Event
On April 13, Shandong Luoxin Pharmaceutical Group Co., Ltd., a subsidiary of Luoxin Pharmaceutical Co., Ltd., received the "Drug Registration Certificate" of Tegolasheng tablet for reflux esophagitis approved and issued by the State Drug Administration.
Brief comment
P-CAB: a new generation of acid inhibition drugs, the mechanism of action is more advantageous. Tegolasheng tablets are potassium competitive acid blocking drugs (P-CAB). Different from proton pump inhibitors (PPI), which are the main acid inhibition drugs in the market, P-CAB can directly inhibit H+/K+-ATP enzymes with fast action, long action time, no need to be activated in strong acid environment, and can inhibit proton pumps in both resting and active states.
The approval of Tigola raw film further enriches China's P-CAB market.
Prior to this, only one P-CAB was approved in China, and in 2019, Vonolasheng in Takeda was approved for the initial treatment of reflux esophagitis (RE), and became the first choice for the treatment of RE recommended by "the consensus of experts on gastroesophageal reflux disease in China in 2020". The approval of Gorasheng tablets will further accelerate the process of P-CAB to replace PPI and expand the domestic P-CAB market space.
Consolidate the company's leading position in the field of digestion
Luoxin Pharmaceutical Co., Ltd. has always had a strong market competitiveness in the field of digestion. this time, the first class of new drugs for Gerasheng tablets were approved for listing, reflecting the company's technical advantages and layout in this field, enriching product pipelines and product reserves, and enhancing the company's core competitiveness.
Luoxin Pharmaceutical Co., Ltd. introduced Tegolasheng to lay out the domestic P-CAB market.
In 2015, Luoxin Pharmaceutical Co., Ltd. reached a cooperation agreement with South Korea's HK inno.N Corporation Company on the introduction of Tegolasheng films. Shandong Luoxin Pharmaceutical Co., Ltd. has won the exclusive right to develop, produce and commercialize the product in China. The project was approved for clinical trials in June 2017, and the results of the first phase III clinical study in 2019 reached the main end point.
Potassium competitive acid blockers (potassium-competitive acid blocker,P-CAB) are a new class of acid-suppressing drugs and are potential substitutes for PPI in the treatment of acid-related diseases. P-CAB reversibly binds to the K + binding site of H+/K+-ATP enzyme, simultaneously inhibits the active and resting H+/K+-ATP enzyme in the cell, and because of its acid stability, it can stay in the secretory tubule for a long time, thus continuously blocking the newly synthesized H+/K+-ATP enzyme, resulting in lasting acid inhibition.
P-CAB has obvious advantages and is expected to become the mainstream drug of acid inhibition.
China has a broad market for acid inhibitors, which is currently dominated by proton pump inhibitors (PPI). The market scale of PPI in 2019 is more than 30 billion yuan. With the change of life style and medication habits, the incidence of digestive acid-related diseases in China is increasing year by year. Excessive secretion of gastric acid can cause gastroesophageal reflux disease, peptic ulcer, Helicobacter pylori infection and other common diseases. PPI is a kind of drugs with the strongest inhibitory effect on gastric acid secretion. Omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole and aprazole are listed in China. As a new generation of reversible proton pump inhibitors, P-CAB is expected to bring new changes to the acid inhibitor market. Compared with PPI, it has the advantages of quick effect, long-lasting acid inhibition, convenient use and so on. With the collection of PPI in China and the upgrading of patients' treatment needs, P-CAB, as a better curative effect, has a broad alternative space.
To consolidate the company's leading position in the field of digestive tract, the company has always had a strong market competitiveness in the field of digestion in the future. This time, class 1 new drugs of Tegolasheng tablets have been approved to be put on the market, enriching the product pipeline and product reserve, enhancing the company's core competitiveness, and consolidating the company's leading position in the field of digestive system. At the same time, it reflects the company's technical advantages and layout in the field of digestive tract system P-CAB.
Clinical studies are under way on two other new indications of Tigorasheng tablets, of which phase Ⅲ clinical trials for indications for duodenal ulcers are under way; clinical trials for indications for the eradication of Helicobacter pylori infection in adults in combination with appropriate antimicrobial therapy have been approved, and two indications are expected to be approved for market around 2024. In addition, on June 23, 2021, Shandong Luoxin and HK inno.N Corporation reached an agreement for Gorasheng injection product to obtain the exclusive R & D, production and commercialization of the product in China. In the future, the new indications and injection forms of raw tablets for Gora will bring more performance contributions to the company.
Profit forecasts, valuations and investment advice
Luo Xin Pharmaceutical Industry is changing from a leader in the field of generics to an active leader in the field of digestion through imitation and creation combined with accumulated strength. We estimate that from 2022 to 2024, the company's operating income will be 6.814 billion yuan, 7.455 billion yuan and 8.347 billion yuan respectively, and the net profit will be 502 million yuan, 710 million yuan and 921 million yuan respectively, corresponding to 27, 19 and 14 times of PE. Coverage for the first time, giving a "overweight" rating.
Insurance reminder
Product sales are not as expected; product research and development fails or lags behind; core technical personnel change risk.
