Ten innovative drugs listed in the first quarter
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Medical Network April 9th ​​With the speed of approval of new drugs, the pace of listing of imported drugs is accelerating, and domestic innovative drugs are also emerging. The data shows that as of December 2018, the number of applications for drug registration waiting in line for review has dropped from nearly 22,000 at the peak of 2015 to less than 3,000. According to the statistics of the Beijing News reporter, since the beginning of 2019, 10 drugs have been listed in China or approved for new indications.
More worthy of expectation is that there are also drugs such as telilizumab in Baekje Shenzhou and enthatinib in Beida Pharmaceutical, which are expected to be approved in the short term. The indications are Hodgkin's lymphoma and non-small. Cell lung cancer.
Drug: Ou Shuangjing (common name: metformin engliflozin)
Enterprise: Boehringer Ingelheim
Approved (listed) time: February 2019
Indications: Adult Type 2 Diabetes
Ou Shuangjing is a one-piece combination of nglippine and metformin hydrochloride for adult patients with type 2 diabetes who are treated with engrelium and metformin hydrochloride. Ou Shuangjing is a simple compound single tablet drug, two The complementary mechanisms of hypoglycemic components provide more potent and long-lasting glycemic control, and can reduce the number of pills taken by patients, thereby increasing patient compliance, and increased compliance can also help to further improve glycemic control.
Drug: Keytruda (referred to as K medicine, generic name: Pabolizumab)
Enterprise: Merck
Approved (listed) time: March 2019
Indications: Non-small cell lung cancer (NSCLC)
The approval of the indications for the Pabolimuzumab changed the survival expectancy of patients with advanced non-squamous non-small cell lung cancer without EGFR or ALK-driven gene mutations. According to the results of relevant clinical trials, the treatment of pabolizumab combined with chemotherapy reduced the relative risk of death by half compared with chemotherapy alone, which means that PD-1 monoclonal antibody is used in eligible NSCLC patients. The sooner you survive, the more likely you are to survive.
Drug: Libitong Dispersible Tablets (Chemical Name: Lamotrigine Dispersible Tablets)
Enterprise: GlaxoSmithKline
Approved (listed) time: January 2019
Indications: children over 2 years old, adults and elderly people with epilepsy
As an upgrade of Libitong's ordinary tablets, Libitong Dispersible Tablets have the characteristics of wide-ranging indications for epilepsy treatment, various specifications, and more accurate initial addition. As the second generation of new anti-epileptic drugs, Libitong has been used for more than 28 years in the world, and the cumulative number of patients has exceeded 10 million. Libiton is the first-line anti-epileptic drug recommended by the British NICE Guide, the American AAN/AES Guide, the Scottish Guide, and the Chinese Clinical Guidelines for Epilepsy.
Drug: Xin Yange (common name: Tadalafil)
　 Enterprise: Changchun Haiyue
Approved (listed) time: February 2019
Indications: male erectile dysfunction
At present, only Celebrex of Lilly Pharmaceuticals and Tadalafil tablets of Changchun Haiyue Pharmaceutical Co., Ltd. have been approved for listing. This also means that Changchun Haiyue has become the first company in China to obtain a generic drug for this product. There are as many as 27 manufacturers in the research, including Huahai Pharmaceutical, China Resources Secco, Qilu Pharmaceutical, etc. As of Changchun Haiyue Pharmaceuticals , 20 have been approved for clinical trials, 9 are in clinical trials, and 5 are submitted. Of the listing applications, three did not approve.
Drug: Ling Zeshu (common name: linaclotide)
Enterprise : AstraZeneca
Approved (listed) time: January 2019
Indications: Adult constipation type irritable bowel syndrome (IBS-C)
Constipation-type irritable bowel syndrome (IBS-C) is a functional bowel disease with recurrent episodes that are characterized by abdominal pain, bloating, and abdominal discomfort. Ze Zeshu is the world's first guanylate cyclase agonist. Its innovative mechanism is to activate intestinal secretion of a guanylate cyclase, which promotes intestinal secretion and reduces constipation by reducing visceral hypersensitivity. The effects of abdominal pain, bloating and constipation in patients with irritable bowel syndrome.
Drug: Degree Access (common name: degree glucosinolate)
Enterprise: Lilly
Approved (listed) time: February 2019
Indications: Adult Type 2 Diabetes
Although there are many drugs for the treatment of diabetes in the clinic, there is still a need for potent, easy-to-use and safe drugs to help patients more easily and smoothly control blood sugar for a long time. Not only does it have good hypoglycemic efficacy and safety, but it is also easy to use once a week, which is conducive to long-term treatment. It helps patients achieve better glycemic control while improving risk factors for multiple cardiovascular diseases such as body weight and blood lipids.
Drug: Spinraza (Nusinersen ) injection
Enterprise: Biogen, Kuntai Enterprise Management (Shanghai) Co., Ltd.
Approved (listed) time: February 2019
Indications: Spinal muscular atrophy (SMA)
Spinal muscular atrophy (SMA), also known as progressive spinal muscular atrophy, spinal muscular atrophy, is a type of disease caused by muscle dysfunction and muscle atrophy caused by anterior horn motor neurons and brainstem motor neuron degeneration. Spinraza is the world's first approved SMA drug and the only drug currently approved for treatment of spinal muscular atrophy in the United States. It takes less than three months to go from application to approval in the United States. Spinraza both for infants and young children, but also for adults.
Drug: Rosuda (common name: lurasidone hydrochloride tablets)
Enterprise: Sumitomo Pharmaceuticals
Approved (listed) time: January 2019
Indications: schizophrenia
Rosuda is a daily antipsychotic drug. Its active pharmaceutical ingredient is lurasidone (lurasidone), which has a unique chemical structure and is believed to be dopamine D2, serotonin (5-HT2A), The serotonin (5-HT7) receptors all have affinity and have antagonistic effects in these receptors. In addition, lurasidone has partial agonism to the serotonin (5-HT1A) receptor and no significant affinity for histamine H1 or muscarinic M1 receptor.
Drug: Rebian (common name: Yiluoumab, evolocumab )
Enterprise: Amgen
Approved (listed) time: January 2019
Indications: Adult atherosclerotic cardiovascular disease (ASCVD)
Rebian (Ilodiazumab) is a groundbreaking cholesterol-lowering drug that inhibits pro-protein convertase subtilisin/Kexin 9 (PCSK9) and low-density lipoprotein (LDL) receptors ( The combination of LDLR) increases the number of LDLRs that can clear LDL in the blood, significantly lowering LDL-C levels in patients with cardiovascular disease, thereby reducing the risk of myocardial infarction and stroke. It is also the first in China to be approved for cardiovascular events. Risk of PCSK9 inhibitors.
Drug: apixaban
Enterprise: Jiangsu Haosen Pharmaceutical Group Co., Ltd.
Approved (listed) time: January 2019
Indications: Adult patients undergoing elective replacement of the hip or knee
Apixaban is the first imitation of the world's heavy anticoagulant drug apixaban (Aleto). Aloft was jointly developed by Bristol-Myers Squibb and Pfizer, and was approved for the first time in the European Union in May 2011. In December 2012, it was approved by the US Food and Drug Administration for listing in the United States; in January 2013, it was approved by the former State Food and Drug Administration to enter China. Since the patent protection period of the original research drug has not expired (patent invalidation date: September 17, 2022), the apixaban tablets of Jiangsu Haosen are not currently available for sale.