Jiangsu Hengrui Pharmaceutical Group Co. Ltd.

iStock, Tomas Ragina Policy uncertainties are impacting biopharma dealmaking from continent to continent, with companies being asked to walk a tightrope on their relations with China. Pharma companies are facing a political minefield as they go about the business of dealmaking. No matter where they turn, uncertainty and sudden policy shifts are rampant. This comes as China innovation rises and European companies face a dearth of innovation. President Donald Trump’s tariffs have sent ripples across the world, spurring retaliation and protectionism. This is upsetting the global nature of the pharma industry, which relies on the freedom to chase innovation wherever it may come from. Right now, that’s increasingly China . “You should go where the best assets are and if equally good assets are available at a lower price, you go where the science is,” Sam Fazeli, director of research for Global Industries and senior pharmaceuticals analyst at Bloomberg Intelligence, told BioSpace . According to GlobalData, large pharma in-licensed 28% of innovative drugs from Chinese biopharma companies in 2024, hitting a record high. Values for these transactions rose 66% from $16.6 billion in 2023 to $41.5 billion a year later. Looking at just the U.S. licensing deals with Chinese firms, GlobalData found that total deal value rose from $15.7 billion in 2023 to $21.3 billion in 2024. Summit Therapeutics is one example making waves. The U.S.-headquartered company licensed an oncology asset from China’s Akeso that has been dubbed a potential “ Keytruda slayer .” The drug, ivonescimab, was just approved in China for lung cancer, but still needs to be tested in the U.S. before it can achieve regulatory clearance here. Amid threats of an all-out trade war, companies are being asked to walk a tightrope. Those headquartered in the U.S. may be under pressure not to deal with China or to reduce activities in the region, Fazeli said. Many of these demands have involved manufacturing and pharmaceutical ingredients, but experts are now starting to wonder if intellectual property and innovative drugs might also come under increasing scrutiny. “While China remains a hub for biopharma innovation, regulatory shifts may disrupt cross-border partnerships and the U.S. access to Chinese drug candidates,” GlobalData senior business fundamentals analyst Ophelia Chan said in a statement. But pharma executives have so far brushed off concerns that executing deals in China may not be wise at this moment. “Science doesn’t know any boundaries,” Gilead CFO Andrew Dickinson said in January. Indeed, pharma executives appear to have no intention of slowing down the trips to China for new assets. According to a survey conducted by Fazeli and his Bloomberg Intelligence colleague Pan Liu, the number of deals for drugs sourced from China is expected to pick up by 5% in 2025, while upfront fees could rise 2.5%. While the survey did pick up on a bit of concern among respondents about the growing geopolitical tensions, the potential treatments coming out of China are just too good to pass up. Companies like Summit are living proof. A Symbiotic Relationship The uptick in biopharma deals involving China came amid a downturn in pharma M&A; companies were instead turning to China’s innovative biotechs to stock up their pipelines, GlobalData’s Chan said. That was despite congressional moves like the BIOSECURE Act, which was never passed but still spurred companies to reduce manufacturing and contracting exposure to China. Dealmaking continued apace, with company after company loading up on exciting Chinese assets. “Up until the end of last year, there was no pressure on them doing anything to do with China,” Fazeli said. The truth is, China needs the deals as much as the pharmas who are snapping up the assets, according to experts who spoke with BioSpace . Indeed, China is doing what it can to encourage companies to keep dipping into its well of innovation. “China has now said that it advises countries not to succumb to U.S. pressure in reducing their interactions with China,” Fazeli said. The Chinese government is content with the uptick in cross-border dealmaking because the country can’t spend more on healthcare amid broader cuts that are underway, according to Jeroen Groenewegen-Lau, head of the science, technology and innovation program at the Mercator Institute for China Studies (Merics) in Berlin. These include volume-based procurement, the national reimbursable drugs list and other initiatives intended to stem rising costs. So the government has been fine with U.S. companies nabbing rights to a promising drug—as in the case of Summit—to develop outside of China. “Sure there are worries over foreign co-ownership of key innovative drugs, but Beijing is not willing to significantly increase healthcare expenditure and its pharma firms need investments so it is encouraging foreign investment to come in so its innovative drugs sector can continue to grow,” Groenewegen-Lau told BioSpace in an email. Moreover, while R&D and