今日（8.21）港股涨跌互现，港股通创新药ETF（159570）历经2天回调后反弹飘红涨近1%，成交额快速突破11亿元，盘中再度吸金3200万元，至此资金已 连续第23天疯狂净流入（7/22-8/21），近20日累计"吸金"超10亿元！截至8月19日，港股通创新药ETF（159570）最新规模超165亿元，规模和流动性持续领 跑！ 截至10:17，港股通创新药ETF（159570）标的指数成分股多数飘红：荣昌生物涨超4%，远大医药、金斯瑞生物科技涨超3%，中国生物制药、信达生物、百 济神州、翰森制药涨超1%，康方生物、石药集团微涨。 | 序号 | 代码 | 名称 | 涨跌幅 | 估算权面 | | --- | --- | --- | --- | --- | | 1 | 1530 | 三生制药 | -0.85% | 7.72% | | 2 | 1177 | 中国生物制药 | 1.88% | 10.45% | | 3 | 9926 | 康方生物 | 0.86% | 13.84% | | 4 | 1801 | 信达生物 | 1.85% | 9.23% | | 5 | 1093 | 石药集团 | 0.39% | 8.7 ...

Core Insights - The report emphasizes the focus on the innovative drug industry chain and reasonably valued medical device targets for investment strategies in the pharmaceutical and biotechnology sector [1][4]. Investment Strategy - The investment strategy suggests paying attention to the innovative drug industry chain and reasonably valued medical device targets. The proposed investment portfolio for August 2025 includes A-shares such as Mindray Medical, WuXi AppTec, Aier Eye Hospital, New Industry, Huatai Medical, Kaili Medical, Aohua Endoscopy, Adebiotech, Aibo Medical, and KingMed Diagnostics, as well as H-shares like Kangfang Biologics, Kelun-Botai Biologics-B, Hutchison China MediTech, Kangnuo-B, Sanofi, WuXi AppTec, Aikang Medical, and Gushengtang [4][5]. Market Trends - The National Healthcare Security Administration (NHSA) has released a list of drugs that passed the initial review for innovative drugs, indicating potential growth from commercial insurance. In 2025, the NHSA received 718 submissions for the basic medical insurance directory, with 534 passing the initial review, and 141 submissions for the commercial insurance innovative drug directory, with 121 passing the initial review [4][9]. Clinical Data and Conferences - The report highlights the upcoming World Lung Cancer Conference (WCLC) and European Society for Medical Oncology (ESMO) meetings, where several domestic innovative drugs will present their research results, showcasing the increasing competitiveness of domestic innovative drugs in global markets [4][9]. Policy Changes - The report notes a shift in the centralized procurement policy, moving away from a simple lowest price reference to a more balanced approach that considers clinical stability, quality assurance, and cost justification. This change is expected to improve the profitability of the medical device industry in the coming years [4][9]. Industry Performance - The pharmaceutical industry showed a 13.93% increase in July, outperforming the CSI 300 index by 10.38%. Sub-sectors such as medical services, chemical pharmaceuticals, and biological products experienced significant growth, with increases of 23.10%, 17.92%, and 12.54% respectively [10][12]. Valuation Insights - The overall valuation level of the pharmaceutical and biotechnology sector is currently at a historical percentile of 80.69%, with a price-to-earnings (PE) ratio of 39.11. The sector's premium relative to the CSI 300 and the entire A-share market is at its five-year average [21][22].

