Mitotane

Other key data to be presented from ViiV Healthcare’s innovative pipeline and portfolio include the exploration of different mechanisms of action through broadly neutralising antibodies as well as real-world insights from established long-acting and 2-drug regimens LONDON--(BUSINESS WIRE)-- ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of 64 abstracts that includes highlights of the company’s next-generation pipeline advancements, alongside data from its diverse portfolio of marketed HIV treatment and prevention options at the Conference on Retroviruses and Opportunistic Infections (CROI 2024) being held in Denver, Colorado, from 3 – 6 March 2024. Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “As leaders in developing long-acting injectables for the treatment of HIV, we’re excited to present new data setting the stage for ViiV’s next generation of medicines and demonstrating how key pipeline assets will target HIV in different ways. These findings, as well as the breadth of data we’ll present on our marketed products, including new interim results from the LATITUDE study, reflect a portfolio and future-looking pipeline focused on ending the HIV epidemic. We look forward to sharing them with the scientific and HIV communities at CROI 2024.” Key abstracts to be presented at CROI 2024 by ViiV Healthcare and its study partners will include: Data introducing our next generation of potential ultra long-acting medicines for HIV: ViiV Healthcare will share findings from a phase I study evaluating different formulations of cabotegravir and their potential for dosing every four months. The ongoing, open-label, single-dose, dose-escalation phase I study in 70 healthy adults assessed both the 200 mg/mL formulation of cabotegravir in combination with recombinant human hyaluronidase PH20 (rHuPH20), as well as a new formulation of cabotegravir (CAB ULA) administered by itself.1 Researchers will share safety and pharmacokinetic findings from both ultra long-acting approaches and their potential for future clinical development. Findings advancing different mechanisms of action in HIV research: New phase IIa findings from the BANNER study of VH3810109 (N6LS), an investigational, broadly neutralising antibody (bNAb), will be presented. Researchers will share findings of the bNAb administered intravenously and the first efficacy findings of its subcutaneous administration.2 Findings from the SPAN study of N6LS, examining the safety and tolerability of the highest subcutaneous and intravenous N6LS doses administered to date, with and without PH20, will also be presented.3 Additionally, efficacy and safety data from a non-ViiV owned bNAb asset, VRC07-523LS, in a phase II, open-label clinical trial used in combination with long-acting CAB for maintenance antiretroviral therapy (ART) will be presented.4 New data on long-acting therapy vs daily oral standard of care, in traditionally non-adherent populations: Interim analysis of the LATITUDE phase III trial will be presented showing that, the injectable antiretroviral treatment for HIV, Cabenuva (cabotegravir and rilpivirine [CAB+RPV LA]), demonstrates superior efficacy compared to daily oral standard of care (SOC) in individuals with a history of antiretroviral adherence challenges. The NIAID/ACTG also announced a modification to the study, where further randomisation has been stopped and participants in the SOC arm are being given the option to switch to the long-acting therapy arm.5 Real-world evidence from across our treatment and prevention portfolios: New findings from SEARCH, a randomised