Chinese Drug Maker Akeso: Biotech's 'DeepSeek Moment' Amid US Competition

In the rapidly evolving landscape of biotechnology, a new contender has emerged from the East, challenging the dominance of established US pharmaceutical giants. Akeso, a Chinese drug maker, has been hailed as the biotech industry's 'DeepSeek moment,' a reference to the groundbreaking AI model that has revolutionized the field of natural language processing. Akeso's innovative approach to bispecific antibodies and its strategic partnerships with international pharmaceutical companies have positioned it as a formidable competitor in the global biotech market.

Akeso's success story begins with its flagship product, ivonescimab, a PD-1/VEGF bispecific antibody that has shown promising results in clinical trials for lung cancer. In a phase III clinical trial comparing ivonescimab with pembrolizumab (Keytruda) for the first-line treatment of PD-L1 positive NSCLC, ivonescimab demonstrated a notable increase in progression-free survival (PFS) period. This superiority was consistent across various subgroups, including age, gender, and patients with liver and brain metastasis. This data suggests that ivonescimab could offer a more effective treatment option compared to Keytruda, which is a leading treatment by Merck Sharp & Dohme.

Akeso's innovative approach to bispecific antibodies, such as ivonescimab and cadonilimab, positions it strongly to compete with established US pharmaceutical companies like Merck Sharp & Dohme, particularly in the context of lung cancer treatments. This is evident from several key points:

1. Superior Clinical Results: Ivonescimab, a PD-1/VEGF bispecific antibody, has shown significant positive results in clinical trials for lung cancer. For instance, in a phase III clinical trial comparing ivonescimab with pembrolizumab (Keytruda) for the first-line treatment of PD-L1 positive NSCLC, ivonescimab demonstrated a notable increase in progression-free survival (PFS) period. This superiority was consistent across various subgroups, including age, gender, and patients with liver and brain metastasis. This data suggests that ivonescimab could offer a more effective treatment option compared to Keytruda, which is a leading treatment by Merck Sharp & Dohme.

2. Unique Mechanism of Action: Ivonescimab combines the power of immunotherapy via a blockade of PD-1 with the anti-angiogenesis benefits of an anti-VEGF into a single molecule. This dual mechanism of action is designed to reduce side effects and safety concerns, potentially making it a more effective and safer treatment option compared to single-target therapies like Keytruda.

3. Global Recognition and Partnerships: Akeso's success with ivonescimab has garnered global recognition. The company has out-licensed the exclusive rights to ivonescimab for development and commercialization in the United States, Canada, Europe, and Japan to Summit Therapeutics Inc. This partnership not only provides Akeso with an upfront payment of US$500 million and potential deal value up to US$5 billion but also leverages Summit's expertise in bringing innovative drugs to market. This strategic move positions Akeso to compete on a global scale with established pharmaceutical companies.

4. Commercial Potential: The commercial potential of ivonescimab is significant. Keytruda, developed by Merck Sharp & Dohme, was the biggest-selling drug globally last year with sales of USD25 billion. Ivonescimab's superior clinical results and unique mechanism of action suggest that it has the potential to capture a significant share of the lung cancer treatment market, challenging the dominance of Keytruda.

5. Pipeline and Innovation: Akeso's pipeline includes multiple bispecific antibodies in various stages of clinical development. For example, cadonilimab (PD-1/CTLA-4) is another bispecific antibody developed by Akeso that is currently in Phase III clinical trials for several indications, including lung cancer. This robust pipeline of innovative therapies further strengthens Akeso's position in the competitive oncology market.

In summary, Akeso's innovative approach to bispecific antibodies, backed by superior clinical results, unique mechanisms of action, global partnerships, and a strong pipeline, positions it to compete effectively with established US pharmaceutical companies like Merck Sharp & Dohme in the lung cancer treatment market.

