Review and approval acceptance dynamics
This week, a total of 18 new drug review and approvals are in the new developments, of which 4 are special approval varieties, 1 priority review variety, 1 special and excellent variety, involving Hengrui, Zhengda Tianqing, Qilu, Yangtze River, Zhejiang Sea. Waiting for many companies. The details are as follows:
Hengruijie News has been successively approved, Class 1 new drugs have been approved for clinical practice, and major tumor-innovative drugs have been approved for marketing, and generic drugs have been approved in the United States.
This week, Hengrui has good news!
Class 1 new drug SHR2554 tablets approved for clinical
On May 8th, Hengrui's two new drugs, SHR2554, used to treat malignant tumors, were approved for clinical use in two sizes of 50mg and 200mg. At present, there are many similar products at home and abroad in the clinical research or pre-clinical development stage, but no similar products have been approved for listing, and there is no relevant sales data. According to the official announcement, up to now, Hengrui Pharmaceutical has invested R&D expenses of approximately 13.5 million yuan in SHR2554 and film research and development projects.
2 billion pounds of tumor innovation drug 19K finally ushered in
The industry has been paying high attention to Hengrui's thiopentazide injection, 19K (HHPG-19K, polyethylene glycol recombinant human granulocyte stimulating factor injection). Last week, it was reported that Hengrui The 19K has been approved by the CFDA in the final step. The news has been confirmed this week. On May 8, the approval status of the application for the listing of Hengrui thiophene filgrastim injection was changed to “approval-to-certificationâ€. According to insiders, the variety has been approved for listing. The drug is clinically used for chemotherapy-related neutropenia in cancer patients, and its peak sales are expected to exceed 2 billion yuan.
Injectable Settlement ANDA approved by the US FDA
On May 9th, Hengrui Pharmaceutical announced that the company had recently received a notice from the US Food and Drug Administration (FDA) that Hengrui’s injection of the thiophene ANDA for FDA was approved for FDA approval, meaning that the company can produce and Sell ​​this product in the US market. Injectable for the treatment of breast cancer, ovarian cancer, control of cancerous body cavity effusion secondary to diffuse or local tumors of various serous cavity diseases, treatment of papillary carcinoma of the bladder surface, but also effective against other lymphoma . Hengrui Medicine has invested R&D expenses of approximately RMB 36.9 million in research and development projects for injection.
Zhengda Tianqing Milestone Lung Cancer Class 1.1 Innovative Drugs Approved
On May 8, Zhengda Tianqing independently developed the 1.1 new drug, erlotinib hydrochloride (Fu Kewei), which was approved for production. On the second day, the company received the approval of the approval from the State Drug Administration. At this point, Zhengda Tianqing has invested in the largest original innovative drugs in the history. The drug is a novel small molecule multi-target tyrosine kinase inhibitor, which can effectively inhibit the kinases such as VEGFR, PDGFR, FGFR and c-Kit, and has the dual effects of anti-tumor angiogenesis and tumor growth inhibition. It has been confirmed by clinical trials that Fukwell is the only single-agent effective oral preparation for anti-angiogenic targeted drugs in advanced non-small cell lung cancer, and the adverse reactions are mild and the patients are well tolerated.
According to industry experts, erlotinib is expected to become the standard of third-line treatment for patients with advanced non-small cell lung cancer. The listing of erlotinib can be said to be a milestone in the history of Zhengda Tianqing. The drug is the first innovative small molecule drug in Zhengda Tianqing in accordance with international research and development processes and standards. It is also the company's most research and development investment anticancer drug.
There are several monoclonal antibodies approved for clinical trials.
This week, on May 8th, five monoclonal antibodies showed the status of “sentâ€, which is likely to be approved clinically. Zhejiang Haizheng's recombinant anti-HER2 humanized monoclonal antibody for injection is coupled with maytansine. Derivatives DM1, recombinant anti-EGFR human mouse chimeric monoclonal antibody injection of Qilu Pharmaceutical, recombinant humanized anti-VEGF monoclonal antibody ophthalmic injection of Shenzhou cells, Patuxuzumab injection of Zhengda Tianqing, Wo The Mori bio subsidiary Jiahe Bio is injected with GB251.
Tairui Shengnuo Bio and Zhejiang Yongzhan Class 1 New Drugs Approved Clinically
On May 9th, Jiangsu Tairui Shengnuo Biomedical Technology Co., Ltd. reported that the class 1 new drug X842 raw materials and capsules showed the status of “approval-to be certifiedâ€. It is understood that the drug is the combination of Terry Ruisheng and Swiss CincluspharmaAG. A potassium ion competitive acid blocker (P-CAB) was developed for the treatment of severe gastroesophageal reflux disease (GERD), acute upper gastrointestinal bleeding, and some other possible conditions based on quick-acting. Preclinical studies have shown that x842 has good chemical stability and has strong and lasting inhibitory effects on histamine, carbachol and pentagastrin gastrin secretion, and has good safety. A new class of drug X842 potassium ion competitive acid blocker (PCAB) has been applied for patents in the United States, the European Union, Canada and China. Jiangsu Tairui Shengnuo has obtained the Chinese patent license of X842 and the Asian market license.
On the same day, the class 1 new drug NB001 tablet declared by Zhejiang Yongzhan Pharmaceutical showed the status of “approval-to be certifiedâ€, which is reported to be an innovative drug for the treatment of chronic pain.
