Top ten keywords of the biomedical industry in 2021

2021 is coming to an end.

The small molecule new drug declaration is also ushering in an outbreak, and the number of declarations this year has exceeded 260

Looking back on the biomedical industry in 2021, we sorted out the following key words

Keyword 1: New Crown Epidemic

In the new crown epidemic, vaccines, neutralizing antibodies, and oral drugs have all made important contributions

In terms of mild treatment, the neutralizing antibodies of Regeneron, Eli Lilly/Junshi, AstraZeneca, Vir Bio, and Tengsheng Bo Pharmaceutical have been approved one after another

In severe cases, the IL-6R antibody failed, and the GM-CSF antibody had limited or failed efficacy.

Towards the end of the year, the focus of new crown treatment was the progress of oral drugs.

Keyword 2: R&D day

For domestic pharmaceutical companies, a sign of 2021 is that many pharmaceutical companies hold R&D day activities for the first time, disclosing the R&D layout, especially the layout of early new technologies and new products

The theme of Hengrui Medicine's Sun Piaoyang is "Go to a cool place".

Keyword 3: PD-1/PD-L1

One focus of domestically produced PD-1 this year is to compete overseas.

After the first echelon, the PD-1 antibody of Yuheng Pharmaceutical, Kangfang Bio/CPTC, the PD-L1 antibody of Corning Jerry/Sidedi/Sincere, and CStone Pharmaceuticals have been approved for listing

Keyword 4: checkpoint

In addition to PD-1/PD-L1, more and more checkpoints have passed post-clinical proof-of-concept

In this context, major pharmaceutical companies began to scan the goods.

After Bristol-Myers Squibb’s PD-1+LAG-3 was successfully used in melanoma phase III clinical trials, BeiGene introduced the overseas rights and interests of Velizhibo’s LAG-3 antibody for US$772 million

Keyword 5: ADC

This year, the ADC field continued the enthusiasm of last year.

While traditional ADCs are hot, new concept ADCs have also emerged one after another, but early clinical frustrations have been repeatedly encountered this year

Keyword 6: double antibody/poly antibody

In the post-PD-1 era, combination therapy and double antibodies have become the absolute mainstream of tumor immunity
.
Taking PD-1 as an example, CTLA-4, TIGIT, LAG-3, VEGF and other clinically proven targets have become human target combinations of double antibodies
.

Some popular target combinations are also facing greater uncertainty.
For example, the PD-L1/TGFβ double antibody M7824 has successively failed in non-small cell lung cancer and cholangiocarcinoma
.

Regarding the bottom layer technology of dual-antibody, you can refer to the article “Comprehensive Combination of Dual-antibody Technology in China”
.
Head pharmaceutical companies such as Hengrui Pharmaceutical (HOT-Ig), BeiGene, and Hibody also began to build dual-antibody technology platforms

Keyword 6: mRNA

In the new crown epidemic, mRNA therapy ushered in a historic development opportunity
.
Moderna currently has a market value of US$100 billion and BioNtech has a market value of US$60 billion
.
Due to the failure of the new crown mRNA vaccine, CureVac has a market value of only 6.
4 billion U.
S.
dollars
.
Sanofi acquired Translate Bio for US$3.
2 billion, giving up the competition of the new crown mRNA vaccine and focusing on the development of a new generation of mRNA vaccines
.

In addition to the new crown, Moderna's cytomegalovirus mRNA vaccine has started Phase III clinical trials
.
BioNtech more widely in the study of mRNA of technologies, including new antigen therapy, CARVac, from free mRNA, mRNA expression of cytokines and antibodies
.

Domestically, Aibo Bio-Bio has completed two rounds of financing of 300 million U.
S.
dollars and 700 million U.
S.
dollars, and Sri Lanka Microbiology completed 1.
2 billion financing
.
Kangsino, Beijing Kexing, and China Microelectronics Institute have also joined the development competition for the new crown mRNA vaccine
.
Jiachen Xihai mainly develops tumor mRNA therapy, and has reached a number of cooperation with Junshi Biology and Tianjing Biology
.
In June 2021, an article published by BCG in Nature counted the R&D pipelines of many domestic mRNA companies
.

Keyword 7: siRNA

In 2021, siRNA will usher in a new era.
Novartis's US$9.
7 billion PCSK9 siRNA therapy has been approved by the FDA and only needs to be administered once every six months
.
Multinational pharmaceutical companies have also begun to compete for siRNA.
Novo Nordisk acquired Dicerna for US$3.
3 billion, Novartis sold Roche’s equity for US$20 billion in cash, and was rumored to acquire Alnylam
.

Vir Bio's preliminary clinical data of hepatitis B siRNA + interferon are positive, and it is expected to achieve a functional cure
.

