Rivaroxaban

在医药行业的发展历程中，药物之间的竞争贯穿始终。从减肥药物市场的激烈角逐，到癌症、心血管病等重大疾病治疗领域的 “药王” 争霸，每一场较量都不仅关乎药企的商业利益，更与患者的健康福祉紧密相连。这些药物对决推动着医药技术的进步，也重塑着医药市场的格局。减肥药物之争：诺和诺德与礼来的 “巅峰之战”当下，肥胖治疗领域成为生物制药竞争的 “主战场”。诺和诺德的司美格鲁肽（semaglutide）和礼来的替尔泊肽（tirzepatide）在这个潜力高达 1500 亿美元的市场中展开激烈争夺。诺和诺德凭借先发优势，其司美格鲁肽早在 2017 年就获批用于治疗 2 型糖尿病（商品名 Ozempic），2021 年又获批用于慢性体重管理（商品名 Wegovy） 。礼来的替尔泊肽则稍晚进入市场，2022 年获批用于 2 型糖尿病（商品名 Mounjaro），2023 年获批用于肥胖症（商品名 Zepbound）。尽管入局较晚，但替尔泊肽凭借更高的减肥功效逐渐缩小与司美格鲁肽的差距。据 GlobalData 制药分析师 Costanza Alciati 分析，二者安全性相似，给药途径和频率也相近，不过替尔泊肽在减肥效果上更胜一筹，且治疗过程中肌肉量流失更少。目前，诺和诺德依靠先发优势和全球市场布局仍保持微弱领先，但其对手礼来凭借积极的商业策略，迅速拓展市场，已在多个主要市场推出替尔泊肽，并抢先在印度上市 Mounjaro，这场减肥药物大战仍胜负难料。癌症药物对决：默沙东 Keytruda 逆袭百时美施贵宝 Opdivo在肿瘤治疗领域，默沙东的 PD - 1 抑制剂 Keytruda 与百时美施贵宝的 Opdivo 之间的竞争堪称经典。2014 年，Opdivo 率先获批上市，凭借更广泛的适应症，初期在市场上占据领先地位，2015 年销售额远超同年获批的 Keytruda。然而，默沙东凭借更出色的临床试验成果和关键的肺癌治疗适应症获批，实现逆袭。如今，Keytruda 已成为癌症治疗的基石药物，获批适应症超 41 个，2024 年销售额高达 295 亿美元。相比之下，Opdivo 的市场表现逐渐黯淡，2024 年销售额仅 93 亿美元。不过，百时美施贵宝并未放弃，2025 年 1 月推出皮下注射剂型的 Opdivo，且其在非小细胞肺癌围手术期治疗方面的获批，为这款药物赢得了新的市场机会。心血管药物较量：Eliquis 力压 Xarelto在心血管疾病治疗领域，由百时美施贵宝和辉瑞联合开发的口服抗凝药 Eliquis，与拜耳和强生合作推出的 Xarelto 展开激烈竞争。Eliquis 自获批十多年来，市场表现强劲，2024 年销售额同比增长 9%，达到 133 亿美元。而 Xarelto 虽早一年获批，但市场份额逐渐被 Eliquis 超越。研究表明，Xarelto 在临床应用中，与 Eliquis 相比，会显著增加患者发生严重缺血或出血事件的风险，全因死亡率也更高。尽管目前尚无头对头的临床试验对二者进行对比，但 Eliquis 凭借更优的临床价值，在市场竞争中占据上风。阿尔茨海默病药物比拼：Leqembi 与 Kisunla 的艰难角逐历经数十年的研发困境，阿尔茨海默病治疗药物终于迎来 Leqembi 和 Kisunla 这两款新药的竞争。Biogen 和卫材联合开发的 Leqembi 率先在 2023 年 1 月通过 FDA 加速审批上市，并于同年 7 月获得完全批准，引发行业轰动。但随后其销售预期多次下调，市场推广面临挑战。礼来的 Kisunla 在审批过程中遭遇波折，2023 年 1 月 FDA 以数据不足为由拒绝其加速审批申请，直到 2024 年 7 月才获批上市。目前，两款药物都面临着脑淀粉样血管病相关影像学异常（ARIA）副作用的困扰，市场接受度也有待提高，这场竞争的最终走向仍不明朗。免疫疾病药物对抗：Humira 与 Stelara 的 “暮年之战”在免疫学领域，艾伯维的 Humira 和强生的 Stelara 曾是两款重磅药物，但如今都面临着专利到期和生物类似药竞争的挑战。Humira 曾连续六年成为全球最畅销药物，2022 年销售额达到 212 亿美元的峰值，但 2023 年失去关键专利保护后，销售额大幅下滑，2024 年不足 90 亿美元。Stelara 在 2023 年达到 108.6 亿美元的销售峰值后，2024 年也有所下降。这两款药物作用机制不同，Humira 靶向 TNF - alpha，Stelara 作用于 IL - 12 和 IL - 23，但在治疗银屑病关节炎、斑块状银屑病、克罗恩病和溃疡性结肠炎等适应症上有重叠。一项头对头研究显示，二者在治疗克罗恩病的临床效果上差异不显著，这也使得它们在市场上的竞争更加激烈。在淋巴瘤治疗领域，艾伯维与强生联合开发的伊布替尼（Imbruvica）和阿斯利康的阿卡替尼（Calquence）同为 BTK 抑制剂，在慢性淋巴细胞白血病（CLL）和小淋巴细胞白血病（SLL）等适应症上展开竞争。目前，伊布替尼凭借更广泛的适应症和市场推广，销售额略高于阿卡替尼。但阿卡替尼增长势头迅猛，2024 年销售额同比增长 24%，且在套细胞淋巴瘤（MCL）等临床治疗上表现出色，逐渐缩小与伊布替尼的差距。这些药物对决是医药行业发展的缩影，每一场竞争都推动着药企不断创新，为患者带来更有效的治疗方案。随着医药科技的持续进步，未来还会有更多 “药王” 诞生，续写医药史上的精彩篇章。参考来源：https://www.biospace.com/business/five-biggest-drug-face-offs-in-pharma-history识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

iStock, leolintang Wegovy and Zepbound are just the latest drug dyads to face-off in the competitive pharma market, continuing a legacy of rivalry that includes blockbuster drugs Keytruda, Humira and Eliquis. Obesity is the most competitive space in biopharma right now. The two frontrunners, Novo Nordisk and Eli Lilly, are locked in a very tight fight for leadership in a market that by some estimates could reach a jaw-dropping $150 billion in the next few years. Novo moved first. Its GLP-1 analog semaglutide was first cleared by the FDA in 2017 as Ozempic for type 2 diabetes. Some four years later, in July 2021, semaglutide won another approval as Wegovy , this time specifically indicated for chronic weight management. Lilly’s weight-loss blockbuster tirzepatide, in comparison, is a relative late-comer, first reaching the U.S. market in 2022 as Mounjaro for type 2 diabetes Then in November 2023, the FDA approved the drug as Zepbound for obesity , setting up the head-to-head battle with Wegovy in the massive and swiftly growing weight loss market. Despite being years behind, Lilly is chipping away at Novo’s lead. Costanza Alciati, pharma