Shanghai Pharmaceuticals introduced a new antacid drug P-CAB for RMB 690 million, and the competitive landscape continues to be reshaped

On October 9, Shanghai Pharmaceuticals announced that its subsidiary Shanghai Xinyi and Guizhou Shengnuo signed an agreement to obtain the exclusive commissioned production and all adaptations of the raw materials and preparations of the new acid inhibitor X842 project in China with a transaction amount of 690 million yuan.

X842 is a potassium ion-competitive acid blocker (P-CAB), a new generation of acid-suppressing drug with a new mechanism.

01 Introduction to P-CAB drugs

Proton pump inhibitors (PPI) are an important class of drugs that inhibit gastric acid secretion, and are currently the strongest class of drugs that inhibit gastric acid secretion.

The clinical use of PPI drugs is huge

Although PPI occupies a dominant share in the field of acid suppression, there are pain points such as short half-life and insufficient acid suppression

In view of this, scientists have turned their attention to a new generation of acid-suppressing drugs-potassium ion competitive acid blocker (P-CAB)

Different from PPI, the advantages of P-CAB are mainly reflected in:

1.

2.

3.

4.

02 P-CAB competitive landscape

With the first dose of full effect, strong acid suppression and unaffected by meals, P-CAB drugs are gradually emerging

(1) Vonoprazan (Vonoprazan) is a potassium ion-competitive acid blocker, developed by Japan's Takeda Pharmaceutical

Chart: Voronolasheng's global sales (100 million yen)

Data source: Takeda Financial Report

In December 2019, NMPA approved the marketing application of Vonolasan for the treatment of reflux esophagitis under the trade name Walker

(2) Tegoprazan (LXI-15028, Tegoprazan) is a potassium ion-competitive acid blocker drug, originally developed by Pfizer, licensed to Raqualiapharma in 2008, and licensed to CJ Healthcare by Raqualiapharma in 2014 , Was finally successfully developed by CJ Healthcare in South Korea, and was approved for marketing by the Korean Ministry of Food and Drug Safety (MFDS) in July 2018

The phase III clinical study of ticolaxine-induced erosive esophagitis is a head-to-head trial with esomeprazole

In addition to tablets, Luoxin Pharmaceutical also deployed ticolaxan injections

(3) Konorrazan (H008) is developed by Kefeiping Pharmaceutical.
It takes effect quickly after oral administration, and has strong and long-lasting acid suppression with good safety
.
Two multi-center, randomized, double-blind, controlled Phase III clinical studies reached all endpoints.
The proportion of subjects who took orally 20 mg Konolazan tablets once a day was 94.
44 by endoscopy of duodenal ulcer healing within 6 weeks.
%; 95.
80% of the subjects whose reflux esophagitis healed by endoscopy within 8 weeks were 95.
80%
.
On September 30, 2021, Konolazan's listing application was accepted
.

(4) Fexuprazan is a potassium ion-competitive acid blocker (P-CAB), developed by Korea Daewong Pharmaceutical
.
The test results showed that the mucosal healing rate and tolerance of patients with erosive esophagitis treated with non-surazan for 8 weeks was good.
Compared with PPI inhibitors, non-surazan showed faster and better heartburn relief.
And this relief is maintained at night
.
In March 2021, Haini Pharmaceuticals, a subsidiary of Yangtze River Pharmaceuticals, introduced non-Surazan rights and interests in China at a maximum cost of RMB 2.
2 billion, and the Phase I clinical trial was launched in July 2021
.

03 Summary

Potassium ion-competitive acid blocker (P-CAB) can directly compete with K+ for binding sites on H+/K+-ATPase through ionic form, and inhibit the H+/K+-ATPase in both static and activated states at the same time, thus effectively Inhibit gastric acid secretion
.
With the first dose of full effect, strong acid suppression and unaffected by meals, the global sales of P-CAB drugs have maintained a good growth momentum against the background of continuous decline in sales of PPI inhibitors
.
In 2020, Vonolasan achieved global sales of 84.
8 billion yen, an increase of 16.
7% year-on-year, and has become an important increase in the acid suppression market
.

Focusing on the domestic market, Takeda Pharmaceutical's Vonuola was listed in December 2019 and is currently covered by medical insurance
.
Luoxin Pharmaceuticals, Shanghai Pharmaceuticals, Kefeiping Pharmaceuticals, and Yangtze River Pharmaceuticals all have in-depth deployments of P-CAB innovative drugs.
Among them, Luoxin Pharmaceuticals and Kefeiping Pharmaceuticals have submitted applications for the listing of P-CAB drugs.
Luoxin Pharmaceuticals Tigola's green film is expected to be the first to be listed
.
However, generic drugs may bring new challenges to this track.
More than ten companies such as CP Tianqing, Shandong New Times, and East China Pharmaceutical have deployed Vonolasheng's generic drugs.
Of course, considering that Vonolasheng is in China The patent will expire in 2026, and it is still difficult for generic drugs to have an impact on new drugs in the short term
.
In general, racing against time and accelerating the launch of innovative drugs may be the key to the Nuggets on the P-CAB track
.