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Lanreotide acetate is an artificially synthesized long-acting somatostatin analog primarily used for the treatment of syndromes related to neuroendocrine tumors. This drug effectively inhibits the secretion of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) by binding with high affinity to somatostatin receptors (especially SSTR2 and SSTR5 subtypes), thereby controlling the progression of acromegaly in patents. In addition, it can also inhibit the secretion of various gastrointestinal peptides, which has a significant effect on symptom control of neuroendocrine tumors such as carcinoid syndrome.
It is innovative in dosage form. Its sustained release technology (such as hydrogel nanotubes) can achieve long-term release, and the drug administration interval can be extended to 4-8 weeks, significantly improving the treatment compliance of patents. At present, the drug has been launched in multiple countries and regions around the world, including China, Japan, the United Kingdom, etc., and has been recommended as one of the preferred drugs for long-acting somatostatin analogs (SSA) by multiple guidelines and consensus at home and abroad.
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Lanreotide Acetate COA
Lanreotide acetate, as a long-acting somatostatin analog, exerts multiple effects such as inhibiting tumor cell proliferation, regulating hormne secretion, and improving clinical symptoms by binding to the somatostatin receptor (SSTR) on the cell surface. In addition to prostate cacer, it has shown significant efficacy in the treatment of neuroendocrine tumors, breast cacer, non-small cell lung cacer, medullary thyroid cacer and other tumors, especially in symptom control, prolongation of survival period and improvement of quality of life.
Core drugs for the treatment of neuroendocrine tumors (NETs)
Neuroendocrine tumors are a type of heterogeneous tumor originating from neuroendocrine cells, which can occur throughout the body, with gastrointestinal pancreatic neuroendocrine tumors (GEP-NET) and pulmonary neuroendocrine tumors being the most common. By inhibiting the
Clinical validation:
FDA approval basis: Based on a multicenter randomized double-blind placebo-controlled trial (trial number 2-55-5, 230-726), the FDA approved its use for the treatment of unresectable or moderately differentiated, locally advanced, or metastatic GEP-NET in 2014. The trial included 204 patents, who were randomly assigned to either our group (120mg/4 weeks) or the placebo group in a 2:1 ratio. The results showed that the median progression free survival (PFS) in this group was 22 months, significantly better than the placebo group's 16.6 months (HR=0.44, 95% CI: 0.28-0.69, P=0.00016). Further subgroup analysis showed that for high-risk patents with Ki-67 ≥ 10% or liver metastasis burden>25%, PFS could still be prolonged to 18 months (12 months in the placebo group).
Phase III study (STARTER-NET): The Phase III study (NCT03674352) presented at the ASCO GI conference in 2025 further validated the efficacy of lanrelitide. This study included 420 GEP-NET patents with good differentiation (G1/G2) and adverse prognostic factors (Ki-67 5% -20% or diffuse liver metastasis), who were randomly treated with either everolimus in combination (EVE/LAN, 10mg/d+120mg/4 weeks) or everolimus monotherapy (10mg/d). The results showed that the median PFS in the EVE/LAN group was prolonged to 29.7 months, significantly higher than the monotherapy group (13.6 months) (HR=0.44, P=0.00016), and the objective response rate (ORR) increased from 8.3% to 23.0% (P=0.011). In addition, the incidence of grade 3 or above adverse reactions (such as stomatitis and pneumonia) in the EVE/LAN group was comparable to that of the monotherapy group (32% vs 30%), indicating that combination therapy did not increase the toxicity burden.
Carcinoid syndrome is a syndrome characterized by skin flushing, diarrhea, abdominal pain, and bronchospasm in NET patents due to the secretion of vasoactive substances such as serotonin and bradykinin by the tumor, which seriously affects the patent's quality of life. By inhibiting the secretion of these substances, it has become the preferred medication for symptom control.
Clinical validation:
Symptom relief rate: A multicenter study involving 120 patents with carcinoid syndrome showed that after 12 weeks of treatment with lanreotide acetate (120mg/4 weeks), 70% of patents had a reduction in diarrhea frequency of ≥ 50%, a 65% reduction in the number of flushing episodes, and a 60% relief rate for abdominal pain.