analyst at GlobalData, told BioSpace in an email that tirzepatide’s efficacy edge has helped Lilly catch up. Broadly speaking, according to Alciati, the safety profiles of Zepbound and Wegovy are similar, with both drugs sharing common side effects like nausea and vomiting. Both products are also matched in terms of the route and frequency of administration. However, Zepbound’s “weight loss efficacy seems to be higher than Wegovy’s,” Alciati said, adding that “according to trials, there seems to be less muscle mass loss associated with Zepbound’s treatment than Wegovy’s.” Currently, Novo’s first-mover advantage and sprawling global footprint has allowed it to maintain a slight lead over Lilly. Last year, the Danish pharma logged roughly $26 billion in sales for Ozempic and Wegovy worldwide, while Lilly’s tirzepatide franchise brought in nearly $16.5 billion globally. But with an aggressive commercial strategy, Lilly is quickly gaining ground. “Eli Lilly’s drug has now been launched in all major markets,” Alciati said. Last month, the Indianapolis pharma launched Mounjaro in India, beating Novo to tap the market of the world’s most populous country. Aside from Wegovy and Zepbound, pharma has witnessed many other dramatic drug rivalries play out over the years, from Keytruda’s comeback and subsequent dominance over Opdivo and the burgeoning competition between Leqembi and Kisunla. In this article, BioSpace looks at some of the biggest pharma face-offs. Cancer: Merck’s Keytruda vs BMS’ Opdivo In the oncology arena, few drugs can hope to stand up against Merck’s blockbuster PD-1 inhibitor Keytruda, which has become a cornerstone of cancer care since its first approval in September 2014. As of writing, Keytruda has more than 41 approvals under its belt. These include several forms of melanoma, hepatocellular carcinoma, breast cancer and, crucially, lung cancer. For the last two years, it has also been the pharma’s top-selling product , bringing in $29.5 billion in 2024. But it wasn’t always that way. Keytruda once played second fiddle to Bristol Myers Squibb’s PD-1 blocker Opdivo. Approved in December 2014, just months behind Keytruda, Opdivo initially took a sizeable lead in the market, bringing in $942 million in 2015 versus Keytruda’s $566 million. “Initially, Bristol Myers Squibb was dominating that race,” William Blair partner Matt Phipps told BioSpace in an interview last month. “They had broader approvals and bigger indications.” Merck, according to Phipps, “completely overtook” BMS due to better trials and crucial approvals in lung cancer. Opdivo never recovered. Last year, the drug brought in $9.3 billion —less than a third of Keytruda’s sales. Still, BMS continues to carve out a cancer niche for Opdivo. In January, BMS won the race to bring a subcutaneous PD-1 treatment to the market, with the FDA signing off on a new formulation of Opdivo that can be delivered with an injection under the skin. Merck’s application for subcutaneous Keytruda is still under review. Meanwhile, an NSCLC approval in October 2024 made Opdivo the first PD-1 blocker that can be used both before and after surgery. Cardio: BMS, Pfizer’s Eliquis vs Bayer, J&J’s Xarelto Two blood thinners brought by four of the biggest pharmas are battling it out in cardiovascular disease. Bristol Myers Squibb and Pfizer’s oral anticoagulant Eliquis is the stronger competitor. Despite being approved more than a decade ago, Eliquis’ market presence continues to grow, surging 9% year-on-year to bring in $13.3 billion in 2024. Meanwhile, its closest competitor is a distant second. Though it won the FDA’s blessing a year ahead of Eliquis in 2011 , Bayer and Johnson & Johnson’s Xarelto has fallen behind its competitor in terms of market share. The drug peaked in 2021 when it earned J&J $2.44 billion in the U.S. and Bayer just over $5 billion in international markets, for a total of around $7.5 billion. Last year Bayer reported roughly $3.85 billion in international sales for Xarelto, while J&J recorded $2.37 billion in the U.S.