study evaluating the real-world impact of the inclusion of long-acting cabotegravir for PrEP in an HIV prevention coverage package compared to the standard-of-care of oral PrEP and PEP alone in rural Uganda and Kenya, will also be presented.6 Real-world evidence findings for the complete long-acting HIV treatment regimen Cabenuva will be presented from the OPERA cohort examining ART-experienced, virally suppressed adults living with HIV who switched to CAB+RPV LA or to an oral regimen.7 Findings for the 2-drug regimen, Dovato (dolutegravir, lamivudine [DTG/3TC]), will include the InfCare HIV study, which presents three-year switch data, from 3-drug regimen to Dovato, in a long-term real-world Swedish cohort.8 This study adds to the body of real-world evidence to date that includes more than 40,000 people living with HIV.9 Here is a list of ViiV Healthcare-sponsored or supported studies to be presented at CROI 2024: Title First Author Presentation Number Presentation Dolutegravir A single once-daily ABC/DTG/3TC tablet predicts safe and effective exposures in children 3 to <6kg H. Chandasana 02770 Poster Tuesday, March 5 2:30-4:00pm MST Population pharmacokinetics of ABC/DTG/3TC FDC to support dosing in peds with HIV-1 (IMPAACT 2019) H. Chandasana 03110 Poster Tuesday, March 5:30-4:00pm MST Dolutegravir and growth in pediatric populations with HIV-1: IMPAACT P1093 and IMPAACT 2019 M. McKenna 01783 Poster Tuesday, March 5 2:30-4:00pm MST Switching to DTG+3TC vs 3-drug regimens in routine clinical care: long-term Swedish data E. Sörstedt 01838 Poster Tuesday, March 5 2:30-4:00pm MST Temporal trends of cardiovascular disease incidence in people with HIV from 2001-2021 N. Jaschinski 02263 Poster Tuesday, March 5 2:30-4:00pm MST Increased cancer risk with low CD4 counts persists despite over 2 years of virological suppression J. Hoy 01462 Poster Wednesday, March 6 2:30-4:00pm MST Cabotegravir for Treatment Long-acting Injectable CAB/RPV is Superior to Oral ART in PWH with adherence challenges: ACTG A5359 A. Rana 03579 Oral Wednesday, March 6 12:51-1:00pm MST Real-world utilization of cabotegravir + rilpivirine in the US: data from Trio Health cohort J. J. Eron 01374 Poster Monday, March 4 2:30-4:00pm MST Real-world effectiveness of cabotegravir + rilpivirine vs. standard of care oral regimens in the US R. K. Hsu 01952 Poster Monday, March 4 2:30-4:00pm MST HIV-1 RNA blips and low-level viral replication: SOLAR (CAB+RPV LA vs. BIC/FTC/TAF) C. Latham 00138 Poster Monday, March 4 2:30-4:00pm MST Model based comparison of cabotegravir pharmacokinetics following thigh and gluteal injections K. Han 03157 Poster Wednesday, March 6 2:30-4:00pm MST Cabotegravir for PrEP SEARCH Randomized trial of Dynamic Choice HIV Prevention including injectable cabotegravir (CAB-LA) J. Kabami 03405 Late-Breaker Oral Tuesday, March 5 10:00-12:00pm MST Pre-exposure prophylaxis with cabotegravir long-acting injectable in the OPERA cohort A. Mills 01400 Poster Monday, March 4 2:30-4:00pm MST Real-world use of cabotegravir long acting for pre-exposure prophylaxis: TRIO cohort K. Mayer 01907 Poster Monday, March 4 2:30-4:00pm MST Cabotegravir PopPK analysis of adults and adolescents living with HIV or at risk for HIV receiving PrEP Y. Lin 03038 Poster Tuesday, March 5 2:30-4:00pm MST Interest in long-acting injectable PrEP among transgender women in the United States E. E. Cooney 00621 Poster Wednesday, March 6 2:30-4:00pm MST Healthcare staff acceptability and feasibility of telehealth delivery of cabotegravir for PrEP A. Liu 03080 Poster Wednesday, March 6 2:30-4:00pm