clinical trials are cheaper to conduct in China, the country does not have a domestic market that can really embrace new therapies, pushing Chinese firms to seek out-licensing or new company formations to push promising treatments to the later trial stages, Groenewegen-Lau said. “This arrangement works well financially for firms in China, the U.S. and the EU, at least well enough for pharma [multi-national corporations] to be keen for this to continue.” But these deals are facing increasing political pressure. This can be particularly difficult for European firms to navigate, as they may wonder how U.S. regulators will respond to their work in China, Groenewegen-Lau noted. “Vice versa, prospects of poor market access in the U.S. for Chinese-owned treatments further drives Chinese firms into the arms of U.S. and European firms,” he said. Fazeli said the escalating China-U.S. trade war could put the symbiotic China-pharma relationship in jeopardy. “China might turn around and say, ‘Look, stop selling your assets to the West,’” Fazeli said. “Nobody seems to talk about that. We all seem to think about will Western governments say, ‘Okay, you can’t do more deals with China’? China might tell us, actually, ‘Stop giving your assets away. Let them go and figure it out themselves.’” A Multipolar World AstraZeneca, for one, has not been deterred. As peer pharmas have dropped billions in manufacturing investments in the U.S. over the past few months, AstraZeneca did the same in China with a $10 billion investment. European pharmas are under intense pressure to boost innovation. Last year, a European Commission report nicknamed the Draghi report after its author, former European Central Bank President Mario Draghi, found that the bloc’s pharma sector is fading due to low investment in R&D and regulatory fragmentation. “Europe spends a substantially lower share of GDP on innovative medicines than the U.S. and, as a result, is falling behind in attracting R&D and manufacturing investments, putting its ability to protect the health of its own people at risk,” AstraZeneca CEO Pascal Soriot said in a statement that was provided to Reuters . He likened the importance of boosting medical innovation in the region to that of defense spending. Last year, European companies outspent U.S.-based ones on China-originated assets, according to a recent report in Nature Reviews Drug Discovery . European companies closed 23 licensing deals valued at $4.6 billion in upfront payments in 2024, compared to 22 deals with U.S. companies totaling $3.5 billion upfront. “Europe would like to improve its competitiveness in pharma but banning or even discouraging partnerships with Chinese firms does not seem to be on the agenda,” Groenewegen-Lau said. “There is less concern over China being a global leader in drug innovation, partly because Europe is more comfortable with the idea of a multipolar world.” Europe’s pharma innovation problems are complex, as is the global political situation. But it’s hard not to attribute some of Europe’s dealmaking in China to what’s happening across the pond in the U.S., said Asmita Sharma, founder of healthcare and IP analysis research firm Intelligience. “There is a shift happening but no one is specifically tying this shift to ‘geopolitical’ reasons yet,” Sharma told BioSpace. “At the same time, the only thing that has changed in the recent months is the geopolitical climate—so, I believe it’s just a matter of time that folks will anchor this shift down to the political climate.” America First In the U.S., it’s still unclear which side of the coin Trump’s tariffs will hit: generic drugs or innovative therapies—or both. To address the manufacturing concerns, Big Pharmas are announcing massive investments in U.S. facilities in an attempt to appease Trump. “It would seem to me that U.S. firms would also be happy to onshore some of the production to the U.S. if the incentives were right, especially if that would enable them to still cherry-pick the best new drugs that Chinese firms develop at a fraction of the cost,” Groenewegen-Lau said. But alarm bells are ringing for the U.S. biotech sector. A congressional commission warned earlier in April that China’s industry is poised to eclipse American innovation as U.S. federal policy has taken the foot off the gas. The commission’s report recommended a national biotechnology strategy and a $15 billion infusion into the industry over the next five years. Senators Todd Young (R-IN) and Alex Padilla (D-CA) followed up days later with a bill to establish the National Biotechnology Coordination Office that would work to boost biotech innovation and ease regulatory burdens. Pfizer CEO Albert Bourla marveled at how Chinese biotechs are “progressing with the speed of light” during his company’s first quarter earnings call on Tuesday. He said the nation has managed to accerate its science immensely in the past four years, catching up to the sizable lead long held by the U.S. He said little money is flowing to U.S.