Core Viewpoint - The report from Huafu Securities indicates that Kangfang Biopharma (9926.HK) is leading globally in the development of its self-researched dual antibody AK112, which is expected to capture the largest share of the global second-generation immuno-oncology (IO) market [1] Financial Projections - The projected revenues for Kangfang Biopharma for the years 2025, 2026, and 2027 are estimated to be 35.18 billion, 57.65 billion, and 93.72 billion CNY respectively [1] - The expected net profits attributable to the parent company for the same years are projected to be -1.86 billion, 8.03 billion, and 29.66 billion CNY respectively [1] Valuation - The reasonable market capitalization for Kangfang Biopharma is estimated to be 222.8 billion HKD [1] - The report maintains a "buy" rating for the company's stock [1]

Core Insights - The enthusiasm for domestic innovative drug development remains strong, with continuous growth in innovative outcomes [1] - In 2024, six domestic innovative drugs are expected to receive their first approvals in overseas markets [1] - In clinical research, the number of clinical trial registrations for domestic innovative drugs surpassed that of the United States in 2023, ranking first globally [1] - The number of first-in-class (FIC) innovations ranks second globally, only behind the United States [1] - Domestic innovative drugs hold a high proportion in both mature and FIC target therapies [1] - The quality of domestic innovations is being validated through head-to-head clinical results of drugs like Zebutine and AK112 in overseas markets [1] - The recognition of Chinese data is increasing at various global conferences [1] - Dongwu Securities indicates that the current logic of the innovative drug industry has shifted to focus on business development (BD) for international expansion [1] - More domestic innovative pharmaceutical companies are utilizing diverse methods such as licensing and joint development to push their self-developed drugs into international markets, aiming for breakthroughs in mature pharmaceutical markets like Europe and the U.S. [1] - This new model of "local innovation to global monetization" is reshaping the industry landscape [1] - The innovative drug index still has significant room for growth compared to its peak in 2021 [1] - The Hong Kong Stock Connect Medical ETF (520510) has been launched, tracking the Hong Kong Stock Connect medical theme index, which covers three major segments of the medical sector [1] - The ETF has over 30% weight in CXO, over 20% in AI medical, and nearly 50% in innovative drugs, and is expected to benefit from trends such as anti-involution, innovative drug internationalization, and the AI technology revolution [1]

Market Performance - The Hang Seng Hong Kong Stock Connect Innovative Drug Select Index (HSSCPB) decreased by 4.06% as of August 7, 2025 [3] - Notable declines in constituent stocks include: Innovent Biologics (09969) down 9.00%, Lepu Biopharma-B (02157) down 8.21%, and CanSino Biologics (09926) down 7.18% [3] - The Hong Kong Innovative Drug Select ETF (520690) fell by 2.79%, with the latest price at 0.98 yuan [3] - Over the past week, the Hong Kong Innovative Drug Select ETF has seen a cumulative increase of 1.62%, ranking in the top half among comparable funds [3] Liquidity and Trading Activity - The Hong Kong Innovative Drug Select ETF had a turnover rate of 16.49%, with a trading volume of 57.78 million yuan, indicating active market participation [3] - The average daily trading volume for the ETF over the past year was 72.86 million yuan [3] Company Performance - BeiGene reported a total revenue of 17.518 billion yuan for the first half of 2025, a year-on-year increase of 46.0% [3] - The company achieved a net profit of 450 million yuan, marking its first half-year profit since its A-share listing [3] - Revenue growth was driven by sales of self-developed products such as Baiyueze® and licensed products from Amgen, alongside improved operational efficiency through cost management [3] Industry Trends - Despite significant financing pressures in primary and secondary markets, enthusiasm for domestic innovative drug research remains high, with continuous growth in innovative outcomes [4] - In 2024, six domestic innovative drugs received their first approvals overseas, reflecting an acceleration in international recognition [4] - In clinical research, domestic innovative drug trial registrations surpassed those in the U.S. for the first time in 2023, ranking first globally [4] - The share of domestic innovative drugs in emerging therapies is notably high, with significant clinical results from products like Zebutini and AK112 [4] Fund Performance - The Hong Kong Innovative Drug Select ETF saw a significant increase of 28 million shares over the past week, ranking in the top half among comparable funds [4] - The ETF experienced a net outflow of 2.0112 million yuan recently, but had net inflows on three out of the last four trading days, totaling 27.5305 million yuan [4] - The management fee for the ETF is 0.50%, and the custody fee is 0.10%, making it the lowest among comparable funds [4] - As of August 6, 2025, the ETF's tracking error for the year was 0.173%, the highest tracking precision among comparable funds [4] Index Composition - The top ten weighted stocks in the HSSCPB index include BeiGene (06160), Innovent Biologics (01801), WuXi Biologics (02269), and others, collectively accounting for 78.31% of the index [5] - The index aims to reflect the performance of Hong Kong-listed companies involved in innovative drug research, development, and production [5]

