10 new drugs of category 1 and 61 imported drugs 2018 into the "new drug year"
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Medical Network January 3, 2018, under the support of a series of policies such as priority review and approval, speeding up the listing of foreign countries and domestically urgently needed drugs in China, the number of independent research and development of new drugs and the number of imported registered varieties in China have surged. According to the statistics of the intranet, in the year of 2018, a total of 10 new drugs in the country were approved for listing, and 61 drugs were approved for import, creating the first in China, the world's first, the fastest review and approval, the largest R&D investment, and the strongest in history...
Up to now, CDE has released a total of 36 batches of drugs to be reviewed for priority evaluation. Among the drugs approved for listing or import this year, most of the drugs have obtained the priority evaluation qualification, and the policies encouraging innovation have come to fruition; In the field of treatment of new drugs, anti-tumor drugs (especially bio-drugs) and anti-viral drugs (including hepatitis B, hepatitis C and HIV) are key areas for the development of pharmaceutical companies, and more and more enterprises are planning to launch rare diseases.
Representative for December : Trepril monoclonal antibody, pertuzumab, and rochataxel
Table 1:1 Partially approved/imported innovative drugs in February
(Source: Minenet database, CDE official website, the same below)
The first domestic PD-1 antibody drug
Treprizumab injection (trade name Tuoyi) is China's first domestic PD-1 antibody drug for the treatment of unresectable or metastatic melanoma after failure of systemic systemic therapy. In addition, Junshi Bio has been around The product has clinical trials for multiple indications, including nasopharyngeal carcinoma, gastric cancer, esophageal cancer, non-small cell lung cancer, malignant lymphoma, and hepatocellular carcinoma. The product was included in the priority review on April 23 as “innovative medicine with obvious therapeutic advantagesâ€.
PD-1 is a fiercely competitive R&D target in China. Up to now, PD-1 of Bristol-Myers Squibb, Merck, Junshi and Cinda has been approved for listing. PD-1 of Hengrui and Baekje Shenzhou has been submitted. The listing application is expected to be approved for listing next year. In addition, there are more than 30 PD-1 in the clinical stage, and the market competition for PD-1 monoclonal antibody will be fierce in the future.
First HER Dimerization Inhibitor Monoclonal Antibody
Pertuzumab injection (trade name Paget) is the first monoclonal antibody called "HER dimerization inhibitor", combined with trastuzumab and chemotherapy for HER2 positive with high risk of recurrence Adjuvant therapy for patients with early-stage breast cancer, this dual-target treatment regimen reduces the risk of recurrence or death in patients with high-recurrence risk of HER2-positive early breast cancer by 25%. The product was included in the priority review on November 7th for “innovative medicine with obvious therapeutic advantagesâ€. At present, Zhengda Tianqing has submitted a clinical application for submitting two new drugs for this product.
The world's first new drug for renal anemia
Rosacestat Capsule (trade name Ai Ruizhuo) can be used to treat anemia caused by chronic kidney disease (CKD) in patients undergoing dialysis. The product was jointly developed by Zibo Jin and AstraZeneca in China. It was included in the priority review on December 18, 2017 and August 9, 2018 on the basis of “innovative medicine with obvious therapeutic advantagesâ€. It is the first in the world. A small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) for the treatment of renal anemia has not yet been marketed in any other country.
Representative in November : Phosphorine propofolf
Table 2: Some of the innovative drugs approved for listing/import in November
The strongest hepatitis B medicine in history
Phosphorine propofolf tablets (abbreviated as TAF, trade name Wei Lide) as a prodrug of tenofovir disoproxil (TDF), the efficacy is comparable to TDF, but the side effects are smaller, is considered to be the best hepatitis B at present Medication. The product was included in the priority review on December 18, 2017 for "viral hepatitis drugs."
Up to now, there have been a number of pharmaceutical companies in China that have developed the generic drug research of phosphopropanovir tablets. Zhengda Tianqing and Jiangxi Qingfeng have submitted listing applications for generic drugs. The BE trials of Sichuan Kelun Pharmaceutical and Qilu Pharmaceutical have already After completing the recruitment of patients, Fujian Guangshengtang Pharmaceutical has launched the BE trial in the near future and is still in the recruitment stage.
Representative in September : furazolinib
Table 3: Some of the innovative drugs approved for listing/import in September
Innovative drugs that are not listed at home or abroad
Furazolinib capsule (trade name Aiyoute) can be used to treat metastatic colorectal cancer. This product was developed by Lilly and Hutchison Whampoa. It is the first drug discovered, developed and approved for marketing in China. The innovative drugs that were not listed outside the market were included in the priority review on September 4, 2017, on the basis of “significant clinical valueâ€.
