All Approved Indications of Five Akeso's Innovative Drugs Included in China's Latest NRDL: Featuring Two First-in-Class Bispecifics with New First-Line Indications and Three Newly Negotiated Drugs

HONG KONG, Dec. 7, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced the successful inclusion of all five of the Company's self-developed innovative drugs into the updated National Reimbursement Drug List (NRDL) for 2025, released by China's National Healthcare Security Administration (NHSA), effective January 1, 2026.  These inclusions cover both newly added indications of previously included drugs, and as well as those participating in national reimbursement negotiations for the first time. With these inclusions, all approved indications for Akeso's five independently commercialized, internally developed drugs are now part of the NRDL.

Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso, said: "We are truly delighted to witness that all approved indications of the company's five self-developed innovative drugs have been successfully included in the National Reimbursement Drug List (NRDL). The inclusion of these drugs—which address major tumor diseases with the highest incidence rates in China, such as lung cancer, gastric cancer, cervical cancer, and nasopharyngeal cancer, as well as metabolic and autoimmune disorders like hypercholesterolemia and psoriasis—enables Chinese patients to be among the first in the world to benefit from optimal treatment options. This achievement reduces the financial burden on patients and provides superior alternatives for tackling significant public health challenges. Notably, even prior to their inclusion in the NRDL, these drugs had already gained extensive and profound recognition from hospitals, physicians, and patients in real-world clinical practice, thanks to their breakthrough clinical value. The successful entry of multiple indications of these five products into the NRDL will further enhance end-users' awareness and trust in the company's innovative drugs, lay a solid foundation for accelerating their broader clinical adoption, propel Akeso's commercialization of innovative drugs into a phase of sustained, rapid, and high-quality development, and strengthen the groundwork for the company's deepened global expansion.

Akeso remains patient-centric and clinical value-driven, committed to developing more breakthrough therapies so that patients worldwide can benefit from novel treatments. This has always been the original intent of our drug innovation, and it is what we take pride in."

Ivonescimab: All 1L and 2L NSCLC Indications Now Covered by NRDL

Akeso's first-in-class PD-1/VEGF bispecific antibody, ivonescimab, has successfully secured the inclusion of its new first-line indication for PD-L1-positive non-small cell lung cancer (NSCLC) in the NRDL. In a Phase III head-to-head clinical trial, ivonescimab demonstrated compelling results, reducing the risk of disease progression or death by 49% compared to pembrolizumab. Notably, ivonescimab is the first drug globally to show significantly superior efficacy over pembrolizumab in a Phase III trial. This breakthrough clinical value has been widely recognized by global academic and biopharma communities, as well as expert evaluators during this year's NRDL negotiation. Ivonescimab for the treatment of EGFR-TKI resistant NSCLC was already included in the NRDL in 2024.

Cadonilimab: All 1L Gastric Cancer, 1L Cervical Cancer, and 2L/3L Cervical Cancer Indications Now Covered by NRDL

Akeso's first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, has successfully negotiated the inclusion of its new first-line gastric cancer and first-line cervical cancer indications into the NRDL. Cadonilimab is the only immuno-oncology drug globally to demonstrate significant clinical benefits in first-line gastric cancer and first-line cervical cancer across all patient populations (regardless of PD-L1 expression), representing breakthrough therapeutic value. Cadonilimab for the treatment of recurrent or metastatic cervical cancer was already included in the NRDL in 2024.

Penpulimab: All 4 Approved Indications Now Covered by NRDL

Penpulimab, a differentiated PD-1 monoclonal antibody, participated in the national reimbursement negotiation for the first time in 2025. Two of its indications—first-line and ≥2L treatment of nasopharyngeal carcinoma (NPC)—have already been approved by the U.S. FDA. During this negotiation, penpulimab successfully secured NRDL inclusion for all four of its approved indications: first-line treatment of squamous NSCLC, first-line treatment of NPC, ≥3L treatment of NPC, and ≥3L treatment of relapsed/refractory classical Hodgkin lymphoma (R/R cHL).

Ebdarokimab (IL-12/IL-23): Psoriasis Indication Now Covered by NRDL

Ebdarokimab is China's first independently developed innovative drug targeting IL-12/IL-23, and the first approved drug from Akeso in the field of autoimmune diseases. Ebdarokimab participated in the national reimbursement negotiation for the first time in 2025, and its indication for the treatment of moderate-to-severe psoriasis was successfully negotiated and included in the NRDL.

Ebronucimab (PCSK9): Both Approved Indications for Hypercholesterolemia Now Covered by NRDL

Ebronucimab participated in the national reimbursement negotiation for the first time in 2025. The two approved indications of ebronucimab, the treatment of primary hypercholesterolemia and mixed dyslipidemia, and heterozygous familial hypercholesterolemia, were both successfully negotiated and included in the NRDL.

Forward-Looking Statement of Akeso, Inc.

This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

About Akeso

Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 26 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

SOURCE Akeso, Inc.