Socazolimab

Biologics License Application currently under review by U.S. FDA; PDUFA goal date of December 28, 2024WALTHAM, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the presentation of longer-term data from its pivotal trial of cosibelimab, its anti-programmed death ligand-1 (“PD-L1”) antibody, in locally advanced and metastatic cutaneous squamous cell carcinoma (“cSCC”) during the European Society for Medical Oncology (“ESMO”) Congress 2024, which is taking place in Barcelona, Spain, from September 13 to 17, 2024. Poster Presentation Title: Cosibelimab in Advanced Cutaneous Squamous Cell Carcinoma (CSCC): Longer-term Efficacy and Safety Results from Pivotal Study “These longer-term results for cosibelimab presented at the ESMO Congress demonstrate a deepening of response over time, with higher objective response and complete response rates than initially observed at the primary analyses, and continue to expand the evidence supporting the efficacy and safety of cosibelimab as a potential new treatment for advanced cSCC,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “We look forward to our upcoming December 28, 2024, Prescription Drug User Fee Act (“PDUFA”) goal date for our Biologics License Application for cosibelimab, and believe, if approved, cosibelimab’s dual mechanisms of action and safety profile may position the product, over time, as the preferred immunotherapy of U.S. oncologists.” Data highlights include: Efficacy With 16 months of additional follow-up since the primary analysis, cosibelimab demonstrated increasing objective response rates (“ORRs”) and complete response rates per independent central review in 109 patients with advanced cSCC. ORRs of 54.8% and 50.0% achieved in locally advanced and metastatic cSCC, with median follow-up durations of 24.1 and 29.3 months, respectively.Results demonstrate a deepening of response over time, with complete response rates of 25.8% and 12.8% in locally advanced and metastatic cSCC, respectively.Clinically meaningful durations of response (“DOR”) were observed, with median DORs not yet reached in either group. Safety Overall, in 192 advanced cSCC patients treated with cosibelimab, a manageable safety profile was observed, with notable low rates of treatment-emergent adverse events (“TEAEs”), severe immune-related adverse events (“irAEs”), and treatment discontinuations. 3.6% of patients experienced an irAE assessed as grade 3, with no observed grade ≥4 irAEs.No events of grade ≥3 pneumonitis, colitis, hepatitis, nephritis, or endocrinopathies.Treatment discontinuation due to TEAEs, regardless of attribution, was observed in 12 patients (6.3%); the most common reason was COVID-19/COVID-19 pneumonia (1.6%). A copy of the poster can be found on the Publications page of the Checkpoint Therapeutics website. In December 2023, the U.S. Food and Drug Administration (“FDA”) issued a complete response letter (“CRL”) for the cosibelimab Biologics License Application (“BLA”) for the treatment of patients with metastatic or locally advanced cSCC who are not candidates or curative surgery or radiation. The CRL only cited findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization (“CMO”) as approvability issues to address in a resubmission. In July 2024, Checkpoint announced it had completed a resubmission of the BLA to the FDA for cosibelimab to potentially address the approvability issues cited in the CRL. The resubmission was accepted by the FDA as a complete response and the FDA has set a PDUFA goal date of December 28, 2024. About Cutaneous Squamous Cell Carcinoma (cSCC)Cutaneous Squamous Cell Carcinoma is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1.8 million cases according to the Skin Cancer Foundation. Important risk factors for cSCC include chronic ultraviolet exposure and immunosuppressive conditions. While most cases are localized tumors amenable to curative resection, approximately 40,000 cases will become advanced, and an estimated 15,000 people will die from this disease each year. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear. The immune-suppressed population represents a challenging target in the treatment of advanced cSCC, as they present with a more aggressive disease and with a higher risk of developing immune-related toxicities from checkpoint inhibitor treatment. About CosibelimabCosibelimab is a potential differentiated, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to PD-L1 and blocks the PD-L1 interaction with the programmed death receptor-1 (“PD-1”) and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained high tumor target occupancy of PD-L1 to reactivate an antitumor immune response and the additional potential benefit of a functional Fc domain capable of inducing antibody-dependent cellular cytotoxicity (“ADCC”) for potential enhanced efficacy. About Checkpoint TherapeuticsCheckpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential differentiated anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, as a potential new treatment for patients with selected recurrent or metastatic cancers, including metastatic and locally advanced cSCC. Checkpoint is also evaluating its lead small-molecule, targeted anti-cancer agent, olafertinib, a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.checkpointtx.com. Forward‐Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended, that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our resubmission of our BLA for cosibelimab and review thereof, our belief that the BLA resubmission potentially addresses all the issues in the CRL, our belief about the comprehensive nature of our BLA resubmission and reaching alignment with the FDA on our cosibelimab BLA resubmission strategy, our ability to work with our third-party CMO and the FDA to adequately address the issues raised in the CRL and execute on a pathway forward for the potential marketing approval of cosibelimab, the adequacy of the responses to the inspection issues submitted to FDA by our third-party CMO, our projections of regulatory review timelines, the commercial potential of cosibelimab, if approved, and the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-PD-1 therapies and the dual mechanism of action of cosibelimab translating into potential enhanced efficacy. Factors that could cause our actual results to differ materially include the following: the risks and uncertainties associated with the regulatory review process; uncertainties regarding the timeline of FDA review of the resubmitted BLA; any inability to successfully work with the FDA to find a satisfactory solution to address any concerns in a timely manner or at all during the review process for the BLA, including any inability to provide the FDA with data, analysis or other information sufficient to support an approval of the BLA; our, and our third party CMO’s, ability to adequately address the issues raised in the CRL; issues associated with any facility inspection or re-inspection of our third party CMO or otherwise during the review process for the BLA; the risk that our third-party CMO will not meet deadlines, and/or comply with applicable regulations; whether the FDA accepts the data and results as included in the BLA resubmission at levels consistent with the published results, or at all; our ability to execute a partnering or other relationship to enable the commercialization of cosibelimab, if approved, on acceptable terms, if at all; the risk that topline and interim data remains subject to audit and verification procedures that may result in the final data being materially different from the topline or