MST Fostemsavir Temsavir treatment enhances bNAb recognition and subsequent clearance of HIV-1 infected cells R. Ferris 02971 Poster Monday, March 4 2:30-4:00pm MST Pipeline: Ultra Long-Acting Cabotegravir Phase I study of cabotegravir long-acting injectable formulations supports ≥4-monthly dose interval K. Han 00251 Oral Monday, March 4 10:00-12:00pm MST Pipeline: Broadly Neutralising Antibodies VH3810109 (N6LS) in antiretroviral therapy–naive adults with HIV-1: phase IIa BANNER efficacy data P. Leone 01911 Oral Monday, March 4 10:00-12:00pm MST Safety and efficacy of VRC07-523LS plus long-acting cabotegravir in the phase 2 ACTG A5357 Trial B. Taiwo 02254 Oral Monday, March 4 10:00-12:00pm MST High-dose VH3810109 (N6LS) ± recombinant human hyaluronidase PH20: phase I SPAN study safety results B. Win 01988 Poster Wednesday, March 6 2:30-4:00pm MST Pipeline: Maturation Inhibitors Next-generation maturation inhibitor GSK3640254 showed broad spectrum potency without MI resistance B. McAuliffe 03095 Poster Wednesday, March 6 2:30-4:00pm MST The preclinical pro maturation inhibitor VH3739937 J. Jeffrey 02819 Poster Wednesday, March 6 2:30-4:00pm MST General HIV Resistance in young children newly diagnosed with HIV in Western Cape, South Africa K. Anderson 01012 Poster Tuesday, March 5 2:30-4:00pm MST DOVATO (dolutegravir and lamivudine) tablets INDICATION Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato. IMPORTANT SAFETY INFORMATION BOXED WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV-1: EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating Dovato. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If Dovato is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of Dovato. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment. CONTRAINDICATIONS Do not use Dovato in patients with previous hypersensitivity reaction to dolutegravir or lamivudine Do not use Dovato in patients receiving dofetilide WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury Discontinue Dovato immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated Hepatotoxicity: Hepatic adverse events have been reported, including cases of hepatic toxicity (elevated serum liver biochemistries, hepatitis, and acute liver failure), in patients receiving a dolutegravir-containing regimen without pre-existing hepatic disease or other identifiable risk factors Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations with use of Dovato. In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn Monitoring for hepatotoxicity is recommended Embryo Fetal Toxicity: Assess the risks and benefits of Dovato and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects Pregnancy testing is recommended before initiation of Dovato. Individuals of childbearing potential should be counseled on the consistent use of effective contraception Lactic Acidosis and Severe Hepatomegaly With Steatosis: Fatal cases have been reported with the use of nucleoside analogs, including lamivudine. Discontinue Dovato if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of Dovato and other drugs may occur (see Contraindications and Drug interactions). Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of Dovato. Adverse reactions The most common adverse reactions (incidence ≥2%, all grades) with Dovato were headache (3%), nausea (2%), diarrhea (2%), insomnia (2%), fatigue (2%), and anxiety (2%). Drug interactions Consult full Prescribing Information for Dovato for more information on potentially significant drug interactions Dovato is a complete regimen. Coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended Drugs that induce or inhibit CYP3A or UGT1A1 may affect the plasma concentrations of dolutegravir Administer Dovato 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, Dovato and supplements containing calcium or iron can be taken with food Use in specific populations Pregnancy: There are insufficient human data on the use of Dovato during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established. Advise individuals of childbearing potential of the potential risk of neural tube defects. Assess the risks and benefits of Dovato and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy or if pregnancy is confirmed in the first trimester Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant Females and Males of Reproductive Potential: Pregnancy testing is recommended before initiation of Dovato. Counsel individuals of childbearing potential taking Dovato on the consistent use of effective contraception Renal Impairment: Dovato is not recommended for patients with creatinine clearance <30 mL/min. Patients with a sustained creatinine clearance between 30 and 49 mL/min should be monitored for hematologic toxicities, which may require a dosage adjustment of lamivudine as an individual component Hepatic Impairment: Dovato is not recommended in patients with severe hepatic impairment (Child-Pugh Score C) For more information, please see full US Prescribing Information for Dovato: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Dovato/pdf/DOVATO-PI-PIL.PDF CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions INDICATION CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction Post-Injection Reactions: Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated Hepatotoxicity: Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected Depressive Disorders: Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation, suicide attempt) have been reported with CABENUVA or the individual products Promptly evaluate patients with depressive symptoms Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions) Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes Long-Acting Properties and Potential Associated Risks with CABENUVA: Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible ADVERSE REACTIONS The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash The safety of CABENUVA in adolescents is expected to be similar to adults DRUG INTERACTIONS Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine) Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes USE IN SPECIFIC POPULATIONS Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant For more information, please see full US Prescribing Information for Cabenuva: APRETUDE (cabotegravir) extended-release injectable suspensions INDICATION APRETUDE is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP. IMPORTANT SAFETY INFORMATION BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who become infected with HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen. CONTRAINDICATIONS Do not use APRETUDE in individuals: with unknown or positive HIV-1 status with previous hypersensitivity reaction to cabotegravir receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine WARNINGS AND PRECAUTIONS Comprehensive Management to Reduce the Risk of HIV-1 Infection: Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs) Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment Counsel HIV-1 uninfected individuals to strictly adhere to the recommended dosing and testing schedule for APRETUDE Potential Risk of Resistance with APRETUDE: There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE Long-Acting Properties and Potential Associated Risks with APRETUDE: Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance Hypersensitivity Reactions: Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated Hepatotoxicity: Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated Depressive Disorders: Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE Promptly evaluate patients with depressive symptoms Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions: The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE ADVERSE REACTIONS The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection. DRUG INTERACTIONS Refer to the full Prescribing Information for important drug interactions with APRETUDE Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir USE IN SPECIFIC POPULATIONS Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation Pediatrics: Not recommended in individuals weighing less than 35 kg For more information, please see full US Prescribing Information for APRETUDE: RUKOBIA (fostemsavir) extended-release tablets INDICATION RUKOBIA, in combination with other antiretrovirals (ARVs), is indicated to treat HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen due to resistance, intolerance, or safety considerations. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Do not use in patients with previous hypersensitivity to fostemsavir or any of the components of RUKOBIA. Do not use RUKOBIA in patients receiving strong cytochrome P450 (CYP)3A inducers, including but not limited to enzalutamide, carbamazepine, phenytoin, rifampin, mitotane, and St John’s wort (Hypericum perforatum). WARNINGS AND PRECAUTIONS Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of RUKOBIA. QTc Prolongation with Higher than Recommended Dosages: RUKOBIA at 2,400 mg twice daily has been shown to significantly prolong the QTc interval of the electrocardiogram. Use RUKOBIA with caution in patients with a history of QTc interval prolongation or in patients with relevant pre-existing cardiac disease or who are taking drugs with a known risk of Torsade de Pointes. Elderly patients may be more susceptible to drug-induced QT interval prolongation. Elevations in Hepatic Transaminases in Patients with Hepatitis B or C Virus Co-infection: Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection. Diligence should be applied in initiating or maintaining effective hepatitis B therapy when starting RUKOBIA in patients co-infected with hepatitis B. Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of RUKOBIA and other drugs may occur (see Contraindications and Drug Interactions). Adverse reactions The most common adverse reaction (all grades, randomized cohort) observed in ≥5% of subjects was nausea (10%). 81% of adverse reactions reported with RUKOBIA were mild or moderate in severity. Drug interactions See the full Prescribing Information for RUKOBIA for a complete list of significant drug interactions. Temsavir may increase plasma concentrations of grazoprevir and voxilaprevir. Use an alternative hepatitis C virus regimen if possible. Use the lowest possible starting dose for statins and monitor for statin-associated adverse events. Patients receiving RUKOBIA should not take doses of estrogen-based therapies, including oral contraceptives, that contain more than 30 mcg/day of ethinyl estradiol. Caution is advised particularly in patients with additional risk factors for thromboembolic events. Use in specific populations Pregnancy: There are insufficient human data on the use of RUKOBIA during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established. Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission, developing viral resistance, and adverse reactions in a breastfed infant. For more information, please see full US Prescribing Information for RUKOBIA: About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in the company's Annual Report on Form 20-F for 2022, and Q4 Results for 2023. Registered in England & Wales: GSK plc ViiV No. 3888792 Healthcare Limited No. 06876960 Registered Office: GSK plc 980 Great West Road Brentford, Middlesex United Kingdom TW8 9GS ViiV Healthcare Limited GSK Medicines Research Centre Gunnels Wood Road, Stevenage United Kingdom SG1 2NY References 1 Han, et al. Phase I Study of Cabotegravir Long-Acting Injectable Formulations Supports ≥4-Monthly Dose Interval. Presented at 31st Conference on Retroviruses and Opportunistic Infections (CROI). March 2024. 2 Leone, et al. VH3810109 (N6LS) in Antiretroviral Therapy–Naive Adults With HIV-1: Phase IIa BANNER Efficacy Data. Presented at 31st Conference on Retroviruses and Opportunistic Infections (CROI). March 2024. 3 Win, et al. High-Dose VH3810109 (N6LS) ± Recombinant Human Hyaluronidase PH20: Phase I SPAN Study Safety Results. Presented at 31st Conference on Retroviruses and Opportunistic Infections (CROI). March 2024. 4 Taiwo, et al. Safety and Efficacy of VRC07-523LS plus Long-Acting Cabotegravir in the Phase 2 ACTG A5357 Trial. Presented at 31st Conference on Retroviruses and Opportunistic Infections (CROI). March 2024. 5 Rana, et al. Long-acting Injectable CAB/RPV is Superior to Oral ART in PWH with adherence challenges: ACTG A5359. Presented at 31st Conference on Retroviruses and Opportunistic Infections (CROI). March 2024. 6 Kamya, et al. SEARCH Randomized trial of Dynamic Choice HIV Prevention including injectable cabotegravir (CAB-LA). Presented at 31st Conference on Retroviruses and Opportunistic Infections (CROI). March 2024. 7 Hsu, et al. Real-World Effectiveness of Cabotegravir + Rilpivirine vs. Standard of Care Oral Regimens in the US. Presented at 31 Conference on Retroviruses and Opportunistic Infections (CROI). March 2024. 8 Sörstedt, et al. Switching to DTG+3TC vs 3-drug regimens in routine clinical care: long-term Swedish data. Presented at 31st Conference on Retroviruses and Opportunistic Infections (CROI). March 2024. 9 Data on File

肺癌、肝癌、乳腺癌等12类癌症又有新药啦！2023年，国内30款抗癌疗法获批上市！ 全球首款全人源BCMA CAR-T获批上市； 中国首款白血病CAR-T疗法获批上市，也是全球首款低于百万的CAR-T疗法； 宫颈癌全人抗PD-L1单抗索卡佐利单抗注射液获批； ... 更大的好消息是，有些已经在中国开展临床试验，这意味着国内的患者可以有机会同步接受美国最新抗癌药物的治疗，并且是免费的。想参加的患者可提交资料至全球肿瘤医生网医学部申请评估（400-666-7998） 据统计，十年前，一种新药从开始申请到最终被中国患者吃到平均需要5年时间，这指的是自费药。如果再算上纳入医保目录所需时间，平均需要等6～8年。相信很多病友对2018年的一部电影《我不是药神》感同身受，也让全社会深刻认识到我们国家癌症病友们面临的生存绝境--无药可用！很多病友在苦苦等待中绝望离去。。。 值得振奋的是，我们国家再也不是过去那个医疗远远落后美国的国家！近两年，众多癌症已经打破了治疗僵局，迎来了首款靶向药物，又有很多幸运的病友们等来了新的希望和治疗选择，相信未来会越来越好！ 肺 癌 01 非小细胞肺癌EGFR20ins-莫博赛替尼 中国首款EGFR 20ins靶向药莫博赛替尼震撼上市！ 药品信息 药品名称： 莫博赛替尼胶囊（Mobocertinib，Exkivity，代号为TAK-788) 研发公司： 日本武田 药物介绍： 2023年1月11日，中国国家药品监督管理局正式批准琥珀酸莫博赛替尼胶囊（Mobocertinib，Exkivity，代号为TAK-788)用于EGFR外显子20插入突变的非小细胞肺癌成年患者。特别值得一提的是，这是国内肺癌患者迎来的首款EGFR外显子20插入突变的靶向疗法，具有里程碑式的意义！同时这款备受患者期待的肺癌新药也有了响当当的中文大名--安卫力！原文链接：刚刚！中国首款肺癌EGFR 20ins靶向药莫博赛替尼震撼上市！ 上市时间： 2023年1月11日 02 非小细胞肺癌EGFR20ins--舒沃替尼 药品信息 药名名称： Sunvozertinib（舒沃替尼，DZD9008） 研发公司： 迪哲医药 药品介绍： 终于来了！首款国研肺癌EGFR20ins新药「舒沃替尼」震撼上市 2023年8月23日，中国国家药品监督管理局正式批准 1类创新药舒沃替尼片（Sunvozertinib，DZD9008）上市， 用于 EGFR外显子20插入突变的非小细胞肺癌 成年患者。特别值得一提的是，这是在中国上市的 首款国研EGFR外显子20插入突变的靶向疗法 ，具有里程碑式的意义！同时这款备受患者期待的肺癌新药也有了响当当的中文大名-- 舒沃哲® ！ 上市时间： 2023年8月23日 03 非小细胞肺癌EGFR-甲磺酸贝福替尼 药品信息 药名名称： 甲磺酸贝福替尼胶囊 研发公司： 贝达药业 药品介绍： 疾病控制率高达94.8%！