CSPC's anti-tumor drug revenue in 2021 exceeds 7 billion and more than 50 innovative drugs are ready to be launched

On March 22, CSPC released its 2021 results
.
As of December 31, 2021, CSPC's revenue was 27.

CSPC 2021 Financial Data

NBP's sales were flat last year, and oncology drug revenue surpassed neurological drugs for the first time

From the perspective of sales revenue in various fields, in 2021, CSPC's product sales in the anti-tumor field surpassed that in the nervous system field for the first time, and sales in 2021 will increase by 22.
5% to 7.
711 billion yuan
.

CSPC Group's main products in various fields and sales in 2021

From: CSPC Annual Report, collated by Insight

The field of nervous system is a long-term advantage of CSPC
.
The main products in this field include Enbipu (Butylphthalide Soft Capsules and Butylphthalide Sodium Chloride Injection), Shuanling (Pentoxifylline Sustained-Release Tablets and Pentoxifylline Injection), Ensi (Pramipexole Hydrochloride) Tablets) and Oulaining (Oxiracetam Capsules and Oxiracetam Injection),

NBP is the dominant single product of CSPC.
Since March 2021, the effectiveness of the new medical insurance negotiated price has improved the availability and competitiveness of the drug, benefiting more patients, and the sales volume has increased significantly, offsetting the price reduction.
influence
.
NBP's sales in 2021 are basically the same as in 2020

Shuanling is mainly used for the treatment of ischemic cerebrovascular disease, peripheral vascular disease, diabetic complications, etc.
The sales revenue in 2021 will double by 213.
3%
.
Enxi is CSPC's first Parkinson's disease treatment drug.

In the field of anti-tumor, CSPC has achieved fruitful results in recent years
.
From the perspective of 2022, CSPC has already approved two new anti-tumor drugs: mitoxantrone hydrochloride liposome injection (Doenda) and PI3Kδ/γ inhibitor Duwei.

CSPC's main anti-tumor products include Duomeisu (doxorubicin hydrochloride liposome injection), Jinyouli (pegylated recombinant human granulocyte-stimulating factor injection) and Kaili (paclitaxel white for injection).
protein-bound type) and Doenda (mitoxantrone hydrochloride liposome injection)
.
Among them, Duomexu's sales revenue in 2021 will increase by 24.

R&D investment exceeds 3 billion yuan for the first time! Innovative drugs continue to develop, and more than 30 models are expected to be launched in the next five years

In 2021, CSPC's R&D investment has grown significantly again, exceeding 3 billion yuan for the first time, an increase of 18.
8% year-on-year to 3.
433 billion yuan (included in the profit and loss statement), accounting for about 15.
1% of the revenue from the patented medicine business
.
At present, the group has about 300 research projects, including more than 40 small molecule innovative drugs, more than 40 large molecule innovative drugs, and more than 30 new preparations, mainly focusing on tumors, immunity and respiration, neuropsychiatry, metabolism, cardiovascular and cerebrovascular System and anti-infective treatment field; it is expected that there will be more than 30 innovative drugs and new preparation products and more than 60 generic drugs on the market in the next five years

In addition to the listed products, CSPC has a number of projects in NDA or key clinical stages
.
Among them, the third-generation EGFR inhibitor introduced by Beida has submitted a marketing application, and the anti-RANKL monoclonal antibody JMT103 for the treatment of giant cell tumor of bone has also completed a key clinical trial

From: CSPC 2021 Annual Report

In terms of business development, CSPC completed 6 product licensing introduction, cooperation and acquisition projects in 2021, involving products in multiple therapeutic areas
.
Synergistic strong clinical development, registration and commercialization capabilities will inject new momentum into future growth
.

Rizetinib (BPI-7711 Capsules) is a product obtained by CSPC through a product authorization and commercialization agreement with Beyerda on March 9, 2021.
CSPC acquired the drug in Greater China (not in Greater China) through equity subscription.
Including Taiwan) exclusive product license and commercialization rights, and also obtained BPI-1178 capsules (CDK4/6 inhibitor) commercial license rights to negotiate first
.
In May of the same year, Rizatinib was applied for listing in China (acceptance number: CXHS2101009), and it is expected to be approved within this year
.

