A Single-Arm, Open-Label, Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Leuprorelin 1-Month (4-Week) Formulation Administered for 24 Months in Children With Central Precocious Puberty

Start Date01 Aug 2026

Sponsor / Collaborator

LG Chem Ltd.

JPRN-jRCTs031260249

/ RecruitingPhase 2

A randomized study of Trastuzumab deruxtecan Against Second-line endocrine Therapy In hormone receptor-positive, HER2-low/ultralow metastatic breast cancer (TRANSITION)

Start Date29 Jun 2026

Sponsor / Collaborator-

NCT07444983

/ Not yet recruitingNot ApplicableIIT

An Exploratory Clinical Study of Rezvilutamide as Adjuvant Therapy for High-Risk Patients After Radical Prostatectomy

The goal of this clinical trial is to learn if Rezvilutamide works to treat high-risk prostate cancer in patients who have recently undergone surgery (radical prostatectomy). It will also learn about the safety of Rezvilutamide. The main questions it aims to answer are:
Does Rezvilutamide, when used as an add-on treatment after surgery, lower the risk of the cancer returning (biochemical recurrence) within 3 years? What is the 36-month metastasis-free survival (MFS) rate for patients receiving this treatment? What is the safety profile of Rezvilutamide combined with ADT, specifically regarding the types, grades, and incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs), and rare adverse events? What are the exploratory findings regarding the status of immune cells after using Rezvilutamide?
Researchers will evaluate the combination of Rezvilutamide and hormone therapy (ADT) to see if it helps keep patients cancer-free.
Participants will:
Take Rezvilutamide: 240 mg once daily, taken orally before or after breakfast. Each cycle is 28 days, for up to 24 cycles. Treatment continues unless biochemical recurrence, disease progression, intolerable toxicity occurs, or the participant withdraws consent, as determined by the investigator.
Receive Androgen Deprivation Therapy (ADT): Leuprorelin 3.75mg via subcutaneous injection, once every 28 days for a total of 12 cycles.

Start Date11 Feb 2026

Sponsor / Collaborator

Fujian Medical University Union Hospital

100 Clinical Results associated with Leuprolide Mesylate

100 Translational Medicine associated with Leuprolide Mesylate

100 Patents (Medical) associated with Leuprolide Mesylate

Literatures (Medical) associated with Leuprolide Mesylate

01 Aug 2026·JOURNAL OF PHARMACOLOGICAL SCIENCES

Differentiation of human-induced pluripotent stem cells into hepatocytes-like cells in 3D culture using functional polymers

Article

Author: Matsunaga, Tamihide ; Hayashi, Hisato ; Kanaki, Tatsuro ; Hashita, Tadahiro ; Hori, Eisei ; Anno, Shiho ; Iwao, Takahiro ; Horikawa, Masato ; Okumura, Hiroki

Suspension culture is superior to planar culture in efficiently growing large numbers of cells. It also greatly improves cell functions by mimicking the in vivo environment. Although several methods are available to differentiate human induced pluripotent stem (iPS) cells into hepatocyte-like cells, their differentiation by suspension culture by using functional polymers remains unreported. We developed a suspension culture system using the functional polymers FP001 and FP003 to generate hepatocyte-like cells with superior phenotypes than human iPS cell-derived hepatocyte-like cells generated in planar culture. Specifically, optimizing the initial spheroid size and utilizing FP003 effectively maintained appropriate spheroid structures, resulting in higher albumin production compared to FP001. In 3D sphere culture, the mRNA expression of albumin (ALB), drug-metabolizing enzymes and transporters, and the activity of CYP1A2 were increased in the presence of 0.01% FP003. Additionally, immunofluorescence analysis confirmed uniform hepatic differentiation throughout the spheroids. These findings suggest that differentiation in 3D sphere culture with the functional polymer FP003 improved the function of human iPS cell-derived hepatocyte-like cells. Therefore, we conclude that this system may be an effective strategy to generate human iPS cell-derived hepatocyte-like cells with enhanced functions.

01 Jun 2026·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

DVCH-LMI: A dual-view contrastive framework for lncRNA-miRNA interaction prediction under class imbalance

Article

Author: Fang, Ying ; Zhao, Qi ; Wang, Zihao ; Liu, Ran

Identifying long non-coding RNA (lncRNA) and microRNA (miRNA) interactions (LMIs) is essential for elucidating post-transcriptional regulation and disease-related molecular mechanisms. Accurate identification of LMIs can facilitate biomarker discovery, RNA-targeted therapeutics, and data-driven drug design. However, robust prediction and candidate prioritization remain challenging due to the limited number of experimentally validated interactions and the large number of unknown pairs. Accordingly, we propose DVCH-LMI, a dual-view contrastive heterogeneous representation learning framework. DVCH-LMI initializes node features with Doc2Vec embeddings trained on k-mer vectors, constructs an adjacency view and a similarity view over shared bipartite interaction semantics, and learns complementary embeddings using two heterogeneous encoders with identical architectures but independent parameters. A symmetric information noise-contrastive estimation (InfoNCE) loss is further introduced to achieve node-level cross-view alignment. The aligned embeddings are then fused, and interaction prediction is performed by a hybrid scorer composed of a similarity branch and a multi-layer perceptron (MLP) branch. To better align with candidate prioritization tasks in computational biology and therapeutic design, we integrate random negative sampling and hard negative sampling to enhance the model's candidate prioritization ability in an imbalanced candidate space. On an animal benchmark dataset, DVCH-LMI achieves AUC of 0.9465 and AUPR of 0.9468 under the 1:1 setting, and it maintains strong positive-oriented ranking performance under more imbalanced settings such as 1:20 and 1:50. Ablation studies verify the effectiveness of key components. Case studies on MALAT1 and NEAT1 further show that DVCH-LMI prioritizes literature-supported interactions. Cross-view alignment visualizations and structure-consistency analyses provide additional representational evidence for the interpretability and reliability of our model. Overall, DVCH-LMI serves as both an effective LMI predictive model and a robust candidate prioritization framework for data-sparse and highly class-imbalanced scenarios, with promising potential for RNA regulatory mechanism studies and RNA-guided drug design.

