What Is Ivonescimab? The Dual-Target Drug from China That Beat Keytruda for the First Time

 A Comprehensive Report on Science, Competition, Regulation and Access

To understand ivonescimab, it helps to recall two established classes of cancer drugs. The first is PD-1/PD-L1 inhibitors (such as pembrolizumab/Keytruda): by preventing the tumour from applying the immune system's "brake", they enable T cells to recognise cancer. The second is anti-VEGF drugs (such as bevacizumab/Avastin): they prevent the tumour from nourishing itself by forming new blood vessels (angiogenesis). For years, these approaches have been used as separate drugs, sometimes together. The idea behind ivonescimab is to combine them in a single antibody.

There is a simple but powerful biological rationale behind this combination. VEGF not only stimulates blood-vessel formation; it also suppresses the immune environment surrounding the tumour, making immunotherapy's job harder. Blocking VEGF removes this suppression and creates conditions in which PD-1 blockade may work more effectively. The two targets have therefore been selected not merely to sit "side by side", but to reinforce each other . The rationale has been known for decades; the novelty is achieving it in one intelligently designed molecule rather than two separate drugs.

Ivonescimab was designed and developed by the Chinese biotechnology company Akeso. In 2022, Summit Therapeutics licensed development and commercialisation rights outside China (North America, South America, Europe, Japan) — one of the most talked-about licensing agreements in biotechnology history. Today, the drug has been tested in more than 47 trials conducted by Akeso and Summit (and the French GORTEC group in head-and-neck cancer), involving more than 4.000 (four thousand) patients in total; the clinical programme includes 15 phase 3 trials and spans more than 17 cancer types, including head-and-neck, biliary tract, pancreatic, breast, liver and colorectal cancer beyond lung cancer.

The licensing agreement is also viewed as a turning point in pharmaceuticals: innovative drugs traditionally flowed from West to East, but ivonescimab reversed that direction. Licensing global rights to a China-born molecule to a US company became a symbol of the "maturation of Chinese biotechnology". The approximately 600% rise in Summit's shares over two years was the financial reflection of this expectation.

The evidence base for ivonescimab rests on a trial family named "HARMONi". Each addresses a different patient group and comparison. Below, we summarise the most important trials in tables and charts — then examine why they are controversial .

To understand ivonescimab's place, we need to consider today's standard. First-line treatment of advanced NSCLC is largely PD-1/PD-L1 immunotherapy (such as pembrolizumab) — alone or with chemotherapy. Ivonescimab seeks to surpass this standard by adding VEGF blockade to the same immunotherapy backbone. The table below compares the three drugs conceptually, while the charts that follow compare them numerically.

Almost all of ivonescimab's strongest trials were conducted only in China . This has sparked one of the most heated debates in oncology and pharmaceutical investment. The issue is that the patient population in China may differ from the global population in important ways.

A less discussed but very important aspect of ivonescimab is its pricing strategy. While Western cancer drugs usually launch at very high prices, ivonescimab was positioned in China at a price prioritising accessibility and quickly entered the National Reimbursement Drug List (NRDL) — becoming covered by Chinese public health insurance (from 1 January 2025). This dramatically reduces out-of-pocket costs for a patient in China.

Here is the question patients most often ask: Can you commercially purchase ivonescimab outside China? For now, the short answer is no. The drug is not licensed (approved) in any country outside China. Summit Therapeutics holds the rights in the US, Europe and other regions, but commercial sales first require FDA/EMA approval — the FDA process is currently at the accepted-BLA stage, with a decision expected around November 2026. Until approval, it is not a product that can be bought from a pharmacy/hospital outside China.

This is the most practical question for a patient in Türkiye. Ivonescimab is not licensed in Türkiye and cannot be routinely prescribed without TİTCK approval. However, Turkish regulations define two exceptional routes to unapproved drugs — with clinical research providing a third route for ivonescimab.

Ivonescimab's future depends on several critical crossroads. The first and most important is the global HARMONi-3 trial: at international centres, it is testing the drug against pembrolizumab plus chemotherapy in both squamous and non-squamous patients. If this trial confirms the Chinese data, ivonescimab's global acceptance will accelerate; if it does not, the hypothesis of a "China-specific effect" will gain strength and the drug's global prospects will become uncertain. The second crossroads is the FDA's decision expected around November 2026—if favourable, the drug will become available in the United States for at least one niche indication (EGFR-mutant 2L+), potentially creating a domino effect for Europe and other regions.

The third, broader question is what ivonescimab will do in cancers beyond the lung (pancreatic, colorectal, head and neck, and liver cancers). Akeso is also conducting phase 3 trials in these areas; a positive signal, especially in a difficult cancer such as pancreatic cancer, could take the drug's value to a completely different level. Finally, the path opened by ivonescimab is bigger than a single medicine: the PD-1/VEGF bispecific class is now a "hot" area, and many companies are developing similar molecules. Whether ivonescimab succeeds or fails, it has therefore permanently placed the idea of "dual-target immunotherapy" on oncology's agenda.

Ivonescimab brings together many trends in modern oncology in a single story: intelligent molecular design (a bispecific, tetravalent structure), the evolution of immunotherapy (from a single target to dual targets), China's rise in drug development, the debate over global generalisability, and the complex relationship between access, cost and regulation. As a drug that has reached more than 70.000 (seventy thousand) patients in China, received three approvals and beaten pembrolizumab head to head, its strength is beyond dispute. But its real test on the global stage—the HARMONi-3 results and the FDA decision—will come in the next few months. For a patient in Turkey, today's reality is clear: it is a strong candidate, but not yet an accessible treatment. This feature has aimed to present the drug's science, promise and limitations honestly together—because well-founded hope begins with complete information.

This article is intended as medical news, a review and information; it does not provide individual treatment guidance. At the time this article was prepared, ivonescimab was approved only in China (NMPA); in the United States, the FDA had accepted the BLA application and a decision was pending; it was not licensed in other countries, including Europe and Turkey. Statements such as "approved in China" or "presented at ASCO" do not mean that the drug is accessible or prescribable in Turkey. Most pivotal HARMONi trials were conducted in Chinese populations, and their global generalisability awaits confirmation in ongoing international trials (HARMONi-3); overall survival data remain immature in some trials. Pricing and reimbursement information is specific to China and does not apply to other countries; the exact cost varies with the dose, indication and local conditions. Individual access routes (clinical trials, medicines from abroad and compassionate access) proceed on a case-by-case basis and through official assessment. Patients must always discuss treatment decisions and access options with their own oncologists, taking their individual disease characteristics and current approval status into account. All data were verified against Lancet publications, ASCO/SITC presentations, official statements by Akeso and Summit Therapeutics, FDA/NMPA notifications and TİTCK legislation.