A Randomized, Double-blind, Two-arm, Parallel-group, Single-dose, Phase 1 Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects

Start Date26 Mar 2025

Sponsor / Collaborator

Celltrion, Inc.

NCT04817540

/ RecruitingPhase 2IIT

Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study)

In this study, we prospectively analyzed molecular subtyping through the PAM 50 test in HER2-negative (IHC1+ or 2+ (FISH/SISH-)) breast cancer patients. A phase 2 single arm study was designed to determine whether the addition of HER2-targeted treatment with treatment increases the pathologic remission rate.

Start Date01 Sep 2021

Sponsor / Collaborator

Gangnam Severance Hospital

NCT06907082

/ CompletedNot ApplicableIIT

Prospective Multicenter Observational Study to Evaluate the Efficacy and Safety of Neoadjuvant Treatment Based on Dual Blockade With Pertuzumab and the Trastuzumab Biosimilar CT-P6 (Herzuma®) in Early HER2-positive Breast Cancer in Routine Clinical Practice

The study hypothesis is to evaluate whether the pCR rate of neoadjuvant chemotherapy and dual blockade with pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) in HER2-positive early breast cancer in PCH is similar to that reported in clinical trials.
Other aspects to be analyzed include the safety of the combination in PCH, as well as the clinical and tumor characteristics of the study population, assessment of radiological and pathological response, and the role of treatment-induced immunogenicity and the value of plasma HER2 determination.

Start Date28 Dec 2020

Sponsor / Collaborator-

100 Clinical Results associated with Trastuzumab-PKRB(Celltrion)

100 Translational Medicine associated with Trastuzumab-PKRB(Celltrion)

100 Patents (Medical) associated with Trastuzumab-PKRB(Celltrion)

Literatures (Medical) associated with Trastuzumab-PKRB(Celltrion)

01 Apr 2025·JCO Precision Oncology

Safety and Efficacy of Anti–Human Epidermal Growth Factor 2 Agents in the Treatment of Biliary Tract Cancers: A Systematic Review

Review

Author: Chakrabarti, Sakti ; Mahipal, Amit ; Jin, Zhaohui ; Pawar, Omkar ; Mangla, Ankit ; Naleid, Nikolas

PURPOSE:

Limited treatment options exist for patients with locally advanced or metastatic biliary tract cancers (BTCs). Recently, several clinical trials provided preliminary evidence for human epidermal growth factor receptor 2 (HER2) as a new target for patients with HER2-expressing BTC. We conducted a systematic review and pooled analysis of the safety and efficacy of anti-HER2 agents in patients with advanced BTCs.

METHODS:

A comprehensive search of PubMed/MEDLINE and EMBASE was performed to identify phase I, II, or III clinical trials published between January 2019 and March 2024 that evaluated anti-HER2 therapy in locally advanced or metastatic BTC. Participant data included in the analysis were from trials evaluating the efficacy and safety of various anti-HER2 agents. The primary end points included objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS). The secondary end points included incidence of treatment-related adverse events (TRAEs), rate of treatment discontinuation, and death.

RESULTS:

The analysis included 368 patients from eight publications diagnosed with advanced BTC. Patients were treated with several anti-HER2 agents including zanidatamab, pertuzumab plus trastuzumab, tucatinib plus trastuzumab, trastuzumab deruxtecan, trastuzumab plus chemotherapy, trastuzumab-pkrb plus chemotherapy, and neratinib. The pooled ORR and DCR were 34% (95% CI, 24 to 44) and 64% (95% CI, 51 to 77), respectively. The pooled weighted PFS and median overall survival were 4.8 and 9.4 months, respectively. The pooled duration of response for the reporting trials was 5.0 months. In the study cohort, 82.6% of patients experienced any adverse event and 32.1% experienced a grade 3-4 adverse event. Only 5.7% of the patients discontinued treatment secondary to TRAEs.

CONCLUSION:

In patients with HER2-expressing BTCs, anti-HER2 therapies are viable options, particularly in the second-line setting.

