Akeso Biopharma raises $250m to accelerate international clinical trials

Akeso Biopharma has successfully raised approximately $250 million through a share placement, drawing significant recognition from international investment firms. The placement saw a majority of subscribers from long-term and healthcare-focused funds, highlighting Akeso’s strong appeal in the global investment landscape. This substantial capital influx serves as a testament to Akeso’s impressive track record in drug innovation and its ability to attract committed investors. By leveraging this strong backing, Akeso aims to enhance its research capabilities and further penetrate international markets, ensuring that its innovative treatments can reach a broader patient base worldwide.

This marks Akeso’s second successful share placement in 2024, boosting its cash reserves to an estimated $1.064 billion (7.5 billion RMB). The company has outlined that seventy percent of the new funds will be dedicated to accelerating the global clinical development of its innovative drug portfolio, with a special emphasis on advancing the clinical trials for several of its most promising candidates. These initiatives will particularly target key markets in China and internationally, with the ultimate goal of addressing unmet medical needs on a global scale. The remaining funds are expected to be used for enhancing the company’s operational efficiency and supporting strategic partnerships that can accelerate drug commercialization.

Dr. Xia Yu, Founder, Chairwoman, President, and CEO of Akeso Biopharma, noted that the swift and efficient completion of this placement underscores the company’s long-term investment potential, which is highly recognized by institutional investors. She emphasized that this financing will significantly bolster Akeso’s global development strategy, particularly for multi-center international clinical trials aimed at exploring the global potential of its independently developed drugs. Dr. Xia further highlighted that the funds would enable the company to expedite the timeline for key projects and support the establishment of collaborations with leading healthcare institutions worldwide, thereby maximizing the impact of Akeso’s innovative treatments. The investment will also be crucial in expanding Akeso’s infrastructure to facilitate the scaling up of its production capabilities, ensuring a seamless path from clinical development to market delivery.

New Approvals Strengthen Akeso’s Competitive Position

In recent developments, Akeso (9926.HK) announced that its PD-1/CTLA-4 bispecific antibody, cadonilimab, received approval from China’s National Medical Products Administration (NMPA) for a new indication. Cadonilimab, when combined with fluoropyrimidine and platinum-based chemotherapy, is now approved for first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. This marks the second approval for cadonilimab in China, following its initial authorization for marketing in June 2022.

The approval was based on the COMPASSION-15/AK104-302 study, which demonstrated promising results. In the study, the proportion of patients with PD-L1 CPS < 5 and PD-L1 CPS < 1 in the Intention-to-Treat population reached 49.8% and 23%, respectively—notably higher than data from previous phase III studies involving other immunotherapies for first-line treatment.

Promising Clinical Data from ESMO 2024

At the 2024 European Society for Medical Oncology (ESMO) Conference, Akeso presented promising phase 2 results from its clinical trial of ivonescimab, an innovative treatment being evaluated in combination with chemotherapy for triple-negative breast cancer (TNBC). The preliminary data from this trial, with only a 10-month median follow-up, indicated that ivonescimab, when used as a first-line treatment for TNBC, displayed excellent efficacy and a favorable safety profile.

Akeso’s ongoing achievements continue to build momentum for its expansion in the global healthcare market, solidifying its competitive edge through rigorous clinical development and strategic innovations. With a growing portfolio of approved treatments and a robust pipeline of clinical candidates, Akeso is well-positioned to become a leader in the biopharmaceutical industry. The company remains focused on enhancing patient outcomes by advancing its research in immuno-oncology and other critical therapeutic areas, setting new standards for efficacy and safety in innovative treatments. These efforts, combined with a clear vision for global outreach, will help Akeso maintain its leadership role in the rapidly evolving healthcare landscape.