Junshi Biology's mid-term report released: revenue surged by 268% in the first half of the year, over 40 innovative pipelines attracted attention

On August 30, Junshi Biological released 2021 interim results

After turning around for the first time in the first quarter, Junshi Biological has achieved sustained profitability

In addition to the rapid progress in commercialization, the interim report also revealed many bright spots

From the perspective of the overall pipeline, Junshi Biologics currently has 44 innovative drugs under development, which are in different stages of research and development

The international layout has also achieved breakthrough results

Also in February of this year, the new crown neutralizing antibody esvirizumab jointly developed by Junshi Biotech and domestic scientific research institutions was granted the US FDA Emergency Use Authorization (EUA).

The commercialization of PD-1 is progressing rapidly, with multiple indications ranking first in the country

Teriplizumab is the first domestically produced PD-1 monoclonal antibody approved by the National Food and Drug Administration (NMPA) in China, and it is also Junshi Bio's first commercial product

In the first half of this year, Junshi Biosciences continued to accelerate the admission rate of teriprizumab to expand market coverage

In order to further expand the market penetration of triprolizumab, in February 2021, Junshi Biotech and AstraZeneca reached a commercial cooperation, granting its teriprolizumab to the urinary oncology field that was subsequently approved for marketing in mainland China.

The rapid expansion of indications will also continue to sustain the growth of teriprizumab

It is reported that teriprizumab has carried out more than 30 clinical studies covering 15 indications in China, the United States and other countries, involving nasopharyngeal cancer, urothelial cancer, lung cancer, gastric cancer, esophageal cancer, liver cancer, breast cancer Wait for new indications

In the first half of the year, milestone progress was made in multiple indications

Judging from the research and development progress disclosed in the interim report, the progress of a number of indications for teriprizumab is leading

Accelerated overseas, the first to submit an FDA listing application

As an innovation-driven biopharmaceutical company, Junshi Bioactively promotes the international clinical layout of innovative drugs and accelerates the pace of internationalization

In March 2021, Junshi Biotech announced that it had begun rolling submission of BLA to the FDA for the treatment of relapsed or metastatic nasopharyngeal carcinoma and obtained rolling review by the FDA.

In particular, it is worth mentioning that this year, a number of clinical research results of teriplizumab have been included in top international academic journals and presented at many international academic conferences, which have been recognized by international authorities

At the annual meeting of the American Society of Clinical Oncology (ASCO 2021) to be held in June 2021, a total of 39 related studies of teriplizumab were presented in a concentrated manner, including an oral report of the general assembly, an oral report of a special session, and 15 posters Displays and several online summaries
.

Among them, ASCO 2021, in the form of the "Late-breaking Abstract" (LBA, Late-breaking Abstract) of the plenary session, released a study of teriprizumab combined with chemotherapy in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma (JUPITER-02 study).
, #LBA2) The latest results
.
This is the first Chinese local innovative drug research to be selected for the plenary meeting since the official record of the ASCO annual meeting
.
In August this year, the full text of the study was also published in the authoritative journal "Nature-Medical" with an impact factor of more than 50 points
.

With a firm commitment to internationalization, Junshi Biologics was the first to taste the fruits of going overseas
.
In the first half of the year, Junshi Bio's explosive growth in revenue was mainly due to the increase in foreign licensing revenue
.

By authorizing treplizumab to Coherus, Junshi Bio will obtain a total of up to US$1.
11 billion in down payment, execution payment (such as Coherus exercise of its option) and milestone payment, plus anything that contains treplizumab A sales share of 20% of the annual net sales of the products in the licensed area
.

As a new crown drug that has attracted much attention, Etesvizumab and Eli Lilly's banivirimab constitute a double antibody therapy after obtaining the FDA's emergency use authorization, and received a 100,000 dose order from the US government worth 210 million U.
S.
dollars
.

Up to now, diabody therapy has been authorized for emergency use in 12 countries around the world
.
According to the new version of the fact sheet and the authorization letter for diabody therapy issued by the FDA, research on fake and true viruses shows that diabody therapy is against Alpha (B.
1.
1.
7) mutants and Delta (B.
1.
617.
2/AY.
3) Neutralizing activity was maintained in the mutant test
.

With the prevalence of different mutants in countries around the world, diabody therapy is expected to be put into use in other countries to support the global fight against the epidemic
.

Continue to expand the R&D pipeline, diversify the portfolio to create differentiation

Junshi Biology adheres to product innovation based on source innovation and independent research and development of biological products, and promotes the enrichment and expansion of product lines through cooperative development, technology transfer or licensing, and products that have synergy with its own original product line
.

From the perspective of the R&D pipeline disclosed in the Interim Report, after a long period of drug development technology accumulation, in-depth exploration in the field of translational medicine, and the establishment of a new drug type platform, Junshi Bio's innovative R&D field has expanded from monoclonal antibody drug types to include small molecules Drugs, peptide drugs, antibody-conjugated drugs (ADCs), bispecific or multispecific antibody drugs, nucleic acid drugs and other types of drugs, as well as the exploration of next-generation innovative therapies for cancer and autoimmune diseases, the number of R&D pipelines jumped to 44 Item
.
This year, the antibody conjugate drug research and development platform and the siRNA drug research and development platform are newly added.
I believe that a batch of self-developed ADCs and small nucleic acid drugs will be added to the pipeline in the future
.

From the perspective of the therapeutic field, Junshi Bio has formed a diversified innovative product portfolio in the fields of tumor immunity, autoimmunity, chronic metabolism, nervous system and anti-infection, established an excellent product iteration system, and created the company's differentiated advantages
.

Junshi Biology has forward-looking layout of multiple innovation targets, and strives to innovate at the source
.
In its research and development pipeline, there is no shortage of first-in-class (first-in-class) or best-in-class (best-in-class) drugs with source innovation, such as: Angoreiximab and UBP1213, which are the first time for a Chinese local company to obtain the National Drug Administration.
Anti-PCSK9 monoclonal antibody and anti-BLyS monoclonal antibody approved by the Bureau of IND; TAB004/JS004 is also the world’s first anti-BTLA monoclonal antibody independently developed by Junshi.
It has been approved by the US FDA and NMPA for clinical trials.
To carry out clinical trials
.

In addition to developing drugs under research on its own technology platform, Junshi Biologics is also actively cooperating with outstanding domestic and foreign biotechnology companies to further expand the product pipeline, deploy the next-generation innovative drug technology platform, and enrich drug combination therapy
.

In July 2021, Junshi Bio and Jiachen Xihai reached a cooperation agreement.
The two parties established a joint venture company to jointly develop new mRNA drugs or vaccines for tumors, infectious diseases, rare diseases and other fields based on the mRNA technology platform
.
With this cooperation, Junshi Bio has expanded the field of drug research and development to the field of mRNA technology
.

In addition, Junshi's foreign cooperation and introduction also involve a new generation of T cell chimeric activation (TEAC) tumor immunotherapy, PARP inhibitor senaparib, anti-tumor small molecule drugs (XPO1 inhibitors, Aurora-A inhibitors, EGFRexon20 inhibitors, Fourth-generation EGFR inhibitor) and so on
.
Focusing on the cornerstone drug of teriprizumab, self-developed products represented by anti-BTLA monoclonal antibody, anti-TIGIT monoclonal antibody, anti-CD112R monoclonal antibody, etc.
will cooperate with the introduction projects reached by the above cooperation to create synergistic and complementary effects.
Diversified pipelines to cover a wider range of people with better survival benefits
.