肺癌国研3代靶向药甲磺酸贝福替尼获批上市 2023年5月31日，中国国家药监局再次传来喜讯，正式批准国研第3代EGFR靶向药 甲磺酸贝福替尼胶囊 上市，用于治疗既往使用EGFR-TKI耐药后产生 T790M突变 的局部晚期或转移性非小细胞肺癌患者。 10月12日，NMPA批准第二项适应症，用于具有表皮生长因子受体（EGFR）外显子19缺失或外显子21（L858R）置换突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。 上市时间： 2023年5月31日 04 非小细胞肺癌ALK-伊鲁阿克 药品信息 药名名称： 伊鲁阿克（代号为WX-0593） 研发公司： 齐鲁制药 药品介绍： 2023年6月28日，中国国家药品监督管理局（NMPA）官网最新公示，齐鲁制药的1类新药伊鲁阿克获批上市，用于既往接受过克唑替尼治疗后疾病进展或对克唑替尼不耐受的间变性淋巴瘤激酶（ALK）阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者的治疗。 上市时间： 2023年6月28日 05 非小细胞肺癌MET--谷美替尼 药品信息 药物名称： 谷美替尼片（SCC244） 研发公司： 海和药物 招募信息： MET+肺癌新药招募信息汇总 药物介绍： 谷美替尼是国研的一款全球自主知识产权口服强效、高选择性小分子MET抑制剂。已公布的临床数据证实，谷美替尼在MET改变的晚期非小细胞肺癌人群中显示了明确疗效。2022年2月17日正式纳入优先审评品种名单，拟定适应症为“具有MET14外显子跳变的局部晚期或转移性非小细胞肺癌(NSCLC)”。 2023年3月8日，国家药品监督管理局官方公布：附条件批准上海海和药物研究开发股份有限公司申报的1类创新药 谷美替尼片 上市，用于具有间质-上皮转化因子 （MET）外显子14跳变 的局部晚期或转移性 非小细胞肺癌 的治疗。 上市时间： 2023年3月8日 原文链接： 超80%患者肿瘤显著缩小或稳定！肺癌国研新药谷美替尼震撼上市 06 非小细胞肺癌MET--伯瑞替尼 药品信息 药名名称： 伯瑞替尼 研发公司： 浦润奥生物 药品介绍： 2023年11月16日，国家药品监督管理局附条件批准1类创新药伯瑞替尼肠溶胶囊上市，用于治疗具有间质-上皮转化因子（MET）外显子14跳变的局部晚期或转移性非小细胞肺癌患者。伯瑞替尼是一种细胞-间质上皮转化因子(c-MET)受体酪氨酸激酶抑制剂，可抑制 c-MET高表达肿瘤细胞的增殖。该药品的上市为MET外显子14跳变非小细胞肺癌患者提供了新的治疗选择。 上市时间： 2023年11月16日 07 非小细胞肺癌MET-特伯替尼 药品信息 药名名称： 特泊替尼（tepotinib，英文商品名：Tepmetko） 研发公司： 默克公司 药品介绍： 12月8，NMPA官网公示，盐酸特泊替尼片已正式获批，用于治疗携带MET外显子14（METex14）跳跃的非小细胞肺癌（NSCLC）患者。 上市时间： 2023年12月8日 08 非小细胞肺癌RET--普拉替尼 药品信息 药物名称： 普拉替尼 研发公司： 基石药业 药物介绍： 2023年6月26日，中国国家药品监督管理局（NMPA）官网最新公示，基石药业引进的创新产品普拉替尼胶囊新适应症获批，用于RET基因融合阳性的局部晚期或转移性非小细胞肺癌（NSCLC）一线治疗。 上市时间： 2023年6月 09 非小细胞肺癌PD-1-纳武利尤单抗 完全缓解率翻11倍！非小细胞肺癌患者获得更多根治机会 药品信息 药品名称： 纳武利尤单抗（opdivo，欧狄沃） 研发公司： 百时美施贵宝 药物介绍： 2023年1月17日，中国国家药品监督管理局（NMPA）批准纳武利尤单抗新适应症，联合铂类双药化疗，作为可切除的非小细胞肺癌成年患者的新辅助治疗方案，无论患者的PD-L1表达情况如何。值得一提的是，这是目前中国唯一一种获批用于非小细胞肺癌新辅助治疗（术前治疗）的免疫疗法。纳武单抗方案在患者术后病理学完全缓解率对比化疗翻了11倍（ 24% vs 2.2% ）！让更多肺癌患者获得根治机会。 上市时间： 2023年1月17日 10 小细胞肺癌-斯鲁利单抗 首款国研PD-1获批小细胞肺癌一线治疗 药品信息 药品名称： 斯鲁利单抗（H药，serplulimab，HLX10) 研发公司： 复宏汉霖 药物介绍： 斯鲁利单抗（H药，serplulimab，HLX10)是由中国自主研发的创新型PD-1药物。2022年1月17日，国家药监局（NMPA）官网公示，国产PD-1抑制剂 斯鲁利单抗（商品名：汉斯状，H药，HLX10） 新适应症获批，联合化疗 一线治疗广泛期小细胞肺癌（ES-SCLC） 。值得一提的是，这是H药在中国获批的第3项适应症，也是 首款获批用于小细胞肺癌的国研PD-1 ！原文链接：小细胞肺癌有新药了！首款国研PD-1斯鲁利单抗带来“一线生机”！ 上市时间： 2023年1月17日 11 小细胞肺癌--阿得贝利单抗 药品信息 药物名称： 阿得贝利单抗（adebrelimab） 研发公司： 恒瑞医药 药物介绍： 阿得贝利单抗是国研人源化抗PD-L1单克隆抗体，能阻断导致肿瘤免疫耐受的PD-1/PD-L1通路，重新激活免疫系统的抗肿瘤活性，从而达到治疗肿瘤的目的。临床数据表明，阿得贝利单抗联合化疗能够显著延长小细胞肺癌患者的总生存期。2022年1月，阿得贝利单抗联合化疗一线治疗广泛期小细胞肺癌适应症的上市申请获得CDE受理。 2023年3月3日，中国国家药监局（NMPA）官网公示，恒瑞医药自主研发的抗PD-L1单抗阿得贝利单抗注射液正式获批上市，用于联合化疗一线治疗广泛期小细胞肺癌（ES-SCLC），同时也有了响当当的大名-- 艾瑞利。 上市时间：2023年3月3日 原文链接：小细胞肺癌喜迎新药！首款国研PD-L1阿得贝利单抗上市！ 乳 腺 癌 12 乳腺癌--DS8201 药品信息 药物名称： 德喜曲妥珠单抗（trastuzumab deruxtecan，DS8201） 研发公司： 阿斯利康；第一三共 招募信息：多癌种“战神”DS8201登陆中国！这些患者快申请！ 药物介绍： DS8201（trastuzumab deruxtecan，T-DXd） ，是一种HER2抗体+伊立替康类化疗药物的偶联药物，属于ADC型药物类型（抗体偶联药物）。目前已在非小细胞肺癌，乳腺癌，胃癌中获批。2022年5月，DS8201在中国被正式纳入优先审评目录，用于治疗HER2低表达乳腺癌患者。 2023年2月24日，中国国家药监局（NMPA）官网最新公示，注射用德曲妥珠单抗（Enhertu）获批上市，用于治疗 既往接受过一种或一种以上抗 HER2 药物治疗的不可切除或转移性 HER2 阳性成人乳腺癌患者 。大名鼎鼎的DS8201终于在中国首次获批上市，同时也有了响当当的中文大名-- 优赫得！ 上市时间： 2023年2月24日 原文链接： 喜讯！多癌种“战神”DS8201中国首个适应症：HER2阳性乳腺癌获批！ 13 乳腺癌--马来酸吡咯替尼片 药品信息 药物名称： 马来酸吡咯替尼片 研发公司： 恒瑞医药 药物介绍： 2023年4月20日，马来酸吡咯替尼片一项新适应症获批，用于治疗表皮生长因子受体2（HER2）阳性、晚期阶段未接受过抗HER2治疗的复发或转移性乳腺癌患者，即一线治疗HER2阳性复发/转移性乳腺癌患者。 上市时间： 2023年4月20日 14 乳腺癌--达尔西利 药品信息 药物名称： 达尔西利（SHR6390，dalpiciclib） 研发公司： 恒瑞医药 药物介绍： 2023年6月26日，中国国家药监局（NMPA）官网最新公示，恒瑞医药的CDK4/6抑制剂达尔西利的新适应症获批，用于联合芳香化酶抑制剂作为初始治疗，适用于激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性局部晚期或转移性乳腺癌患者。 上市时间： 2023年6月 15 乳腺癌-马吉妥昔单抗 药品信息 药名名称： 马吉妥昔单抗（margetuximab） 研发公司： 再鼎 药品介绍： 9月1日，中国NMPA宣布，马吉妥昔单抗注射液获批上市，用于治疗转移性HER2阳性乳腺癌患者三线及以上治疗。 上市时间： 2023年9月1日 肝 癌 16 肝癌--卡瑞利珠单抗 双“艾”方案获批肝癌一线治疗 药品信息 药名名称： 卡瑞利珠单抗（艾瑞卡 ） 研发公司： 恒瑞医药 药品介绍： 中国国家药品监督管理局（NMPA）官网最新公示，恒瑞医药抗PD-1单抗注射用卡瑞利珠单抗新适应症上市申请已获得批准，联合阿帕替尼（艾坦 ）（“双艾”组合）用于晚期肝细胞癌一线治疗，这是卡瑞利珠单抗在中国获批的第9项适应症，也是中国首个获批的用于治疗晚期肝细胞癌的PD-1抑制剂与小分子抗血管生成药物组合，为晚期肝癌患者带来用药新选择。 