▎WuXiEdited by Kant Content Team

Recently, GlobalData, a well-known data analytics and research company, released a list of the top 20 global biopharmaceutical companies. In this ranking, Eli Lilly, Johnson & Johnson, and Novo Nordisk secured the top three positions. The content team at WuXi AppTec will summarize for our readers the progress these pharmaceutical companies made in 2023, as well as the R&D achievements they have recently announced.

▲Top 20 Biopharmaceutical Companies in 2023 (Source: Re-tabulated by the WuXi AppTec content team based on Reference [1])

Eli Lilly and Company

Eli Lilly's significant growth in 2023 was driven by the development of the blockbuster drug tirzepatide, a GIP/GLP-1 receptor dual agonist.In May 2022, the U.S. FDA approved tirzepatide (brand name: Mounjaro) for marketing, to be used in conjunction with diet and exercise to improve glycemic control in adult patients with type 2 diabetes. In November last year, tirzepatide received another approval.Approved by the U.S. FDA(Product name: Zepbound), used to help obese or overweight adult patients lose weight and maintain stable weight. Mounjaro's positive performance in the first, second, and third quarters of 2023, along with the subsequent approval of Zepbound, were key drivers of Eli Lilly's overall growth.

Johnson & Johnson

Johnson & Johnson has made extensive layouts for different treatment modalities in recent years. In August last year, its bispecific T-cell engager antibody Talvey (talquetamab), which targets CD3 and GPRC5D, was approved by the U.S. FDA.Accelerated ApprovalFor the treatment of adult patients with relapsed or refractory multiple myeloma. Johnson & Johnson entered into an agreement with Cellular Biomedicine Group (CBMG) in May 2023.Reach Cooperation, obtaining CBMG's bispecific autologous CAR-T therapy, and earlier this year through an investment of $20 billionAcquisitionAmbrx Biopharma Expands Its Antibody-Drug Conjugate (ADC) Pipeline. Earlier this month, Johnson & Johnson's investigational antibody therapy nipocalimab receivedBreakthrough Therapy Designation, used to treat pregnant women at high risk of severe hemolytic disease of the newborn (HDFN).The press release noted that if approved, nipocalimab would become the first approved therapy for this patient population.

Novo Nordisk

Novo Nordisk's重磅drug semaglutide was approved by the U.S. FDA for上市in 2017 and 2021, respectively, forType 2 DiabetesPatient's Blood Glucose Control (Brand Name: Ozempic) and TreatmentSimple ObesityPatient (Trade Name: Wegovy).The successful launch of the drug has driven the overall growth of Novo Nordisk, which continues to expand its presence in the weight loss and diabetes fields.Actively improve the potential side effects of drugs and expand new indications.

MSD

In addition to focusing on the expansion of its blockbuster drug PD-1 inhibitor Keytruda for various cancer indications, MSD continued to expand its presence in the cancer field last year. In October last year, MSD reached a $22 billion agreement with Daiichi Sankyo for three ADCs under development.Cooperation Agreement, to jointly develop therapies for the treatment of various solid tumors. In addition,The personalized neoantigen mRNA cancer vaccine mRNA-4157, developed through the collaboration between MSD and Moderna, in combination with Keytruda, continues to make progress.Last December, the two companies announced the 3-year follow-up data of this combination therapy for the treatment of high-risk melanoma (Stage III/IV) patients after surgical resection. The analysis showed,This combination therapy significantly improved patients' recurrence-free survival (RFS) rate by 49% and distant metastasis-free survival (DMFS) rate by 62%.

AbbVie（AbbVie）

In May 2023, the bispecific antibody therapy Epkinly (epcoritamab), jointly developed by AbbVie and Genmab, was approved by the U.S. FDA.Accelerated ApprovalLaunched for the treatment of relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).This is the first bispecific antibody therapy approved by the FDA for the treatment of patients with DLBCL. This innovative therapy was also listed by the industry media Evaluate as one of the top ten potential blockbuster therapies expected to be approved this year.In November last year, AbbVie reached a total of approximately $10.1 billionAcquisitionImmunoGen, Inc., obtains its folate receptor alpha (FRα)-targeted ADC therapy Elahere (mirvetuximab soravtansine).

