The market prospect of new drugs for renal anemia is considerable, and domestic pharmaceutical companies are actively layout

【Pharmaceutical Network Industry News】China's chronic kidney disease patients (CKD) up to more than 130 million, an average of one in every 10 people, the disease has become an important public health problem in China, and renal anemia is a common complication of chronic kidney disease, the main reason for its occurrence is the gradual loss of kidney function, resulting in a decrease in erythrocytotropin
.
At present, the main means of treatment for renal anemia are erythropoietin (EPO) and iron
.
Clinical commonly used is EPO for the treatment of CKD anemia, EPO drugs can be divided into ordinary and long-acting type, the current global marketing of long-acting erythropoietin preparations include alfadabupotin, methoxypolyene glycol recombinant human erythropoietin, etc.
, and China's marketed long-acting erythropoietin preparations are Nesbao (daypoetin α injection), the product was approved for marketing in June 2020, achieving the first breakthrough of long-acting EPO in the field of renal anemia in China, bringing new choices for the treatment of patients with renal anemia in China
。 In recent years, with the continuous research and exploration of the pharmaceutical community, it has been found that oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) are more flexible through oral administration, and can avoid injection-related pain and discomfort, and the production cost is lower than EPO, which has outstanding
advantages.
In China, AstraZeneca carried the original product of HIF-PHIs of Vabojin to enter the Chinese market in December 2018, and the product officially entered the Chinese medical insurance catalog
after negotiations in 2019.
The 2021 version is restricted to anemia caused by chronic kidney disease, including dialysis and non-dialysis patients
.
Salubris mentioned in a survey in October this year, "HIF-PHI products have a good prospect in China, and the cumulative sales of the listed rofloxostat exceeded 1.
5 billion yuan as of the end of June 2022, an increase of 46% in the first half of this year compared with the fourth quarter of last year and 94%
compared with the first half of last year.
" Some insiders predict that with the continuous launch of new products such as HIF-PHIs, the market penetration rate continues to increase, which is expected to gradually erode the EPO market
.
At present, many domestic pharmaceutical companies are also laying out this market, including new drugs and generic drugs
.
For example, many pharmaceutical companies are challenging the research and development
of roxadustat.
In October, Tongyuan Pharmaceutical said on the interactive platform that the company's research product roxadustat project is still in the pharmaceutical research stage, and if it obtains drug production approval, the company will fulfill its information disclosure obligations
in a timely manner.
Baihua Pharmaceutical also replied to investors on the investor relations platform in September that it has recently successfully challenged the patent of roxadustat capsule crystal form, and the project is currently undergoing research and development
.
On November 9, according to the clinical trial database of Wurongyun China, the HIF-PHI targeted new drug - HEC53856 tablets independently developed by Dongguang Pharmaceutical announced a new clinical trial for healthy subjects, and the experimental professional item was the [14C]NT-001 (HEC53856) clinical trial
of substance balance in healthy subjects.
The breed received clinical implied license on June 22 this year for the treatment of anemia associated with chronic kidney disease, including dialysis and non-dialysis patients
.
In addition to tablets, Dongguang Pharmaceutical also has self-developed class 1 new drug HEC53856 capsules intended for the treatment of anemia associated with chronic kidney disease, including dialysis and non-dialysis patients
.
The product was submitted by the company to CDE in August 2018 for the Class 1 clinical application of Chinese Pseudonym, and was licensed for clinical trial
by default in November 2018.
It is reported that the product also has a number of phase 1 clinical trials for renal anemia in progress
.
FOR EXAMPLE, IN JANUARY THIS YEAR, SALUBRIS SUBMITTED A CLASS 3 GENERIC DRUG APPLICATION FOR ENNALASTAT TABLETS, WHICH WAS INTRODUCED BY THE COMPANY FROM JAPAN TOBACCO INC.
IN DECEMBER 2019, AND IS EXPECTED TO BECOME THE FIRST TWO HIF-PHI DRUGS
LISTED IN CHINA.
It is reported that compared with the existing therapy, enaldustat tablets have a clear mechanism to improve anemia, which can not only promote the production of endogenous erythropoietin, but also improve the utilization of iron; It also has good safety and efficacy, which can significantly improve patient compliance
.
In addition, there are also HIF-PHIs drugs such as AND-017 of Hangzhou Andao Pharmaceutical and SSS-17 of Shenyang 3SBio Pharmaceutical in China, and some have reached the clinical phase II stage
.
If clinically successful, more new treatment options
will be available for patients with renal anemia after marketing.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.