Looking back on the inventory analysis of import drug approval data in 2018

In many people's wechat friends circle, there is a saying: 2018 is far away, I will miss her It can be said that 2018 is destined to be a year of profound changes in China's pharmaceutical industry: there are various medical circles, the national health and Health Commission and the health insurance bureau have been established, the aftereffect of the long-term vaccine event is continuous, the strong promotion of generic drug consistency evaluation has stopped abruptly at the end of the year, the implementation of zero tariff for imported oncomatous drugs, the purchase with 4 + 7 volume has aroused many concerns, and doctor clove has opened the veil of health empire .. The wheel of history rolls forward, but looking back on the past, what we have experienced, what we think about, and what we look up to, will give us enlightenment and inspiration Today, we mainly review the approval of imported drugs in 2018: According to the information provided by the database of the State Drug Administration, at present, there are 4300 registration numbers of imported drugs in China, involving nearly 30 treatment fields such as anti-tumor, anti infection, cardio cerebrovascular, digestive system, etc., 461 of which were approved in 2018, 359 of which were re registered, 102 of which were newly approved (involving 59 products) According to the preliminary statistics of the author, in 2018, they were obtained through priority review There are 25 kinds of imported drugs that have to be approved for marketing, accounting for about half of the latest approved varieties (see Table 1 for details) in recent years, the state adheres to the principle of patient-centered, launches a series of policies to accelerate the pace of listing of imported drugs, accelerate the evaluation and approval of drugs urgently needed in clinical practice, and promote the listing of new drugs on the market in China as soon as possible In August 2015, the State Council issued the opinions on the reform of the review and approval system for pharmaceutical and medical devices; in October 2017, the central office and the State Office issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices; In December 2017, the former State Food and Drug Administration issued the opinions of the General Administration on encouraging drug innovation to implement priority review and approval; in April 2018, the State Food and Drug Administration issued the announcement on relevant matters of customs clearance and inspection of imported chemicals; In May 2018, the State Drug Administration and the National Health Commission issued the announcement on optimizing the review and approval of drug registration; in July 2018, the State Drug Administration issued the announcement on adjusting the review and approval procedures of drug clinical trials (No 50, 2018); In August 2018, the drug evaluation center (CDE) of the State Drug Administration issued the notice on Soliciting Opinions on the list of clinically urgent new drugs on the market abroad Table 1 among the imported drugs approved through the priority review in 2018, antineoplastic drugs take the first place, which are basically innovative drugs with obvious treatment advantages, followed by drugs for rare diseases and children: ★ antineoplastic drugs Roche: a new breast cancer drug, patozumab injection, combined with trastuzumab and chemotherapy, is used for adjuvant treatment of early breast cancer patients with high risk of recurrence who are positive for human epidermal growth factor receptor 2 (HER2) Roche: new lung cancer drug ansanza (aletinib hydrochloride capsule): it is used for the treatment of anaplastic lymphama kinase (ALK) - positive local advanced or metastatic non-small cell lung cancer (NSCLC) In November 2017, ansanza was approved as the first-line treatment for ALK positive non-small cell lung cancer in the United States In December 2017, ansanza was approved in the European Union as the first-line treatment for ALK positive non-small cell lung cancer In March 2018, ansanza entered the priority review procedure of drug review center of China National Drug Administration In August 2018, ansanza was officially approved, basically realizing the synchronous listing with Europe and the United States Pfizer: the new breast cancer drug aiboxin (piperacillin capsule) is used to treat locally advanced or metastatic breast cancer with hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative It should be used in combination with aromatase inhibitor as the initial endocrine therapy for postmenopausal women The drug was approved for marketing in the United States through a rapid approval process in 2015 for the treatment of advanced breast cancer Weicai: a new liver cancer drug, lovima (lovatinib mesylate capsule), is used to treat unresectable liver cell carcinoma (HCC) which has not received systematic treatment before