How Much Will ADC Drugs Sell In 2021

As a powerful anti-cancer drug, ADC drug has become another hot research direction after PD-1. From its own principle and structure, it is composed of monoclonal antibody (mAb), coupling chain (linker) and low cytotoxicity. Molecules (cytotoxin/payload) are composed of three parts. Through the binding of monoclonal antibodies to specific antigens on the surface of tumor cells, cytotoxic drugs are directed to the tumor lesions. Compared with traditional chemical drugs and biological drugs, the safety and effectiveness are significantly improved. As a result, the ADC field has made great progress in the past 10 years, and the therapeutic window has continued to expand. According to the forecast of Evaluate Pharma and BCG, the global ADC market is expected to reach 12.9 billion US dollars in 2024, with a compound annual growth rate from 2018 to 2024. The rate is about 35%.

A few days ago, the annual financial reports of major pharmaceutical companies have been announced one after another, and the sales performance of ADCs has also been disclosed.

Up to now, 14 ADC drugs have been approved for marketing in the world, including Pfizer's Mylotarg and Besponsa, Roche's Kadcyla, Polivy, AstraZeneca's Lumoxiti, Enhertu, Seagen/Takeda Pharmaceutical's Adcetris, Padcev, Seagen/Genmab's Tivdak , GlaxoSmithKline's Blenrep, Gilead's Trodelvy, Rakuten Aspyrian's Akalux, ADC Therapeutics' Zynlonta, Rongchang Bio's Vidicitumab, the treatment areas involve lymphoma, leukemia, breast cancer, multiple myeloma, breast cancer cancer, head and neck cancer, urothelial cancer, etc.

Among them, Kadcyla and Adcetris have both been listed in China. In addition, Besponsa has been included in the list of varieties to be prioritized by the State Food and Drug Administration, and the application indication is relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL).

According to the financial results announced by major pharmaceutical companies, Kadcyla will occupy the first place in ADC drug sales performance with CHF 1.982 billion in 2021. The performance growth is mainly driven by the indication of early breast cancer adjuvant therapy. The growth trend may slow further in the face of competition from Enhertu in second-line breast cancer indications.

The combined sales of Adcetris jointly developed by Seagen and Takeda reached 1.306 billion US dollars, second only to Kadcyla. Adcetris has been approved for 6 adult indications. At present, Seagen and Takeda are actively promoting a large-scale Phase III clinical development project with the purpose of To build Adcetris into a primary care drug for the treatment of CD30-positive lymphoma and redefine the clinical first-line treatment of lymphoma.

AstraZeneca's Enhertu is worth $426 million in 2021, and in January, the U.S. FDA accepted a supplemental biologics license application for Enhertu for the treatment of HER2-positive metastatic breast cancer previously treated with an anti-HER2 regimen patients, and granted priority review status for the application, and it is expected to be approved for marketing in the first half of 2022. Applications for the same indications have also been submitted to the EU and Japan simultaneously. A comprehensive clinical development program is also evaluating the safety and efficacy of Enhertu in multiple HER-targeted cancers, including breast, gastric, lung, and colorectal cancers.

Gilead's Trodelvy, with revenue of $380 million in 2021, is the best performing ADC drug in the market in recent years.

In addition, Padcev, Polivy, Besponsa, Blenrep, and Tivdak have disclosed sales performance, with sales revenue of $340 million, $271 million, $192 million, $122 million, and $06 million in 2021, respectively.

In addition to the above-mentioned products, the performance of other ADC drugs has not yet been disclosed, including the first domestic ADC drug Rongchang Bio's Vidicitumab.

In China, thanks to the continuous improvement of the domestic innovative drug research and development level, domestic enterprises have also quickly followed up in the ADC drug research and development, including TOT BIOPHARM, Hengrui Medicine, Kelun Pharmaceutical, Genting Xinyao, Bio-Otai, Zhejiang Medicine and other companies have products that have entered the clinical stage. In addition to most targets targeting HER2, others include c-Met, EGFR, Trop-2, CD20, BCMA, and others.

In the 2021 Nature Reviews Drug Discovery, "The oncology market for antibody-drug conjugates", it is estimated that in 2026, the global sales of currently listed ADCs will exceed US$16.4 billion; among them, Enhertu may become the highest sales volume with US$6.2 billion. ADC.