Big Pharma's Key 2025 Catalysts: Pipeline Milestones and Product Highlights
Johnson & Johnson
Medical Device R&D and Manufacturer
As the disclosure of multinational pharmaceutical companies' 2024 financial reports is coming to an end, each company has shown notable performance highlights. So, what major milestone events will the pharmaceutical giants achieve in 2025 to contribute new strength to this year's performance? The following is Insight Database's summary of MNC milestones for 2025 based on the 2024 financial reports.Heavyweight Catalyst Event(Partial), for industry reference.
Myasthenia Gravis Monoclonal Antibody to Be Approved for the First Time! Two New Drugs Submit for Marketing Authorization for the First Time
In 2025, Johnson & Johnson will achieve a significant breakthrough in its innovative drug pipeline as a major monoclonal antibody targeting FcRn is about to be approved, opening a new front.Daratumumab,Guselkumab, etc.Multiple core products are expected to gain new indications,Deepen the Layout in the Fields of Immunology and Oncology:
Nicalimab Targeting FcRn（Nipocalimab）WillFirst Approval for Market Launch（US/EU）, used forMyasthenia Gravis, and will also submitWarm Antibody TypeAutoimmune Hemolytic AnemiaMarketing Application for New Indications（US）； Daratumumab Targeting CD38 Achieved Sales in 24 Years$11.67 billion(+19.8% YoY), Subcutaneous formulations will be available in 25 years.Smoldering Multiple MyelomaNew Indications（US/EU）； Another heavyweight pillar product, the EGFR/c-Met bispecific antibody Amivantamab（Amivantamab）, will be approved in 25 yearsSubcutaneous Injection（US/EU）； Guselkumab Targeting IL23A（Guselkumab）, 24-year sales volume is$3.67 billion(+16.6% YoY), there will be in 2025Six New Indications Approved for Marketing, respectively, ulcerative colitis(Subcutaneous induction)、Crohn's Disease(Subcutaneous induction)、Pediatric Psoriasis,Crohn's Disease, Juvenile Psoriatic Arthritis, Ulcerative Colitis.
Two new drugs have been submitted for marketing approval for the first time, targeting the gaps in oral therapies for psoriasis and unmet clinical needs in depression, further strengthening the layout in autoimmune and neuroscience fields:
Planned Initial SubmissionNew Oral Medication for PsoriasisIcotrokinra Marketing Application（US/EU）, this isThe First ProductOral IL-23R-targeted drug successfully completes Phase III study; Will be submitted for the first timeOral KOR InhibitorAticaprant Marketing Application（US）, used forMajor Depressive Disorder。
Johnson & Johnson will unveil multiple clinical data, ranging from RPGR gene therapy challenging hereditary eye diseases, to amivantamab expanding its reach in solid tumors, and further to IL-23R peptide drugs making cross-disciplinary moves in intestinal inflammation:
Announcement of Key Phase III Clinical Results for RPGR Gene Therapy, Used forX-linked Retinitis Pigmentosa；
Announcement of Amivantamab for Use in ChinaSquamous Cell Carcinoma of the Head and Neck、Colorectal Cancer；
Announcement of IL-23R Oral Peptide Icotrokinra forUlcerative ColitisPhase II Clinical Results.