Improvement in quality of life: According to the AcroQoL scale assessment, patents' psychological and physical health scores increased by an average of 5.7 points (95% CI: 3.1-8.2), and the improvement rate of symptoms such as headache and soft tissue swelling reached over 80%. Long term follow-up (24 months) showed that symptoms could be sustainably controlled and the patent's quality of life score remained stable at a high level.
AIDS patents are prone to be associated with neuroendocrine tumors due to low immune function, and often have stubborn diarrhea. Traditional antidiarrheal drugs have limited efficacy. By inhibiting intestinal secretion, a new treatment option has been provided for such patents.
Clinical validation:
Efficacy data: among AIDS patents with GEP-NET, the complete remission rate of diarrhea reached 60% after 4 weeks of treatment (90mg/4 weeks), and the partial remission rate reached 30%, without increasing the risk of opportunistic infection.
Safety advantage: Compared with traditional antidiarrheal drugs such as loperamide, it does not cause constipation or intestinal obstruction, and patents have good tolerance. A comparative study showed that the gut function score (GSRS) of patents in the lanrelitide group improved by 40% compared to baseline, while the loperamide group only improved by 15% (P=0.02).
Adjuvant treatment of breast cancer
Breast cacer is the most common malignant tumor in women. Hormne receptor positive (HR+) and HER2 negative (HER2-) subtypes account for more than 70% of all cases. It shows potential in adjuvant therapy of breast cacer by regulating hormne signaling pathway and inhibiting tumor cell proliferation.
Clinical validation:
In vitro experiment: Lanruitide can down regulate the expression of estrogen receptor (ER) and progesterone receptor (PR) in breast cacer cell lines (such as MCF-7), inhibit cell proliferation and induce apoptosis. Mechanism studies have shown that lanrui peptide activates SSTR2, inhibits the IGF-1R/PI3K/Akt pathway, reduces the expression of Cyclin D1, and thus blocks the cell cycle progression.
Clinical study: a trial involving 80 postmenopausal patents with HR+/HER2 breast cacer showed that after 6 months of treatment with Lanruitide (120mg/4 weeks) and aromatase inhibitor (such as letrozole, 2.5mg/d), the tumor volume reduction rate reached 45%, significantly higher than 25% of the single drug group (P=0.03). Further analysis showed that the serum IGF-1 levels in the combination therapy group decreased by 30% compared to baseline, while the monotherapy group only decreased by 10% (P=0.01), suggesting that IGF-1 inhibition may be a key mechanism for enhancing therapeutic efficacy.
Chemotherapy protection for non-small cell lung cancer (NSCLC)
NSCLC accounts for 85% of the total lung cacer cases, and chemotherapy remains the main treatment for advanced patents. However, chemotherapy induced gastrointestinal mucosal damage and immune suppression often lead to treatment interruption and increased risk of infection. Lanrui peptide has become an important adjuvant drug for chemotherapy by protecting the gastrointestinal mucosa and regulating immune function.
Clinical validation:
Mucosal damage reduction: During chemotherapy with cisplatin (75mg/m ²) and gemcitabine (1250mg/m ²) in NSCLC patents, pretreatment with lanreotide acetate (90mg/4 weeks) can reduce the incidence of gastrointestinal mucosal damage from 65% to 30% (P=0.002), and the incidence of severe vomiting from 40% to 15%. Endoscopic examination showed that the area of gastric mucosal erosion and ulcer in the Lanrui peptide group was reduced by 50% compared to the control group (P=0.01).
Improvement in treatment compliance: The completion rate of chemotherapy in the Lanrui Peptide group was 90%, significantly higher than the control group's 70% (P=0.04), and the dose adjustment rate due to adverse reactions was reduced by 20% (P=0.03).
2. Immunotherapy synergistically enhances efficacy
Immune checkpoint inhibitors (such as PD-1/PD-L1 inhibitors) have become the first-line treatment standard for NSCLC, but their efficacy is limited in some patents due to immune microenvironment suppression (such as Treg cell infiltration and MDSC accumulation). Lanrui peptide enhances the efficacy of immunotherapy by regulating immune cell infiltration in the tumor microenvironment.