Domestically, the IPO of Ruibo Biotech Innovation Board was terminated, and Shengnuo Pharmaceutical will be listed on the Hong Kong Stock Exchange on December 30, becoming the first domestic small nucleic acid drug
.
Hausen Pharmaceuticals completed two siRNA collaborations within a week, and Qilu Pharmaceuticals introduced Arbutus's hepatitis B siRNA therapy for US$300 million
.

Keywords 8: New drug internal circulation

China's biomedical industry is undergoing rapid evolution.
BeiGene, Cinda Biotech, etc.
have raised sufficient ammunition in the capital market, and they also have the willingness to internationalize
.
On the other hand, as the primary market continues to be hot, the innovation of a new wave of start-up biotechnology companies has increased significantly.
In this context, the internal circulation of new drugs has become a new trend
.
However, although the leading companies are actively deploying internationalization, it is difficult for them to directly compete on the sales side in the European and American markets in a short time
.
Therefore, the model of future cooperative transactions will be more complicated.
Innovative drugs may be authorized from the start-up Biotech to domestic leading pharmaceutical companies, and the leading pharmaceutical companies will advance to a certain extent to authorize foreign rights and interests to multinational pharmaceutical companies
.

Keyword 9: Frustration of innovative drugs going overseas

Domestically-made innovative drugs are going to sea one after another, but the failure of new drug research and development is normal, and both pharmaceutical companies and the capital market need to adapt to the process of facing failure
.

In April 2021, the Phase III clinical failure of Conberxipro International, the capitalized development expenditure of 1.
4 billion yuan was transformed into the current profit and loss in 2020, resulting in net profit from 840 million yuan to -270 million yuan
.
It is estimated that the production center built by Kanghong Pharmaceutical in Beijing Yizhuang can only be converted to CDMO
.

In November 2021, Conrad announced that the global phase II clinical trial of IL-4R antibody CBP-201 for the treatment of moderate to severe atopic dermatitis has reached the primary end point, and the phase III clinical trial will be initiated in the middle of 2022
.
After the news, Conrad’s stock price plummeted 55%, mainly because the market speculated that its efficacy data would not match Dupixent's historical data, and the market outlook was bleak
.

In September 2021, Wanchun Pharmaceutical announced the success of the Phase III clinical trial of Panabulin, and the stock price fell by 33%.
In December 2021, the FDA refused to approve the listing of Panabulin
.
The FDA believes that a phase III registered clinical trial cannot fully prove the benefit of treatment, and requires a second registered clinical trial to obtain sufficient evidence to support the approval of the CIN indication
.

In December 2021, Kuaiblai Pharmaceutical announced that the interim analysis data of the US Phase III clinical trial of Prokalamide did not meet the primary endpoint, and that the enrollment criteria will be adjusted to high-risk patients in the future.
Kuaiblai Pharmaceutical’s stock price fell by 70%
.

Keywords 10: new targets, new technologies

Intellia/Regeneron's first human trial of CRISPR has obtained positive data, and Intellia's market value is close to tens of billions of dollars
.
PCSK9 CRISPR animal experiments show that it is expected to achieve the goal of life-long effective one-time administration
.

Regeneron strives to build a gene center, hoping to complete the whole process of target discovery-verification-transformation based on functional genomics data, subverting the traditional drug research and development model
.
Currently, Regeneron has discovered GPR75, a new target for obesity, and B4GALT1, a new target for lowering lipids
.

Lei Li Ping discovered a new target of tumor immunity combined with CD93, Li Hongliang discovered a new target of NASH, ALOX12, French scientists discovered a new target of autoimmunity, ChemR23, American scientists discovered a new target of type 1 diabetes SerpinB13, a new target of tumor immunity PLA2, The Chinese University of Hong Kong Scientists have discovered HDAC8, a new target for liver cancer
.

Domestically, original innovations are also emerging.
Rao Yi’s original foundation, Huayi, has developed sleep regulation and rhythm regulation drugs.
His first new drug has been submitted to IND.
Wang Xiaodong Viterilon has developed apoptosis-related drugs.
The first drug RIP1 inhibitor has been Obtained clinical approval, Shao Feng's Yanming Biology develops drugs related to the pyrolysis mechanism
.

Summarize

2021 is not easy for the pharmaceutical industry and is full of various challenges
.
Medical insurance negotiations continue to compress the profit margin and market prospects of innovative drugs, and the secondary market continues to pull back
.
The homogeneity competition is intensifying.
After PD-1, Claudin 18.
2, CD47, etc.
continue to face excessive competition
.
However, new opportunities are also gestated under the challenge.
The exploration of new technologies and new drug forms is more active, differentiated substitution is homogenized, capital is forced to start to try to embrace innovation and take risks, the process of internationalization is accelerating, and the background of localization substitution The lower industrial chain continues to improve
.