Nofazinlimab

September 27, 2024 I Cereno Scientific (Nasdaq First North: CRNO B), a pioneering biotech developing innovative treatments for rare and common cardiovascular disease, today announced positive topline results from the Phase IIa trial of CS1 in Pulmonary Arterial Hypertension (PAH). The results demonstrate that CS1 is safe, well tolerated and has positive impact on clinically relevant parameters such as risk, functional class and hemodynamics. “ I am delighted to share the topline data from the Phase IIa trial of CS1 in PAH. Key results from the study demonstrate both that the primary endpoint was met with good safety and tolerability of CS1 in patients with PAH, and, in addition, we also show a positive impact already after 12 weeks on clinical parameters meaningful to patients and regulatory authorities. These results, together with our foundation of preclinical data, strengthen our conviction that CS1 is a disease-modifying therapy for PAH. We are excited to now move forward with the next development phase with CS1. Our mission is to deliver a drug addressing the pathological remodeling which is progressing the PAH disease and to provide a valuable addition to the PAH toolbox of therapeutics ”, said Sten R. Sörensen, CEO, Cereno Scientific. Pulmonary Arterial Hypertension PAH is a debilitating and fatal disease with no spontaneous improvement. Epigenetic mechanisms through histone deacetylase (HDAC) drive disease progression and continuous deterioration. The disease pathology is defined by endothelial dysfunction, inflammation, vasoconstriction, hypertrophy and remodeling of pulmonary small arteries, leading to poor lung function, right heart failure and ultimately death. Existing treatment alternatives are insufficient and do not address the root cause of the disease. The goal of PAH treatment is to improve risk score status (measured by amongst others REVEAL risk score), symptoms and physical capacity (measured by functional class) and hemodynamics (measured by mean Pulmonary Arterial Pressure, mPAP and Pulmonary Vascular Resistance, PVR), to ultimately improve both patients’ quality of life and extend survival. “ PAH is a rare and devastating disease for patients suffering from it. Despite advances in treatment options there is still a pronounced need for effective, safe and disease-modifying therapies for these patients. The results presented today with primary endpoints met regarding safety and tolerability and supporting signs of clinical efficacy including improvement in risk score, improvement of functional class and impact on mean pulmonary pressure are promising,” said Dr. Raymond Benza, Network Director of Pulmonary Hypertension at Mount Sinai Icahn School of Medicine, New York; and Principal Investigator of the Phase IIa trial of CS1 . CS1 and the CS1-003 Phase IIa trial CS1 is an HDAC inhibitor that works through epigenetic modulation, being developed as a