▎WuXiEdited by Kant Content Team

Recently, GlobalData, a well-known data analytics and research company, released the list of the top 20 global biopharmaceutical companies.In this list, Eli Lilly, Johnson & Johnson, and AbbVie rank in the top three.The content team of WuXi AppTec will organize the progress made by these pharmaceutical companies in 2024, as well as the R&D achievements recently announced, for our readers.

Eli Lilly and Company

Eli Lilly's significant growth in 2024 is closely tied to the development of the blockbuster drug tirzepatide. It has already received FDA approval (brand name Zepbound) for helping obese or overweight adult patients lose weight. In 2024,Zepbound also receivedFDA ApprovalUsed to improve snoring conditions in obese patients with moderate to severe obstructive sleep apnea (OSA), becoming the first approved prescription drug for treating this patient population.In 2025, the indication for tirzepatide in treating heart failure with preserved ejection fraction (HFpEF) is expected to gain approval from the U.S. FDA.Phase 3 Clinical TrialIt significantly reduced the risk of worsening heart failure events in obese patients with HFpEF. In addition, the results of two Phase 3 clinical trials of its next-generation oral weight-loss therapy, orforglipron, conducted in patients with type 2 diabetes and obesity are expected to be announced, supporting regulatory submissions.

Johnson & Johnson

In 2024,Johnson & Johnson's EGFR/MET Bispecific Antibody Rybrevant Secures Multiple Regulatory Approvals.United StatesFDA ApprovalIt is used in combination with Lazcluze, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, as a first-line treatment for patients withEGFRAdult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring exon 19 deletions or the L858R substitution mutation in exon 21. The combination therapy consisting of this treatment and standard chemotherapy has also been approved.FDA ApprovalTreatment of previously treated NSCLC patients. Its重磅IL-23 inhibitor Tremfya was approved for the treatment of moderate to severe active ulcerative colitis (UC). In 2025, its potential blockbuster therapy targeting the neonatal Fc receptornipocalimabExpected to be approved for the treatment of generalized myasthenia gravis. The company has initiated the submission of TAR-200 to the U.S. FDA.New Drug Application(NDA), used to treat high-risk non-muscle invasive bladder cancer (HR-NMIBC) patients with carcinoma in situ who do not respond to Bacillus Calmette-Guérin (BCG).

AbbVie

AbbVie completed its acquisitions of ImmunoGen and Cerevel Therapeutics in 2024, further expanding its oncology and neuroscience R&D pipelines. The acquisition of ImmunoGen obtained"First-in-class" Antibody-Drug Conjugate (ADC) Elahere has been approved.Full approval from the FDA, for the treatment of patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.In 2025, its JAK inhibitor Rinvoq for the treatment of adult giant cell arteritis (GCA)Regulatory ApplicationExpected to be approved. Potential "first-in-class" antibody-drug conjugatetelisotuzumab vedotinExpected to be approved for the treatment of adult patients with locally advanced or metastatic non-squamous NSCLC who have been previously treated and exhibit overexpression of the c-Met protein.

Novo Nordisk

The number of patients globally treated with GLP-1 drugs from Novo Nordisk has increased nearly threefold in the past three years.. Its blockbuster therapy Ozempic (semaglutide) has further expanded its usage scope and was recently approved.FDA ApprovalUsed to reduce the risk of nephropathy progression, renal failure (end-stage renal disease), and cardiovascular disease-related mortality in adult patients with type 2 diabetes and chronic kidney disease (CKD).The Company's Next-Generation Weight Loss TherapyCagriSemaIn Phase 3 Clinical TrialsREDEFINE 1In China, the average weight loss of subjects was 22.7%.The subcutaneous injection weight-loss therapy Amycretin inPhase 1b/2a Clinical TrialAlso achieved positive results in China, reducing the weight of subjects by 22% at 36 weeks. In addition, its long-acting hemophilia A therapy, Mim8, inPhase 3 Clinical TrialIn China, over 70% of patients did not experience bleeding that required treatment, and the company plans to submit the regulatory application for Mim8 this year.

Merck & Co., Inc. (MSD)

Merck'sHeavyweight PD-1 inhibitor Keytruda continues to secure new indications, and itsSubcutaneous injection formulation inPhase 3 Clinical TrialAchieved Dual Primary Endpoints in China`, is expected to support the submission of regulatory applications. Its "first-in-class" potential blockbuster therapy Winrevair in clinical trials`ZENITHAndHYPERIONPositive results were achieved in China, with the potential to further expand the treatable population of pulmonary arterial hypertension patients. In 2024, the company's 21-valent pneumococcal conjugate vaccineCapvaxiveObtained FDA approval for marketing.Merck Also Steps into the Field of Weight Loss Drug Development, through collaboration with Hansoh PharmaReach Cooperation, including the small molecule GLP-1 receptor agonist HS-10535 (MK-4082).

