The development of antibody drugs can be traced back to the early 20th century, but it was not until the 1990s that they truly entered a period of rapid development. In the early 20th century, scientists began to attempt to extract antibodies from animals and use them to treat human diseases. However, due to limitations in antibody sources and the specificity of antibodies, research progress on antibody drugs has been slow.
In the 1980s, scientists began to successfully synthesize artificial monoclonal antibodies using genetic recombination technology. In 1986, the US FDA approved the world's first monoclonal antibody therapeutic drug, anti-CD3 monoclonal antibody OKT3, for anti rejection reactions in organ transplantation. This technological breakthrough marked the birth of the first generation of antibody drugs and accelerated the research progress of antibody drugs.
The first generation of antibody drugs, namely mouse derived monoclonal antibodies, originated from mouse serum, but the strong immune rejection caused by heterologous proteins limited the application of such drugs. Since then, antibody drugs have gone through a process of mouse derived → mouse derived human chimeric → fully humanized transformation.
In recent years, with the increasing maturity and refinement of monoclonal antibody technology, research on antibody drugs has entered the era of the fourth generation of antibody drugs. The fourth generation antibody drugs mainly refer to antibody drugs developed based on new technologies such as multivalent antibodies and bispecific antibodies, which have higher affinity, better specificity, and stronger therapeutic effects.
Overall, the development of antibody drugs has gone through a process from antibody extraction to gene recombination technology, and then to the continuous application and innovation of new technologies such as multivalent antibodies, antibody conjugated drugs (ADCs), and bispecific antibodies, bringing more hope and opportunities for human disease treatment.
At present, global research on antibody drugs is gradually focusing on ADC and bispecific antibody technologies to seek innovation and breakthroughs in antibody drugs.
Since the FDA approved the first ADC drug Mylotarg in 2000, a total of 15 ADC drugs have been launched worldwide. During the three years from 2019 to 2021, three ADC products were launched each year, but only one ADC product was launched in 2022. These marketed products are generally evenly distributed between solid tumors and hematological tumors in terms of indications.
As for R&D companies involved in ADC, they include multinational pharmaceutical companies such as Pfizer, Roche, GSK, as well as companies focused on ADC R&D such as Seagen, Daiichi Sankong, ADC Therapeutics. It is worth mentioning that China's Rongchang Biotechnology has also emerged in this field.
From the perspective of target selection, these ADC drugs involve targets including CD33, CD30, HER2, CD22, CD79b, Nectin-4, Trop-2, BCMA, EGFR, CD19, TF, and FR alpha. The selection of these targets is aimed at targeting different types of cancer cells and utilizing the specificity of ADC to deliver cytotoxins to malignant cells.
The concept of bispecific antibodies was first proposed in 1960, and the first bispecific drug, Catumaxomab, was approved for marketing in Europe in 2009 for the treatment of malignant ascites. However, the drug was withdrawn from the market in 2017. However, Catumaxomab has already restarted its listing plan and may be relisted within the next two years.
As of now, a total of 12 dual drug drugs have been approved for market worldwide. Among them, 2022 can be said to be the "harvest year" for dual resistance drugs, as six dual resistance drugs were approved for marketing during this year.
Due to its significant therapeutic advantages and continuous global approvals in recent years, global pharmaceutical companies are closely monitoring the development progress of ADCs and bispecific drugs. At the same time, Chinese companies have also increased their investment in this field in recent years. Compared to Europe, America, and other countries that have achieved good results in the field of dual impedance and ADC, China's dual impedance and ADC market can only be considered as just beginning, but it is not too late for a newcomer. In recent years, China's achievements in the fields of dual impedance and ADC have also grown rapidly like mushrooms after rain. Chinese research institutions and pharmaceutical companies have actively invested in research and development, and have made remarkable progress in these fields. Some industry insiders believe that there is still significant development space in the domestic dual antibody and ADC drug markets.
As domestic pharmaceutical companies gradually begin to layout in the field of bispecific antibodies and ADCs, increasing investment in the research and development of bispecific antibodies and ADC drugs, Chinese local enterprises have also gradually launched related products, such as Rongchang Biotechnology (Vedixitumumab, China's first original ADC drug) and Kangfang Biotechnology (Cardonimumab Injection, the world's first PD-1/CTLA-4 bispecific antibody new drug), which marks important progress in the field of bispecific antibodies and ADCs in China.
The participation and product launch of these local enterprises signify the improvement of China's R&D capabilities and innovation level in the fields of dual antibody and ADC. With the continuous advancement of technology and the expansion of the market, Chinese pharmaceutical companies are expected to make more breakthroughs and achievements in the fields of dual antibody and ADC. Although China started late in the fields of dual antibody and ADC, it may not be impossible for latecomers to catch up. The research and development of antibody drugs provide more treatment options and opportunities for cancer patients in China, and are expected to improve their treatment outcomes and survival rates.
To promote communication and innovation in the antibody industry, the 6th Golden Autumn October Antibody Industry Development Conference will be held as scheduled on October 14-15, 2023. The conference aims to provide an interactive platform for researchers to communicate and contribute to the further development of the antibody industry.