01 Feb 2025·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Challenges with effective removal of surfactants from monoclonal antibody formulations

Article

Author: Suryanarayanan, Raj ; Nejadnik, Reza ; Gurvich, Vadim J ; Refaat, Hesham ; Rathore, Anurag S ; Ahmad, Aziz ; Kamel, Eman

Buffer exchange is a critical step in biologics development, playing a pivotal role in removing contaminants, adjusting sample conditions, and facilitating compatibility studies. The efficiency of centrifugal concentrators for polysorbate removal was compared to a two-step approach involving a surfactant removal column followed by buffer exchange. Trastuzumab-pkrb from Herzuma® was used. While a 30 kDa centrifugal concentrator was ineffective in polysorbate removal, a 50 kDa concentrator caused partial removal. Surfactant removal column proved more effective in removing polysorbates. Buffer exchange using polysorbate-containing formulation buffer, even with a 50 kDa concentrator, accumulated polysorbate, revealing the need for a different approach in small-scale formulation. Adding polysorbate in a separate step after buffer exchange appeared to be a good strategy to prevent this problem. The two approaches did not reveal any differences in the protein aggregation behavior.

01 Oct 2023·Cancer

A phase 2 multicenter study of docetaxel-PM and trastuzumab-pkrb combination therapy in recurrent or metastatic salivary gland carcinomas.

Article

Author: Shim, Byoung-Yong ; Kim, Sung-Bae ; Park, Sehhoon ; Shin, Seong Hoon ; Seo, Seyoung ; Kim, Ji-Won ; An, Ho-Jung ; Kim, Min Kyoung ; Kim, Ju Won ; Ahn, Myung-Ju ; Choi, Yoon Ji ; Oh, So Yeon ; Park, Lee Chun ; Kim, Jae-Joon ; Lee, Se-Hoon ; Lee, Keun-Wook ; Lee, Jiyun ; Jung, Hyun Ae ; Kang, Eun Joo

BACKGROUND:

Salivary duct carcinoma (SDC) is uncommon but is the most aggressive subtype of salivary gland carcinomas. The high positivity rate for human epidermal growth factor receptor 2 (HER2) led to an investigation of the efficacy of HER2-targeted agents. Docetaxel-PM (polymeric micelle) is a low-molecular-weight, nontoxic, biodegradable, and docetaxel-loaded micellar formulation. Trastuzumab-pkrb is a biosimilar to trastuzumab.

METHODS:

This was a multicenter, single-arm, open-label phase 2 study. Patients with HER2-positive (immunohistochemistry [IHC] score of ≥2+ and/or HER2/chromosome enumeration probe 17 [CEP17] ratio of ≥2.0) advanced SDCs were enrolled. Patients received docetaxel-PM (75 mg/m² ) and trastuzumab-pkrb (8 mg/kg in the first cycle and 6 mg/kg in subsequent cycles) every 3 weeks. Primary end point was objective response rate (ORR).

RESULTS:

A total of 43 patients were enrolled. The best objective responses were partial response in 30 (69.8%) patients and stable disease in 10 (23.3%) patients, leading to an ORR of 69.8% (95% confidence interval [CI], 53.9-82.8) and a disease control rate of 93.0% (80.9-98.5). Median progression-free survival, duration of response, and overall survival were 7.9 (6.3-9.5), 6.7 (5.1-8.4), and 23.3 (19.9-26.7) months, respectively. Patients with HER2 IHC score of 3+ or HER2/CEP17 ratio ≥2.0 demonstrated better efficacies compared to those with HER2 IHC score of 2+. Thirty-eight (88.4%) patients experienced treatment-related adverse events (TRAE). Because of TRAE, nine (20.9%), 14 (32.6%), and 19 (44.2%) patients required temporary discontinuation, permanent discontinuation, or dose reduction, respectively.

CONCLUSIONS:

The combination of docetaxel-PM and trastuzumab-pkrb demonstrated promising antitumor activity with a manageable toxicity profile in HER2-positive advanced SDC.

PLAIN LANGUAGE SUMMARY:

Salivary duct carcinoma (SDC) is uncommon but is the most aggressive subtype of salivary gland carcinomas. SDC shares morphological and histological similarities with invasive ductal carcinoma of breast, which led to an investigation of hormonal receptor and human epidermal growth factor receptor 2 (HER2)/neu expression status in SDC. In this study, patients with HER2-positive SDC were enrolled and treated with combination of docetaxel-polymeric micelle and trastuzumab-pkrb. Promising antitumor activities were shown with objective response rate of 69.8%, disease control rate of 93.0%, median progression-free survival of 7.9 months, median duration of response of 6.7 months, and median overall survival of 23.3 months.

