Bivalirudin

2024年12月12日，普利制药的钆特酸葡胺注射液（商品名：普利影显®）、泊沙康唑注射液（商品名：普利泊沙®）在第十批国家药品集中采购中双双中标！ 1 普利影显®钆特酸葡胺注射液 普利制药普利影显®钆特酸葡胺注射液此次集采中标规格为：15ml:5.6535g。 普利影显®钆特酸葡胺注射液是海南普利制药股份有限公司生产的大环类离子型核磁共振造影剂。 普利制药的钆特酸葡胺注射液已于2024年6月获得美国FDA批准，其他国家正在申报中。该品种为中美双报品种，国内与美国市场共用一条生产线，同质量标准，同产品品质，质量稳定可靠。 普利制药钆特酸葡胺注射液获美国FDA上市批准 钆特酸葡胺注射液属于普利制药的原料制剂一体化品种，其原料来自海南普利制药股份有限公司子公司安徽普利药业有限公司。作为原料制剂一体化品种，普利制药的钆特酸葡胺注射液不会受制于原料药市场，可稳定保障临床供应。 普利制药钆特酸葡胺原料登记内容 普利影显®钆特酸葡胺注射液中国获批5个规格，分别：5ml:1.8845g、10ml:3.769g、15ml:5.6535g、20ml:7.538g、100ml:37.69g（以钆特酸葡胺计）。规格齐全，与原研Guebert的美国获批规格一致，能全面满足临床不同患者核磁共振增强检查项目需要。 2 普利泊沙®泊沙康唑注射液 普利制药普利泊沙®泊沙康唑注射液此次集采中标规格为：16.7ml:0.3g。 泊沙康唑是新一代三唑类抗真菌药物，相对于同类型其他产品，其抗菌活性强，抗菌谱更广，安全性更高，是众多国内外权威指南共识推荐用于真菌感染预防和治疗一线药物。 泊沙康唑注射液目前已纳入2024版国家医保目录，是医保乙类品种。此外，在2024年6月，国家药品监督管理局发布公告，将其适应症扩大至2岁及以上儿童人群，并有明确的儿童用法用量。可以预见，泊沙康唑注射液的临床应用势必会进一步扩大。 泊沙康唑注射液儿童适应症和用法用量的修订内容 普利泊沙®泊沙康唑注射液是中美双报品种，目前美国市场正在审评中，除了美国外，普利制药也将布局英国、澳大利亚、新西兰等国家。 3 普利制药集采情况 自2018年年底国家开展集采试点工作以来，医药集采已逐渐成为一种重要的药品和医用耗材采购模式，让更多患者受益。普利制药也响应国家政策，目前有多个产品已实现集采中标，覆盖多个治疗领域。普利制药集采中选品种如下：地氯雷他定片、左乙拉西坦注射用浓溶液于第三批集采中选；注射用比伐芦定、左氧氟沙星片于第四批集采中选；注射用阿奇霉素于第五批集采中选；依替巴肽注射液于第七批集采中选；注射用达托霉素、注射用伏立康唑于第八批集采中选；阿奇霉素干混悬剂于第九批集采中选；以及此次的第十批集采中选产品钆特酸葡胺注射液、泊沙康唑注射液。在集采项目执行期间，普利制药能够精准把控时间节点，严格遵循质量标准，确保每一批次集采任务都能够按时、保质、保量地顺利完成。未来，普利制药将继续秉持“质量第一、患者至上”的原则，积极参与国家集采项目，为推动我国医药行业的健康发展做出更大的贡献。 诚邀合作，欢迎垂询，国内招商： GNXS@hnpoly.com 0571-89385059 4 关于普利制药 普利制药股份有限公司1992年成立于海口，是中国医药制剂国际化先导企业和国家工信部智能制造示范企业，其子公司浙江普利已被国家工信部纳入工业转型升级中国制造2025年儿童药重点项目企业。普利制药2017年在创业板上市后，短短3年已成为中国上市公司科技创新百强企业。公司从事药品国际化开拓以来，至今已获得了170余个国际制剂上市许可，产品远销世界各地。 未来，普利制药将一如既往地实施“先进高端制造, 面向国内国际”的全球战略，持续不断研发更多更好的药物；走向世界，为民族医药工业的强大持续作出贡献，让中国老百姓用上出口欧美的国际化高品质健康品。

Industry veterans John Maraganore, Ph.D., and Rachel Meyers, Ph.D., to provide strategic guidance on the company’s RNA Actuating platform to develop a new class of RNA medicines that upregulate protein coding genesCAMBRIDGE, Mass., Dec. 10, 2024 (GLOBE NEWSWIRE) -- CAMP4 Therapeutics Corporation (“CAMP4”) (Nasdaq: CAMP), a clinical-stage biotechnology company developing a pipeline of regRNA-targeting therapeutics designed to upregulate gene expression with the goal of restoring healthy protein levels across a range of genetic diseases, today announced the appointments of John Maraganore, Ph.D., and Rachel Meyers, Ph.D., as strategic advisors to the Company. For nearly 20 years, Dr. Maraganore served as the founding Chief Executive Officer and Director of Alnylam where he led the company’s programs in RNA interference through global commercialization, resulting in the launch of the first four RNAi therapeutics, ONPATTRO®, GIVLAARI®, OXLUMO®, and LEQVIO®. Additionally, Dr. Meyers brings more than two decades of life sciences leadership, research, and development experience in RNA-based medicines, having spent nearly 14 years at Alnylam where she most recently served as Senior Vice President of Research and RNAi Lead Development. She currently sits on the company’s Scientific Advisory Board. “We feel privileged and are delighted to welcome Drs. Maraganore and Meyers to our CAMP4 team as strategic advisors,” said Josh Mandel-Brehm, Chief Executive Officer of CAMP4. “We view their joining the team as a testament to the promise and potential of our approach for upregulating gene expression to potentially address a broad range of diseases. As we prepare for 2025, we look forward to benefiting from their insights and expertise as we advance our efforts in bringing potentially transformative RNA medicines to patients in need of disease-modifying solutions.” Dr. Maraganore added, “The targeted upregulation of gene expression has been a long-standing challenge for the field, and by applying established and clinically validated antisense oligonucleotide technology to groundbreaking science, CAMP4 could potentially make a meaningful impact on patients across a broad range of diseases. I look forward to working with them as they pioneer the field of upregulation.” Prior to his role at Alnylam, Dr. Maraganore led the product franchises in oncology, cardiovascular, inflammatory, and metabolic diseases for Millennium Pharmaceuticals, in addition to leadership of M&A, strategy, and biotherapeutics. Earlier in his career, Dr. Maraganore invented and spearheaded the development of ANGIOMAX® (bivalirudin) for injection