卡瑞利珠单抗联合阿帕替尼对比索拉非尼作为一线治疗可以显著延长晚期肝细胞癌患者的无进展生存期和总生存期。 上市时间： 2023年1月31日 食 管 癌 17 食管癌--替雷利珠单抗 药品信息 药物名称： 替雷利珠单抗（商品名：百泽安） 研发公司： 百济神州 药物介绍： 2023年5月23日，中国国家药监局（NMPA）官网最新公示，百济神州抗PD-1抗体替雷利珠单抗（商品名：百泽安）的新适应症获批，用于联合化疗用于一线治疗不可切除的局部晚期、复发或转移性食管鳞状细胞癌（ESCC）。这是替雷利珠单抗在中国获批的第11项适应症。 上市时间： 2023年5月 18 食管癌-斯鲁利单抗 药品信息 药名名称： 斯鲁利单抗（HLX10） 研发公司： 复宏汉霖 药品介绍： 9月22日，中国NMPA公示，抗PD-1单抗斯鲁利单抗注射液的新适应症获得批准，用于联合化疗一线治疗局部晚期/复发或转移性食管鳞状细胞癌（ESCC）。 上市时间： 2023年9月22日 骨 髓 瘤 19 骨髓瘤-伊基奥仑赛注射液 药品信息 药物名称： 福可苏®（伊基奥仑赛注射液） 研发公司： 驯鹿生物&信达生物 药物介绍： 2023年6月30日，中国药监局（NMPA）批准驯鹿生物和信达生物联合研发的靶向BCMA CAR-T疗法-伊基奥仑赛注射液上市，用于治疗复发或难治性多发性骨髓瘤（R/R MM）患者，这些患者既往接受过3种或3种以上的治疗（至少使用过一种蛋白酶体抑制剂及免疫抑制剂）。这是中国获批的首款BCMA CAR-T疗法，同时也是全球首款全人源靶向BCMA的CAR-T疗法，开创了复发难治骨髓瘤治疗新纪元！原文链接：里程碑！全球首款全人源靶向BCMA CAR-T“福可苏”获批上市！ 上市时间： 2023年6月 白 血 病 20 白血病-纳基奥仑赛 中国获批上市的首款白血病CAR-T疗法（99.9万元/支） 药品信息 药物名称： 纳基奥仑赛 研发公司： 合源生物 药物介绍： 纳基奥仑赛注射液国内定价为99.9万元/支。纳基奥仑赛注射液是首款中国白血病治疗领域CAR-T细胞治疗产品。2023年11月8日，合源生物宣布，国家药品监督管理局（NMPA）已正式批准其CAR-T产品 源瑞达®（纳基奥仑赛注射液） 的新药上市申请（NDA），用于治疗成人复发或难治性B细胞急性淋巴细胞白血病（r/r B-ALL）。据介绍，纳基奥仑赛注射液采用全球独特的CD19 scFv（HI19a）结构和国际领先的生产制造工艺，且在成人r/r B-ALL注册临床研究中生产成功率达到100%。 上市时间： 2023年11月27日 21 白血病/淋巴瘤-阿可替尼 药品信息 药名名称： 康可期（英文商品名：Calquence，通用名：阿可替尼胶囊） 研发公司： 阿斯利康 药品介绍： 9月1日，中国NMPA正式批准血液肿瘤产品康可期（英文商品名：Calquence，通用名：阿可替尼胶囊）新适应症上市，单药治疗既往至少接受过一种治疗的成人慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）患者。 上市时间： 2023年9月1日 胆 管 癌 22 胆管癌-度伐利尤单抗 首款一线免疫疗法 药品信息 药物名称： 度伐利尤单抗 研发公司： 阿斯利康 药物介绍： 2023年11月7日，基于全球Ⅲ期研究TOPAZ-1的三阳结果，国家药品监督管理局（NMPA）批准度伐利尤单抗（商品名：英飞凡®）获批新适应症，即度伐利尤单抗联合吉西他滨和顺铂用于局部晚期或转移性胆道癌（BTC）成人患者的一线治疗。这意味着，已被证明能够显著改善BTC患者生存的免疫联合方案将应用于中国临床，并惠及更多中国患者 CDE受理时间： 2023年11月 淋 巴 瘤 23 淋巴瘤-格菲妥单抗 全球首款双特异性抗体 药品信息 药物名称： 高罗华（英文商品名：Columvi，中英文通用名：格菲妥单抗/glofitamab） 研发公司： 罗氏 药物介绍： 2023年11月，高罗华获得中国国家药品监督管理局（NMPA）批准，用于治疗既往接受过至少两线系统性治疗的复发或难治性弥漫性大B细胞淋巴瘤(R/R DLBCL)成人患者。作为全球首个且目前唯一对R/R DLBCL患者进行固定周期治疗的双特异性抗体，格菲妥单抗在华获批上市，标志着中国淋巴瘤治疗开始迈入双抗治疗新时代。 24 淋巴瘤--阿可替尼 药品信息 药物名称： 阿可替尼胶囊（acalabrutinib，商品名：康可期） 研发公司： 阿斯利康 药物介绍： 2023年3月22日，中国国家药监局（NMPA）官网最新公示，由阿斯利康（AstraZeneca）研发的BTK抑制剂阿可替尼胶囊正式中国获得上市批准，用于治疗既往至少接受过一种治疗的成人套细胞淋巴瘤（MCL）患者阿可替尼曾获得美国FDA授予优先审评资格、突破性疗法认定和孤儿药资格。 上市时间： 2023年3月 25 淋巴瘤--盐酸可泮利塞 药品信息 药物名称： 注射用盐酸可泮利塞（copanlisib） 研发公司： 拜耳 药物介绍： 2023年5月23日，中国国家药监局（NMPA）官网最新公示，拜耳（Bayer）PI3K抑制剂注射用盐酸可泮利塞（copanlisib）在中国的首个适应症获批，用于治疗既往至少接受过两种系统性治疗的复发或难治性滤泡性淋巴瘤（FL）成人患者。 获批数据显示：接受copanlisib单药治疗的患者总缓解率（ORR）达到了59%，包括14%的完全缓解（CR）。 上市时间： 2023年5月 26 淋巴瘤--阿基伦赛注射液 药品信息 药物名称： 阿基伦赛注射液 研发公司： 复兴凯特 药物介绍： 2023年6月26日，中国国家药监局（NMPA）官网最新公示，复星凯特递交的阿基仑赛注射液新适应症获批，用于一线免疫化疗无效或在一线免疫化疗后12个月内复发的成人大B细胞淋巴瘤（r/r LBCL）。 上市时间： 2023年6月 肾 癌 27 肾癌--伏罗尼布 药品信息 药物名称： 伏罗尼布（CM082，vorolanib） 研发公司： 贝达药业 药物介绍： 2023年6月8日，中国国家药监局（NMPA）官网最新公示，贝达药业递交的1类新药伏罗尼布片获批上市，用于既往接受过酪氨酸激酶抑制剂（TKI）治疗失败的晚期肾细胞癌患者。伏罗尼布（CM082，vorolanib）是贝达药业在研的新一代多靶点激酶抑制剂。 上市时间： 2023年6月 肾上腺皮质癌 28 肾上腺皮质癌-米托坦片 药品信息 药名名称： 米托坦片（mitotane） 研发公司： HRA Pharma Rare Diseases 药品介绍： 9月8日，中国NMPA公示，H米托坦片（mitotane）已在中国获批上市，适应症为肾上腺皮质癌（ACC）。 上市时间： 2023年9月8日 尿 路 上 皮 癌 29 尿路上皮癌--纳武利尤单抗 无病生存期翻倍！尿路上皮癌首款辅助免疫疗法获批 药品信息 药品名称： 纳武利尤单抗（opdivo，欧狄沃） 研发公司： 百时美施贵宝 药物介绍： 2023年1月19日，中国国家药品监督管理局（NMPA）批准纳武利尤单抗（纳武单抗，欧狄沃）新适应症，作为单药方案，用于辅助治疗接受根治性切除术后伴有高复发风险的尿路上皮癌患者。这是首款在中国获批用于尿路上皮癌辅助治疗的PD-1抑制剂。接受纳武单抗辅助治疗的患者中位无病生存期为22.0个月，达到了对照组患者的10.9个月的2倍！ 上市时间： 2023年1月19日 宫 颈 癌 30 宫颈癌-索卡佐利单抗注射液 药品信息 药名名称： 索卡佐利单抗注射液 研发公司： 兆科 药品介绍： 12月21日，中国NMPA公示，索卡佐利单抗注射液获批上市，治疗复发性或转移性宫颈癌。索卡佐利单抗注射液（首克注利单抗，Socazolimab）是一款全人抗PD-L1单抗。 上市时间： 2023年12月21日 以上新药仅为众多研发热点中的一小部分，还有众多的新药研发，创新技术纷纷在路上，相信2024年将有更多的药物获批上市！除此之外，还有多款正在研发的抗癌新药也显示出广谱抗癌的实力。 “方舟援助计划” 可以为患者提供上市新药和未上市新药免费治疗的机会。 相信随着医学研究的不断深入，越来越多的新药即将研发上市，将有更多的病友跨过一个又一个5年！ 参考资料：美国FDA官网、中国NMPA官网