Akeso's strategic advantages from its partnerships with international pharmaceutical companies, such as Summit Therapeutics and Pfizer, significantly influence its market penetration and competitive edge in the global biotech industry. These collaborations provide Akeso with global market access, enhanced clinical development capabilities, innovation opportunities, and financial support. For instance, Akeso's partnership with Summit Therapeutics for the development and commercialization of ivonescimab in the United States, Canada, Europe, and Japan provides Akeso with an upfront payment of US$500 million and a total potential deal value of up to US$5 billion, including regulatory and commercial milestone payments. Additionally, Akeso will receive a low double-digit percentage of royalties on net product sales of ivonescimab. This deal allows Akeso to leverage Summit's expertise and established market presence in these regions, facilitating the global commercialization of ivonescimab.



Akeso's collaboration with Pfizer to explore the potential of combining ivonescimab with Pfizer's "antibody-drug conjugates" for treating various solid tumors enhances Akeso's clinical development capabilities. This partnership allows Akeso to leverage Pfizer's extensive experience in targeted cancer therapies, potentially leading to more effective treatment regimens. The collaboration also provides Akeso with access to Pfizer's regulatory expertise, which can expedite the approval process for new combination therapies.

Akeso's focus on combination therapies and its pipeline of novel bispecific antibodies, ADCs, and trispecific antibodies align with the evolving landscape of cancer treatment by leveraging the potential of these innovative therapies to enhance treatment efficacy and address unmet medical needs. This strategy positions Akeso for long-term growth and potential market dominance in several ways:

1. Combination Therapies: Akeso is actively exploring combination therapies, which are becoming increasingly important in oncology. For instance, Akeso has launched over 50 clinical trials for combination therapies leveraging the clinical potential of cadonilimab and ivonescimab. This approach is in line with the industry trend of "me-better" strategies, where incremental improvements to existing treatment regimens can extend the lifespan of blockbuster drugs and maintain market dominance.

2. Novel Bispecific Antibodies: Akeso has developed several bispecific antibodies, such as cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), which have shown promising results in clinical trials. For example, ivonescimab demonstrated significant positive results in a Phase III trial for first-line PD-L1 positive NSCLC, outperforming pembrolizumab (Keytruda) in progression-free survival. This success highlights the potential of bispecific antibodies to provide superior clinical benefits and address the need for effective treatments in tumors with low or negative PD-L1 expression.

3. ADCs and Trispecific Antibodies: Akeso is also advancing research and clinical development across a diverse range of targets, including ADCs, bispecific ADCs, and trispecific antibodies. The company's first differentiated ADC, AK138D1, has received an IND application, and new drugs featuring ADCs, bispecific ADCs, and trispecific antibodies are in the pipeline. This diversification of the product portfolio enhances Akeso's ability to maximize the clinical impact of its key offerings and establish a strong base for medium to long-term global growth.

4. Global Clinical Development: Akeso's strategy includes accelerating the global clinical development of innovative drugs, with a primary focus on its core products in both China and international markets. The company has successfully raised approximately $250 million USD through a share placement, which will be allocated to accelerating the global clinical development of innovative drugs. This financial backing supports Akeso's efforts to enhance the global value exploration of its internally developed new drugs and further strengthen its competitiveness in the international market.

5. Partnerships and Collaborations: Akeso's partnerships and collaborations, such as the agreement with Summit Therapeutics for the development and commercialization of ivonescimab in the United States, Canada, Europe, and Japan, demonstrate the significant global commercial potential of its innovative therapies. These partnerships provide Akeso with the expertise and resources needed to bring its groundbreaking oncology pipeline products to market and improve the quality of life for patients with serious unmet medical needs.

In conclusion, Akeso's focus on combination therapies and its pipeline of novel bispecific antibodies, ADCs, and trispecific antibodies align with the evolving landscape of cancer treatment by leveraging innovative therapies to enhance treatment efficacy and address unmet medical needs. This strategy positions Akeso for long-term growth and potential market dominance by maximizing the clinical impact of its key offerings, establishing a strong base for global growth, and enhancing its competitiveness in the international market.