Roche

Roche's VEGF Inhibitor Ranibizumab Monoclonal Antibody Drug Delivery SystemSusvimo ObtainedFDA Approval, for the treatment of diabetic macular edema.Patients only need to receive treatment twice a year, and their vision is expected to be maintained.Recently, Genentech, a subsidiary of the company, announced that the U.S. FDA has approved the thrombolytic agent.TNKase(Tenecteplase) launched for the treatment of adult acute ischemic stroke (AIS). This isThe First Stroke Drug Approved by the FDA in Nearly 30 YearsIn 2025, the pivotal Phase 3 clinical trial of giredestrant, a potential "best-in-class" selective estrogen receptor degrader for first-line treatment of HR+/HER2- breast cancer patients, is expected to report results.

Novartis

Novartis' Potential Blockbuster Therapy Fabhalta Receives U.S.FDA ApprovalExpanded indications for use in reducing proteinuria levels in adult patients with IgA nephropathy (IgAN). It recently also received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use.Recommendation, supporting the approval for treating adult patients with C3 glomerulopathy (C3G). The company's PSMA-targeted radioligand therapy Pluvicto,In the treatment of metastatic castration-resistant prostate cancer (mCRPC) patients who have not received taxane chemotherapyPhase 3 Clinical TrialThe proportion of patients achieving complete remission increased nearly 8 times.Novartis expects to submit regulatory applications this year to expand the indications for Pluvicto.

AstraZeneca

AstraZeneca's Key PD-L1 Inhibitor Imfinzi Receives U.S. ApprovalFDA Approval, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after receiving platinum-based concurrent chemoradiotherapy (cCRT). Its regulatory application for the treatment of muscle-invasive bladder cancer (MIBC) has also been accepted by the FDA.Priority Review Status, and is expected to be approved in the second quarter of this year. Enhertu, an antibody-drug conjugate jointly developed with Daiichi Sankyo, was recently approved.FDA ApprovalTreating HR-positive, HER2-low or ultra-low expression breast cancer patients. The company's executives stated,Enhertu is expected to become the standard treatment for various breast cancers with different levels of HER2 expression.In 2025, Datroway, another antibody-drug conjugate jointly developed with Daiichi Sankyo, was approved.FDA ApprovalLaunched for the treatment of HR-positive, HER2-negative pretreated breast cancer patients. The phase 3 clinical trial of Datroway for NSCLC and triple-negative breast cancer is expected to report results this year.

Pfizer

December 2024,U.S. FDAAccelerated ApprovalPfizer's BRAF inhibitor Braftovi, in combination with Erbitux and a chemotherapy regimen (including fluorouracil, leucovorin, and oxaliplatin), is used to treat patients with metastatic colorectal cancer who have been detected to carry the BRAF V600E mutation.Its subcutaneous injection PD-1 inhibitor Sasanlimab recently in pivotalPhase 3 Clinical TrialIn China, the primary endpoint was reached, and when used in combination with BCG, it significantly improved the event-free survival (EFS) of BCG-naïve, high-risk non-muscle invasive bladder cancer patients. In 2025, Pfizer's respiratory syncytial virus (RSV) vaccine Abrysvo is expected to be approved in the EU. Recently, the company reached an agreement with Summit Therapeutics.Clinical Trial CollaborationTo evaluate the efficacy of ivonescimab, a bispecific antibody targeting PD-1/VEGF, in combination with various antibody-drug conjugates from Pfizer, for the treatment of multiple solid tumors.

Amgen

Amgen's Potential "First-in-Class" Weight Loss Therapy MariTidePhase 2 Clinical TrialPositive results were obtained in China,In obese or overweight individuals without type 2 diabetes, MariTide achieved an average weight loss of approximately 20% at week 52.Its Phase 3 clinical trial is expected to launch in the first half of this year. Tezspire, a "first-in-class" monoclonal antibody co-developed with AstraZeneca, is for the treatment of patients with chronic rhinosinusitis with nasal polyps (CRSwNP).Phase 3 Clinical TrialPositive results were obtained in China. It also receivedBreakthrough Therapy Designation, used to treat patients with chronic obstructive pulmonary disease (COPD).

