Cinda's 21 Class 1 New Drugs Expose, 3 New Drugs Attack Over 26 Billion Market

Pharm.
com.
cn, September 1st, as the leading domestic Biotech, Cinda Biotech has realized the commercialization of five products in ten years, and the sixth commercial product will be born soon
.
In 2021H1, the company's first Class 1 new drug sales exceeded 1.
4 billion yuan, and the three newly added first-line indications caught up with the new round of medical insurance negotiations
.
At present, Cinda Biosciences has 22 new drugs in the clinical stage, focusing on tumor, autoimmune, metabolic diseases and other disease fields, covering monoclonal antibodies, double antibodies, CAR-T and small molecule drugs
.
Five of these products are in the critical phase II/III clinical phase, and IBI-376 (PI3Kδ inhibitor) and IBI-326 (BCAR CAR-T) will soon submit NDA applications
.
PD-1 sold 1.
4 billion in half a year ! Three new first-line indications were added.
Recently, Cinda Bio's PD-1 sales were disclosed.
In 2021H1, Daboshu (sintilimab injection) sales exceeded 1.
4 billion yuan, with strong sales growth and occupying a leading market share
.
The company said that the large-scale stainless steel bioreactor production line has brought market-competitive cost advantages to Daboshu, which has increased the GMP profit margin of product sales from 79.
9% in the same period last year to 87.
3% in the first half of 2021
.
BeiGene and Hengrui Pharmaceuticals also disclosed the sales of PD-1 in their semi-annual reports.
The sales of tislelizumab in 2021H1 were US$124 million (approximately 800 million yuan), a year-on-year increase of 148%; Cary Lilizumab began to implement the medical insurance negotiation price in March this year, a decrease of 85%, coupled with many problems such as difficulty in entering the hospital and different implementation times of medical insurance in various regions, resulting in a negative growth in the sales revenue of carrelizumab from the previous month
.
Daboshu (sintilimab injection) is an innovative PD-1 inhibitor jointly developed by Eli Lilly and Innovent in China.
The cooperation has now expanded to the global market
.
In December 2018, Daboshu was approved for the treatment of classic Hodgkin’s lymphoma.
In November 2019, Daboshu passed medical insurance negotiations and became the first PD-1 inhibitor in the country to enter the national medical insurance catalog
.
As the validity period of the negotiation agreement is about to end, Daboshu will participate in the medical insurance negotiation again in October this year, and a number of its newly approved first-line indications are also expected to be included in the 2021 version of the medical insurance negotiation catalog
.
In the first half of 2021, Sintilimab injection was approved for three new first-line indications, including first-line non-squamous non-small cell lung cancer, first-line squamous non-small cell lung cancer and first-line hepatocellular carcinoma
.
In addition, the listing application of Sintilimab injection for second-line squamous non-small cell lung cancer is under review and is expected to be approved by the end of 2021
.
At present, the indications of Sintilimab injection are still being expanded.
The indications for first-line esophageal squamous cell carcinoma, first-line gastric cancer and second-line EGFR-positive non-small cell lung cancer are expected to be applied for listing from the end of 2021 to early 2022
.
It is worth mentioning that the first-line non-squamous non-small cell lung cancer listing application for Sintilimab injection has been accepted by the US FDA
.
It is reported that Cinda Bio has a total production capacity of 24,000 liters.
The company expects that the production capacity will be expanded to 60,000 liters by the end of the year, which will further increase the number of products and production efficiency
.
With the expansion of production capacity, the approval of new indications and the development of overseas markets, Sintilimab's sales are expected to increase
.
  　　Commercialization of 5 products, attacking the market of over 26 billion tinib drugs.
  　　2021 is the tenth year of Cinda Biotech’s establishment.
The first class 1 new drug PD-1 was approved at the end of 2018.
At present, the company has 5 products commercialized. .
In 2020, 3 biosimilar drugs of Cinda Biologics have been approved for marketing successively, including Dyutong (bevacizumab injection), Sullivan (adalimumab injection) and Dabohua (rituximab) Injection)
.
In June 2021, Cinda Bio's Pemigatinib was approved for listing in the Taiwan market; in August 2021, Su Lixin's prefilled injection form was approved for listing in China
.
