The research and development, clinical and manufacturing of biomedicine not only represent advanced technology, but also are closely related to the health needs of the people and the development strategy of “Healthy China”. In 2019, China will continue to deepen the reform of the review and approval system for medicines and medical devices, combine the newly revised drug management law, innovate the communication mechanism with drug applicants, increase the research and development of new drugs, and accelerate the domestic market for new drugs overseas. New medicines imported from abroad have been launched on the market, which have added a lot of weight to our fight against disease and brought new hope to patients. When the last calendar is about to turn in 2019, we will look back at the research and development of drugs, introduce you to several special new drugs that were launched this year, and learn about the important breakthroughs that these drugs have brought to the treatment of diseases. Please see this special plan-
In recent years, due to the rapid progress of biotechnology and a more thorough understanding of the mechanisms of tumors and other complex diseases, the focus of drug development has gradually transitioned from cardiovascular and antibacterial drugs to tumors, immunotherapy, and breakthrough drugs with major curative effects.
Pertuzumab: another puzzle to fill breast cancer treatment
Breast cancer is the most common malignancy in women. Most of the recommended treatment options for HER2-positive breast cancer in the Guidelines and Guidelines for the Diagnosis and Treatment of Breast Cancer of the Chinese Cancer Society (2015 Edition) (hereinafter referred to as the “Guide”) contain trastuzumab. However, after receiving trastuzumab combined with chemotherapy, about 1/4 of patients with HER2-positive early breast cancer still have disease recurrence or death after 10 to 11 years, and a higher proportion of patients with high-risk early breast cancer have recurrence or death. Pertuzumab, another anti-HER2 drug mentioned in the Guide, was officially launched in China in April this year!
Professor Shao Zhimin, Director of the Institute of Oncology, Fudan University, Director of the Breast Cancer Institute, Director of Major Surgery and Director of Breast Surgery, said, “The combined use of Pertuzumab and Trastuzumab as two targets can synergize and fully inhibit Discontinuing the HER2 signaling pathway, curbing tumor cell growth at the source, and further reducing the risk of recurrence of HER2-positive breast cancer. Analysis of the Chinese subgroup of patients shows that Pertuzumab + Trastuzumab combined with chemotherapy regimen can enable the entire Chinese patient population The population has a 31% reduced risk of recurrence or death; for high-risk groups with lymph node positive (LN +) or hormone receptor negative (HR-), the risk of recurrence or death is reduced by 35% and 45%, respectively. ”
Wei Lide: Hepatitis B clinical is not far away
2019 is a happy year for patients with hepatitis B, because the stronger new drug for hepatitis B, propofol tenofovir fumarate (brand name Welit, abbreviated as TAF), was officially launched in China in January. This is also the only new hepatitis B drug approved in China in the past 5 years, and it also marks that Chinese chronic hepatitis B patients and European and American countries have simultaneously acquired global innovative drugs.
So what advantages does TAF have over its predecessors?
At present, anti-HBV drugs mainly include two major categories, namely interferons (mainly pegylated interferon alpha) and nucleoside (acid) analogs (including lamivudine, telbivudine, adefo (Tetravirate, tenofovir disoproxil, entecavir). They all have their own obvious shortcomings, such as the high price of interferon antiviral drugs, many adverse reactions, some patients are ineffective, and other shortcomings of oral nucleoside (acid) analogues are prone to drug resistance and easy to relapse after discontinuation. TAF is actually an upgraded version of the previously marketed drug Viread (Werred, generic name: Tenofovir disoproxil fumarate). In clinical trials, TAF has been shown to have very high antiviral efficacy at less than one-tenth the dose of Wyred, while showing better safety and avoiding kidney damage and drug resistance issues. It can be said that the emergence of TAF has made patients not far from clinical negative!
At present, TAF can be bought in many pharmacies in China, but many patients say that the price is slightly more expensive, the monthly cost is more than 1,000 yuan, taking it over the years, there must be some economic pressure.
Rosuda: a new option for schizophrenia
On January 24, 2019, the State Drug Administration of China granted Rocheda (Lurasidone Hydrochloride Tablets), an atypical antipsychotic drug, an import drug license for schizophrenia.
