According to the FDA, a drug granted first-in-class designation is a drug
that uses an entirely new and unique mechanism of action to treat a disease.
In recent years, with the release of a series of policies to encourage pharmaceutical innovation, more and more pharmaceutical companies with R&D strength in China, such as Legend Biologics, Inming Biologics, Hutchison Biologics, Junshi Biologics, Hengrui Pharmaceutical, etc.
, have gradually shifted from Fast follow to focus on the research and development
of first-in-class innovative drugs.
In the pharmaceutical environment where innovation has become the trend, a successfully developed first in class drug is often considered by the industry to bring high returns, highlighting the strength of Biotech and enhancing market competitiveness
.
However, recently, the first in class diabetes drug "Dopagliatin Tablets" has fallen in stock price after being approved for marketing, which has aroused the attention of
the industry.
According to public information, dopagliatin tablets were announced on October 8 for approval, and the drug is suitable for improving blood sugar control
in adults with type 2 diabetes.
According to reports, dozagliatin is a glucokinase (GK) activator, which acts on glucokinase targets in glucose storage and output organs such as islets, intestinal endocrine cells and liver, and improves blood glucose homeostasis imbalance
in patients with type 2 diabetes.
Public information shows that glucokinase (GK), as the first key enzyme of intracellular glucose metabolism, mediates the body's glucose perception and regulation, and is the key to the body's own glucose stability maintenance mechanism - blood glucose homeostasis autoregulation, and basic studies have shown that patients with type 2 diabetes mellitus (T2DM) generally have GK damage, resulting in abnormal blood glucose homeostasis autoregulation mechanism, impaired human body's own blood sugar regulation ability, and blood glucose homeostasis
.
GKA drug was once considered by the industry to be a sugar control drug with relatively large market prospects, and the number of diabetic patients in China is huge, which has increased from 90 million in 2011 to 140 million in 2021, and it is expected that this number will be as high as 175 million by 2045; and as a chronic disease, diabetics need almost lifelong medication
.
At present, Hua Medicine has signed a cooperation agreement
with United Complete Pharmaceutical on the commercial production of dopagliatin tablets.
In addition, as early as August 2020, Hua Medicine and Bayer reached a cooperation, and Hua Medicine is responsible for clinical development, registration, product supply and distribution as a drug marketing authorization holder
.
Bayer, as a marketing service provider, is responsible for marketing, promotion and medical education activities
of the product in China.
However, the performance of the capital market is relatively cold, as of the close of October 10, Hua Medicine Pharmaceutical's share price fell by 24.
11%; On October 11, the stock price continued to fall, falling by 19.
40%.
For the reasons for the overturn of the stock, some analysts believe that the domestic diabetes drug market is fiercely competitive, and there are currently nine categories of hypoglycemic drugs on the market, oral drugs include metformin, sulfonylurea secretagogues, gleniide secretagogues, thiazolidinedione (TZD), α-glycosidase inhibitors, DPP-4 inhibitors, SGLT-2 inhibitors, etc.
; Injectable drugs include GLP-1 agonists and insulin
.
The clinical data of dopagliatin tablets do not stand out, and the effect is quite controversial
.
This also warns other pharmaceutical companies that the research and development of first in class drugs needs to be patient-centered to meet unmet clinical needs, "The core purpose of innovative drug research and development is to bring better treatment options to patients around the world, rather than simply blazing a trail
in undruggable targets.
" ”
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