01 Jan 2020·World journal of urology

A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients

Article

Author: Jievaltas, Mindaugas ; Mao, John ; DeGuenther, Mark ; Simpson, Kelle ; Li, Yuhua ; Patockova, Jitka ; Huang, Shih-Tsung ; Chien, Ben ; Hu, Chu-Hsuan ; Lee, Yisheng ; Mincik, Ivan ; Student, Vladimir ; Shore, Neal

OBJECTIVES:

To determine the safety, efficacy and pharmacokinetic (PK) profile of a pre-mixed depot formulation of leuprolide mesylate subcutaneous injectable suspension (LMIS) 50 mg for up to 1 year of treatment for subjects with advanced prostate cancer.

PATIENTS AND METHODS:

In this open-label, multicenter study, prostate cancer patients with indication for androgen ablation therapy received two subcutaneous injection of LMIS 50 mg 6 months apart and were followed for an additional 6 months. Two efficacy primary end points were the percentage of subjects with a serum testosterone level ≤ 50 ng/dL by Day 28 as well as the percentage of subjects with similar testosterone suppression from Day 28 to Day 336.

RESULTS:

Of the 137 enrolled subjects, 15 (10.9%) subjects did not complete the study, including 5 subjects who terminated early due to an adverse event. By Day 28, 98.5% (95% confidence interval 94.8-99.8) of the subjects achieved a castrate testosterone level. At the end of the study, 97% and 95.9% of the subjects had serum testosterone level ≤ 50 ng/dL and ≤ 20 ng/dL, respectively. LMIS 50 mg significantly reduced serum prostate-specific antigen levels after its first injection and this PSA declination effect remained until the end of the study. No statistically significant change was observed in worsening bone pain or urinary symptom assessments during the study. Hot flush (48.9%) and hypertension (14.6%) were the two most common adverse events reported.

CONCLUSIONS:

LMIS 50 mg, administered at 6-month intervals, effectively suppressed serum testosterone level, and demonstrated a consistent safety profile.

News (Medical) associated with Leuprolide Mesylate

23 Jul 2026

·www.biospace.com

Accord BioPharma Announces Commercial Availability of Denosumab Biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu)