Representatives in August : pyrrolidine, alittinib, and peribupril
Table 4: Some of the innovative drugs approved for listing/import in August
The first solid tumor innovative drug based on clinical phase II results in China
A new class of anti-breast cancer drug developed by Hengrui Medicine, pyrrolidine maleate (trade name: Ai Ruini) is an oral epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2). The dual inhibitor of tyrosine kinase was first applied for clinical trial on May 27, 2011, and was included in the priority review on September 26, 2017 for "important clinical value". August 13, 2018, its listing application After the examination and approval was completed and approved for listing, it became the first innovative drug in China to receive solid tumors based on the results of Phase II clinical research and obtained conditional approval from the State Food and Drug Administration.
First-line treatment for ALK- positive non-small cell lung cancer
Roche's Aletinib Hydrochloride Capsule (trade name An Shengsha) can be used to treat anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). The product was included in the priority review on March 28th on the grounds of “innovative medicine with obvious therapeutic advantagesâ€. It took only 194 days from CDE to approved listing.
From November to December 2017, An Shengsha was approved in the United States and the European Union for first-line treatment of ALK-positive non-small cell lung cancer. According to the results of international clinical studies, An Shengsha is used for first-line treatment of ALK-positive advanced non-small cell lung cancer, which can extend the median progression-free survival (PFS) time to 34.8 months. There are nearly three times the treatment plan; the risk of brain metastasis can be reduced by 84%, and the risk of disease progression or death can be reduced by more than half.
China's first CDK4/6 inhibitor
Pfizer's Capsules (trade name Aiboxin), developed by Pfizer, can be combined with aromatase inhibitors for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast. Initial endocrine therapy in postmenopausal women with cancer. The product was approved for marketing in the United States in 2015 with a rapid approval process for the treatment of advanced breast cancer.
Pipersilili is China's first approved CDK4/6 inhibitor and was included in the priority review on November 22, 2017. At present, Nanjing Haina Pharmaceutical Science and Technology has applied for 3.1 new drugs and has been approved for clinical treatment. Qilu Pharmaceutical has applied for generic drugs in four categories and is currently in the “in review and approval†status.
July Representative: Pabolizumab
Table 5: Some of the innovative drugs approved for listing/import in July
The fastest review and approval of imported anti-cancer biopharmaceuticals
Pabolizumab injection (trade name Kelida) is the only PD-1 receptor drug approved for the treatment of advanced melanoma in China. The original researcher Merck submitted the CDE application on February 11, and on November 7 The “innovative medicine with obvious therapeutic advantages†was included in the priority review. It took only more than five months from the contracting of CDE to the approval of the listing, setting a record for the fastest review and approval of Chinese imported anti-tumor biological agents. Pabolizumab has received 14 FDA-approved breakthrough drug approvals in the United States, and has been approved for up to 12 indications covering 9 different advanced tumors. It is currently the most widely accepted indication cover tumor. PD-1 monoclonal antibody.
Representatives in June : Navuliyub, Danovir, Seritinib
Table 6: Some of the innovative drugs approved for listing/import in June
China's first PD-1 antibody drug
Navramide monoclonal injection (trade name Odivo), developed by Bristol-Myers Squibb, is China's first approved PD-1 antibody drug for the treatment of epidermal growth factor receptor (EGFR) gene mutation negative and Degenerative lymphoma kinase (ALK)-negative, previously advanced or metastatic non-small cell lung cancer (NSCLC) with disease progression or intolerance after platinum-containing regimen chemotherapy. Based on CheckMate-078's key, randomized phase III clinical data, this product demonstrates long-term survival benefits for domestic NSCLC patients. The product was included in the priority review on December 18, 2017 for “innovative drugs with significant therapeutic advantagesâ€.
The first domestically developed hepatitis C DAA drug
The first class of new drug danoviride sodium tablets (also known as Danolive sodium tablets, trade name Gonowei) developed by Songli is the first direct antiviral drug (DAA) developed by domestic companies for the treatment of hepatitis C. On February 28, 2017, the priority review was based on the “direct antiviral treatment for hepatitis Câ€.
Danolivir is a new generation of NS3/4A protease inhibitors. Phase III clinical trials in mainland China have shown that after 12 weeks of treatment, the cure rate (SVR12) is 97% in patients with genotype 1 non-cirrhosis; The cure rate in patients with genotype 4 non-cirrhosis is 100%.