Rizetinib is an irreversible and highly selective third-generation small molecule epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) with significant inhibitory activity against EGFR sensitive mutations and EGFR T790M resistance mutations
.
Although the competition of the third-generation EGFR inhibitors has become a red sea, with the sales ability of CSPC, it is still expected to share the cake in this large market
.

Domestic competition of third-generation EGFR inhibitors

KN026 is a product obtained through the cooperation between CSPC and Corning Jereh in August 2021.
CSPC obtained the exclusive development and commercialization license rights of KN026 single drug and combination drug in mainland China for a maximum of RMB 1 billion in this cooperation
.

KN026 is a HER2 double antibody that can simultaneously bind two non-overlapping HER2 epitopes (subunit 2 and subunit 4), and is expected to become the next blockbuster product for HER2 targets
.
In addition to ZW25 (clinical phase III) introduced by BeiGene from Zymeworks, KN026 is the fastest-growing HER2 double antibody in China, and the competition in this field is relatively small
.
According to the Insight database, the drug was first applied for clinical trials in 2017 and started clinical trials in 2018.
It is currently in Phase III clinical stage for gastric cancer
.

KN026 Domestic Project Details

From: Insight database project progress module (http://db.
dxy.
cn/v5/home/)

CM310 is a cooperative product of CSPC and Connoya, which is an anti-IL-4Rα monoclonal antibody
.
On March 10, 2021, CSPC obtained the rights and interests of CM310 respiratory system indications in China (excluding Hong Kong, Macao and Taiwan) with an initial payment of 70 million yuan + development milestone payment of 100 million yuan + sales milestones and sales commissions
.
In the same year, the two companies further cooperated twice: on September 23, the two companies announced a strategic alliance agreement to jointly identify, research, develop and commercialize one or more neurological disease products; November 22 The two companies formally signed an agreement on the exclusive development and commercialization of the anti-TSLP recombinant humanized monoclonal antibody CM326 in moderate to severe asthma and chronic obstructive pulmonary disease (COPD) and other respiratory diseases, involving an initial payment of RMB 100 million + development milestones of RMB 100 million payment
.

According to the Insight database, the first clinical application for CM310 was submitted in China in May 2019
.
At present, the indications for atopic dermatitis are in phase III clinical development, and the indications for asthma and chronic sinusitis with nasal polyposis are in phase II clinical development
.

CM310 Project Details

From: Insight database project progress module (http://db.
dxy.
cn/v5/home/)

Early Pipeline Overview

According to the annual report of CSPC, the company not only has an advantageous nanotechnology platform, but has developed nanoliposomes, albumin nanoformulations, polymer micelles, and lipid nanoparticles for the delivery of nucleic acid drugs and nucleic acid vaccines.
A number of core delivery technologies; it also focuses on the development of multifunctional protein and antibody drugs in the field of macromolecules, such as double antibodies, tertiary antibodies and new ADC drugs, and in the field of small molecules, focusing on building PROTAC, LYTAC and AI technology-based screening platforms
.

Benefiting from the empowerment of the nanotechnology platform, CSPC has rapidly built a high-quality nucleic acid drug development platform to achieve end-to-end R&D capabilities
.
Taking mRNA vaccines as the forerunner, we will deploy other vaccine products and chronic disease products in the field of small nucleic acids, including multivalent mRNA vaccines for new coronavirus mutants, and small nucleic acid drugs with the potential to be administered once every six months
.

The enterprise analysis module of the Insight database includes 80 innovative drug projects deployed by CSPC through various subsidiaries around the world, and the pipeline is briefly sorted out here
.
In addition to the projects that have been listed/reported for listing, CSPC also has 54 clinical development projects, 9 clinical projects submitted for approval, and 8 preclinical projects
.

Overview of CSPC's innovative drugs under development

From: Insight Database Enterprise Analysis Module (http://db.
dxy.
cn/v5/home/)

In terms of therapeutic areas, there is no doubt that CSPC will focus on anti-tumor drugs in the future
.
Except for Jinyouli, the company's listed innovative drugs are all chemical drugs, and chemical drugs still account for the highest proportion of innovative drugs under development, but antibody drugs are continuing to accumulate, 15 monoclonal antibodies, 7 double An ADC project is under development
.

From the target heat map, we can clearly see the key layout targets of CSPC
.
Including EGFR and VEGFR in the field of chemical drugs, CLDN-18.
2 (4), CD3 (3), 4-1BB (3), HER2 (3) in the field of biological drugs
.

