Core Viewpoint - The introduction of a dual-track payment system for innovative drugs in China, combining basic medical insurance and commercial health insurance, marks a significant shift in the industry, providing a structured approach to address the payment challenges faced by high-priced innovative drugs [2][5][34]. Summary by Sections Introduction - The release of the new medical insurance directory and the first commercial health insurance directory for innovative drugs signifies the establishment of a dual-track payment system in China [2]. Innovative Drug Payment Mechanism - The reliance on a single payment channel through medical insurance has become unsustainable due to rising costs and the increasing number of high-priced innovative drugs [5]. - The latest medical insurance directory adds 114 new drugs, with 50 being class 1 innovative drugs, achieving a negotiation success rate of 88%, the highest ever [5]. Commercial Health Insurance Directory - The first commercial health insurance directory includes 19 high-value innovative drugs, providing a structured payment pathway for drugs previously excluded from medical insurance [8][20]. - This directory signals a shift in the payment structure, where both basic medical insurance and commercial insurance will share the payment responsibilities for innovative drugs [8][21]. Challenges in Medical Insurance - Despite the expansion of the medical insurance directory, high-priced innovative drugs still face significant barriers to entry due to strict cost-effectiveness evaluations and negotiation mechanisms [10][11]. - The trend indicates that medical insurance is moving towards risk control rather than merely expanding coverage [10][16]. Filling the Payment Gap - The introduction of the commercial health insurance directory is a necessary response to the limitations of the medical insurance system, providing a payment avenue for high-value drugs that have been excluded [18][21]. - The directory includes drugs with high clinical value and costs, addressing the long-standing payment vacuum in the market [18][20]. Growth Opportunities for Innovative Drugs - The commercial health insurance directory opens new growth avenues for high-priced innovative drugs, allowing for a broader patient reach and a more structured payment approach [23][24]. - The directory is expected to enhance the commercial health insurance market, with high-value innovative drugs becoming a core differentiator in product offerings [24]. Structural Bottlenecks for Commercial Health Insurance - There are significant barriers to the short-term adoption of the commercial health insurance directory, including data insufficiency, product risk acceptance, and user payment behavior [28][29][30]. - The lack of real-world data on innovative drug usage complicates pricing and risk assessment for insurance companies [29]. Conclusion - The dual-track payment system represents a structural change in the payment landscape for innovative drugs, but challenges remain in achieving widespread accessibility and effective implementation [34][35]. - The commercial health insurance system is expected to play an increasingly important role in providing payment solutions for innovative drugs, although it will take time to fully realize its potential [36].

Investment Rating - The report maintains an investment rating of "Outperform" [5] Core Insights - The innovative drug sector is experiencing rapid growth, with several new drugs being quickly incorporated into the medical insurance directory as of October 2025 [3][20] - The report highlights significant increases in the number of drugs entering hospitals, particularly those newly included in the insurance directory, indicating strong market demand [3][19] Weekly New Drug Market Review - From November 24 to November 30, 2025, the top five performing new drug companies were: Frontline Bio (+23.12%), Yifang Bio (+15.74%), Rongchang Bio (+15.39%), Kangfang Bio (+14.86%), and Jakes (+14.18%). The five companies with the largest declines were: Yongtai Bio (-4.11%), Nothland (-3.33%), Junshengtai (-2.78%), Boan Bio (-2.09%), and Dongyao Pharma (-1.11%) [1][14] Suggested Focus Stocks - The report suggests focusing on several companies with promising catalysts, including: 1. Companies with MNC certification and high overseas sales potential: Sanofi, Lianbang Pharma, and Kelun Biotech 2. Companies with overseas data catalysts: Betta Pharma, Hutchison China MediTech, and Yimeng Bio 3. Potential heavyweights for overseas MNC licensing: Fuhong Hanlin, Shiyao Group, and Yifang Bio 4. New innovative drug technology breakthroughs: small nucleic acids, in vivo CAR-T, fat reduction and muscle gain, autoimmune CAR-T/bispecific antibodies, and gene therapy [2][18] New Drug Industry Key Analysis - The National Healthcare Security Administration updated the data on innovative drugs included in the insurance directory as of October 2025, showing rapid hospital entry for several newly included domestic innovative drugs. Notable drugs with fast entry rates include: - Hengrui Medicine's Tazobactam - Innovent Biologics' Toripalimab - Haisco's Alogliptin and Clopidogrel - Sinopharm's Aliskiren and Amlodipine - Shanghai Yizhong's Paclitaxel polymer micelles - Kangfang Bio's Ivoris monoclonal antibody [3][19] New Drug Approval and Acceptance Status - This week, 11 new drugs or new indications received approval for market entry, while 13 new drugs or new indications were accepted for review [4][24] New Drug Clinical Application Approval and Acceptance Status - This week, 54 new drug clinical applications were approved, and 44 new drug clinical applications were accepted [8][27]