Summary of the Conference Call for Kangfang Biotech Company Overview - **Company**: Kangfang Biotech - **Date**: August 6, 2025 Key Points Industry and Company Focus - Kangfang Biotech has strategically shifted focus from PD-1 monoclonal antibodies to bispecific antibodies as limitations of PD-1 therapies become apparent, showcasing its market foresight and strategic vision [2][3] - The company has demonstrated exceptional R&D efficiency, with all early-stage innovative drugs successfully advancing to commercialization or registration clinical stages, particularly core products AK104 and AK112, which have surpassed domestic average development speeds [2][3] Product Development and Clinical Trials - AK112 has shown outstanding performance in clinical trials for first-line wild-type non-small cell lung cancer (NSCLC), with the Harmony II study indicating a 49% reduction in progression and mortality risk compared to K drug, without significant increase in severe adverse reactions [4][13] - AK112 is being tested across multiple indications, including triple-negative breast cancer, biliary cancer, pancreatic cancer, and colorectal cancer, aiming to cover more patient groups who cannot use PD-1 inhibitors or have poor responses [4][19] Internationalization Achievements - Kangfang Biotech has made significant strides in international development, including licensing its monoclonal antibody to Merck in 2015 and a $5 billion exclusive licensing deal with Summit for Ivosidenib in 2022, marking a record for Chinese innovative drug out-licensing [6] - The company’s PD-1 monoclonal antibody received FDA approval in April 2025, becoming the first innovative biopharmaceutical independently developed by a Chinese company to achieve this milestone [6] Market Potential and Competitive Advantage - The second-generation immuno-oncology (IO) market is projected to be 3 to 4 times larger than the PD-1/PD-L1 inhibitor market, with AK112 positioned as a first-mover with significant value potential [2][7] - AK112's unique tetravalent structure enhances affinity for PD-1 and VEGF, significantly improving related signaling pathway effects and demonstrating superior safety in clinical trials compared to monoclonal antibodies or monoclonal antibody-VEGF combinations [11] Future Development and Market Outlook - The market is expected to focus on AK112's overseas clinical layout and collaboration progress in 2025, with potential for re-licensing or acquisition impacting asset revaluation [7] - The overall market for PD-1/PD-L1 inhibitors is projected to exceed $90 billion by 2028, with second-generation IO drugs potentially surpassing $300 billion in market size [9] Financial Projections - AK104 is expected to exceed 4 billion RMB in risk-adjusted peak sales in China, while AK112 could reach 8.5 billion RMB domestically and $23.3 billion in overseas markets, leading to a total valuation exceeding $200 billion for Kangfang Biotech [28][29] Pipeline and Future Innovations - Kangfang Biotech is not limited to bispecific antibodies but is also developing a range of candidates, including dual-target ADCs and other innovative therapies across various indications, indicating a robust pipeline for future growth [25][26] Conclusion - Kangfang Biotech's strategic pivot towards bispecific antibodies, strong R&D capabilities, international partnerships, and a promising pipeline position it favorably within the rapidly evolving oncology market, with significant growth potential anticipated in the coming years [2][29]