Roche

Roche's CD3 x CD20-targeted bispecific antibody Columvi (glofitamab) was approved in March and June last year, respectively.Health CanadaAndU.S. FDAApproved for the treatment of R/R DLBCL patients. Trial results show that this therapy can bring about a complete response (CR) rate of approximately 40% in R/R DLBCL patients.Roche's investigational KRAS G12C inhibitor, divarasib, achieved confirmed response rates of 53.4% and 29.1% in patients with non-small cell lung cancer and colorectal cancer, respectively, in a Phase 1 clinical trial, positioning it as a potential "best-in-class" drug.In addition,Roche's Two New Drugs, Crovalimab and Inavolisib, Are Expected to Receive Regulatory Approval in 2024These two drugs are respectively used for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer.

Novartis

Novartis' Tafinlar (dabrafenib) in combination with Mekinist (trametinib) received FDA approval last year.ApprovalThis approval makes Tafinlar + Mekinist the first approved combination targeted therapy for the treatment of pediatric patients with low-grade glioma harboring the BRAF V600E mutation. Novartis expects to complete more than 15 pivotal marketing applications across four core therapeutic areas by 2027.Novartis will also promote three breakthrough technologies to expand its medium- and long-term growth space: the application of radiopharmaceuticals in solid tumors, the use of CAR-T cell therapy in immune diseases, and the application of siRNA in neurological and cardiovascular diseases.

AstraZeneca

AstraZeneca is actively expanding its presence in the field of oncology, with the goal of having its drugs treat over 50% of lung cancer patients and one-third of breast cancer patients by 2030. AstraZeneca’s R&D pipeline includes several next-generation cancer immunotherapies and antibody-drug conjugates, such as volrustomig, a bispecific antibody targeting PD-1 and CTLA-4; rilvegostomig, a bispecific antibody targeting PD-1 and TIGIT; and AZD0901, an antibody-drug conjugate targeting CLDN18.2, among others.Beyond oncology, the company believes that the R&D pipeline in the cardiovascular, renal, and metabolic (CVRM) disease areas contains multiple potential blockbuster therapies.In November last year, AstraZeneca reached an agreement with Eternity Bioscience to develop the small molecule GLP-1 receptor agonist (GLP-1RA) AZD5004 for potential treatment of obesity, type 2 diabetes, and other comorbidities. Key projects in the CVRM field also include baxdrostat for hypertension and the oral PCSK9 inhibitor AZD0780.

Pfizer

Pfizer spent approximately $43 billion in March last year.AcquisitionSeagen, acquiring its multiple oncology ADC drugs, including the Nectin-4-targeted ADC therapy Padcev (enfortumab vedotin), which received full FDA approval in December last year for first-line treatment of patients with advanced or metastatic urothelial cancer. Additionally, Pfizer has also invested in the development of weight loss therapies. Clinical trial results from the Phase 2b study of its oral small molecule GLP-1 receptor agonist danuglipron showed efficacy in patients with type 2 diabetes.Danuglipron significantly reduced patients' glycated hemoglobin (HbA1c), fasting blood glucose levels, and body weight. In patients receiving the highest dose of danuglipron, HbA1c decreased by 1.16 percentage points, and body weight was reduced by 4.17 kilograms.

Amgen (Amgen)

Amgen's key achievements in 2023 include building a rare disease pipeline through the acquisition of Horizon and Tavneos. Additionally, its potential "first-in-class" investigational weight loss therapy, MariTide (AMG133), is a peptide conjugate drug (antibody-peptide conjugate) that conjugates two GLP-1 analogs at specific sites of a monoclonal antibody targeting the gastric inhibitory polypeptide receptor (GIPR), activating the GLP-1 receptor while inhibiting GIPR. The results of the Phase 1 clinical trial of this therapy showed,Obese patients only need one injection per month. After 85 days of high-dose MariTide treatment, their weight can be reduced by 14.5% (approximately 26 catties). Notably, these patients can still maintain a weight reduction of 11.2% even 150 days after discontinuing the medication.

