The continuous evolution of the old and new in the pharmaceutical industry will play the two strong voices of the development of pharmaceutical equipment

There is only about half a month left in 2021.
Looking back on this year, the internal structure of the pharmaceutical sector has clearly differentiated.
For example, the CXO, in vitro diagnostics, and biological products sectors have all achieved rapid growth.
The Chinese medicine sector has also grown rapidly, and the medical device sector The growth rate of the sector has slowed down
.
Looking forward to 2022, some securities firms have pointed out that in the post-epidemic era, new and old iterations of the domestic pharmaceutical industry are in the ascendant, and "internationalization" and "innovation" will become the strong voices of the era of the development of pharmaceutical equipment
.
The continuous evolution of the old and new in the pharmaceutical industry will play the two major developments of pharmaceutical equipment (picture source: Pharmaceutical Network) In fact, judging from the actions and transformation directions of domestic pharmaceutical equipment companies in recent years, it is also centered on "internationalization" and "innovation.
" These two points are unfolding
.
In medicine, innovation is still the main theme
.
In terms of policies, a series of medical reform policies in recent years, including consistency ratings, centralized drug procurement, medical insurance control fees, and speeding up the review and review of new drugs, have continued to force the transformation and upgrading of the pharmaceutical industry, and the country has ushered in a major trend of innovation.
Against this background, many traditional pharmaceutical companies are gradually increasing R&D investment, transforming from focusing on generic drugs to high-end generic drugs and innovative drugs
.
On November 10, the "Annual Report on the Current Status of Clinical Trials in China's New Drug Registration 2020" published by CDE showed that in 2020, a total of 2,602 clinical trials were registered in China, an overall increase of 9.
1% compared with 2019
.
Among them, clinical trials of innovative drugs accounted for more than half, up to 57%
.
Since 2021, the enthusiasm for domestic pharmaceutical innovation and R&D has remained high.
As of December 8 this year, there were 782 new drug varieties approved for clinical trials in China in early 2021, involving more than 500 companies
.
Among them, Hengrui Medicine has submitted 31 clinical trial applications in the first nine months of this year, and has obtained 23 approvals
.
In the first half of 2021 alone, 5 new drug applications were approved, which is close to the number of approvals for the entire year of 2020
.
In terms of internationalization, there are more and more cases of cooperative transactions between domestic innovative pharmaceutical companies and overseas pharmaceutical companies
.
In 2020, the number of blockbuster products for the license out of domestic innovative pharmaceutical companies will be 12.
Entering 2021, license out will be more frequent.
According to data, from the beginning of 2021 to August, the number of overseas authorized projects of domestic innovative pharmaceutical companies has exceeded 30
.
At the same time, the amount of overseas authorized transactions of domestic innovative drugs has also continued to set new records.
For example, on January 12, 2021, BeiGene and Novartis reached an agreement on the development, production and commercialization of tellizumab in multiple countries.
In cooperation and licensing agreements, BeiGene obtained a total transaction value of more than US$2.
2 billion
.
In August of this year, Rongchang Biotech’s new ADC drug vedicituzumab authorized Seattle Genes for a transaction amount of US$2.
6 billion, including a US$200 million down payment and a milestone payment of up to US$2.
4 billion
.
In addition, many domestically produced innovative drugs are actively challenging to apply for FDA listing
.
For example, in March 2021, Junshi Biotech stated that Teriplimumab has submitted a marketing application to the US FDA, making it the first domestic anti-PD-1 monoclonal antibody to submit a new drug marketing application (BLA) to the FDA
.
Subsequently, domestic PD-1 monoclonal antibody companies represented by BeiGene and Innovent Biotech also submitted their respective PD-1 monoclonal antibody product listing applications to the FDA
.
On May 18 this year, the PD-1 inhibitor Sintilizumab BLA jointly developed by Cinda Biosciences and Eli Lilly Pharmaceuticals was approved by the US FDA and entered the formal review stage.
Sintilizumab has also become the first complete product.
China's independent research and development of innovative biological drugs that have been accepted by European and American regulatory agencies and entered the formal review stage
.
Some organizations believe that the 2022 meeting will be the "first year of internationalization" for domestically produced PD-1 monoclonal antibodies
.
In terms of equipment, the centralized procurement policy has gradually affected the industry structure
.
On November 5, 2020, the national centralized procurement of coronary stents was launched.
The centralized procurement of coronary stents reduced the stents with an average price of 13,000 yuan to hundreds of digits, opening the prelude to the reform of the national centralized procurement system for high-value medical consumables
.
Subsequently, centralized procurement in the field of orthopedics followed one after another
.
On September 29, 2021, the notice of the "14th Five-Year" universal medical security plan was released
.
The plan proposes that the state organizes centralized drug procurement in a normalized and institutionalized manner, and continues to expand the scope of centralized procurement of high-value medical consumables organized by the state
.
Under the background of the normalization of centralized procurement, the industry believes that the 135 billion yuan high-value medical consumables industry will face reshaping and cut off the sales of surrogates
.
In this context, device companies need to speed up innovation and transformation, and reduce the pressure and risks that are brought to companies due to centralized procurement and price cuts
.
At the same time, internationalization is also a major direction for future breakthroughs in domestic equipment
.
The industry predicts that under the impetus of innovation and the impact of the epidemic, China's medical device exports have doubled, and the pattern of at least 1/3 of the localization rate of products less than 50% is expected to be changed
.
At present, in response to the impact of centralized procurement, many equipment companies have actively transformed themselves
.
For example, a person from Lepu Medical said in an interview with the media that the company continues to develop and promote new products to market, and build product innovation portfolio solutions.
As the company's core products continue to grow, the contribution of a single product to sales will gradually decrease.
Try to minimize the impact of centralized procurement on the company; on the other hand, the company actively promotes its internationalization strategy and effectively reduces the risks caused by domestic centralized procurement policies through the globalization of products
.