-based companies, while “China is doing the opposite.” Bourla tied the issue back to national security, which is how Trump has framed his exploration of tariffs against the pharmaceutical industry. “Imagine if in the next pandemic, the medicines that will help will not be invented in this country, but in another country. That will be a problem,” Bourla said. Fazeli said some of his colleagues think the Trump administration could come for China licensing deals in an effort to encourage U.S. biotech investment. Trump issued an executive order in February called the America First Investment Policy that lays out the administration’s position on inbound and outbound investments with China and other nations deemed adversaries. The order specifically mentions biotech, but it’s still unclear how the industry will be affected. “I think the effort might be to try and redirect the dollars to U.S. biotechs,” Fazeli said. “But if they don’t have the assets, they don’t have the assets.” H.C. Wainwright analysts suggested in an April 22 note that all the regulatory and political uncertainty could actually drive investors into the hands of U.S. biotechs. “We expect U.S.-anchored companies to benefit from heightened visibility with both regulators and investors,” the firm wrote. PitchBook similarly thinks the next era of biotech will be “ America-first ,” in lock step with Trump’s policies. One strategy that venture capital firms have been using to bring a bit more U.S. ownership to a Chinese asset has been to form a new U.S.-based company around the therapy. The original Chinese innovator will typically hang on to an equity stake but the parties aren’t exactly exchanging cash like they would in a buyout or licensing deal, Fazeli said. This was the strategy behind weight loss biotech Kailera Therapeutics , which launched in October 2024 with a massive $400 million series A, a handful of high-pro backers and several assets from China’s Jiangsu Hengrui Pharmaceuticals. Its lead drug HRS9531 has already posted weight loss results in line with Eli Lilly’s Zepbound. These deals could still face regulatory scrutiny, say through a ban on publicly listing companies with a certain percentage of Chinese ownership, Fazeli said. The bottom line for pharmas, regardless of where they are headquartered, is that they face a world of uncertainty right now.

In 2024, the field of cancer therapeutics has witnessed remarkable progress in targeting Claudin 18.2 (CLDN18.2). As a protein highly expressed in several malignancies—particularly gastrointestinal cancers such as gastric and pancreatic cancer—CLDN18.2 has emerged as a highly promising therapeutic target. Antibody-drug conjugates (ADCs) developed against this target, including Zolbetuximab, IBI-343, LM-302, and SHR-A1904, have shown encouraging preclinical and clinical results. These innovations not only improve patient survival but also pave the way for more personalized treatment approaches. By selectively recognizing and attacking tumor cells while minimizing damage to normal tissues, these agents are redefining the landscape of cancer therapy. CLDN18.2 is an isoform of Claudin-18, which belongs to the Claudin family of proteins. This family comprises transmembrane proteins that play crucial roles in maintaining tight junctions between epithelial and endothelial cells. Tight junctions function as both physical barriers, preventing the free passage of substances through the paracellular space, and as regulators of ion and small molecule permeability. The depiction of Claudin protein structures1 Structurally, Claudins share common features, including four transmembrane domains, two extracellular loops (ECL1 and ECL2), and intracellular N- and C-termini. CLDN18.2 is predominantly expressed in differentiated epithelial cells of the gastric mucosa, exhibiting highly specific expression under normal physiological conditions. However, during malignant transformation, the disruption of tight junctions caused by uncontrolled tumor proliferation can expose CLDN18.2 epitopes, making them accessible for targeted therapeutic intervention. Main characteristics of claudins2 From a proliferation perspective, evidence suggests that CLDN18.2 may interfere with intercellular communication and signal transduction pathways, influencing the cell cycle and promoting tumor growth. High expression of CLDN18.2 has been associated with increased tumor cell proliferation in several studies, likely due to its role in maintaining cell polarity and regulating cell growth. In terms of invasion and metastasis, abnormal activation of the CLDN18.2 gene may alter cell membrane functionality and enhance tissue permeability. This disruption facilitates tumor cells in breaching the basement membrane and invading surrounding tissues, thus promoting both local and distant metastases. Aberrant CLDN18.2 expression also impairs normal cell polarity and structural integrity, further weakening tissue barriers and enabling cancer cell dissemination. While CLDN18.2 expression is typically confined to gastric mucosal cells under normal conditions, it is significantly upregulated in various cancers, including