China's first second-generation ALK inhibitor
Seretinib Capsule (commercially known as the best) is the first second-generation ALK inhibitor to enter China for anaplastic lymphocytes that have previously undergone treatment with crizotinib or are intolerant to crizotinib. Tumor kinase (ALK)-positive patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The product was included in the priority review on May 23, 2017 and January 29, 2018, on the basis of “significant therapeutic advantages compared to existing treatmentsâ€.
May Representative: Aibo Weitai, Erlotinib
Table 7: Some of the innovative drugs approved for listing/import in May
The world's first long-acting HIV-1 fusion inhibitor
Aboweitai (trade name Ai Ke Ning), a class 1 new drug for research and development independently developed by cutting-edge organisms, is used to treat HIV-1 infected people who have received antiviral drugs. The product is the world's first long-acting HIV-1 fusion inhibitor, China's first original anti-Ai Xin drug, with global intellectual property rights.
Aiboweitai belongs to gp41 inhibitor, and its new molecular mechanism of action makes it effective against the main epidemic HIV-1 virus and drug-resistant virus. Long-acting injection mode is an important supplement and improvement of oral drug treatment. The product was included in the priority review on November 3, 2016.
Zhengda Tianqing research and development of the largest drug
Non-small cell lung cancer class 1 new drug, erlotinib hydrochloride hydrochloride (trade name Fu Kewei) is a class 1 new drug independently researched and developed by Zhengda Tianqing for more than 10 years. It is also the most anti-cancer drug invested by the company so far in 2017. On April 27th, it was included in the priority review on the grounds that it has a significant therapeutic advantage compared to existing treatments.
Erlotinib is a novel small molecule multi-target tyrosine kinase inhibitor that can effectively act on VEGFR, PDGFR, FGFR, c-Kit and other targets, and has dual effects of anti-tumor angiogenesis and tumor growth inhibition. According to industry experts, erlotinib is expected to become the standard of third-line treatment for patients with advanced non-small cell lung cancer.
Representative in April : nine-valent HPV vaccine, recombinant cytokine gene-derived protein
Table 8: Some of the innovative drugs approved for listing/import in April
Minimum review and approval time
The nine-valent human papillomavirus vaccine (referred to as the nine-priced HPV vaccine, trade name Jia Da Xiu) is suitable for women aged 16 to 26, three doses of immunization program to prevent cervical cancer, the product was in the United States and the European Union in 2014 and 2015 respectively. Approved. On April 23, the nine-priced HPV vaccine was included in the priority review on the grounds of “having a clear clinical advantage.†It took only 8 days from CDE to approved listing, which is called rocket speed. On May 11, Merck held a price negotiation on the net in Hainan, and the negotiated price was 1,298 yuan / share.
The world's first third class of hepatitis B treatment drugs
Recombinant cytokine gene-derived protein injection (trade name Le Fu Neng) is the first bio-drug developed by Jiehua Biotech after 18 years. It is the third class of drugs for treating hepatitis B except for direct antiviral drugs and interferons. Based on the molecular structure of the human natural immunoregulatory protein, Jiehua Biotechnology has developed a new type of highly efficient human immune function regulatory protein molecule, which has been shown to treat viral diseases, malignant tumors and more effectively through the regulation and enhancement of immune function. The effect of autoimmune diseases is an "immunotherapy" drug. The results of clinical unblinding showed that the e antigen conversion rate (clinical cure rate) reached 49.06% in patients with hepatitis B who were treated with Le Fu can be treated for 6 months, which is superior to other drugs currently used internationally.
January representative: Exenatide microspheres
Table 9: Some of the innovative drugs approved for listing/import in January
China's first weekly GLP-1 receptor agonist preparation
The exenatide microsphere for injection (trade name Baidayang) is China's first and only approved glucagon-like peptide-1 (GLP-1) receptor agonist weekly preparation, once a week for administration Treat type 2 diabetes. Exenatide microspheres continue to provide steady-state exenatide levels through sustained-release microspheres, thereby significantly reducing dosing frequency, reducing gastrointestinal side effects, and increasing drug stability and patient compliance. Clinical trials have shown that exenatide microspheres can reduce glycated hemoglobin (HbA1c) by 1.3%-1.9% once a week, and can reduce body weight by 2.0kg-3.7kg. In addition, exenatide microspheres can reduce systolic blood pressure and blood lipid levels in patients, significantly reducing the risk of all-cause mortality, and safety.
Source: Minenet database, CDE official website, public company announcement