Now there is no doubt that the ADC track is hot.
By the end of 2021, the number of ADC drugs already on the market in the world has reached 14, and a set of data released by the authoritative journal Nature shows that only 10 ADC drugs listed before 2020 will create a global market of more than $16.4 billion in 2026.
Another side of the soaring is the track "getting together". According to statistics, the number of ADC drugs that have been disclosed in the world exceeds 300, especially it is worth mentioning that Chinese companies account for one-third of them. In 2021, the ADC field has entered a new era in which the market scale "explodes" and the competitors "inner volume" parallel, how will the ADC track develop next, and how should the enterprise be laid out? It has become the biggest problem facing all the ADC companies that have joined the war and have been pouring in since.
In the last month of December 2021, the world's ADC giants held a total of R&D days to showcase their 2021 achievements and disclose their latest R&D pipeline and technology platform layout in the ADC field. From the first and third communists that have become the absolute backbone of the ADC field, we may find a reference.
01
What's in the way of a year?
As early as 2020, the first three parties formulated a clear R&D strategy for their ADC drugs: maximizing the three core ADC products, identifying business growth drivers outside the three core ADC products, and selecting and confirming innovative technology platforms outside the DXd-ADC technology platform.
At the December 2021 R&D Day, the first three shared the specific progress of pipeline products during the year. Whether it's the three core ADCs showing significant clinical benefits, the budding DS-7300, or the approval of Deeptact and Yescarta overseas, or so on. The results of the first three in 2021 are not achieved overnight, and every solid step helps the first and third parties to develop steadily and gradually achieve the 5-year business goal.
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02
"Head-to-head trials" with Best-in-class
How to achieve such ambitious goals? Even if they are leaders in the field of ADC, the first and third parties will face the reality of more and more challenges from latecomers. In addition to accelerating the development of new products and enriching the multi-level pipeline layout to seek perfection and speed, how to continue its own differentiated advantages and build a moat?
The answer given by the first three totals is, head-to-head testing. In August 2021, First Three Republics partner AstraZeneca jointly announced that it had achieved positive results in its global head-to-head phase III clinical trial, DESTINY-Breast 03. In September 2021, detailed data from the DESTINY-Breast03 study were unveiled at LBA1 (Late-breaking Abstract), the most important section of the annual meeting of the European Society of Clinical Oncology, which showed that T-DXd significantly reduced the risk of disease progression or death by 72% compared to T-DM1. An independent data monitoring committee (IDMC) concluded that T-DXd was significantly better than T-DM1. In this first confrontation between anti-HER2 ADC drugs, T-DXd became the new standard for second-line treatment of HER2-positive advanced breast cancer.
As the most blockbuster star product of the new generation of ADC drugs, the second-line treatment standard is not the end point of T-DXd. The first three co-planned territory is larger, and a series of clinical studies of T-DXd are comprehensively laid out in breast cancer: destiny-Breast 09 research challenges the standard treatment of HER2-positive metastatic breast cancer in the first line; DESTINY-Breast 05 and 11 studies are compared with her2-positive early breast cancer adjuvant and neo-adjuvant standard treatment, respectively, aiming to fully establish T-DXd as the king of HER2-positive breast cancer treatment.
In terms of other indications, T-DXd in September 2020 and January 2021 has been approved as a new indication for gastric cancer in Japan and the United States, respectively, becoming the world's first ADC drug approved for the treatment of HER2-positive metastatic gastric cancer. T-DXd also obtained breakthrough therapy for HER2 mutant non-small cell lung cancer in the United States. The Drug Evaluation Center of the State Drug Administration of China also qualified T-DXd as a breakthrough therapy for gastric cancer indications.
Subsequent phase III clinical studies initiated in HER2-positive gastric cancer, colorectal cancer, and HER2 mutant non-small cell lung cancer will demonstrate the firm confidence of the first and third groups in the T-DXd Best-in-class and thereby continue their strengths in the ADC field.