safe, effective and disease modifying treatment for PAH. CS1 targets the root cause of the disease, aiming to reverse the pathological vascular remodeling of the small lung arteries. CS1-003 is a Phase IIa trial evaluating the safety, tolerability, pharmacokinetics, and exploratory efficacy of CS1 on top of standard-of-care in patients with PAH. The study initially had as an objective to recruit 30 patients. In June, recruitment was stopped after the Study Clinical Steering Committee concluded that there was sufficient data for evaluating the next steps in development. The study, which was performed at 10 clinical sites in the US, randomized 25 patients to CS1 treatment, out of which 21 patients completed the treatment without protocol deviations. CS1 – Phase IIa safety data – Primary endpoint of safety and tolerability met successfully The primary endpoint of safety and tolerability was met successfully: CS1 Phase IIa – Compelling positive impact on exploratory clinical efficacy parameters Efficacy data from the three doses were pooled together due to therapeutic drug exposure (i.e. plasma concentration) also in the low dose group. CS1 showed compelling positive impact on exploratory clinical parameters already over a 12-week treatment period: “ I am very pleased with the positive outcomes we are seeing in our patients following treatment with CS1. Their improvements in health and well-being are encouraging and reflect the potential effectiveness of the therapy. The majority of my patients have expressed interest in enrolling into the Expanded Access Program. This progress reaffirms my commitment to advancing treatments that can make a meaningful difference in patients’ lives with PAH ,” said Dr. Jason Guichard , Advanced Heart Failure and Transplant Cardiology, Department of Medicine, Division of Cardiology, Prisma Health-Upstate, Assistant Professor of Medicine, University of South Carolina School of Medicine Greenville and investigator in the Phase IIa trial of CS1 in PAH. CS1 phase II a study clinical data, together with preclinical information, is consistent with reversing pathological remodeling An in-depth analysis made on a subgroup of patients with a remarkable response showed: The data from the CS1-003 trial, together with recently announced preclinical data from our HDAC inhibitor program, directly demonstrating our HDAC-inhibitor program’s dose-dependent positive impact on reverse vascular remodeling in small lung arteries, provide a basis for assuming that CS1 may act with a disease-modifying capacity in PAH. Clear path forward to develop a disease-modifying therapy for PAH​ Cereno will be initiating discussions with regulatory bodies based on these encouraging results and will progress pursuing a pivotal trial of CS1 in PAH. A comprehensive analysis of the complete CS1-003 data will be conducted, with the findings to be presented at upcoming medical conferences and published