Recently, Xinlitai issued a corporate announcement stating that the application for clinical trials of the innovative drug SAL0114 tablets independently developed by its company and intended to be used for severe depression has been accepted by the National Medical Products Administration
After being hit hard by centralized procurement, Xinlitai released a news about the new progress of innovative drugs that could see the light of boosting performance, and at the same time sparked heated discussions in the industry
Is the chance of following the AXS-05 medicine stable?Is the chance of following the AXS-05 medicine stable?
According to the inquiry of Yaozhi Patent Tong, SAL0114 tablet is a pharmaceutical composition containing duloxetine.
In the pharmaceutical composition, the mass ratio of deuterated dextromethorphan or its salt to duloxetine or its salt is 110 : 110
Due to its patent protection, more information about the SAL0114 film is not yet known, but careful netizens have found that the target of the SAL0114 film may follow is the AXS-05 of a listed company AXSM in the United States
AXS-05 is a new type of oral N-methyl-D-aspartate (NMDA) receptor antagonist used to treat depression and other central nervous system (CNS) diseases
It is worth noting that the AXS-05 drug combination is dextromethorphan and bupropion.
Like SAL0114 tablets, the composition contains dextromethorphan
Dextromethorphan is a non-competitive NMDA receptor antagonist with antitussive effect.
Later studies have found that it may have antidepressant effects; bupropion is a norepinephrine and dopamine reuptake inhibitor and a Nicotinic acetylcholine receptor antagonists can increase the bioavailability of dextromethorphan
The duloxetine in Xinlitai SAL0114 has the same mechanism of action as bupropion.
It is NA (norepinephrine) and 5-HT (5-triptamine).
It was once a blockbuster anti-inflammatory agent originally developed by Eli Lilly.
One of the depressive drugs
It is worth noting that AXS-05 received a breakthrough therapy in 2019, and NDA was given priority review by the FDA in 2020, which once caused AXSM's stock price to soar
However, in August this year, the company received a letter from the FDA regarding its NDA-stage product AXS-05, stating that it was defective.
AXSM has resubmitted the application after rectification.
No surprises, it is expected to be approved in April next year.
According to public data, there are currently more than 350 million depression patients in the world, and China accounts for more than a quarter of the total number of patients, and the growth rate is very fast.
The current global market size has exceeded tens of billions of dollars, and it is expected to be 2030 , The overall market size of antidepressants in China alone will exceed RMB 20 billion
It is also worth mentioning that clinical antidepressants have undergone several generations of updates.
Both the widely used serotonin inhibitors or norepinephrine inhibitors have slow onset of action, and side effects that may aggravate symptoms two weeks before the medication.
, Increase the risk of suicide; and AXS-05 is a brand-new mechanism of antidepressant action, which takes effect quickly and greatly reduces the problem of aggravation of pre-symptoms
Once AXS-05 is on the market, it will be a replacement for the current antidepressant drugs
Therefore, Xinlitai SAL0114 tablet is developed following AXS-05, and it is very likely to become a better follow drug, and the probability of being a drug is greatly improved.
If it goes smoothly, it may shorten the time to market and become a "magic drug" in the domestic independent research and development of new antidepressant drugs.
"Sell, sell, sell," and "buy, buy, buy," aggressively attack innovative drugs, will "bottom out"?"Sell, sell, sell," and "buy, buy, buy," aggressively attack innovative drugs, will "bottom out"?
Returning to the Xinlitai company itself, in recent years, Xinlitai has suffered serious setbacks, but it has maintained intensive cultivation of chronic disease drugs, continued to innovate and research and developed, and has successfully transformed into an innovative drug company
SAL0114 is not the first innovative drug for chronic treatment in its layout
As we all know, Xinlitai originated from "Taijia", a chronic cardiovascular drug.
The revenue of generic drugs was once comparable to Hengrui Pharmaceuticals
However, with the reform of medical policies, centralized procurement of medicines, and the rise of innovative biological drugs in China; Xinlitai, as a "die loyal fan" of centralized procurement, has appeared in the past 6 batches of centralized procurement.
, And some of its varieties have won the bid, but at the same time, its performance has declined due to the failure of its core product "Taijia" in the 4+7 volume procurement and other factors, which forced its innovation and transformation
To this end, Xinlitai has launched various "sell-off-sell" models to withdraw funds while slimming down generic drugs
In December 2020, Xinlitai signed an agreement with Langu Pharmaceutical to transfer all its rights and interests in erlotinib hydrochloride and rivaroxaban products in mainland China; in October 2020, Xinlitai and Tianfang Pharmaceutical Signed a technology transfer contract to transfer all rights and interests of Dapoxetine Hydrochloride in mainland China, including but not limited to product research and development, production, sales, marketing, and related patents declared for 28 million yuan.
While increasing the layout of innovative research and development, "buy, buy and buy", aggressively attack innovative drugs
Some time ago, Xinlitai cost 27 million US dollars to introduce a long-acting hypoglycemic drug-signed an agreement with South Korea D&D, and obtained the exclusive license for the intellectual property rights and technical information of the innovative drug DD01 owned by D&D in mainland China.
According to the semi-annual report, there are currently 44 research projects, including 25 chemical drugs (including 16 innovative projects and 9 generic drugs under review); 12 biological drugs (including 7 innovative projects), of which 5 have entered Phase III clinical research phase
Xinlitai's main research drug projects and clinical progress
Data source: Semi-annual report, compiled by Yaozhi.
Innovative R&D pipelines are abundant, and R&D is inseparable from R&D investment.
In recent years, Xinlitai has increased R&D investment.
In the first half of 2021, R&D investment was 331 million yuan, accounting for 24.
05% of revenue, a year-on-year increase of 39.
Overview of Xinlitai R&D investment over the years
Image source: Yaozhi Data
Nowadays, a blockbuster drug SAL0114 with a high probability of being a drug has been approved for clinical application, and with its rich R&D pipeline layout, Xinlitai may be an underestimated silent farmer.
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Public information such as corporate announcements