gastric and pancreatic cancers. This persistent expression even after malignant transformation, combined with exposure of the epitope due to tight junction disruption, makes CLDN18.2 an attractive target for antibody-based therapies, particularly in cancers with limited treatment options. ADC Therapies Targeting CLDN18.2Zolbetuximab: The First Approved CLDN18.2-Targeted Monoclonal AntibodyZolbetuximab is the first globally approved therapeutic specifically targeting CLDN18.2. It is a chimeric IgG1 monoclonal antibody designed for the treatment of gastric and gastroesophageal junction (GEJ) adenocarcinomas. By binding selectively to CLDN18.2, a transmembrane protein highly expressed on certain gastric cancer cells, Zolbetuximab induces direct cancer cell death. Moreover, it activates two major immune-mediated mechanisms: antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). ADCC involves the recruitment of immune effector cells, such as natural killer (NK) cells, to the tumor site, leading to targeted destruction of cancer cells.CDC triggers the complement system to form membrane attack complexes (MACs) that lyse tumor cells.The development of Zolbetuximab was underpinned by its successful performance in two pivotal Phase III clinical trials—SPOTLIGHT and GLOW. In the SPOTLIGHT trial, Zolbetuximab combined with mFOLFOX6 chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone: Median PFS: 10.61 months vs. 8.67 monthsMedian OS: 18.23 months vs. 15.54 monthsSimilarly, the GLOW trial demonstrated that Zolbetuximab combined with CAPOX chemotherapy also yielded superior outcomes compared to CAPOX alone. Based on these positive results, Zolbetuximab has received regulatory approval in multiple countries and regions, including Japan, the United States, and the European Union, for the treatment of specific subtypes of gastric cancer. It remains the first and only approved CLDN18.2-targeted therapy to date. Although initially developed for gastric and GEJ adenocarcinomas, Zolbetuximab’s therapeutic potential could extend to other malignancies, such as pancreatic, biliary tract, esophageal, and lung cancers, where CLDN18.2 expression is also elevated. Expression testing is typically required to identify patients who are most likely to benefit from Zolbetuximab therapy. As understanding of CLDN18.2 biology deepens, it is anticipated that Zolbetuximab could be explored in combination strategies, such as with immune checkpoint inhibitors or other targeted therapies, to further enhance efficacy and reduce adverse effects. Additionally, the success of Zolbetuximab has catalyzed the development of next-generation CLDN18.2-targeted agents, promising new hope for patients with limited treatment options. These advances are expected to significantly contribute to the evolution of personalized cancer care, enabling more precise, effective, and individualized therapeutic strategies. Bispecific Antibody LB-4330LB-4330 is a bispecific antibody developed by L&L Biopharma, designed to leverage its dual-targeting capability to activate CD8+ T cells within the tumor microenvironment, thereby enhancing the body's immune response against cancer. By doing so, LB-4330 not only directly attacks cancer cells but also mobilizes the patient’s immune system for a more effective and sustained anti-tumor response. The mechanism of action of LB-4330 relies on its unique structural design, which enables simultaneous binding to CLDN18.2 and specific receptors on the surface of CD8+ T cells. This dual specificity allows LB-4330 to accumulate at tumor sites and activate T cells, triggering the release of cytotoxic substances to kill cancer cells. Moreover, LB-4330 may also enhance anti-tumor immunity through additional, less well-characterized mechanisms, such as modifying the tumor microenvironment or improving dendritic cell function. These features position LB-4330 as a promising therapeutic candidate, particularly for patients with advanced or metastatic cancers that are resistant to conventional treatments. The major CD8+ T cell states in human tumors3 Currently, LB-4330 is in Phase II clinical development, focusing on evaluating its safety and efficacy in patients with advanced or metastatic solid tumors. According to information released by L&L Biopharma, LB-4330 has shown encouraging potential in an open-label, Phase Ib/II dose-escalation and expansion study. This study aims to explore the drug’s effects at various doses to identify an optimal dosing range that maximizes therapeutic benefit while minimizing adverse events. Although detailed clinical results have yet to be fully disclosed, preliminary data indicate that LB-4330 is well-tolerated and has demonstrated meaningful clinical activity in certain patient populations. Beyond its established indications in gastric cancer, pancreatic cancer, and ovarian cancer, researchers are investigating the potential of LB-4330 in other tumor types. Given the widespread expression of CLDN18.2 across multiple malignancies, LB-4330 could emerge as a broad-spectrum anti-cancer agent. Furthermore, as