in a reputable medical journals. “ We are excited to take the next steps in our journey to make a meaningful impact for patients with PAH. Our plans include engaging with regulatory authorities to in pursuing a pivotal trial for CS1 and to continue enrolling patients in our Expanded Access Program . The CS1-003 trial demonstrated compelling signs of clinical efficacy already over a 12-week treatment period and we expect to see additional positive impact of CS1 with longer use of our drug in patients with PAH ” said Dr. Rahul Agrawal, CMO and Head of R&D, Cereno Scientific Webcast presentation on Monday, September 30 Cereno Scientific will host a webcast including a Q&A session where CEO Sten R. Sörensen, CMO and Head of R&D Dr. Rahul Agrawal, CSO Dr. Björn Dahlöf and Head of Preclinical Development, Nicholas Oakes, will present the CS1-003 topline results. Date and time: Monday, September 30, 2024, at 14:00 CET How to join: https://ir.financialhearings.com/cereno-scientific-2024 The webcast and presentation will be available on the Company’s website after the webinar at: https://cerenoscientific.com/events-presentations/ About the CS1-003 trial The CS1-003 trial titled “A Phase II, Prospective, Randomized, Open-label, Blinded Endpoint, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of 3 Doses of CS1 in Subjects With Pulmonary Arterial Hypertension ” (NCT05224531) randomized adult PAH patients with WHO Functional class II or III, stable on standard of care therapy for 90 days, to one of three total daily doses of CS1; 480 mg, 960 mg or 1920 mg. Subjects were enrolled for up to 22 weeks including a treatment period of 12 weeks. The trial was conducted at 10 specialist clinics in the US. 25 patients were randomized to CS1 treatment out of which 21 patients completed the treatment without protocol deviations. The study’s primary endpoint was to evaluate the safety and tolerability of CS1 treatment in patients with PAH. Other relevant standard endpoints used in previous studies of this patient group have been measured and evaluated in an exploratory fashion. A collaboration agreement with global healthcare company Abbott has allowed Cereno to use their cutting-edge technology CardioMEMS HF System in the trial, to measure mean Pulmonary Arterial Pressure (mPAP) and other hemodynamic parameters. CS1-003 is a Phase IIa trial that is not powered for statistically significant detection or exclusion of efficacy-related parameters. On June 28, 2024, Cereno announced the decision to close patient recruitment to the Phase IIa trial CS1-003 by July 1st, 2024, after the Study Clinical Steering Committee concluded that there was sufficient data for evaluating the next steps in development. About PAH Pulmonary Arterial Hypertension (PAH) is a rare disease and diagnosed with high blood pressure in the pulmonary circulation. Globally, the disease affects approximately 10 in 100,000 people. It is a