Entasis Therapeutics Holdings, Inc.

XACDURO is a new FDA-approved treatment used to fight against HABP/VABP infections caused by isolates of Acinetobacter baumannii-calcoaceticus complex, which can include those resistant to carbapenems (CRAB). In the U.S., it is estimated there are more than 40,000 cases of Acinetobacter each year and approximately 40 percent are carbapenem-resistant.1,2 Patients with HABP/VABP caused by Acinetobacter infections face high mortality and significant costs due to drug resistance and limited approved treatment options. WALTHAM, Mass.--(BUSINESS WIRE)-- Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced that XACDURO® (sulbactam for injection; durlobactam for injection) is now available in the United States for patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). “XACDURO’s pathogen-targeted approach is a significant advancement in the way healthcare professionals treat Acinetobacter, one of the most serious antibiotic-resistant pathogens known to cause life-threatening pneumonia that is associated with high morbidity and mortality rates,” said Pavel Raifeld, Chief Executive Officer, Innoviva. “The addition of XACDURO to our portfolio of critical care medicines underscores our commitment to this space by providing healthcare professionals with differentiated therapeutic options to help improve patient outcomes.” XACDURO received regulatory approval from the U.S. Food and Drug Administration (FDA) in May 2023 and is now available by prescription through specialty pharmacy distributors in a healthcare setting. The FDA approval was based on strong scientific evidence, including results from the landmark Phase 3 ATTACK trial, published in The Lancet: Infectious Disease, evaluating the safety and efficacy of XACDURO versus colistin in patients with infections caused by Acinetobacter.3 In the trial, XACDURO demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a significant difference in clinical cure rates.3 XACDURO was well tolerated and exhibited a favorable safety pro the clinical program. In clinical studies, XACDURO was shown to significantly lower the incidence of nephrotoxicity.3 Fewer serious adverse events were observed compared to treatment with colistin, and there was lower treatment discontinuation due to adverse reactions versus colistin with one patient experiencing anaphylactic shock, which lead to discontinuation of treatment for that patient.3 Acinetobacter infections are now the fifth most common cause of deaths attributable to drug resistance across the globe and pose greatest threat to patients on ventilators in hospitals and nursing homes. The Acinetobacter pathogen has become resistant to most antibiotics used to treat HABP and VABP including carbapenems and third generation cephalosporins. This has caused Acinetobacter to become increasingly difficult to treat with no clear standard of care antibiotic regimen for these resistant infections. “Every minute matters when managing critical care patients with life-threatening pneumonia, especially when caused by carbapenem-resistant Acinetobacter baumannii pathogen. Antibiotic-resistant pathogens can complicate treatment strategies and compromise treatment efficacy, often resulting in increased mortality rates for intensive care unit patients,” said Margaret