Zhengda Qing pulmonary artery hypertensive drug "Maxitentan tablets" first imitation is about to be approved.

(Source: NMPA)The first oral preparation approved by the FDA for PAH, with sales of $1.327 billion in 2019 Masitentan (also known as masittan, Macitentan, product name: Opsumit/Aopu Shu) Original research The company, which was approved by the FDA in October 2013, is the first oral preparation approved for pulmonary hypertension (PAH), and the compound patent CN100432070 has been granted until 2021.
(Source: FDA) In 2017, Johnson and Johnson acquired Acoteron, a new joint venture, Idorsia, and Machtentan.
, which is owned by Johnson and Johnson, reported sales of $1,327 million in 2019, up 9.2% year-on-year.
submitted an application to NMPA for the listing of Machytentan in December 2016, was added to the self-checking list in May 2017, was approved for listing in October 2017 and announced the official listing of Machytentan in March 2018.
(Source: Pharmaceutical Intelligence Data) Two competing for the first imitation so far, a total of two domestic Zhengda Qing, Xuantai two submitted to the market application for the maxitentan tablet generic drug.
(Source: CDE) It is worth mentioning that in April 2020, Shanghai Xuantai's MaxiTentan tablet (size 10mg) ANDA application was provisionally approved by the FDA, ANDA s211026.
is the first imitation in the United States, the current U.S. original research product compound patents are still in the patent protection period, after the final approval in the U.S. market for sale.
, that is to say, the U.S. market Xuantai lead, and the domestic market, is a big day ahead of the first step.
February 22, 2019, the Ministry of Finance, the General Administration of Customs, the General Administration of Taxation and the Drug Administration jointly issued the Notice on the Value Added Tax Policy on Rare Disease Drugs, and Maxitentan was listed as one of the first rare disease drugs.
ERA maxitentan, which can significantly reduce patient deterioration rates by up to 55% with a single drug, is a next-generation endopisin-infested antagonist (ERA) that has rapidly accumulated more than 30,000 patient treatment benefits worldwide.
SERAPHIN study confirms that maxitentan is currently the only study data supporting a single drug that can significantly reduce the patient's deterioration rate by 55% of the ERA (Figure 1), the patient's 7-year estimated survival rate of 62.6% (open label study) (Figure 2), higher than the current world's largest registered study REVEAL (U.S.) 7-year survival rate (49%), so that more patients live longer.
the REVEAL study, a population matching the SERAPHIN study was selected, and a predictive model analysis was established and it was found that the risk of death in the masitentan group was 31% lower than in the prediction group.
Maxitentan makes patients less hospitalized, significantly reducing PAH-related hospitalization rates (up to 49.8 percent) and hospital days (up to 52.3 percent), reducing the burden of treatment, enjoying more family time, significantly improving the quality of life, making patients live better and increasing their confidence in returning to society.
addition, the liver toxicity of machytentan is low, there is no need for routine monitoring of liver function, the overall safety is good.
1 Machtentan monotherapy reduces the risk of deterioration/death Figure 2 Maxitentan SERAPHIN open label trial: 7-year PAH survival rate of 62.6% Most drugs used to treat PAH rely on imported pulmonary hypertension (pul) Monaryarterialhypertension, PAH) is a malignant cardiovascular disease that causes increased pulmonary arterial resistance, pulmonary vascular remodeling, right chamber hypertrophy, and ultimately right heart failure and even death, with a fatality rate similar to cancer.
paH is divided into several types, namely, idiopathic pulmonary hypertension, connective tissue disease-related pulmonary hypertension and congenital heart disease-related pulmonary hypertension.
In May 2018, the five ministries jointly issued the First List of Rare Diseases, which is selected by authoritative experts in different fields according to certain working procedures, based on the disease situation, medical technology level, disease burden and guarantee level of our population.
the first batch of rare diseases listed in the list of 121 species, of which idiopathic pulmonary hypertension in the PAH treatment experienced 3 eras, before 1990 for the traditional drug treatment era, 1990-1998 for the era of eprostol, after 1998 for the emerging era of targeted therapy.
, the incidence of pulmonary hypertension in China is 1 to 2 per 1 million, which belongs to the category of rare diseases.
According to pharmaceutical data, domestic antihypertensive drugs in the market a total of 1149 production approvals, imported drugs have 23 approvals, only imported drugs have 10 approvals involving 5 varieties of drugs, respectively, Acoteron's maxitentan, Acoteron's Poseidon tablets, Bayer's Leosi tablets and GSK's Antilsentan, all of which are drugs for the treatment of PAH.
with the approval of the positive day maxitentan tablets, the domestic PAH treatment heavy drugs are believed to gradually bid farewell to the era of imports alone.
references: s1. Pulido T, etal. NEnglJMed2013;369:809-18. [2] Rogerio Souzaetal.Long-termsurvivalandsafetywithmacitentaninpatientswithpulmonaryarterialhypertension: ResultsfromtheSERAPHINstudyanditsopen-labelextension. [3] Ghofrani, A., Benza, R., etc. (2018). Usingcontrolledandreal-worlddatainconcerttoassesssurvivalinpulmonaryarterialhypertension: InsightsfromSERAPHINANDREVEAL.Pneumologie, 72 (S01), pp. S78-S78 channickRN, etal. JACCHeartFail2015; 3:1-8. [5] Mehta, etal. CHEST (2016), doi:10.1016/j.chest.2016.08.1473. [6] Huang Lan, JingZC.ChinaPHDiagnosisandtreatmentguideline2018.ChinJ Cardiol, 2018; 46 (12): 933-964.