Akeso's Oncology Breakthrough: Pioneering a New Era in Asia-Pacific Cancer Therapeutics

In the rapidly evolving landscape of oncology therapeutics, Akeso Inc. (9926.HK) has emerged as a trailblazer, leveraging cutting-edge science and strategic foresight to redefine cancer treatment paradigms. The company's recent breakthrough with ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, marks a pivotal moment not only for its pipeline but for the broader Asia-Pacific oncology sector. With robust clinical data, regulatory momentum, and a global expansion strategy, Akeso is positioning itself as a key player in a market projected to grow at a compound annual rate of 12.3% through 2030.

Clinical and Regulatory Milestones: A Foundation for Growth

Akeso's HARMONi-2 trial (AK112-303) delivered groundbreaking results in non-small cell lung cancer (NSCLC), demonstrating a 49% reduction in disease progression risk and a 22.3% reduction in mortality risk compared to pembrolizumab. These outcomes, published in The Lancet, secured National Medical Products Administration (NMPA) approval in China for ivonescimab as a first-line therapy for PD-L1-positive NSCLC. This achievement is particularly significant given the drug's chemotherapy-free profile, addressing a critical unmet need in oncology.

The drug's success has been amplified by its inclusion in China's National Reimbursement Drug List (NRDL), ensuring affordability and accessibility for millions of patients. Meanwhile, Akeso is advancing ivonescimab into Phase III trials for metastatic colorectal cancer (mCRC) and hepatocellular carcinoma (HCC), with the HARMONi-GI6 trial already enrolling patients. These trials target high-prevalence cancers in Asia-Pacific, where mCRC and HCC incidence rates are among the highest globally.

Strategic Partnerships and Global Ambitions

Akeso's expansion beyond China is underpinned by strategic alliances and a global clinical development plan. The partnership with Summit Therapeutics for ivonescimab's U.S. and European development underscores the company's intent to scale its reach. Additionally, collaborations with Pfizer to explore combinations with antibody-drug conjugates (ADCs) highlight Akeso's commitment to innovation.

In Southeast Asia and India, Akeso is replicating its Chinese success model by securing local regulatory approvals and optimizing market access through partnerships with regional distributors. The company's IO 2.0 + ADC 2.0 strategy—combining bispecific antibodies with next-generation ADCs like AK146D1 and AK138D1—positions it to address “cold tumors” and IO-resistant cancers, a $15 billion market opportunity by 2030.

Long-Term Market Potential: Akeso's Competitive Edge

Akeso's diverse pipeline—spanning 23 registrational/Phase III trials—ensures a steady stream of data to support label expansions and global approvals. The company's cadonilimab, a PD-1/CTLA-4 bispecific antibody, has already secured approvals in China for cervical and gastric cancers, with global trials in HCC and NSCLC underway. This dual-biologics approach (ivonescimab and cadonilimab) creates a moat against competitors, as bispecifics are expected to capture 30% of the IO market by 2030.

Financially, Akeso's 2025 interim results reveal a 25% year-on-year revenue increase to RMB 2 billion, driven by ivonescimab and cadonilimab. With 13 Phase III trials in progress and NRDL inclusion in China, the company is well-positioned to sustain growth. Moreover, its AI-driven drug discovery platform accelerates R&D timelines, reducing costs and enhancing scalability in emerging markets.

Investment Thesis: Akeso as a High-Growth Play

For investors, Akeso represents a compelling opportunity in the Asia-Pacific oncology boom. Key catalysts include:
1. Global approvals for ivonescimab in mCRC and HCC.
2. Expansion into India and Southeast Asia, where cancer incidence is rising and reimbursement reforms are underway.
3. ADC pipeline advancements, which could unlock new revenue streams in $10 billion+ indications.

However, risks include regulatory delays in international markets and intense competition from global pharma giants. Akeso's first-mover advantage in bispecific antibodies and its cost-effective manufacturing model mitigate these risks, particularly in price-sensitive markets.

Conclusion: A Catalyst for the Future

Akeso's recent breakthroughs and strategic execution underscore its potential to become a global oncology leader. With a first-in-class pipeline, robust commercial execution, and a clear path to international expansion, the company is well-positioned to capitalize on the Asia-Pacific's $45 billion oncology market. For investors seeking exposure to the next wave of immuno-oncology innovation, Akeso offers a high-conviction, long-term opportunity.

Investment Recommendation: Buy with a 12-month target of HK$120/share, reflecting a 30% upside from current levels. Monitor Phase III trial readouts and regulatory updates in Q4 2025 for near-term catalysts.