68Ga-DOTA-TATE

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议继抗体药物、ADC、基因疗法等热门领域之后，核药领域也受到国内企业的关注，由于核药存在放射性，且有半衰期的限制，使得行业具有多重壁垒，有较高的准入门槛，市场格局也因此而更加稳定，企业纷纷入局这一稀缺赛道。据不完全统计，2023年1-9月全球核药领域共发生17起融资事件，融资总金额突破13亿美元。国内市场，东诚药业、中国同辐、恒瑞医药、远大医药、先通医药等本土企业均在加速布局。今年，国内核药领域就有4起融资，所涉及的药物类型包括放射性疗法、抗肿瘤创新疗法、个体化细胞疗法等。其中，先通医药超11亿元的融资，成为国内医疗健康领域2023年最大一笔融资，引发业内关注。核药上市公司情况目前国内涉及核药业务的上市公司有诺华制药、东诚药业、远大医药、中国同辐和东曜药业，基本情况如下：10月24日，诺华发布2023年三季报：Q3全球净销售额118亿美元，同比增长12%，主要系诺华旗下多款创新药强劲增长推动的；营收18亿美元，同比增长13%，净利润为15亿美元，同比增长37%，主要是由于非经常性项目驱动营业收入的增加和税率降低导致的。诺华2023年前三季度净销售额累计340亿美元，同比增长10%；营收72亿美元，同比增长31%；净利润59亿美元，同比增长41%。其增长引擎包括核药Pluvicto(+217%)，Q3营收2.56亿美元，前三季度营收达7.07亿美元。CD20抗体Kesimpta（奥法妥木单抗）(+124%)、Entresto（沙库巴曲缬沙坦钠）(+31%)、CDK4/6抑制剂Kisqali（瑞波西利）(+76%)和Scemblix (+157%)。目前诺华在核药领域共布局了5条管线，涉及广泛期小细胞肺癌、胃肠胰神经内分泌肿瘤、实体瘤、转移性去势抵抗性前列腺癌（mCRPC）等领域。在诺华获批的RDC药物中，Lutathera是 FDA 批准的第一个治疗胃肠胰神经内分泌肿瘤的放射性药物。2018年获批至今，其累积销售额已超过20亿美元。2022年3月，诺华第二款治疗型核药Pluvicto®（177Lu-PSMA-617）获批，用于治疗PSMA阳性、经治疗进展的前列腺癌。2023年10月26日，诺华公司宣布，美国食品和药物管理局已将 Pluvicto药物短缺问题列为已解决状态。自5月份以来，诺华一直在努力扩大 Pluvicto 的生产规模，每周的生产能力增加了一倍多。诺华致力于提供稳定、可靠的 Pluvicto 供应，使患者能够随时获得这一重要药物。Pluvicto的成功，一方面得益于选择的靶点PSMA是前列腺癌治疗中较为成熟的靶点，一方面得益于恰好发现天然高亲和、高内吞的多肽前体，经过一系列改造和优化，获得更好成药性。今年第一季度，Pluvicto在供应短缺和新患者启动工作暂停的情况下，仍达到2.11亿美元的销售额。第二季度，Pluvicto的销售额为2.4亿美元。基于此，2023年Pluvicto的营收有望超过10亿美元，进而跻身“重磅炸弹”行列。                       东诚药业是中国核医疗领先企业之一，2015年东诚药业通过收购云克药业进入核药领域，在市场占有率和核药品种方面都在奋力追赶中国同辐。云克注射液和碘[125I]密封籽源、锝[99mTc]替曲膦注射液等为其主要产品。其市场占有率约21.6%，仅次于中国同辐。目前，东诚药业运营的核药房已超20个。东诚药业透露，未来3到5年内，将完成30个核药房的布设，覆盖到全国95%以上人口。据2023年半年报显示，东诚药业实现营业收入17.85亿元，同比增长1.13%。归属于上市公司股东的净利润1.84 亿元，同比增长9.23%。营业成本9.89亿元，同比下降；其中研发费用支出1.63亿元，同比增长117.96%，主要是研发活动投入增加所致。分板块来看，报告期内核药业务板块销售收入5.02亿元，同比增长19.18%，其中重点产品18F-FDG实现营业收入2.15亿元，同比增长18.48%；云克注射液实现营业收入1.24亿元，同比增长 22.66%；碘[125I]密封籽源实现营业收入8,326.87万元，同比增长51.28%。通过近几年的并购，东诚药业在核医药领域初步完成了产品线的布局，聚焦于肿瘤、神经退行性疾病、心脑血管疾病等重点领域，形成“筛查—诊断—治疗”放射性药品全覆盖。现有产品覆盖了国内主流核医药品种，不仅包括诊断类正电子药物 18F-FDG、单光子药物锝[99mTc]标记药物和其他药物尿素[14C]胶囊，还拥有治疗类药物云克注射液、碘[125I]密封籽源、碘[131I]化钠口服液等多个产品，公司将进一步完善核药产品线布局，满足市场对于精准诊疗的需求。其重点产品如下：远大医药集团有限公司是一家科技创新型国际化医药企业，核心业务横跨制药科技、核药抗肿瘤诊疗及心脑血管精准介入诊疗科技、生物科技三大领域。核药抗肿瘤诊疗板块是远大医药全球化程度最高的板块之一，在核药抗肿瘤诊疗板块已实现了研发、生产、销售、监管资质等多个环节的全方位布局，建立了完整的产业链。据2023年半年报显示，远大医药上半年实现营收59.89亿港元，同比增长14.9%；归母净利润10.29亿港元，同比去年增长44.9%。如果不计算对Telix投资的公允价值变动收益2.29亿港元和一次性行政罚款约3.23亿港元，上半年归母净利润约11.24亿港元，同比增长3.1%。研发工作及项目支出4.97亿港元，同比下降68.9%；分销费用为16.38亿港元，同比增长19.3%，主要系营收大幅增长所致。在核药抗肿瘤诊疗板块，远大医药重磅创新产品易甘泰钇[90Y]微球注射液(简称“易甘泰”)国内推广顺利；此外，公司核药板块用于诊断透明细胞肾细胞癌的全球创新放射性核素偶联药物(RDC)TLX250-CDx在中国开展的I期临床研究完成首例患者入组并给药；用于治疗胶质母细胞瘤的TLX101以及用于治疗胃肠胰腺神经内分泌瘤的ITM-11在中国获批开展I期临床研究；用于治疗外周血管动脉出血的创新液体栓塞剂LavaTM获得美国FDA的上市批准；用于治疗脑动静脉畸形的术前栓塞剂KonaTM向FDA递交了上市前审批申请。中国同辐自1983年成立以来，聚焦药品的研发、生产、销售，同时兼营放射源、辐照、核医疗装备和独立医学检验实验室服务。公司65.23%的收入、84.55%的毛利来源于药品板块，属于核医药行业。核医药行业是一个高潜力、高门槛、高收益的行业，作为中国核医药行业的领军企业，中国同辐是国内最大的显像诊断及治疗用放射性药品、尿素呼气试验药盒及测试仪、以及放射免疫分析药盒制造商。据2023年半年报显示，中国同辐上半年实现营收27.41亿元，同比增长4.62%，主要系公司放射源、放射治疗设备及相关服务分部的收益均显著增长所致。研发费用支出1.36亿元，同比增长16.26%；销售费用支出12.56亿元，同比增长15.55%，主要系报告期内放射治疗设备及相关服务业务量较上年同期增长较大，从而导致相应的销售成本增加所致。从收入结构来看，报告期内公司药品收入17.88亿元，同比增长1.34%；放射源产品销售收入2.27亿元，同比增长31.69%；辐照收入0.77亿元，同比增长3.6%；放射治疗设备及相关服务4.02亿元，同比增长49.31%；其他业务2.48亿元，同比下降27.23%。截至2023年6月30日，中国同辐拥有多款处于各种研发阶段的显像诊断及治疗用放射性药品，其中，氟[18F]化钠注射液已完成临床试验并提交上市注册申请，碘[131I]-MIBG注射液正在开展III期临床试验，氟[18F]司他明注射液、锝[99mTc]硫化胶体注射液、氟[18F]贝他嗪注射液、氟[18F]-L多巴注射液、68Ga-Dotatate注射液、镥[177Lu]氧奥曲肽注射液等药物已获批开展临床试验，以及其它多种处于临床前研发阶段的显像诊断及治疗用放射性药品。