Sanofi

Recently, Sanofi has made breakthrough progress in multiple research and development fields. The monoclonal antibody collaboration with Teva Pharmaceuticalsduvakitug inPhase 2b TrialIn China, it enabled patients with ulcerative colitis and Crohn's disease to achieve remission by the 14th week, demonstrating the potential of a "best-in-class" therapy.. Meanwhile,Fitusiran, a monthly subcutaneous siRNA therapy co-developed with Alnylam, reduced patients' annualized bleeding rate by 90% in two Phase 3 studies., whose listing application has been accepted by the regulatory authorities in China and the United States. This therapy has been listed by the well-known industry institution Clarivate as potentially being the futureHeavyweight New DrugOne of them. In addition, the supplemental Biologics License Application for Dupixent, the重磅 anti-inflammatory drug co-developed by Sanofi and Regeneron, has been granted by the U.S. FDA.Priority Review Eligibility，Expected to become the first targeted drug for adult bullous pemphigoid.At the same time, Sanofi is also preparing the marketing applications for its Bruton's tyrosine kinase (BTK) inhibitors, tolebrutinib and rilzabrutinib, for the treatment ofNon-relapsing Secondary Progressive Multiple Sclerosis(nrSPMS) andImmune Thrombocytopenia（ITP）。

Gilead Sciences

Gilead Sciences has recently made significant R&D progress in multiple areas. In February this year, the company announced that the new drug application for lenacapavir, used for HIV pre-exposure prophylaxis, has been accepted by the U.S. FDA.Priority Review Status。The therapy inAccepted by the European Medicines Agency a week laterMarketing Authorization Application。LenacapavirIf approved,Will become the first HIV prevention regimen that requires only two injections per year.In addition, the European Commission has granted conditional approval to its pharmaceuticals.seladelparLaunched, in combination with ursodeoxycholic acid (UDCA) for the treatment of primary biliary cholangitis patients who respond inadequately to UDCA monotherapy, or as a monotherapy for patients with poor tolerance.In December last year, the U.S. FDA granted Trop-2 targeted antibody-drug conjugateTrodelvyBreakthrough Therapy Designation for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed after platinum-based chemotherapy.

Bristol Myers Squibb

Recently, Bristol-Myers Squibb has made significant breakthroughs in the fields of immuno-oncology and mental health. In February this year, the U.S. FDA accepted the application for Opdivo in combination with Yervoy for the first-line treatment of patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer.Supplemental Biologics License Application(sBLA), and granted Breakthrough Therapy Designation and Priority Review status. Meanwhile, Phase 3CheckMate-816 TrialThe final overall survival analysis showed,Opdivo Combined with Platinum Doublet Chemotherapy as Neoadjuvant Therapy Significantly Prolongs Survival Compared to Chemotherapy Alone in Patients with Resectable NSCLC.September 2024,Approved by the U.S. FDACobenfyOral capsules for the treatment of adults with schizophrenia, the first antipsychotic drug targeting cholinergic receptors., marking a major innovation in the treatment mechanism of mental illnesses.

Vertex Pharmaceuticals

Vertex Recently Welcomes Multiple Positive Regulatory Developments. Casgevy, the CRISPR gene-editing therapy co-developed with its partner CRISPR Therapeutics, was approved for marketing in the UK in November 2023, becoming the world's first approved CRISPR gene-editing therapy. In January this year, the US FDA approved the company’s “first-in-class” therapy.JournavxLaunched for the treatment of moderate to severe acute pain in adults.According to the FDA press release, Journavx is the first non-opioid pain medication based on a new mechanism approved by the FDA, marking a new era of treatment in the field of pain management.The press release pointed out that this drug is the first new mechanism drug for treating acute pain in more than twenty years. At the end of last year,The U.S. FDA approved the company's development of the next-generation cystic fibrosis transmembrane conductance regulator (CFTR) modulator combination.Alyftrek Launch, for the treatment of patients aged 6 years and above who carry at least one F508del mutation or others responsive to AlyftrekCFTRCystic fibrosis patients with gene mutations.

CSL

Hemgenix, a gene therapy developed by CSL, was approved by the U.S. FDA in November 2022 and by the EU in February 2023 for one-time treatment of patients with moderate to severe hemophilia B. This therapy won the Galien Award's Best Orphan Drug/Rare Disease Product in 2023, known as the "Nobel Prize of the pharmaceutical industry." Additionally, the European Commission approved this "first-in-class" therapy last month.Andembry Launch, used to prevent hereditary angioedema (HAE) attacks in adult and adolescent patients aged 12 years and older.The press release noted that it is the first HAE attack prevention therapy that requires only one injection per month and targets plasma protein factor XIIa (FXIIa).The U.S. FDA is currently reviewing this therapy.