Koziel, MD, Chief Medical Officer, Innoviva. “Other treatment options may have high rates of resistance and adverse events, including nephrotoxicity.4 The availability of XACDURO is a much-needed advancement that can now provide healthcare professionals with an innovative therapy option to safely and effectively manage Acinetobacter pneumonia.” About Acinetobacter Members of the Acinetobacter baumannii-calcoaceticus complex (Acinetobacter) are Gram-negative, opportunistic human pathogens that predominantly infect critically ill patients, often resulting in severe pneumonia and bloodstream infections.5 They can infect other body sites, such as the urinary tract and the skin.5 Acinetobacter is considered a global threat in the healthcare setting due in part to its ability to acquire multidrug resistance.6 Acinetobacter is resistant to penicillins and has also acquired resistance genes for almost all antibiotics used to treat Gram-negative bacteria, including fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems.6 The Centers for Disease Control and Prevention (CDC) has identified carbapenem-resistant micro-organisms as an urgent threat.7 Globally, Acinetobacter baumannii was among the top six leading pathogens for deaths associated with resistance in 2019.8 Carbapenem-resistant Acinetobacter is considered a Priority 1 pathogen by the World Health Organization (WHO).9 Globally, there are about a million cases each year of Acinetobacter, and about two-thirds of those are carbapenem-resistant Acinetobacter baumannii.1 More than 300,000 global deaths annually are associated with carbapenem-resistant Acinetobacter.8 About XACDURO® XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, approved in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter. XACDURO® INDICATION & USAGE Indication XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Limitations of Use XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of XACDURO and other antibacterial drugs, XACDURO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION Contraindications: XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO or other beta-lactam antibacterial drugs. Warnings and Precautions: Hypersensitivity was observed in patients treated with XACDURO in clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before initiating therapy with XACDURO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens. If an allergic reaction occurs, discontinue XACDURO. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with XACDURO should be assessed. Prescribing XACDURO in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions: The most common adverse reactions reported in >10% of patients treated with XACDURO were liver test abnormalities (19%), diarrhea (17%), anemia (13%), and hypokalemia (12%). To report SUSPECTED ADVERSE REACTIONS, contact Innoviva Specialty Therapeutics, Inc. at 1-800-651-3861 or FDA at 1-800-FDA-1088 or . Before administering, please see the Full Prescribing Information for XACDURO. About Innoviva Specialty Therapeutics Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, include GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva Specialty Therapeutics’ products, through its affiliate, Entasis Therapeutics Inc., include XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). For more information about Innoviva Specialty Therapeutics, please visit here. About Innoviva Innoviva, Inc., is a diversified holding company with a portfolio of royalties and other healthcare assets, including Innoviva Specialty Therapeutics, a subsidiary focused on delivering innovative therapies in critical care and infectious disease. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/vilanterol, FF/VI) and ANORO® ELLIPTA® (umeclidinium bromide/vilanterol, UMEC/VI). Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. For more information on Innoviva, please visit here. Forward Looking Statements This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, formerly, TRELEGY® ELLIPTA® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives beyond the existing respiratory portfolio); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (COVID-19). Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2022 and Quarterly Reports on Form 10-Q, which are on the Securities and Exchange Commission (SEC) and available on the SEC’s website at . Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. References _______________________ 1 Spellberg B, Rex JH. The Value of Single-Pathogen Antibacterial Agents. National Review Drug Discovery. 2013 Dec;12(12):963. doi: 10.1038/nrd3957-c1. Epub 2013 Nov 15. 2 Gupta V, Ye G, Olesky M, Lawrence K, Murray J, Yu K. National Prevalence Estimates For Resistant Enterobacteriaceae and Acinetobacter Species In Hospitalized Patients In the United States. International Journal of Infectious Disease. 2019 Aug;85:203-211. doi: 10.1016/j.ijid.2019.06.017. Epub 2019 Jun 20. PMID: 31229615. 3 Kaye, Keith S.,Shorr, Andrew F., et al. Efficacy and Safety Of Sulbactam–Durlobactam Versus Colistin for the Treatment Of Patients With Serious Infections Caused By Acinetobacter baumannii–calcoaceticus Complex: a Multicentre, Randomised, Active-Controlled, Phase 3, Non-Inferiority Clinical Trial (ATTACK). The Lancet: Infectious Disease. Published May 11, 2023. DOI: (23)00184-6. 4 Katip W, Uitrakul S, Oberdorfer P. Clinical Efficacy and Nephrotoxicity of the Loading Dose Colistin for the Treatment of Carbapenem-Resistant Acinetobacter baumannii in Critically Ill Patients. Pharmaceutics. 2021 Dec 24;14(1):31. doi: 10.3390/pharmaceutics14010031. PMID: 35056926; PMCID: PMC8780224. 5 Ballouz T, Aridi J, Afif C, et al. (2017) Risk Factors, Clinical Presentation, and Outcome of Acinetobacter baumannii Bacteremia. Front. Cell. Infect. Microbiol. 7:156. doi: 10.3389/fcimb.2017.00156 6 Kyriakidis I, Vasileiou E, Pana ZD, Tragiannidis A. Acinetobacter baumannii Antibiotic Resistance Mechanisms. Pathogens. 2021 Mar 19;10(3):373. doi: 10.3390/pathogens10030373. PMID: 33808905; PMCID: PMC8003822. 7 Centers for Disease Control and Prevention, “Carbapenem-Resistant Acinetobacter baumannii (CRAB): An Urgent Public Health Threat in United States healthcare facilities,” August 2021: . Accessed: September 8, 2023 8 Antimicrobial Resistance Collaborators. Global Burden Of Bacterial Antimicrobial Resistance in 2019: a Systematic Analysis. Lancet. 2022; 399(10325):629-655. (21)02724-0/fulltext 9 World Health Organization, “WHO Publishes List Of Bacteria For Which New Antibiotics Are Urgently Needed,” February 27, 2017: . Accessed: September 8, 2023