Biosimilars strengthen access to treatment for certain bone health conditions. RALEIGH, N.C. , July 23, 2026 /PRNewswire/ -- Accord BioPharma , Inc., the U.S. specialty division of Intas Pharmaceuticals , Ltd., focused on the development of oncology, immunology and central nervous system (CNS) therapies, today announced the launch of two denosumab biosimilars—OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu)—expanding access to more affordable therapies for patients. OSVYRTI and JUBEREQ are FDA-approved as interchangeable biosimilars to Prolia® and XGEVA®, respectively, and represent Accord BioPharma's first products developed and manufactured end to end, by its parent entity. 1-4 OSVYRTI is indicated for treatment of postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. As an interchangeable biosimilar to Prolia, OSVYRTI carries a Boxed Warning for severe hypocalcemia in patients with advanced kidney disease and was approved with a Risk Evaluation and Mitigation Strategy (REMS) program through which Accord will fulfill obligations related to such warning. 1 JUBEREQ is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. 2 Please see below for Important Safety Information for OSVYRTI and JUBEREQ. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Strengthening Access to Treatment for Certain Bone Health Conditions "For patients living with osteoporosis or cancer-related bone loss, the ability to access proven therapy is vital," said Chrys Kokino, President, Accord North America. "With the simultaneous launch of OSVYRTI and JUBEREQ, we are proud to provide access to additional options for these critical conditions and to back that commitment with real support for patients through AccordCares, our patient support program." Bone health conditions, including those for which OSVYRTI and JUBEREQ are approved, represent a significant and growing burden on patients and the U.S. healthcare system. Fragility fractures affect approximately 1.9 million Americans annually and are responsible for approximately 500,000 hospital admissions and 180,000 nursing home admissions. The annual number of fractures is projected to increase to 3.2 million by 2040. 5 An estimated 300,000 to 600,000 Americans are living with cancer-related bone metastases from solid tumors at any given time, and more than 35,000 Americans are diagnosed with multiple myeloma each year — a disease commonly associated with bone complications. 6-7 In 2024, Medicare Part B spending on denosumab products exceeded $2 billion, underscoring the need for more affordable alternatives. 8 OSVYRTI is available at a wholesaler acquisition cost (WAC) of $1,800.41 per 60 mg/mL single-dose pre-filled syringe, and JUBEREQ at a WAC price of $3,311.75 per 120 mg/1.7 mL (70 mg/mL) single-dose vial, supplying providers with more cost-efficient acquisition options for denosumab therapy. Beyond pricing, Accord BioPharma has worked to ensure broad coverage of these products at launch. As of July 1 st , both brands are Preferred on Cigna Advantage, Performance, and Legacy Performance commercial pharmacy benefit drug lists. Additionally, on September 1 st , both brands will be Preferred on the Cigna commercial medical benefit. Through AccordCares, eligible commercially insured patients may be able to access both OSVYRTI and JUBEREQ for as little as $0. A Milestone in Accord BioPharma's Growth Launching OSVYRTI and JUBEREQ marks another step in Accord BioPharma's evolution as a fully integrated biosimilar company: one that drives the science, the process, and the outcome. The company's goal of bringing 20 biosimilars to the U.S. market by 2030 reflects not just its ambition but also its infrastructure to deliver on it. "OSVYRTI and JUBEREQ represent a proud milestone in our work with Accord BioPharma to independently manufacture and bring these biosimilars to the U.S. market," said Binish Chudgar, Chairman and Managing Director of Intas. "Biosimilars have a critical and lasting role to play in the U.S. healthcare system, and we remain committed to helping more patients access the proven therapies they need, while delivering meaningful cost savings." Contact: abipr@accordhealthcare.com IMPORTANT SAFETY INFORMATION FOR OSVYRTI® (denosumab-desu) injection, for subcutaneous use OSVYRTI ® (denosumab-desu) is biosimilar to PROLIA ® (denosumab) BOXED WARNING AND ADDITIONAL IMPORTANT SAFETY INFORMATION WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE See full prescribing information for complete boxed warning. • Patients with advanced chronic kidney disease are at greater risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported. • The presence of chronic kidney disease-mineral bone disorder (CKD¬-MBD) markedly increases the risk of hypocalcemia. • Prior to initiating OSVYRTI in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with OSVYRTI in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD. Contraindications: OSVYRTI is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating OSVYRTI. OSVYRTI is contraindicated in women who are pregnant and may cause fetal harm. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment. OSVYRTI is contraindicated in patients with hypersensitivity to denosumab products. Reactions have included anaphylaxis, facial swelling and urticaria. Severe Hypocalcemia and Mineral Metabolism Changes: Pre-existing hypocalcemia must be corrected prior to initiating therapy; severe hypocalcemia and fatal cases have been reported with denosumab products. Adequately supplement all patients with calcium and vitamin D. In patients without advanced CKD who are predisposed to hypocalcemia and disturbances of mineral metabolism, assess serum calcium and mineral levels (phosphorus and magnesium) 10 to 14 days after OSVYRTI injection. In some postmarketing cases, hypocalcemia persisted for weeks or months and required frequent monitoring and intravenous and/or oral calcium replacement, with or without vitamin D. Patients with Advanced Chronic Kidney Disease Patients with advanced chronic kidney disease (eGFR <30 mL/min/1.73 m²), including dialysis-dependent patients, are at high risk for severe hypocalcemia after denosumab products administration, which can lead to hospitalization, life-threatening events, or death. CKD-MBD and concomitant calcimimetic use further increase risk. Assess for mineral bone disorder before OSVYRTI treatment, monitor serum calcium weekly for the first month, then monthly, and educate patients on hypocalcemia symptoms and the need for adequate calcium and activated vitamin D supplementation. Same Active Ingredient: Patients receiving OSVYRTI should not receive other denosumab products concomitantly. Hypersensitivity: Clinically significant hypersensitivity including anaphylaxis has been reported with denosumab products. Symptoms included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of OSVYRTI. Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing and has been reported in patients receiving denosumab products. An oral exam should be performed prior to initiation of OSVYRTI. Concomitant administration of drugs associated with ONJ may increase the risk of developing ONJ. The risk of ONJ may increase with duration of exposure to denosumab products. For patients requiring invasive dental procedures, clinical judgment should guide the management plan based on individual benefit-risk assessment. Patients suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. Extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of OSVYRTI should be considered based on individual benefit-risk assessment. Atypical Subtrochanteric and Diaphyseal Femoral Fractures : Atypical low-energy, or low trauma fractures of the shaft have been reported with denosumab products. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with antiresorptive agents. Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral, and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g. prednisone) at the time of fracture. During OSVYRTI treatment, advise patients to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of OSVYRTI therapy should be considered, pending a risk/benefit assessment, on an individual basis. Multiple Vertebral Fractures Following Discontinuation of Treatment: Following discontinuation of denosumab treatment, fracture risk increases, including the risk of multiple vertebral fractures. New vertebral fractures occurred as early as 7 months (on average 19 months) after the last dose of denosumab. Prior vertebral fracture was a predictor of multiple vertebral fractures after denosumab discontinuation. Evaluate an individual's benefit/risk before initiating treatment with OSVYRTI. If OSVYRTI treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy. Serious Infections: Serious infections leading to hospitalization were reported more frequently in patients taking denosumab. Serious skin infections, and infections of the abdomen, urinary tract and ear were more frequent in patients treated with denosumab. Endocarditis was also reported more frequently in denosumab-treated patients. Advise patients to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis. Patients on concomitant immunosuppressant agents or with impaired immune systems may be at increased risk for serious infections. In patients who develop serious infections while on OSVYRTI, prescribers should assess the need for continued therapy. Dermatologic Adverse Reactions: Epidermal and dermal adverse events such as dermatitis, eczema and rashes occurred at a significantly higher rate in patients taking denosumab. Most of these events were not specific to the injection site. Consider discontinuing OSVYRTI if severe symptoms develop. Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported with denosumab products. Consider discontinuing OSVYRTI use if severe symptoms develop. Suppression of Bone Turnover: Treatment with denosumab resulted in significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry. The significance and effect of long-term treatment with denosumab products are unknown. Monitor patients for consequences, including ONJ, atypical fractures, and delayed fracture healing. Hypercalcemia in Pediatric Patients with Osteogenesis Imperfecta: OSVYRTI is not approved for use in pediatric patients. Hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab products. Some cases required hospitalization. Most Common Adverse Reactions: Postmenopausal osteoporosis: Greater than 5% and more common than placebo: back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials. Male osteoporosis: Greater than 5% and more common than placebo: back pain, arthralgia, and nasopharyngitis. Glucocorticoid-induced osteoporosis: Greater than 3% and more common than active-control group were: back pain, hypertension, bronchitis, and headache. Bone loss due to hormone ablation for cancer: Greater than or equal to 10% and more common than placebo: arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. INDICATIONS OSVYRTI is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or . OSVYRTI (denosumab-desu) injection is supplied in a 60 mg/mL single-dose prefilled syringe. Click here for full Prescribing Information , including Boxed Warning . PROLIA ® (denosumab) is a registered trademark of Amgen Inc. IMPORTANT SAFETY INFORMATION FOR JUBEREQ® (denosumab-desu) injection, for subcutaneous use JUBEREQ ® (denosumab-desu) is biosimilar to XGEVA ® (denosumab) IMPORTANT SAFETY INFORMATION Contraindications: JUBEREQ is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy. JUBEREQ is contraindicated in patients with known clinically significant hypersensitivity to denosumab products. Same Active Ingredient: Patients receiving JUBEREQ should not receive other denosumab products concomitantly. Hypersensitivity: Clinically significant hypersensitivity including anaphylaxis has been reported with denosumab products. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue JUBEREQ therapy permanently. Hypocalcemia: Severe symptomatic hypocalcemia and fatal cases have been reported. Correct pre-existing hypocalcemia prior to JUBEREQ treatment, and fatal cases have been reported. Monitor calcium levels throughout therapy, especially in the first weeks, and administer calcium, magnesium, and vitamin D as necessary. Concomitant use of calcimimetics and other drugs that can lower calcium levels may worsen hypocalcemia risk and serum calcium should be closely monitored. Advise patients to contact a healthcare provider for symptoms of hypocalcemia. Increased risk of hypocalcemia has been observed in patients with renal dysfunction, most commonly with severe dysfunction CrCl (<30 mL/min and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake. Osteonecrosis of the Jaw (ONJ): ONJ has been reported manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials the incidence of ONJ was higher with longer duration of exposure. Predisposing factors for developing ONJ include a history of tooth extraction, poor oral hygiene, and use of a dental appliance. Other risk factors include immunosuppressive therapy, use of angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections. Perform an oral examination and appropriate preventive dentistry prior to the initiation of JUBEREQ and periodically during therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment. Consider temporary discontinuation of JUBEREQ if an invasive dental procedure must be performed. Patients who are suspected of having or who develop ONJ while on JUBEREQ should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Atypical Subtrochanteric and Diaphyseal Femoral Fractures : Atypical femoral fractures have been reported with denosumab products. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. During JUBEREQ treatment, advise patients to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of JUBEREQ therapy should be considered, pending a risk/benefit assessment. Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons: Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in denosumab product-treated patients with giant cell tumor of bone and patients with growing skeletons within one year of treatment discontinuation. Monitor for signs and symptoms of hypercalcemia after treatment discontinuation and treat appropriately. Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation: MVF have been reported following discontinuation of treatment with denosumab products. Patients at higher risk for MVF include those with risk factors for or a history of osteoporosis or prior fractures. When JUBEREQ treatment is discontinued, evaluate the patient's risk for vertebral fractures . Embryo-Fetal Toxicity: JUBEREQ can cause fetal harm when administered to a pregnant woman. Based on data from animal studies and its mechanism of action, JUBEREQ is expected to result in adverse reproductive effects. Verify the pregnancy status of females of reproductive potential prior to the initiation of JUBEREQ. Advise pregnant women and females of reproductive potential that exposure to JUBEREQ during pregnancy or within 5 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of JUBEREQ . Most Common Adverse Reactions: Bone Metastasis from Solid Tumors: Greater than or equal to 25%: fatigue/asthenia, hypophosphatemia, and nausea. Multiple Myeloma: Greater than or equal to 10%: diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. Giant Cell Tumor of Bone: Greater than or equal to 10%: arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. Hypercalcemia of Malignancy: Greater than 20%: nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea. INDICATIONS JUBEREQ is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or . JUBEREQ (denosumab-desu) injection is supplied in a 120 mg/1.7 mL (70 mg/mL) single-dose vial. Click here for full Prescribing Information . XGEVA ® (denosumab) is a registered trademark of Amgen Inc. About Accord BioPharma Accord BioPharma, Inc. is the U.S. specialty division of Intas Pharmaceuticals, Ltd., one of the world's most experienced biosimilar developers. Focused on the therapeutic areas of oncology, immunology, and CNS, Accord BioPharma is committed to expanding patient access to high-quality, affordable biologic therapies. The company's FDA-approved commercial portfolio includes UDENYCA® (pegfilgrastim-cbqv) – a biosimilar to NEULASTA® (pegfilgrastim); FILKRI™ (filgrastim-laha) – a biosimilar to NEUPOGEN® (filgrastim); IMULDOSA® (ustekinumab-srlf) – a biosimilar to STELARA® (ustekinumab); HERCESSI™ (trastuzumab-strf) – a biosimilar to HERCEPTIN® (trastuzumab); OSVYRTI® (denosumab-desu) – a biosimilar to Prolia® (denosumab); JUBEREQ® (denosumab-desu) – a biosimilar to Xgeva® (denosumab); ENNUMO™ (pegfilgrastim-pccg) – a biosimilar to NEULASTA®; and CAMCEVI® (leuprolide mesylate) injectable emulsion. Accord BioPharma has received FDA approval on additional products including IMMGOLIS™ (golimumab-sldi) – a biosimilar to Simponi® (golimumab), and IMMGOLIS INTRI™ (golimumab-sldi) – a biosimilar to Simponi Aria® (golimumab). The company's strategic goal is to launch 20 biosimilar products in the U.S. by 2030. For more information, visit . References: OSVYRTI® (denosumab-desu) Prescribing Information. Accord BioPharma. JUBEREQ® (denosumab-desu) Prescribing Information. Accord BioPharma. Prolia® (denosumab) Prescribing Information. Amgen. XGEVA® (denosumab) Prescribing Information. Amgen. Keen MU, et al. Osteoporosis in Females. StatPearls. Updated June 29, 2025. DiCaprio MR, et al. Narrative review of the epidemiology, economic burden, and societal impact of metastatic bone disease. Ann Jt . 2022 Jul 15:7:28. doi: 10.21037/aoj-20-97. National Cancer Institute. Cancer Stat Facts: Myeloma. SEER. 2024. Centers for Medicare & Medicaid Services. Medicare Part B Spending by Drug. Accessed March 26, 2026. All trademarks, logos and brand names are the property of their respective owners. View original content to download multimedia: SOURCE Accord BioPharma

