Since 2018, China's a new force suddenly rises. With the support of national policies, the domestic innovative drugs have been effective in the following aspects: efficacy, safety, reliability, and price advantage.
In 2020, under the double attack of epidemic situation and policy, the pharmaceutical industry has also made remarkable achievements. According to incomplete statistics, as of December 18, the State Drug Administration has approved a total of nine class 1 new drugs (chemical drugs) this year.
01
Fluzoparide, a class 1 innovative drug of Hengrui medicine
On December 14, 2020, the State Food and Drug Administration announced that fluzopali capsule was approved by nmpa for listing.
Fluzopari capsule (trade name: ariyi) is a small molecule PARP inhibitor, which is used for the treatment of platinum sensitive recurrent ovarian cancer, fallopian tube cancer or primary peritoneal cancer with BRCA mutation (gbrcam) after second-line or above chemotherapy.
According to the Chinese drug clinical trial registration and information publicity platform, a total of 24 clinical studies are being carried out, of which 10 have been completed, involving indications including breast cancer, prostate cancer, ovarian cancer, gastric cancer, etc. it is the first domestic PARP inhibitor.
At present, four PARP inhibitors have been listed in the world, including olaparide, lucaparide, nirapali and taprazolaparide. Before that, there were two kinds of PARP inhibitors on the domestic market, namely, olapari from AstraZeneca approved for listing in August 2018 and nilapali capsules from zaiding pharmaceutical approved for listing in December 2019.
02
Class 1 innovative drug of haisike: cyclophenol injection
On December 14, 2020, the State Food and Drug Administration announced that ciproflol injection was approved by nmpa.
Ciprofol injection (trade name: sishuning), a GABAA receptor agonist, is used for sedation in gastrointestinal endoscopy.
Up to now, 20 phase I-III clinical studies have been registered in China, of which 16 have been completed and 4 are in progress. The indications include sedation and / or anesthesia in painless digestive endoscopy, induction of general anesthesia, sedation and / or anesthesia in fiberoptic bronchoscopy, induction and maintenance of general anesthesia, sedation in ICU, etc.
Ciprofol injection is the first innovative drug product of haisike. It is an improved new drug of propofol, a classic anesthetic and sedative drug. Its efficacy is significantly higher than that of propofol, and its safety is better than that of propofol.
03
Ensatinib hydrochloride capsules: a class 1 innovative drug of Beida pharmaceutical
On November 20, 2020, the State Food and Drug Administration announced that nsatinib hydrochloride capsules were approved by nmpa for listing.
Ensatinib hydrochloride capsule (trade name: beminar), an inhibitor of anaplastic lymphoma kinase (ALK), is used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with ALK positive who have previously received or are intolerant of clottinib.
Compared with similar imported drugs, nsatinib has more advantages in curative effect, especially in patients with intracranial metastasis, with higher response rate and controllable safety.
It is reported that this product is the first domestic class 1 new drug for the treatment of advanced NSCLC with ALK mutation in China, providing a new treatment option for NSCLC patients.
04
Ravidavir hydrochloride tablets: a class 1 innovative drug of Geli biology
On July 29, 2020, ravidavir hydrochloride tablets were approved by nmpa.
Ravidavir hydrochloride tablets (trade name: xinlilai), a NS5A inhibitor, combined with ritonavir enhanced danorevir sodium tablets and ribavirin, are used in the treatment of non cirrhotic adult patients with chronic hepatitis C virus infection of genotype 1b, and can not be used as a single drug treatment.
The marketing of this product will provide more choices for non cirrhotic adult patients with chronic hepatitis C virus 1b infection.
05
Class 1 innovative drug of humanwell pharmaceutical - rimazole besylate for injection
On July 16, 2020, rimazole benzenesulfonate for injection was approved by nmpa.
Remazolam besylate for injection (trade name: Rima), a new ultra short acting GABAA receptor agonist, can be used for sedation in invasive treatment such as colonoscopy and bronchoscopy.
The drug will have broad clinical application prospects in painless diagnosis and treatment sedation, general anesthesia, ICU sedation, local anesthesia sedation and other fields in the future, and provide clinicians with more drug choices.
06
Zebutinib capsule: a new drug of Baiji Shenzhou
On June 2, 2020, zebutinib capsule was approved by nmpa.
Zabutinib capsule (trade name: bayattze) is a selective inhibitor of Bruton's tyrosine kinase (Btk). It is used in adult patients with mantle cell lymphoma (MCL) who have received at least one treatment and adult patients with chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) who have received at least one treatment.
On November 15, 2019, zebutinib was approved by FDA of the United States, becoming the first anti-cancer new drug completely developed by Chinese enterprises independently and approved to go on the market by FDA, bringing a zero breakthrough for China's original research and development. The product will provide more choices for MCL patients and CLL / SLL patients when it is launched in China.
Currently, there are four Btk inhibitors on the market, including ibotinib, akatinib, zebutinib, and velexbru of Ono pharmaceutical.
07
1 new drugs for Silver Valley -- benzene, quetiaponium nasal spray
In March 17, 2020, phenyl quetiapine nasal spray was approved by NMPA.
Phenyl quetiaponium nasal spray (trade name: Bi Liting) is a selective M cholinergic receptor antagonist, which is used to improve the symptoms of rhinitis, nasal congestion, nasal itching and sneezing caused by allergic rhinitis.
BCQ nasal spray is the first internationally synthesized and highly selective M cholinergic receptor antagonist in China. It has been listed as a major tendering topic of the Beijing Municipal Science and Technology Commission. Because of its low toxic and side effects, safe use, wide range of people, it has a huge market prospect, and provides a new drug choice for patients with allergic rhinitis.
08
Ametinib mesylate tablets: a class 1 innovative drug of hausen pharmaceutical
On March 17, 2020, ametinib mesylate tablets were approved by nmpa.
Ametinib mesylate tablets (trade name: amiloride) are listed as epidermal growth factor receptor kinase inhibitors. They are used in adult patients with locally advanced or metastatic non-small cell lung cancer who have been treated with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) before or after treatment, and whose egfrt790m mutation is positive.
It is reported that as the world's second third-generation EGFR-TKI innovative drug, and the world's first third-generation EGFR-TKI with a median progression free survival of more than one year (second-line use), Amelia's listing provides clinicians with new choices and brings long-term and high-quality survival hope for more patients with advanced non-small cell lung cancer.
09
Keyingeling class 1 innovative drug: clopevir Hydrochloride Capsules
On February 11, 2020, clomivir hydrochloride capsule was approved by nmpa.
Clomivir hydrochloride capsule (trade name: kailiwei) is a kind of NS5A inhibitor. It can be used in combination with sofbuvir in the treatment of newly diagnosed or interferon treated adult chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis.
Clomivir hydrochloride capsule is the second domestic class 1 new drug for hepatitis C in China. Its marketing will help to increase the accessibility of domestic anti HCV drugs and meet the clinical drug demand.
In recent years, the state has constantly introduced policies to encourage drug innovation. There is no doubt that innovation and development is the general trend. At the same time, with the normalization of procurement with volume, generic drugs enter the era of low profit. Innovative drugs with high technical barriers have become the key direction of pharmaceutical research and development.
