Ceftolozane

October 9, 2024 6:45 am ET Merck Underscores Continued Commitment to Fighting Infectious Diseases with More than 40 Data Presentations Across Vaccines, Antibacterials and Antivirals, Including Respiratory Syncytial Virus, Pneumococcal Disease and HIV For the First Time, Full Results will be Highlighted from the Phase 2b/3 Trial of Clesrovimab (MK-1654), an Investigational Respiratory Syncytial Virus Preventative Monoclonal Antibody for Infants RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced its plans to present new research findings demonstrating the continued impact of its increasingly broad and diverse vaccines and infectious disease portfolio and the potential of its innovative pipeline at IDWeek 2024 in Los Angeles, CA, from October 16-19. Data to be presented include a late-breaker oral presentation of positive detailed results from the Phase 2b/3 trial evaluating clesrovimab (MK-1654), an investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease; data from the Phase 3 STRIDE-8 trial evaluating CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) in adults 18-64 years of age at increased risk of pneumococcal disease; as well as a late-breaker oral presentation of Week 48 data from the Phase 2 study evaluating an investigational once-weekly oral combination regimen of islatravir, the company’s nucleoside reverse transcriptase translocation inhibitor (NRTTI), and Gilead’s lenacapavir, a first-in-class capsid inhibitor, for treatment of people with HIV-1 infection. “The breadth of innovative research we will showcase during IDWeek 2024 is a testament to our ongoing commitment to advancing science with the pursuit of addressing persisting global health needs, such as RSV,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories. “We are proud of our company’s longstanding legacy and continued momentum in helping to treat and prevent a variety of potentially serious infectious diseases for individuals around the world and across all stages of life – from birth through older adulthood – and we look forward to sharing these data.” Key data from Merck’s portfolio and pipeline to be presented during IDWeek 2024: First time data from the Phase 2b/3 study evaluating a single dose of clesrovimab (MK-1654) administered to pre-term and full-term infants (Abstract #166, Late Breaker Oral Abstract Session: Respiratory Viruses Across All Ages); First presentation of results from the interim analysis of the Phase 3 trial evaluating the safety and efficacy of clesrovimab versus palivizumab in infants and children at increased risk for severe RSV disease (Abstract #167, Late Breaker Oral Abstract Session: Respiratory Viruses Across All Ages); First presentation of data from the Phase 3 STRIDE-8 trial evaluating CAPVAXIVE in vaccine-naïve adults 18-64 years of age at increased risk of pneumococcal disease (Abstract #45, Poster Session: Adult Vaccines); Week 48 data from the Phase 2 study evaluating once-weekly oral islatravir plus lenacapavir (Abstract #577, Late Breaker Oral Abstract Session: What's Going Viral); Data from the SPECTRA (Study of Prescribing patterns and Effectiveness of Ceftolozane/Tazobactam [C/T] Real-world Analysis) study (multiple abstracts) and updates from the SMART (Study for Monitoring Antimicrobial Resistance Trends) surveillance program (multiple abstracts). Details on abstracts listed above and additional key abstracts for Merck: RSV A Phase 2b/3 Study to Evaluate the Efficacy and Safety of an Investigational Respiratory Syncytial Virus (RSV) Antibody, Clesrovimab, in Healthy Preterm and Full-Term Infants. A. Sinha. Abstract #166, Oral Abstract, Late Breaker Abstract Session: Respiratory Viruses Across All Ages Phase 3, Randomized, Controlled Trial Evaluating Safety, Efficacy, and Pharmacokinetics (PK) of Clesrovimab in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease. O. Ramilo. Abstract #167, Oral Abstract, Late Breaker Abstract Session: Respiratory Viruses Across All Ages Pneumococcal A Phase 3, Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Investigational Adult-Specific Pneumococcal Conjugate Vaccine, in Pneumococcal Vaccine-Naïve Adults 18–64 Years of Age with Increased Risk for Pneumococcal Disease. P. Scott. Abstract #45, Poster Session: Adult Vaccines Disparities and Inequities in the Burden of Pneumococcal Disease in US Adults. N. Cossrow. Abstract #242, Poster Session: HAIs: Device-Associated (CLABSI, CAUTI, VAP) Quantifying the Impact of Introducing a New Adult-Focused PCV in the United States. O. Sharomi. Abstract #58, Poster Session: Adult Vaccines HIV Week 48 Results of a Phase 2 Study Evaluating Once-weekly Oral Islatravir Plus Lenacapavir. A. Colson. Abstract #577, Oral Abstract, Late Breaker Abstract Session: What's Going