AstraZeneca: the ovarian cancer targeting drug olapari (also known as olapari), is the first ovarian cancer targeting drug in China, the first PARP inhibitor, which is used for the maintenance treatment of platinum sensitive recurrent ovarian cancer Bristol Myers Squibb: an immunotumor treatment drug, opdivo nafulizumab injection, is used to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have negative mutations in the epidermal growth factor receptor (EGFR) gene and negative anaplastic lymphoma kinase (ALK), who have been treated with platinum containing chemotherapy for Disease progression or intolerance The drug belongs to PD-1 inhibitor and is the first approved immunotumor treatment drug in China Mershadong: PD-1 inhibitor keytruda (coreda, pabolizumab), used in non-small cell lung cancer, malignant melanoma and other tumors MSD's heavyweight products have successively obtained 14 FDA granted breakthrough drug approval qualifications in the United States, and have been approved as many as 12 indications, covering 9 different types of advanced tumors At present, MSD is the most widely approved PD-1 monoclonal antibody covering tumor types Novartis: tumor drug zandak (seretinib capsule), which is a small molecule inhibitor of anaplastic lymphoma kinase (ALK) with high selectivity and efficiency, is suitable for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have been treated with clozatinib before or who are resistant to clozatinib Mershadong: Nine doses of HPV vaccine, suitable for women aged 16 to 26 years old, with three doses of vaccination procedure The vaccine was approved in the United States and the European Union in 2014 and 2015, respectively Takeda: tumor drug enray (isazolam citrate capsule), combined with lenalidomide and dexamethasone as the first all oral treatment scheme, is used to treat adult patients with multiple myeloma who have received at least one previous treatment; ★ rare disease drug Alexion company, Switzerland: ekuzumab injection is used to treat paroxysmal sleep hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in adults and children, both of which are rare in the world Sanofi: obajie is used for the treatment of relapsing multiple sclerosis, a rare disease Hoffmann Roche: the rare disease drug is emecezumab injection, which is used for the treatment of hemophilia A patients with coagulation factor Ⅷ inhibitor ★ children's medication Sanofi: fasuk (lablehai for injection) is used for the control of uric acid level in children with leukemia and lymphoma These patients have hyperuricemia or high tumor load There is a risk that tumor cells will dissolve after tumor chemotherapy, which will lead to the increase of secondary plasma uric acid level, so as to reduce the risk of tumor lysis syndrome and ensure the continuity of treatment Maruho Co., Ltd.: Children's faropenem sodium granules, anti infective drugs for children Lilly: oral tuomoxitine hydrochloride solution for the treatment of attention deficit / hyperactivity disorder (ADHD) in children and adolescents In addition, some innovative drugs with unique efficacy or breakthrough in the fields of Ophthalmology and respiratory system were approved: Bayer: a new ophthalmic drug, aliya (intraocular injection solution of abacept), for the treatment of adult diabetic macular edema (DME); Otsuka pharmaceutical: delamanic tablet is used for the treatment of adult MDR-TB patients as part of the combined treatment plan when it is unable to form an effective treatment plan due to drug resistance or tolerance UCB: Viagra ® (lakosamide tablets) for the combination treatment of partial seizures with or without secondary generalized seizures in adults and adolescents (16-18 years old) Amgen: a cholesterol lowering drug, evolocumab, is used to treat homozygous familial hypercholesterolemia (hofh) in adults or adolescents over 12 years old GlaxoSmithKline: a new chronic obstructive pulmonary disease drug, orexin, a dry powder inhaler containing two bronchodilators, is used for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) Blyngju G John: Sihe Huaneng Bei Le (tiotropium bromide / O Datlow inhalation spray) is used for long-term maintenance treatment of patients with chronic obstructive pulmonary disease (including chronic bronchitis and emphysema) It is the only bronchodilator (double expansion agent) that contains thiotropium bromide and the only inhalation device of soft mist in the field of chronic obstructive pulmonary disease Although the global competition is intensifying at present, to maintain the healthy development of the domestic pharmaceutical market, only we keep an open attitude at all times While encouraging the innovation and development of domestic drugs, we also actively introduce foreign advanced drugs and therapies as well as foreign innovative drugs urgently needed in clinical practice, so as to provide more drug choices for the public and encourage and promote domestic pharmaceutical enterprises.