BURLINGAME, Calif.--(BUSINESS WIRE)-- Innoviva Inc. (NASDAQ: INVA) (“Innoviva” and “the Company”), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced the appointment of Stephen Basso as its Chief Financial Officer, effective August 21, 2023. “We are excited to welcome Stephen to our executive leadership team and believe the Company will benefit greatly from his background and experience,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “I look forward to working with Stephen to advance our strategy and create shareholder value.” Mr. Basso brings more than 30 years of experience in the financial services industry and financial leadership in the pharmaceutical industry. Prior to joining Innoviva, Mr. Basso served as Chief Financial Officer and Chief Operating Officer at Cybrexa Therapeutics. Before Cybrexa, Mr. Basso held a variety of finance leadership positions in the industry, including as Senior Vice President of Finance at Inozyme Pharma, Inc., Vice President of North American commercial operations and global finance at Alexion Pharmaceuticals, Inc., and various finance roles at Pfizer, Inc. and Fidelity Investments. Mr. Basso received a Bachelor of Science in business from Providence College and a Master of Business Administration in finance from Boston College. Mr. Basso added, “I am thrilled to join Innoviva at a critical time in its development. Working alongside such a dedicated team, I am confident we will capitalize on many opportunities for value creation and growth." About Innoviva Innoviva is a diversified holding company with a portfolio of royalties and other healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/ vilanterol, “FF/VI”) and ANORO® ELLIPTA® (umeclidinium bromide/ vilanterol, “UMEC/VI”). Under the Long-Acting Beta2 Agonist (“LABA”) Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s other healthcare assets include infectious disease and hospital assets stemming from acquisitions of Entasis Therapeutics, including its lead asset XACDURO® (sulbactam-durlobactam) for the treatment of hospital-acqauire bacterial pneumonia and ventilator-assoicated bacterial pneumonia, and La Jolla Pharmaceutical, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. Forward Looking Statements This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA®, GIAPREZA®, XERAVA® and XACDURO® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (“COVID-19”); the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company’s growth strategy. Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2022 and Quarterly Reports on Form 10-Q, which are on the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at . Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

今日（8月8日），再鼎医药公布了2023年第二季度的财务业绩。该公司2023年第二季度产品收入合计为6890万美元，同比增长45%；2023年第二季度的研发开支为7670万美元，2022年同期为6610万美元。此外，再鼎医药也公布了公司的产品进展和未来发展规划。根据再鼎医药新闻稿：该公司产品组合中有13个处于后期开发阶段的管线；到2028年底，再鼎医药预计将有超过15个商业化阶段产品。———✦近期产品进展✦———再鼎医药已经建立了差异化的产品和管线组合，其中包括13个处于后期开发阶段的管线。自上次财报发布以来，该公司在产品和候选产品方面取得诸多进展，其中包括两款商业化产品取得新的注册批准。2023年6月，中国国家药品监督管理局（NMPA）批准FcRn拮抗剂卫伟迦（艾加莫德α注射液）的上市申请，与标准治疗药物联合，用于治疗乙酰胆碱受体（AChR）抗体阳性的成人全身型重症肌无力（gMG）患者。再鼎医药预计今年晚些时候卫伟迦将在中国内地商业化上市。2023年5月，中国台湾地区药械审批部门批准肿瘤电场治疗爱普盾用于治疗胶质母细胞瘤（GBM）患者的上市许可申请。———✦关键候选产品进展✦———一、肿瘤领域则乐（尼拉帕利，PARP抑制剂）：2023年7月，JAMA Oncology发表了3期临床研究PRIME的研究数据，支持了则乐作为中国更广泛的新诊断晚期卵巢癌患者维持治疗的应用，并证明了相较300mg固定起始剂量，基于基线体重和血小板计数采用则乐200mg或300mg的个体化起始剂量，能够为患者带来显著临床获益且提升了安全性和耐受性。