Viral Undesired Weight Gain and Associated Healthcare Outcomes Among People with HIV on Antiretroviral Treatment. B.K. Tadese. Abstract #540, Poster Session: HIV: Treatment Antivirals Drug-Drug Interactions (DDIs) with Letermovir (LET) for Cytomegalovirus (CMV) Prophylaxis in Pediatric (Birth to <18 Years of Age) Hematopoietic Cell Transplant (HCT) Recipients. L. Danziger-Isakov. Abstract #1196, Poster Session: Pediatric Viral Studies A SFGM-TC Real-world Study to Characterize Pediatric Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) and Identify Both the Cytomegalovirus (CMV) Serology Status of Both Recipients and Their Donors. X. Bourge. Abstract #2356, Poster Session: Virology: Epidemiology of Viral Infections Virologic and Clinical Outcomes Among Participants Hospitalized in a Phase 3 Trial Comparing Molnupiravir with Placebo for Treating Mild-to-Moderate COVID-19. M. Johnson. Abstract #1928, Poster Session: COVID-19: Complications, Coinfections and Clinical Outcomes Antibiotics Treatment Patterns Among Hospitalized Patients with Gram-Negative Infection Treated with Imipenem/Cilastatin/Relebactam (I/R): Retrospective US-Based EHR Medical Chart Review. E. Yucel. Abstract #1075, Poster Session: Novel Agents Effectiveness of Imipenem-Relebactam for Multidrug-resistant Pseudomonas AeruGinosa in PnEumonia and Bloodstream Infections in the United States (MIRAGE): Preliminary Results. R. Shields. Abstract #1105, Poster Session: Novel Agents Comparative Effectiveness of Early Treatment with Ceftolozane/Tazobactam (C/T) Relative to Polymyxin (PB)-based Therapy for Non-COVID-19 Patients (pts) with Pneumonia (PNA) due to Multi-drug Resistant Pseudomonas Aeruginosa (MDR-PSA) Across US Hospitals. T. Lodise. Abstract #1537, Poster Session: Treatment of Antimicrobial Resistant Infections Clinical Outcomes in Patients Hospitalized with Exacerbation of Chronic Respiratory Infections Treated with Ceftolozane/Tazobactam: Results from SPECTRA. E. Yucel. Abstract #1074, Poster Session: Novel Agents Describing the Clinical Characteristics, Treatment Patterns and Outcomes in Hospitalized Pneumonia Patients Treated with Ceftolozane/Tazobactam (C/T): Insights from the SPECTRA Study. E. Yucel. Abstract #1076, Poster Session: Novel Agents Treatment Patterns and Clinical Outcomes in Hospitalized Patients with Febrile Neutropenia Treated with Ceftolozane/Tazobactam: A Subgroup Analysis of the SPECTRA Study. E. Yucel. Abstract #1113, Poster Session: Novel Agents Study of Prescribing patterns and Effectiveness of Ceftolozane/Tazobactam [C/T) Real-world Analysis Results (SPECTRA): Results of Immunocompromised Patients. E. Yucel. Abstract #2305, Poster Session: Transplant: Studies of Empiric and Preemptive Therapy Study of Prescribing patterns and Effectiveness of Ceftolozane/Tazobactam (C/T) Real-world Analysis (SPECTRA): Clinical Outcomes and Treatment Patterns from Mexico. E. Yucel. Abstract #1077, Poster Session: Novel Agents Antimicrobial Epidemiology/Surveillance Susceptibility of Clinical Non-Morganellaceae Enterobacterales Isolates from Bloodstream and Respiratory Tract Infections to Imipenem/Relebactam and Comparators: SMART United States 2020-2022. M. Wise. Abstract #1519, Poster Session: Treatment of Antimicrobial Resistant Infections Activity of Ceftolozane/Tazobactam, Imipenem/Relebactam and Comparators Against Clinical MDR and DTR non-Morganellaceae Enterobacterales and Pseudomonas Aeruginosa Stratified by Patient Age and Hospital Ward: SMART United States 2020-2022. M. Wise. Abstract #1518, Poster Session: Treatment of Antimicrobial Resistant Infections About Clesrovimab (MK-1654) Clesrovimab (MK-1654) is an investigational, extended half-life monoclonal antibody (mAb) developed as a passive immunization for the prevention of RSV. Clesrovimab is designed to be administered as the same single dose, regardless of birth weight, and is being studied in healthy pre-term, full-term and at-risk infants to provide direct, rapid and durable protection through their first RSV season against mild, moderate and severe RSV. About CAPVAXIVE CAPVAXIVE is Merck’s approved 21-valent pneumococcal conjugate vaccine indicated for active immunization for the prevention of invasive disease and pneumonia in adults 18 years of age and older. CAPVAXIVE is specifically designed to help address Streptococcus pneumoniae serotypes predominantly responsible for adult invasive pneumococcal disease (IPD), including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B compared to other pneumococcal vaccines. CAPVAXIVE is administered as a single dose. Select Safety Information for CAPVAXIVE Do not administer CAPVAXIVE to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid. Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE. The most commonly reported (>10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%). The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%). Vaccination with CAPVAXIVE may not protect all vaccine recipients. Authorized Use of LAGEVRIO™ (molnupiravir) in the U.S. LAGEVRIO (molnupiravir) is authorized for use under an Emergency Use Authorization (EUA) for the treatment of adults with mild-to-moderate coronavirus disease 2019 (COVID-19): who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. LAGEVRIO is not approved for any use, including the treatment of COVID-19, but is authorized for emergency use by the FDA under an Emergency Use Authorization (EUA). The emergency use of LAGEVRIO is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1) unless the declaration is terminated or authorization revoked sooner. Limitations of Authorized Use LAGEVRIO is not authorized: for use in patients who are less than 18 years of age for initiation of treatment in patients hospitalized due to COVID-19. Benefit of treatment with LAGEVRIO has not been observed in subjects when treatment was initiated after hospitalization due to COVID-19 for use for longer than 5 consecutive days for pre-exposure or post-exposure prophylaxis for prevention of COVID-19 LAGEVRIO may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which LAGEVRIO belongs (ie, anti-infectives). Selected Safety Information for LAGEVRIO Contraindications No contraindications have been identified based on the limited available data on the emergency use of LAGEVRIO authorized under this EUA. Warnings and Precautions There are limited clinical data available for LAGEVRIO. Serious and unexpected adverse events may occur that have not been previously reported with LAGEVRIO use. LAGEVRIO is not recommended for use during pregnancy. Based on findings from animal reproduction studies, LAGEVRIO may cause fetal harm when administered to pregnant individuals. There are no available human data on the use of LAGEVRIO in pregnant individuals to evaluate the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. LAGEVRIO is authorized to be prescribed to a pregnant individual only after the healthcare provider has determined that the benefits would outweigh the risks for that individual patient. If the decision is made to use LAGEVRIO during pregnancy, the prescribing healthcare provider must document that the known and potential benefits and the potential risks of using LAGEVRIO during pregnancy were communicated to the pregnant individual. There is a pregnancy registry that monitors pregnancy outcomes in individuals exposed to LAGEVRIO during pregnancy. The prescribing healthcare provider must document that a pregnant individual was made aware of the pregnancy registry at https://covid-pr.pregistry.com or 1-800-616-3791. Pregnant individuals exposed to LAGEVRIO or their healthcare providers can also report the exposure by contacting Merck Sharp & Dohme LLC, Rahway, NJ, USA at 1-877-888-4231. Advise individuals of childbearing potential of the potential risk to a fetus and to use an effective method of contraception correctly and consistently during treatment with LAGEVRIO and for 4 days after the final dose. Prior to initiating treatment with LAGEVRIO, assess whether an individual of childbearing potential is pregnant or not, if clinically indicated. Hypersensitivity reactions, including anaphylaxis, have been reported with LAGEVRIO. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue LAGEVRIO and initiate appropriate medications and/or supportive care. LAGEVRIO is not authorized for use in patients less than 18 years of age because it may affect bone and cartilage growth. The safety and efficacy of LAGEVRIO have not been established in pediatric patients. Adverse Reactions The most common adverse reactions occurring in ≥1% of subjects in the LAGEVRIO treatment group in the Phase 3 double-blind MOVe-OUT study were diarrhea (2% versus placebo at 2%), nausea (1% versus placebo at 1%), and dizziness (1% versus placebo at 1%) all of which were Grade 1 (mild) or Grade 2 (moderate). Serious adverse events occurred in 7% of subjects receiving LAGEVRIO and 10% receiving placebo; most serious adverse events were COVID-19 related. Adverse events leading to death occurred in 2 (<1%) of the subjects receiving LAGEVRIO and 12 (2%) of subjects receiving placebo. Drug Interactions No drug interactions have been identified based on the limited available data on the emergency use of LAGEVRIO. No clinical drug-drug interaction trials of LAGEVRIO with concomitant medications, including other treatments for mild-to-moderate COVID-19, have been conducted. Pregnancy/Breastfeeding There are no data on the presence of molnupiravir or its metabolites in human milk. It is unknown whether