. Stocks likely to benefit from medical insurance negotiations and commercial insurance innovative drug directories: - Beneficiaries of medical insurance directory: 恒瑞医药, 康诺亚, 迈威生物, 智翔金泰, 海创药业 - Beneficiaries of commercial insurance innovative drug directory: 药明巨诺, 科济药业 [2][20] New Drug Approval and Acceptance - This week, four new drug or new indication applications were approved, and five new drug or new indication applications were accepted in the domestic market [9] - A total of 46 new drug clinical applications were approved, and 31 new drug clinical applications were accepted [10] Key Domestic Market Events - 信达生物 announced a global strategic partnership with Takeda to accelerate the development of new generation tumor immunotherapy and antibody-drug conjugate therapies [11] - 康宁杰瑞 and 石药集团 announced that their HER2 bispecific antibody-drug conjugate JSKN003 received breakthrough therapy designation from the CDE [11] - 和黄医药 presented clinical data for HMPL-A251 at the AACR-NCI-EORTC conference [11] Key Overseas Market Events - 罗氏 received FDA approval for Gazyva/Gazyvaro for the treatment of active lupus nephritis in adult patients [12] - Electra Therapeutics announced that its therapy ELA026 received breakthrough therapy designation from the FDA and PRIME qualification from the EMA [12] - 安斯泰来 announced that the FDA accepted its supplemental biologics license application for the antibody-drug conjugate Padcev in combination with Keytruda [12]

Core Points - The Hong Kong Innovative Drug ETF (159567) closed down 0.12% with a trading volume of 797 million yuan on October 24, 2024 [1] - The fund was established on January 3, 2024, with a management fee of 0.50% and a custody fee of 0.10% [1] - As of October 23, 2024, the fund's latest share count was 8.225 billion shares, with a total size of 6.801 billion yuan, reflecting a year-to-date increase of 1980.29% in shares and 1700.12% in size [1] Fund Performance - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 65.38% during the tenure [2] - The fund's performance benchmark is the National Index for Hong Kong Innovative Drugs, adjusted for valuation exchange rates [1] Liquidity and Trading Activity - Over the last 20 trading days, the ETF has accumulated a trading amount of 22.849 billion yuan, with an average daily trading amount of 1.142 billion yuan [1] - Since the beginning of the year, the ETF has recorded a total trading amount of 227.996 billion yuan over 195 trading days, averaging 1.169 billion yuan per day [1] Top Holdings - The ETF's top holdings include: - Innovent Biologics (9.52% holding, 26 million yuan market value) - WuXi Biologics (9.47% holding, 25.8 million yuan market value) - BeiGene (8.73% holding, 23.8 million yuan market value) - CanSino Biologics (7.62% holding, 20.8 million yuan market value) - China National Pharmaceutical Group (7.17% holding, 19.6 million yuan market value) [2]