PP-4 inhibitor is a new type of hypoglycemic drug, the mechanism of action is: by inhibiting the dipeptyl peptidase IV.
(DPP-4) and reduce the inactivation of GLP-1 in the body, so that endogenous GLP-1 levels increase, GLP-1 in a glucose concentration-dependent manner to increase insulin secretion, inhibit glucagon secretion, and then achieve the effect of
lowering blood sugar.
Due to its good safety and tolerability, and no obvious impact on body weight, it will not increase the risk of hypoglycemia and many other advantages, the clinical use of DPP-4 inhibitors has been increasing in recent years, and its market size is also expanding, attracting many local pharmaceutical companies to actively layout
.
The data shows that in 2021, the market size of DPP-4 inhibitors has exceeded 4 billion yuan, an increase of nearly 25% year-on-year, and it also presents a broad market prospect
overseas.
It is understood that in the domestic market, the currently listed DPP-4 inhibitor products include siglitine, vifiglitine, alogeliptin and lifiglitine, etc.
, which are basically preparations that need to be taken daily, in order to improve the dependence of patients, some local pharmaceutical companies are working hard to overcome the bottleneck of daily medication and reduce the frequency
of patient medication.
For example, Hisco recently announced that its two-weekly administration of long-acting DPP-4 inhibitor HSK7653 tablets has completed two Phase 3 clinical trials and achieved preliminary statistical analysis results
.
In both trials, more than 900 patients with type 2 diabetes mellitus were enrolled, and the trial results showed good clinical results and reached a preset endpoint
.
Hisco said that it will submit a listing application for HSK7653 tablets to NMPA as soon as possible in accordance with relevant regulations
.
If successfully approved for marketing, HSK7653 tablets will become the world's first hypoglycemic drug bi-weekly preparation, its hypoglycemic effect is safe, effective and stable, and the frequency of taking the drug once a week can ensure better medication compliance, which will hopefully provide a better choice
for the treatment of patients with type 2 diabetes.
In addition to Hisco, many local pharmaceutical companies are also actively deploying in this field, some are self-developed new drugs, some are generic drugs, and some are introduced through authorization to lay out product lines
.
Recently, CSPC Pharmaceutical Group announced that its subsidiary CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co.
, Ltd.
(SPC) has reached a preset endpoint in two key clinical trials of the new class 1 drug "plumaglistin tablets" (DBPR108 tablets) for the treatment of type 2 diabetes, and the Group intends to submit an application for
pre-market communication to the State Food and Drug Administration of China in the near future.
In March, Kelun Pharmaceutical announced that its DPP-4 inhibitor hypoglycemic drug "treglitine succinate tablets" was approved by
the State Food and Drug Administration for drug registration.
Trelogtin succinate tablets are a new ultra-long-acting oral hypoglycemic drug, originally researched from Takeda and Furiex, for the world's first weekly oral hypoglycemic drugs, providing diabetes patients with more convenient medication options, is expected to greatly improve the convenience and compliance of patients
.
Earlier, in October 2021, Huadong Pharmaceutical announced that it had signed an agreement with Takeda Pharmaceutical to acquire an exclusive commercialization interest in the Chinese mainland of the latter's listed innovative alogliptin benzoate tablets (trade name
: Nixinna ®).
After the completion of this transaction, Huadong Pharmaceutical will have a commercial interest in Nixinna ® in China, and Takeda Pharmaceutical will continue to be responsible for the production and supply
of Nixina ®.
Huadong Pharmaceutical said that the introduction of alogliptin benzoate tablets will further enrich the company's product pipeline in the field of diabetes, form a synergistic effect with the existing key varieties in the field of diabetes, and consolidate and enhance the company's market competitiveness
in the field of domestic diabetes specialty drugs.
It is worth mentioning that Huadong Pharmaceutical has frequent layout in DPP-4 inhibitors, and has already obtained the drug registration certificate of sitagliptin metformin tablets (I) (50/500mg) in November 2020, and siglitine metformin tablets (50/850mg) have also been declared for production
.
The data shows that the number of approved domestic DPP-4 inhibitor approvals is 73, involving 6 major products
.
With more and more pharmaceutical companies in this track layout, the industry believes that after 2022 or 2023, DPP-4 inhibitors will enter the era of
domestic Class 1 new drugs blowout.
In this context, the pharmaceutical companies that have laid out first may have more opportunities, and as domestic products are listed one after another, it will also change the situation of monopolizing the market by multinational pharmaceutical companies in the
past.