Core Insights - The lipid-lowering market is projected to reach $35 billion, with some drugs entering the long-term prevention field for cardiovascular event risk reduction (CVRR) [1][2] - Two significant lipid-lowering drugs are expected to report critical Phase III results in 2026, targeting PCSK9 and Lp(a) [1][2] - The development of cardiovascular and cardiac drugs is entering a harvest phase, with a focus on Phase III progress [1] Group 1: Key Developments in Lipid-Lowering Drugs - Novartis' PCSK9 small nucleic acid Leqvio and ASO drug Pelacarsen are under close observation for their Phase III trials, which could expand the market for lipid-lowering therapies [1][2] - Merck's MK-0616, the first oral cyclic peptide PCSK9 to enter Phase III, is expected to influence the long-term trajectory of the PCSK9 market [2] Group 2: Emerging Targets and Innovations - Arrowhead Pharmaceuticals' Plozasiran (ARO-APOC3) is set for FDA approval for treating familial chylomicronemia syndrome (FCS), marking a significant advancement in the siRNA field [3] - Eli Lilly's Lp(a) small molecule inhibitor Muvalaplin has initiated Phase III trials, with plans to enroll 10,450 participants, expected to complete by 2031 [3] Group 3: Direct-to-Consumer (DTC) Transformation - Major pharmaceutical companies like Eli Lilly, AbbVie, and Pfizer are launching online Direct-to-Consumer platforms, breaking traditional barriers in drug sales [4] - This shift aims to attract more self-paying users, particularly in the chronic disease sector, which is anticipated to capture the largest market share in the future [4]

Core Insights - The lipid-lowering market is projected to reach $35 billion, with some drugs entering the long-term cardiovascular event risk reduction (CVRR) prevention field [1][2] - Two significant lipid-lowering drugs are expected to report critical Phase III results in 2026, targeting PCSK9 and Lp(a) [1][2] - The development of cardiovascular and cardiac drugs is entering a harvest phase, with a focus on Phase III progress [1] Group 1: Lipid-Lowering Drugs and Market Potential - Novartis' PCSK9 small nucleic acid Leqvio and ASO drug Pelacarsen are under close observation for their Phase III trials, which could expand the market for lipid-lowering treatments [1][2] - The potential success of Novartis' VICTORION trials could signify a shift of PCSK9 from merely lowering cholesterol to long-term cardiovascular protection, with expectations of exceeding $6 billion in future market potential [2] - Merck's MK-0616, the first oral cyclic peptide PCSK9 entering Phase III, is anticipated to influence the long-term trajectory of the PCSK9 market [2] Group 2: Breakthroughs in Other Lipid-Lowering Targets - Arrowhead Pharmaceuticals' Plozasiran (ARO-APOC3) is set for FDA approval for treating familial chylomicronemia syndrome (FCS), marking a significant advancement in the siRNA field [3] - Eli Lilly's Lp(a) small molecule inhibitor Muvalaplin has initiated Phase III trials, aiming to enroll 10,450 participants, with completion expected by 2031 [3] - The Lp(a) field is becoming a competitive space with multiple large pharmaceutical companies advancing their candidates into Phase III trials, indicating a robust development landscape [3] Group 3: Direct-to-Consumer (DTC) Transformation - Major pharmaceutical companies like Eli Lilly, AbbVie, and Pfizer are launching online Direct-to-Consumer platforms, signaling a shift in drug sales strategies [4] - This transformation aims to break traditional barriers between serious medical endpoints and consumer markets, potentially attracting more self-paying users [4] - The focus on chronic disease management is expected to yield significant market share in the future [4]