severe, debilitating disease with no spontaneous improvement. The disease is characterized by a progressive narrowing of the pulmonary arterial vessels ultimately leading to right heart failure and death. Life expectancy is 2.5 years without therapy and 7.5 years on current standard of care. PAH has a major impact on quality of life and causes shortness of breath, fatigue, chest pains, reduced ability to work, unnatural swelling, fainting and heart palpitations. This has significant implications for a patient’s physical, mental, and social well-being. There is currently no cure available for PAH with the exception of lung transplantation, which patients are often too seriously ill to undergo. Current standard of care, mainly vasodilators, improves the patient’s symptoms and involves, at best, a moderate slowing of the disease progression. There is therefore a great need for safer therapies with disease-modifying capacity that address the root causes of PAH and that can give patients an increased opportunity for an improved quality of life and a longer life. About CS1 Drug candidate CS1 is an HDAC inhibitor that works through epigenetic modulation, being developed as a treatment for the rare disease PAH. CS1 holds the potential to be an effective, safe and disease-modifying drug, targeting the root cause of the disease by reverse remodeling. In preclinical cardiovascular disease models, HDAC inhibitors have shown disease-modifying potential through reverse pathological remodeling, as well as anti-fibrotic, anti-inflammatory, pulmonary pressure-reducing, and anti-thrombotic effects. CS1’s unique efficacy profile aligns well with the underlying mechanisms of PAH, positioning it to address the critical unmet need for more effective treatment options. The goal of CS1’s development is to improve quality of life and extend survival for patients with PAH. CS1 is part of Cereno’s HDACi portfolio, untapping the potential of epigenetic modulation in CVD. CS1 has been granted orphan drug status in both the US and EU. Since January 30, 2024, CS1 is approved by the FDA for Expanded Access, as an extension of the ongoing Phase IIa trial CS1-003 evaluating CS1 in PAH. The EAP gives patients that have completed the Phase IIa trial the opportunity to, after being judged suitable and to benefit from CS1 treatment by investigators, continue CS1 treatment of PAH when no comparable or satisfactory alternative therapy options are available. The EAP allows Cereno to, under a formal FDA-approved protocol, collect safety and efficacy data from long-term exposure to CS1 in patients with PAH. As such, this initiative not only supports the treatment of PAH patients but also enables Cereno to gather additional CS1 usage documentation for regulatory discussions and Phase IIb/III pivotal study design planning. On August 30, 2024, the Company announced that the first patient had been dosed under the EAP. About Cereno