Review and approval status
In addition, there are 9 varieties of drugs received this week, as follows:
China's first clinical application for PDL1/CTA4 monoclonal antibody was contracted
On May 7, Jiangsu Kangning Jerry's clinical application for recombinant humanized PDL1/CTLA-4 bispecific single domain antibody Fc fusion protein injection was undertaken. Up to now, a total of 18 PD-1 antibody drugs, 15 PD-L1 antibody drugs, 2 PDCD-1, PD-1 antibody drugs, 1 CD-8, PD-1 antibody drugs, and 1 PD- have been declared in China. 1/CTLA-4 bispecific antibody drug.
Beijing Recreational Guardian's nine-priced HPV vaccine clinically undertaken
On April 28, it took only 9 days for Merck's cervical cancer nine-valent vaccine to be approved for marketing in China, which is enough to see the urgent need for cervical cancer nine-valent vaccine in China. There are five companies in China that have a nine-valent vaccine, and the fastest one is approved in November 2017. On May 7th, Beijing Kangle Guardian's recombinant nine-valent human papillomavirus (6/11/16/18/31/33/45/52/58) vaccine (Escherichia coli) clinical application, this vaccine The second Class 1 preventive biological product independently developed by the company. The vaccine is used for the prevention of human papillomavirus infections of HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58 and related diseases such as cervical cancer caused by infection. The company currently has a trivalent HPV vaccine in the clinical research stage, and has completed the ethical review work.
Important drug smell
2017 global sales runner-up 8.2 billion Eylea? Another indication was approved in China
On May 8, the State Drug Administration approved Ailiya (Abesep intraocular injection solution) for the treatment of adult neovascular (wet) age-related macular degeneration (nAMD). Ailia? Three months after being approved for the treatment of diabetic macular edema (DME) in China in February this year, it was again approved by the State Drug Administration for the treatment of neovascular (wet) age-related macular degeneration (nAMD). ). nAMD is an important preventable blinding disease.
Ai Li Ya is the world's first fully humanized fusion protein, which can bind VEGF dimer more effectively and has higher affinity. It can block VEGF-A, VEGF-B and PLGF at the same time, and has a wider target. At the same time, it acts longer and has a longer lasting effect. At present, there are five indications for ABC's intraocular injection solution, which have been approved for marketing in more than 100 countries around the world. Since the introduction of ABC's intraocular injection solution, it has been used in more than 20 million worldwide. In 2017, its global sales reached US$8.2 billion, making it the world's best-selling drug runner.
Merck's heavy hepatitis C drug New Zealand is approved in China
Recently, Merck Corporation announced that its heavy hepatitis C new drug, BHP (external trade name ZEPATIER), has been approved by the State Drug Administration for the treatment of adult patients with type 1 and type 4 chronic hepatitis C. Zebida is composed of two new chemical entities (NCEs), the NS5A inhibitor elbavir and the NS3/4a protease inhibitor graviprevir. It is a Direct-acting Antiviral (DAA).
Hyperkalemia drug VELTASSA supplement application approved by FDA
On May 8, Relypsa, a company of the Vifor Pharmaceutical Group, announced that the company's application for a new drug supplement for the high-potassium drug VELTASSA (PATIROMER) oral suspension was approved by the US FDA. Hyperkalemia often coexists with other diseases, including chronic kidney disease, heart failure, diabetes, and/or high blood pressure. This update will be effective immediately in the United States. The update of the instructions was based on the results of the clinical phase IV TOURMALINE study, which showed no statistically significant differences in the range of indicators (3.8-5.0 mEq/L) compared with the oral Veltassa group with or without meals.
The new lung cancer drug Ensartinib has an efficiency of 80%
A recent experimental data on Ensartinib was published, which is 80% effective for patients without ALK-targeted therapy, with a progression-free survival of 26.2 months. Ensartinib is currently conducting an international multi-center phase III clinical study. Ensartinib, code-named X-396, is a capsule of traits developed by Xcovery Holdings Company LLC, a subsidiary of Beida Pharmaceuticals. Ensartinib is a new generation of ALK inhibitors for the treatment of lung cancer. It has anti-ALK activity for the treatment of lung cancer patients with ALK mutations. It can also target MET, ABL, Axl, EPHA2, LTK, ROS1 and SLK.
Prior to this, there were many targeted drugs for ALK, such as crizotinib, erlotinib, and lorazinib. In vitro cytology experiments, Ensartinib's ability to inhibit ALK-positive lung cancer cell lines is currently 10 times that of first-line treatment for lung cancer. Not only that, but also for L1196M and C1156Y mutations that cause crizotinib resistance, X-396 Shows strong inhibitory activity.
The first new drug for depression in 50 years, the new phase of the new therapy for Johnson & Johnson depression reached the primary end point
Johnson & Johnson's Janssen has recently published two positive results for patients with treatment-resistant depression. The Phase III clinical study of the esketamine nasal spray in the study has reached the primary efficacy endpoint. The findings will be made public at the recent annual meeting of the American Psychiatric Association in New York. Esketamine intranasal is a new drug molecule being developed by Janssen, a non-competitive antagonist of N-methyl-D-aspartate (NMDA) receptor. It has a completely new mechanism of action of drugs, unlike current depression therapies. Esketamine has received two breakthrough treatments from the US FDA, including treatment for drug-resistant depression (November 2013) and the onset of suicide risk of major depression (August 2016).
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