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核医学系列报告(二):国内核药迎来商业化兑现期,RDC具备比肩ADC的潜力
Ping An Securities· 2025-04-15 14:44
Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical sector [1]. Core Insights - The commercialization of nuclear medicine is accelerating, with significant growth in diagnostic nuclear drugs and the potential for domestic nuclear drugs to reach a commercialization inflection point [3][17]. - The report highlights the successful commercialization of Pluvicto and Lutathera, which are expected to generate substantial revenues, with Pluvicto projected to exceed $5 billion in peak sales [3][12]. - The report emphasizes the similarities between Radioligand Therapy (RDC) and Antibody-Drug Conjugates (ADC), suggesting that RDC could replicate the success of ADC in the market [3][22]. Summary by Sections Part 1: Overseas Nuclear Drug Rapid Growth, Domestic Commercialization Period - Overseas nuclear drugs are experiencing rapid commercialization, with Pluvicto achieving $1.392 billion in revenue in 2024, a 42% increase, and Lutathera generating $724 million, a 20% increase [3][12]. - The combined revenue from these two drugs for Novartis reached $2.116 billion, indicating the ongoing value realization of nuclear drugs [3][12]. - The report notes that the domestic nuclear drug market is set to expand significantly, with five new nuclear drugs approved since 2020, including Yttrium-90 microspheres from Yuan Da Pharmaceutical, which is expected to generate nearly HKD 500 million in revenue in 2024, a growth rate exceeding 140% [3][20]. Part 2: RDC Expected to Replicate ADC Success Path - RDC shares structural and mechanistic similarities with ADC, consisting of a targeting ligand, a linker, and a radioactive nuclide [3][22]. - The report outlines that both RDC and ADC have followed similar validation timelines, with ADC gaining market traction after the success of Enhertu, while RDC is now gaining attention following the success of Pluvicto [3][22]. - The market for new nuclear drugs is projected to reach approximately $4-5 billion in 2024, comparable to the ADC market size around 2021 [3][22]. Part 3: Domestic Nuclear Drug Pipeline Overview - The report details the current pipeline of domestic nuclear drugs, with three products in the NDA stage, including Novartis's PSMA diagnostic and therapeutic drugs [3][49]. - The leading targets in domestic research remain PSMA, FAP, and SSTR, with companies like Yuan Da Pharmaceutical and Xiantong Pharmaceutical leading in clinical project numbers [3][53]. - The anticipated approval of Novartis's two PSMA-targeted products in Q2 2025 is expected to further stimulate the domestic nuclear medicine market [3][20].
康宁杰瑞制药(09966) - 自愿公告 - JSKN003获得国家药监局突破性疗法认定
2025-03-18 00:00
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 (於開曼群島註冊成立的有限公司) (股份代號:9966) 自願公告 JSKN003獲得國家藥監局突破性療法認定 1 關於JSKN003 JSKN003是一種靶向HER2雙表位ADC,其通過糖基定點偶聯技術將拓撲異構酶 I抑制劑連接至抗體KN026(重組人源化抗HER2雙特異性抗體)的N糖基化位點 處。點擊反應偶聯物較馬來醯亞胺-邁克爾反應的偶聯物具有更好的血清穩定 性。雙表位HER2靶向性使JSKN003具有更強的內吞誘導及旁觀者殺傷效應,使 其在HER2表達腫瘤中具有較強的抗腫瘤活性。 關於本公司 本公司是一家中國領先的生物製藥公司,在雙特異性抗體、多功能蛋白質工程及 ADC方面擁有完善的專有技術平台。本公司高度差異化的內部管線由處於不同研 發階段的腫瘤單克隆抗體、雙特異性抗體及ADC組成,包括一種已獲國家藥監局 批准上市及三種處於臨床後期階段的藥 ...