North Sea Kangcheng Nerlynx has been approved for listing in Taiwan.

In January 2018, North Sea Kangcheng signed an exclusive license agreement with Puma Biotechnology for the development and commercialization of Nerlynx in Greater China (Mainland, Taiwan, Hong Kong, Macau).
Nerlynx is an oral drug used in women with her2 plus early breast cancer who have undergone surgery, chemotherapy, and quorpormal monotomatox-assisted therapy.
data from Phase III clinical trial ExteNET confirmed that Nerlynx significantly reduced the risk of recurrence in PATIENTs with heror2 plus early breast cancer, benefiting most from women who started Nerlynx treatment within 12 months of hormone receptor-positive (HR-plus) and completion of qualrinsium zumas," and 42 percent lower risk of recurrence in these women.
at present, in the clinic, the effective treatment of tumor has been mainly surgical excision, in addition to surgery treatment is called auxiliary treatment, the purpose is to eliminate the remaining micrometrifying lesions, reduce the chance of tumor recurrence and metastasis, improve the cure rate.
enhanced complementary therapy is the next step after complementary therapy to further reduce the risk of breast cancer recurrence.
Nerlynx's approval, the listing will provide female breast cancer patients with a new and important treatment option, further reducing the risk of recurrence of HER2-positive breast cancer.
medication, Nerlynx has a recommended dose of 240 mg (6 tablets 40 mg), taken orally once daily, with food, for a year.
note that preventive treatment against diarrhea should be initiated during Nerlynx's first administration and should continue during the first 2 treatment cycles (56 days) and then continue to be given preventive treatment for anti-diarrhea if needed to prevent drug-induced diarrhoea.
breast cancer is the most common tumor in women, with about 20%-25% of breast cancer tumors over-expressing HER2 proteins.
, HER2-positive breast cancer tends to be more aggressive than other types of breast cancer, increasing the risk of disease progression and death.
Despite studies showing that quralmon can reduce the risk of recurrence after early HER2-positive breast cancer, up to 25% of patients relapse after receiving quralmonal zumas. patients with recurrent metastatic HER2-positive breast cancer
are usually incurable, and metastases include lateral breasts, brain, lungs, bones, etc., and brain metastasis is one of the main causes of death.
Nerlynx-neratinib Chemical Structure (Photo: medchemexpress.cn) Nerlynx (neratinib) is an oral, powerful, irreversible tyrosine kinase inhibitor (TKI) that inhibits tumor growth and metastasis by blocking the transduction of pan HER family (HER1, HER2, HER4) and downstream signaling pathways.
the mechanism of action of the drug is different from Roche herceptin (quralmestin) and the new breast cancer drug Perjeta (patozumab), the latter 2 are monoclonal antibody drugs, targeting HER2 receptors on the surface of HER2-positive cancer cells.
note, Nerlynx is the first u.S. and European Union-approved for intensive complementary therapy for HER2 plus early breast cancer, which was approved in the U.S. in July 2017 and september 2018 in the U.S. and the European Union, respectively, for postoperative completion of qurillazumab antistto-assisted treatment for herr2 plus early-stage breast cancer patients.
February 2020, the FDA approved a new appopathy for Nerlynx: Capecitabine, for HER2-positive metastatic breast cancer patients who have previously received two or more HER2 targeted therapy treatments (three-line diseases).
results from Phase III NALA studies show edited that The Third Line HER2-positive metastatic breast cancer of the Nerlynx-Capatabin combination scheme significantly prolonged the disease's progression survival compared to Tykerb (lapatinib, Lapatini) and Capethabin combination scheme (medium PFS: 8.8 months vs. 6.6 months; HR-0.76, 95% CI: 0.63, 0.93; p-0.0059), 12-month disease-in-progression survival rate (29% vs 15%), 24-month progression survival rate (12% vs 3%).
, compared to the Tykerb-Capeata-bedintreatment group, the total lifetime (OS) of the Nerlynx-Capitabin treatment group was extended (median OS: 21 months vs 18.7 months), the objective remission rate (ORR) increased (32.8% vs 26.7%), and the median remission duration (DOR) was extended (8.5 months 5.6 months).
Puma is working with a global authorized partner to seek approval for the second indication in all countries and regions that currently have Nerlynx approved.
Original source: Canbridge Pharmaceuticals Receivs Marketing for NERLYNX (neratinib) in Taiwan Source: China HER2 Plus First Oral Complementary Drug for Early Breast Cancer! North Sea Kangcheng Nerlynx (Neratini) approved listing in Taiwan!