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

North Sea Kangcheng Pharmaceutical Co., Ltd. (North Sea Kangcheng, CANbridge) recently announced that Taiwan's Food and Drug Administration (TFDA) has approved Nerlynx (neratinib, Malai oladini tablets): for human epidermal growth factor receptor 2 (HER2) positive early breast cancer (eBC) adult patients, after the completion of trastuzumab complementary treatment.
Nerlynx was approved for listing in Hong Kong in November 2019 and in Mainland China in May 2020.
In January 2018, North Sea Kangcheng signed an exclusive license agreement with Puma Biotechnology for the development and commercialization of Nerlynx in Greater China (China, Taiwan, Hong Kong, Macau).
Nerlynx is an oral drug used in women with early stage breast cancer who have underwent surgery, chemotherapy, and trito-bead monotherapy.
Data from Phase III clinical trial ExteNET confirmed that Nerlynx significantly reduced the risk of recurrence in patients with HER2 plus early breast cancer, benefiting the most from women who initiated Nerlynx therapy within 12 months of hormone recepcetox positive (HR-plus) and completed throtonin monotherapy, for which the risk of recurrence was reduced by 42 percent over five years.
At present, in clinical practice, the effective treatment of tumors has been mainly surgical excision, except for surgery treatment is called auxiliary treatment, the purpose is to eliminate the remaining small metastatic lesions, reduce the chance of tumor recurrence and metastasis, improve the cure rate.
intensive complementary therapy is the next step after complementary treatment to further reduce the risk of breast cancer recurrence.
Nerlynx will provide a new and important treatment option for female breast cancer patients, further reducing the risk of recurrence of HER2-positive breast cancer.
, the recommended dose for Nerlynx is 240 mg (6 tablets 40 mg), once daily orally, with food, for one year.
It is important to note that preventive anti-diarrhoea treatment should be initiated during the first dosing of Nerlynx and continues during the first 2 treatment cycles (56 days), after which preventive anti-diarrhoea treatment can continue if required to prevent drug-based diarrhea.
cancer is the most common tumor in women, about 20%-25% of breast cancer tumors overextend the HER2 protein.
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 that have shown that querto-bead monotherapy can reduce the risk of recurrence after surgery for early HER2-positive breast cancer, up to 25% of patients relapsed after receiving trito-bead monotherapy.
patients with recurrent metastatic HER2-positive breast cancer are usually incurable, and the metastasis site includes the lateral breast, brain, lungs, bones, etc., and brain metastasis is one of the main causes of death in patients.
Nerlynx-neratinib Chemical Structure (Photo: medchemexpresspress.cn) Nerlynx (nalatini) is an oral, powerful, irreversible tyrosine kinase inhibitor (TKI) that inhibits tumor growth and metastasis by blocking transducing of the Pan-HER family (HER1, HER2, HER4) and downstream signaling paths.
The mechanism of action of the drug is different from Roche Herceptin (Qutojum) and the new breast cancer drug Perjeta (Patojum) and the 2nd is a monoclonal antibody drug, targeting HER2 receptors on the surface of HER2-positive cancer cells.
It is worth noting that Nerlynx is the first enhanced complementary treatment drug approved in the United States and the European Union for HER2 plus early breast cancer, approved in the United States and the European Union in July 2017 and September 2018, respectively, for intensive complementary treatment in patients with HER2 plus early breast cancer who have completed the treatment after surgery.
February 2020, the FDA approved Nerlynx for a new condition, Capecitabine, for HER2-positive metastatic breast cancer patients who have previously received two or more HER2 targeted therapies for failed (third-line diseases).
results from phase III NALA studies showed that Nerlynx-Capertabin combination three-line HER2-positive metastatic breast cancer significantly extended disease progression survival (mid-PFS: 8.8 months vs 6.6 months) compared to the Tykerb (lapatinib, lapatini) and Capertabin combinations." HR-0.76, 95% CI: 0.63, 0.93; p-0.0059), 12-month disease progression-free survival (29% vs 15%), 24-month progression-free survival (12% vs 3%).
In addition, the total survival (OS) of the Nerlynx-Caperabin treatment group increased (medium OS: 21 months vs 18.7 months), objective remission rate (ORR) increased (32.8% vs 26.7%), and the medium remission duration (DOR) increased (8.5 months vs 5.6 months) compared to the Tykerb-Cape-amperin treatment group.
Puma is working with globally authorized partners to seek approval for the second adaptation in all countries and territories that have currently approved Nerlynx.
original source: CANbridge Pharmaceuticals Receives Marketing approval for NERLYNX (neratinib) in Taiwan Original title: China HER2 plus first oral assisted treatment for early breast cancer! North Sea Kangcheng Nerlynx (Nalatini) approved listing in Taiwan! This article is from Bio Valley, please download Bio Valley APP (