据2023年半年报显示，东曜药业上半年实现营收3.28亿元，同比增长80%，主要来自核心产品贝伐珠单抗注射液朴欣汀®销量持续攀升。其中产品销售收入为人民币2.78亿元，同比增长167%，主要来自核心产品贝伐珠单抗注射液朴欣汀®。研发费用为49,969千元，同比下降28.9%，主要系产品管线优化、聚焦研发资源所致；销售费用为人民币197,376千元，同比增长182%，主要系自研产品销量增加，随之带来营销推广费用的增加所致。2023年4月22日，东曜药业与智核生物签订战略合作协议，双方将进一步巩固和深化合作，快速推进基于偶联技术的放射性创新药物的开发。此次合作会将进一步加深东曜药业与智核生物在放射性药物领域的合作，东曜药业将提供完整的抗体偶联开发方案，而智核生物将依托乙级放射性同位素实验室提供完整的放射性同位素标记开发方案。总结总体来看，核药在国内外都正处于或者即将进入高速发展阶段，作为发展的源动力，围绕靶点、分子、适应症、核素的科技创新或将成大势所趋，全球核药研发市场呈现一片繁荣，部分药企也率先抢占了市场先发优势，比如诺华的创新产品核药Pluvicto上半年销售额4.51亿美元，同比增长14%，预计全年突破10亿美元。由于核药需要受到国家严格的监管，使其展现出高门槛、高研发壁垒等显著特点，未来或许仍将继续上演并购大戏。随着远大医药、先通医药、恒瑞医药等新鲜血液的不断涌入，中国RDC创新加速，赛道持续升温，有望打破我国核药市场长期被中国同辐、东诚药业双寡头垄断的局面。参考资料：公司官网END

Enrollment for the randomization phase of SPLASH completed prior to EOY 2022, meeting previous guidanceINDIANAPOLIS, Jan. 12, 2023 (GLOBE NEWSWIRE) -- POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or “POINT”), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, today announced the completion of enrollment for the randomization phase in the pivotal phase 3 SPLASH trial, on schedule and meeting previous guidance. SPLASH is a multi-center, randomized, open label assessment of 177Lu-PNT2002 in participants with PSMA-expressing metastatic castration resistant prostate cancer who have progressed on androgen receptor pathway inhibitor therapy and refuse, or are not eligible for, chemotherapy. Enrollment for randomization was completed on schedule with more than 390 participants randomized across 55 SPLASH trial sites in North America, Europe, and the United Kingdom. “We are proud to have reached this important milestone for the PNT2002 program,” said Jessica Jensen, Executive Vice President, Clinical Development of POINT Biopharma. “Our incredibly talented cross-functional team collaborated tirelessly to ensure that, despite the extraordinary circumstances of a pandemic, POINT’s first phase 3 global trial remained on track. Our success is a testament to both the expertise of our team and the level of enthusiasm for radioligand therapy in the oncology community. We are grateful for patients who agreed to be screened for this study, the trial investigators and their hard-working staff, our research partners, and the POINT team for their passion and commitment to the program. We look forward to continuing to work diligently to advance novel treatment options for patients as we accelerate the discovery, clinical development, and manufacturing of radioligand therapies.” On November 14, 2022, POINT announced a set of strategic collaboration agreements with Lantheus Holdings Inc. (NASDAQ: LNTH) related to POINT’s PNT2002 and PNT2003 product candidates, which closed on December 20, 2022. Under the agreements, POINT will fund and complete its phase 3 SPLASH trial for PNT2002, following which Lantheus will file the New Drug Application (NDA) in collaboration with POINT. For PNT2003, POINT recently received the OZM-067 clinical trial data sets from the trial sponsor. POINT will facilitate the analysis of the data sets. Lantheus will prepare and submit the regulatory filings in the U.S. The companies have formed joint steering committees to oversee the clinical studies, regulatory