Core Insights - Akeso, Inc. has successfully included all five of its self-developed innovative drugs in the updated National Reimbursement Drug List (NRDL) for 2025, effective January 1, 2026, which enhances patient access to these treatments [1][2][3] Group 1: Drug Inclusion Details - All approved indications for Akeso's five independently commercialized drugs are now part of the NRDL, addressing major tumor diseases and autoimmune disorders prevalent in China [1][2] - Ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, has secured inclusion for its new first-line indication for PD-L1-positive non-small cell lung cancer (NSCLC), demonstrating a 49% reduction in disease progression or death compared to pembrolizumab in clinical trials [3][4] - Cadonilimab, another first-in-class bispecific antibody, has successfully negotiated inclusion for first-line indications in gastric and cervical cancers, showing significant clinical benefits across all patient populations [4] - Penpulimab has achieved NRDL inclusion for all four of its approved indications, including treatments for nasopharyngeal carcinoma and classical Hodgkin lymphoma [5] - Ebdarokimab, targeting IL-12/IL-23, has been included for the treatment of moderate-to-severe psoriasis, marking Akeso's first drug in the autoimmune disease sector [7] - Ebronucimab has secured inclusion for both of its approved indications related to hypercholesterolemia, enhancing its market presence [8] Group 2: Strategic Implications - The successful inclusion of these drugs in the NRDL is expected to reduce the financial burden on patients and provide superior treatment alternatives, thereby addressing significant public health challenges in China [2] - The recognition of these drugs in clinical practice prior to NRDL inclusion indicates their breakthrough clinical value and enhances trust among healthcare providers and patients [2] - This achievement lays a solid foundation for accelerating broader clinical adoption and supports Akeso's ongoing commercialization efforts, positioning the company for sustained growth and global expansion [2][3] Group 3: Company Overview - Akeso is a leading biopharmaceutical company focused on the research, development, manufacturing, and commercialization of innovative biological medicines, with a robust pipeline of over 50 assets in various therapeutic areas [12] - The company utilizes an integrated R&D innovation system and has developed a comprehensive drug development platform, which includes bispecific antibody technology [12] - Akeso aims to provide affordable therapeutic antibodies globally while creating significant commercial and social value, striving to become a leading player in the biopharmaceutical industry [12]

Business Highlights - Akeso's commercial sales revenue in 2025H1 reached RMB 1.402 billion, a 49% year-on-year increase[16, 24] - The company has 13 Phase III/registrational trials of ivonescimab covering lung cancer and expanding to cold tumors[13] - The company has 10 phase III clinical studies of cadonilimab across lung cancer, gastric cancer, liver cancer and cervical cancer[13] - Penpulimab receives FDA approval in the United States[14] Pipeline Development - Three blockbuster new drug candidates entered clinical stage[19] - Six Phase III clinical trials reached the primary endpoint[20] - Ivonescimab's first global Phase III trial received positive results[84] - Manfidokimab (IL-4Rα) Reached Endpoints in the Registrational Phase III Trial for Atopic Dermatitis[116] Financial Performance - 1H 2025 Revenue reached RMB 1.412 billion, a 33.7% growth from 1H in 2024[16] - The company has cash and short-term financial assets of approximately RMB 7.14 billion[16] - Sales and Marketing expense as a percentage of sales decreased from 55% in 2024H1 to 48% in 2025 H1[136, 140]