EndoTAG-1

中国上海和美国马萨诸塞州剑桥， 2023年6月28日——再鼎医药（纳斯达克股票代码：ZLAB；香港联交所股份代号：9688）今天宣布，国家药品监督管理局（NMPA）已受理瑞普替尼（repotrectinib）的新药上市申请，用于治疗ROS1阳性的局部晚期或转移性非小细胞肺癌成人患者。 再鼎医药总裁、全球肿瘤研发负责人Rafael Amado博士表示，“很高兴国家药监局受理了我们提交的瑞普替尼的新药上市申请，这进一步支持了瑞普替尼可能成为治疗中国ROS1阳性非小细胞肺癌患者的潜在同类最优疗法。由于目前获批疗法的获益持久性有限，发生耐药及不可避免的肿瘤进展，这部分患者存在巨大的未被满足的需求。我们期待在审评过程中积极配合药监局，共同努力将这款重要药物尽早带给有需要的患者。” 今年5月，国家药监局药品审评中心（CDE）将瑞普替尼纳入优先审评，用于治疗ROS1阳性的局部晚期或转移性非小细胞肺癌成人患者。 关于瑞普替尼 瑞普替尼是靶向作用于包括非小细胞肺癌在内的晚期实体瘤ROS1和NTRK致癌因子的新一代激酶抑制剂。携带ROS1和NTRK基因融合的肿瘤患者在接受目前已获批准的靶向治疗后，通常会出现耐药突变，这些突变限制了药物与靶点的结合，最终导致肿瘤进展。瑞普替尼是针对ROS1阳性转移性NSCLC的首款新一代TKI，独特设计用于解决疾病进展的关键驱动因素。再鼎医药和Turning Point Therapeutics（被BMS收购）正在开展与瑞普替尼相关的两项研究，其中TRIDENT-1是一项针对成人的注册性1/2期研究，CARE是一项针对儿童患者的1/2期研究。在TKI初治和TKI经治患者中，瑞普替尼显示出抗肿瘤活性和持久应答。再鼎医药负责TRIDENT-1注册性研究在大中华区（中国内地、香港、澳门和台湾地区）的患者招募工作，Turning Point Therapeutics负责全球其他地区的患者招募。 FDA此前已授予瑞普替尼三项突破性疗法认定，用于未接受过ROS1 TKI治疗的ROS1阳性转移性非小细胞肺癌患者；治疗既往接受过一个前线ROS1 TKI并且未接受铂类化疗的ROS1阳性转移性非小细胞肺癌患者；治疗既往接受过一个或两个前线TRK TKI治疗、无论是否接受过化疗都出现疾病进展、且没有令人满意的替代疗法的NTRK基因融合的晚期实体瘤患者。此外，瑞普替尼此前还获得过FDA授予的四项快速通道（Fast-Track）资格认定，包括用于ROS1 TKI初治的ROS1阳性晚期非小细胞肺癌患者；既往曾接受过一个前线铂类化疗和一个前线ROS1 TKI治疗的ROS1阳性晚期非小细胞肺癌患者；既往接受过一个前线ROS1 TKI、未接受过铂类化疗的ROS1阳性晚期非小细胞肺癌患者；以及既往至少接受过一个前线化疗以及一个或两个前线TRK TKI治疗后进展且没有满意替代治疗的NTRK阳性晚期实体瘤患者。2017年，瑞普替尼还被FDA授予“孤儿药”资格认定。 瑞普替尼被国家药品监督管理局（NMPA）药品审评中心（CDE）授予三项突破性疗法认定：未接受过ROS1 TKI治疗的ROS1阳性转移性非小细胞肺癌患者；既往接受过一个前线ROS1 TKI并且未接受过铂类化疗的ROS1阳性转移性非小细胞肺癌患者；既往接受过一个前线ROS1 TKI和个前线铂类化疗的ROS1阳性转移性非小细胞肺癌患者。 再鼎医药拥有在大中华区开发和商业化瑞普替尼的独家授权许可。 关于中国非小细胞肺癌 肺癌是中国最常见的癌症类型，也是癌症死亡的主要原因。2022年中国肺癌新发病例约871,000例，死亡病例约767,000例 1 。非小细胞肺癌约占肺癌的85%，约70%的非小细胞肺癌在初步诊断时为局部晚期或转移。在中国，ROS1重排约占晚期非小细胞肺癌患者的2%-3%。 1 Changfa Xia, et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. 资料: (1) Changfa Xia, et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. 关于再鼎医药 再鼎医药（纳斯达克股票代码：ZLAB； 香港联交所股份代号：9688）是一家以研发为基础、处于商业化阶段的创新型生物制药公司，总部位于中国和美国。我们致力于通过创新产品的发现、开发和商业化解决肿瘤、自身免疫疾病、感染性疾病和中枢神经系统疾病领域未被满足的巨大医疗需求。我们的目标是利用我们的能力和资源努力促进中国及全世界人类的健康福祉。 有关再鼎医药的更多信息，包括我们的产品、业务活动、合作伙伴关系、研发以及其他事项或进展，请访问www.zailaboratory.com或关注公司官微：再鼎医药。 再鼎医药前瞻性声明 本新闻稿包含关于再鼎医药未来预期、计划和展望的陈述，包括但不限于我们就瑞普替尼在大中华区商业化的前景和计划，瑞普替尼的安全性和有效性，优先审评的注册路径。需要注意的是，优先审评并不保证药品获批。该等前瞻性陈述可能包括 “旨在”、“预计”、“相信”、“有可能”、“估计”、“预期”、“预测”、“目标”、“打算”、 “可能”、“计划”、“可能的”、“潜在”、“将”、“会”等词汇和其他类似表述。该等陈述构成《1995年美国私人证券诉讼改革法案》中定义的“前瞻性声明”。前瞻性声明并非对过往事实的陈述，亦非对未来表现的担保或保证。前瞻性声明基于我们截至本新闻稿发布之日的预期和假设，并且受到固有不确定性、风险以及可能与前瞻性声明所预期的情况存在重大差异的情势变更的影响。实际结果可能受各种重要因素的影响而与前瞻性声明所示存在重大差异，该等因素包括但不限于：(1)我们成功商业化自身已获批上市产品并从中产生收入的能力；(2)我们为自身的运营和业务计划提供资金并为该等活动获取资金的能力；(3)我们候选产品的临床开发和临床前开发的结果；(4)相关监管机构对我们的候选产品作出审批决定的内容和时间；(5)新型冠状病毒（COVID-19）疫情对我们的业务和整体经济、监管和政治状况的影响；（6）在中国运营相关的风险和(7)我们向美国证券交易委员会备案的最新年报或季报和其他报告中指出的风险因素。我们预计后续事件和发展将导致我们的预期和假设改变，但除法律要求之外，不论是出于新信息、未来事件或其他原因，我们均无义务更新或修订任何前瞻性声明。该等前瞻性声明不应被视为我们在本新闻稿发布之日后任何日期的意见而加以信赖。 关于再鼎医药的更多投资者相关信息，请登录www.SEC.gov或访问 www.zailaboratory.com . 有关更多信息，敬请垂询： 投资者关系： Christine Chiou / Lina Zhang +1 (917) 886-6929 / +86 136 8257 6943 christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com 媒体： Shaun Maccoun / Xiaoyu Chen +1 (415) 317-7255 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com