understanding of CLDN18.2 biology deepens and combination strategies with other therapies (such as chemotherapy, radiotherapy, or immunotherapy) are explored, the application prospects for LB-4330 appear increasingly expansive. Despite its promising profile, several challenges must be addressed before LB-4330 can be widely adopted. These include the need to accurately identify patients most likely to benefit from the therapy—often requiring precise measurement of CLDN18.2 expression—and the necessity for long-term safety evaluations. Additionally, further mechanistic studies, optimization of dosing strategies, and identification of ideal combination regimens with existing therapies will be critical to fully unlocking LB-4330’s therapeutic potential. CLDN18.2-Targeting ADCsSeveral antibody-drug conjugates (ADCs) have been developed to target Claudin 18.2 (CLDN18.2), including IBI-343, LM-302, SHR-A1904, ATG-022, Sonestatug vedotin, and SKB-315. These agents utilize a specific antibody to recognize and bind to CLDN18.2 antigens on the surface of cancer cells, delivering a potent cytotoxic payload intracellularly to induce tumor cell death. Developed by companies such as Innovent Biologics, LaNova Medicines, Hengrui Medicine, Antengene Corporation, and Kelun-Biotech, these ADCs span various stages of clinical development (from Phase II to Phase III) and show promise in treating gastric cancer, esophageal cancer, and other CLDN18.2-positive solid tumors. 1) IBI-343IBI-343 is an innovative ADC developed by Innovent Biologics. It combines a highly specific anti-CLDN18.2 antibody with a cytotoxic small-molecule drug. This design enables precise targeting of CLDN18.2-expressing tumor cells, facilitating selective delivery of the cytotoxic agent and minimizing damage to normal tissues, thus improving both safety and efficacy. In preclinical studies, a single administration of IBI-343 significantly inhibited tumor growth in xenograft models with low antigen expression, maintaining low tumor volumes for up to 21 days. This finding suggests that IBI-343 is not only effective against tumors with high CLDN18.2 expression but also shows robust activity in tumors with lower antigen levels. This bystander effect enhances IBI-343’s appeal as a cancer therapeutic, particularly in tumors with heterogeneous antigen expression within the tumor microenvironment. IBI-343 has been granted Breakthrough Therapy Designation by China’s National Medical Products Administration (NMPA) for two indications: (1) advanced gastric/gastroesophageal junction adenocarcinoma patients with positive CLDN18.2 expression who have received at least two prior systemic therapies, and (2) advanced pancreatic ductal adenocarcinoma patients with positive CLDN18.2 expression who have received at least one prior systemic therapy. This designation accelerates the development timeline and underscores the potential importance of IBI-343 as a novel treatment option, particularly for patients with difficult-to-treat cancers. 2) LM-302LM-302 is an antibody-drug conjugate (ADC) developed by Lanpu Biopharmaceuticals (also known as Lansion Biotechnology). This investigational therapy combines a highly specific anti-CLDN18.2 monoclonal antibody with a cytotoxic payload, monomethyl auristatin E (MMAE). The design enables the antibody to selectively bind to the CLDN18.2 antigen expressed on tumor cell surfaces and deliver the cytotoxic agent directly into cancer cells, thereby achieving targeted tumor cell killing. As of the latest updates, LM-302 has been granted three Orphan Drug Designations (ODDs) by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer, gastric cancer, and gastroesophageal junction (GEJ) cancer. In China, LM-302 has advanced into Phase III clinical trials, indicating that the drug has demonstrated sufficient safety and preliminary efficacy in earlier studies and is now undergoing larger, more diverse patient evaluations to confirm its therapeutic potential. Moreover, LM-302 has been proposed for inclusion under China’s National Medical Products Administration (NMPA)/Center for Drug Evaluation (CDE) Breakthrough Therapy designation. The targeted indication is for patients with locally advanced or metastatic gastric or GEJ adenocarcinoma who are CLDN18.2-positive and have received at least two prior lines of systemic therapy. A Phase II clinical trial is also underway to evaluate the efficacy, safety, and tolerability of LM-302 in combination with toripalimab (an anti-PD-1 antibody) in patients with CLDN18.2-positive advanced gastrointestinal tumors. The primary endpoint of this study is to assess the efficacy of the LM-302 and toripalimab combination, with secondary objectives including safety, pharmacokinetics, immunogenicity, and the correlation between CLDN18.2/PD-L1 expression and antitumor activity. It is worth noting that Lanpu Biopharmaceuticals had previously entered into an exclusive licensing agreement with Turning Point Therapeutics, granting Turning Point rights to develop and commercialize LM-302 outside of Greater China and South Korea. However, following Bristol Myers Squibb’s acquisition of Turning Point, the licensing status of LM-302 has shifted, and the asset is now listed as "global" in ownership. 