News (Medical) associated with Trastuzumab-PKRB(Celltrion)

30 Jun 2025

·www.globenewswire.com

Celcuity Reports Clinical Data from Two Early Phase Studies of Gedatolisib

• In the Phase 1 portion of the CELC-G-201 clinical trial evaluating gedatolisib plusdarolutamide in men with metastatic castration resistant prostate cancer (“mCRPC”),the six-month radiographic progression free survival (“rPFS”) rate was 66% • In a Phase 2 clinical trial of gedatolisib plus trastuzumab-pkrb as 3L+ therapy in patients with HER2+ metastatic breast cancer (“mBC”), the objective response rate (“ORR”) was 43% • No patients discontinued gedatolisib due to a treatment-related adverse event (“AE”) in either clinical trial MINNEAPOLIS, June 30, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced preliminary clinical data for gedatolisib in two early phase clinical trials. Gedatolisib is a multi-target inhibitor that addresses all four class I PI3K isoforms and the mTOR complexes mTORC1 and mTORC2 to induce comprehensive blockade of the PI3K/AKT/mTOR (“PAM”) pathway. Phase 1 Clinical Trial in mCRPCIn the Phase 1 portion of a clinical trial evaluating gedatolisib plus Nubeqa® (darolutamide), an approved androgen receptor inhibitor, 38 patients with mCRPC were randomly assigned to receive 600 mg darolutamide twice daily combined with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib in Arm 2. In both arms, gedatolisib was administered once weekly for three weeks, then one week off. Additionally, all patients received prophylactic treatment for stomatitis. The preliminary Phase 1 data set utilized a May 30, 2025 data cut-off. The preliminary efficacy and safety analyses for the combined arms showed: The six-month rPFS was 66%.No patients discontinued treatment due to a treatment-related AE and no dose reductions were required with gedatolisib or darolutamide.No Grade 3 hyperglycemia was reported.Grade 2-3 stomatitis was reported in four (10.5%) patients - three (7.9%) Grade 2 and one (2.6%) Grade 3. Additional preliminary results for the Phase 1 portion of the clinical trial will be presented at a medical conference later this year. “We are very encouraged by this preliminary efficacy and safety data,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “The 66% six-month rPFS rate for this novel combination therapy compares favorably to published data for androgen receptor inhibitors in this setting. With no treatment-related discontinuations and less than 3% of patients experiencing Grade 3 stomatitis, we believe it is important to explore additional dose options for gedatolisib. Available gedatolisib pharmacokinetic (PK) data from other clinical trials in solid tumors suggests a relationship between efficacy and dose levels. Since this preliminary data indicates that the optimal gedatolisib dose for patients with mCRPC may not yet have been reached, the company amended the clinical trial protocol to enable exploration of additional doses in the Phase 1/1b portion of this clinical trial to determine the recommended Phase 2 dose.” In the amended Phase 1 portion of the clinical trial, up to six patients are planned to be enrolled in each of three arms and treated with different doses. Upon completion of Phase 1, up to an additional 40 patients will be randomly assigned to up to four Phase 1b cohorts to determine the recommended Phase 2 dose (“RP2D”). Dose levels will be selected based on the results from the Phase 1 clinical trial. In the Phase 2 dose expansion study, which will include subjects from the Phase 1/1b clinical trial, up to 18 additional subjects will be enrolled to achieve a total of approximately 30 subjects treated with the RP2D. All patients will also receive standard doses of darolutamide. Phase 2 Clinical Trial in HER2+ Metastatic Breast CancerIn this investigator-sponsored Phase 2 clinical trial, 44 patients with HER2+/PIK3CA mutated mBC were treated with gedatolisib plus standard doses of trastuzumab-pkrb. No prophylaxis for stomatitis was administered. The median number of prior anti-HER2 therapies enrolled patients received in the metastatic setting was four or more; 86% of patients had received at least three prior anti-HER2 therapies. The data cut-off was February 10, 2025. Key efficacy and safety results, as presented at the American Society of Clinical Oncologists meeting in June 2025, showed: The ORR among all patients enrolled was 43%.Median PFS was 6.0 months (95% CI, 5.0-7.7).Median overall survival was 24.7 months (95% CI; 17.3-NA).No patients discontinued gedatolisib due to a treatment-related AE.One (2.3%) patient experienced Grade 3 hyperglycemia. “The 43% ORR reported in patients who received at least three prior lines of anti-HER2 treatment for their disease is very encouraging and compares favorably to published data for other available therapies in this group of patients,” said Dr. Gorbatchevsky. “The regimen was well tolerated, and no patients discontinued gedatolisib due to treatment-related AEs. While additional clinical studies are needed, this data suggests gedatolisib in combination with HER2 targeted therapy may be an effective and well tolerated therapeutic option for patients with HER2+ mBC.” About Celcuity Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PI3K/AKT/mTOR (“PAM”) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is currently recruiting patients. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X. Forward-Looking Statements This press release contains statements that constitute "forward-looking statements" including, but not limited to, the size and design of our clinical trials; the timing of initiating and enrolling patients in, and receiving data from, our clinical trials; the impact of clinical trial data on our gedatolisib development program; the costs and expected results from any ongoing or planned clinical trials; the market opportunity for gedatolisib; the ability of our clinical trial data to support the filing of a new drug application; our expectations regarding our ability to obtain U.S. Food and Drug Administration approval to commercialize gedatolisib; revenue expectations; our strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib; our anticipated use of cash; and the strength of our balance sheet. In some cases, you can identify forward-looking statements by terminology such as "may," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "intends" or "continue," and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Forward-looking statements are subject to numerous risks, uncertainties, and conditions, many of which are beyond our control. These include, but are not limited to, unforeseen delays in our clinical trials, our ability to obtain and maintain regulatory approvals to commercialize our products and the market acceptance of such products, the development of therapies and tools competitive with our products, our ability to access capital upon favorable terms or at all, and those risks set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission on March 31, 2025. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We undertake no obligation to update these statements for revisions or changes after the date of this press release, except as required by law. View source version of release on GlobeNewswire.com Contacts: Celcuity Inc.Brian Sullivan, bsullivan@celcuity.comVicky Hahne, vhahne@celcuity.com(763) 392-0123 ICR HealthcarePatti Bank, patti.bank@icrhealthcare.com(415) 513-1284