Thanks to the rapid year-on-year growth of the flagship product Daboshu and the significant revenue contribution from four newly-listed drugs, Cinda Bio will achieve product revenue of 1.
855 billion yuan in 2021H1, a year-on-year increase of 101.
4%
.
  　　Innovent's commercial product Pemigatinib is a selective fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor with Best-in-Class potential
.
This product was jointly developed by Incyte and Cinda Bio, which is responsible for the commercialization of China, Hong Kong, Macau and Taiwan
.
In July 2021, the NDA application for Pemigatinib tablets was accepted by the CDE, and the indication is for the second-line treatment of advanced cholangiocarcinoma with FGFR2 fusion or rearrangement
.
In addition, the first-line indication for cholangiocarcinoma of Pemigatinib tablets is already in the phase III clinical stage
.
It is worth mentioning that Cinda Bio is expected to usher in the sixth commercial product-IBI-348 (Olverembatinib) this year
.
Olverembatinib is China’s first third-generation BCR-ABL targeted drug resistant chronic myelogenous leukemia (CML) treatment.
Its NDA application was accepted by the CDE in 2020, and it has been included in the priority review and breakthrough therapy category.
Approved at the end of 2021
.
In July 2021, Cinda Biotech and Yasheng Pharmaceutical reached a strategic cooperation, and the two parties will jointly develop and commercialize IBI-348 in Greater China
.
Cinda's biological product pipeline has released 3 tinib drugs, including Pemigatinib, Olverembatinib and Taletrectinib
.
Protein kinase inhibitors (tinib drugs) are currently one of the research and development areas that domestic pharmaceutical companies are keen on, and their market growth potential is huge
.
According to data from Menet.
com, in 2020, the terminal market of protein kinase inhibitors in China's urban public hospitals , county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) will exceed 26 billion yuan, with sales in 2018-2020 The growth rates were 40.
31%, 57.
58%, and 29.
79%
.
Sales of Terminal Protein Kinase Inhibitors in Public Medical Institutions in China (Unit: 10,000 Yuan) Source: Mynet.
com China's public medical institutions terminal competitive landscape   　　21 types of Class 1 new drugs are under development! Monoclonal antibodies, double antibodies, and CAR-T are   　　deployed together.
Cinda Bio is committed to becoming a global biopharmaceutical company.
The company invested 1.
042 billion yuan in R&D in 2021H1, a year-on-year increase of 29.
0%, mainly for the development and priority of pipeline products in the company's later development stage.
Global development of research products
.
According to data from Meinenet, in addition to products that have been commercialized or submitted for NDA, Innovent has 22 new drugs in the clinical stage in China, of which 21 are Class 1 new drugs, involving diseases such as tumors , metabolism, immunity, and fundus diseases .
There are layouts for popular targets such as CD47, LAG-3 and TIGIT
.
Among the 22 products, only 3 Class 1 new drugs such as IBI376, IBI344 and IBI362 are small molecule chemical drugs, and the remaining products are macromolecular biological drugs, covering the fields of monoclonal antibodies, double antibodies and CAR-T.
Many products have First- In-Class or Best-in-Class potential
.
  　　Innovent is mainly researching new drugs IBI322 (PD-L1/CD47), IBI318 (PD-1/PD-L1), IBI315 (PD-1/HER2), IBI321 (PD-1/TIGIT), IBI319 (PD-1) /4-1BB) and IBI323 (LAG-3/PD-L1) and other 6 double antibodies are already in the phase I clinical stage
.
Among them, IBI-322 is the first PD-L1/CD47 double antibody to enter the clinical stage in the world
.
5 products in critical Phase II / III clinical stages, including IBI310, IBI376 (Parsaclisib), IBI326 , IBI344 (Taletrectinib), IBI306 and so on
.
Among them, IBI-376 and IBI-326 will submit NDA applications from the end of 2021 to early 2022.
IBI-376 is used to treat relapsed or refractory follicular lymphoma/marginal zone lymphoma, and is a potential best-in-class PI3Kδ inhibitor; IBI -326 is used for the treatment of relapsed or refractory multiple myeloma, and is potentially the best-in-class BCAR CAR-T
.
  　　Data source: Mi Nei.
com database, company announcement