HER2-plus breast cancer introduces new drug "To Naitani tablets" to be approved in China

Recently, The listing application for Neratinib (name Nerlynx) (accepting number JXHS1800039) has been changed to "in approval" and is expected to be approved next monthRenatini is the world's first approved drug for EXTENDed complementary treatment for HER-2-positive early breast cancer patients, adapted to adult patients who have previously been treated with a drug that contains ctributobere to reduce the risk of breast cancer recurrence(source: NMPA)the effectiveness of the hertinib for early and late HER-2 positive breast cancer-assisted therapy
the anti-reverse pan-HERtyine kinase inhibitor in her-2 drugs is currently the most widespread target, acting at targets such as HER1/HER2/HER4Developed by Puma Corporation, the drug was approved for marketing by the FDA in July 2017, and in February 2018, Beihai Kangcheng and Puma signed exclusive licensing agreements for development and commercialization of Natoni in Chinese mainland, Taiwan, Hong Kong, China, and Macau, ChinaBeihai Kangcheng submitted an application for the listing of Naitini in September 2018(Source: CDE)For HER-2-positive early breast cancer patients, the ExteNET study showed a significantly lower risk of IDFS events in HER2-positive breast cancer patients in terms of enhanced postoperative complementary therapyin addition, the NALA study, published in 2019ASCO, is a boon for patients with advanced HER-2-positive metastatic breast cancerNalA study is a global, random, open label Phase III clinical study, a total of 621 patients who have received anti-HER2 treatment for stage IV metastatic breast cancer, China has the largest number of patients in the world, a total of 129 cases, all patients in a 1:1 random group after receiving the Natinib Joint Cappedabin (N-C) and Rapatinib united cappedatin (L-C) treatmentThe study's common primary endpoints were the intervention, safety, and so on of locally assessed PFS, ORR, Clinical Benefit Rate (CBR), Remission Duration (DoR) and Central Nervous System (CNS) transferfound that the overall population had a 24% lower risk of disease progression or death than the Lapatinib group (HR ?0.76, p?0.006) and PFS had achieved an absolute benefit of 2.2 months (HR?0.76; p?0.0059)In addition, ORR (33% vs27%), CBR (45% vs36%) ;DoR (8.5 vs 5.6 months) improved, and CNS transfer intervention decreased (22.8% vs29.2%, p.043)by analyzing the response rate of the treated population in the trial, it can be seen that, based on the more durable anti-tumor activity of the Chinese group, the Chinese subgroup and the total population benefited in the same way, some of the benefits were even more significant, through further analysis, it was learned that the proportion of Chinese patients who had previously accepted pametzumab, T-DM1 drug treatment was lower than the overall population, so the benefits from the subsequent treatment of nalini were more obvious than the overall populationfrom the central nervous system brain metastasis, for the baseline no-brain metastasis of patients, the nalini group can effectively prevent brain metastasis, delay the incidence of brain metastasis, for the baseline asymptomatic brain metastasis patients, the nalini group can better treat brain metastasis, reduce the progression of brain metastasis HER-2 positive breast cancer treatment drug
According to GLOBOCAN2018 statistics show that in 2018 the number of new breast cancer patients in the world is 2.089 million, the second most common cancer, after lung cancer, in the female population, the incidence of breast cancer is the first According to the latest report released by the National Cancer Center in 2019, the number of new breast cancer cases in China in 2015 was 304,000, accounting for 7.81 percent of all new cases of all cancers in the country, with the fifth highest incidence rate among the total population and the highest among women human epidermal growth factor receptor 2 (HER-2) is part of the her family of receptor tyrosine kinases, which also includeS EGFR (HER1), HER3, and HER4 Her-2 receptors are embedded in cell membranes and are highly specific to the human epidermal growth factor EGF When EGF is combined with HER-2, it causes double-polymerization of HER-2, which in turn triggers intracellular phosphorylation and transmission of intracellular messaging, and finally maintains normal cell growth and division about 20-30% of breast cancers will have HER-2 overperformance When HER-2 is over-performed, cells can cause abnormally rapid growth due to overstimulation, which eventually causes cancer At present, the treatment of HER-2-positive breast cancer drugs are mainly divided into three categories, namely, monoantigen, TKI small molecules and conjugate globally targeted HER-2 breast cancer treatment drugs