Generic drug competition continues to intensify, how should pharmaceutical companies avoid "internal rolls"

【Pharmaceutical Network Market Analysis】Due to the late start of China's modern pharmaceutical industry, most of the pharmaceutical enterprises in China are still dominated by
generic drugs.
According to the "Blue Book of Generic Drugs in China", the size of China's generic drug market in 2019 is about 970.
7 billion yuan, and although the overall market size of generic drugs in 2020 has fallen to 808.
7 billion yuan due to the impact of the epidemic, the proportion of generic drugs is as high as 63%, and the market share of generic drugs is still increasing
。 Generic drug competition continues to intensify, how should pharmaceutical companies avoid "internal volume" (picture source: pharmaceutical network) It should be noted that although the generic drug market has broad prospects, with the landing of a series of medical reform policies, the overall pattern of China's pharmaceutical market is accelerating, generic drugs are lowering, and the intensification of competition has become the trend of the times
.
So in such an "inward" environment, how should pharmaceutical companies respond? In this regard, analysts pointed out that pharmaceutical companies should first transform to innovation; Second, it is necessary to accelerate the promotion of consistency evaluation; In addition, it is also necessary to accelerate the "going to sea"
of products.
It is understood that in recent years, a large number of generic drug companies are transforming to innovative drugs, and under the vigorous development, the impact of the generic drug collection policy on its performance is gradually fading, and the results of innovation transformation have begun to appear
.
For example, Hengrui, which has increased R&D investment and bet on innovative drugs in recent years, by the end of 2021, 10 innovative drugs have been approved for listing in China, more than 60 innovative drugs are under clinical development, and more than 250 clinical trials have been carried out
at home and abroad.
In the first half of 2021, the company's revenue proportion of innovative drugs has reached 42.
3%, an obvious
increase over the previous year.
In addition, Kelun Pharmaceutical, which once started with generic drugs, is also making efforts to innovate and transform
.
The company has more than 50 innovative large and small molecule projects, promoted 12 innovative clinical projects, and developed 9 innovative preclinical stage projects and more than 30 drug discovery stage projects
.
Of course, not all pharmaceutical companies have the strength to transform to the direction of innovative drugs, so the industry suggests that pharmaceutical companies can also make efforts towards high-end generic drugs
.
It is reported that in recent years, Puli Pharmaceutical has adhered to the manufacturing positioning of high-end generic drugs, and has made a lot of gains
.
For example, Puli Pharmaceutical issued an announcement on September 5 that two drugs of the company recently obtained the registration approval issued by the State Food and Drug Administration
.
Among them, pantoprazole sodium for injection is suitable for acute upper gastrointestinal bleeding
caused by duodenal ulcer, gastric ulcer, acute gastric mucosal lesions, complex gastric ulcer, etc.
Terlipressin injection is a synthetic long-acting vasopressin that is mainly used to treat esophageal variceal bleeding
.
It is reported that the teripressin injection developed by Puli Pharmaceutical is the first imitation in China
.
Industry analysts believe that low-end generic drugs are gradually being eliminated by the market or replaced
by high-quality products.
Therefore, generic drug companies can achieve transformation and upgrading by building technical barriers, and target high-end generic drugs, first generic drugs, improved new drugs or biosimilars with significant characteristics such as greater technical difficulty, small competition and high profits
.
Consistent evaluation of generic drugs refers to the quality consistency evaluation of generic drugs that have been approved for marketing, in stages and batches, in accordance with the principle of consistency with the quality and efficacy of the original drug
.
At present, in the context of the normalization of collection, the evaluation has obviously become the "admission ticket" for generic drugs to participate in the collection
.
Since the beginning of this year, domestic pharmaceutical companies have been accelerating the evaluation of the quality and efficacy consistency of generic drugs, and the news of the evaluation has also continued to come
.
For example, some time ago, Shuangcheng Pharmaceutical announced that the company's 4 classes of generic drugs tripreline acetate injection were approved for production and regarded as over-evaluated, ranking first in China
.
On August 10, the State Food and Drug Administration information shows that Huahai Pharmaceutical's 4 classes of generic drugs Duloxetine hydrochloride enteric-coated capsules and sitagliptin phosphate tablets were approved for production and regarded as the same evaluation At present, from the public information of various pharmaceutical companies, pharmaceutical companies such as Yangtze River, Qilu, China Biopharmaceutical, CSPC, and Hengrui have performed very positively
in the evaluation.
Among them, as of April 22 this year, Yangtze River Pharmaceutical has 105 varieties have been evaluated, which are mainly concentrated in the treatment areas
of systemic anti-infective drugs, anti-tumor and immunomodulators, digestive system and metabolites.
In addition, it is worth mentioning that there are 25 winners
.
In fact, under the background of the intensification of the "internal volume" of the domestic generic drug market, the pace of international development of domestic generic drugs "going to sea" has long been accelerating
.
For example, in recent years, Hengrui has spared no effort to implement the internationalization strategy
.
One of the three paths to its "internationalization" development is about generic drugs
.
Hengrui has said that it will continue to accelerate the pace of FDA and EU certification of generic pharmaceutical preparations, and strengthen the global sales
of domestic preparations with the export of preparations that have reached the international advanced level through European and American certification.
It will also promote the registration and sales of key varieties in the European, American and Japanese markets, strengthen the registration of other emerging markets, and strive to raise the company's overseas sales to a new level
.
According to the data, Hengrui's foreign revenue in 2021 accounted for 2.
39%.

However, it should be noted that although China's generic drugs are accelerating, the challenges they face are increasing, and competition is intensifying
.
Therefore, how to choose the sales model of the approved products in the future, and how to quickly solve various regulatory problems after listing, etc.
, also need further consideration
.
Disclaimer: Under no circumstances does the information herein or the opinions expressed in this article constitute investment advice
to any person.