3) SHR-A1904SHR-A1904 is an ADC independently developed by Hengrui Medicine. It consists of a highly specific anti-CLDN18.2 antibody linked to a cytotoxic payload—a topoisomerase inhibitor (TOPOi). This design enables the ADC to selectively bind to CLDN18.2-expressing tumor cells and deliver its potent payload intracellularly, resulting in targeted cancer cell death. At the 2024 European Society for Medical Oncology (ESMO) Congress, early clinical data on SHR-A1904 were presented for the treatment of patients with CLDN18.2-positive gastric cancer and gastroesophageal junction adenocarcinoma (GC/GEJC). The results demonstrated manageable safety and promising antitumor activity, with an objective response rate (ORR) of 55.6% and a disease control rate (DCR) of 88.9%. Beyond gastric cancer, SHR-A1904 is also being investigated for other CLDN18.2-expressing solid tumors, highlighting its broad therapeutic potential. Notably, Hengrui Medicine entered into a collaboration agreement with Merck KGaA, Darmstadt, Germany, valued at up to €1.4 billion. Under this agreement, Merck has secured global exclusive development, manufacturing, and commercialization rights for SHR-A1904 outside of mainland China. This strategic partnership reflects strong international recognition of SHR-A1904's potential and positions it for global success. SHR-A1904 has been evaluated across multiple dose levels. The 6.0 mg/kg cohort demonstrated the best efficacy, achieving an ORR of 55.6% and a DCR of 88.9%. The safety profile was considered manageable, although some dose-limiting toxicities (DLTs) were observed at higher doses. With ongoing Phase III clinical trials, SHR-A1904 is poised to become a promising new treatment option for patients with CLDN18.2-positive cancers. Furthermore, through its international collaborations, SHR-A1904 is expected to benefit a broader patient population worldwide. ConclusionAs a member of the Claudin family, Claudin 18.2 (CLDN18.2) plays a vital role in maintaining tight junctions between epithelial and endothelial cells and is aberrantly overexpressed in various cancer types. This unique biological characteristic makes CLDN18.2 an ideal target for cancer therapy. Several CLDN18.2-targeted antibody-drug conjugates (ADCs)—including Zolbetuximab, IBI-343, LM-302, and SHR-A1904—have demonstrated significant antitumor activity with favorable safety profiles. Particularly, Zolbetuximab has achieved groundbreaking clinical success as the first approved therapy targeting CLDN18.2 for the treatment of gastric and gastroesophageal junction adenocarcinoma. Additionally, bispecific antibodies such as LB-4330, which enhance antitumor immune responses, are further expanding the therapeutic landscape of CLDN18.2 targeting. Globally, research on CLDN18.2-targeted therapies has become a major area of focus. More than 90 candidate therapies targeting CLDN18.2—including monoclonal antibodies, bispecific antibodies, CAR-T cells, and ADCs—are currently under development. The success of programs such as IBI-343 not only highlights the innovation capacity of Chinese biopharmaceutical companies but also provides valuable models for future drug development. As clinical trials progress and technologies advance, CLDN18.2-targeted therapies are expected to offer new hope for a broader range of cancer patients, driving forward the era of personalized medicine and precision oncology. These developments mark a deeper understanding of cancer biology and herald the arrival of more CLDN18.2-based therapies, ultimately benefiting patients worldwide. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery! Reference 1. Cao W, Xing H, Li Y, Tian W, Song Y, Jiang Z, Yu J. Claudin18.2 is a novel molecular biomarker for tumor-targeted immunotherapy. Biomark Res. 2022 May 31;10(1):38. doi: 10.1186/s40364-022-00385-1. PMID: 35642043; PMCID: PMC9153115.2. Kubota Y, Shitara K. Zolbetuximab for Claudin18.2-positive gastric or gastroesophageal junction cancer. Ther Adv Med Oncol. 2024 Jan 3;16:17588359231217967. doi: 10.1177/17588359231217967. PMID: 38188462; PMCID: PMC10768589.3. van der Leun AM, Thommen DS, Schumacher TN. CD8+ T cell states in human cancer: insights from single-cell analysis. Nat Rev Cancer. 2020 Apr;20(4):218-232. doi: 10.1038/s41568-019-0235-4. Epub 2020 Feb 5. PMID: 32024970; PMCID: PMC7115982.