Scientific AB Cereno Scientific develops innovative treatments for rare and common cardiovascular disease. The lead drug candidate, CS1, is an HDAC (histone deacetylase) inhibitor that acts as an epigenetic modulator with pressure-reducing, reverse-remodeling, anti-inflammatory, anti-fibrotic and anti-thrombotic properties. A Phase IIa trial evaluating CS1’s safety, tolerability, and exploratory efficacy in patients with the rare disease pulmonary arterial hypertension (PAH) demonstrated that CS1 was safe, well-tolerated and showed a positive impact on exploratory clinical efficacy parameters. CS1 study data, together with preclinical information, is consistent with reversing pathological remodeling. A collaboration agreement with global healthcare company Abbott allowed Cereno to use their cutting-edge technology CardioMEMS HF System in the trial. Since January 2024, we are delighted that the FDA´s Expanded Access Program will enable patients with PAH, a serious life-threatening disease condition, to gain access to CS1 where no comparable alternative therapy options are available. Cereno’s pipeline comprises two additional programs in development through research collaborations with the University of Michigan CS014 is a new chemical entity with a multi-fold mechanism of action as an epigenetic modulator – regulating platelet activity, fibrinolysis, and clot stability for the prevention of thrombosis without an increased risk of bleeding as documented in preclinical trials. The drug candidate has also demonstrated a favorable profile in preclinical models of other cardiovascular diseases, such as PAH, with reverse remodeling of pulmonary arterial vessels and effects on vascular fibrosis. On 28th of June, 2024, Cereno initiated a first-in-human Phase I trial of CS014. Preclinical candidate CS585 is an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular disease. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Pulmonary Hypertension and thrombosis prevention without increased risk of bleeding. CS585 was in-licensed from the University of Michigan in 2023. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. Based in Kendall Square, Boston, Massachusetts, US. Cereno is listed on the Nasdaq First North (CRNO B). The Certified Adviser is Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information is on www.cerenoscientific.com. SOURCE: Cereno Scientific

2024年上半年总收入为人民币2.542亿元，公司财务状况稳健并首次实现盈利。截至2024年6月30日现金储备为人民币8.14亿元。 舒格利单抗（PD-L1）针对IV期非小细胞肺癌（NSCLC）的新药上市申请在欧盟获批，国产PD-L1首度成功出海。 与Ewopharma达成舒格利单抗在中东欧地区的商业化战略合作，2024年内还将在全球范围内建立更多商业合作伙伴关系。预计2025年初开始进入欧洲及其他海外市场销售，并支持公司持续盈利。 管线2.0重磅产品CS5001是截至目前首个在实体瘤和淋巴瘤中均展示出临床抗肿瘤活性的ROR1抗体偶联药物（ADC）。预期2024年内针对淋巴瘤适应症启动具有注册潜力的1b期研究。 另一款管线2.0重磅产品CS2009（PD-1、CTLA4和VEGFa三特异性抗体），预期 2024/2025年提交新药临床试验申请。 与恒瑞医药达成泰吉华 ® （阿伐替尼）在中国大陆区域的商业合作。 泰吉华 ® 转移至境内生产的药品上市注册申请获中国国家药品监督管理局批准，普吉华 ® （普拉替尼）的该项申请目前正在药品审评中心审评中。成功地产化后将显著降低两款精准治疗药物的成本并提高产品的长期盈利能力。 