Sanofi (Sanofi)

One of Sanofi's key R&D focuses is further expanding the indications for its blockbuster drug Dupixent, which has already been approved for treating nine different conditions. Recently, Dupixent met the primary endpoints in two Phase 3 clinical trials for the treatment of chronic obstructive pulmonary disease (COPD), potentially adding a new indication for this blockbuster drug.Besides Dupixent, there are 12 new molecular entities with blockbuster potential in Sanofi's R&D pipeline.The launch of these therapies and vaccines, together with the expansion of Dupixent's indications, will support the company’s further development in the future.

Vertex Pharmaceuticals

And with the approval and market launch of Casgevy (exagamglogene autotemcel, exa-cel), a CRISPR gene-editing therapy co-developed by Vertex and its partner CRISPR Therapeutics in the UK in November 2023, it has becomeWorld's First ApprovedCRISPR gene-editing therapy. The U.S. FDA subsequently approved the therapy in December 2023 and January this year for the treatment ofSickle Cell Anemia(SCD) and Transfusion Dependenceβ-Thalassemia(TDT) patients.In addition to focusing on the development of gene-editing therapies, Vertex is also about to submit its selective NaV1.8 inhibitor VX-548 for the treatment of moderate to severe acute pain.New Drug Application（NDA）。The press release noted that if approved, this would become the first new painkiller with a novel mechanism of action in decades.In addition, Vertex also announced earlier this month that its next-generation triple combination therapy (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of cystic fibrosis (CF) achieved positive results in three Phase 3 clinical trials.Positive ResultsThe company is expected to submit marketing applications to regulatory authorities in the United States, the European Union, and Canada by mid-2024.

Bristol-Myers Squibb

Bristol-Myers Squibb's current pipeline covers four areas: oncology, hematology, cardiovascular diseases, and immunological disorders. Among them, 11 major approved drugs are in the growth phase, and 12 research projects are about to enter or have already entered the marketing application stage.In 2024, the company is expected to reach important milestones for 12 key pipelines.Including those from KarunaAcquisitionKarXT is expected to receive its first marketing approval for the indication of schizophrenia in China, along with the first clinical trial results for a cell therapy targeting the autoimmune disease systemic lupus erythematosus (SLE).

Gilead Sciences

Gilead Sciences' strategic transformation is gradually taking shape. From 2019 to 2023, the number of clinical pipelines increased by 88%, with five new drugs launched. Oncology has also become a key component of the company’s pipeline. Trodelvy, an antibody-drug conjugate targeting Trop-2, has been approved for the treatment of three different cancer types and is currently involved in over 30 active clinical trials, demonstrating potential for treating a wide range of cancer types.Gilead Sciences is expected to have updates on at least five Phase 3 clinical trials in 2024. In the oncology field, there are three Phase 3 clinical trials for Trodelvy, while in the HIV field, there is a Phase 3 clinical trial for the long-acting HIV drug lenacapavir for post-exposure prophylaxis.

Regeneron

Regeneron's growth has mainly been driven by the approval of its high-dose treatment by the U.S. FDA.Ophthalmic Drug Eylea(Aflibercept), used to treat patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy.Aflibercept is an ocular injectable agent with the main component being a vascular endothelial growth factor (VEGF) inhibitor. The 8 mg dose level of aflibercept was jointly developed by Regeneron and Bayer. This new concentrated high-dose formulation can increase the amount of medication delivered per treatment and is expected to extend the dosing interval while maintaining the efficacy and safety profiles observed at the approved dose levels.