Heatmap of new drug targets under development by CSPC

From: Insight Database Enterprise Analysis Module (http://db.
dxy.
cn/v5/home/)

CLDN-18.
2 is one of the targets of CSPC's key layout
.
Jump from the heat map to view the details of the target project.
On this target, CSPC has laid out 3 clinical phase I projects, which belong to different subsidiaries.
The monoclonal antibody drug NBL-015 developed by NovaRock has a clinical start time of December 2021; the ADC drug SYSA1801 developed by CSPC Zhongqi and the ADC drug CPO102 developed by Conjupro will both start clinical trials in August 2021
.
In addition, NovaRock has also developed a CLDN-18.
2/4-1BB double antibody, which is in preclinical development
.

CSPC CLDN-18.
2 target new drug

From: Insight Database Global New Drug Module (http://db.
dxy.
cn/v5/home/)

It is worth mentioning that CSPC has also achieved external authorization cooperation on this target
.
In August 2021, CSPC announced that its subsidiary NovaRock has reached a cooperation with FlameBiosciences, Inc.
, granting the other party to develop its fully human anti-Claudin18.
2 monoclonal antibody NBL-015 in Greater China (including mainland China, Hong Kong, Macau and Taiwan).
) outside the development, manufacturing and commercialization interests
.
In addition, NovaRock will also use its NovaTE bispecific antibody technology platform to cooperate with FlameBiosciences to discover and pre-clinically develop two new double antibodies.
All expenses will be borne by FlameBiosciences.
The company will obtain the development, manufacturing and commercialization of these two double antibodies in the region.
exclusive rights
.

This is an important milestone for CSPC's self-developed innovative drugs to go overseas.
In this transaction, CSPC received an upfront payment of US$7.
5 million, a development milestone of US$172.
5 million and a sales milestone of US$460 million, up to US$640 million
.

NBL-015 is a fully human anti-Claudin18.
2 monoclonal antibody optimized by protein engineering with enhanced ADCC, CDC and ADCP effects
.
NBL-015 was previously granted orphan drug designation by the US FDA for the treatment of pancreatic cancer and gastric cancer (including esophagogastric junction cancer)
.

Details of NBL-015 Domestic Clinical Trial

From: Insight database (http://db.
dxy.
cn/v5/home/)

Claudin18.
2 is one of the isoforms of Claudin18 and is the most studied Claudin family protein in gastric cancer so far
.
In normal tissues, the expression of Claudin18.
2 is restricted to differentiated epithelial cells of the gastric mucosa with high selectivity, but Claudin18.
2 is widely activated in human malignancies, including gastric, esophageal, pancreatic, lung, and ovarian cancers cancer, and therefore a promising target for tumor therapy in these cancer types
.
According to the Insight database, there are currently more than 20 projects in China, including monoclonal antibody, double antibody, ADC, and CAR-T
.

CLDN-18.
2 Domestic Competition Landscape

From: Insight database target module (http://db.
dxy.
cn/v5/home/)

CD3 projects are all from the double antibody platform of Youzhiyou
.
CSPC acquired a 39.
56% stake in Wuhan Youzhiyou Bio-Pharmaceutical Co.
, Ltd.
in January 2018 at a total price of no more than 356 million yuan, and then continued to transfuse blood to Youzhiyou to deepen cooperation
.
Youzhiyou owns the YBODY® bispecific antibody technology platform.
Currently, a total of 9 bispecific antibodies (including fusion proteins) are under development, and 4 have entered clinical development
.

Youzhiyou clinical stage pipeline

From: Insight database project progress module (http://db.
dxy.
cn/v5/home/)

At present, the fastest progress in this field is CD3/EPCAM dual antibody M701, which will start Phase II clinical trials in July 2021
.
M701 is the first drug for the treatment of cancerous ascites in China that introduces multiple mechanisms of immunity and targeting.
It can recruit patients' autoimmune T cells through CD3, then guide immune cells to target tumor cells through EpCAM, and finally activate T cells to kill tumor cells.
The effect of treating ascites
.

M701 Project Details

From: Insight Database Global New Drug Module (http://db.
dxy.
cn/v5/home/)

The 3 projects of the 4-1BB target are in the preclinical development stage and come from NovaRock, a subsidiary of CSPC
.

CSPC 4-1BB target preclinical project