High-quality biosimilar authorized major pharmaceutical companies; what are the layouts of Biotech's deep-growing new drugs?

Driven by innovation, leading in biology

According to the Pharnexcloud database ( 140 drugs were listed for the first time in the world in 2020, of which 21 are listed in China for the first time and 14 are biological drugs.

At present, the urgent global need for prevention and treatment of major diseases and the hot spot in the field of new drug research and development are still aimed at malignant tumors, neurodegenerative diseases, viral infectious diseases, and autoimmune diseases

Monoclonal Antibody Drugs

Biological drugs include monoclonal antibodies (including double antibodies), ADCs, recombinant therapeutic proteins, vaccines, blood products, cell and gene therapy, and other biological therapies

Among them, "Yao Wang" adalimumab (trade name "Xiumei") is the most well-known

Biotech, the full name of Biotech Biopharmaceutical Co.

On November 7, 2020, Glorious® was approved for listing

Continue to invest in research and development, temporarily turn losses into profits

(2020 full-year results, derived from the company's Hong Kong stock prospectus)

As we all know, R&D activities in the field of biomedicine have the characteristics of high technical risk, long R&D cycle, and large capital investment

Biotech’s 2020 annual report shows that as of December 31, 2020, the company has achieved operating income of 185 million yuan for 2020; R&D expenses (R&D) of 562 million yuan ; operating income has increased by 184 million yuan over the same period of the previous year.

On July 29, 2021, Biotech disclosed its 2021 semi-annual performance forecast.

Layout of tumor immunity, diversified pipelines

(List of Biotech's latest R&D pipelines (as of August 20, 2021))

Approved clinical

According to the Yaorong Cloud database ( four monoclonal antibodies, BAT2306, BAT6026 (new drug for OX40 antibody), BAT6021 and BAT6005, have all been approved for clinical use

2 new TIGIT drugs

(1) BAT6021 injection: BAT6021 is a T cell immunoglobulin and ITIM domain protein (TIGIT) monoclonal antibody

(2) BAT6005: It is an anti-TIGIT monoclonal antibody of IgG1 subtype with normal Fc effect function, which is planned to be developed for tumor treatment

BAT7104: BAT7104 is a bispecific antibody drug targeting PD-L1/CD47 , designed to inhibit PD-1/PD-L1 and CD47/SIRP-α pathways

Clinical Phase I

HER2 mAb BAT1006, CTLA4 mAb BAT4706, PD-1 mAb BAT1308 and BAT4406F, and IL-17 mAb BAT2306 have advanced to the first clinical phase

Clinical Phase II

BAT5906 is a new class 1 anti-VEGF drug independently developed by Biotech.
It exerts its efficacy by specifically binding to human VEGF.
It is currently in the second phase of clinical trials
.

Clinical Phase III

Golimumab biosimilars BAT2506, Useltuzumab biosimilars BAT2206 and IL-6R monoclonal antibody BAT1806 have launched Phase III clinical trials
.

BAT1806 (tocilizumab): recombinant humanized anti-interleukin 6 receptor (IL-6) monoclonal antibody BAT2506 (golimumab) independently developed by the company: the world's first biosimilar candidate for Simpuny Golimumab can target the inhibition of TNF-α activity and is suitable for patients with immune diseases such as ankylosing spondylitis and rheumatoid arthritis
.

(The mechanism of BAT1706, the picture is from the company's annual report)

Submission of listing stage (BLA/NDA)

BAT1706 (bevacizumab) is currently in the listing application stage in China, the United States, and the European Union.
It is the first Avastin candidate biosimilar developed by a Chinese company and launched a global multi-center clinical trial .
Brazil's Biomm and overseas Cipla Limited companies carry out a commercial cooperation license out to expand more global market shares
.

BAT2094 (Batifiban) is currently in the domestic market application stage.
It is a small molecule GPIIb/IIIa antagonist drug candidate.
It is labeled to prevent thrombosis induced by platelet aggregation in ACS patients undergoing PCI
.

New drug research and development: failure is often accompanied by

On March 4, 2021, Biotech announced that it has terminated the clinical trials of Trop-2 targeting ADC BAT8003 and PD-1 monoclonal antibody BAT1306
.
This is the third project that Biotech has terminated this year.
Prior to that, Biotech had terminated its HER2 targeting ADC BAT8001 project on February 9th, and a total of nearly 340 million yuan has been invested in the three projects
.