Since its launch in 2015, it has been prescribed to more than 200,000 patients globally. The drug is currently approved for use in both men and women, expanding its market potential. Despite facing competition from other CDK4/6 inhibitors like Novartis' KISQALI and Eli Lilly's VERZENIO, IBRANCE maintains a strong position in the metastatic setting. LAS VEGAS, April 24, 2025 /PRNewswire/ -- DelveInsight's " IBRANCE Market Size, Forecast, and Market Insight Report" highlights the details around IBRANCE, a CDK4/6 inhibitor. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of IBRANCE. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Pfizer's IBRANCE (palbociclib) Overview IBRANCE is an oral medication that inhibits CDKs 4 and 6, which are crucial regulators of the cell cycle that drive cellular progression. In the U.S., IBRANCE is approved for treating adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. It is used in combination with an aromatase inhibitor as a first-line endocrine therapy for postmenopausal women or men or with fulvestrant for patients whose disease has progressed after endocrine treatment. IBRANCE is currently authorized in over 90 countries and has been prescribed to more than 200,000 patients worldwide. Learn more about IBRANCE projected market size for metastatic HR+/HER2− breast cancer @ IBRANCE Market Potential The HR+ HER2- subtype is the most commonly found type of breast cancer, characterized by cancer cells that have estrogen and progesterone receptors but do not overexpress HER2. A patient's journey typically begins with the onset of concerning symptoms, leading to a comprehensive clinical evaluation and various imaging tests. DelveInsight estimates that approximately 211K new cases of HR+/HER2– breast cancer occurred in the US in 2024. CDK4/6 inhibitors currently dominate the first-line treatment market and represent a significant advancement in the management of HR+/HER2-ve breast cancer. The data from large, randomized clinical trials are both strong and consistent. While single-agent endocrine therapies have shown limited benefits in the first and subsequent treatment lines for women with ER-positive metastatic breast cancer (mBC), combination therapies have emerged as a more effective option for many patients. In recent years, the treatment landscape for HR+/HER2−ve breast cancer has been transformed with the introduction of highly active targeted therapies, including CDK4/6 inhibitors, mTOR inhibitors, PARP inhibitors, new oral SERDs, and PI3K inhibitors. These advances have expanded the range of treatment options and improved survival outcomes for these patients. The market for metastatic HR+/HER2− breast cancer in the 7MM is projected to grow during the forecast period (2025–2034) due to the introduction of several novel therapies in the market. Discover more about the metastatic HR+/HER2− breast cancer market in detail @ Metastatic HR+/HER2− Breast Cancer Market Report Emerging Competitors of IBRANCE Some of the drugs in the pipeline include Gedatolisib (Celcuity), ARV-471 (Arvinas and Pfizer), OP-1250 (Olema Pharmaceuticals), KEYTRUDA (Merck), and Rupitasertib (Evexta Bio), among others. In December 2024, Arvinas and Pfizer presented preliminary data from the ongoing Phase 1b portion of the TACTIVE-U sub-study of vepdegestrant in combination with abemaciclib among patients with locally advanced or metastatic ER+/HER2- breast cancer at the San Antonio Breast Cancer Symposium (SABCS) 2024. In December 2024, Olema Pharmaceuticals presented clinical results from the ongoing Phase Ib/II study of palazestrant in combination with ribociclib in patients with ER+/HER2- advanced or metastatic breast cancer at SABCS 2024. To know more about the number of competing drugs in development, visit @ IBRANCE Market Positioning Compared to Other Drugs Key Milestones of IBRANCE In February 2021, Pfizer Inc. announced that the U.S. Patent and Trademark Office (USPTO) has granted a U.S. Patent Term Extension (PTE) certificate for IBRANCE. This extension prolongs the validity of U.S. Patent No. RE47,739 ('739) by over four years, now lasting until March 5, 2027. In April 2019, Pfizer announced that the FDA has approved a supplemental New Drug Application (sNDA) to broaden the uses of IBRANCE in combination with an aromatase inhibitor or fulvestrant, now including men with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced or metastatic breast cancer. In March 2017, Pfizer Inc. revealed that the FDA has approved a supplemental New Drug Application (sNDA) for IBRANCE, its pioneering cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor, following the positive outcomes from the confirmatory Phase 3 trial PALOMA-2. In September 2016, Pfizer Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive recommendation for the marketing authorization of IBRANCE® (palbociclib) in the European Union (EU). This recommendation is for its use in treating women with hormone receptor-positive, HER2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. In February 2016, Pfizer announced that the FDA has approved a new indication for IBRANCE 125mg capsules, expanding its use. The approval allows IBRANCE to be used in combination with fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in women whose disease has progressed after endocrine therapy. In February 2015, Pfizer announced that the FDA granted accelerated approval for IBRANCE in combination with letrozole to treat postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as the initial endocrine-based therapy for their metastatic disease. Discover how IBRANCE is shaping the metastatic HR+/HER2− breast cancer