molnupiravir has an effect on the breastfed infant or effects on milk production. Based on the potential for adverse reactions in the infant from LAGEVRIO, breastfeeding is not recommended during treatment with LAGEVRIO and for 4 days after the final dose. A lactating individual may consider interrupting breastfeeding and may consider pumping and discarding breast milk during treatment and for 4 days after the last dose of LAGEVRIO. Males of Reproductive Potential While the risk is regarded as low, there is a theoretical risk for LAGEVRIO to affect offspring of treated males based on its mechanism of action. Advise sexually active individuals with partners of childbearing potential to use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose of LAGEVRIO. The risk beyond three months after the last dose of LAGEVRIO is unknown. Required Reporting for Serious Adverse Events and Medication Errors The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all serious adverse events and medication errors potentially related to LAGEVRIO within 7 calendar days from the healthcare provider’s awareness of the event. Submit adverse event and medication error reports, using FDA Form 3500, to FDA MedWatch using one of the following methods: Complete and submit the report online: www.fda.gov/medwatch/report.htm Complete and submit a postage-paid FDA Form 3500 ( https://www.fda.gov/media/76299/download ) and return by: Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or Fax to 1-800-FDA-0178, or Call 1-800-FDA-1088 to request a reporting form In addition, please provide a copy of all FDA MedWatch forms to: Merck Sharp & Dohme LLC, Rahway, NJ, USA by: Fax: 215-616-5677 Email: dpoc.usa@merck.com Indications for PREVYMIS® (letermovir) PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). PREVYMIS is indicated for prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]). Selected Safety Information for PREVYMIS Contraindications PREVYMIS is contraindicated in patients receiving pimozide or ergot alkaloids. Increased pimozide concentrations may lead to QT prolongation and torsades de pointes. Increased ergot alkaloids concentrations may lead to ergotism. PREVYMIS is contraindicated with pitavastatin and simvastatin when co-administered with cyclosporine. Significantly increased pitavastatin or simvastatin concentrations may lead to myopathy or rhabdomyolysis. Warnings and Precautions The concomitant use of PREVYMIS and certain drugs may result in potentially significant drug interactions, some of which may lead to adverse reactions (PREVYMIS or concomitant drugs) or reduced therapeutic effect of PREVYMIS or the concomitant drug. Intravenous formulation of PREVYMIS contains the excipient hydroxypropyl betadex. PREVYMIS injection should be used only in patients unable to take oral therapy and patients should be switched to oral PREVYMIS as soon as they are able to take oral medications. If possible, intravenous administration should not exceed 4 weeks. In patients with renal impairment, accumulation of hydroxypropyl betadex may occur. In adult patients with CLcr less than 50 mL/min and in pediatric patients with a similar degree of renal impairment (based on age-appropriate assessment of renal function) receiving PREVYMIS injection, closely monitor serum creatinine levels. Animal studies have shown the potential for hydroxypropyl betadex to cause ototoxicity. The active ingredient, letermovir, is not known to be associated with ototoxicity. Adverse Reactions The rate of adverse events occurring in at least 10% of adult HSCT recipients treated with PREVYMIS and at a frequency at least 2% greater than placebo were nausea (27% vs 23%), diarrhea (26% vs 24%), vomiting (19% vs 14%), peripheral edema (14% vs 9%), cough (14% vs 10%), headache (14% vs 9%), fatigue (13% vs 11%), and abdominal pain (12% vs 9%). Hypersensitivity reaction, with associated moderate dyspnea, occurred in one adult HSCT recipient following the first infusion of IV PREVYMIS after switching from oral PREVYMIS, leading to treatment discontinuation. The most common adverse event occurring in at least 10% of adult kidney transplant recipients treated with PREVYMIS and at a frequency greater than valganciclovir was diarrhea (32% vs 29%). The safety profile of PREVYMIS in pediatric subjects was consistent with the safety profile observed in clinical trials of PREVYMIS in adults. Drug Interactions If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily in adult and pediatric patients 12 years of age and older. If PREVYMIS is co-administered with cyclosporine in pediatric patients less than 12 years of age, dose adjustment may be required. Co-administration of PREVYMIS may alter the plasma concentrations of other drugs and other drugs may alter the plasma