In the world of innovative drug development, FIC (First in Class) molecules and BIC (Best in Class) molecules are like two powerful currents, converging to become the main driving force behind pharmaceutical innovation. FIC molecules create new pathways, offering early market advantages through scientific breakthroughs; BIC molecules, on the other hand, refine existing pathways, winning market recognition through superior product features. However, the world of innovation is vast, and in addition to these two main tracks, there are many products that stand out due to unique development strategies, collectively narrating the exciting story of innovative drug research and development.
As benchmarks for original innovation, FIC drugs' core advantage lies in creating an unshakable market barrier after pioneering entirely new fields. These drugs not only enjoy market exclusivity but also establish industry authority by defining clinical standards, often leading to substantial market returns. Typical representatives include Ojjaara (momelotinib), Camzyos (mavacamten), Tezspire (tezepelumab), Pluvicto (lutetium [177Lu] PSMA-617), Winrevair (sotatercept), Truqap (capivasertib), and Vabysmo (faricimab).
Ojjaara (momelotinib) is a breakthrough drug in the field of myelofibrosis, with sales reaching $451 million in its first full year after launch. Myelofibrosis is a rare and severe bone marrow proliferative tumor with limited treatment options and bleak chances of cure. Existing treatments like Jakafi/Jakavi (ruxolitinib) can alleviate symptoms like spleen enlargement but may worsen anemia. In contrast, Momelotinib works by inhibiting the JAK-STAT signaling pathway related to inflammation and additionally suppressing AVCR1 (activin A receptor type 1) to stimulate red blood cell production, offering a dual effect of controlling inflammation and improving anemia. As the only drug that improves anemia symptoms in myelofibrosis patients, Ojjaara has brought hope to desperate patients.
Similarly, in the field of solid tumors, new stars are rising. Truqap (capivasertib), the world’s first AKT inhibitor, can precisely treat HR+/HER2- breast cancer patients with PIK3CA/AKT1/PTEN mutations by inhibiting AKT kinase activity and blocking the PI3K/AKT/mTOR pathway. It fills a clinical gap and generated $430 million in sales in its first year on the market.
Pluvicto (lutetium [177Lu] PSMA-617) is the first radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) that can precisely irradiate prostate cancer. With the potential to replace whole-body radiotherapy, Pluvicto achieved $1.392 billion in sales by its third year, unlocking the first "blockbuster" achievement in the radiopharmaceutical field. This year, the treatment indication for Pluvicto may expand to metastatic castration-resistant prostate cancer (mCRPC) patients who have not received taxane chemotherapy, offering a new revenue growth point and further validating the commercial potential of radiopharmaceuticals.
Tezspire (tezepelumab), a respiratory product, also crossed the $1 billion threshold in its third year on the market. It is the world’s only TSLP-targeting drug, which can treat patients who respond poorly to traditional IL-4/IL-5-targeted therapies, offering potential for market expansion. Currently, Tezspire is exploring expanded indications, and a Phase III study for chronic obstructive pulmonary disease (COPD) is expected to start in the first half of this year.
In the cardiovascular field, Winrevair (sotatercept) and Camzyos (mavacamten) are shining. Winrevair (sotatercept) is a revolutionary new drug for pulmonary arterial hypertension (PAH) that generated $419 million in sales within less than a year, far surpassing the previous bestseller, Opsumit (macitentan). Unlike traditional therapies like Opsumit, which only dilate blood vessels, Winrevair may reverse or delay disease progression, achieving "disease-modifying" effects. The Phase III STELLAR trial showed that when combined with standard treatment, Winrevair reduced the risk of clinical worsening or death by 84% compared to placebo plus standard therapy (HR=0.16).
Camzyos is the world’s first myosin inhibitor for treating obstructive hypertrophic cardiomyopathy (HCM), filling a long-standing gap in targeted therapies for this condition. Currently, Camzyos is the only approved drug for targeted treatment of HCM, with no direct competitors. However, a competitor, Aficamten (CK-274), with BIC potential, has already filed for approval.
Vabysmo (faricimab), a new ophthalmic product, continues to show its explosive potential. Compared to traditional VEGF monoclonal antibodies, faricimab innovates in its mechanism by inhibiting both VEGF-A (vascular endothelial growth factor A) and Ang-2 (angiopoietin-2), offering durable multiple effects. With superior efficacy and a longer dosing interval, Vabysmo has become the top choice for ophthalmic patients. In 2024, Vabysmo expanded its indications across the three major pharmaceutical markets of the U.S., Europe, and China, maintaining rapid sales growth, and achieved $4.4 billion in sales in its third year.
Scientific innovation never stops at the first breakthrough, and BIC molecules can surpass FIC ones by upgrading efficacy, safety, and other aspects. Typical representatives include Wegovy (semaglutide), Zepbound (tirzepatide), Leqvio (inclisiran), Beyfortus (nirsevimab), Carvykti (ciltacabtagene autoleucel), and Breyanzi (lisocabtagene maraleucel).
