June_ADC Topics｜Pfizer's $43 Billion Seagen Acquisition as a Potential ADC New Drug Opportunity

Published On: 2023/06/02|Categories: 大健康(Healthcare)|

How powerful is ADC, the new innovative modular missile drug, and why is Pfizer willing to spend US$43 billion to snatch the acquisition of Seagen from Merck (MSD)? The strong merger opens up unlimited business opportunities for ADC Antibody Drug Conjugate (ADC), what are the hidden business opportunities and commercial value?

Pfizer once again to acquire, in addition to benefit from the COVID-19 best-selling vaccine (Pfizer/BNT) business outside the epidemic of the financial momentum brought about by the strong, expanding the product portfolio to drive the growth of innovative drug sales is still the international pharmaceutical companies to create revenue unchanged keynote. According to the financial report, Seagen's revenue will reach US$2 billion in 2022, a year-on-year growth of 23% compared to 2021, with the main revenue contributions coming from three aspects: the four existing marketed drugs, royalties, and collaboration licensing agreements, etc., of which the four marketed drugs include three ADC drugs for the treatment of lymphomas (Adcetris), and three ADC drugs for the treatment of lymphomas (Adcetris).^®with sales of $839 million in 2022), bladder cancer (Padcev^®(Tivdak) and cervical cancer (Tivdak), with sales of US$451 million in 2022.^®(with sales of $63 million in 2022), and a small molecule chemical for colorectal cancer treatment (Tukysa^®Pfizer's new ADC drug, Mylotargine, is expected to exceed $10 billion in revenue growth by 2030 as the company expands the benefits of the new indication extensions for these drugs and approvals of other new ADC drug candidates. Historically, Pfizer's new ADC drug, Mylotarg, has been shown to be a significant contributor to the company's growth.^®The acquisition of Seagen's key internal ADC technology will help Pfizer master the ADC core technology platform in depth, and will continue the development of the existing ADC new drug candidates, thus enhancing Pfizer's leading position in the anticancer drug market in the future.

ADC新藥高速成長，市場看好ADC新藥商機

根據Research and Market(2023/3)報告指出 2022 年全球ADC新藥市場規模約 59億美元，預估 2026 年可成長 2 倍達到 130.6 億美元，複合年增長率為 22%，截止目前ADC上市藥物已湧現出三款銷售近10億美元的藥物分別為治療乳癌Kadcyla^®(2022年銷售22.65 億美元)、治療淋巴瘤Adcetris^®(2022年銷售額達8.39億美元)和治療乳癌Enhertu^®(2022年銷售12億美元)，表示ADC新藥在療效與銷售上具有瓜分現有腫瘤市場的潛力。ADC的概念提出至今已有100多年的歷史，截止目前US FDA已核准13項ADC藥物上市，如表一，2020-2022年期間US FDA已核准5個ADC藥物上市，表示目前平均每年約有1-2款ADC新藥核准，隨著ADC技術成熟和法規清晰，ADC已成為美國各大藥廠競爭的重要領域，目前ADC核准藥物如Seagen(3款)、Genetech/Roche (2款)、AZ(2款)，以及輝瑞(2款)，隨著此次輝瑞收購Seagen勢必將改變ADC技術佈局的版圖。此外根據ClinicalTrials.gov網站數據(2023/3)，全球目前已有 1,894 項 ADC 註冊進行臨床試驗包含100多個ADC候選藥物，其中研發熱點適應症仍是腫瘤，從上述資料中不難發現ADC新藥已形成快速成長期趨勢，儼然成為各家藥廠寄予厚望的新藥開發關鍵技術領域。

Table I,2020年至2022surname NianUS FDA核准ADC新藥

資料來源:智璞產業趨勢研究所整理(如需完整資訊，請來電索取)

備註: 2020/10/26 Gliead以 210 億美元收購 Immunomedics

國際大廠創新藥ADC明燈指路，台廠多有發揮空間

根據Back Bay ADC新藥資產交易數據顯示，過去五年國際間ADC在抗癌藥領域的交易價值高於其他技術領域如雙特異性抗體(bispecific antibody)，且多數ADC新藥在藥物發現和臨床前階段，就能展示出顯著的抗癌療效，因此在在臨床前和臨床階段ADC候選藥物就能創造出數10億美元的階段性里程碑金，且ADC候選新藥平均交易價值可高達20億美元。

台灣ADC新藥部隊已陸續部屬，期待未來在ADC新藥開發領域嶄露頭角，過去台灣本來就具備高附加價值抗癌原料藥的製造基礎，隨著新一代生物製藥技術發展，結合抗體藥藥廠的技術優勢，如台耀(原料藥)和台康(抗體)共同開發乳癌生物相似藥Kadcyla^®，或者是生技中心以高達6.9億元台幣授權金技轉給原料藥廠旭富子公司嘉正生技的可搭載2項化療物的ADC鏈結技術平台，都逐漸顯示台灣新藥開發市場對ADC技術的高度重視，無論是以CDMO委託開發暨製造服務的永昕和泰福，或是大分子抗體藥和小分子化學藥藥廠，以及台灣專長於化學合成和藥物技術新創的建誼生技和免疫工坊等產業鏈分工切入ADC佈局已形成。整體而言，新一代ADC新藥在有效承載藥物選擇方面仍有很多創新機會，目前選擇不再局限於標準的細胞毒殺藥物，而是朝向發現更多的靶向藥物或免疫藥物。由於ADC藥物製造困難，特別是抗體與細胞毒殺藥物的結合，需要深度化學和生物學專業知識，台灣過去擅長改良新藥的發展，並期待未來看到台灣自主研發的ADC新藥接軌國際。

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