Core Insights - The company achieved total product revenue exceeding 3.3 billion yuan in Q3 2025, reflecting a robust year-on-year growth of approximately 40%, surpassing expectations, driven by oncology and comprehensive pipeline products [1] - The strategic partnership with Takeda, valued at up to 11.4 billion USD, marks a significant step in the company's globalization strategy, with an initial payment of 1.2 billion USD and potential milestone payments [2] Revenue Growth - The core products, including Xinlianli (信迪利单抗), showed steady growth, while products like Masitide (玛仕度肽) and Tolezomab (托莱西单抗) demonstrated significant market access and channel marketing effectiveness, leading to accelerated revenue contributions [1] - The company has received approval for 16 products, with 2 additional products under review, indicating a strong product pipeline [1] Strategic Partnership - The collaboration with Takeda involves three core innovative drugs, including IBI363, IBI343, and IBI3001, with a focus on global development and commercialization [2] - IBI363 is expected to have a market potential exceeding 40 billion USD, with specific segments like second-line lung cancer and first-line colorectal cancer contributing significantly to this figure [2] Financial Projections - The revenue forecast for 2025-2027 has been revised upwards, with expected revenues of 12.787 billion, 22.479 billion, and 20.464 billion yuan, reflecting growth rates of 35.72%, 75.79%, and -8.96% respectively [2] - The projected net profit attributable to the parent company is estimated at 994 million, 7.251 billion, and 3.013 billion yuan for the same period [2]

Core Insights - The Hong Kong pharmaceutical market is experiencing a significant rebound, driven by the recent national negotiations regarding innovative drug pricing, with the Hong Kong Stock Connect Innovative Drug ETF (159570) surging over 2% and achieving a trading volume exceeding 3.2 billion CNY [1][3]. Group 1: Market Performance - The Hong Kong Stock Connect Innovative Drug ETF (159570) has seen a net inflow of nearly 700 million CNY during the trading session, indicating strong investor interest [1]. - As of October 31, the ETF's latest scale has surpassed 20.3 billion CNY, leading in both scale and liquidity among its peers [1]. - The top ten constituent stocks of the ETF account for 72.47% of its weight, showcasing a concentrated investment in innovative pharmaceuticals [7]. Group 2: Company Developments - Innovative drug companies are gaining attention due to the ongoing negotiations for the 2025 National Medical Insurance Directory, which includes a new commercial health insurance innovative drug directory [3]. - Notably, CAR-T cell therapy companies are in focus, with five high-cost CAR-T therapies passing the initial review for the commercial insurance directory, potentially increasing patient access [3]. - In Q3 2025, Innovent Biologics reported a total product revenue exceeding 3.3 billion CNY, reflecting a robust year-on-year growth of approximately 40%, driven by strong performance in oncology and other therapeutic areas [6][7]. Group 3: Clinical Trials and Global Expansion - Innovent Biologics and Pfizer have initiated two global Phase III clinical trials for their PD-1/VEGF dual antibody, SSGJ-707, targeting advanced non-small cell lung cancer and metastatic colorectal cancer [6]. - The trials are expected to enroll 1,500 and 800 patients respectively, with completion dates projected for early 2029 and early 2030, indicating a strong commitment to global market entry [6]. Group 4: Industry Outlook - Analysts suggest that the ongoing policy support for innovative drugs will likely lead to rapid revenue growth for those included in the medical insurance directory, benefiting both patients and pharmaceutical companies [4]. - The innovative drug sector is expected to continue its upward trajectory, with leading companies making significant progress both domestically and internationally [4][6].