CSL

The gene therapy Hemgenix (etranacogene dezaparvovec) developed by CSL was approved by the U.S. FDA in November 2022 andEUApproved for one-time treatment of patients with moderate to severe hemophilia B.Clinical trials showed that the therapy significantly increased the level of clotting factor IX in patients, reduced prophylactic treatment with clotting factor IX, and decreased the annual bleeding rate by 54%.Hemgenix was granted Breakthrough Therapy Designation, Orphan Drug Designation, and Priority Review by the U.S. FDA. This therapy won the "Nobel Prize of the pharmaceutical industry" last year.Galen PrizeBest Product for Rare/Orphan Diseases

GSK

GSK performed strongly in 2023 across its four core therapeutic areas—infectious diseases, HIV, respiratory/immunology, and oncology. For example, the Respiratory Syncytial Virus (RSV) vaccine received regulatory approval in the United States, the European Union, and Japan, becoming the first approved RSV vaccine to reach the market. Additionally, GSK's JAK inhibitor Ojjaara (momelotinib) became the first to receive FDA approval last September.ApprovalA drug for the treatment of myelofibrosis patients with anemia, aimed at alleviating key symptoms such as anemia and splenomegaly associated with the disease.In 2024, the company’s oncology R&D pipeline is expected to see a series of advancements. Among them, the Phase 3 clinical trial of the combination therapy consisting of the PD-1 inhibitor Jemperli (dostarlimab) and the anti-TIM3 antibody cobolimab for the treatment of non-small cell lung cancer (NSCLC) is anticipated to yield results.

Daiichi Sankyo

Daiichi Sankyo's ADC platform utilizes a topoisomerase I inhibitor, DXd, and a cleavable linker. Currently, the platform has five ADC drugs in clinical development. Among them, Enhertu, an ADC therapy targeting HER2, has received approval for four indications in the United States. Enhertu and Dato-DXd, which targets Trop-2, are being co-developed with AstraZeneca, while HER3-DXd, DS-7300 targeting B7-H3, and DS-6000 targeting CDH6 are being co-developed with MSD.Daiichi Sankyo's future R&D strategy is divided into two major directions: accelerating the development of five ADCs in the pipeline and the "Next wave" of new drug R&D, including oncology, specialty medicines, and vaccines.For the five ADCs under development, Daiichi Sankyo's strategy is to simultaneously expand into more tumor types and earlier lines of treatment.

Takeda Pharmaceutical Company Limited

Fruzaqla (fruquintinib), a drug co-developed by Takeda and its partner Hutchmed, received approval from the U.S. FDA in November of last year.Approved for Marketing, for the treatment of specific colorectal cancer patients. Earlier this month, the U.S. FDAApprovalEohilia (Budesonide Oral Suspension) Launched to Treat Eosinophilic Esophagitis (EoE) Patients Aged 11 and Above. The press release noted that this is the first FDA-approved oral therapy for EoE, offering hope to address significant unmet patient needs.Takeda said early last year that 10 of its late-stage development projects are expected to file for new drug marketing applications or expand indications in the coming years.

Moderna

Moderna currently has 45 R&D projects, 37 of which are in clinical development. The company has leveraged its mRNA technology platform to advance late-stage clinical development programs in the fields of respiratory diseases, latent virus vaccines, personalized cancer vaccines, and rare disease therapies.These late-stage clinical development programs include RSV and influenza vaccines. The Phase 3 clinical trial of an mRNA vaccine for the prevention of cytomegalovirus (CMV) is expected to yield efficacy data this year. The Phase 3 clinical trial of a personalized cancer vaccine, developed in collaboration with Merck, for the treatment of melanoma and non-small cell lung cancer is also currently enrolling patients. An mRNA therapy for methylmalonic acidemia (MMA) and propionic acidemia (PA) is expected to enter pivotal clinical trials in 2024. These late-stage R&D programs will support the company’s continued growth.

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References:

[1] Top 20 global biopharmaceutical companies report 1.6% market capitalization growth to $3.67 trillion in 2023, reveals GlobalData. Retrieved February 21, 2024 from https://www.globaldata.com/media/business-fundamentals/top-20-global-biopharmaceutical-companies-report-1-6-market-capitalization-growth-to-3-67-trillion-in-2023-reveals-globaldata/

[2] Lilly Edges Out J&J to Top 20 BioPharma Market Cap List for 2023. Retrieved February 21, 2024 from https://www.biospace.com/article/eli-lilly-edges-out-j-and-j-to-top-20-biopharma-market-cap-list-for-2023-/

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