Screenshot source: Johnson & Johnson financial report
New Drug for IgA Nephropathy to Be Approved for the First TimeHeavyweight Nuclear Medicine Adds New Indications
Novartis 2025 Pipeline in Full Swing: Rising Star for IgA Nephropathy Poised for Global First Approval, Multiple Key Products Simultaneously Expanding Indication Boundaries:
New Drug for IgA Nephropathy: Atrasentan(Atrocantan)Will WelcomeFirst Approval for Marketing（FDA）, this isNovartis$3.5 billionAcquisition of Chinook CompanyA ETA antagonist, which has also been submitted for marketing approval in China;
Pluvicto, a nuclear medicine, is set to receive FDA approval for a new indication, intended forNot received taxane chemotherapyPSMA-Positive Metastatic Castration-Resistant Prostate Cancer（mCRPC) Patient. The drug was first approved in 2022, and its revenue reached$13.92 billion, an increase of 42% year-on-year;
Oral Complement Factor B Inhibitor Iptacopan（Fabhalta）Will Welcome the Third New Indication（US/JP/EU）, used forC3 Glomerulopathy（C3 G）. The drug was first approved for use in December 2023.Paroxysmal Nocturnal Hemoglobinuria, August 24th, approved again for use inIgA Nephropathy, Total sales in China reached$1.29 billion。
Oral BTK Inhibitor Remibrutinib(Remibrutinib)In the United States, the European Union, and China（China has submitted）For the first timeSubmit an application for listing, forChronic Spontaneous Urticaria（CSU）, is another重磅product from Novartis in the autoimmune field;
Heavyweight nuclear medicine Pluvicto to submit a new indication application to the FDA for marketing, used forMetastatic Hormone-Sensitive Prostate Cancer（mHSPC）；
Cosentyx（Secukinumab）Will be submitted in the United States and the European UnionGiant Cell Arteritis（GCA）Marketing application for a new indication.
Secukinumab is used forGCA AndPolymyalgia Rheumatica（PMR）The key Phase III clinical results will be read out;
Two pivotal Phase III clinical readouts for the BAFFR-targeted monoclonal antibody Ianalumab are expected, respectively forSjögren's Syndrome（SjS）AndSecondary Immune Thrombocytopenia（ITP）;
The nuclear medicine Pluvicto is used formHSPC Key Phase III Clinical Results Read Out.
Screenshot source: Novartis financial report
Pfizer
RSV Vaccine Abrysvo to Be Approved in Europe for Respiratory Syncytial Virus Infection in Adults Aged 18-59. The vaccine was previously approved for individuals aged 60 and above, with global sales in 2024.$755 million(Year-on-year -15%), withExpansion of Applicable Population，Future sales are expected to increase;
ADC Brentuximab Vedotin Targeting CD30（Adcetris）Will be approved for new indications in the United States, used forDiffuse Large B-Cell Lymphoma（DLBCL）, the drug's revenue in 2024 reached$1.089 billion；
PARP Inhibitor Talazoparib（Talzenna）, in combination with enzalutamide, will be approved by the FDA for mCRPC patients,Regardless of Mutation Status。
For the first timePublication of SELP Monoclonal Antibody Lnclacumab forSickle Cell DiseaseKey Phase III Clinical Results;
Announcement of ER PROTAC Drug Vepdegestrant as Second-Line TreatmentER-Positive Breast CancerThe key Phase III clinical results;
BCMA/CD3 Bispecific Antibody Elranatamab, to Reveal a Study onMultiple MyelomaPhase III clinical results;
Hemophilia Monoclonal AntibodyHympavzi（Matacizumab）, will be announcedHemophilia A and Hemophilia B(Containing inhibitors of coagulation factors VIII and IX in the body)Phase III Clinical Results.
In addition, several potential key projects have been launched, includingOncology Field Atirmociclib(CDK4 Inhibitor)、Sigvotatug vedotin（ITGB6 ADC）, Metabolic Field Danuglipron（GLP1R Agonist）、Ponsegromab(GDF15 Monoclonal Antibody)etc.
AstraZeneca
Durvalumab（Imfinzi）New Indication Approval for Anticipatory Use in Combination with ChemotherapyMuscle-invasive Bladder Cancer, is expected to becomeIn this curative treatmentThe First and OnlyPerioperative Immunotherapy Regimen.This indication was submitted for marketing in the U.S. in December 2024 and granted priority review, with the FDA expected to make a regulatory decision in Q2 2025.