interim data we previously published; the risk that safety issues or trends will be observed in the clinical trial when the full safety dataset is available and analyzed; the risk that a positive primary endpoint does not translate to all, or any, secondary endpoints being met; risks that regulatory authorities will not accept an application for approval of cosibelimab based on data from the Phase 1 clinical trial; the risk that the clinical results from the Phase 1 clinical trial will not support regulatory approval of cosibelimab to treat cSCC or, if approved, that cosibelimab will not be commercially successful; risks related to our chemistry, manufacturing and controls and contract manufacturing relationships; risks related to our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks related to our need for substantial additional funds; other uncertainties inherent in research and development; our dependence on third-party suppliers; government regulation; patent and intellectual property matters; competition; unfavorable market or other economic conditions; and our ability to achieve the milestones we project, including the risk that the evolving and unpredictable Russia/Ukraine conflict and COVID-19 pandemic delay achievement of those milestones. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K, and in our other filings with the U.S. Securities and Exchange Commission. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. This press release and prior releases are available at www.checkpointtx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. Company Contact:Jaclyn JaffeCheckpoint Therapeutics, Inc.(781) 652-4500ir@checkpointtx.com Investor Relations Contact:Ashley R. RobinsonManaging Director, LifeSci Advisors, LLC(617) 430-7577arr@lifesciadvisors.com Media Relations Contact:Katie KennedyGregory FCA610-731-1045checkpoint@gregoryfca.com

8月28日，李氏大药厂控股有限公司(简称“李氏大药厂”或“集团”，股份编号：00950)发布公告：截至2024年6月30日止6个月中期业绩，集团取得收益达到6.58亿港元，较2023年同期增长了28.5%。这一增长主要得益于多款纳入《国家基本医疗保险、工伤保 险和生育保险药品目录》（国家医保目录）的产品表现突出，其中曲前列尼尔注射液《芮旎尔®》的销售额增幅高达56.8%，而《芮舒延®》及《曲特恪®》分别录得187.2%和232.1%的增长。此外，药品集中采购（药品集采）计划中选产品如那屈肝素钙注射液《立腾菁®》的销售额激增近十倍。 创新驱动与精准布局 助推业绩增长 2024年上半年，尽管中国制药行业面临多重挑战，李氏大药厂却展现了卓越的抗风险能力与创新驱动的增长动力，集团在这一期间取得了显著的业绩提升。集团的毛利亦有所改善，整体毛利较去年同期增长23.2%，达到3.51亿港元。这一成绩得益于集团策略转向专利及仿制药领域，尤其是国家医保和药品集采计划的影响下，相关产品的销售占比显著提升。 李氏大药厂持续在心血管、女性健康、儿科、罕见病、皮肤科及产科等领域深耕，推动新药研发。上半年，集团的研发费用较去年同期减少25.5%，主要得益于成本优化及资源合理配置。然而，集团依然保持着强大的项目管道，多个创新药品已进入临床后期开发阶段。集团旗下肿瘤研发分支——中国肿瘤医疗有限公司（COF）在肿瘤领域的表现尤为突出。COF正积极推进包括索卡佐利单抗注射液《善克钰®》在内的多个肿瘤项目，并已取得了显著进展。 制造升级与市场并进 激发新质生产力 在制造设施方面，合肥基地的生产设备升级已顺利完成，并正为迎接美国食品药品监督管理局的现场核查作准备。南沙基地也在不断提升工艺技术，以确保生产效率的进一步提高。在销售和营销方面，李氏大药厂不断强化市场能力，多个新产品成功纳入国家医保目录，显示了集团扩大市场准入、提升患者负担能力的决心。 新征程 新趋势 新发展 展望未来，尽管行业竞争激烈、市场环境复杂，李氏大药厂将继续通过严格的成本控制和效率提升策略，推动业务的可持续发展。集团坚定信心，认为当前的战略措施不仅能应对眼前的挑战，更将为股东创造更高的价值。 2024年是李氏大药厂成立30周年，集团将在不断变革的行业环境中，保持战略定力，继续深耕创新，以卓越的业绩回馈市场与股东的信任。李氏大药厂在迈入30年新台阶的同时，将以新征程、新趋势、新发展的姿态，迎接未来的挑战与机遇。 往期回顾 ◆  不断突破，勇攀高峰——记李氏大药厂罕见病产品事业部布累迪宁®半年会 ◆  “解冻”之旅 | 肌萎缩侧索硬化（ALS）质控标杆医院参访交流顺利举行 ◆  智驭未来，安全先行——李氏大药厂信息安全培训圆满成功 ◆  处暑之韵，秋思悠长 关于李氏大药厂 - 亞太地區最具創新力的上市企業 - 李氏大药厂控股有限公司（简称“李氏大药厂”或“集团”, 股份编号: 00950）成立于1994年，是一家结合了研发驱动和市场导向的生物医药集团公司，总部位于香港。李氏大药厂于2002年7月在香港联合交易所（简称：“港交所”）创业板上市，并于2010年5月成功转至港交所主板上市。李氏大药厂在中国大陆拥有两大综合性生产研发基地，即：兆科合肥基地（位于安徽省合肥市高新区）和兆科广州基地（位于广东省广州市南沙区），目前员工总数超过1200人。 李氏大药厂立足中国大陆，放眼国际，通过坚实和稳固的投入建设，全面覆盖整合了药物研发、临床研究、药政注册、生产制造、销售与市场推广等各个环节。集团集中于心血管科、妇科与产科、儿科、罕见病、肿瘤科、皮肤科、精神科等多个重要疾病领域开发不同阶段的专利新药和高端仿制药。李氏大药厂与20余家国际公司建立了广泛的合作关系，目前在中国大陆、香港、澳门及台湾地区推广及销售25种包含专利新药、仿制药物及授权引进的国外已上市进口药品。 李氏大药厂现有超过40个处于不同开发阶段的产品，既有自主研发产品，也有通过来自美国、欧洲及日本等公司通过授权引进进行研发、生产以及商业化的产品。 李氏大药厂的使命是通过提供治疗各种疾病的创新产品，以改善患者健康及提高生活质量，成为亚洲一家成功的生物医药集团。 下滑查看更多 免责声明：本公众号发布或转载企业宣传资讯，仅供读者参考之用，并不构成收购、购买或认购依据，并不构成任何个人化的投资劝诱或建议。因本公布全部或任何部分内容而产生或因倚赖该等内容而引致的任何损失承担任何责任。 企业文化公共关系部出品 文章来源：集团官网 编辑：张慧玲 排版：樊扬波 审核：方玲 关注 李氏大药厂 与“李”同行 招商专线 刘小姐 020-39062882