ASKC109

2024年10月8日，信达生物制药集团（香港联交所股票代码：01801），一家致力于研发、生产和销售肿瘤、自身免疫、心血管及代谢、眼科等重大疾病领域创新药物的生物制药公司，与奥赛康药业（深圳交易所股票代码：002755）签署合作协议，宣布双方就第三代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）靶向药物利厄替尼片（奥壹新®）达成独家商业化合作。 奥赛康药业将作为合作产品的上市许可持有人，负责合作产品的商业化生产及供货，并根据合作协议向信达生物支付销售推广服务费。信达生物取得合作产品在中国大陆地区的独家推广销售权，将按合作协议约定向奥赛康药业支付首付款、注册里程碑和销售里程碑款项。 利厄替尼是具有自主知识产权、全新分子实体、活性显著的口服的第三代EGFR-TKI。目前，利厄替尼片（奥壹新®）的两项适应症的新药上市申请（NDA）在国家药品监督管理局（NMPA）审评审批中，分别为1）既往经EGFR酪氨酸激酶抑制剂（TKI）治疗时或治疗后出现疾病进展，并且经检测确认存在EGFR T790M突变阳性，或原发性EGFR T790M突变阳性的局部晚期或转移性非小细胞肺癌成人患者的治疗；2）具有表皮生长因子受体（EGFR）外显子 19 缺失（19DEL）或外显子 21置换突变（L858R）的局部晚期或转移性非小细胞肺癌成人患者的一线治疗。 在一项多中心、随机、双盲、阳性对照III期临床试验中，利厄替尼头对头吉非替尼一线治疗EGFR敏感突变的局部晚期或转移性非小细胞肺癌患者，达到主要研究终点。该III期临床研究的相关数据及分析计划在未来学术大会或学术期刊上发表。早先，利厄替尼在2022年美国临床肿瘤学会（ASCO）年会上以壁报的形式展示了其2b期临床研究结果。 信达生物制药集团创始人、董事长兼CEO俞德超博士表示：“很高兴与奥赛康药业达成本次战略合作，奥赛康是中国创新实力优异的制药企业，期待我们的合作能够为中国肿瘤患者带来更新的治疗方案。肺癌是目前中国乃至全世界高发的瘤种，信达生物与合作伙伴一起在肺癌治疗领域打造了广泛强大的创新药产品组合，涵盖信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®）， 塞普替尼胶囊（睿妥®），氟泽雷塞片（达伯特®）和他雷替尼（ROS1抑制剂，NDA审评中）。我们与奥赛康在利厄替尼片（奥壹新®）的合作有望给广大的EGFR突变肺癌患者提供一个创新靶向药物，同时这将进一步提升信达生物在肿瘤治疗领域的领先地位。信达生物还将与业界同仁共同努力，携手共同推进提高创新药物在中国的可及性及可负担性，让更多的中国患者尽早受益。” 奥赛康药业董事、总经理马竞飞表示：“我们很高兴和信达生物达成战略合作。抗肿瘤是奥赛康聚焦的四大药物治疗领域之一，肿瘤产品线包含化疗药、小分子靶向药、生物药。利厄替尼片（奥壹新®）是奥赛康首个创新药，用于国内发病率、死亡率最高的癌种，瞄准突变率最高的肺癌分子靶标开发，致力于为广大的EGFR突变肺癌患者提供有效药物。信达生物在肺癌领域具有丰富的产品管线，能够与利厄替尼片形成优势协同。同时，信达生物拥有专业高效的市场推广团队和强有力的商业化能力，相信本次合作将有助于利厄替尼片（奥壹新®）充分体现临床价值，使更多患者获益。” 关于EGFR突变非小细胞肺癌 - 滑动查看更多介绍 - 肺癌是全球死亡率最高的恶性肿瘤，其发病率位居全球恶性肿瘤发病率的第二位，也是中国发病率、死亡率最高的恶性肿瘤。在所有肺癌中非小细胞肺癌（NSCLC）大约占80%至85%，约70%的NSCLC患者在诊断时已是不适于手术切除的局部晚期或转移性疾病。EGFR是NSCLC中最常见的驱动基因，30%~50%的亚裔NSCLC患者存在EGFR基因突变，EGFR-TKI是该类患者一线标准治疗推荐，其中第三代EGFR-TKI具有广泛的适用人群。 关于利厄替尼片 - 滑动查看更多介绍 - 利厄替尼是具有自主知识产权、全新分子实体、活性显著的口服的第三代EGFR-TKI。 目前，利厄替尼片（奥壹新®）的两项适应症的新药上市申请（NDA）在国家药品监督管理局（NMPA）审评审批中，分别为1）既往经EGFR酪氨酸激酶抑制剂（TKI）治疗时或治疗后出现疾病进展，并且经检测确认存在EGFR T790M突变阳性，或原发性EGFR T790M突变阳性的局部晚期或转移性NSCLC成人患者的治疗；2）具有表皮生长因子受体（EGFR）外显子 19 缺失（19DEL）或外显子 21置换突变（L858R）的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。 在一项多中心、随机、双盲、阳性对照III期临床试验中，利厄替尼对照吉非替尼一线治疗EGFR敏感突变的局部晚期或转移性非小细胞肺癌患者，已达到主要研究终点。该III期临床研究的相关数据及分析计划在未来学术大会或学术期刊上发表。 早先，利厄替尼在2022年美国临床肿瘤学会（ASCO）年会上以壁报的形式展示了2b期临床研究结果。该研究探索了利厄替尼治疗既往EGFR-TKI治疗后进展的EGFR T790M+局部晚期或转移性NSCLC的疗效与安全性。研究结果显示，经独立评审委员会（IRC）评估的客观缓解率（ORR）为68.8%，疾病控制率（DCR）为92.4%，缓解持续时间（DoR）为11.1个月，无进展生存期（PFS）为11.0个月。脑转移（CNS）患者颅内ORR为56.1%，CNS患者PFS为10.6个月，提示利厄替尼对CNS患者具有较好的疗效。 2024年10月，信达生物与奥赛康就利厄替尼片在中国达成独家商业化合作。 关于信达生物 - 滑动查看更多介绍 - “始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。公司已有11个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®）， 雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®）和氟泽雷塞片（达伯特®）。目前，同时还有5 个品种在NMPA审评中，3个新药分子进入III期或关键性临床研究，另外还有18个新药品种已进入临床研究。 公司已与礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及17余万普通患者，药物捐赠总价值34亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。 详情请访问公司网站：www.innoventbio.com或公司领英账号Innovent Biologics。 关于奥赛康药业 - 滑动查看更多介绍 - 奥赛康药业成立于2003年，是一家创新与研发驱动的医药制造企业。公司自主研发了中国第一支国产化质子泵抑制剂（PPI）注射剂，经二十多年的发展，药物治疗领域已覆盖消化、抗肿瘤、抗感染和慢性病四大领域。在中国医药细分市场具有较高的品牌影响力。 奥赛康药业通过自主研发与引进合作双向发力，重点聚焦小分子靶向创新药和肿瘤免疫生物创新药的研发。目前主要在研项目共计48项，包括已公开的11项重点在研化学、生物创新药。其中，抗肿瘤创新药利厄替尼片处于申请上市阶段，ASKC109（麦芽酚铁胶囊）、ASKB589（Claudin18.2单抗）处于临床III期研究阶段，另有多款创新药处于早期临床及临床前研究阶段。 奥赛康药业秉持“为健康 健康行”的企业使命，瞄准临床急需和未被满足的临床需求，坚守初心，向新而行，加快创新成果向现实生产力转化，研发上市更多国产优质新药、好药，为提高患者用药的可及性、先进性和可持续性，助力生物医药产业高质量发展贡献奥赛康力量。 详情请访问公司网站：www.ask-pharm.com。 声明： *信达生物不推荐未获批的药品/适应症的使用。 *雷莫西尤单抗注射液（希冉择®）和塞普替尼胶囊（睿妥®）由礼来公司研发。 前瞻性声明 本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断地更新这些预测性陈述。 这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。 本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