Schizophrenia is a serious mental disorder. According to World Health Organization statistics, more than 21 million people worldwide are suffering from schizophrenia. As of the end of 2016, the number of registered schizophrenics in China was about 4.05 million.
The existing schizophrenia treatment drugs can be roughly divided into two categories: one is a typical antipsychotic drug; the other is an atypical antipsychotic drug, which generally has a dopamine D2 / 5-HT2A receptor antagonistic effect. Typical antipsychotics can effectively alleviate positive symptoms, but they can cause serious adverse reactions of the extrapyramidal system (EPS, which is a component of the human motor system, whose main function is to regulate muscle tone and coordinated movement and balance of muscles); atypical Antipsychotic drugs have a lower risk of EPS while guaranteeing the control of positive symptoms. However, the problems of significant weight gain and metabolic disorders caused by antipsychotic drugs have brought new problems to the treatment of schizophrenia.
Rosuda is an atypical antipsychotic taken once daily, and its active pharmaceutical ingredient is lurasidone. Compared with other existing anti-schizophrenia drugs, lurasidone has a unique chemical structure that can block dopamine D2 receptors and improve positive symptoms of psychosis; block 5-HT2A receptors and improve cognitive and emotional symptoms ; Blocking 5-HT7 receptors can help improve mood, sleep, and cognitive status. In addition, the risk of side effects such as cognitive impairment, weight gain, and sedation with this drug is relatively low. Rosuda’s listing will provide a new treatment option for patients with schizophrenia in China. Ainuoquan: Heavy Weapon to Eliminate Hepatitis C
China has the largest number of people infected with hepatitis C in the world, with about 10 million people. Hepatitis C has long been a serious public health topic, because severe hepatitis C can progress to cirrhosis or liver cancer, which is life-threatening, especially for patients with chronic kidney disease combined with hepatitis C, which has previously lacked suitable treatment options. In May of this year, Ainuoquan (Garavivir Pirentavir Tablets) was approved by the China National Drug Administration for the treatment of chronic hepatitis C virus infections of type 1, 2, 3, 4, 5 or 6 genes. Adult patients with cirrhosis or compensatory cirrhosis.
Professor Xie Qing from Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, said: “Ainuoquan is a pan-genotype solution with the shortest course of treatment for patients with newly diagnosed and chronic hepatitis C without cirrhosis. It is a more advanced direct antiviral therapy. Hepatitis C cure plan. “Ai Nuoquan has a virological cure rate of more than 99% for all patients with primary genotypes (genes 1 to 6) who are newly treated and who have no cirrhosis. Because it is not metabolized by the kidneys, Ainol is suitable for patients with any degree of renal impairment (including those undergoing dialysis) without the need to adjust the dosage. The virological cure rate is nearly 100%.
Professor Wei Lai, director of the Hepatobiliary and Pancreatic Pancreas Center at Tsinghua University’s Beijing Tsinghua Chang Gung Hospital, said: “Ainuoquan is undoubtedly another heavy weapon for us to eliminate the public health threat of hepatitis C.”
Bureau Veritas: new helper against HIV
In August 2019, Bittovir was approved by China’s State Food Administration for the treatment of HIV-1 virus (Human Immunodeficiency Virus Type 1 is the main strain that causes acquired immunodeficiency syndrome) infection.
Bituvir is a three-in-one compound, one single tablet taken orally daily, which perfectly combines the latest generation of integrase chain transfer inhibitors Bictivir and the best backbone drug Davaol and Safety, therefore known as the “most secure” HIV monolithic complete program.
As of 2018, there are about 150,000 newly discovered HIV-infected people in China. At the same time, the number of people living with HIV receiving antiretroviral therapy is steadily increasing. Professor Li Taisheng, director of the Department of Infectious Diseases, Peking Union Medical College Hospital, said that Bitovavir has a highly effective antiviral effect, a high resistance barrier and proven good tolerability, and will be used in the treatment of HIV-1 virus infection for the majority of patients in China Provide an important new option.