舒格利单抗针对一线胃癌的新药上市申请在中国大陆获批，针对IV期NSCLC的新药上市申请正在英国药品和医疗保健用品管理局审评中。 公司将于中国香港时间8月26日上午10:00-11:00举行中期业绩的中文投资者电话会议。 苏州 2024年8月23日 /美通社/ -- 基石药业（股票代码：2616.HK），一家专注于抗肿瘤药物研发的创新驱动型生物医药企业，今日公布其2024年年度中期业绩及近期业务亮点。 基石药业首席执行官、研发总裁、执行董事杨建新博士表示："2024年上半年，基石药业取得了亮眼的财务业绩表现，也迎来了公司发展的重要转折点。凭借多渠道收入和持续成本控制，公司已首次实现盈利，稳健的财务状况也为公司未来的增长奠定了坚实的基础。 舒格利单抗在欧盟获批一线IV期非小细胞肺癌（NSCLC）适应症，是基石药业全球化布局的关键突破。除了今年上半年与Ewopharma在中东欧地区达成的商业合作外，我们预计2024年还将在包括西欧在内的多个其他国家和地区建立更多商业化合作，并且在2025年初舒格利单抗将投入全球销售网络。我们相信这款潜在同类最佳的PD-L1单抗将带来可观收入，支持公司实现持续盈利。 管线2.0是基石药业的"新质生产力"。其中CS5001（ROR1 ADC）在2024年内将针对淋巴瘤启动具有注册潜力的1b期研究，并计划在年底的美国血液学会年会（ASH）上披露更多最新的临床数据。CS2009（PD-1/CTLA4/VEGF三特异性抗体）的首次人体试验预期于2024/2025年启动。同时，我们还会将更多具有全球权益的创新抗肿瘤和自免产品推向临床。 继去年与艾力斯签订普吉华 ® （普拉替尼）在中国大陆的商业化推广协议并顺利完成过渡之后，在今年上半年我们与恒瑞医药就泰吉华 ® （阿伐替尼）在中国大陆区域的推广达成商业合作。不久之前，我们获得了中国国家药品监督管理局对于泰吉华 ® 地产化上市申请的批准，并且为普吉华 ® 提交了申请。我们相信地产化后显著降低的成本，加上合作伙伴在销售端不断发力，这两款精准治疗药物在中国市场的销量将快速增长，并且为基石药业在未来数年带来持续的利润。 注册方面，今年上半年舒格利单抗在中国大陆成功获批一线胃癌适应症，进一步拓宽了在国内市场的覆盖范围。在海外市场，舒格利单抗针对一线IV期NSCLC的新药上市许可申请（MAA）目前正在英国药品和医疗保健用品管理局（MHRA）审评中，该适应症此前刚被欧盟委员会批准上市。我们也计划向欧洲药品管理局（EMA）递交舒格利单抗其他适应症，如III期NSCLC、一线胃癌、一线食管鳞癌和复发难治性结外NK/T细胞淋巴瘤的MAA。 展望未来，基石药业将与合作伙伴紧密协作，提升泰吉华 ® 和普吉华 ® 在中国市场、以及舒格利单抗在全球市场的竞争力和销量；持续将管线2.0中的创新产品推向临床；继续在全球范围拓展公司业务以实现持续盈利。" 财务摘要 国际财务报告准则计量： 收入 截至2024年6月30日止六个月为人民币2.542亿元，其中药品销售收入人民币1.183亿（阿伐替尼和普拉替尼）、人民币1.226亿元的授权费以及人民币1330万元的舒格利单抗特许权使用费收入。授权费收入增加的1.226亿元在很大程度上抵销了药品销售收入减少的人民币1.286亿元，因而总收入同比减少人民币730万元或下降了2.8%。 研发开支 截至2024年6月30日止六个月为人民币6620万元，较截至2023年6月30日止六个月的研发开支减少人民币1.206亿元，主要由于里程碑费用及第三方合约成本以及雇员成本减少所致。 行政开支 截至2024年6月30日止六个月为人民币4670万元，较截至2023年6月30日止六个月的8920万元减少了人民币4250万元，主要由于雇员成本降低。 销售及市场推广开支 截至2024年6月30日止六个月为人民币6280万元，较截至2023年6月30日止六个月的1.314亿元减少了人民币6860万元，主要是由于雇员成本降低。 期内利润 截至2024年6月30日止六个月为人民币1570万元，较截至2023年6月30日止六个月的亏损人民币2.092亿元转亏为盈，主要是由于运营开支大幅减少和毛利增加。 非国际财务报告准则计量： 研发开支 截至2024年6月30日止六个月，扣除以股份为基础的付款开支后为人民币7100万元，较截至2023年6月30日止六个月的1.981亿元减少了人民币1.271亿元，主要由于里程碑费用及第三方合约成本以及雇员成本降低。 行政以及销售及市场推广开支 截至2024年6月30日止六个月，扣除以股份为基础的付款开支后为人民币1.096亿元，较截至2023年6月30日止六个月的人民币1.831亿元减少了人民币7350万元，主要由于雇员成本减少所致。 期内利润 截至2024年6月30日止六个月，扣除以股份为基础的付款开支后为人民币1080万元，较截至2023年6月30日止六个月的期内亏损人民币1.83亿元转亏为盈，主要是由于运营开支大幅减少和毛利增加。 业务摘要 截至2024年6月30日止六个月及截至本公告日期，我们的产品管线和业务经营均已取得重大进展。我们在此期间取得的成就包括： 主要管线亮点 免疫治疗 舒格利单抗（PD-L1） 欧盟获批： 2024年7月，欧盟委员会（EC）批准舒格利单抗（商品名：Cejemly ® ）联合含铂化疗用于无EGFR敏感突变, 或无ALK, ROS1, RET基因组肿瘤变异的转移性NSCLC成人患者的一线治疗。国产PD-L1首度成功出海！舒格利单抗另一项针对一线IV期NSCLC的MAA目前正在英国MHRA审评中。 战略合作： 2024年5月，我们与欧洲医药公司Ewopharma 达成商业化战略合作， Ewopharma将取得舒格利单抗在瑞士和18 个中东欧国家的商业化权利。基石药业将最高获得5130万美元的首付款以及后续注册及销售里程碑付款。 新适应症获批： 2024年3月，舒格利单抗在中国获批第五项适应症——用于联合含氟尿嘧啶类和铂类药物化疗用于表达PD-L1（综合阳性评分[CPS] ≥5）的不可手术切除的局部晚期或转移性胃及胃食管结合部腺癌的一线治疗。 顶刊发表： 2024年2月，GEMSTONE-304研究（一线食管鳞癌）的无进展生存期（PFS）最终分析结果及总生存期（OS）期中分析结果刊发于顶级医学期刊—《Nature Medicine》。 长期生存数据： 2024年7月，GEMSTONE- 302 研究（一线IV期NSCLC）的长期OS分析结果被接收为壁报形式并将在2024年欧洲肿瘤内科学会（ESMO）大会上展示。 纳入指南： 2024年，择捷美 ® （舒格利单抗）作为一类（1A证据）推荐，分别被纳入中国CSCO胃癌诊疗指南（2024版）、CSCO食管癌诊疗指南（2024版）、CSCO免疫检查点抑制剂临床应用指南（2024版）、以及淋巴瘤免疫治疗中国专家共识（2024版）。 