The eight new drugs were approved in China

a number of new drugs have recently been approved for sale or approved in China, according to the drug approval documents released by China's State Drug Administration (NMPA) on Feb. 2. This article is an ancication of eight new drugs that have received much attention, including prostate cancer, heart failure, non-squamous non-small cell lung cancer, thyroid myelin-like cancer and other diseases.
1, Bayer: ODM-201 300mg film clothingdrug action mechanism / target: androgen inhibitor ODM-201 (darolutamide) is a new type of oral androgen inhibitor (AR) inhibitor developed jointly by Bayer and Orion. It has a unique chemical structure that binds to AR with high affinity and exhibits strong antagonism activity, thus inhibiting ar function and the proliferation of prostate cancer cells. In July 2019, the drug was approved by the U.S. FDA to treat patients with non-metastatic desopathic prostate cancer (nmCRPC).In China, ODM-201's listing application was accepted in February 2020 and subsequently included in the priority review with a clear therapeutic advantage. According to the CDE public information, the drug's current approval of the adaptive disorder is - suitable for the treatment of non-metastatic desopathic prostate cancer patients. A Phase 3 study of nmCRPC patients showed that the mid-level non-transferable survival of patients in the ODM-201 treatment group was 40.4 months, compared with 18.4 months in the control group, and the ODM-201 group reduced the risk of cancer metastasis or death by 59%.2. AstraZeneca: Dagled net tabletsDrug action mechanism/target: SGLT2 inhibitorDagrid tablets are an oral sodium-glucose co-transport protein 2 (SGLT2) inhibitor developed by AstraZeneca. SGLT2 is a transport protein in the kidneys that assists in the re-absorption of glucose. SGLT2 inhibitors reduce glucose levels in the blood by inhibiting the function of SGLT2 by allowing more glucose to be excreted from the urine. In China, Dagledge was first approved in 2017 to improve blood sugar control in adults with type 2 diabetes.According to the CDE Priority Review Public information, Dagrid's new adaptation, approved this time, is for adult patients with reduced blood test scores for heart failure (HFrEF), reducing the risk of cardiovascular death and worsening heart failure, and improving heart failure symptoms. According to publicly available data, the safety and effectiveness of Dagrid net use for heart failure were evaluated in a randomized, double-blind, placebo-controlled study. Studies have shown that after about 18 months, patients treated with Dagle net treatment had fewer cardiovascular deaths, hospitalizations for heart failure, and emergency heart failure than placebos.3, Hesco: cyclophenol emulsiondrug action mechanism / target: short-acting GABAA subject regulatorpublic information shows that cyclopolycol emulsion injection (research and development code HSK3486) is a venous anesthetic drug developed by Hesco over eight years. The drug is a short-acting GABAA subject regulator, similar to the mechanism of action of propofol, but more effective and safe. Hesco intends to develop the drug for surgical all-hemp induction, endoscopic sedation/anesthesia, ICU sedation and other adaptations.In December 2020, the epophenol emulsion was approved for the first time by NMPA for sedation in endoscopy in the digestive tract, the first new class 1 drug approved by Hesco Pharmaceuticals. According to CDE publicity information, the new adaptation of this product approved for general anaesthetic induction. The adaptation application was accepted in January 2020 and was included in the priority review in February 2020 with a clear therapeutic advantage.4. Xinda Bio: Syndicate monoantigen injectionDrug action mechanism/target: anti-PD-1 antibodyHuman immunoglobulin G4 (IgG4) monoclonal antibody, can specifically bind to T cell surface PD-1 molecules, thereby blocking the tumor immune tolerance of PD-1/PD-L1 path, reactivate the anti-tumor activity of lymphocytes, to achieve the purpose of treating tumors. At the end of 2018, the drug was approved for the first time in China for the treatment of relapsed/incurable classic Hodgkin's lymphoma.According to an earlier press release issued by Cinda Bio, the new adaptation to Cindi's monoantigen is a first-line treatment for non-squamous non-small cell lung cancer (NSCLC). It is reported that the new adaptation application is based on a randomized, double-blind, Phase 3 controlled clinical trial (ORIENT-11). The results of the mid-term analysis showed that the intra-period analysis showed that the single-anti-joint (injection with pyrethroid di sodium) significantly extended the patient's progress-free survival, reaching the preset efficiency criteria: the mid-term analysis data cut-off date, the medium follow-up time was 8.9 months, and the neutral non-progression survival of the trial group was 8.9 months, higher than the control group's 5.0 months.5, Positive day: hydrochloric acid atrotini capsule drug action mechanism / target: VEGFR, PDGFR, FGFR, c-Kit, etc A multi-target small molecule tyrosine kinase inhibitor developed, the main targets include endothoste growth factor subject (VEGFR), plate derived growth factor subject (PDGFR), fibroblast growth factor inhibitor (FGFR), c-Kit, etc. Earlier, the drug has been approved in China for the treatment of advanced or metastasis non-small cell lung cancer, soft tissue sarcoma, small cell lung cancer. According to the Zhengda Tianqing press release, the new adaptation to the drug's approval this time is "for the treatment of patients with clinical symptoms or unexistable localized advanced or metastatic thyroid myelin-like cancer with clinical symptoms or clear disease progression". Clinical study data showed that patients with thyroid myelin cancer treated with hydrochloric acid atrotinib capsules had a 9.6-month increased progression and a 47 percent lower risk of tumor recurrence than the placebo group. Moreover, the product has a low rate of adverse reactions, a low severity, and the vast majority of controllable reactions. 