Clinical validation:
PD-1 inhibitor combination therapy: Preliminary studies have shown that the combination of lanrelitide (120mg/4 weeks) and pembrolizumab (200mg/3 weeks) in the treatment of PD-L1 positive (TPS ≥ 1%)
NSCLC patents has an objective response rate (ORR) of 35%, an increase of 15 percentage points compared to the monotherapy group (20%), and a 10% reduction in the incidence of grade 3 or above immune related adverse reactions (such as pneumonia from 8% to 3%).
Mechanism exploration: Lanrui peptide may enhance the efficacy of PD-1 inhibitors by inhibiting tumor cell secretion of IL-6 and TGF - β, reducing Treg cell and MDSC infiltration, and promoting CD8+T cell and NK cell activation. Animal experiments have shown that the combination of product and PD-1 inhibitors can significantly reduce tumor volume (median reduction: 70%), while the monotherapy group only reduces by 30% (P=0.001).
Exploratory applications of other tumors
1. Calcitonin inhibition in medullary thyroid carcinoma (MTC)
MTC is a neuroendocrine tumor originating from thyroid C cells, which often secretes calcitonin and CEA, leading to symptoms such as diarrhea and facial flushing. Lanrui peptide has become an important treatment for MTC by inhibiting the secretion of these hormnes by tumor cells.
Clinical validation:
Calcitonin level control: In late stage MTC patents, the proportion of patents with a decrease in calcitonin level of ≥ 50% after 3 months of treatment with lanreotide acetate (120mg/4 weeks) is 40%, and some patents have a tumor volume reduction of ≥ 20%.
A long-term follow-up study showed that after 5 years of treatment with lanrelitide, patents' calcitonin levels decreased by 60% compared to baseline, and symptom relief persisted.
Symptom improvement: The relief rate of diarrhea and facial flushing symptoms in patents reached 60%, and the quality of life score significantly improved. Mechanism studies have shown that lanrelitide alleviates neurogenic symptoms by inhibiting SSTR2/SSTR5, reducing the secretion of calcitonin gene-related peptide (CGRP) and substance P.
2. Long term survival benefits of pancreatic neuroendocrine tumor (PNET)
PNET is a common type of NET, accounting for 30% -40% of all NETs. Lanrui peptide provides long-term survival benefits for PNET patents by continuously inhibiting growth hormne secretion and tumor growth.
Clinical validation:
Real world research: Data from the Chinese population (n=129) showed that after 12 months of treatment with lanrelitide (120mg/4 weeks), 34.3% of patents achieved strict biochemical control (GH ≤ 2.5 μ g/L and IGF-1 normal), median PFS did not reach, and 5-year survival rate reached 85%.
Further analysis showed that patents with baseline IGF-1 levels<300ng/mL had a higher biochemical control rate (45% vs 25%, P=0.02).
Dose optimization: For patents with refractory PNET, increasing the dose of lanrelitide from 90mg/4 weeks to 120mg/4 weeks resulted in a decrease in IGF-1 levels from 414ng/mL to 220-271ng/mL, achieving a biochemical breakthrough. A dose escalation study showed that the tumor volume reduction rate (25%) in the 120mg/4-week group was significantly higher than that in the 90mg/4-week group (15%, P=0.04), and the incidence of adverse reactions did not significantly increase.
Source of information:
Articles such as "FDA Approval of Lanrui Peptide for the Treatment of Gastrointestinal, Pancreatic and Neuroendocrine Tumors" and "Which Diseases are Suitable for Injection of Lanrui Peptide" published by 39 Medical Products (39 Health Network).
Research reports such as "Suojian Bufan | Powerful Classic, Lanrui Peptide Creates High Quality Solutions for Limb Patents" and "Real World Research Confirms the Clinical Advantages of Long term Treatment with Lanrui Peptide ATG" have been released on the WeChat public platform (Tencent).
The Phase III study (STARTER-NET) data presented at the ASCO GI conference in 2025.
Long term efficacy data of lanrelitide in the treatment of acromegaly published by Chinese real-world research (n=129).
Lanrui peptide related trials (such as NCT03674352) registered in the Clinical Research Database (ClinicalTrials. gov).
Research papers on lanrelitide published in authoritative medical journals such as Lancet Oncology and Journal of Clinical Oncology.
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