Core Insights - Akeso, Inc. reported record commercial sales in China and significant global advancements in its oncology and autoimmune pipelines for the first half of 2025, driven by its "IO 2.0 + ADC 2.0" strategy [2][11][34] - The company has established itself as a leader in immuno-oncology bispecific antibodies, particularly with cadonilimab and ivonescimab, which are being evaluated in numerous global clinical trials [5][6][9][22] - Akeso's non-oncology portfolio is also expanding, with recent product launches and ongoing developments in autoimmune diseases, contributing to overall growth [10][31][36] Financial Performance - Total commercial sales increased by 49.20%, from RMB 939.4 million in the first half of 2024 to RMB 1,401.6 million in the first half of 2025, reflecting robust market penetration [11] - Research and development expenses for the same period were RMB 731.2 million, with total cash and equivalents amounting to RMB 7,138.4 million as of June 30, 2025 [12] Oncology Pipeline - Ivonescimab and cadonilimab are being evaluated in 23 registrational/Phase III trials and over 20 Phase II studies globally, with ivonescimab demonstrating statistically significant overall survival benefits in its trials [6][8][18] - Cadonilimab has received approvals for multiple indications, including first-line treatments for cervical and gastric cancers, addressing significant unmet needs in immunotherapy [22][23][25] Non-Oncology Pipeline - The company has launched ebdarokimab and ebronucimab, with upcoming launches for gumokimab and manfidokimab, enhancing its competitive position in the autoimmune sector [10][31][35] - Akeso's innovative candidates targeting neurological diseases and other chronic conditions are also progressing through development [32][36] Strategic Initiatives - Akeso is advancing a next-generation pipeline of bispecific ADCs and dual-payload ADCs, aiming to redefine the oncology treatment landscape [27][29] - The company is open to strategic collaborations to enhance its global reach and maximize therapeutic value [26]

Core Viewpoint - Akeso, Inc. has received approval to initiate a global Phase II trial for cadonilimab, a bispecific antibody, to treat advanced hepatocellular carcinoma (HCC) in patients previously treated with other therapies, addressing a significant unmet need in cancer treatment [1][4][6] Group 1: Clinical Development - The COMPASSION-36/AK104-225 trial is a pivotal part of cadonilimab's global development strategy, aiming to improve treatment options for patients with HCC who have developed resistance to existing therapies [2][3] - Cadonilimab is the first bispecific antibody approved globally for cancer immunotherapy, demonstrating potential in combination therapies for HCC and other malignancies [5][6] Group 2: Market Need - HCC is a prevalent cancer, with approximately 865,000 new cases reported globally in 2022, and there are currently no FDA-approved second-line therapies for patients whose disease progresses after first-line treatment [4][6] - The lack of effective second-line treatment options for advanced malignancies highlights the critical need for new therapeutic strategies, which cadonilimab aims to address [3][4] Group 3: Research and Innovation - Akeso is advancing multiple clinical trials for cadonilimab, including studies for neoadjuvant therapy and combination therapies with other agents, showcasing its commitment to addressing cancer immunotherapy resistance [6][10] - The company has a robust pipeline of over 50 innovative assets, with 24 candidates in clinical trials, reflecting its focus on developing first-in-class and best-in-class therapies [10]

Group 1 - Akeso, Inc. has successfully enrolled the first patient in its Phase Ia clinical trial for AK146D1, a bispecific Antibody-Drug Conjugate (ADC) targeting Trop2 and Nectin4, marking its first bispecific ADC to enter clinical trials [1] - AK146D1 has received approvals from the U.S. FDA, Australia's TGA, and China's NMPA to begin clinical trials, indicating strong regulatory support for the product [1] - Akeso is the only company globally with two approved cancer immunotherapy bispecific antibodies, cadonilimab and ivonescimab, establishing a strong leadership advantage in the IO+ADC space [2] Group 2 - ADC therapeutics are a key component of Akeso's "IO+ADC" 2.0 strategy, which aims to reshape the global treatment landscape and set new standards for cancer care [3] - The company emphasizes the potential of innovative bispecific ADCs like AK146D1 to unlock global clinical opportunities and enhance cancer therapies [4] - Trop2 and Nectin4 are ideal targets for ADC therapy due to their high expression in various tumor types and low expression in normal tissues, which may improve treatment efficacy [4][5] Group 3 - AK146D1 is the first bispecific ADC targeting both Trop2 and Nectin4, with preclinical studies showing strong anti-tumor activity and favorable safety profiles [5] - The development of AK146D1 holds significant potential for improving treatment outcomes for cancer patients, highlighting Akeso's commitment to advancing cancer therapies [5]

Investment Rating - The report maintains a "Buy" rating for several healthcare stocks, including Wuxi Apptec and Eyebright, based on their strong growth potential and market positioning [11]. Core Insights - The EU's planned restrictions on Chinese medtech firms' access to public procurements over EUR 5 million are expected to have limited impact on the covered companies, as most do not participate in such procurements and have manageable revenue exposure to the EU market [3]. - The healthcare indices in China showed positive performance, with HSHCI rising by 4.1% and HSHKBIO by 4.5% during the week of June 2-6, 2025, indicating a favorable market trend [2]. - Recent approvals in the drug sector include Akeso's cadonilimab for cervical cancer and Hansoh's aumolertinib for NSCLC in the UK, showcasing ongoing innovation and regulatory progress in the industry [4][5]. Summary by Sections Market Access and Regulatory Environment - The EU's International Procurement Instrument investigation concluded that China has limited EU medical device producers' access to government contracts, leading to the proposed restrictions [3]. - Companies like Mindray and MGI Tech have established local manufacturing facilities, which may help mitigate the impact of these restrictions [3]. Drug Approvals and Developments - Akeso's cadonilimab received approval for treating first-line cervical cancer, while Innovent and Hutchmed's sintilimab + fruquintinib application was accepted for renal cell carcinoma [4]. - Hansoh's aumolertinib has been approved in the UK for specific NSCLC patients, indicating a strong pipeline for innovative therapies [4]. Stock Performance and Recommendations - The report highlights top picks in the healthcare sector, including Wuxi Apptec and Eyebright, based on their expected solid fundamental recovery and market share potential [11]. - The report notes that the chemicals sector outperformed healthcare indices, with a 1.7% increase in A shares and a 3.8% increase in H shares [12].