Drug ApprovalAcquisitionClinical Result

13 Jul 2026

·www.prnewswire.com

Foresee Pharmaceuticals Appoints Brian J. Groch as Chief Commercial Officer to Spearhead Commercial Launch of FP-001 42 mg for Central Precocious Puberty

TAIPEI, July 9, 2026 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announced the appointment of Brian J. Groch as Chief Commercial Officer, effective July 1, 2026. In this strategic executive role, Brian will oversee Foresee's global commercial launch strategy and preparations for FP-001 42 mg (six-month ready-to-use subcutaneous long-acting injectable of leuprolide mesylate) for the treatment of central precocious puberty (CPP) in the United States, Taiwan, and potentially other markets. Brian is a seasoned healthcare executive with more than 30 years of industry background and experience in the pharmaceutical industry including multiple leadership roles at Remi Therapeutics, Shield Therapeutics, Veru Inc., and Horizon Therapeutics. He has many years of experience leading global market access strategies and commercial executions, successfully driving the commercialization and market adoption of various treatments across multiple disease areas. Prior to his executive roles, he worked as a Director of Health Policy and Regional Sales at Novartis and spent more than 13 years working for Merck on large-scale commercial and marketing management programs. "I am pleased to announce that Brian J. Groch has joined Foresee as Chief Commercial Officer," said Dr. Ben Chien, Ph.D., Chairman and Chief Executive Officer of Foresee Pharmaceuticals. "Brian will lead Foresee in building a commercial team to launch the FP-001 for the treatment of CPP patients in the U.S., Taiwan, and potentially other selected countries. We are excited that Foresee will build upon our R&D success and transition into a new phase of building direct commercialization capabilities." Foresee is systematically executing its global regulatory roadmap for the CPP program: U.S. Market: The New Drug Application (NDA) submission to the U.S. FDA is targeted for the second half of 2026. Global Markets: Marketing authorization applications will be submitted to health agencies in Taiwan and other strategic territories between late 2026 and the first half of 2027. Ongoing Initiatives: Engage in pre-NDA meetings and regulatory discussions to ensure a streamlined review process. About Central Precocious Puberty (CPP) Central Precocious Puberty is a condition characterized by premature activation of the pituitary-gonadal axis, leading to early puberty. If left untreated, CPP can result in accelerated bone maturation and reduced final adult height, as well as significant psychosocial challenges for affected children. The current standard of care involves treatment with GnRH agonists to halt pubertal progression. About FP-001 42 mg FP-001 42 mg is an investigational, sustained-release ready-to-use, subcutaneous formulation of leuprolide mesylate being developed for the treatment of CPP. It is designed to provide continuous suppression of gonadotropin secretion for 6 months following a single subcutaneous injection, offering a less-frequent, ready-to-use dosing alternative to existing therapies. About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in April 2022. Additionally, CAMCEVI ETM was approved by the U.S. FDA on August 25, 2025. Foresee was notified by its licensing partners in April and May 2026 regarding the successful drug approvals in Canada and the granting of EMA marketing authorization in the EU. For FP-001, 42 mg 6-month LAI formulation in central precocious puberty (CPP), the Casppian Phase 3 clinical trial successfully reached its primary endpoint in December 2025 (p-value = 0.0005), with an NDA submission to the U.S. FDA planned in the second half of 2026. The Phase 3 clinical trial of CAMCEVI 6-month LAI formulation for premenopausal breast cancer in China has been completed, and in May 2026, the licensing partner submitted a marketing authorization application for leuprolide acetate injectable emulsion for the additional indication of premenopausal breast cancer, which has been accepted by China's National Medical Products Administration (NMPA) for substantive review. Building on the success of CAMCEVI's formulation development, Foresee's proprietary SIF technology platform is now expanding into the central nervous system (CNS) field, which represents a potential multi-billion-dollar market. Two CNS-targeted long-acting injectable (LAI) candidates, FP-018 (Cariprazine LAI) and FP-016 (VMAT2 LAI), are expected to enter human clinical trials in late 2027. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, successfully completed a Phase 2 proof-of-concept study in allergic asthmatic patients. Future development of aderamastat will be in rare immune-fibrotic diseases, including cardiac sarcoidosis. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy volunteers, with development targeted in severe asthma and COPD. In January 2026, the global rights for the MMP-12 Inhibitor series were exclusively licensed to Primevera Therapeutics LLC for all subsequent R&D. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients was initiated in the second quarter of 2025. SOURCE Foresee Pharmaceuticals Co., Ltd. 21% more press release views with Request a Demo

