Innovation is on the way!

2021, which is about to end, will be another year when the achievements of innovative drugs will shine
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According to incomplete statistics, China’s National Food and Drug Administration (NMPA) approved at least 61 new drugs (excluding new indications, improved new drugs, biosimilar drugs, traditional Chinese medicines, and vaccines) this year, of which 25 were imported from China.

36 new drugs (according to the acceptance number)

This year, China’s National Food and Drug Administration (NMPA) approved at least 61 new drugs

Among these approved new drugs, we see that some of the world’s leading innovative technologies have achieved breakthroughs from 0 to 1 in China, such as CAR-T products and antibody-conjugated drugs (ADC); drug development in the post-new crown era Another breakthrough, the first new crown neutralizing antibody combination therapy was born in China; whether it is independent research and development or cooperative introduction, more innovative results are reaching patients at a faster speed
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1.
These cutting-edge technologies have achieved breakthroughs from 0 to 1

1.
These cutting-edge technologies have achieved breakthroughs from 0 to 1

In the past 20 years, the development of life sciences and new drug R&D technology has promoted many innovative therapies to clinical applications, such as cancer immunotherapy, ADC, CAR-T products, RNAi therapy, mRNA technology.
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In China, these cutting-edge technologies are accelerating the pace of development , Bring more clinical benefits to patients
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Among them, the revolutionary tumor treatment program CAR-T products will be launched in China in 2021
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This product is genetically engineered to transform the patient's own T cells, making them a powerful weapon against cancer, and is expected to bring long-term relief and even hope of clinical cure for patients

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CAR-T, a revolutionary tumor treatment program, will be launched in China in 2021

In June 2021, China ushered in the first ADC product independently developed by a local Chinese company

▲Schematic diagram of antibody conjugated drugs (picture source: produced by WuXi AppTec's content team)

▲Schematic diagram of antibody conjugated drugs (picture source: produced by WuXi AppTec's content team)

In addition, some innovative drugs will achieve new breakthroughs in a certain field in China in 2021
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For example, the "first-in-class" new drug Tatacept developed by Rongchang Biological , which has a new drug structure and dual-target mechanism of action, is the first treatment for systemic lupus erythematosus (SLE) approved for marketing in China in more than 60 years.

Of Chinese indigenous new drugs

"First-in-class" drug Thai it Sipp who Wolfowitz imatinib, which is China's first approved selective MET inhibitor

At the same time, we see that there are many global forefront of innovative technologies are being developed, such as dual / multi-specific antibody, CRISPR gene therapy products editing, oncolytic viruses, mRNA therapy, targeted protein degradation therapy
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It is hoped that these new technologies will continue to open up the boundaries of new drugs, thereby benefiting a wider group of patients

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2.
After the vaccine, the development of new crowns and new drugs "breaks the game"

2.
After the vaccine, the development of new crowns and new drugs "breaks the game"

The arrival of the new crown epidemic disrupted people's lives and silently changed the world
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But challenges and opportunities always coexist

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In China, a variety of inactivated vaccines and adenovirus vaccines have been widely used to prevent new coronavirus infections and have contributed to the fight against the epidemic
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In the post-new crown era, scientists are still making unremitting efforts to develop drugs for COVID-19

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It marks that Chinese biomedical companies and researchers have finally achieved a "zero" breakthrough in the research and development of new crown neutralizing antibodies

This therapy took less than 20 months from initial laboratory research to approval
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This is the value of real concentration

3.
Accumulation and development, China's "Biotech" accelerates growth

Among the new drugs approved in 2021, we have also seen the rapid growth of Chinese biomedical companies
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Many Chinese "Biotech" in the clinical stage, with the approval of the company's first new drug, have successfully advanced to "Biopharma" with commercial products
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For example, after more than ten years of development, Yasheng Pharmaceutical , which was established in 2009, ushered in the first approved new drug-oribatinib in November 2021.
This is also the first new drug developed by a Chinese company.
The third-generation BCR-ABL inhibitors have brought new treatment options to patients with specific chronic myeloid leukemia
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In addition, Yasheng Pharmaceutical has also established a global cutting-edge product pipeline in the field of new drug development in the apoptosis pathway
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Established in 2009, Yasheng Pharmaceutical