treatment landscape @ IBRANCE Drug IBRANCE Market Dynamics IBRANCE is a targeted therapy that has revolutionized the treatment of hormone receptor-positive, HER2-negative breast cancer, particularly in combination with aromatase inhibitors or letrozole. Developed by Pfizer, IBRANCE was one of the first CDK4/6 inhibitors approved by the FDA for metastatic breast cancer, and its approval has significantly changed the treatment landscape. The drug works by inhibiting cyclin-dependent kinases 4 and 6, which are key regulators of the cell cycle, thus preventing cancer cells from proliferating. Its market dynamics have been shaped by the growing demand for targeted therapies, as well as the increasing focus on precision medicine and improved patient outcomes. The global market for IBRANCE has been positively impacted by its proven efficacy in clinical trials and its ability to extend progression-free survival in breast cancer patients. The drug's market dominance is underpinned by its widespread acceptance and adoption by oncologists worldwide. However, competition is intensifying, with other CDK4/6 inhibitors such as VERZENIO (abemaciclib) and KISQALI (ribociclib) entering the market, offering similar benefits but with some distinct clinical profiles. This competitive landscape has led to strategic pricing and marketing strategies by Pfizer, aiming to maintain IBRANCE's market leadership while managing pressures from generic alternatives. Additionally, the evolving reimbursement landscape and regulatory policies around oncology drugs are crucial factors influencing the market dynamics. Health insurers and government healthcare programs often scrutinize the cost-effectiveness of cancer treatments, which can impact the pricing and accessibility of IBRANCE in different markets. Another factor is the rising focus on combination therapies, as IBRANCE is often used in conjunction with other drugs like letrozole, which boosts its efficacy and market potential. The shift toward personalized cancer treatment regimens is expected to continue fueling demand for CDK4/6 inhibitors like IBRANCE, especially in more advanced stages of breast cancer. In terms of geographical markets, IBRANCE has seen significant uptake in North America and Europe, where the healthcare infrastructure supports innovative cancer therapies. However, emerging markets, where the economic barriers to accessing expensive cancer treatments can be higher, present a challenge to the widespread use of IBRANCE. Pfizer's ongoing efforts to expand in these regions, through partnerships and pricing adjustments, will be key to ensuring continued growth in global market share. Overall, the IBRANCE market is poised for steady growth, driven by clinical advancements, increasing breast cancer diagnoses, and the continual push toward more targeted, effective therapies. Dive deeper to get more insight into IBRANCE's strengths & weaknesses relative to competitors @ IBRANCE Market Drug Report Table of Contents Related Reports Metastatic HR+/HER2− Breast Cancer Market Metastatic HR+/HER2− Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic HR+/HER2− breast cancer companies, including Merck, Arvinas, Olema Pharmaceuticals, Celcuity, Roche, AstraZeneca, Daiichi Sankyo, Eli Lilly, Sermonix Pharmaceuticals, Genentech, Veru Pharma, DualityBio, BioNtech, Evgen Pharma, Carrick Therapeutics, EQRx, G1 Therapeutics, Immutep, among others. HR+/HER2− Breast Cancer Pipeline HR+/HER2− Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HR+/HER2− breast cancer companies, including Regor Therapeuics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Seagen Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche, among others. Breast Cancer Market Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key breast cancer companies including Veru, Sanofi, Roche, AstraZeneca, Eli Lilly, EQRx, Gilead, Sermonix Pharmaceuticals, Evgen Pharma, Tyme, Genentech, Daiichi Sankyo, among others. Metastatic Breast Cancer Pipeline Metastatic Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key metastatic breast cancer companies, including Roche, RemeGen, SynCore Biotechnology, Allarity Therapeutics, Daiichi Sankyo Company, Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Byondis B.V., Jiangsu Hansoh Pharmaceutical Co., Ltd., Shanghai Miracogen Inc., Ambrx, Inc., Daehwa Pharmaceutical Co., Ltd., Phoenix Molecular Designs, GlycoMimetics Incorporated, Rhizen Pharmaceuticals SA, Menarini Group, Samus Therapeutics, Inc., Hanmi Pharmaceutical Company Limited, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Immutep Limited, Arvinas Inc., G1 Therapeutics, Mirati Therapeutics Inc., Chia Tai Tianqing Pharmaceutical, Shanghai Pharmaceuticals Holding Co., Ltd, Pfizer, OncoTherapy Science, Inc., Eisai Inc., Dizal Pharmaceuticals, Jiangsu Hengrui Medicine Co., Tyme, Inc, Orion Pharma, HiberCell, Inc., Rhizen Pharmaceuticals SA, Hutchison Medipharma Limited, OncoPep Inc., Taizhou Hanzhong biomedical co. LTD, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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