filings, manufacturing, and commercial readiness for both PNT2002 and PNT2003. POINT will develop commercial production capacity and manufacture clinical and commercial supply for both PNT2002 and PNT2003. Lantheus has the rights to commercialize both assets post regulatory approval, excluding certain Asian territories1. [1] Japan, South Korea, China (including Hong Kong, Macau, and Taiwan), Singapore, and Indonesia are retained by POINT. About the SPLASH TrialThe phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in participants with PSMA-expressing metastatic castration resistant prostate cancer (mCRPC) who have progressed on androgen receptor pathway inhibitor (ARPI) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study enrolled over 390 participants across North America, Europe, and the United Kingdom. Participants were randomized 2:1 with those in arm A receiving PNT2002 and those in arm B receiving either abiraterone or enzalutamide. Participants in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from their first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall response rate, overall survival, and pharmacokinetics. More information about the trial is accessible at ClinicalTrials.gov, identifier NCT04647526. About the OZM-067 TrialThe OZM-067 trial, sponsored by the University Health Network (UHN), is a prospective single-arm, multi-center study to evaluate the efficacy and safety of lutetium-177 octreotate in patients with 68Ga-DOTATATE-identified, somatostatin receptor-positive neuroendocrine tumors. More information about the trial is accessible at ClinicalTrials.gov, identifier NCT02743741. About POINT Biopharma Global Inc.POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision medicine by combining a portfolio of radiopharmaceutical assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for rare medical isotopes like actinium-225 (225Ac) and lutetium-177 (177Lu). POINT’s active clinical trials include FRONTIER, the phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment. More information about the SPLASH trial can be found at https://www.splashtrial.com/. Learn more about POINT Biopharma Global Inc. at https://www.pointbiopharma.com/. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential attributes and benefits of POINT’s product candidates and the format and timing of POINT’s product development activities and clinical trials. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, our ability to obtain funding for our operations, our ability to maintain the license agreements underlying our product candidates, competition, the ability of POINT to grow and manage growth profitably and retain its key employees, the impact of COVID-19 on POINT’s business, the ability to maintain the listing of POINT’s common stock on the NASDAQ, changes in applicable laws or regulations, the possibility that POINT may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described in POINT's Annual Report on Form 10-K filed with the SEC on March 25, 2022 and subsequent filings with the SEC. Most of these factors are outside of POINT’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Investor Relations Contact:Daniel PearlsteinAssociate Director, Corporate Strategyinvestors@pointbiopharma.com