Group 1: Rise of RDC Drugs - The development of Radiopharmaceutical Drug Conjugates (RDC) is gaining momentum in the field of oncology, driven by the need for more precise, effective, and less toxic treatment methods [1][2] - The history of radioactive substances in medicine dates back to 1896, with significant advancements in nuclear medicine applications, particularly in diagnostics, which dominate over 90% of the market [2] - Traditional nuclear medicines like Iodine-131 and Radium-223 have been widely used in clinical treatments, with Iodine-131 being effective for thyroid conditions since 1941 and Radium-223 approved by the FDA in 2013 for prostate cancer bone metastases [2] Group 2: Mechanism and Composition of RDC - RDCs combine targeting molecules with radioactive isotopes to create a new type of integrated diagnostic and therapeutic drug, allowing for precise localization of diseased tissues and simultaneous treatment [7][10] - The key components of RDC include targeting ligands, linkers, chelators, and radioactive isotopes, each serving specific functions to ensure effective delivery and action against cancer cells [9][10] - The unique ability of RDCs to integrate diagnosis and treatment makes them a versatile tool in clinical applications, with common isotopes used for diagnosis being Gallium-68 and for treatment being Lutetium-177 [10] Group 3: Global R&D Landscape of RDC - The RDC sector has seen significant R&D achievements, with 11 RDC drugs currently on the market, including 9 diagnostic and 2 therapeutic agents, focusing on targets like PSMA and SSTR for prostate and neuroendocrine tumors [11][12] - Novartis leads the international market with strategic acquisitions, including AAA and Endocyte, resulting in flagship products Lutathera and Pluvicto, with Pluvicto projected to achieve $1.392 billion in sales by 2024 [12][16] - Other major pharmaceutical companies such as Roche, Eli Lilly, Bayer, and AstraZeneca are investing heavily in RDC development, each committing over $1 billion to find promising pipelines [16] Group 4: Domestic Market Dynamics in China - Over 120 Chinese companies are involved in RDC R&D, with leading firms like Yuan Da Pharmaceutical developing innovative products targeting various cancers [17] - Heng Rui Pharmaceutical is also a key player with multiple pipelines, including three RDCs in Phase III clinical trials, targeting PSMA and SSTR [17][18] - New entrants like Xiantong Pharmaceutical and Yunhe Pharmaceutical are emerging, with innovative products entering clinical trials, indicating a growing competitive landscape in the domestic RDC market [20][23]

Group 1 - The company YuanDa Pharmaceutical Group has received formal acceptance from the National Medical Products Administration for its innovative radiopharmaceutical drug TLX591, aimed at treating metastatic castration-resistant prostate cancer (mCRPC) [2] - TLX591 is set to be evaluated in a global Phase III clinical trial involving over 500 patients across multiple countries, including China, the USA, Australia, and New Zealand, comparing its efficacy and safety against standard treatment [2] - Prostate cancer is a common malignancy among elderly men, ranking second in incidence and fifth in mortality among male cancers globally, and sixth and seventh in China respectively [2] Group 2 - The global prostate cancer treatment market was estimated at $15.2 billion in 2021 and is projected to grow to $24.9 billion by 2030 [3] - Traditional radiotherapy for prostate cancer in China has high cumulative radiation doses, leading to complications that significantly affect patients' quality of life, indicating a clinical need for lower radiation exposure treatment options [3] - YuanDa Pharmaceutical is focusing on the global development strategy of nuclear medicine for oncology, aiming to expedite the registration and commercialization of innovative nuclear drugs, with TLX591 potentially becoming a significant product for the company [3]

以下文章来源于阿基米德Biotech ，作者阿基米德君 阿基米德Biotech . 生物医药第三方独立观察，客观中立，深入浅出，松弛愉悦，写作纯为兴趣，不接广告 超长续航模式。 来源 | 阿基米德Biotech （ID：ArchimedesBiotech） 资本寒冬，一家上市Bi o t e c h也没有挂掉。 1 8A生物科技七年之痒，7 0家公司（含摘B）仍然整整齐齐，一家没少，即使市值最小 的北海康成账上现金仅剩1亿元，但管理层认为2025年有足够的营运资金，即使诺辉健 康复牌暂时没有进展，但离生死大限还有5个月。 中国创新药处于少年时代，（在上市公司层面）有着足够的容错率和包容度，如同《百 年孤独》中初创的"马孔多"，这里全是年轻人，没有死亡，自然没有墓地。 然而，站在中国创新药1 0年节点之上，两大蜕变还是发生了。 今 非 昔 比 ， 《 创 新 药 供 给 侧 改 革 》 （ 2021 年 7 月 ） 指 出 的 内 卷 和 泡 沫 ， 如 今 都 不 再 严 重。 一是行业主要矛盾的蜕变，从同质化竞争的内部矛盾，转为中国生物科技快速崛起与美 国维持生物科技创新领域领导地位之间的外部矛盾。 二是创 ...

为放射性药物提供从非临床到临床转化的一体化服务。 本文为IPO早知道原创 作者｜C叔 微信公众号｜ipozaozhidao 据IPO早知道消息，今年11月，放射性药物领域创新型企业通瑞生物制药（成都）有限公司（下 称"通瑞生物"）宣布完成超1亿美元A+轮融资。本轮融资由深创投制造业转型升级新材料基金（下 称"深创投集团"）、泰珑投资共同领投，高瓴创投（GL Ventures）、三生制药（1530.HK）、光 华梧桐、某知名产业投资机构等多家机构和产业方共同参与投资，凯乘资本担任独家财务顾问。 本轮融资将帮助进一步完善公司靶向前体发现等核心技术平台，升级创新RDC药物高通量筛选能 力，加速多条国际领先研发管线、特别是α核素RDC药物的临床开发进程，为全球患者带来更有效的 治疗方案。 随着现代医学对精准诊断和治疗的需求不断增加，放射性药物凭借其独特的优势，在肿瘤、心血管疾 病、神经系统疾病等多个领域展现出巨大的应用前景。2023年，诺华的两款放射性配体疗法药物成 功上市并在商业上取得很大成就，与此同时，礼来以14亿美元对核药企业Point实施收购，而BMS （百时美施贵宝）斥资41亿美元收购核药企业RayzeBi ...

集团核药抗肿瘤诊疗板中，3款RDC产品已进入III期临床阶段。 本文为IPO早知道原创 作者｜罗宾 此外，ITM-11还可与远大医药另一款用于诊断GEP-NETs的RDC产品TOCscan形成产品组合，实 现对GEP-NETs的诊疗一体化，有望为我国GEP-NETs患者提供全新的诊疗方案。 近两年，远大医药在核药领域发力，搭建了国际化水平的肿瘤介入技术平台和RDC技术平台。公告 显示，远大医药在核药抗肿瘤诊疗板的12款创新产品储备中，已有4款RDC创新药获批开展临床研 究，其中3款进入III期临床阶段，包括诊断前列腺癌的产品TLX591-CDx、诊断透明细胞肾细胞癌产 品TLX250-CDx，以及治疗GEP-NETs的产品ITM-11。集团目前是进入中国III期临床研究中诊断 和治疗类RDC创新药总计储备最多的企业。 本文由公众号IPO早知道（ID：ipozaozhidao）原创撰写，如需转载请联系C叔↓↓↓ 微信公众号｜ipozaozhidao 据IPO早知道消息，远大医药（0512.HK）于10月14日发布公告，集团用于治疗胃肠胰腺神经内分 泌瘤的全球创新放射性核素偶联药物（RDC）ITM-11的一项II ...