Clinical ResultPhase 1Phase 2Phase 3ASCO

16 Jun 2025

·pipelinereview.com

Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients

INCHEON, South Korea I June 15, 2025 I Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA ® (ustekinumab-stba), a biosimilar to STELARA ® (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis (PsO) or psoriatic arthritis (PsA). [1] With this approval, STEQEYMA now offers all dosage forms and strengths of its reference product, providing flexibility to meet physicians’ clinical needs while supporting treatment continuity for patients. In December 2024, the FDA approved STEQEYMA in 45mg/0.5mL and 90mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous infusion in adult and pediatric patients 6 years and older with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn’s disease and ulcerative colitis. “Managing inflammatory diseases in pediatric patients can be particularly complex,” said Hetal Patel, PharmD MBA, Vice President of Medical Affairs at Celltrion USA. “The new dosage form and strength of STEQEYMA allow us to better meet the specific needs of young patients, giving physicians a valuable treatment option with flexibility, supported by a well-established safety and efficacy profile.” “We are proud to offer a new presentation of STEQEYMA that aligns with the indications of the reference product,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “This approval reinforces our commitment to broadening access for all patient populations, including children aged 6 years and older living with chronic inflammatory conditions. As a company with a strong legacy in immunology, we are dedicated to ensuring broader access and flexibility in care for patients of all ages.” The FDA approval of STEQEYMA was based on the totality of evidence, including the results from a phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. The clinical results demonstrated that STEQEYMA and its reference product, ustekinumab, are highly similar, and have no clinically meaningful differences in terms of safety and efficacy. [2],[3] The FDA has granted STEQEYMA full interchangeability with STELARA across all indications of STELARA, following the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025. Notes to Editors: About STEQEYMA ® (ustekinumab-stba) STEQEYMA ® , formerly known as CT-P43, is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases. It encompasses all indications approved for the STELARA ® reference product, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn’s disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older. STEQEYMA is available in both subcutaneous and intravenous formulations. The subcutaneous injection comes in 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe and 45mg/0.5mL solution in a single-dose vial. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial. INDICATIONS STEQEYMA ® (ustekinumab-stba) is indicated for the treatment of: For more information, see Full Prescribing Information . About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us . and stay updated with our latest news and events on our social media: LinkedIn , Instagram , X , and Facebook . About Celltrion USA Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion’s FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA ® (infliximab-dyyb), TRUXIMA ® (rituximab-abbs), HERZUMA ® (trastuzumab-pkrb), VEGZELMA ® (bevacizumab-adcd), YUFLYMA ® (adalimumab-aaty), AVTOZMA ® (tocilizumab-anho), STEQEYMA ® (ustekinumab-stba), STOBOCLO ® (denosumab-bmwo), OSENVELT ® (denosumab-bmwo) and OMLYCLO ® (omalizumab-igec), as well as the novel biologic ZYMFENTRA ® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media: LinkedIn . References [1] STEQEYMA U.S. prescribing information (2025) [2] Papp KA et al., Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III study. BioDrugs. 2023; Online ahead of print. Available at: https://link.springer.com/article/10.1007/s40259-023-00630-5#article-info [Last accessed June 2025] [3] Papp K et al., Efficacy and Safety after Switch from Reference Ustekinumab to Ustekinumab Biosimilar (CT-P43) in comparison with the Maintenance Group (CTP43 or Reference Ustekinumab) in Patients with Moderate-to-Severe Plaque Psoriasis: 1-Year Result. [EADV 2023, Abstract #4035]. Available at: https://eadv.org/wp-content/uploads/scientific-abstracts/EADV-congress-2023/Biologics-immunotherapy-targeted-therapy.pdf [Last accessed June 2025] SOURCE: Celltrion