Rossastat Capsules: Leading Revolutionary Change in Renal Anemia Treatment Model
At the end of last year, the State Food and Drug Administration approved the approval of the first-class innovative drug Rosacestat capsules (brand name: Irrigox) through priority review and approval procedures for the treatment of anemia caused by chronic kidney disease in patients undergoing dialysis treatment. . Today, this innovative medicine made in Beijing is moving from China to the world. In September this year, rosalastam was approved for marketing in Japan, clinical trials have been completed in the United States and Europe and other countries, and a marketing application is about to be submitted to the drug regulatory department. .
Rosasastat capsule is a new drug that creates “3 firsts”, namely the world’s first small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor to treat renal anemia; for the first time in China Become the first country in the world to approve a new type 1 innovative drug mechanism of action, applicable to anemia caused by chronic kidney disease, can promote the expression of endogenous erythropoietin and the absorption and utilization of iron, and effectively improve the symptoms of anemia; July this year The results of two Phase III clinical trials of rosastatin capsules in China were published in the world’s top medical journal “New England Journal of Medicine”. This is the first time that the journal has published a phase III clinical trial of a new drug by a doctor in Mainland China. . In addition, in the selection of pharmaceutical innovation brands held by the China Association for the Promotion of Drugs, Rosacetast Capsule won the 2019 Most Clinically Valuable Innovative Medicine Award.
Chen Nan, a professor at Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine and Hao Chuanming, a professor at Huashan Hospital affiliated to Fudan University, who led the clinical trials of rosastatin, said that the advent of this new drug has broken the field of renal anemia in the past 30 years without new mechanisms and targets The emergence of some drugs is expected to lead the revolutionary revolution of the treatment model of renal anemia.
Fulaimei: Can significantly improve the compliance of sugar friends
The State Food and Drug Administration announced on May 7 that it has approved the approval of the first-class innovative drug polyethylene glycol losenatide injection (trade name: Fulaimei) through the priority review and approval process for adults to improve type 2 diabetes. Blood sugar control.
Glucagon-like peptide 1 (GLP-1) is a type of “incretin” naturally secreted by the human gastrointestinal mucosa, which can bind to receptors on islet cells and stimulate insulin secretion, thereby exerting a role in reducing blood sugar . Previously, GLP-1 receptor agonist antihyperglycemic drugs approved in China were short-acting preparations, which were exenatide (2 times a day), liraglutide (1 time a day), and bener Lupin (3 times a day), Risenatide (1 time a day). Flyme is not only China’s first independent long-acting GLP-1 receptor agonist, but also the world’s first PEGylated (ie polyethylene glycol) long-acting GLP-1 receptor agonist.
According to the “Injection Administration Burden Study Report for Diabetes Patients” released in August 2018, 90% of patients who have poor control of oral hypoglycemic drugs have concerns about starting daily hypoglycemic injections, and 32% Injecting patients have considered giving up treatment because of the complexity of the injection. 72% of patients believe that the inconvenience of the injection method has affected them to complete the injection treatment in accordance with the doctor’s order, and 89% of patients believe that the failure to inject the injection has affected the blood glucose control effect. Fulaimei only needs to be injected once a week and can be used at any time of the day (before or after meals), which will undoubtedly greatly improve the convenience and compliance of medication for diabetes patients, and improve the overall treatment of diabetes in China. At present, there are two dosage forms of Fulaimei, the price is between 300 and 400 yuan.
Shinbek: a landmark new topical treatment for psoriasis
In May 2019, the national class 1 innovative drug Ben Vermod Cream (trade name: Simbike) was approved for marketing through the priority approval process of the State Drug Administration for local treatment of mild to moderately stable silver in adults. Dandruff. This drug is the world’s first, and has been listed as a major national scientific and technological achievement in the “Twelfth Five-Year Plan” and “Major New Drug Creation” by the Ministry of Science and Technology. It is an epoch-making drug for the international treatment of psoriasis in the past 30 years.