Group 1 - The core viewpoint of the article emphasizes that under the pressure of medical insurance policies, going overseas has become an inevitable choice for China's innovative pharmaceutical industry due to increasing aging population and limited domestic market space for innovative drugs [3][8] - The pressure on medical insurance balance is growing, with the elderly population reaching 217 million in 2023, accounting for 15.4% of the total population, leading to increased medical demand and expenditure [9][11] - The proportion of commercial insurance in medical expenses is only 6.5%, significantly lower than in countries like the US and Japan, making it difficult to support innovative drug payments in the short term [12][15] Group 2 - Despite financing pressures in the primary and secondary markets, the enthusiasm for domestic innovative drug research and development remains high, with a 11.2% year-on-year increase in clinical approvals for innovative drugs in 2024 [31][32] - In 2024, a record 39 domestic innovative drugs were approved for market launch, indicating a significant growth in the innovative drug pipeline [33][34] - The number of clinical trials for innovative drugs in China has surpassed that of the US, ranking first globally, with 1,903 trials registered in 2024 [45][49] Group 3 - The overseas market offers higher pricing and larger market space for innovative drugs, with the price of innovative drug Zebutini in China being only about 3% of its price in the US and Europe [23][25] - Japan's experience shows that innovation and going overseas are essential paths to break domestic pressures, as seen in the historical context of Japan's pharmaceutical industry [27][28] - The case of Takeda Pharmaceutical illustrates that innovation and international expansion are crucial for growth, with its revenue from the US market reaching 51.5% by 2024 [28][29] Group 4 - License out transactions are rapidly increasing, with 2024 seeing a total transaction amount exceeding $10 billion, accounting for 31.9% of heavy transactions globally [5][77] - The types of license out transactions are becoming more diverse, with emerging technologies like ADC and dual antibodies gaining traction [81][82] - The research and development stage of license out projects is shifting earlier, with 64% of products in the preclinical stage in 2024 [83][84] Group 5 - Foreign investments are gradually expanding from purchasing innovative drug products to acquiring domestic innovative pharmaceutical companies, as seen in recent acquisitions by AstraZeneca and Genmab [89][90] - The NewCo model is emerging as a new financing method, allowing domestic innovative pharmaceutical companies to split off parts of their product pipelines to attract investment [92][93]

Summary of Key Points from the Conference Call Industry Overview - The focus is on the next-generation immuno-oncology (IO) therapeutics, which include bi/trispecific PD-1/VEGF, PD-1/IL-2, and PD-1/VEGF/CTLA4 candidates that have the potential to significantly alter cancer treatment landscapes [1][11][19]. Market Potential - The total addressable market (TAM) for next-generation IO products is estimated to exceed US$62 billion, driven by the expiration of key patents like Keytruda and Opdivo in 2028 [2][19][24]. - The current market for PD-1 IO therapies is projected to reach over US$50 billion, with significant growth expected as new candidates enter the market [11][19]. Company-Specific Insights Akeso Inc (9926.HK) - Akeso's ivonescimab has demonstrated statistically significant improvements in progression-free survival (PFS) in the HARMONi-2/HARMONi-6 trials, with promising overall survival (OS) data [2][29]. - Target price (TP) raised to HK$185 from HK$98, reflecting strong revenue growth and a robust pipeline [5][31]. - The company has achieved significant revenue of Rmb2.1 billion in 2024 and has transitioned from a high-risk rating to a buy rating [5][31]. Innovent (1801.HK) - Innovent's IBI363 has shown promising data in IO-treated non-small cell lung cancer (NSCLC) and is expected to launch pivotal trials in 2H25 [2][32][33]. - TP increased to HK$105 from HK$90, with a focus on next-generation IO and antibody-drug conjugate (ADC) combinations [5][34]. 3SBio (1530.HK) - 3SBio is developing SSGJ-707 (PD-1/VEGF) and is expected to present more data in upcoming meetings [27]. - TP raised to HK$36 from HK$21, reflecting increased peak sales forecasts [5][28]. Shanghai Junshi Biosciences (1877.HK) - Junshi is conducting Phase 2 studies for JS207, with data expected in 3Q25 [35]. - TP adjusted to HK$32 from HK$17, indicating growth potential [5][36]. Sino Biopharmaceutical (1177.HK) - Sino Biopharmaceutical announced the acquisition of LaNova Medicines to enhance its innovative pipeline [37]. - TP increased to HK$8.80 from HK$6.20, reflecting progress in drug development [5][38]. Investment Opportunities and Risks - There are numerous business development (BD) opportunities as multinational corporations (MNCs) seek to replenish their pipelines with new drugs [3][24]. - The expiration of patents for leading IO products creates a competitive landscape, necessitating innovation and strategic partnerships [3][24]. Clinical Data and Progress - Promising clinical data for next-generation IO candidates, including head-to-head comparisons, have garnered investor interest [11][16]. - The report emphasizes the importance of clinical data in determining market share and probability of success (PoS) for each candidate [4][18]. Conclusion - The next-generation IO space presents significant investment opportunities, with several companies showing promising clinical data and strong market potential. Adjustments in target prices reflect the anticipated growth and success of these candidates in the evolving oncology landscape [5][18][19].