SAN FRANCISCO and SUZHOU, China, Oct. 7, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, and Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm, 002755.SZ), announced that the two parties have entered into a strategic collaboration regarding limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for the treatment of lung cancer. Under the agreement, Innovent will obtain the exclusive commercialization rights for limertinib in mainland China, and will be entitled to receive a commercialization service fee based on the product's net sales in the region. Ask-Pharm as the MAH holder, will be responsible for the production and commercial supply of limertinib and will be eligible for upfront, regulatory and sales milestone payments. Limertinib is an orally administrated, third-generation novel EGFR TKI with proprietary rights. Two New Drug Applications (NDAs) for limertinib have been accepted and are under review by China's National Drug Administration (NMPA): (1) for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, confirmed by a validated diagnostic test, whose disease has progressed after EGFR TKI therapy; and (2) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. In a multi-center, randomized, double-blind, controlled Phase 3 clinical trial, limertinib's efficacy and safety were compared with gefitinib in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations. The Phase 3 clinical trial met its primary endpoint, and detailed data and analysis will be presented at future academic conferences or published in academic journals. Previously, results of limertinib from a Phase 2b clinical study were presented in a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "We are delighted to enter this strategic collaboration with ASK Pharm, one of the most innovative biopharmaceutical companies in China, which will further strengthen Innovent's leadership in oncology. Together with our partners, Innovent has successfully developed a series of high-quality innovative medicines for lung cancer treatments, including TYVYT® (sintilimab Injection), BYVASDA® (bevacizumab Injection), Retsevmo® (selpercatinib), Dupert® (fulzerasib) and Taletrectinib (ROS1 Inhibitor, NDA under review). The addition of limertinib will offer a valuable new treatment option for Chinese patients with EGFR-mutated lung cancer. Innovent remains committed to investing in innovation and collaborative partnerships, aiming to enhancing the accessibility and affordability of innovative therapies in China to benefit even more patients." Mr. Jingfei Ma, Director and General Manager of ASK Pharm, stated: "We are pleased to form a strategic partnership with Innovent Biologics. Oncology is one of the four core areas of focus for ASK Pharm, and our oncology product line spans chemotherapy drugs, small molecule targeted drugs, and biologics. Limertinib, ASK Pharm's first innovative drug, targets the cancer type with the highest incidence and mortality rates in China. Focused on addressing the most common mutations in lung cancer, Ask-Pharm is committed to providing effective drugs for the vast number of patients with EGFR-mutated lung cancer. Innovent has a rich product pipeline in the field of lung cancer, which can form advantageous synergies with limertinib. In addition, with Innovent's professional and efficient marketing team and proven commercialization capabilities, we are confident that this cooperation will help limertinib to fully realize its clinical value, so that more patients can benefit from it." About EGFR mutation-positive non-small-cell lung cancer (NSCLC) Lung cancer is the leading cause of cancer-related death and the second more common cancer worldwide. In China, it has both the highest incidence and mortality rates among malignant tumors. Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of all lung cancers, and approximately 70% of NSCLC patients are diagnosed with locally advanced or metastatic disease that is not eligible to surgical resection. EGFR is the most frequent driver mutation in NSCLC, with 30% to 50% of Asian NSCLC patients having EGFR mutations. EGFR-TKIs are the recommended first-line standard of care for this group, with third-generation EGFR inhibitors offering the broadest applicability. About Limertinib Limertinib is an orally-administrated, third-generation EGFR TKI with proprietary rights, classified as a new molecular entity. Two New Drug Applications (NDAs) of limertinib are currently under review by China's National Drug Administration (NMPA): (1) for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, confirmed by an approved test, whose disease has progressed following EGFR TKI therapy; and (2) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. In a multi-center, randomized, double-blind, controlled Phase 3 clinical trial, the efficacy and safety of limertinib were compared to gefitinib in the first-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR mutations. The Phase 3 clinical trial met its primary endpoint, and the results will be presented at future academic conferences or published in academic journals. Results from a Phase 2b clinical study were presented in a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. In October 2024, Innovent and ASK Pharm entered into a strategic collaboration and license agreement regarding limertinib in mainland China. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications (NDA) under regulatory review, 3 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. About Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) Founded in January 2003, Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) is a research-based pharmaceutical enterprise that integrates and streamlines innovative research and development with manufacture, marketing promotion and sales of proprietary pharmaceuticals, fine chemicals and health-care products. ASK Pharm specializes in digestive disease, multidrug resistant infection, oncology and chronic disease areas. ASK Pharm focuses on the R&D of small-molecule targeted innovative drugs and immuno-oncology biologic drugs. Currently, there are 48 major research projects, including 11 disclosed key projects focused on innovative chemical and biologic drugs. Among these, the innovative anti-tumor drug Limertinib are in the NDA stage, while ASKC109 (maltol iron capsules) and ASKB589 (Claudin18.2 monoclonal antibody) are in Phase III clinical trials. ASK Pharm has Ranked among the top 20 best industrial enterprises in China's pharmaceutical R&D pipeline for 14 consecutive years and it has also received numerous honors such as "Top Ten National R&D Innovators", "Best National Enterprise for Investment", and "National Torch Program High-Tech Enterprises". For more information, visit . Innovent's Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED