Sanofi's "tens of billions of heavyweights" or is it under siege?

Medical Network, March 15 News CSPC recently announced that Shanghai Jinmante Biotechnology Co.
, Ltd.
, a wholly-owned subsidiary of the company, entered into an agreement with Connoa Biomedical Technology (Chengdu) Co.
, Ltd.
("Kanoa Bio") , The content is about the exclusive authorized development and commercialization of the product CM310 in moderate to severe asthma and chronic obstructive pulmonary disease (COPD) and other respiratory diseases
.
CM310 is a recombinant humanized monoclonal antibody injection targeting human interleukin 4 receptor α subunit (IL-4Rα) with independent intellectual property rights developed by Connoa Biosciences
.
Specific to this target field, the direct target drug is Sanofi’s super heavy variety Dupixent (Dupilumab, Chinese trade name: Dabituo)
.
At the beginning of February this year, Sanofi announced its 2020 performance report.
Net income was 36.
04 billion euros, down 0.
2% year-on-year.
Dupixent is undoubtedly Sanofi's current most reliant product
.
In the Chinese market, in June last year, Dupixent was approved by the National Medical Products Administration (NMPA), and entered the medical insurance with a rapid price cut in the new round of medical insurance price negotiations.
The market promotion is at a critical stage of rapid expansion
.
However, similar to the PD-1/L1 market situation, IL-4R is also a key area where many local companies are intensively deployed
.
The review and approval of reforms and medical insurance payment reforms are "two-wheel drive".
The accessibility and affordability of local innovative drugs are improving.
Will Dupixent's IL-4R track also encounter PD- The same competitive scene in the 1/L1 field?
Import substitution pressure has increased.

Dupixent is a monoclonal antibody drug targeting IL-4R jointly developed by Sanofi/Regeneron.
Since it was first approved by the U.
S.
FDA in March 2017, Dupixent has shown amazing market explosiveness.

.
In Sanofi’s previous strategic planning, Dupixent, vaccines, R&D pipelines, and the Chinese market were jointly regarded as the four major strategic directions driving its future performance growth.
Sanofi set Dupixent’s peak sales target at "100 Billion euros"
.
In addition to atopic dermatitis in adults and children , Dupixent has been approved by the U.
S.
FDA in October 2018 as an indication for moderate to severe asthma in adults
.
In addition, chronic obstructive pulmonary disease (COPD) and other respiratory diseases also have a huge patient population and unmet needs
.
At present, China clinical trials are also progressing around Dupixent's respiratory disease indications such as asthma and COPD
.
In this announcement of CSPC, the exclusive rights and interests in the development and commercialization of CM310 respiratory diseases are important bargaining chips
.
According to the agreement between the two parties, Jinmante Biotech will obtain the exclusive right to grant the product from Connoa Biotechnology to carry out the product in the People’s Republic of China (excluding Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan) for these indications.
Developed and commercialized, and became a marketing authorization holder (MAH)
.
As of now, as an innovative product benchmarked with Dupixent, CM310 has been approved by clinical trials for the indications of moderate to severe asthma in China in July 2019, and phase II clinical trial research has been carried out.
In the future, it will be classified as category 1 of therapeutic biological products.
New drug declaration
.


Market analysis believes that, considering that Dupixent’s atopic dermatitis indications have been on the market, and will quickly enter medical insurance six months after the product is approved, Sanofi will invest huge resources in hospital admission and promotion of this product in the future, and strive to The segmented field "holds high" and builds first-mover advantage
.
However, local companies are investing more and more in R&D, and Fast-follow R&D strategies are being followed up faster and faster.
Whether it is in the field of atopic dermatitis or respiratory diseases, the impact of local me-too innovative drugs on imported innovative products will increase.
Big
.
There is no basis for making this judgment
.
After the approval of Opdivo and Keytruda in 2018, as a number of innovative products from local companies have been launched one after another, as represented by companies such as Hengrui Pharmaceuticals , BeiGene , Junshi Biological, and Xinda Biological , domestic PD-1s have been approved one after another.
In just a few years, the PD-1/L1 market has set off fierce competition.
After the domestic PD-1 entered the medical insurance, Merck and BMS had to substantially adjust the drug donation plan to challenge the market situation of similar domestic products entering the medical insurance by reducing prices in a disguised manner .
Nowadays, multinational corporations are accelerating the process of global innovative products entering the Chinese market.
However, the "pocket" of the National Medical Insurance Bureau cannot pay for expensive imported drugs for a long time .
It is not difficult to foresee that, in the context of the transformation and upgrading of China's pharmaceutical industry, China's local pharmaceutical companies continue to accumulate industrial innovation, and the pressure of local substitution of imported innovative drugs may continue to increase.
Multinational companies must more actively adapt to the rules of the game in the Chinese market .

　　The
reform of the local innovation and quality upgrade drug regulatory system continues to deepen, the number of new drugs reviewed and approved has increased year by year, and the competitive situation in the innovative drug market has become more and more complicated .
While the market opportunities that emerged in the special time window have received intensive attention from many companies, the threshold of clinical value of new drug research and development is gradually increasing.





.
Based on the significant clinical value of Th2 pathway in the field of autoimmune diseases, a number of new IL-4, IL-5, and IL-13 antibody drugs have been approved one after another.
There are already Dupilumab (IL-4R), Mepolizumab (IL-5) ), Benralizumab (IL-5R) , Reslizumab (IL-5) , including a variety of products
.
Specifically in the field of IL-4R, in addition to Connoa Biology, which has attracted much attention this time, there are also Conrad (CBP-201), Kangfang Biology (AK120), Hengrui Medicine (SHR1819), Quanxin Biology (QX005N) ), Sansheng Guojian (661), Maiji Biological (MG010) and other enterprises
.
Obviously, similar to the fight for the PD-1 market by "thousands of troops and horses", the future competition in the IL-4R market will also be extremely fierce
.
At the same time, every local market reshuffle in a subdivision field also tests the comprehensive strength of local pharmaceutical companies in terms of technology, team, execution, and innovation, so as to enable a group of highly potential innovative companies to achieve leap-forward development.
Eventually stand out
.
Pharmaceutical innovation and risks follow, just as Biotech has announced the termination of projects in three areas including PD-1, Trop-2, and HER2 in just one month.
In the future, local innovative companies will ultimately continue to rise and fall in the IL-4R field.
It is worth looking forward to
.
Industry insiders believe that the following R&D strategy is a stage of industry and enterprise development.
Whether it is generic drugs or me-too innovative drugs, it has achieved imports to a certain extent in terms of enriching clinical drug selection and improving drug availability.
Substitution provides an important guarantee for public health , but the core pursuit of higher-value medical innovation is to focus on unmet clinical needs
.
What is more noteworthy is that large local pharmaceutical companies have begun to see innovation opportunities in China’s pharmaceutical industry, and are actively embracing start-up biomedical innovation companies for resource integration and industrial chain cooperation.

.
In addition to CSPC, Hengrui Pharmaceuticals invested in Yingli Pharmaceuticals, Luye Pharmaceuticals acquired Boan Biology, and Huadong Pharmaceuticals invested in Quanxin Biologicals.
Industrial integration around local pharmaceutical innovations is accelerating
.