while at Biogen and was also a scientist at ZymoGenetics, Inc., and the Upjohn Company. He currently serves as a Venture Partner at ARCH Venture Partners, a Venture Advisor at Atlas Ventures, an Executive Partner at RTW Investments, a Senior Advisor for Blackstone Life Sciences, and a Senior Advisor for Jeffries Financial Group. Beyond his leadership roles in the investment community, Dr. Maraganore also sits on the Board of Directors for multiple publicly traded companies, including Beam Therapeutics, Kymera Therapeutics, Rapport Therapeutics, and Takeda Pharmaceuticals. He received his B.A., M.S., and Ph.D. in biochemistry and molecular biology at the University of Chicago. Dr. Meyers currently serves as a member of the Board of Directors of Korro Bio (Nasdaq: KRRO), a biopharmaceutical company focused on discovering, developing, and commercializing a new class of genetic medicines based on editing RNA, and also holds a variety of advisory roles within the biotech community. Most recently, she served as Founder and Chief Scientific Officer at Faze Medicines, a Third Rock Ventures-spawned biotech company focused on treating diseases of high unmet need through the perturbation of biomolecular condensates. Earlier in her career, Dr. Meyers was a senior scientist at Millennium Pharmaceuticals and today serves on multiple scientific advisory boards, including the National Advisory Board on Innovation and Entrepreneurship through the Department of Commerce. Furthermore, she is listed as an inventor on numerous patents and patent applications and has authored many peer-reviewed publications. Dr. Meyers received her postdoctoral training with Lew Cantley at Harvard Medical School in signal transduction and earned her Ph.D. in biology from Nobel laureate Phil Sharp at the Massachusetts Institute of Technology in in vitro transcription. She earned her BA in Biochemistry from Brandeis University. “I’ve had the unique opportunity to work alongside tremendously talented professionals who have led the shaping of the RNA medicines space,” said Dr. Meyers. “Having been at the forefront of these scientific breakthroughs, I believe now more than ever RNA-based therapies are poised to continue transforming how we treat patients with complex diseases. Having the opportunity to advise CAMP4 as they continue advancing the field is an extension of the work to which I’ve committed my career.” About CAMP4 Therapeutics CAMP4 is developing disease-modifying treatments for a broad range of genetic diseases where amplifying healthy protein may offer therapeutic benefits. Our approach amplifies mRNA by harnessing a fundamental mechanism of how genes are controlled. To amplify mRNA, our therapeutic ASO drug candidates target regRNAs, which act locally on transcription factors and are the master regulators of gene expression. CAMP4’s proprietary RAP Platform™ enables the mapping of regRNAs and generation of therapeutic candidates designed to target the regRNAs associated with genes underlying haploinsufficient and recessive partial loss-of-function disorders, of which there are more than 1,200, in which a modest increase in protein expression may have the potential to be clinically meaningful. Learn more about us at www.CAMP4tx.com and follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning CAMP4’s plans, objectives, expectations and intentions; the timing and results of ongoing and future clinical trials, including expectations on the timing of reporting SAD and MAD data from and seeking regulatory approval for the CMP-CPS-001 trial; its growth strategy; and cash balance guidance. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; risks related to the operations of the Company’s suppliers; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as well as other information we file with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain and are not guarantees of future events. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, you should not unduly rely on these forward-looking statements. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contacts Investor Relations:Sandya von der WeidLifeSci Advisorssvonderweid@lifesciadvisors.com Media:Jason Braco, Ph.D.LifeSci Communicationsjbraco@lifescicomms.com