6. Astellas: Fumaric acid gretinib tablets Drug action mechanism/target: FLT3 Public information shows that Gretini is a drug found by Astellas in collaboration with Kotobuki Pharmaceutical Co., Ltd., Astellas has exclusive rights in the global development, manufacture and commercial of Gintilini. Studies have shown that ginibs can inhibit two common FLT3 mutations found in about one-third of patients with acute myeloid leukemia, FLT3-ITD and FLT3-TKD. It is reported that it is able to maintain the inhibition of FLT3 activity in the body, and is not easy to produce bone marrow inhibition. In addition, it inhibits tyrosine kinase, a subject called AXL, blocking a potential mechanism that makes tumor cells resistant. In China, Gretinib's application for a new drug to market was accepted in April 2020 and subsequently included in the priority review for "qualified approved drugs". According to the priority review public information, the drug was approved this time for the adaptation of: for the treatment of FLT3 mutation-positive recurrence or resophageal acute myeloid leukemia adult patients. It is worth mentioning that ginib has been included in the CDE in the third batch of clinically urgent need for new drugs abroad. 7. Mercaconol (MSD): Posaconaz injection drug action mechanism/target: biosynthesis posaconazole, which inhibits steroids, is derived from icconazole and plays its antifactoxic activity by inhibiting the biosynthesis of steroids. It inhibits steroid C14 demthylation more than icconazole, especially for asphalt. Previously, Moshadong's Posakonaz oral suspension (Nokofei) has been approved for listing in China and will be included in China's national health insurance list in 2019. Its approved adaptations include: 1) prevention of invasive ascertic and Candipella infections; This time approved in China for Posaconazole injection, which is a new intravenous dosage form of Posaconazole. It is reported that the product uses envelope technology to improve the solubility of Posaconazole in water, for insoluble drugs to make injections provides a good solution. 8, excellent ratio (UCB): lacosamine tablets drug action mechanism / target: selective action on slow inactive sodium channel lacosamine is a new anti-epileptic drug, in the mechanism of action is unique in that it can selectively act on slow inactive sodium channel, prolong sodium channel inactive state time, can more effectively reduce the inflow of sodium ions, reduce neuron excitability. In December 2018, lacosaamine tablets (Vipette) were approved in China for combined treatment of partial seizures associated with or not accompanied by secondary comprehensive seizures in adults and adolescents (16-18 years of age). According to public information, the product became the first new anti-epileptic drug approved in the Chinese market in 11 years, and with its unique advantages for some epileptic patients to bring new treatment options. The Ukip pill has been approved again, presumably as a new allergy. According to the Drug Clinical Trial Registration and Information Disclosure Platform, for lacausamine tablet dosage forms, the company has completed a Phase 3 international multi-center clinical trial to evaluate the effectiveness and safety of lacosaamine as a combined treatment for adult patients with partial epilepsy (accompanied or not accompanied by secondary comprehensive seizures). In addition, a number of clinical studies are under way, including a Phase 3 International Multi-Center Open Long-Term Extension Study to evaluate the effectiveness and safety of lacosaamine as a combination therapy for the treatment of partial seizure epilepsy subjects in children. Congratulations to these new drugs on their approval in China or on their new adaptive diseases, and look forward to their early entry into the patient's side, bringing more treatment options to the patient. Note: The purpose of this article is to introduce the progress of medical and health research, not the recommended treatment plan. For guidance on treatment options, visit a regular hospital. (Pharmaceutical Mingkangde
) : China's State Drug Administration Government Service Portal. Retrieved Feb 3, 2021, from the National Drug Administration accepted a new adaptation application from Dabershu® (Cindili monoantigen injection) for the treatment of patients with first-line non-squamous non-small cell lung cancer. Retrieved April 24, from #/news/197 [3] U.S. FDA accepts New Drug Application for review and grants Priority Review for darolutamide. Retrieved April 29, 2019, from the field of oncology | Zhengtian Qing Anrotini thyroid myelin cancer adaptation was approved. Retrieved Feb 03, 2021, from china's State Drug Administration Drug Review Center priority review public information. From