1、 =AchievedPOTENTIAL APPROVALS US/EUPLANNED SUBMISSIONS US/EUPOTENTIAL CLINICAL DATASum of Check ChangeSum of Check ChangeSum of Check ChangePhase IIIOPSUMIT(macitentan)USOPSUMIT(macitentan)USSIMPONI(golimumab)P P TREMFYA(guselkumab)EUPediatric Pulmonary Arterial Hypertension(TOMORROW)Pediatric Pulmo

2、nary Arterial Hypertension(TOMORROW)EUPediatric Ulcerative ColitisCrohns Disease(GALAXI)P PUSOPSYNVI(macitentan/tadalafil STCT)UPTRAVI(selexipag)STELARA(ustekinumab)P P TREMFYA(guselkumab)EUPulmonary Arterial HypertensionP PEUPediatric Pulmonary Arterial Hypertension(SALTO)P PEUPediatric Crohns Dise

3、aseUlcerative Colitis Monotherapy(QUASAR)P PUSEDURANT(rilpivirine)REKAMBYSUSTREMFYA(guselkumab)P P RYBREVANT(amivantamab)EUHIV pediatric 2-12 year oldP PEUHIV AdolescentsPediatric PsoriasisSubcutaneous(PALOMA-3)P PUSBALVERSA(erdafitinib)USnipocalimabP PUSTREMFYA(guselkumab)ERLEADA(apalutamide)EUUrot

4、helial Cancer(THOR)EUGeneralized Myasthenia GravisP PEUCrohns Disease(GALAXI)High Risk Prostate Cancer(PROTEUS)USDARZALEX(daratumumab)USSPRAVATO(esketamine)monotherapyUSTREMFYA(guselkumab)P P seltorexantFrontline multiple myeloma transplant eligible(PERSEUS)Treatment Resistant Depression(TRD4005)Ped

5、iatric Juvenile Psoriatic ArthritisAdjunctive treatment for major depressive disorder with insomnia symptomsP PUSCARVYKTI(ciltacabtagene autoleucel)P PUSRYBREVANT(amivantamab)P PUSTREMFYA(guselkumab)P P nipocalimabP PEURelapsed Refractory multiple myeloma w/1-3 PL(CARTITUDE-4)P PEUSubcutaneous(PALOM

6、A-3)P PEUUlcerative Colitis Monotherapy(QUASAR)Generalized Myasthenia GravisP PUSRYBREVANT(amivantamab)P PUSDARZALEX(daratumumab)USTREMFYA(guselkumab)TREMFYA(guselkumab)P PEUFrontline Non Small Cell Lung Cancer in combination with chemotherapy(PAPILLON)P PEUFr