Second-Generation BTK InhibitorAcalabrutinib（Calquence）Gavinetclor with or without Obinutuzumab will be approved as a fixed-duration first-line CLL treatment in the United States, at which point Acalabrutinib will becomeThe only second-generation BTK inhibitor available for both progressive and fixed-course treatments；
TROP2 ADC Dato-Dxd（Datroway）Will be approved for use in the United StatesTreatment of EGFR-Mutant Non-Small Cell Lung Cancer in Later Lines, It has been submitted to the FDA for market approval in November 2024. The approval of the lung cancer indication is crucial for the competitive landscape of TROP2 ADC.
Selumetinib（Koselugo）To be approved in the U.S. for adult Type I Neurofibromatosis; currently approved for pediatric patients aged 3 years and above, with sales in 2024.$530 million。
Seven Phase III Data on the Way: PTHR1 Agonist Challenges Hypoparathyroidism, Next-Gen SERD Refreshes First-Line Breast Cancer Treatment, ATR Inhibitor Tackles PD-1 Resistant NSCLC, Innovative Therapies for Hypertension and Rare Diseases Debut:
Camizestrant isNext-Generation Oral SERD, to be announced for the first timeCombination with CDK4/6 InhibitorsFirst-line treatment for advanced HR-positive breast cancer patients with ESR1 tumor mutationsThe KeyPhase III Results (SERENA-6)。Media predicts that the net present value of Cagrisema will reach$4.5 billion;
Anselamimab is aChimeric IgG1κ Antibody, will be announced for the first time for use inAL AmyloidosisKey Phase III Results（CAEL101-302/ CAEL101-301）, which has currently received the FDA Fast Track designation and is expected to be submitted for marketing approval in 2025;
Gefurulimab Third-Generation C5 Inhibitor, will be announced for the first time for use inMyasthenia GravisKey Phase III Results (ALXN1720-MG-301), is expected to becomeOnce-Weekly Subcutaneous Injection Therapy for Home Use；
Eneboparatide is a product acquired through the acquisition of Amolyt Pharma.PTHR1 Agonist, will be announced for the first time for the treatment ofHypoparathyroidismKey Phase III CALYPSO Study Results;
Ceralasertib is aOral ATR Kinase Inhibitor, will announce for the first time the combination of durvalumab and chemotherapyFor use after PD-1/L1 resistancePhase III Clinical Results of NSCLC(LATIFY)；
Baxdrostat is a drug used for the treatment ofHypertensionHighly selective aldosterone synthase inhibitor（ASI）, will announce the key results of the Phase III BaxHTN study for the first time;
Efzimfotase alfa The Second-Generation TNSALP Enzyme Replacement Therapy, Will Announce Key Phase III Results for Hypophosphatasia for the First Time (HICKORY/CHESTNUT)。
Eli Lilly
Eli Lilly's Innovative Drug Boom in 2025: The World’s First Oral SERD Drug, Imlunestrant, to Launch Globally; Tirzepatide Expands from Weight Loss into Heart Failure, Strengthening Its Presence in Oncology and Metabolic Disease Therapies:
Oral ER Degradation Agent (SERD）Imlunestrant will be approved in the United States and Japan for ER+/HER2- metastatic breast cancer, which will be a significant milestone for the drug.World's First；
Star Product: Tirzepatide（Tirzepatide）Used forHeart Failure with Preserved Ejection Fraction（HFpEF）Will be approved in the United States and the European Union. In 2024, tirzepatide revenue skyrocketed, contributing$16.46 billion, accounting for nearly one-third of Eli Lilly's total revenue in 2024;
Pitozumab（Pirtobrutinib）Is FDA-approvedThe First Reversible BTK Inhibitor, Expected to gain approval for CLL in the U.S. and EU by 2025.Full Approval License(Note: Japan is also mentioned in the financial report, but no information on conditional approval was found in the company's announced product listing approval or in PMDA's review documents.)；
Mijizumab（Mirikizumab）It is a humanized IgG4 antibody that selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway, and is expected to be approved in the EU and Japan in 2025 forCrohn's Disease；
Donanemab is expected to be approved for use in the EUEarly Alzheimer's Disease。
Except forIn addition to the upcoming submission for marketing approval of pirtobrutinib and tirzepatide for new indications, Eli Lilly also has two new drugs that will be submitted to regulatory authorities for marketing application for the first time:
Insulin efsitora alfa（LY3209590）Is aOnce a weekAn insulin fusion protein that combines a novel single-chain variant of insulin with the human IgG2 Fc domain, the drug is expected to be submitted for the first time in 2025 for treatment.Type 2 DiabetesThe listing application;
Orforglipron is aNovel, Efficient, Orally Administrable Non-Peptide GLP-1RA, In 2018, Eli Lilly$50 millionThe upfront payment was introduced by Chugai Pharmaceutical, and the project will submit its first marketing application in 2025 for use inObesity.
