Catadegbrutinib

Eli Lilly's anticipated launches of two cardiometabolic medicines stand out in Clarivate's Drugs to Watch report for 2026. Johnson & Johnson also has two drugs on this year's list. Eli Lilly has dominated headlines in recent months, recently taking the crown as the most valuable company in the biopharma industry by market cap. And the song remains much the same in analytics firm Clarivate's Drugs to Watch 2026 report.The annual outlook, which identifies (PDF) 11 potential blockbusters and transformative medicines, highlights two cardiometabolic treatments from the Indianapolis company, which have yet to be approved but could ultimately take the place of its current cash cows Mounjaro and Zepbound.Lilly’s investigational treatments are daily GLP-1 pill orforglipron, which is slated for an FDA decision by March of this year, and triple-action, weekly injection retatrutide, which Clarivate expects will be ready for launch in 2028.Both assets are under development in obesity, diabetes and a host of other related indications. The Clarivate analysts project that orforglipron will generate a whopping $11.1 billion in obesity sales and $5.2 billion in diabetes sales in 2031, though the forecasts partially overlap due to shared populations. Retatrutide is expected to deliver $10 billion in obesity revenue and $20 billion in diabetes revenue, again with some overlap between estimates.Clarivate’s report highlights the continued ascent of the obesity and metabolic disease market, as well as how Lilly has positioned itself to take full advantage. Morgan Stanley projects the overall cardiometabolic medicine market will reach $150 billion by 2035.“The GLP-1 receptor agonist (RA) revolution is entering a new phase of maturation and diversification,” Clarivate wrote. “Orforglipron and retatrutide exemplify the next generation of metabolic therapies: oral formulations that promise improved adherence, triple-hormone mechanisms that deliver superior weight loss and expanded therapeutic applications spanning from brain health to renal disease.” As for the 2031 sales projections of the drugs on Clarivate’s 2026 list, orforglipron and retatrutide eclipse all others. The remaining medicines Clarivate highlighted have much lower sales projections than Lilly's, with no others expected to surpass the $2-billion threshold in 2031, according to Clarivate’s reckoning.Johnson & Johnson is the only other company with two drugs named—bladder cancer treatment Inlexzo, which gained FDA approval in September of last year, and immunotherapy icotrokinra, which Clarivate expects will be launched this year. The analysts project 2031 sales of the duo at $1.8 billion and $1.5 billion, respectively.Inlexzo made the grade with Clarivate for its bladder-sparing, “paradigm-shifting” drug-releasing system, which allows for extended release of the chemotherapy gemcitabine directly to patients' bladders through an intravesical system that can be placed in minutes in an outpatient setting.Icotrokinra, meanwhile, is poised to become the first-to-market targeted oral peptide designed to block the interleukin (IL)-23 receptor, which plays a key role in the inflammatory process in moderate-to-severe plaque psoriasis as well as ulcerative colitis, Clarivate said.Clarivate also singled out two protein degrader cancer drugs, including BeOne Medicine’s BGB-16673. The once-daily oral treatment is set for a potential launch in 2027 and has the potential to become a “paradigm-changing treatment for B-cell malignancies,” the report notes. The asset could be effective at treating multiple hematological cancers as well, according to the analysts. Clarivate projects the drug's sales at $1.2 billion in 2031.The other protein degrader on Clarivate's radar is Bristol Myers Squibb’s mezigdomide, which is expected to launch in 2026 and could generate $1.5 billion in 2031. The oral second-generation cereblon E3 ligase modulator could be a new option for patients with relapsed or refractory multiple myeloma who've previously been treated with immunomodulatory drugs, Clarivate said.Yet another oncology drug on the list comes in the form of Celcuity’s gedatolisib, which is set up for launch this year and is expected to deliver $1.1 billion in sales in 2031.Clarivate also selected Otsuka’s voyxact, which is expected to launch in 2026 and generate $955 million in 2031 sales. The first-in-class selective A proliferation-inducing ligand (APRIL) inhibitor could serve as a “high-impact, disease-modifying entrant" in IgA nephropathy (IgAN), also known as Berger’s disease, the Clarivate team predicts. The analytics team made another rare disease pick in GSK’s Exdensur, which was approved in December and is expected to generate sales of $510 million in 2031. The monoclonal antibody, which targets IL-5, is the first approved ultra-long-acting biologic with a six-month dosing schedule for severe asthma, providing greater convenience over currently available IL-5 inhibitors that require monthly or bimonthly dosing. Also on Clarivate’s list are two drugs that recently suffered untimely rejections from the FDA. Sanofi’s multiple sclerosis treatment tolebrutinib is a potential first-in-class, brain-penetrant Bruton tyrosine kinase (BTK) inhibitor. But its prospects have been dampened by both efficacy and safety concerns raised in an FDA complete response letter (CRL).Corcept Therapeutics’ Cushing syndrome drug relacorilant also was hit with an unexpected CRL from the U.S. regulator last month, with the agency suggesting it did not have enough information from the company to make a benefit-risk assessment of the treatment. That medication is also due for an FDA decision in platinum-resistant ovarian cancer this July, Clarivate pointed out. 