这些数据表明，与安慰剂相比，接受则乐维持治疗显著延长了患者无进展生存期，且使疾病进展或死亡风险降低了55%。肿瘤电场治疗：2023年7月，再鼎医药合作伙伴NovoCure公司宣布收到来自独立数据监察委员会的建议，支持继续进行肿瘤电场治疗用于胰腺癌的3期临床研究PANOVA-3。预先指定的中期分析得出结论，已完成入组的PANOVA-3临床研究应按计划进行最终分析。再鼎医药在大中华区参与了该研究。2023年6月，再鼎医药和NovoCure公司宣布，非小细胞肺癌（NSCLC）3期临床研究LUNAR达到主要终点，证实为接受铂类化疗后的转移性NSCLC患者带来具有显著统计学意义和临床意义的总生存期改善。再鼎医药在大中华区参与了该研究。与标准治疗相比，肿瘤电场治疗联合标准治疗提供了具有显著统计学意义和临床意义的超过3个月的中位总生存期改善，且未增加系统性毒性。肿瘤电场治疗联合免疫检查点抑制剂在中位总生存期方面实现接近8个月的改善。Krazati（adagrasib，KRAS G12C抑制剂）：2023年7月，再鼎医药完成了全球3期临床研究KRYSTAL-10在中国的患者入组，该研究旨在评估adagrasib联合西妥昔单抗对比化疗用于经治的晚期KRASG12C突变结直肠癌患者；2023年6月，再鼎医药完成了全球2期临床研究KRYSTAL-7在中国的患者入组，该研究旨在评估adagrasib联合帕博利珠单抗一线治疗晚期KRASG12C突变NSCLC患者。瑞普替尼（ROS1/TRK抑制剂）：继2023年5月瑞普替尼被纳入优先审评后，2023年6月，再鼎医药宣布NMPA已受理瑞普替尼的新药上市申请（NDA），用于治疗ROS1阳性的局部晚期或转移性NSCLC成人患者；2023年5月，再鼎医药合作伙伴百时美施贵宝宣布，瑞普替尼用于同样适应证的新药上市申请已获美国FDA受理，并被授予优先审评资格，PDUFA日期为2023年11月27日。Bemarituzumab（抗FGFR2b单抗）：2023年7月，再鼎医药完成全球3期临床研究FORTITUDE-101的中国内地首例患者入组，该研究旨在评估bemarituzumab联合化疗，对比安慰剂联合化疗，用于FGFR2b过度表达的胃癌一线治疗。二、自身免疫疾病、感染性疾病和中枢神经系统疾病领域卫伟迦（艾加莫德，FcRn拮抗剂）：2023年6月，argenx公司宣布FDA批准Vyvgart Hytrulo（艾加莫德皮下注射剂型）注射液用于全身型重症肌无力（gMG）皮下注射；2023年7月，NMPA受理了再鼎医药提交的艾加莫德皮下注射剂型用于治疗成人gMG患者的上市申请。2023年7月，再鼎医药和合作伙伴argenx公布了Vyvgart Hytrulo用于成人慢性炎性脱髓鞘性多发性神经根神经病（CIDP）患者的全球注册性研究ADHERE的阳性主要数据。再鼎医药在大中华区参与了该研究。研究结果亮点包括：达到主要研究终点；与安慰剂相比，Vyvgart Hytrulo可降低复发风险61%；在开放标签A阶段，67%的患者确认出现临床改善（ECI），表明IgG自身抗体在CIDP的生物学机制中发挥着重要作用；安全性和耐受性与此前的临床研究和已确认的卫伟迦的安全性特征一致。2023年5月，再鼎医药在中国入组了艾加莫德皮下注射剂型用于成人大疱性类天疱疮（BP）患者的全球性2/3期研究BALLAD中的首例患者。Xacduro（舒巴坦钠-度洛巴坦钠，亚太区权益）：2023年5月，再鼎医药合作伙伴、Innoviva的全资子公司Entasis Therapeutics宣布，FDA批准Xacduro用于治疗由鲍曼不动杆菌-醋酸钙不动杆菌复合体（不动杆菌）的敏感菌株引起的医院获得性细菌性肺炎和呼吸机相关性细菌性肺炎（HABP/VABP）成人患者。在中国，NMPA正在审评该产品的新药上市申请，并已将其纳入优先审评。KarXT（xanomeline-trospium，M1/M4型毒蕈碱乙酰胆碱受体激动剂）：2023年6月，再鼎医药在中国内地入组了评估KarXT治疗精神分裂症的注册性桥接研究的首例患者。———✦2023年预期重要里程碑事件✦———一、肿瘤领域肿瘤电场治疗：再鼎医药合作伙伴NovoCure公司将公布全球关键性临床研究INNOVATE-3的主要数据解读，该研究旨在评估肿瘤电场治疗联合紫杉醇治疗铂耐药卵巢癌患者的疗效。Krazati（adagrasib，KRAS G12C抑制剂）：再鼎医药合作伙伴Mirati Therapeutics将更新adagrasib联合帕博利珠单抗用于治疗携带KRASG12C突变的一线NSCLC患者的全球2期研究KRYSTAL-7的临床数据。再鼎医药正在大中华区参与该临床研究。Mirati公司将公布通过多种研发路径开展针对一线KRASG12C突变NSCLC的临床开发计划的进展。Mirati公司将向FDA提交用于治疗三线及以上KRASG12C突变的晚期结直肠癌患者的加速审批补充新药上市申请（sNDA）。Odronextamab（CD20 x CD3双特异性抗体）：再鼎医药合作伙伴再生元（Regeneron）将启动用于治疗滤泡性淋巴瘤（FL）和弥漫性大B细胞淋巴瘤（DLBCL）（包括前线治疗）的确证性研究。再生元预计将获得该药用于治疗复发╱难治性FL和DLBCL的上市申请的受理。麦甘乐（马吉妥昔单抗，靶向HER2的单抗）：用于转移性HER2阳性乳腺癌患者三线及以上治疗的新药上市申请有望获得NMPA批准。二、自身免疫疾病、感染性疾病和中枢神经系统疾病领域卫伟迦（艾加莫德，FcRn）：再鼎医药合作伙伴argenx公司将于2023年第四季度公布艾加莫德皮下注射剂型用于治疗天疱疮的注册性3期研究ADDRESS和用于治疗免疫性血小板减少症（ITP）的注册性3期研究ADVANCE-SC的关键性数据。再鼎医药在大中华区参与了这两项研究。argenx公司将于2023年第四季度启动艾加莫德治疗甲状腺眼病（TED）的注册性研究。KarXT（xanomeline-trospium，M1/M4型毒蕈碱乙酰胆碱受体激动剂）：再鼎医药合作伙伴Karuna公司将于2023年第三季度向FDA提交KarXT用于治疗精神分裂症的新药上市申请。Karuna公司将启动用于治疗阿尔茨海默病精神病性障碍的3期研究ADEPT-2和ADEPT-3。再鼎医药计划在大中华区参与相关研究。———✦2023年投资者日活动✦———此外，再鼎医药还于2023年6月20日举办了投资者日活动，并公布了5年增长规划，包括到2028年底实现以下目标：到2028年拥有超过15款商业化阶段产品（目前拥有5款）；到2028年拥有超过8款具有全球权利的进入临床阶段的管线（目前拥有3款），并且每年至少提交1项新药临床研究申请（IND）；2023年至2028年间保持50%以上的营收复合年增长率；实现收入显著增长和营业利润率持续提升，到2025年年底实现公司盈利。再鼎医药创始人、董事长兼首席执行官杜莹博士表示，2023年第二季度公司继续成功推进各项业务。公司商业化产品保持强劲增长，按固定汇率计算产品净收入增长了53%，同时公司多个后期开发项目和早期产品管线都取得了重要进展。最为重要的是，FcRn拮抗剂卫伟迦（艾加莫德α注射液）获NMPA批准上市，这使得公司有资格参与2024年中国国家医保药品目录谈判。近期艾加莫德用于慢性炎性脱髓鞘性多发性神经根神经病（CIDP）治疗取得的阳性研究数据，让公司对其在多个适应症领域成为潜在重磅药物充满信心。参考资料：[1]再鼎医药公布2023年第二季度财务业绩和公司进展. Retrieved Aug 8, 2023, from https://mp.weixin.qq.com/s/juvv4TpED4NFR5xOzf45pw识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。