GeneScience ：CAMCEVI®Leuprolidehas been formally accepted for review.
On June 1, Changchun GeneScience Pharmaceutical announced that the New Drug Application (NDA) for its Leuprorelin Mesylate Injection (6M) has been accepted by the CDE for the proposed treatment of breast cancer. (Source: Company official website)
Leuprorelin Mesylate Injection (development code: FP-001/Changchun GeneScience093) is a long-acting gonadotropin-releasing hormone agonist (GnRHa) formulation, intended to be administered via a once-every-six-month subcutaneous injection regimen.
In November 2020, Changchun GeneScience Pharmaceutical entered into an exclusive license agreement with Foresee Pharmaceuticals for the FP-001 program (covering two specifications), with a total value exceeding US$100 million. Under the agreement, Changchun GeneScience Pharmaceutical holds the rights to the product in China (excluding Taiwan). The drug has already been approved for marketing in the United States, the European Union, and Taiwan (China) for androgen deprivation therapy in advanced prostate cancer. In February 2025, Changchun GeneScience Pharmaceutical announced that the NDA for the prostate cancer indication had been accepted by the NMPA in China, with acceptance number JXHS2500024. This breast cancer submission represents the second indication for the drug.
The current NDA submission is primarily based on a pivotal clinical study (Changchun GeneScience093-301) conducted in Chinese premenopausal breast cancer patients. The primary endpoint was the proportion of patients who maintained serum estradiol levels at postmenopausal levels from Week 4 to Week 48 after dosing. The study results demonstrated that Leuprorelin Mesylate Injection (6M) effectively suppressed estradiol to postmenopausal levels. While achieving comparable therapeutic efficacy, the dosing interval was extended from 12 weeks to 24 weeks, thereby reducing injection frequency and improving treatment adherence.
Buy CAMCEVI®（Leuprolidehas） online from China and save up to 80% on costs . no insurance needed . compare prices from a certified HongKong pharmacy .with fast shipping. Contact us now on WhatsApp to get the latest prices.