Regeneron

Regeneron recently achieved several important regulatory advances. In addition to the above-mentioned重磅 anti-inflammatory drug Dupixent, jointly developed with Sanofi, which is expected to become the first targeted drug for adult bullous pemphigoid,The Committee for Medicinal Products for Human Use of the European Medicines Agency also recentlyRecommendationLinvoseltamab, a bispecific antibody, conditionally approved for the treatment of adult patients with relapsed or refractory multiple myeloma., The European Commission is expected to make a final decision in the coming months. Meanwhile, the U.S. FDA has accepted Regeneron's therapy.odronextamabResubmittedBiologics License Application(BLA), used to treat patients with relapsed or refractory follicular lymphoma who have received two or more lines of systemic therapy.

GSK

GSK has recently made several important breakthroughs in the field of research and development. Last month, the U.S. FDAApprovalIts vaccine Penmenvy (MenABCWY) is used for people aged 10 to 25 to prevent invasive diseases caused by common meningococcal serogroups.The vaccine has been awarded Clarivate.SelectionHas the potential to become a blockbuster drug in the next five years.Earlier this month, the US FDA accepted GSK's investigational therapy depemokimab for review.BLA, for the treatment of asthma patients with type 2 inflammation characteristics and chronic rhinosinusitis patients with nasal polyps whose condition is not well controlled.According to the press release, if approved, the drug will become the first ultra-long-acting biologic that requires dosing only once every six months.At the same time, the FDA has also accepted GSK's gepotidacinListing Application，This therapy is expected to become the first new oral antibiotic for the treatment of uncomplicated urinary tract infections in over 20 years.The FDA is expected to announce the review results by March 26, 2025.

Daiichi Sankyo

Daiichi Sankyo has recently made significant progress in the field of ADC therapy.Its Trop-2 targeted ADC therapy Datroway, co-developed with AstraZeneca, received approval from the U.S. FDA in January this year.Approved for Marketing, applicable to HR-positive, HER2-negative advanced breast cancer patients who have previously received endocrine therapy and chemotherapy. Phase 3 trials show that this therapy reduces the risk of disease progression or death by 37% compared to chemotherapy. The EU review results are expected to be announced in the first quarter of this year. Meanwhile, the HER2-targeted drug Enhertu, developed by the two parties, was approved in the same month.FDA Re-Approval, for the treatment of patients with HER2-low or ultra-low expression advanced breast cancer. In addition, what was announced at the beginning of this monthLatest Clinical ResultsShows that Enhertu significantly improves overall survival in HER2-positive gastric cancer patients as a second-line therapy; independent data monitoring committee recommends early unblinding.The press release stated that Enhertu is the first HER2-targeted therapy to significantly improve overall survival in HER2-positive gastric cancer patients as a second-line treatment in a randomized Phase 3 clinical trial.

Takeda

Takeda has been making frequent moves recently. Last month, TakedaBridGene BiosciencesReached a strategic collaboration and licensing agreement exceeding 800 million US dollars. According to the agreement,BridGene will leverage its chemoproteomics platform IMTAC to discover novel small-molecule drug candidates targeting undruggable targets in the fields of immunology and neurology.At the end of last year, Takeda reached an agreement with Keros TherapeuticsExclusive Agreement, to advance the development of elritercept, an activin A-targeted protein. Elritercept is currently undergoing late-stage clinical trials for evaluation of its efficacy and safety in treating myelodysplastic syndromes (MDS) and myelofibrosis (MF). In addition to the collaboration deal, the company is also co-developing a potential "first-in-class" investigational natural hormone, hepcidin, with Protagonist Therapeutics.Polypeptide Mimetic Rusfertide, also achieved remarkable results in the Phase 3 trial VERIFY. The study met its primary endpoint as well as all four key secondary endpoints, with rusfertide as an add-on to standard treatment.Enabling nearly 80% of patients with polycythemia vera (PV) to no longer require phlebotomy treatment.

UCB (China)

The U.S. FDA in November last yearApprovalUCB's Bimzelx is used to treat adult patients with moderate to severe hidradenitis suppurativa (HS).According to the press release, Bimzelx is the first approved therapy that can simultaneously and selectively inhibit interleukin-17A (IL-17A) and interleukin-17F (IL-17F).Industry media Fierce Biotech once referred to Bimzelx as having the potential to become a blockbuster drug. In the same month, dapirolizumab pegol (DZP), a CD40 ligand-targeted therapy co-developed by the company and Biogen, also achieved positive results in the Phase 3 PHOENYCS GO study.Positive ResultsAnalysis shows that the trial met its primary endpoint, and the combination of DZP with standard treatment significantly improved disease activity in patients with moderate to severe systemic lupus erythematosus (SLE).

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