New product: Zhengda Tianqing abitrone acetate tablet approved for market

Recently, the application for listing of Zhengda Tianqing abitrone acetate tablets (qingkeshu) was approved by the State Drug Administration Abiterone acetate combined therapy has been designated as the first-line or second-line treatment option for prostate cancer by European and American clinical guidelines, which has the characteristics of strong activity, high selectivity and significant clinical advantages Prostate cancer drugs belong to a new mechanism of action The product is a kind of androgen biosynthesis inhibitor, which can inhibit the activity of CYP17 and achieve the anti-tumor effect The original research enterprise is Johnson & Johnson It was listed in the United States on April 28, 2011 at the earliest, and its trade name (zytiga) In 2018, thanks to the outbreak of European market, global sales reached a record high of 3.5 billion US dollars Prostate cancer is the second most common tumor type for men in the world, with about 1.3 million newly diagnosed patients in 2018 In China, prostate cancer is the most common urogenital cancer in men, with an incidence rate of 9.8/10 million Abiolone acetate combined with prednisone in the treatment of metastatic castration resistant prostate cancer (mcrpc) Clinical trials show that the product can significantly reduce the prostate specific antigen level of patients with castrated and refractory prostate cancer who have received or have not received ketoconazole treatment, who have received paclitaxel chemotherapy or failed, who have had a history of chemotherapy, and who have metastasized, showing a strong anti-cancer activity The product has strong anti-cancer activity and high selectivity; it is designated as the first-line or second-line treatment option for prostate cancer by European and American clinical guidelines; through bioequivalence research, it is confirmed that it has the same safety and effectiveness as the reference original preparation Compared with ketoconazole, abidone acetate has higher CYP17A1 selectivity, and its inhibition on CYP17A1 is irreversible, with strong activity and high selectivity Compared with the placebo group, the total median survival time of the product was prolonged by 4.4 months The clinical advantage was significant, and the incidence of adverse reactions was low, most of which were controllable Abiterone acetate combined therapy has been designated as the first-line or second-line treatment option for prostate cancer by European and American clinical guidelines The formulation process of Zhengda Tianqing abiolone acetate tablets is consistent with that of the reference original preparation, and through bioequivalence study, it is confirmed that it has the same safety and effectiveness as the reference preparation After the product goes on the market, it will provide more treatment options for domestic patients with metastatic castration resistant prostate cancer, reduce the drug burden of patients, and truly benefit patients It is worth mentioning that on July 5th, the new 4 types of listing application of Hengrui pharmaceutical abiolone acetate tablets was approved, becoming the first domestic manufacturer to obtain the listing qualification of this kind of generic drugs Now, Zhengda Tianqing has been approved and joined the competition to challenge the original research and development.