Novel next-generation Bruton tyrosine kinase (BTK)-targeted protein degrader APG-3288 has received investigational new drug (IND) clearance from the U.S. FDA, marking another major expansion to the company’s global innovative pipeline. Ascentage Pharma will conduct a global Phase I study evaluating APG-3288 in patients with relapsed/refractory B-cell malignancies. ROCKVILLE, Md. and SUZHOU, China, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that its novel next-generation BTK-targeted protein degrader, APG-3288, has received the IND clearance from the U.S. Food and Drug Administration (FDA) and is poised to enter a clinical study in patients with relapsed/refractory B-cell malignancies. This clearance officially opens the chapter on Ascentage Pharma’s clinical development in the field of targeted degradation and marks another major expansion to the company’s global innovative pipeline. This is a global, multicenter, open-label Phase I study designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of APG-3288 in patients with relapsed/refractory hematologic malignancies. BTK is a key kinase in the B-cell receptor (BCR) signaling pathway and plays a central role in the activation, proliferation, and survival of B-cells. Aberrant BTK activation is closely associated with the initiation and progression of multiple B-cell malignancies such as B-cell lymphoma (including diffuse large B-cell lymphoma, mantle cell lymphoma, and follicular lymphoma), chronic lymphocytic leukemia (CLL), and Waldenström's macroglobulinemia (WM) 1 . Beyond oncology indications, BTK also plays a critical role in both BCR- and Fc receptor-mediated signal transduction in innate immune cells. As a result, the aberrant activation of BTK has been implicated in the pathogenesis of various autoimmune and inflammatory diseases 2 . BTK inhibitors have drastically improved treatment outcomes for patients with B-cell malignancies. However, BTK mutations and remodeling of signaling pathways often lead to acquired resistance during prolonged treatment. There remains an urgent clinical need for new drugs promising novel mechanisms of action 3 . APG-3288 is the first novel, highly potent and selective BTK degrader developed utilizing Ascentage Pharma’s proprietary proteolysis-targeting chimera (PROTAC) technology platform. This candidate induces the formation of a ternary complex consisting of the BTK target, the PROTAC, and the Cereblon E3 ubiquitin ligase, leading to proteasome-mediated degradation of the BTK target. Unlike conventional BTK inhibitors, APG-3288 is designed to act through degradation rather than inhibition, inducing rapid, potent, highly selective, and sustained degradation of both wild-type BTK and multiple BTK mutants associated with resistance to existing BTK inhibitors. Critically, this approach blocks the BCR-BTK signaling axis at its source, thereby overcoming resistance to BTK inhibitors and potentially providing a novel and differentiated therapeutic strategy for BTK-targeted treatment 4 . In preclinical studies, compared to other BTK degraders in development, APG-3288 demonstrated more potent BTK degradation, higher selectivity, and more favorable PK properties that highlighted the drug’s potential 5 . Yifan Zhai, M.D., Ph.D., Chief Medical Officer of Ascentage Pharma , said, “Compared to existing conventional BTK inhibitors, Ascentage Pharma’s BTK degraders developed with our PROTAC technology can achieve complete degradation of target protein and are enabled by a molecular mechanism that can induce stronger efficacy. APG-3288 represents a strategic clinical stage candidate in the field of BTK-targeted therapies. Its high selectivity, potency, and consistent PK/PD profiles across multiple BTK-resistant models fully validate our differentiated design capabilities of PROTAC-based therapeutic candidates. This FDA clearance marks a major milestone for the development of APG-3288 and strategic pipeline expansion that underscores our persistent innovation in the field of hematologic malignancies. It also lays a strong foundation for our future exploration of the combinatory potential between APG-3288 and our existing proprietary small-molecule agents. We plan to accelerate the global clinical development of APG-3288 and actively explore the therapeutic potential of protein degraders in hematologic malignancies and other BTK-driven diseases, with the goal of bringing more new treatment options to patients as soon as possible.” *APG-3288 is currently under investigation and has not been approved by the U.S. FDA References: [1]. Pal Singh, S., F. Dammeijer, and R.W. Hendriks, Role of Bruton’s tyrosine kinase in B cells and malignancies. Molecular Cancer, 2018. 17(1). [2]. Mirre De Bondt, Janne Renders, Sofie Struyf, Niels Hellings, Inhibitors of Bruton's tyrosine kinase as emerging therapeutic strategy in autoimmune diseases Autoimmunity Reviews, Volume 23, Issue 5, 2024. [3]. Wang, E., et al., Mechanisms of Resistance to Noncovalent Bruton’s Tyrosine Kinase Inhibitors. New England Journal of Medicine, 2022. 386(8): p. 735-743. [4]. Zhang, D., et al., NRX-0492 degrades wild-type and C481 mutant BTK and demonstrates in vivo activity in CLL patient-derived xenografts. Blood, 2023. 141(13): p. 1584-1596. [5]. Wu, Y., et al., Translational modelling to predict human pharmacokinetics and pharmacodynamics of a Bruton's tyrosine kinase‐targeted protein degrader BGB‐16673. British Journal of Pharmacology, 2024. 181(24): p. 4973-4987. About Ascentage Pharma Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The Company has built a rich pipeline of innovative drug products and candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, as well as next-generation kinase inhibitors. The lead asset, Olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. All indications are covered by the China National Reimbursement Drug List (NRDL). The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or POLARIS-2, of Olverembatinib for CML, as well as global registrational Phase III trials for patients with newly diagnosed Ph+ ALL and SDH-deficient GIST patients. The Company’s second approved product, Lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax is being commercialized in China following National Medical Products Administration (NMPA) approval for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including BTK inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA-cleared GLORA study of Lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with acute myeloid leukemia (AML); and the GLORA-4 study in patients with newly diagnosed higher-risk myelodysplastic syndrome (HR MDS), a study that was simultaneously cleared by the U.S. FDA, the EMA of the EU, and China CDE. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit . Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Special note regarding forward-looking statements and industry data” in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, the sections headed “Forward-looking Statements” and “Risk Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts Investor Relations: Stella Yang Ascentage Pharma Stella.Yang@ascentage.com +1 (301) 792-6286 Stephanie Carrington ICR Healthcare AscentageIR@icrhealthcare.com +1 (646) 277-1282 Media Relations: Sean Leous ICR Healthcare AscentagePR@icrhealthcare.com +1 (646) 866-4012