July_New Drugs｜ADC Gold Rush Continues to Grow

the (whole) worldADCThe growth rate of new drugs is as high as23.4%Market Size4Year after year growth2.8times (multiplier)

     According to Research and Market (2024), the global ADC drug market size is estimated to be approximately US$8.78 billion in 2023, and is forecast to grow 2.82-fold to US$24.8 billion in 2028, with a CAGR of 23.4%. 15 ADC drugs have been marketed globally, as shown in Table 1, with sales of 5 ADC drugs exceeding the US$1 billion mark, namely Enhertu, an Astroglide/Daiichi Sankyo treatment for breast cancer, which is the first drug to be marketed globally. Currently, there are 15 ADC drugs on the market worldwide, as shown in Table 1, of which 5 new ADC drugs have sales of more than US$1 billion, namely, Enhertu (AstraZeneca/Daiichi Sankyo) for breast cancer and Daiichi Sankyo for breast cancer.^® Kadcyla, Roche's treatment for breast cancer.^®Pfizer's Adcetris for Lymphoma^®Pfizer/Anstellaria Padcev for Bladder Cancer^®, and Trodelvy, Gilead's therapeutic drug for breast and bladder cancer.^®The ADC star, Enhertu, is one of the most popular drugs in the world.^®3 years on the market, $2.566 billion in revenue, 5 U.S. approved cancer indications, and the first therapeutic advantage to treat any HER2-positive solid tumor.

Table I,ADCPre-New Drugs5Big Sales Ranking

Source: Organized by Ji-Pu Industrial Trend Research Institute.

Oncology New Drugs Apparent ADC new drug gold rush fever continues to burn, the international pharmaceutical companies crazy rush into, optimistic about the development of ADC new drugs for three main reasons, respectively, ADC new drug R & D platform know-how for the biotechnology and pharmaceutical industry is extremely valuable for the development of the reason from the ADC drugs in the drug design and assembly flexibility, the core strategy of new drug development is nothing more than first in class or best in class, in terms of the first new drug, the ADC new drug commercial opportunities in the innovative ADC technology in new targets, new linkers, best in class. The core strategy of new drug development is either first in class or best in class. In terms of first in class, the commercial opportunities of new ADC drugs lie in the application of innovative ADC technologies in new targets, new linkers and new therapeutic areas, the development of antibodies utilizing innovative targets (first in class/ or bispecific targets), or the replacement of antibodies with functional compounds, peptide chains, and other components. We are also working on the development of new drugs by replacing antibodies with functional compounds, peptides, or nucleotides that are chemically conjugated to a wide range of specific therapeutic agents to create new drugs with innovative therapeutic regimens. In terms of best-in-class, the commercial opportunity of ADC new drugs lies in the revitalization of past drug assets. ADC new drugs have a competitive advantage in development cost and speed, and make use of past successful antibodies and chemotherapeutic drugs to carry out chemical linkage combinations, and rapidly develop the best quality and efficacy of new drugs for leading anticancer drugs based on the safety and efficacy of the past drugs. Secondly, ADC technology has been used in cancer treatment to enhance efficacy and avoid drug resistance, and a number of new marketed ADC drugs have been approved for applications such as the continuous expansion of indications or combination therapies, such as ADC (Padcev®) plus PD-1 (Keytruda®) for the treatment of advanced bladder cancer, as well as Enhertu®, which is a new drug that has been approved for the treatment of advanced bladder cancer.^®The sales performance of new drugs will show the way for ADC new drug development to share the $200 billion market in the field of cancer treatment and bring a predictable prospect; C. Facing the patent cliff of original research new drugs, when the patent of new antimicrobial drugs expires to face the challenge of biosimilar drugs, the major international pharmaceutical companies will inevitably look for new growth points to reduce the loss of revenues, therefore, the ADC drugs are also regarded as a continuation of the patents of the antibody drugs (or chemotherapeutic drugs) and the technical barrier to continuation of development strategy, after all, developing new anticancer drugs is time-consuming and expensive, and must bear high risk uncertainty. Therefore, ADC drugs are also regarded as a development strategy for the continuation of patent and technology barrier continuity of antibody drugs (or chemotherapeutic drugs), after all, the development of brand new anticancer drugs is time-consuming and expensive, and must bear the uncertainty of high risk. 2024 is the beginning of the ADC new drugs and there will be a new wave of increased competition, in addition to the recent Merck (Merck) and Daiichi Sankyo to increase the amount of 5.5 billion dollars to co-develop the three DXd ADCs, to make up for the previous failure of the Merck to grab relatives. In addition to Seagen, which it failed to acquire ADC technology, Danish pharmaceutical company Genmab acquired China's ProfoundBio for US$1.8 billion, Johnson & Johnson acquired Ambrx for US$2 billion, and French company Ipsen signed a US$900 million partnership agreement with Sutro Biopharma to join the ADC race. International pharmaceutical companies have invested billions of dollars in the ADC new drug development competition, among which the entry of European pharmaceutical companies is even more eye-catching, which demonstrates that the trend of ADC new drug development is strong and the subsequent development is worth looking forward to.

Taiwan's Rush to AttackADCBusiness Opportunities fromADCInnovative Drug Design and High-end Manufacturing

Under the ADC new drug development boom, with the iterative innovation of innovative drug design concepts, new drug targets, and new complex technologies, the highly complex ADC drug research and development, manufacturing and production management, GMP management, supply chain management, and safety and security management not only put forward extremely high demands and challenges, but also bring huge business opportunities for the research and development and mass production of new ADC drugs. It is expected that the current ADC drug development model of 70%-80% will adopt the strategy of R&D and design together with CDMO commissioned development and design. In Taiwan, in terms of new drug selection, there are AIDS ADC of Zhongyu, which proposes new ADC therapeutic design, or GlycOB, a novel glycoconjugated ADC platform of Hodin. In terms of CDMO commissioned ADC high-end manufacturing, there are commissioned development opportunities for TAYAO (Taikang), TAIFU (Hodin/Zhongyu), YONGXIN/KENYI (Sung-Te), and so on, which are modeled after the license granted to YEUNGSON by LegoChem Bio of Korea for up to US$1.7 billion. With the experience of Janssen's US$1.7 billion license from LegoChem Bio in Korea and the strategy of major international CDMO companies in ADC technology development, it is believed that Taiwan companies are also expected to make their presence felt in the international arena of new ADC drug development and high-end ADC manufacturing.

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