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Recently, the status of the 5.
1 category import application of Takeda "Vonola Fumarate Green Tablets" (the relevant acceptance number is JXHS2000072/73) has been changed to "under approval" in the NMPA, and it is expected that the drug will be approved in China soon.
New adaptation Disease
.
Originally researched vonoprazan fumarate (Takecab), also known as voronolazan fumarate, is a potassium ion competitive acid blocker (P-CAB) discovered by Takeda.
It blocks H+, The K+ channel of K+-ATPase competitively blocks the binding of K+ to the enzyme, and can stay in the parietal cells for a long time, thereby quickly inhibiting the secretion of gastric acid
.
In February 2015, the drug was approved in Japan for the treatment of acid-related diseases, including reflux esophagitis, gastric ulcer, duodenal ulcer, and prevention during treatment with low-dose aspirin or non-steroidal anti-inflammatory drugs Recurrence of gastric ulcer or duodenal ulcer and eradication of Helicobacter pylori were launched in South Korea in July 2018
In China, the original research voronola fumarate was born in December 2019 and was approved by the NMPA for the treatment of reflux esophagitis under the trade name Walker
.
It is reported that in the first three quarters of 2020, Walker's sales in public hospitals in key domestic provinces and cities will be 110,000 yuan
In addition, Takeda has also submitted two other registration applications for voronolasan fumarate in the country, the relevant acceptance numbers are JXHS2000040/41 (CDE acceptance time is 2020/04/23) and JXHS2000072/73 (CDE acceptance time 2020/06/04), the specific indication is unknown
.
According to public information, the patent for the voronolasan fumarate compound expires on August 29, 2026, and the process patent expires on February 24, 2030
.
At present, many domestic enterprises have begun to deploy the voronola fumarate bio-generic drug market.
Moreover, Kefeiping Medicine has made an improved innovation based on the pharmacodynamic group of voronolasan fumarate.
The free base part of its structure is combined with acetic acid to form acetate.
The route of administration is changed from the original oral agent to the injection.
Voronolazan Acetate Injection was released
.
The drug is currently in Phase 1 clinical trials in China and is mainly used to treat peptic ulcer bleeding
P-CAB inhibitor Nuggets domestic acid inhibitor market
P-CAB inhibitor Nuggets domestic acid inhibitor marketAcid inhibitors are the basis for the treatment of acid-related diseases and play a key role in promoting mucosal healing and improving symptoms
.
From the H2 receptor antagonist (H2RA) that appeared in the 1970s, to the proton pump inhibitor (PPI) in the 1980s, to the potassium ion competitive acid blocker (P-CAB) Vonola that was launched in 2015 Health, acid suppression drugs have gone through three different eras
H2RA has a short duration of action, high recurrence rate, easy tolerance, limited control of acid secretion caused by food stimulation, and poor efficacy in relieving symptoms of gastroesophageal reflux disease (GERD) and eradicating Helicobacter pylori (Hp)
.
PPIs are the most widely used acid inhibitors in clinical applications, but they have the disadvantages of instability, short half-life, influence of CYP2C19 gene polymorphism, limited time of taking the drug, and slow onset of action
At present, 3 P-CABs have been approved globally, such as Takeda’s Vonolasan, Yuhan’s Revaprazan (Revaprazan) and CJ Healthcare’s Tegoprazan (Tegoprazan)
.
Among them, revaprazan is the first P-CAB approved in the world.
However, only one P-CAB of Voronola has been approved in China
.
However, Chinese pharmaceutical companies are also actively deploying the P-CABs market.
Among them, Yangtze River Pharmaceutical introduced Fexuprazan (non-Surazan) from the Korean biopharmaceutical company Daewoong Pharmaceutical in March this year, and Luoxin Pharmaceutical successively introduced it in October 2015.
In June and June 2021, Tigolasan tablets and injections were introduced from HK inno.
N Corporation (formerly CJHealthCare Corporation) in South Korea, and X842 was introduced from Ciclus Pharma.
Among them, non-surazan is in Phase 1 clinical trials in China.
, Tigolasheng tablets were reported for domestic production in January this year, and the relevant acceptance number is CXHS2000047.
X842 is in phase 3 clinical trials in China
.
In addition, China Kefeiping Pharmaceutical independently developed a new generation of P-CAB-Konolazan Hydrochloride (R&D code H008)
.
The drug is mainly used to treat duodenal ulcer, gastric ulcer, reflux esophagitis and Helicobacter pylori infection.
It is currently in Phase 3 clinical trials
.
Preclinical and clinical studies have shown that H008 has significant alternative advantages over PPI and H2 receptor antagonists.
It also shows better efficacy, pharmacokinetics and safety characteristics among similar P-CAB drugs.
It may be in the past 30 years.
The best P-CAB
.
PPIs are currently the drugs of choice for the treatment of acid-related diseases
.
It is reported that the market size of terminal PPI injections in public medical institutions in China in 2019 has reached 40 billion yuan, of which esomeprazole, rabeprazole, pantoprazole, omeprazole, lansoprazole and ipura Omeprazole occupies most of the market share, and esomeprazole, rabeprazole, pantoprazole, omeprazole and lansoprazole are the key varieties of centralized procurement because of their large dosage and high amount.
It has been included in the national and local collections respectively
.
Based on its own advantages and the approval of similar new products in the future, P-CABs are expected to pose a threat to PPIs and gradually seize its market share
.