concentrations of PREVYMIS. Consult the full Prescribing Information prior to and during treatment for potential drug interactions. Closely monitor serum creatinine levels in patients with CLcr less than 50 mL/min using PREVYMIS injection. PREVYMIS is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment. Use in Specific Populations The safety and effectiveness of PREVYMIS have not been established for: HSCT recipients less than 6 months of age or weighing less than 6 kg, or Kidney transplant recipients less than 12 years of age or weighing less than 40 kg. For patients with creatinine clearance (CLcr) greater than 10 mL/min (by Cockcroft-Gault equation), no dosage adjustment of PREVYMIS is required based on renal impairment. The safety of PREVYMIS in patients with end-stage renal disease (CLcr less than 10 mL/min), including patients on dialysis, is unknown. Following the completion of PREVYMIS prophylaxis, monitoring for CMV reactivation in HSCT recipients is recommended. Indications and usage for RECARBRIO™ (imipenem, cilastatin, and relebactam) RECARBRIO is indicated for the treatment of patients 18 years of age and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible gram-negative microorganisms: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens . RECARBRIO is indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae , and Pseudomonas aeruginosa . RECARBRIO is indicated in patients 18 years of age and older who have limited or no alternative treatment options for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible gram-negative microorganisms: Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Fusobacterium nucleatum, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Parabacteroides distasonis , and Pseudomonas aeruginosa . Approval of the cUTI and cIAI indications is based on limited clinical safety and efficacy data for RECARBRIO. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of RECARBRIO and other antibacterial drugs, RECARBRIO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Selected Safety Information for RECARBRIO Hypersensitivity Reactions : RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity (severe systemic allergic reaction such as anaphylaxis) to any component of RECARBRIO. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. Before initiating therapy with RECARBRIO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta-lactams, and other allergens. If a hypersensitivity reaction to RECARBRIO occurs, discontinue the therapy immediately. Seizures and Other Central Nervous System (CNS) Adverse Reactions : CNS adverse reactions, such as seizures, confusional states, and myoclonic activity, have been reported during treatment with imipenem/cilastatin, a component of RECARBRIO, especially when recommended dosages of imipenem were exceeded. These have been reported most commonly in patients with CNS disorders (eg, brain lesions or history of seizures) and/or compromised renal function. Anticonvulsant therapy should be continued in patients with known seizure disorders. If CNS adverse reactions including seizures occur, patients should undergo a neurological evaluation to determine whether RECARBRIO should be discontinued. Increased Seizure Potential Due to Interaction with Valproic Acid : Concomitant use of RECARBRIO, with valproic acid or divalproex sodium may increase the risk of breakthrough seizures. Avoid concomitant use of RECARBRIO with valproic acid or divalproex sodium or consider alternative antibacterial drugs other than carbapenems. Clostridioides difficile –Associated Diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including RECARBRIO, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C difficile may need to be discontinued. Development of Drug-Resistant Bacteria : Prescribing RECARBRIO in the absence of a proven or strongly suspected bacterial infection or 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 frequently reported adverse reactions occurring in ≥5% of HABP/VABP patients treated with RECARBRIO were aspartate aminotransferase increased (11.7%), anemia (10.5%), alanine aminotransferase increased (9.8%), diarrhea (7.9%), hypokalemia (7.9%), and hyponatremia (6.4%). The most frequently reported adverse reactions occurring in ≥2% of cUTI and cIAI patients treated with RECARBRIO were diarrhea (6%), nausea (6%), headache (4%), vomiting (3%), alanine aminotransferase increased (3%), aspartate aminotransferase increased (3%), phlebitis/infusion site reactions (2%), pyrexia (2%), and hypertension (2%). Indications and usage for ZERBAXA® (ceftolozane and tazobactam) ZERBAXA is indicated for the treatment of adult patients (18 years and older) with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa , and Serratia marcescens . ZERBAXA is indicated for the treatment of adult and pediatric patients (birth to less than 18 years old) with complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis , and Pseudomonas aeruginosa . ZERBAXA used in combination with metronidazole is indicated for the treatment of adult and pediatric patients (birth to less than 18 years old) with complicated intra-abdominal infections (cIAI) caused by the following susceptible Gram-negative and Gram-positive microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus , and Streptococcus salivarius . Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Important Safety Information for ZERBAXA Patients with renal impairment : Decreased efficacy of ZERBAXA has been observed in patients with baseline CrCl of 30 to <50 mL/min. In a clinical trial of adult patients, patients with cIAIs with CrCl >50 mL/min had a clinical cure rate of 85.2% when treated with ZERBAXA plus metronidazole vs 87.9% when treated with meropenem. In the same trial, patients with CrCl 30 to <50 mL/min had a clinical cure rate of 47.8% when treated with ZERBAXA plus metronidazole vs 69.2% when treated with meropenem. A similar trend was also seen in the cUTI trial. Dose adjustment is required for adult patients with CrCl 50 mL/min or less. All doses of ZERBAXA are administered over 1 hour. Monitor CrCl at least daily in patients with changing renal function and adjust the dose of ZERBAXA accordingly. Hypersensitivity : ZERBAXA is contraindicated in patients with known serious hypersensitivity to the components of ZERBAXA (ceftolozane/tazobactam), piperacillin/tazobactam, or other members of the beta-lactam class. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials. Before initiating therapy with ZERBAXA, make careful inquiry about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactams. If an anaphylactic reaction to ZERBAXA occurs, discontinue use and institute appropriate therapy. Clostridioides difficile -associated diarrhea (CDAD) , ranging from mild diarrhea to fatal colitis, has been reported with nearly all systemic antibacterial agents, including ZERBAXA. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is confirmed, antibacterial use not directed against C. difficile should be discontinued, if possible. Development of drug-resistant bacteria : Prescribing ZERBAXA in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria. Adverse reactions in adult patients with HABP/VABP : The most common adverse reactions occurring in ≥5% of adult patients receiving ZERBAXA in the HABP/VABP trial were hepatic transaminase increased (11.9%), renal impairment/renal failure (8.9%), and diarrhea (6.4%). Adverse reactions in adult patients with cIAI or cUTI : The most common adverse reactions occurring in ≥5% of adult patients receiving ZERBAXA in the cUTI and cIAI trials were headache (5.8%) in the cUTI trial, and nausea (7.9%), diarrhea (6.2%), and pyrexia (5.6%) in the cIAI trial. Adverse reactions in pediatric patients with cIAI or cUTI : The most common adverse reactions occurring in ≥7% of pediatric patients receiving ZERBAXA in the cIAI trial were diarrhea (17%), thrombocytosis (16%), pyrexia (13%), abdominal pain (11%), vomiting (10%), increased aspartate aminotransferase (7%), and anemia (7%). The most common adverse reactions occurring in ≥7% of pediatric patients receiving ZERBAXA in the cUTI trial were thrombocytosis (9%), leukopenia (8%), diarrhea (7%), and pyrexia (7%). Pediatric Use : There is insufficient information to recommend dosage adjustment for pediatric patients younger than 18 years of age with cIAI and cUTI with eGFR 50 mL/min/1.73m2 or less. ZERBAXA is not recommended in pediatric patients who have an eGFR 50 mL/min/1.73m2 or less. Pediatric patients born at term or pre-term may not have an eGFR of 50 mL/min/1.73m2 or greater at birth or within the first few months of life. 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Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). Please see Prescribing Information for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) at https://www-merck-com.libproxy1.nus.edu.sg/product/usa/pi_circulars/c/capvaxive/capvaxive_pi.pdf and Patient Information/Medication Guide for CAPVAXIVE at https://www-merck-com.libproxy1.nus.edu.sg/product/usa/pi_circulars/c/capvaxive/capvaxive_ppi.pdf Before prescribing LAGEVRIO (molnupiravir) please read the Fact Sheet for Healthcare Providers, including Mandatory Requirements for Administration of Molnupiravir under Emergency Use Authorization, at https://www-merck-com.libproxy1.nus.edu.sg/eua/molnupiravir-hcp-fact-sheet.pdf and Fact Sheet for Patients and Caregivers at https://www-merck-com.libproxy1.nus.edu.sg/eua/molnupiravir-patient-fact-sheet-english.pdf Please see Prescribing