Phase 3Drug ApprovalClinical ResultImmunotherapy

16 Jun 2025

·www.celltrion.com

Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients

Approval of 45mg/0.5mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for pediatric patients with plaque psoriasis (PsO) or psoriatic arthritis (PsA) under 60kg The FDA previously approved STEQEYMA® 45mg/0.5mL, 90mg/mL in a single-dose prefilled syringe for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous infusion in December 2024 STEQEYMA now matches all dosage forms and strengths of its reference product, STELARA® STEQEYMA now matches all dosage forms and strengths of its reference product, STELARA® INCHEON, South Korea, June 15, 2025 -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis (PsO) or psoriatic arthritis (PsA).[1] With this approval, STEQEYMA now offers all dosage forms and strengths of its reference product, providing flexibility to meet physicians' clinical needs while supporting treatment continuity for patients. In December 2024, the FDA approved STEQEYMA in 45mg/0.5mL and 90mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous infusion in adult and pediatric patients 6 years and older with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. "Managing inflammatory diseases in pediatric patients can be particularly complex," said Hetal Patel, PharmD MBA, Vice President of Medical Affairs at Celltrion USA. "The new dosage form and strength of STEQEYMA allow us to better meet the specific needs of young patients, giving physicians a valuable treatment option with flexibility, supported by a well-established safety and efficacy profile." "We are proud to offer a new presentation of STEQEYMA that aligns with the indications of the reference product," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "This approval reinforces our commitment to broadening access for all patient populations, including children aged 6 years and older living with chronic inflammatory conditions. As a company with a strong legacy in immunology, we are dedicated to ensuring broader access and flexibility in care for patients of all ages." The FDA approval of STEQEYMA was based on the totality of evidence, including the results from a phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. The clinical results demonstrated that STEQEYMA and its reference product, ustekinumab, are highly similar, and have no clinically meaningful differences in terms of safety and efficacy.[2],[3] The FDA has granted STEQEYMA full interchangeability with STELARA across all indications of STELARA, following the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025. Notes to Editors: About STEQEYMA® (ustekinumab-stba) STEQEYMA®, formerly known as CT-P43, is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases. It encompasses all indications approved for the STELARA® reference product, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn's disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older. STEQEYMA is available in both subcutaneous and intravenous formulations. The subcutaneous injection comes in 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe and 45mg/0.5mL solution in a single-dose vial. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial. INDICATIONS STEQEYMA® (ustekinumab-stba) is indicated for the treatment of: Plaque Psoriasis (PsO) in adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Psoriatic Arthritis (PsA) in adults and pediatric patients 6 years of age and older with active psoriatic arthritis. Crohn's Disease (CD) in adult patients with moderately to severely active Crohn's disease. Ulcerative Colitis (UC) in adult patients with moderately to severely active ulcerative colitis. Ulcerative Colitis (UC) in adult patients with moderately to severely active ulcerative colitis. IMPORTANT SAFETY INFORMATION STEQEYMA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STEQEYMA Serious infections have occurred. Avoid starting STEQEYMA during any clinically important active infection. If a serious or clinically significant infection develop, discontinue STEQEYMA until the infection resolves. Serious infections from mycobacteria, salmonella, and BCG vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances. Evaluate patients for TB prior to starting STEQEYMA. Initiate treatment of latent TB before administering STEQEYMA. Ustekinumab products may increase risk of malignancy. The safety of ustekinumab products in patients with a history of or a known malignancy has not been evaluated. Monitor all patients receiving STEQEYMA for signs of malignancies. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STEQEYMA. If Posterior Reversible Encephalopathy Syndrome (PRES) is suspected, treat promptly, and discontinue STEQEYMA. Avoid use of live vaccines in patients during treatment with STEQEYMA. Non-live vaccinations received during STEQEYMA treatment may not elicit enough immune response to prevent disease. If diagnosis of noninfectious pneumonia is confirmed, discontinue STEQEYMA and institute appropriate treatment. The most common adverse reactions (≥3%) reported in patients receiving ustekinumab were: Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, and fatigue. CD: vomiting, nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. UC: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. The most common adverse reactions (≥3%) reported in patients receiving ustekinumab were: Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, and fatigue. CD: vomiting, nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. UC: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. For more information, see Full Prescribing Information. About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us. and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo) and OMLYCLO® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", "anticipate" the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks STELARA® is a registered trademark of Johnson & Johnson. STEQEYMA® is a registered trademark of Celltrion, Inc., used under license. References [1] STEQEYMA U.S. prescribing information (2025) [2] Papp KA et al., Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III study. BioDrugs. 2023; Online ahead of print. Available at: https://link.springer.com/article/10.1007/s40259-023-00630-5#article-info [Last accessed June 2025] [3] Papp K et al., Efficacy and Safety after Switch from Reference Ustekinumab to Ustekinumab Biosimilar (CT-P43) in comparison with the Maintenance Group (CTP43 or Reference Ustekinumab) in Patients with Moderate-to-Severe Plaque Psoriasis: 1-Year Result. [EADV 2023, Abstract #4035]. Available at: https://eadv.org/wp-content/uploads/scientific-abstracts/EADV-congress-2023/Biologics-immunotherapy-targeted-therapy.pdf [Last accessed June 2025]