In the study, patients whose medication management was guided by IDgenetix achieved a 35% increase in medication response and a 64% increase in remission compared to patients whose medication was not guided by the test FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced real-world study data demonstrating that use of IDgenetix® to guide medication management can significantly improve medication response and remission rates in patients diagnosed with moderate to severe depression, compared to current standard-of-care treatment. The data was shared via a poster presentation at the May 2023 American Psychiatric Association (APA) Annual Meeting held in San Francisco. “Unlike other pharmacogenomic tests, which only consider a patient’s drug-gene interactions, IDgenetix takes into account a patient’s drug-drug interactions and lifestyle factors, and can provide a more comprehensive overview of which medications will be effective therapies for the patient,” said Kelly Wosnik, DNP, NP-C, owner and nurse practitioner at Bristol Health, and co-author of the study. “As supported by the data in this study, using IDgenetix to guide personalized medication selection can help improve the care of patients suffering from moderate to severe depression by offering hope of improved medication response and remission.” In the study, patients whose medication management was guided by IDgenetix achieved a 35% increase in medication response and a 64% increase in remission rate at eight weeks compared to patients whose medication was not guided by the test. These results demonstrate the potential value of IDgenetix in guiding improved medication management compared to the standard-of-care, trial-and-error approach, and are consistent with the previously published randomized control trial (RCT) using IDgenetix.1 The study abstract can be accessed via APA’s website here. IDgenetix is Castle’s next-generation pharmacogenomic (PGx) test that incorporates the results of a 15-gene variant panel with drug-drug interaction data and lifestyle factors to provide medication recommendations for patients with mental health conditions, such as depression and anxiety. Using the IDgenetix test report, clinicians may be able to more precisely tailor treatments to individual patients, rather than relying on trial and error, potentially reducing the chances of side effects or ineffective treatments. In an RCT, patients diagnosed with severe depression whose medication management was guided by the IDgenetix test showed a greater than two and a half times improvement in remission rates at eight and 12 weeks compared to those who were not guided by IDgenetix.1 About IDgenetix® IDgenetix® is a pharmacogenomic (PGx) product test for depression, anxiety and other mental health conditions designed to analyze a patient’s genetic make-up to guide timely and evidence-based decisions on the optimal drug for each patient. IDgenetix is designed to provide important genetic information to clinicians to help guide personalized treatment plans for their patients, with the potential to help patients achieve a faster therapeutic response and improve their chances of remission by identifying appropriate medications more efficiently than the standard-of-care, trial-and-error approach. IDgenetix provides drug-drug and drug-gene interactions and is supported by a published, peer-reviewed randomized controlled trial that demonstrated clinical utility over the standard of care when physicians used IDgenetix prior to prescribing a medication. More information about Castle’s tests can be found at . About Castle Biosciences Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors. Castle’s current portfolio consists of tests for skin cancers, uveal melanoma, Barrett’s esophagus and mental health conditions. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to predict systemic therapy response in patients with moderate-to-severe psoriasis, atopic dermatitis and related conditions. To learn more, please visit and connect with us on LinkedIn, Facebook, Twitter and Instagram. DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeq, TissueCypher and IDgenetix are trademarks of Castle Biosciences, Inc. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the potential of IDgenetix to (i) significantly improve medication response and remission rates in patients diagnosed with moderate to severe depression compared to current standard of care treatment; (ii) provide a more comprehensive overview of which medications will be effective therapies for the patient; (iii) help improve the care of patients suffering from moderate to severe depression by offering hope of improved medication response and remission rate; (iv) add value by guiding improved medication management compared to the standard-of-care, trial-and-error approach; and (v) enable clinicians to more precisely tailor treatments to individual patients, rather than relying on trial and error, potentially reducing the chances of side effects or ineffective treatments. The words “can,” “may,” “potential,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results shown in this study, including with respect to the discussion of IDgenetix in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law. 1. Bradley P, Shiekh M, Mehra V, et al. Improved efficacy with targeted pharmacogenetic-guided treatment of patients with depression and anxiety: A randomized clinical trial demonstrating clinical utility. J Psychiatr Res. 2018 Jan;96:100-107. doi: 10.1016/j.jpsychires.2017.09.024. Epub 2017 Sep 23. PMID: 28992526.