—a total of over $6.2 billion. There are likely several reasons for why Eliquis has cleanly outperformed Xarelto, and one of them might be a question of clinical value. A 2021 study published in JAMA showed that in a Medicare population of more than 580,000 patients with atrial fibrillation, Xarelto was associated with significantly elevated risks of major ischemic or hemorrhagic events, such as fatal bleeding, as compared with Eliquis. Total mortality was also worse with Xarelto. Similarly, a 2023 study in Circulation found that Xarelto significantly heightened the risk of ischemic stroke and major bleeding versus Eliquis in patients in the Optum Clinformatics Data Mart database. There have been no well-designed and well-controlled head-to-head trials to compare the drugs. Alzheimer’s: Biogen, Eisai’s Leqembi vs Lilly’s Kisunla Decades of dispiriting clinical failures have finally produced two winners in Alzheimer’s disease. A tough market showdown has followed. In one corner is Biogen and Eisai’s embattled Leqembi and on the other is Eli Lilly’s newer challenger Kisunla. The anti-amyloid antibody Leqembi first won regulatory clearance in January 2023 under the FDA’s accelerated pathway before becoming the industry’s first fully approved Alzheimer’s therapy in July 2023. The buzz around Leqembi was strong, despite questions about the strength of the efficacy results and whether the benefits outweighed the risks. Phase III data presented in September 2022 helped revitalize the anti-amyloid theory, experts said at the time. In June 2023, an FDA advisory committee unanimously endorsed Leqembi’s full approval. Meanwhile, Kisunla’s path to approval was more fraught. In January 2023, the FDA turned down Lilly’s bid for accelerated approval, citing the need for more data from patients who had been treated for at least 12 months. The drug eventually won the regulator’s blessing in July 2024 , almost a year to the day behind Leqembi. Now, however, Leqembi’s edge doesn’t seem so large. Biogen and Eisai have struggled to get the drug off the ground and have been forced at least twice to lower their sales projection for the asset. In March, for instance, Eisai revealed that it expects Leqembi to bring in from ¥250 billion to ¥280 billion (approximately $1.7 billion to $1.9 billion) in its fiscal year 2027—a roughly 50% decline from a prior projection. For fiscal year 2024, which ends this month, the Japanese firm expects full-year sales of around $280 million for Leqembi. Lilly has already launched Kisunla in the U.S. but has yet to report sales figures. But both drugs have faced concerns about side effects called ARIA, which can signal bleeding or swelling in the brain. They have also faced slow uptake as physicians and health systems struggle to adapt to the new treatment paradigm. I&I: AbbVie’s Humira vs J&J’s Stelara Two pharma giants are duking it out in the immunology space with blockbuster drugs that are past their prime. AbbVie’s Humira was for six straight years the world’s best-selling drug. The biologic peaked in 2022 , bringing in $21.2 billion. But since losing key patent protections in 