Nofazinlimab (PD-1) 全球 III期试验： 2024年3月，完成了nofazinlimab 联合LENVIMA ® (lenvatinib)用于一线治疗不可切除或转移性肝细胞癌（HCC）患者的全球III期试验的预设期中分析；我们并无观察到新增或意外安全性信号；独立数据监察委员会（iDMC）建议在不修改方案的情况下进行持续随访，直至OS最终评估。 管线 2.0 CS5001，一种受体酪氨酸激酶样孤儿受体1（ROR1）抗体偶联药物（ADC） 首次人体（ FIH）试验： 在美国、澳大利亚及中国进行中。截至本公告日期，已递增至第10剂量水平，尚未观察到DLT，且尚未达到MTD。 抗肿瘤活性： CS5001 具有良好的耐受性和安全性，在各种实体瘤和血液瘤中已表现出令人鼓舞的抗肿瘤活性。并且，CS5001 是目前首个已知的在实体瘤和淋巴瘤中均显示出临床抗肿瘤活性的ROR1 ADC。 ASCO数据披露： 2024年6月1日，我们在2024 年美国临床肿瘤学会（ASCO）年会上以壁报形式展示了最新的FIH研究数据。我们亦计划于2024年底美国血液学会年会（ASH）上公布更多淋巴瘤的临床数据。 潜在注册性 Ib期研究： 我们预计于2024年内启动多个适应症、具有注册潜力的Ib期剂量扩展研究以优化剂量。 ROR1抗体开发： 此外，我们已识别有潜力的候选ROR1 抗体克隆用于免疫组化（IHC），并且我们计划在1b期剂量扩展研究中评估ROR1 表达与疗效之间的关系。 CS2009（PD-1/CTLA4/VEGF三特异性抗体） 潜在的同类首创 /同类最优： CS2009是潜在的同类首创/同类最优的下一代肿瘤免疫骨架产品，其靶向肿瘤微环境中的三个关键免疫抑制途径，并且可加深基于PD-(L)1疗法治疗高发肿瘤类型（包括NSCLC及肝癌）的疗效。 IND递交： 目前正处于IND准备阶段，预计于2024/2025年提交IND申请。 同类首创（FIC）/同类最优ADC CS5006（创新靶点）和CS5005（SSTR2 ADC）： 两个同类首创ADC项目正在向完成临床候选分子的筛选阶段推进。其中一个针对多种高发肿瘤适应症并采用内部机器学习生物信息学算法识别的新型肿瘤相关抗原的ADC项目 CS5006，预计将于2025年提交IND申请。另一同类首创SSTR2 ADC——CS5005 的先导抗体已选定。共轭先导分子在体外及体内均表现出令人鼓舞的疗效，预计将于2025年提交IND申请。 CS5007（EGFRxHER3双特异性ADC）及其相应的双特异性抗体CS2011 ，正在向临床前候选药物阶段推进。CS5007 (CS2011)靶向EGFR和HER3，两者均为经过充分验证的靶点，经证实具有同源有效性。预计将于2025年提交IND申请。 自身免疫多特异性抗体 CS2013 为靶向两个对B细胞发育至关重要的靶点的双特异性分子，目前处于发现阶段，预期在2024年底前获得先导分子。 CS2013是一种旨在解决目前治疗系统性红斑狼疮（SLE）、IgA肾病（IgAN）及B细胞介导自身免疫性疾病的致命弱点的分子。 精准治疗 普吉华 ® （普拉替尼） 地产化推进中： 2024年4月，普吉华 ® （普拉替尼胶囊）转移至境内生产的药品上市注册申请获中国国家药品监督管理局药品审评中心受理。目前审评正在进行中。 商业化过渡： 2023年11月，我们与艾力斯签订普吉华 ® 在中国大陆独家商业化推广协议。2024年上半年，我们已将商业活动转移至艾力斯，目前正与艾力斯紧密合作。 泰吉华 ® （阿伐替尼） 地产化申请获批： 2024年6月和8月，泰吉华 ® （阿伐替尼片）300mg和100mg两种规格的由境外转移至境内生产的药品上市注册申请分别获得中国国家药品监督管理局批准。 商业化合作： 2024年7月，我们与恒瑞医药建立商业合作关系，将泰吉华 ® 在中国大陆的独家推广权授予恒瑞。基石药业将获得人民币3,500万元的首付款，同时泰吉华 ® 在中国大陆的销售收入仍将纳入基石药业财报，而恒瑞将向基石药业收取服务费。 纳入医保目录： 泰吉华 ® 已于2023年被纳入中国国家医保目录，用于治疗携带PDGFRA外显子18 突变（包括PDGFRA D842V突变）的不可切除或转移性 GIST成人患者。更新后的国家医保目录已自2024年1月1日起实施。 纳入指南： 普吉华 ® 及泰吉华 ® 已被纳入15 项中国国家指南，用于多个治疗领域的检测及治疗，比如NSCLC、甲状腺癌（TC）、胃肠道间质瘤（GIST）、系统性肥大细胞增生症（SM）等。 未来及愿景 展望未来，我们将继续推进创新管线药物的研发，并最大化已上市产品的商业价值。近期催化剂预计如下： 舒格利单抗： 预计于2024年下半年在英国获得用于一线治疗IV期NSCLC的MAA正式批准；2024年内还将在全球范围内建立更多商业合作伙伴关系。 CS5001： 在国际学术会议（如2024年下半年的ASH）上披露最新的临床安全性及疗效数据；于2024年启动具有注册潜力的1b期试验；预计于2024年或2025年达成全球业务拓展（BD）合作关系。 CS2009： 预计于2024/2025年提交IND申请。 CS5006： 预计于2025年提交IND申请。 CS5005： 预计于2025年提交IND申请。 CS2011/CS5007： 预计于2025年提交IND申请。 普吉华 ® （普拉替尼）： 预期转移至境内生产的药品上市注册申请于2025年上半年获批。 Nofazinlimab： 预计2025年上半年完成OS的最终分析，并建立中国以外地区的合作伙伴关系。 投资者中期业绩电话会议 公司将于2024年8月26日星期一上午10:00至11:00（中国香港时间）举办2024年投资者中期业绩电话会议。请通过以下链接参加电话会议： https://s.comein.cn/AHDiL （密码：564723）。 关于基石药业 基石药业（香港联交所代码: 2616）成立于2015年底，是一家专注于抗肿瘤药物研发的创新驱动型生物医药企业，致力于满足中国和全球癌症患者的殷切医疗需求。截至目前，公司已成功上市4款创新药、获批15项新药上市申请（NDA）以及9项适应症。当前研发管线均衡配置了潜在同类首创或同类最佳的抗体偶联药物（ADC）、多特异性抗体、以及免疫疗法和精准治疗药物在内的16款候选药物。同时，基石药业拥有一支资深管理团队，"全链条"覆盖临床前探索、临床转化、临床开发、药物生产、商务拓展、商业运营等关键环节。 如需了解有关基石药业的更多信息，请访问： www.cstonepharma.com 。 投资者关系: ir@cstonepharma.com 媒体关系: pr@cstonepharma.com 前瞻性声明 本文所作出的前瞻性陈述仅与本文作出该陈述当日的事件或资料有关。除法律规定外，于作出前瞻性陈述当日之后，无论是否出现新资料、未来事件或其他情况，我们并无责任更新或公开修改任何前瞻性陈述及预料之外的事件。请细阅本文，并理解我们的实际未来业绩或表现可能与预期有重大差异。本文内所有陈述乃本文章刊发日期作出，可能因未来发展而出现变动。