Akeso’s Cadonilimab and Ivonescimab Listed in China’s NRDL

Akeso, Inc., a prominent company in the biopharmaceutical sector, has revealed that its two pioneering bispecific antibody drugs—cadonilimab (a PD-1/CTLA-4 bispecific antibody) and ivonescimab (a PD-1/VEGF bispecific antibody)—have been added to the latest edition of the National Reimbursement Drug List (NRDL) by the National Healthcare Security Administration in China. This updated list will be enacted starting January 1, 2025.

Cadonilimab is approved for use in patients with relapsed or metastatic cervical cancer (R/M CC) who have seen their condition advance following platinum-based chemotherapy.

Ivonescimab is approved for managing epidermal growth factor receptor (EGFR) mutated, locally advanced, or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC).

**Overview of China’s Healthcare Coverage**:

In China, the medical insurance framework extensively includes basic medical coverage, work-related injury protection, and maternity insurance, thereby providing cover to over 95% of its populace. The NRDL specifies drugs that qualify for reimbursement via the medical insurance fund. Statistical reports indicate that in 2023, expenditures from these funds on NRDL medications constituted 90% of total hospital procurement orders.

**Leadership Commentary:**

Dr. Xia Yu, Akeso’s founder, chairwoman, president, and CEO, commented on this milestone: “Including cadonilimab and ivonescimab in the NRDL underscores the innovative and clinical importance of these unique biologics, both crafted by Akeso. This achievement is pivotal to expanding patient access to pioneering treatments and significantly diminishes the financial load on patients, enabling broader access to world-class therapies. This step harmonizes with Akeso’s fundamental mission of promoting public health through scientific and technological advancements.”

**Cadonilimab’s Innovativeness:**

Cadonilimab is an extraordinary bispecific antibody targeting PD-1 and CTLA-4 that leverages a synergic antitumor mechanism to substantially improve therapeutic effects, offering remarkable effectiveness while lessening toxicity. Recent data indicates that cadonilimab benefits both PD-L1 positive and negative populations, particularly addressing the unmet need among PD-L1 negative individuals—who previously lacked effective treatments. For R/M CC, cadonilimab demonstrated a median overall survival (mOS) exceeding 18 months, with an objective response rate (ORR) of 31.3% and a complete response rate (CR) of 13.1%. In PD-L1 positive patients, the ORR reached 43.8%, a median progression-free survival (mPFS) of 6.34 months, and an mOS yet to be determined.

Cadonilimab gained NMPA approval for the first-line treatment of advanced gastric cancer in September 2024. A supplementary new drug application (sNDA) for advanced cervical cancer treatment is currently under review. Cadonilimab is robustly recommended across 16 clinical treatment guidelines and consensus statements targeting various cancers, including gastric, gynecological, liver, esophageal, and nasopharyngeal cancers. Moreover, cadonilimab is active in over 23 clinical trials across 16 indications, including tests for gastric, lung, liver, cervical, and pancreatic cancers, with 8 trials in the registration phase III phase.

**Ivonescimab’s Breakthrough Mechanism:**

Ivonescimab, the premier bispecific antibody merging cancer immunotherapy and anti-angiogenesis pathways, demonstrated remarkable results in the phase III HARMONi-A trial, reducing the risk of disease progression or death by 54% for 2L+ EGFRm NSCLC patients, with encouraging long-term survival benefits. The phase III HARMONi-2 trial positioned ivonescimab monotherapy favorably over pembrolizumab in first-line treatment of PD-L1-positive NSCLC, establishing its superior efficacy. Ivonescimab, the sole drug to show superior efficacy over pembrolizumab in a phase III head-to-head trial globally, is under the priority review for first-line treatment in PD-L1-positive NSCLC.

Ivonescimab holds strong recommendations in six essential clinical treatment guidelines. The drug partakes in over 25 clinical trials spanning more than 17 cancer types, including lung, head and neck squamous cell carcinoma, biliary tract, pancreatic, breast, hepatocellular carcinoma, and colorectal cancers, with nearly 10 Phase III trials advancing smoothly both in China and internationally.

Akeso stands at the forefront of the biopharmaceutical domain, dedicated to the R&D, manufacturing, and marketing of first-class biologic medicines worldwide.