Core Viewpoint - The company reported a product revenue exceeding 3.3 billion yuan in Q3, representing a year-on-year growth of approximately 40%, surpassing market expectations. This strong performance is attributed to the robust advancement of both oncology and non-oncology businesses, with continuous product volume increase. Additionally, the collaboration with Takeda is expected to lead to multiple global Phase III clinical studies for IBI363 and IBI343, with potential market opportunities exceeding 40 billion USD and 8 billion USD respectively for these indications [1][2]. Group 1 - The company achieved product revenue exceeding 3.3 billion yuan in Q3, with a year-on-year growth of about 40% [1]. - The strong revenue performance is driven by the steady progress in both oncology and non-oncology pipelines, with significant contributions from core products such as Sintilimab and other major products [1]. - The collaboration with Takeda is seen as a significant step towards internationalization, with expectations for IBI363 and IBI343 to enter global Phase III clinical studies [2]. Group 2 - The company has expanded its commercialized products to 16, making it the Chinese pharmaceutical company with the most marketed monoclonal antibodies [3]. - The R&D pipeline is progressing efficiently, with several products in various stages of clinical trials, including IBI343 and IBI354 [3]. - Revenue projections for the company are estimated at 11.806 billion yuan, 15.382 billion yuan, and 21.092 billion yuan for the years 2025 to 2027, with a target price set at 129.61 HKD [3].

Summary of the Conference Call for Innovent Biologics Company Overview - **Company**: Innovent Biologics - **Industry**: Biopharmaceuticals, specifically focusing on oncology and immunotherapy Key Points and Arguments Oncology Products - **IBI363 Performance**: - Achieved a 12-month overall survival (OS) rate of 70.9% in third-line treatment for lung cancer and 82.2% in MSS colorectal cancer, comparable to first-line therapies [2][6] - Expected to be a strong candidate for first-line indications due to its promising data and safety profile [6][11] - **Sales Projections**: - Anticipated sales for oncology products to exceed 8 billion RMB in 2024 and reach 11 billion RMB in 2025 [3] Non-Oncology Products - **Product Launches**: - Launched several key products including Masitide, Tisotumab vedotin, and Toripalimab, establishing a robust non-oncology portfolio [5] - Masitide is projected to achieve peak sales exceeding 8 billion RMB due to its strong market positioning and user experience [2][8] Clinical Trial Success - **Clinical Data**: - Innovent's drugs have shown a disease control rate (DCR) exceeding 60% and a long duration of response (DOR), indicating a lower likelihood of resistance [12][13] - The DOR for colorectal cancer is reported at 7.5 months, with progression-free survival (PFS) expected to be 3-4 months [14] Strategic Development - **R&D Strategy**: - Focus on major cancer types while expanding into other cold and hot tumor populations, with nearly 20 products in the pipeline [15] - Continuous clinical trials for various cancers including liver, stomach, and ovarian cancers [15] Market Potential - **IBI363 Internationalization**: - High potential for international market entry, expected to be a key player among second-generation immuno-oncology drugs [7] - **Financial Outlook**: - Projected to turn profitable in 2025, with revenues expected to reach 11.8 billion, 15.4 billion, and 21.1 billion RMB from 2025 to 2027, respectively [26] - Estimated net profits of 800 million, 1.2 billion, and 3 billion RMB for the same period [26] Valuation - **DCF Valuation**: - Estimated reasonable market capitalization of approximately 221.5 billion HKD, with a target price of 100.29 HKD per share [27] Other Notable Products - **Tisotumab vedotin**: - Demonstrated significant efficacy and safety in treating thyroid eye disease, with peak sales expected to reach 2 billion RMB [19] - **PCSK9 Inhibitor**: - Tric monoclonal antibody for treating primary hypercholesterolemia has been well-received since its launch in August 2023, with peak sales projected to exceed 2 billion RMB [20] - **L23 for Psoriasis**: - Expected to provide effective treatment options for psoriasis and other autoimmune diseases, with a peak sales forecast of over 3 billion RMB [21] Innovations - **IBI302 for Age-related Macular Degeneration**: - A dual-target drug showing a 40% reduction in new macular atrophy cases compared to existing treatments, currently in phase III trials [22][23] - **IBI3,002 for Autoimmune Diseases**: - A novel dual-antibody targeting IL-4 and TSLP, showing promising results in preclinical studies, with initial data expected by year-end [25] Conclusion - Innovent Biologics is positioned for significant growth in both oncology and non-oncology sectors, with a strong pipeline and promising clinical data supporting its market potential and financial outlook. The company is recommended as a strong investment opportunity in the innovative pharmaceutical sector [27]