Drug ApprovalClinical ResultPhase 3Immunotherapy

100 Deals associated with Trastuzumab-PKRB(Celltrion)

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KEGG	Wiki	ATC	Drug Bank
-	-	L01XC03	DB00072

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Colorectal Cancer	Japan	Nippon Kayaku Co., Ltd.	01 Oct 2023
Stomach Cancer	Canada	Celltrion Healthcare Co., Ltd.	01 Sep 2019
Advanced HER2-Positive Breast Carcinoma	Australia	Celltrion Healthcare Australia Pty Ltd.	17 Jul 2018
HER2 Positive Breast Cancer	Australia	Celltrion Healthcare Australia Pty Ltd.	17 Jul 2018
HER2 positive Gastroesophageal Junction Adenocarcinoma	Australia	Celltrion Healthcare Australia Pty Ltd.	17 Jul 2018
Early Stage Breast Carcinoma	European Union	Celltrion Healthcare Hungary Kft	09 Feb 2018
Early Stage Breast Carcinoma	Iceland	Celltrion Healthcare Hungary Kft	09 Feb 2018
Early Stage Breast Carcinoma	Liechtenstein	Celltrion Healthcare Hungary Kft	09 Feb 2018
Early Stage Breast Carcinoma	Norway	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2 Positive Stomach Adenocarcinoma	European Union	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2 Positive Stomach Adenocarcinoma	Iceland	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2 Positive Stomach Adenocarcinoma	Liechtenstein	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2 Positive Stomach Adenocarcinoma	Norway	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2-positive gastric cancer	European Union	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2-positive gastric cancer	Iceland	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2-positive gastric cancer	Liechtenstein	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2-positive gastric cancer	Norway	Celltrion Healthcare Hungary Kft	09 Feb 2018
Hormone receptor positive breast cancer	European Union	Celltrion Healthcare Hungary Kft	09 Feb 2018
Hormone receptor positive breast cancer	Iceland	Celltrion Healthcare Hungary Kft	09 Feb 2018
Hormone receptor positive breast cancer	Liechtenstein	Celltrion Healthcare Hungary Kft	09 Feb 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Gastroesophageal Junction Adenocarcinoma	Phase 2	United States	Celltrion, Inc.	10 Jun 2018
Neoplasm Metastasis	Phase 2	United States	Celltrion, Inc.	10 Jun 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01084876 (Compare, CTgov)	Phase 3	Metastatic breast cancer	475	CT-P6 (CT-P6)	fcsgtekwhe = ocybvfpkkf bczickkkkx (ttvzsiaetf, mbznmqjlyv - svxyishrhw) View more	-	11 Feb 2025
				Herceptin (Herceptin)	fcsgtekwhe = xdzkraomxq bczickkkkx (ttvzsiaetf, escqezygcs - czawxsjitm) View more