Information for PREVYMIS (letermovir) at https://www-merck-com.libproxy1.nus.edu.sg/product/usa/pi_circulars/p/prevymis/prevymis_pi.pdf , Patient Information/Medication Guide for PREVYMIS at https://www-merck-com.libproxy1.nus.edu.sg/product/usa/pi_circulars/p/prevymis/prevymis_ppi.pdf and Instructions for Use for PREVYMIS at https://www-merck-com.libproxy1.nus.edu.sg/product/usa/pi_circulars/p/prevymis/prevymis_ifu.pdf Please see Prescribing Information for RECARBRIO (imipenem, cilastatin, and relebactam) at https://www-merck-com.libproxy1.nus.edu.sg/product/usa/pi_circulars/r/recarbrio/recarbrio_pi.pdf Please see Prescribing Information for ZERBAXA (ceftolozane and tazobactam) at https://www-merck-com.libproxy1.nus.edu.sg/product/usa/pi_circulars/z/zerbaxa/zerbaxa_pi.pdf Media Contacts: Julie Cunningham (617) 519-6264 Courtney Ronaldo (908) 442-5695 Investor Contacts: Peter Dannenbaum (732) 594-1579 Alexis Constantine (732) 594-1578 Source: Merck & Co., Inc.

深度聚焦多肽、多肽偶联药物研发、质控、工艺开发，展位咨询&免费入场券：联系电话181 1603 6798，扫码立即获取免费入场券： 文章来源：多肽圈 ｜中肽生化内容团队编辑 根据2024年4月15日的市值排行榜，全球前十名的生物制药公司所拥有的多肽/拟肽资产如下： 01 礼来（7146.3亿美元） Tirzepatide ·   Mounjaro (tirzepatide)：2型糖尿病，2022年5月13日获批 ·   Zepbound (tirzepatide)：肥胖症，2023年11月8日获批 ·   Forteo (Teriparatide)：骨质疏松症，2022年11月26日获批 Teriparatide 02 诺和诺德（5645.6亿美元） Semaglutide ·   Wegovy (semaglutide)：肥胖症，2021年6月4日获批 ·   Rybelsus (semaglutide)：2型糖尿病（口服），2019年9月20日获批 ·   Ozempic (semaglutide)：2型糖尿病，2017年12月5日获批 ·   Victoza (liraglutide)：2型糖尿病，2010年1月25日获批 ·   Saxenda (liraglutide)：肥胖症，2014年12月23日获批 Liraglutide 03 强生（3554.9亿美元） 无上市多肽资产 04 默沙东（3185.0亿美元） ·   CANCIDAS® (caspofungin acetate，环肽): 棘白菌素类抗真菌药物，针对对其他抗真菌药物难治或不耐受的侵袭性曲霉菌病成人患者，2001年1月26日获批。 caspofungin ·   CUBICIN® (daptomycin for injection，环肽)：脂肽抗生素，用于治疗由革兰氏阳性菌引起的全身性和危及生命的感染，2023年9月12日获批。 Daptomycin ·   ZEPATIER（Grazoprevir环肽+ elbasvir）: 丙型肝炎，第二代丙型肝炎病毒蛋白酶抑制剂，2016年1月28日获批。 ·   ZERBAXA (ceftolozane环肽 and tazobactam)：复方抗生素药物，用于治疗成人复杂性尿路感染和复杂性腹腔内感染。Ceftolozane 是一种头孢菌素抗生素（β-内酰胺类），开发用于治疗对常规抗生素耐药的革兰氏阴性菌感染。2014年12月19日获批。 ceftolozane 05 艾伯维（2873.4亿美元） 无上市多肽药物 06 阿斯利康（2137.1亿美元） ·   Zoladex (goserelin acetate implant)：用于抑制性激素（睾酮和雌激素）产生的药物，用于乳腺癌和前列腺癌的治疗。它是一种可注射的促性腺激素释放激素激动剂（GnRH 激动剂）。1989年12月29日获批。 Goserelin ·   Bydureon (exenatide)：2型糖尿病。2012年1月27日获批。 ·   Byetta (exenatide injection)：2型糖尿病。2005年4月28日获批。 exenatide ·   Symlin (pramlintide acetate)：用于治疗糖尿病（1 型和 2 型）的注射胰淀素类似物药物。2005年3月16日获批。 ·   Zestril (lisinopril dihydrate)：血管张力素转化酶抑制剂（ACE抑制剂）药物，用于治疗高血压、心脏衰竭和心肌梗塞。2003年1月7日获批。 Lisinopril ·   ARGATROBAN (argatroban injection, solution)：直接凝血酶抑制剂，用于预防或治疗肝素诱导的血小板减少症（HIT）患者的血栓形成。2000年6月30日获批。 Argatroban 07 罗氏（1986.6亿美元） 无上市多肽药物 08 诺华（1934亿美元） ·   Cibacen® (benazepril hydrochloride)：治疗高血压、心力衰竭和糖尿病肾病，1999年6月16日获批。 Benazepril ·   Locametz (gallium Ga 68 gozetotide)：放射性药物，由与前列腺特异性膜抗原 (PSMA) 靶向配体 Glu-Urea-Lys(Ahx)-HBED-CC缀合的 68Ga 制成，用于通过正电子发射断层扫描 (PET) 对前列腺癌进行成像。2022年3月23日获批。 Gallium Ga 68 gozetotide（图片来源：Wikipedia） ·   Lutathera (lutetium Lu 177 dotatate, 环肽): 镥元素放射性同位素与 DOTA-TATE 的螯合复合物，用于肽受体放射性核素治疗 (PRRT)。用于治疗患有胃肠胰神经内分泌肿瘤 (GEP-NET) 的成人癌症，这些肿瘤对激素受体生长抑素呈阳性。2018年1月26日获批。 Lutetium Lu 177 dotatate（图片来源：Wikipedia） ·   Neoral/Sandimmune (cyclosporine环肽, USP Modified): 强效免疫抑制剂，用于治疗类风湿性关节炎、狼疮、牛皮癣和其他自身免疫性疾病。1995年7月获批。 Cyclosporine A ·   NETSPOT (gallium Ga 68 dotatate injection)：Ga 68 dotatate 注射液与 PET 扫描（正电子发射断层扫描）结合使用，可定位成人和儿童的生长抑素受体阳性神经内分泌肿瘤 (NET)。 ·   Pluvicto (lutetium Lu 177 vipivotide tetraxetan)：用于接受了雄激素受体 (AR) 途径抑制和紫杉醇类化疗治疗的成年患者，患有前列腺特异性膜抗原（PSMA）阳性的转移性去势抵抗性前列腺癌（mCRPC）。 lutetium Lu 177 vipivotide tetraxetan（图片来源：Wikipedia） ·   Sandostatin (octreotide acetate环肽): 用于治疗产生生长激素的肿瘤 (例如肢端肥大症和巨人症)。1998年11月25日获批。 Octreotide 09 辉瑞（1463.3亿美元） ·   ACCUPRIL (quinapril HCI) ·   ACCURETIC® (quinapril HCl/hydrochlorothiazide)：Quinapril用于治疗高血压、心力衰竭和糖尿病肾病。它是高血压的一线治疗方法。 Quinapril ·   ALTACE (ramipril)：Ramipril是一种 ACE 抑制剂类药物，用于治疗高血压、心力衰竭和糖尿病肾病。它还可以用作 55 岁以上患者的预防药物，以降低高危患者（例如一些糖尿病患者和血管疾病患者）心脏病发作、中风或心血管死亡的风险。 Ramipril ·   AMPICILLIN FOR INJECTION (Ampicillin Sodium)：Ampicillin是一种抗生素，属于青霉素家族的氨基青霉素类。用于预防和治疗多种细菌感染，如呼吸道感染、尿路感染、脑膜炎、沙门氏菌病和心内膜炎。它还可用于预防新生儿 B 族链球菌感染。它可以口服、肌肉注射或静脉注射。 Ampicillin ·   BIVALIRUDIN (bivalirudin)：比伐卢定（Bivalirudin）是一种特异性、可逆的直接凝血酶抑制剂 (DTI)。它是天然药物水蛭素的合成同系物，水蛭素存在于药用水蛭的唾液中。它是一种短肽，是一种有效且高度特异性的凝血酶抑制剂，可抑制循环凝血酶和凝块结合凝血酶，同时还抑制凝血酶介导的血小板活化和聚集。用于治疗肝素诱导的血小板减少症并预防经皮冠状动脉介入治疗期间的血栓形成。 ·   BLEOMYCIN：Bleomycin（博来霉素）是一种来自轮枝链霉菌的相关糖肽抗生素复合物。适应症包括霍奇金淋巴瘤、非霍奇金淋巴瘤、睾丸癌、卵巢癌和宫颈癌等。通常与其他癌症药物一起使用，通过肌肉注射、皮下注射或静脉注射。它抑制 DNA 代谢并用作抗肿瘤药物，尤其是实体瘤。 Bleomycin ·   CEFAZOLIN (cefazolin)：头孢唑林（Cefazolin）是一种用于治疗多种病原细菌的抗细菌药，尤其针对蜂窝组织炎、泌尿道感染、肺炎、心内膜炎、败血性关节炎及胆道发炎等疾病，也可用来预防手术前或手术中B群链球菌感染。 Cefazolin ·   CEFEPIME (Cefepime) ·   MAXIPIME (cefepime hydrochloride)：Cefepime（头孢吡肟）是第四代头孢菌素类抗生素。头孢吡肟对革兰氏阳性菌和革兰氏阴性菌具有更广泛的活性，比第三代药物对这两种类型的生物体的活性更强。 Cefepime ·   CEFOBID (cefoperazone sodium)：cefoperazone（头孢哌酮）是第三代头孢菌素抗生素。