2023, its sales have declined steeply : last year, Humira made just under $9 billion . On the other hand, J&J’s Stelara never reached the same sales heights as Humira. At its peak in 2023, Stelara raked in $10.86 billion before dipping 4.6% to $10.34 billion last year. Like AbbVie’s biologic, Stelara is contending with copycat competitors. After it lost market exclusivity in 2023, several biosimilars have entered the U.S. market, including Amgen’s Wezlana and Sandoz’s Pyzchiva . Both Humira and Stelara work by tamping down the inflammatory response and share a substantial overlap in their indications, including psoriatic arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis. The specific mechanisms by which the drugs exert their therapeutic effects differ, however. Humira targets TNF-alpha, while Stelara acts on IL-12 and IL-23. All three molecules are crucial parts of the inflammatory cascade and often act synergistically, with slight differences in functionality. IL-12 and IL-23 explicitly encourage inflammation, for instance, while TNF-alpha can have both pro- and anti-inflammatory effects. In May 2021, a head-to-head study showed that despite these mechanistic nuances, Stelara and Humira are largely clinically similar. In patients with Crohn’s disease, Stelara induced a 64.9% clinical remission rate at 52 weeks, while Humira achieved a 61% remission rate at the same time point—a difference that failed to reach statistical significance. Lymphoma: AstraZeneca’s Calquence vs AbbVie’s, J&J’s Imbruvica The blood cancer field is witness to a BTK inhibitor battle between AbbVie and J&J’s Imbruvica, the first-comer, and AstraZeneca’s Calquence, which entered the ring four years later. The bad blood between the two goes way back to the biotech days, when Pharmacyclics developed what would become Imbruvica and rival Acerta Pharma championed Calquence. The rivalry was chronicled in Nathan Vardi’s book For Blood and Money: Billionaires, Biotech, and the Quest for a Blockbuster Drug . Both drugs work by blocking the Bruton’s tyrosine kinase, an enzyme that plays a crucial signaling role in the proliferation and activity of B cells. Because they share a mechanism of action, the two products also have wide overlap in their indications. Imbruvica and Calquence are both approved for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL). Currently, Imbruvica has a slight edge. Last year, AbbVie reported nearly $3.35 billion in worldwide sales for the drug, as opposed to Calquence’s $3.13 billion. Imbruvica also has broader coverage: Aside from the indications that it shares with Calquence, it is also approved for chronic graft versus host disease and the rare blood cancer Waldenström’s macroglobulinemia. But Calquence is quickly gaining ground. In 2024, AstraZeneca’s asset grew 24% year-on-year, while Imbruvica slid 6.9%. Calquence is also catching up clinically. A May 2024 readout showed that AstraZeneca’s drug, when combined with standard chemoimmunotherapy, can boost progression-free survival in untreated patients with mantle cell lymphoma (MCL). AbbVie and J&J had pulled Imbruvica’s accelerated approval in this indication nearly a year before. Calquence remains approved for MCL under the FDA’s accelerated pathway. Meanwhile, real-world data presented at the 2024 Congress of the European Hematology Association showed that patients with CLL or SLL who were treated with Calquence had longer time to discontinuation or death than comparators on Imbruvica. Time to next treatment was also longer in the Calquence group, as reported by OncLive at the time.