Core Viewpoint - The company achieved rapid revenue growth in the first half of 2025, turning a profit and exceeding market expectations [1] Financial Performance - In the first half of 2025, the company reported total revenue of 5.95 billion yuan, a year-on-year increase of 50.6% [1] - The company's IFRS profit improved significantly to 830 million yuan, compared to a loss of 390 million yuan in the same period of 2024, an increase of 1.23 billion yuan [1] - Non-IFRS profit also showed significant improvement, reaching 1.21 billion yuan, up from a loss of 160 million yuan in 2024 [1] - The gross profit margin for the first half of 2025 was 86.0%, up 3.1 percentage points from 82.9% in the previous year [2] - Research and development expenses were 1.009 billion yuan, a decrease of 391 million yuan compared to the previous year [2] - As of July 31, the company had approximately 2 billion USD in cash, indicating a strong financial position [2] Product Development and Clinical Trials - The new generation IO drug IBI363 is advancing rapidly in clinical trials, with a global Phase III trial for squamous non-small cell lung cancer already initiated [2] - The company has also started key clinical studies for IO treatment of melanoma and is preparing for a Phase III trial for third-line CRC [2] - Clinical data presented at the ASCO conference showed excellent efficacy for IBI363 in non-small cell lung cancer, melanoma, and colorectal cancer [3] - The company has expanded its commercialized products to 16, making it the Chinese company with the most approved monoclonal antibody products [3] Commercialization and Market Expansion - The PCSK9 monoclonal antibody has entered the national medical insurance directory, leading to rapid market penetration [4] - The company’s product for thyroid eye disease has achieved stable commercialization, providing new treatment options for patients [4] - The metabolic pipeline product, Ma Shidu, received approval for weight loss indications, with ongoing high-efficiency commercialization efforts [5] - A strategic partnership with Alibaba Health aims to create a comprehensive health management solution for overweight or obese individuals [5] Revenue Forecast and Investment Recommendations - The company is expected to generate revenues of 11.806 billion yuan, 15.382 billion yuan, and 21.092 billion yuan from 2025 to 2027 [5] - A DCF valuation suggests a reasonable market capitalization of 221.5 billion HKD, with a target price of 129.61 HKD, maintaining a "buy" rating [5]

Investment Rating - The report maintains an investment rating of "Outperform" with a target price set for leading stocks [3][4]. Core Insights - The innovative drug sector is experiencing fluctuations, but several catalysts are anticipated, including academic conferences, business development achievements, and negotiations for medical insurance [2]. - The National Medical Insurance Administration has updated the data on innovative drugs included in the medical insurance directory, showing rapid hospital admissions for several newly included domestic innovative drugs [2][22]. Summary by Sections Weekly New Drug Market Review - From August 4 to August 10, 2025, the top five companies in the new drug sector by stock price increase were: Beihai Kangcheng (+73.1%), Jiahe Biotech (+39.0%), Gilead Sciences (+30.3%), Heyu Biotech (+21.1%), and Hengrui Medicine (+15.3%). The top five companies with the largest declines were: Hutchison China MediTech (-13.8%), Frontier Biotech (-13.4%), Yifang Biotech (-11.7%), Haichuang Pharma (-9.9%), and Maiwei Biotech (-9.2%) [1][16]. Recommended Stocks to Watch - The report suggests focusing on potential overseas licensing opportunities for significant products, including differentiated GLP-1 assets from companies like Zhongsheng Pharma, Kangyuan Pharma, and Gilead Sciences. Additionally, upgraded PD-1 products from Kangfang Biotech and others are highlighted [2][22]. Key Analysis of the New Drug Industry - The report notes that several innovative drugs newly included in the medical insurance directory are rapidly entering hospitals, with notable growth in hospital admissions for drugs such as Zaiqiang Pharma's recombinant thrombin and Hengrui Medicine's Tazemetostat [2][22][23]. New Drug Approval and Acceptance Status - This week, three new drug applications were approved, including Adalimumab injection from Wuhan Biological Products Research Institute, Dulaglutide injection from Shandong Boan Biotech, and Evinacumab injection from Xi'an Janssen [28][29]. Additionally, four new drug applications were accepted, including Trastuzumab injection from Amgen and others [28][30]. Clinical Application Approval and Acceptance Status - A total of 55 new drug clinical applications were approved this week, while 31 new drug clinical applications were accepted [10][31].