Common topical treatments for psoriasis include glucocorticoids and vitamin D3 derivatives. Glucocorticoids have fast effects and good effects, but they have the disadvantage of being easily repeatable; vitamin D3 derivatives are the “gold standard” for non-hormonal topical drugs. Because of its definite curative effect, Simbike is significantly better than the current “gold standard” for psoriasis. Simbike is a tyrosine protein kinase inhibitor that exerts a therapeutic effect by inhibiting T cell tyrosine protein kinase, interfering / blocking the release of cytokines and inflammatory mediators, T cell migration, and skin cell activation.
Patients can go to the regular hospital dermatology department to prescribe Ben Weimod cream, and then go to the local professional DTP pharmacy (After the patient gets a prescription in the hospital, the pharmacy delivers the medicine at the time and place specified by the patient or family according to the prescription, and cares And track the patient’s medication progress, provide professional services such as medication consultation, etc.) to purchase on their own, each priced at about 500 yuan.
Beilizumab: the first new drug for lupus erythematosus in 60 years
On July 18, belizumab was listed in China through priority review and approval for active, autoantibody-positive systemic lupus erythematosus patients undergoing standard treatment. Beilizumab is the world’s first monoclonal antibody for systemic lupus erythematosus, and the first new drug for lupus erythematosus in more than 60 years (the previous drug was a Chloroquine).
Lupus erythematosus is an autoimmune-mediated connective tissue disease with prominent manifestations of immune inflammation. It is divided into discoid lupus erythematosus and systemic lupus erythematosus according to clinical manifestations. The former is mainly confined to the neck, and the latter is diffuse. It is a chronic autoimmune disease involving multiple systems, multiple organs, and multiple autoantibodies. At present, the routine treatment of lupus erythematosus in clinical practice is to use hormones + immunosuppressants, but this treatment scheme is only effective for some patients and will bring many adverse reactions, such as infection, osteoporosis and cardiovascular abnormalities, obesity, etc. . Beliximab is the first inhibitor to act on B lymphocyte stimulating factors, which can achieve continuous disease control, help stabilize long-term symptoms, and improve patients’ long-term prognosis. The results of a 10-year clinical study published at the annual meeting of the European Society of Rheumatology showed that the proportion of patients achieving remission through belizumab treatment gradually increased over time, with a total remission rate of 65.2% in the 10th year.
However, the current price of belizumab is somewhat high, and it is not included in the medical insurance list. The injection powder for 120 mg / bottle costs about 2,000 yuan.
Phase 9: Filling the 17-year gap in new Alzheimer’s disease drugs worldwide
The State Drug Administration announced on the evening of November 2. Conditional approval of the market registration application of mannut sodium capsules (brand name: Phase 9) for mild to moderate Alzheimer’s disease and improvement of patients’ cognitive function . This drug is an innovative drug independently researched and developed in China with independent intellectual property rights. It has obtained major special support from major national new drug creation technologies, filling the gap of no new drugs in the field of Alzheimer’s disease treatment in the past 17 years.
Alzheimer’s disease, commonly known as Alzheimer’s disease, is a persistent neurological disorder that progresses slowly and worsens over time. The average survival time of patients after diagnosis is only 3-9 years, and there are signs of cognitive decline, behavioral disorders, and decline in living ability. Therefore, Alzheimer’s disease is also known as “God’s most vicious curse on humans.” .
The team of Geng Meiyu from the Shanghai Institute of Materia Medica, Chinese Academy of Sciences has persisted for 22 years. With the joint efforts of Ocean University of China, Shanghai Institute of Materia Medica, Chinese Academy of Sciences and Shanghai Green Valley Pharmaceutical Co., Ltd., the original and innovative drugs successfully developed in the ninth phase broke the “God’s most vicious for humans.” “The curse” also dispelled the haze over the development of new drugs for Alzheimer’s disease. The ninth phase has improved the cognitive dysfunction by remodeling the intestinal flora balance, inhibiting the abnormal increase in specific metabolites of the intestinal flora, reducing peripheral and central inflammation, reducing beta amyloid deposition and over-phosphorylation of Tau protein.
The first phase of the ninth period is expected to be launched in all channels across the country at the end of December. The pricing will follow the principle of “not only making it affordable for Chinese people, but also able to compete internationally”.