The termination of clinical trials of BAT8001, BAT8003 and BAT1306 resulted in the failure of Biotec's ADC pipeline.
The company re-focused pipeline development to the field of tumor immunity, which triggered a heated discussion in the medical industry for a while, and once again made people understand new drugs.
High failure rate of R&D
.

The birth of innovative drugs not only consumes huge manpower, material resources and time costs; drug development is not an easy task.
Biotech took the initiative to publicly disclose that the results of its research projects in the third phase of clinical trials did not meet the standards, which was actually a time The new breakthroughs left a deep impression on everyone but also gave a certain encouragement.
Even if it fails, it means that China's pharmaceutical industry can still achieve greater progress in the future.
Failure will only give us lessons and lessons.
Reach higher standards in the future
.

Dr.
Shengfeng Li, the founder and general manager of Biotech, said that although the company's ADC drugs are suspended, the company will develop new ADC platforms, including new linkers and toxins, and will further develop more For the candidate product, failure will become the driving force for this innovative company to move forward in the future
.

The research and development and listing of new drugs is a long-term work, and there are many uncertain factors, which are easily affected by many factors such as technology, approval, and policies.
There are many uncertainties in the progress and results of clinical trials, and the future product market competition.
Aotai has gradually moved from the early deployment of a variety of biosimilar drugs to innovative biopharmaceuticals, further increasing the research and development of new drugs, daring to contain huge investment in new drug projects in time, and continue to develop other popular targets.
The pipeline is rich but still in the early stage.
For the company, it faces many challenges and at the same time is full of hope.
With the continuous advancement of the research and development process in the future, it will take time to prove its success
.
The company’s pre-clinical targets include: CD40 antibody, IL-1β antibody, ANGPTL3 new drugs, long-acting VEGF, EGFR/VEGF, and so on
.

Further reading

Biotech R&D pipeline combing can see the derivative reading of this article:

Biotech's 21 R&D pipelines are sorted out, and new tumor immune drugs are heavily stocked, involving many popular targets such as TNF-α and CD20

development path

In July 2003, Biotech Biotechnology (Guangzhou) Co.
, Ltd.
was formally established

In March 2013, submitted the "Recombinant Human Anti-TNF-α Monoclonal Antibody Injection" (BAT1406) clinical trial application to the former CFDA

In January 2014, submitted a clinical trial application for "recombinant humanized anti-VEGF monoclonal antibody injection" (BAT1706) to the national CFDA

In December 2015, "Recombinant Human Anti-TNF-α Monoclonal Antibody Injection" BAT1406 was approved for clinical trials

In 2016, "Recombinant Humanized Anti-VEGF Monoclonal Antibody Injection" BAT1706, "Recombinant Humanized Anti-HER2 Monoclonal Antibody-Maytansine Conjugate for Injection" (BAT8001) obtained domestic clinical trial approval; submitted "Recombinant Humanized anti-IL-6 receptor monoclonal antibody injection" clinical trial application

In November 2017, "Recombinant Humanized Anti-IL-6 Receptor Monoclonal Antibody Injection" was approved for domestic clinical trials

In March 2018, recombinant Fc glycosylation modified anti-CD20 humanized monoclonal antibody injection obtained domestic clinical trial approval

In November 2019, the company name was changed to Biotech Biopharmaceutical Co.
, Ltd.
, and Glaly® (Adalimumab Injection) was approved by the State Food and Drug Administration for listing

In 2020, Biotech will be listed on the Sci-tech Innovation Board of the Shanghai Stock Exchange, and it will reach a cooperation with Pharmapark on BAT2506 in Russia and other CIS countries; it has reached a cooperation with Biomm on BAT1706 in Brazil; it has signed with BeiGene on the authorization and distribution of BAT1706 in China , Supply Agreement

In April 2021, Biotech and Biogen reached a cooperation on BAT1806

refer to:

NMPA/CDE;

Pharmacy Cloud Data, Cloud Data, FDA/EMA/PMDA;

Public disclosure by related companies;

https:// Biotech: 21 R&D pipelines are sorted out, and new tumor immune drugs are heavily stocked, involving many popular targets such as TNF-α_;

Biotech's 2020 financial report;

Biotech's first quarter report of 2021;

Biotech Hong Kong Stock Prospectus,

https://www1.
hkexnews.
hk/app/sehk/2021/103301/documents/sehk21032301191_e.
pdf;

Progress of cooperation with biogen, http://data.
eastmoney.
com/notices/detail/688177/AN202107211505220666.
html;

http://epub.
cnipa.
gov.
cn/tdcdesc.
action?strWhere=CN104341504A;

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