NCT01084863 (Compare, CTgov)	Phase 1/2	Metastatic breast cancer	143	Paclitaxel+CT-P6 (CT-P6 & Paclitaxel)	yurodteony(rnxyvruggl) = qnwznonxan oeikdqumzt (sgnsggprkn, 15000) View more	-	24 Jan 2025
				Herceptin+Paclitaxel (Herceptin & Paclitaxel)	yurodteony(rnxyvruggl) = kynynndbfj oeikdqumzt (sgnsggprkn, 9820) View more
ASCO2023	Not Applicable	BREAST CANCER, EARLY-ONSET \| Breast Cancer \| Metastatic Gastric Carcinoma	642	CT-P6	ewdlaekrmh(tfvqhevhjc) = nxqeruiyaw zcvcquvcuh (tjvtgnkzne )	Positive	31 May 2023
NCT03755141 (KCSG BR 18-14/KM10B, Pubmed) Manual	Phase 2	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 Positive	128	treatment of physician's choice +Herzuma	xsvguppyzj(jlduxbhrcy) = wmvjtqsbqk gynriqrwqc (glcdlcegyd, 2.8 - 7.2) View more	Positive	17 Aug 2022
NCT03614364 (KCSG HN18-08/KM11, ASCO2022) Manual	Phase 2	Salivary duct carcinoma HER2 Positive	43	Nanoxel+Herzuma	gevblgvmwk(yxkmvlfotu) = ovficketep hisdoarqdw (gdfitnjyhz, 52 - 81) Met View more	Positive	02 Jun 2022
NCT02162667 (Pubmed \| Breast Cancer Res Treat)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant \| Adjuvant human epidermal growth factor receptor-2 (HER2)-positive	-	CT-P6	liucakyyws(ajhzutynat): HR = 1.23 (95% CI, 0.78 - 1.93) View more	-	01 Aug 2021
				Trastuzumab
NCT02162667 (Phase III trial comparing neoadjuvant then adjuvant trastuzumab and its biosimilar candidate CT-P6 in HER2 positive early breast cancer, CTgov)	Phase 3	HER2 Positive Breast Cancer	562	Trastuzumab	dtcwoizeen = zxwspbdvrn elwglmvaok (pskejhtzpp, fafskhclnd - ijqdrvbqjc) View more	-	29 Oct 2019
NCT02162667 (Pubmed \| Cancer Chemother Pharmacol)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant \| Adjuvant	562	CT-P6	eoveuykvuz(eqhegelrue) = cvzrtjckoh urkvpuhqhu (acpenqulbg )	Positive	01 Oct 2019
				Trastuzumab	eoveuykvuz(eqhegelrue) = nwvszzoaul urkvpuhqhu (acpenqulbg )
NCT02162667 (Phase III trial comparing neoadjuvant then adjuvant trastuzumab and its biosimilar candidate CT-P6 in HER2 positive early breast cancer, SABCS2019)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant \| Adjuvant HER2 positive	549	CT-P6	icowjdhrzx(snvjrteusl) = qqesocwqgv kpspmvteww (jsuhwgtxba, 80% - 90%) View more	Positive	15 Feb 2019
				Reference Trastuzumab (RTZ)	icowjdhrzx(snvjrteusl) = vahjyeotvg kpspmvteww (jsuhwgtxba, 85% - 93%) View more
NCT02162667 (SABCS2018)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant \| Adjuvant HER2 positive	549	CT-P6	tewtiqaxys(rqgipckrte) = Grade 3 of Adams-Stokes syndrome occurring 5 months after the completion of 1-year treatment fzdwmisssx (aqwafpjmdh ) View more	Positive	15 Feb 2018
				Reference Trastuzumab

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