它是少数能有效治疗对这些抗生素耐药的假单胞菌感染的头孢菌素抗生素之一。 Cefoperazone ·   CEFTRIAXONE (ceftriaxone)：头孢曲松（ceftriaxone）是一种第三代头孢菌素抗生素，用于治疗多种细菌感染，包括中耳感染、心内膜炎、脑膜炎、肺炎、骨和关节感染、腹内感染、皮肤感染、尿路感染、淋病和盆腔炎。 ceftriaxone ·   CORTISPORIN (neomycin and polymyxin B sulfates, and hydrocortisone acetate)：新霉素/多粘菌素 B/氢化可的松以 Otosporin 品牌销售，是一种用于治疗外耳炎和某些眼部疾病的药物。 Polymyxin B  (多粘菌素 B，环肽) 可以单独以Poly-Rx 等商品名出售，是一种用于治疗脑膜炎、肺炎、败血症和尿路感染的抗生素。虽然它对许多革兰氏阴性感染有用，但对革兰氏阳性感染没有用。Polymyxin B由Polymyxin B1和B2两种环肽组成。 Polymyxin B1（左）和Polymyxin B2（右） ·   NEOSPORIN G.U. Irrigant (neomycin sulfate – polymyxin B sulfate) ·   NEOSPORIN Ophthalmic Solution (neomycin and polymyxin B sulfates, and gramicidin)：新孢菌素滴眼液由新霉素/多粘菌素B/杆菌肽组成，适用于局部治疗敏感细菌引起的外眼及其附件的浅表感染。此类感染包括结膜炎、角膜炎和角结膜炎、睑缘炎和睑结膜炎。 杆菌肽（gramicidin），也称为杆菌肽 D，是离子载体抗生素杆菌肽 A、B 和 C 的混合物，分别占混合物的 80%、5% 和 15%。每种都有 2 种isomer，因此混合物有 6 种不同类型的杆菌肽分子。它们可以从短芽孢杆菌土壤细菌中提取。杆菌肽是含有 15 个氨基酸的线性肽，不同于不相关的杆菌肽 S，后者是一种环肽。 ·   DAPTOMYCIN (daptomycin，环肽)：达托霉素（Daptomycin）是一种脂肽抗生素，用于治疗由革兰氏阳性菌引起的全身性和危及生命的感染。 Daptomycin ·   ENALAPRILAT (enalaprilat)：Enalaprilat (依那普利拉) 是enalapril (依那普利) 的活性代谢物。它是ACE 抑制剂，是一种抗高血压药，用于在口服治疗不可行时治疗高血压。 Enalapril和Enalaprilat ·   ERAXIS (anidulafungin，环肽)：Anidulafungin（阿尼芬净）是一种半合成棘白菌素，用作抗真菌药物。当与伏立康唑联合使用时，它还可能用于治疗侵袭性曲霉菌感染。它是棘白菌素类抗真菌药物的一员。其作用机制是抑制 (1→3)-β-D-葡聚糖合酶，后者是一种对真菌细胞壁合成很重要的酶。 Anidulafungin ·   PAXLOVID (nirmatrelvir and ritonavir)：Paxlovid是由nirmatrelvir和ritonavir两种成分组成的抗SARS-Cov-2病毒口服药，其中nirmatrelvir是活性成分，为拟肽分子，是3C 样蛋白酶抑制剂。 Nirmatrelvir ·   PIPERACILLIN AND TAZOBACTAM (piperacillin and tazobactam)：Piperacillin (哌拉西林)和tazobactam (他唑巴坦) 联合疗法用于治疗身体许多不同部位（例如胃或肠、肺、皮肤、女性生殖器官）的细菌感染。 哌拉西林和他唑巴坦组合是抗生素，属于青霉素和 β-内酰胺酶抑制剂药物组。 Piperacillin ·   SYNAREL (nafarelin acetate)：Nafarelin是一种促性腺激素释放激素激动剂（GnRH 激动剂）药物，用于治疗子宫内膜异位症和青春期早期。它还用于治疗子宫肌瘤、控制体外受精 (IVF) 中的卵巢刺激，以及作为变性激素治疗的一部分。 Nafarelin ·   SYNERCID I.V. (quinupristin环肽/dalfopristin)：Synercid I.V.（奎奴普丁和达福普丁）是一种复方抗生素，用于治疗血液和其他身体系统的严重感染。 Quinupristin ·   TAZICEF (ceftazidime)：头孢他啶（ceftazidime）是第三代的头孢菌素抗生素。 ceftazidime ·   Vancomycin Hydrochloride：盐酸万古霉素是一种抗菌处方药，用于治疗某些细菌感染，例如由艰难梭菌和金黄色葡萄球菌引起的感染。 艰难梭菌和金黄色葡萄球菌是可引起 HIV 机会性感染 (OIs) 的细菌。OIs是一种与免疫系统健康的人相比，拥有较弱免疫系统的人（例如艾滋病毒感染者）发生的频率更高或更严重的感染。 10 安进（1432.4亿美元） ·   Kyprolis (carfilzomib)：Carfilzomib是一种选择性蛋白酶体抑制剂的抗癌药物。 Carfilzomib ·   Parsabiv (Etelcalcetide)：Etelcalcetide是一种拟钙药物，用于治疗血液透析患者的继发性甲状旁腺功能亢进症。Etelcalcetide 通过结合并激活甲状旁腺中的钙敏感受体发挥作用。 Etelcalcetide END 免责声明：本文信息来源于网络，本文仅作知识交流与分享及科普目的，不涉及商业宣传，不作为相关医疗指导或用药建议。文章如有侵权请联系删除。 深度聚焦多肽、多肽偶联药物研发、质控、工艺开发，7月相约苏州，联系电话18116036798上下滑动查看议程 7月25日上午：主会场 多肽药物蓝海布局 9:00-9:30 李学臣，香港大学化学系理学院副院长 多肽药物和蛋白偶联的新策略 9:00-9:30 王珠银，深圳肽盛生物科技有限公司董事长 3D结构多肽库的构建和靶向穿膜肽筛选 9:30-10:00 马亚平，深创生物董事长 靶向核素药物研究与开发 10:30-10:50 茶歇&交流 10:50-11:20 徐寒梅，中国药科大学教授；南京安吉生物科技有限公司创始人 新靶点多肽药物发现及PDC药物研究进展 11:20-11:50 钱海，中国药科大学理学院院长兼药物科学研究院新药研究中心主任 话题确认中 11:50-12:20 圆桌讨论：多肽药物脱颖而出的关键、未来如何保持高热度、内卷何时到来？ 刘东舟，华东医药首席科学官/创新药全球研发中心总经理 容明强，成都佩德生物医药有限公司董事长 马亚平，深创生物董事长 王珠银，深圳肽盛生物科技有限公司董事长 邵军，同宜医药（苏州）有限公司首席技术官 部分嘉宾确认中 12:20-14:00 午餐&休息 7月25日下午：论坛一 多肽药物研发进展 14:00-14:30 周建伟，南京医科大学教授/南京明人医药科技有限公司创始人 基于JWA基因的多肽创新药研究 14:30-15:00 容明强，成都佩德生物医药有限公司董事长 基于生存策略的动物毒素多肽新药开发 15:00-15:30 江苏万略医药科技有限公司 话题确认中 15:30-15:50 茶歇&交流 15:50-16:20 韩俊峰，上海贺普药业股份有限公司总裁 贺普拉肽研究进展 16:20-16:50 方小翠,国家纳米科学中心,高级工程师 肿瘤免疫治疗用靶向溶瘤多肽的药物转化 16:50-17:20 张晓君，石药集团北京研究院制剂四所所长 多肽药物长效递送研发进展 7月25日下午：论坛二 多肽药物质控与生产 14:00-14:30 邵军，同宜医药（苏州）有限公司首席技术官 多肽类药物工艺与质量控制要点 14:30-15:00 姜建军，江苏诺泰澳赛诺生物制药有限公司，多肽事业部总经理/集团副总经理/研究院副院长 多肽药物合成新工艺 15:00-15:30 大西 弘晃，三菱化学株式会社 Purification of Cyclic Peptide and Its Analogues with Polymeric Separation Media 15:30-15:50 茶歇&交流 15:50-16:20 李子刚，北京大学深圳研究生院，化学生物学与生物技术学院执行院长/深圳湾实验室，坪山生物医药研发转化中心主任 新颖稳定多肽方法学开发及其在多肽药物开发中的应用 16:20-16:50 苏贤斌，南京工业大学教授、博士生导师 连续流动绿色多肽合成（拟定） 16:50-17:20 刁星星，中国科学院上海药物研究所研究员，课题组长/苏州锐迪欧医药科技有限公司创始人 新类型药物PDC LN005体外、体内代谢研究策略 7月26日上午：论坛一 多肽药物研发进展 9:00-9:30 陈小新，广东众生睿创生物科技有限公司联合创始人、董事、总裁 基于GLP-1的单分子多重受体激动剂治疗肥胖和NASH的研究进展 9:30-10:00 谢天，甘李药业股份有限公司，医学事务部负责人 GLP-1研发的挑战与布局 10:00-10:30 温晓芳，浙江道尔生物科技有限公司副总裁 GLP-1/GCG/FGF-21三靶点激动剂在NASH中的临床前开发 10:30-10:50   茶歇&交流 10:50-11:20 景书谦，鸿运华宁（杭州）生物医药有限公司 创始人、董事长兼首席执行官 GLP药物研发进展及商业化前景 11:20-11:50 夏帅，复旦大学基础医学院青年研究员 广谱抗冠状病毒多肽类融合抑制剂的研究 11:50-14:00   午餐&休息 14:00-14:30 张传亮，青岛科技大学化工学院，副教授 长效降糖减重药物的差异化开发：基于BH3模拟肽的PTP1B/TC-PTP抑制剂/降解剂的设计与研发 14:30-15:00 韩智豪，中国药科大学特聘副研究员，硕士生导师 基于仿生多肽的放射性药物研究 15:00-15:30 杨浩哲，香港交易所，环球上市服务部助理副总裁 香港交易所助力医药企业融资上市 7月26日上午：论坛二 多肽药物质控与生产 9:00-9:30 丁伟，南京知和医药科技有限公司副总，多肽首席科学家 多肽药物质量研究中的常见问题与解决方案 9:30-10:00 刘磊，江苏大学材料科学与工程学院副院长 多肽基功能生物界面用于肿瘤细胞的捕获与分离 10:00-10:30 曹宇，重庆派金生物科技有限公司生产总监 长效胰岛素结构相关杂质控制和表征 10:30-10:50   茶歇&交流 10:50-11:20 赵军锋，广州医科大学教授 无保护氨基酸合成多肽 11:20-11:50 郭建，上海胜普泽泰医药科技有限公司副总裁 多肽偶联药物CMC要点分享 11:50-14:00   午餐&休息 7月26日下午：论坛二 PDC药物研发 14:00-14:30 张普文，浙江汉鼎医药有限公司总经理 多肽糖胺聚糖等新型PDC药物的研发 14:30-15:00 张富尧，上海弼领生物创始人、董事长&CEO 纳米PDC：用于药物高效递送的纳米列车 15:00-15:30 马步勇，上海交通大学药学院教授 蛋白质动态结构的AI预测与应用 15:30-16:00 朱勍，浙江工业大学，生物制药与生物材料研究所所长 C-C键环肽及其偶联药物新进展 戳“阅读原文”立即报名多肽药物论坛吧!