For another example, Kangfang Bio , established in 2012, has been deeply involved in the development of innovative antibody drugs for many years
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In August 2021, the company's first innovative drug, Piampril, jointly developed by the company and CP Tianqing, was approved in China
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This is a differentiated anti-PD-1 monoclonal antibody, which uses a more stable IgG1 antibody form, which is expected to reduce the risk of adverse reactions such as fever after treatment
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The company's other potential "first-in-class" bispecific antibody AK104 has also entered the listing application stage
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Founded in 2012, Kangfang Bio

The rapid growth of companies such as Yasheng Pharmaceutical and Kangfang Biological is an excellent example of the rapid development of many Chinese innovative drug companies and the achievement of research and development results, which truly benefit patients
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Public information shows that in 2021, there will also be Deqi Pharmaceuticals XPO1 inhibitor Celiniso, the new real biological AIDS drug Azivudine, Mengke Pharmaceuticals new anti-infective drug Contizolamide, and Zejing Pharmaceuticals multi-target anti-tumor The drug Donafinil, the PD-L1 inhibitor envolimab which can be injected subcutaneously by Sidi Medicine/Kang Ning Jereh, and the new crown neutralizing antibody combination therapy of Ambavir Mab/Romivirimab, Yuheng Bio-anti-PD-1 antibody Sepalizumab and Huahao Zhongtian epothilone anticancer drug Utidelon are the first new drugs approved by these companies
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And these "firsts" are just a starting point, and more new generations of innovative therapies are being bred and grown in their product pipeline
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These "firsts" are just a starting point, and more new generations of innovative therapies are being bred and grown in their product pipeline
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Of course, the rapid development of these companies is inseparable from the assistance of policy guidance, talent accumulation, capital support, and the empowerment of industrial partners.
These are also indispensable elements in a complete biomedical ecosystem
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Take the third-generation BCR-ABL inhibitor Orebatinib approved by Ascent Pharmaceuticals this year as an example.
In 2018, the company began to cooperate with WuXi AppTec's wholly-owned subsidiary Hequan Pharmaceuticals on this project
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With the help of industry-leading technology platform and scale advantages, as well as the quality system in line with international standards, Hequan Pharmaceutical has saved precious time for the application and approval of the oribatinib project.
Hequan Pharmaceuticals is still providing services for the project.
Full support
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At the same time, some innovative drug companies have achieved a number of new drugs on the market in 2021
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For example, BeiGene brought four new drugs, including PARP1/2 inhibitor Pamipali and IL-6 inhibitor Stuximab, to Chinese patients during the year
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Another example is CStone Pharmaceuticals, which successively approved three innovative anti-cancer drugs in China during the year: RET inhibitor pratinib, precision targeted drug avatinib, and anti-PD-L1 monoclonal antibody sugarizumab
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There is also Rongchang Biological, which has obtained approval for two innovative drugs, the new SLE treatment drug Tatacept and the innovative ADC therapy vedicitumumab, in 2021
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These products are either independently developed or imported from overseas.
In either case, it shows that Chinese companies are playing a more important role and contributing more power in accelerating the process of new drugs to benefit patients
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4.
Multi-pronged approach to help patients with innovative drugs have access

4.
Multi-pronged approach to help patients with innovative drugs have access

In recent years, the intensity and achievements of China's drug regulatory reforms are obvious to all
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For example, the implementation of accelerated channels such as priority review, conditional approval, breakthrough treatment varieties, etc.
, enables "special" review of innovative drugs, orphan drugs, children's drugs, and clinically urgently needed new drugs
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In our statistics this time, the proportion of products that have been accelerated to market through special channels such as priority review and conditional approval accounted for nearly 78.
7%
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Nearly 78.
7% of products that have obtained accelerated approval to go on the market through special channels such as priority review and conditional approval
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Among them, accelerating the review and approval of overseas new drugs that are urgently needed in clinical practice has become one of the priorities of the NMPA Drug Evaluation Center in recent years
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According to incomplete statistics, 2 021 there were at least 10 models in urgent need of foreign clinical drug approved in China , such as Amgen (Amgen) A Pumi Sterling psoriasis drug, Takeda (Takeda) hereditary angioedema and drug Icatibant New drug for Gaucher's disease, Verazilase α for injection, Astellas new drug for acute myeloid leukemia, geritinib, Sanofi (Sanofi) new drug for hemophilia B, Ainocoagulin α for injection, Bojian ( Biogen) two new multiple sclerosis drugs, dimethyl fumarate and fampridine sustained-release tablets, and Kyowa Kirin targeting FGF23 brosoyuumab
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2 021 there were at least 10 models in urgent need of foreign clinical drug approved in China

In addition, many innovative overseas products have also come to Chinese patients this year, such as Roche's IL-6 monoclonal antibody drug satrizumab, oral SMA therapy risporan, and the new flu drug Mabalol Shawei, etc.
, Novo Nordisk's once-a-week diabetes drug smeglutide, etc.
, Novartis anti-CD20 monoclonal antibody ofatumumab, etc.
, Pfizer's new ADC therapy Ogai Tocilizumab, antifungal isaconazole, etc.
, Bristol-Myers Squibb (BMS) CTLA-4 inhibitor ipilimumab, GlaxoSmithKline (GSK) anti-IL-5 monoclonal antibody mepolizumab Anti-HIV dual-drug therapy, dolutegravirlamivudine, etc.
, Bayer's androgen receptor inhibitor dalotamide, Sun Pharma's SMO inhibitor solidji phosphate, Tanabe Mitsubishi (Mitsubishi Tanabe) DPP-4 inhibitor titagliptin hydrobromide, etc.
, I won’t repeat them here
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At the same time, a number of innovative products imported from overseas authorized by Chinese companies will also be approved in China in 2021
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For example, BeiGene introduced stuximab for injection of IL-6 inhibitor, GD2 targeting antibody dtuximab β, and carfilzomib for injection of second-generation proteasome inhibitors, which are precisely introduced by CStone.
The anti-cancer drugs pratinib and avatinib, the new anti-infective drug omacycline tosylate introduced by Zai Lab, the new anti-cancer drug repetinib, the XPO1 inhibitor Celiniso introduced by Deqi Pharmaceutical, etc.

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All of the above means that Chinese patients are using global new drugs faster and faster
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A variety of innovative products imported from overseas authorized by Chinese companies All of these mean that Chinese patients are getting faster and faster to use global new drugs
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In terms of local innovations, the following are approved in China in 2021: Hengrui Pharmaceuticals TPOR agonist Hytropopaethanolamine, Aidi Pharmaceuticals' new AIDS drug Ainovirin, Hisun Pharmaceuticals' new cholesterolemia drug Haibomaibu, Hausen Pharmaceuticals new chronic hepatitis B drug imitinofovir, Renfu Pharmaceuticals new narcotic drug propofol disodium phosphate, Iris Pharmaceuticals third-generation EGFR-TKI vometinib, Shenzhou cell hemophilia therapy recombinant human Coagulation factor Ⅷ, microchip bio-diabetes new drug sitaglipta sodium, Yangzijiang Pharmaceutical's new anti-infective drug Levoornidazole Disodium Phosphate, Yuekang Pharmaceutical's PED5 inhibitor Aldenafil and so on
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Due to limited space, this article will not introduce them one by one
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Behind the birth of every new drug, there is a story that belongs to it
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And the starting point and final end point of this story will return to solving the needs of patients
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Whether it is commendable source innovation, follow-up incremental innovation, or cooperation and introduction to achieve drug access, the ultimate goal of R&D innovation is to benefit patients
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We look forward to seeing more achievements in innovative research and development of new drugs in the upcoming 2022, more diseases being overcome, and people's health being better protected
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Behind the birth of every new drug, there is a story that belongs to it
.
And the starting point and final end point of this story will return to solving the needs of patients
.

Reference materials:

Reference materials:

[1] NMPA official website, company websites and public information

[1] NMPA official website, company websites and public information