Summary of Conference Call Records Industry Overview - The Chinese innovative pharmaceutical industry is experiencing accelerated development, driven by internationalization, policy support, and technological breakthroughs [3][4] - The recognition of Chinese innovative drugs in international markets is increasing, with a notable rise in BD (business development) transactions and large upfront payments [1][3] Key Companies Innovent Biologics (信达生物) - Sales revenue from tumor products has rapidly increased, surpassing 8 billion RMB in 2024 and expected to reach 11 billion RMB in 2025 [1] - IBI363 shows significant efficacy in lung cancer and colorectal cancer, with a 12-month overall survival (OS) rate of 70.9% in lung cancer patients [7][8] - The company has a strong competitive advantage in the tumor field, with multiple potential products and a robust pipeline [9] - Non-tumor products like Masudutai and others are also entering the sales phase, with peak sales expected to exceed 8 billion RMB [10] Kangfang Biopharma (康方生物) - Revenue growth is projected to exceed 70% in 2025 and around 40% in 2026, driven by continuous product approvals and market expansion [1][13] - AK112, a core product targeting PD-1 and VEGF, shows rapid clinical advancement and high safety, particularly in squamous cell carcinoma [14][15] - The company is actively pursuing early treatment research for PD-1 resistant patients, differentiating itself from competitors [2][17] Technological Breakthroughs - Innovations in ADC (Antibody-Drug Conjugates), IO (Immuno-Oncology) bispecific antibodies, GLP-1, and T-cell engagers are leading industry advancements [1][3] - Kangfang's dual antibody technology platform has significantly improved R&D success rates, with rapid approval timelines for key products [13] Investment Insights - Recommended investment targets include companies like Heng Rui Medicine, BeiGene, and others in both A-share and H-share markets [5] - Key investment considerations include overseas sales potential and anticipated business development activities [4] Future Catalysts - For Innovent, upcoming catalysts include the initiation of clinical trials for various products and expected data readouts in 2026 [11] - Kangfang is expected to continue rapid progress in overseas clinical research and expand its market presence [18][24] Market Valuation - Kangfang's current reasonable market value is estimated at 200.098 billion RMB, with a target price of 222.93 RMB based on DCF model calculations [25]

Group 1 - The core viewpoint of the report is that the target price for Kangfang Biotech (09926) has been raised by 21.7%, from HKD 115 to HKD 140, while maintaining a "Buy" rating [1] - Key short-term catalysts include: 1) Overseas application and complete data publication of the HARMONi study; 2) Publication of the AK112-306 study at ESMO 2025; 3) Results of multiple product/indication health insurance negotiations in Q4 2025; 4) Progress of more early-stage projects like ADC [1] - The company is optimistic about the overseas approval prospects of Ivosidenib, with a clearer path for it to become a new generation I/O cornerstone drug, replacing PD-(L)1 single-target therapies [1] Group 2 - Cardunili's overseas development has initiated liver cancer research, with the recent approval of its third indication for first-line cervical cancer in the general population, and potential participation in health insurance negotiations later this year [2] - The company is starting a Phase II study of Cardunili in combination with Lenvatinib overseas, with expectations of seeing more assets registered and listed in the next 2-3 years [2] - The differentiated ADC development strategy is progressing well, with the first ADC (HER3) entering clinical trials and the first bispecific ADC AK146D1 completing its first patient enrollment [2]