In 2025,Lilly to Present Six Key Phase III Clinical Data for the First Time on Oral GLP-1R AgonistOrforglipron, Tirzepatide, Pirtobrutinib, Retatrutide:
First PublicationOral GLP-1R AgonistOrforglipron is used forObesityAnd for use inType 2 DiabetesKey Phase III Clinical Results;
First Disclosure of Tirzepatide for Diabetes PatientsSecondary Prevention of Cardiovascular EventsKey Phase III Clinical Results;
First disclosed comparison in untreated CLL patientsPirtobrutinib in Combination with Bendamustine and Rituximab, and a Comparison in CLL PatientsKey Phase III Clinical Results of Pirtobrutinib vs. Ibrutinib;
First AnnouncementGLP1R/GIPR/GCGR TriagonistRetaLutide（Retatrutide）Used forObesity and Knee OsteoarthritisThe key Phase III clinical results.
Roche
In 2025, Roche will receive regulatory approvals for a total of 7 indications, covering areas such as oncology and autoimmune diseases, involving three antibody drugs:
CD3/CD20 Bispecific Antibody Glocotuzumab（Columvi）New Therapy Expected to Be Approved in the U.S. and EU This Year, Combined with Gemcitabine and Oxaliplatin for Second-Line and Above Recurrent/Refractory TreatmentDiffuse Large B-Cell Lymphoma; The drug was approved for marketing in June 2023 at the earliest, with global sales in 2024.$195 million。
CD3/CD20 Bispecific Antibody Motuzumab（Lunsumio）WillFirst Approval of Subcutaneous Injection Formulation(United States), for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior lines of systemic therapy.
Obinutuzumab Targeting CD20（Gazyva）Will be taken down in the United States for the first timeLupus NephritisNew indications, the drug was first approved in November 2013, with global sales reaching $24 billion in 2024.$1.03 billion。
Multiple new drugs will unveil Phase III clinical trial results, including four new drugs being disclosed for the first time. These are a next-generation ER degrader, IL1RL1 monoclonal antibody, IL-6 monoclonal antibody, and BTK inhibitor:
First AnnouncementNew Generation Oral ER DegraderResults from two pivotal Phase III clinical trials of Giredestrant, including Giredestrant in combination with Everolimus versus endocrine therapy plus Everolimus, and Giredestrant in combination with Palbociclib versus Letrozole plus Palbociclib for ER+/HER2- locally advanced or metastatic breast cancer.Breast CancerPatient;
First Disclosure of IL1RL1 Monoclonal Antibody Astegolimab forChronic Obstructive Pulmonary DiseaseDiseaseThe key Phase III clinical results;
First Announcement of IL-6 Monoclonal Antibody Vamikibart forUveitic Macular EdemaThe key Phase III clinical results;
First Announcement of BTK Inhibitor Fenebrutinib forRelapsing Multiple SclerosisAndPrimary Progressive Multiple SclerosisThe key Phase III clinical results.
Screenshot source: Roche financial report
This article only manually compiles the significant milestone events of the aforementioned companies for 2025, and does not represent all of the company's milestones for this year.For the 2024 product sales of MNC enterprises that have released their financial reports, our Insight database has already recorded them all. Welcome to click on the link to the original article for inquiries.。
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