Phase 2Drug ApprovalPhase 1Phase 3Executive Change

18 May 2026

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FDA Approves IMMGOLIS™ (golimumab-sldi) and IMMGOLIS INTRI™ (golimumab-sldi), First Biosimilars to Simponi® (golimumab) and Simponi Aria® (golimumab); Accord BioPharma to Lead U.S. Commercialization

FDA approval of IMMGOLIS and IMMGOLIS INTRI breaks new ground in patient access, marking the first biosimilar option to golimumab biologic therapy in the U.S. IMMGOLIS is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA), in combination with methotrexate, and moderately to severely active ulcerative colitis (UC), while IMMGOLIS INTRI is approved for the treatment of adults with moderately to severely active RA in combination with methotrexate Accord BioPharma expands growing biosimilar portfolio as exclusive U.S. commercialization partner for IMMGOLIS and IMMGOLIS INTRI RALEIGH, N.C. , May 18, 2026 /PRNewswire/ -- Accord BioPharma , Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncology, immunology and central nervous system (CNS) therapies, announced today that the U.S. Food and Drug Administration (FDA) has approved IMMGOLIS™ (golimumab-sldi), a biosimilar to Simponi® (golimumab), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate, and adult patients with moderately to severely active ulcerative colitis (UC). The FDA also approved IMMGOLIS INTRI™ (golimumab-sldi), a biosimilar to Simponi Aria® (golimumab), for the treatment of adults with moderately to severely active RA in combination with methotrexate. Simponi, Simponi Aria, IMMGOLIS, and IMMGOLIS INTRI each carry a Boxed Warning for Serious Infections and Malignancy; please see the Boxed Warnings for IMMGOLIS and IMMGOLIS INTRI below. 1,2 IMMGOLIS and IMMGOLIS INTRI are the first FDA-approved golimumab biosimilars, and will be commercialized in the United States exclusively by Accord BioPharma. IMMGOLIS and IMMGOLIS INTRI were designated interchangeable by the FDA for rheumatoid arthritis and ulcerative colitis. For the first time, patients with rheumatoid arthritis and ulcerative colitis will have an FDA-approved biosimilar option for both Simponi and Simponi Aria, a pivotal step toward broader access to biologic therapy. As the exclusive U.S. commercialization partner for IMMGOLIS and IMMGOLIS INTRI, Accord BioPharma plans to make these products available to patients and providers in Q4 2026. "As the first golimumab biosimilars approved in the U.S., IMMGOLIS and IMMGOLIS INTRI represent a meaningful new option for people in the U.S. who are living with the chronic, debilitating autoimmune conditions associated with moderately to severely active rheumatoid arthritis or ulcerative colitis and need more affordable medication," said Chrys Kokino, President of Accord North America. "This approval answers a clear demand in the U.S. market and helps advance our ambitious goal to bring 20 biosimilars to market by the year 2030." "Biosimilars are one of the most powerful tools we have to improve affordability and access across the U.S. healthcare system," said Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals." With Accord BioPharma's deep expertise, dedicated team, and bold vision, the team is well positioned to bring this first-of-its-kind product to U.S. patients and providers later this year." IMMGOLIS and IMMGOLIS INTRI were developed by Bio-Thera Solutions, which will maintain responsibility for manufacturing and product supply. IMMGOLIS is not indicated for and should not be used or administered for the treatment of adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate; adult patients with active ankylosing spondylitis (AS); or pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis (UC). IMMGOLIS INTRI is not indicated for and should not be used or administered for the treatment of Active Psoriatic Arthritis (PsA) in patients 2 years of age and older; adult patients with active Ankylosing Spondylitis (AS); or Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older. IMPORTANT SAFETY INFORMATION IMMGOLIS (golimumab-sldi) injection, for subcutaneous use IMMGOLIS (golimumab-sldi) is a biosimilar* to SIMPONI ® (golimumab) IMMGOLIS INTRI (golimumab-sldi) injection, for intravenous use IMMGOLIS INTRI (golimumab-sldi) is a biosimilar* to SIMPONI ARIA ® (golimumab) BOXED WARNING AND IMPORTANT SAFETY INFORMATION WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving golimumab products. Discontinue IMMGOLIS/IMMGOLIS INTRI if a patient develops a serious infection or sepsis. Perform test for latent TB; if positive, start treatment for TB prior to starting IMMGOLIS/IMMGOLIS INTRI. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children. and adolescent patients treated with TNF blockers, of which IMMGOLIS/IMMGOLIS INTRI is a member. Serious Infections: Patients treated with golimumab products are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue IMMGOLIS/IMMGOLIS INTRI if a patient develops a serious infection. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis have been reported with TNF-blockers, of which IMMGOLIS/IMMGOLIS INTRI is a member. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. The concomitant use of a TNF-blocker and abatacept or anakinra was associated with a higher risk of serious infections; therefore, the concomitant use of IMMGOLIS/IMMGOLIS INTRI and these biologic products is not recommended. Treatment with IMMGOLIS/IMMGOLIS INTRI should not be initiated in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants such as corticosteroids or methotrexate may be at greater risk of infection. Monitoring Closely monitor patients for the development of signs and symptoms of infection during and after treatment with IMMGOLIS/IMMGOLIS INTRI. Discontinue IMMGOLIS/IMMGOLIS INTRI if a patient develops a serious infection, an opportunistic infection, or sepsis. For a patient who develops a new infection during treatment with IMMGOLIS/IMMGOLIS INTRI, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, initiate appropriate antimicrobial therapy, and closely monitor them. Tuberculosis Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving TNF-blockers, including patients who have previously received treatment for latent or active tuberculosis. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating IMMGOLIS/IMMGOLIS INTRI and periodically during therapy. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient. Invasive Fungal Infections If patients develop a serious systemic illness and they reside or travel in regions where mycoses are endemic, consider invasive fungal infection in the differential diagnosis. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections and consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections. Hepatitis B Reactivation The use of TNF blockers, of which IMMGOLIS/IMMGOLIS INTRI is a member, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic HBV carriers. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients who received concomitant immunosuppressants. All patients should be tested for HBV before initiating TNF-blocker therapy. For patients who test positive for hepatitis B surface antigen, consult a physician with expertise in the treatment of hepatitis B before initiating TNF-blocker therapy. Exercise caution when prescribing IMMGOLIS/IMMGOLIS INTRI for patients identified as carriers of HBV and closely monitor for active HBV infection during and following termination of therapy. Discontinue IMMGOLIS/IMMGOLIS INTRI in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of IMMGOLIS/IMMGOLIS INTRI and monitor patients closely. Malignancies: Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤ 18 years of age), of which IMMGOLIS/IMMGOLIS INTRI is a member. Most of the patients were receiving concomitant immunosuppressants. The risks and benefits of IMMGOLIS/IMMGOLIS INTRI should be considered prior to initiating therapy in patients with a known malignancy other than a successfully treated nonmelanoma skin cancer (NMSC) or when considering continuing a TNF-blocker in patients who develop a malignancy. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including golimumab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Congestive Heart Failure (CHF): Cases of worsening CHF and new onset CHF have been reported with TNF blockers, including golimumab products. Some cases had a fatal outcome. Patients with CHF should be closely monitored during therapy. Discontinue IMMGOLIS/IMMGOLIS INTRI if new or worsening symptoms of CHF appear. Demyelinating Disorders: Use of TNF blockers, of which IMMGOLIS/IMMGOLIS INTRI is a member, has been associated with rare cases of new onset or exacerbation of central nervous system demyelinating disorders, including multiple sclerosis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Prescribers should exercise caution in considering the use of IMMGOLIS/IMMGOLIS INTRI in patients with central or peripheral nervous system demyelinating disorders. Consider discontinuation of IMMGOLIS/IMMGOLIS INTRI if these disorders develop. Autoimmunity: Treatment with TNF blockers, including IMMGOLIS/IMMGOLIS INTRI, may result in the formation of antinuclear antibodies and rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with IMMGOLIS/IMMGOLIS INTRI, treatment should be discontinued. Use with Other Drugs: The concomitant use of a TNF blocker and abatacept or anakinra was associated with a higher risk of serious infections; therefore, the use of IMMGOLIS/IMMGOLIS INTRI in combination with these products is not recommended. Care should be taken when switching between biological disease modifying antirheumatic drugs since overlapping biological activity may further increase the risk of infection. Upon initiation or discontinuation of IMMGOLIS/IMMGOLIS INTRI in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. Hematologic Cytopenias: There have been reports of pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia in patients receiving golimumab products. Exercise caution when using TNF blockers, including IMMGOLIS/IMMGOLIS INTRI, in patients who have or have had significant cytopenias. Vaccinations/Therapeutic Infectious Agents: Patients treated with IMMGOLIS/IMMGOLIS INTRI may receive vaccinations, except for live vaccines. If possible, it is recommended that prior to initiating therapy with IMMGOLIS/IMMGOLIS INTRI, patients be brought up to date with all immunizations in agreement with current immunization guidelines. It is recommended that therapeutic infectious agents not be given concurrently with IMMGOLIS/IMMGOLIS INTRI due to the possibility of clinical infections, including disseminated infections. Hypersensitivity Reactions: Serious systemic hypersensitivity reactions (including anaphylaxis) have been reported following golimumab product administration. Some reactions occurred after the first administration of golimumab products. If an anaphylactic or other serious allergic reaction occurs, discontinue IMMGOLIS/IMMGOLIS INTRI and institute appropriate therapy. Most Common Adverse Reactions: Most common adverse reactions with IMMGOLIS in adults (incidence > 5%) are upper respiratory tract infection, nasopharyngitis, and injection site reactions. Most common adverse reactions with IMMGOLIS INTRI (incidence ≥ 3%) are: upper respiratory tract infection, alanine aminotransferase increased, viral infection, aspartate aminotransferase increased, neutrophil count decreased, bronchitis, hypertension, and rash. INDICATIONS IMMGOLIS is a tumor necrosis factor (TNF) blocker indicated for the treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate adult patients with moderately to severely active ulcerative colitis (UC) IMMGOLIS INTRI is a tumor necrosis factor (TNF) blocker indicated for the treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or . IMMGOLIS (golimumab-sldi) injection is supplied in a 50 mg/0.5 mL and 100 mg/mL single-dose prefilled syringe. IMMGOLIS INTRI (golimumab-sldi) injection is supplied in a 50 mg/4 mL (12.5 mg/mL) solution in a single-dose vial. Click here for full Prescribing Information for IMMGOLIS. Click here for full Prescribing Information for IMMGOLIS INTRI. SIMPONI and SIMPONI ARIA ® (golimumab)are registered trademarks of Johnson & Johnson and its affiliates. About Accord BioPharma Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and central nervous system (CNS) therapies. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. The company is advancing an ambitious pipeline with the goal of bringing 20 biosimilars to the U.S. market by 2030. The company's current commercial portfolio includes the full UDENYCA ® (pegfilgrastim-cbqv) franchise, including the UDENYCA prefilled syringe, autoinjector, and on-body injector, IMULDOSA ® (ustekinumab-srlf), a biosimilar to Stelara ® (ustekinumab), HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin ® (trastuzumab), and CAMCEVI ® (leuprolide) 42 mg injectable emulsion. Please refer to the Important Safety Information and full Prescribing Information for these products, and to the Boxed Warning for HERCESSI. Accord BioPharma has received FDA approval on five additional products: CAMCEVI ® (leuprolide) ETM (every three months), OSVYRTI ® (denosumab-desu) – a biosimilar to PROLIA ® (denosumab), JUBEREQ ® (denosumab-desu) – a biosimilar to XGEVA ® (denosumab), FILKRI™ (filgrastim-laha) – a biosimilar to NEUPOGEN® (filgrastim), and ENNUMO™ (pegfilgrastim-pccg) – a biosimilar to NEULASTA® (pegfilgrastim). The company plans to announce the commercial launch of these products later this year. Please refer to the Important Safety Information and full Prescribing Information for these products, and to the Boxed Warning for OSVYRTI. For more information, visit AccordBioPharma.com . About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. For more information, please visit References: IMMGOLIS (golimumab-sldi) Full Prescribing Information. Accord BioPharma. IMMGOLIS INTRI (golimumab-sldi) Full Prescribing Information. Accord BioPharma. All trademarks, logos and brand names are the property of their respective owners. Contact: abipr@accordhealthcare.com View original content to download multimedia: SOURCE Accord BioPharma

Drug ApprovalClinical ResultBiosimilar

100 Deals associated with Leuprolide Mesylate

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Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Advanced Prostate Carcinoma	Israel	Foresee Pharmaceuticals Co., Ltd.	11 Jul 2024
Hormone-dependent prostate cancer	European Union	Accord Healthcare SL	24 May 2022
Hormone-dependent prostate cancer	Iceland	Accord Healthcare SL	24 May 2022
Hormone-dependent prostate cancer	Liechtenstein	Accord Healthcare SL	24 May 2022
Hormone-dependent prostate cancer	Norway	Accord Healthcare SL	24 May 2022
Prostatic Cancer	United States	Accord BioPharma, Inc.	25 May 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	NDA/BLA	China	Changchun Genescience Pharmaceuticals Co., Ltd.	28 May 2026
Breast Cancer	NDA/BLA	China	Accord BioPharma, Inc.	28 May 2026
Premenopausal breast cancer	Phase 3	China	Foresee Pharmaceuticals Co., Ltd.	21 Aug 2024
Premenopausal breast cancer	Phase 3	China	Changchun Genescience Pharmaceuticals Co., Ltd.	21 Aug 2024
Premenopausal breast cancer	Phase 3	China	FAREVA PAU	21 Aug 2024
Puberty, Precocious	Phase 3	United States	Changchun Genescience Pharmaceuticals Co., Ltd.	02 Jun 2023
Puberty, Precocious	Phase 3	United States	Foresee Pharmaceuticals Co., Ltd.	02 Jun 2023
Puberty, Precocious	Phase 3	China	Changchun Genescience Pharmaceuticals Co., Ltd.	02 Jun 2023
Puberty, Precocious	Phase 3	China	Foresee Pharmaceuticals Co., Ltd.	02 Jun 2023
Puberty, Precocious	Phase 3	Taiwan Province	Foresee Pharmaceuticals Co., Ltd.	02 Jun 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05341115 (PUPIL, CTgov)	Phase 4	Puberty, Precocious	80	Leuprorelin Acetate	xhgbcjdxxn = cqkrpagnfw kzxbghfvef (zmxtixoyaz, svjwtueesv - ezjfewsijv) View more	-	13 Jan 2026
NCT03261999 (FDA_CDER) Manual	Phase 3	Advanced Prostate Carcinoma	144	CAMCEVI ETM	rccbeqolxf(jkologarvf) = ajyanaoqev hhdzvhmjly (mdgkrodcxt, 92.7 - 98.9) View more	Positive	25 Aug 2025
ASCO2024	Not Applicable	Prostatic Cancer testosterone levels	240	Leuprorelin alone	lyytkirhdw(hehasyqkme) = oglpwrzxrl rtedaozqdp (xoatxoublm, 37-1 - 136) View more	Positive	24 May 2024
ASCO2024	Not Applicable	Prostatic Cancer testosterone levels	240	Leuprorelin + Novel Hormonal Agent	lyytkirhdw(hehasyqkme) = nzztqjarqy rtedaozqdp (xoatxoublm, 37-1 - 136) View more	Positive	24 May 2024
NCT03261999 (CTgov)	Phase 3	Prostatic Cancer	144	Leuprolide Mesylate	zghfmqhjzi = skbirsrdhe sznolewgsq (cxwnpllscc, vclqqnkutd - ufgmcyikkw) View more	-	04 May 2020
NCT02712320 (CTgov)	Phase 3	Advanced Prostate Carcinoma	30	LMIS 50 mg	hjepultorb = wycfenantu fsluiubmce (abkcdootgv, ajqdnnhlaf - wcutmrrcnb) View more	-	12 Sep 2018
NCT02234115 (CTgov)	Phase 3	Advanced Prostate Carcinoma	137	Leuprolide Mesylate	qmdpnogolt(zolamlobjm) = bhjlkjuyde famxsbxcvv (gmyqztgpvn, kvubneibiw - edlbbpwsdc) View more	-	13 Apr 2018
ASCO2004	Phase 3	Breast Cancer Adjuvant	599	Leuprorelin acetate 3M-Depot	nieamnudnw(readsmvzmc) = bofcgyuwnh hegpblbodo (bcgadyolam ) View more	Positive	15 Jul 2004
ASCO2004	Phase 3	Breast Cancer Adjuvant	599	CMF chemotherapy	nieamnudnw(readsmvzmc) = ngcdainlof hegpblbodo (bcgadyolam ) View more	Positive	15 Jul 2004

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