The GLP-1 field has seen continuous excitement, with products evolving from diabetes treatments to weight loss solutions. Since liraglutide unlocked the weight loss effect, the GLP-1 era for weight loss began, and subsequent products like Wegovy (semaglutide) and Zepbound (tirzepatide) quickly became two of the leading weight loss drugs due to their exceptional weight loss effects and lower injection frequency. Wegovy, which first opened the market, reached $8.448 billion in sales in 2024 (+86%) after three years of market penetration. Zepbound, with its dual-target mechanism, leveraged the popularity of GLP-1 to quickly penetrate the market, generating $4.926 billion in its first year (+270%). Both products are now expanding into markets beyond weight loss, aiming to break pharmaceutical industry records for single-product sales.
The PCSK9 field has also witnessed exciting innovation with both new and old products. Leqvio (inclisiran), which uses siRNA technology, offers more significant lipid-lowering effects and longer dosing intervals (once every six months vs. monthly), greatly improving patient adherence and differentiating itself from traditional PCSK9 monoclonal antibodies. As a result, Leqvio has achieved rapid sales growth, reaching $754 million in 2024 (+114%). The iteration continues, with Merck’s oral PCSK9 inhibitor enlicitide completing Phase III studies this year and potentially joining the market race next year.
The RSV infection story further illustrates that BIC innovation not only enhances efficacy but also focuses on unmet clinical needs. Compared to previous-generation RSV monoclonal antibody products, Beyfortus (nirsevimab) shows significant advantages in safety and long-lasting effects and can cover a broader range of infant populations. Moreover, unlike vaccines that require active immunization, Beyfortus provides immediate passive immunity protection with a safer risk profile, meeting the rigid needs of infants. As the only RSV monoclonal antibody for infants, Beyfortus has maintained strong commercial performance, with sales soaring 205% in 2024, reaching $2.147 billion and entering the "blockbuster" territory. However, Beyfortus will soon face competition as Merck’s clesrovimab has filed for approval, potentially taking some market share.
In the CAR-T field, the rise of Carvykti (ciltacabtagene autoleucel) and Breyanzi (lisocabtagene maraleucel) is also a classic case. Carvykti, developed by Legend Biotech, is the second BCMA CAR-T therapy to be launched. Although Carvykti missed the first-mover advantage, it established a therapeutic edge with a high objective response rate (ORR) of 98% and rapidly surpassed the pioneer Abecma (idecabtagene vicleucel), becoming the second-largest-selling CAR-T therapy with $936 million in sales in 2024 (+93%). With increasing production capacity and expanding indications, this drug is expected to become the best-selling CAR-T therapy.
Breyanzi, the fourth CD19 CAR-T therapy, optimizes the cell composition to achieve a better balance between efficacy and safety. In addition to covering the last-line and second-line treatment for large B-cell lymphoma, it also expands to mantle cell lymphoma (MCL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). As a result, although Breyanzi was launched later, its differentiated technology and broader indications led to rapid sales growth, reaching $747 million in 2024 (+105%). However, Breyanzi faces strong competition from Yescarta (axicabtagene ciloleucel), and it remains to be seen if Breyanzi can continue its rise.
FIC/BIC are not the only answers in the new drug development race; some products find success through unique development strategies. Typical representatives include Eylea HD (aflibercept), Phesgo (trastuzumab + pertuzumab), and Cabenuva (cabotegravir + rilpivirine).
Eylea HD (aflibercept 8mg) tells the story of formulation optimization and product lifecycle management. Eylea (aflibercept 2mg) has had a lasting impact in ophthalmology, but the emergence of Vabysmo (faricimab) interrupted its progress toward becoming a "blockbuster." However, the high-dose version, Eylea HD, entered the market in 2023 and achieved a successful "debut" due to its significantly extended dosing interval, generating $1.2 billion in sales (+148%) in its first year.
Phesgo (trastuzumab and pertuzumab subcutaneous combination) and Cabenuva (cabotegravir + rilpivirine) have revolutionized treatment patterns through combination therapies, proving that innovation focused on improving the patient experience can also be highly successful.
Phesgo achieves a synergistic effect with its dual molecules, reducing the injection time from 2.5 hours to 5-8 minutes, greatly improving treatment efficiency. Its commercial success validates its clinical value, with Phesgo’s global sales in 2024 increasing by 62% to $1.982 billion.
Cabenuva (cabotegravir + rilpivirine) is the world’s first monthly long-acting injection HIV treatment, offering an advantage over traditional daily oral therapies for patients with poor adherence or those seeking privacy protection. After covering adult and adolescent HIV-1 infected patients, Cabenuva joined the "blockbuster" club in 2024, with global sales reaching $1.296 billion (+47%). However, competitors have emerged—Sunlenca (lenacapavir), requiring only biannual injections, was launched a year later. Sunlenca’s super-long-acting properties may divert some patients.
Overall, FIC and BIC are the main characteristics of the 16 best-selling new drugs. However, successful drugs are not limited to FIC and BIC; innovation is not restricted to the molecular level. Some products have achieved wide market recognition through unique development strategies, demonstrating the importance of deeply understanding and precisely responding to clinical needs. This is the core competitive advantage of any product. Additionally, commercial success also depends on clear market positioning and differentiated strategies. Whether leading the way as FIC, perfecting as BIC, or exploring new pathways as strategic players, the ability to identify one’s advantages and convert them into market value is equally important.
