China Monoclonal Antibody Market by Targets (PD-1,CD20,HER2,VEGF,EGFR,TNF-?) Research Report, 2018-2025

China Monoclonal Antibody Market by Targets (PD-1,CD20,HER2,VEGF,EGFR,TNF-?) Research Report, 2018-2025

Jan 2019 Chisult Insight Co., Limited Pharmaceutical215 Pages Price :
$ 3600

China’s oncology drug market has grown rapidly in recent years. Revenue of the oncology drugs in China grew from RMB83.4 billion in 2013 to RMB139.4 billion in 2017, representing a CAGR of 13.7%. It is expected to further grow to RMB262.1 billion in 2022 at a CAGR of 13.5% from 2017, and to RMB654.1 billion in 2030 at a CAGR of 12.1% from 2022.

While the majority of the top ten oncology drugs globally in 2017 are either molecularly targeted drugs or immuno-oncology drugs, seven out of the top ten oncology drugs in China are chemotherapy drugs and only three are molecularly targeted drugs. This difference between the global market and the China market suggests significant potential for molecularly targeted drug and immuno-oncology drug market growth in China. Three drugs among the top10 oncology drugs globally were recently approved in China in 2018, indicating China is at its early stage of its paradigm shift to molecularly targeted drugs and immuno-oncology drugs.

Among all types of cancers, lung cancer, liver cancer, stomach cancer, colorectal cancer and breast cancer are the top five cancer types in China by incidence rate, accounting for more than 50% of the annual incidence in the aggregate. The incidences of lung cancer, colorectal cancer and esophageal cancer are expected to grow at higher CAGRs than the others. Such higher CAGR for lung cancer is attributed to the growing smoking population and air pollution. As for colorectal and esophageal cancer, the higher CAGRs are attributable mainly to increasingly prevalence of unhealthy dietary habits.

mAbs (including fusion proteins) only accounted for 5.4% of China’s biologics market in 2017, while globally the figure was 43.2% in the same year, representing a sizable market potential. With the inclusion of more mAbs into the NRDL, sales revenue of China’s mAbs market is expected to grow to RMB69.6 billion in 2022, representing a CAGR of 42.6% from 2017 to 2022, which will outpace the growth of China’s overall biologics market. The diagram below illustrates the size of China’s mAb market from 2013 to 2017 and the estimated market size from 2018 to 2022.

In addition to monotherapies, PD-1/L1 inhibitors have shown significant potential in combined therapies. PD-1/PD-L1 inhibitors market is still at an early stage of development but has strong growth potentials. The market size of PD-1 and PD-L1 inhibitors together is estimated to grow to RMB37.4 billion in 2022, representing a CAGR of 534.4% from 2018 to 2022, and further increase to RMB98.4 billion in 2030, representing a CAGR of 12.8% from 2022 to 2030.

In December 2018, the State Drug Administration ( NMPA ) announced that it would conditionally approve the listing of the first domestically produced PD-1 monoclonal antibody, tripril monoclonal antibody injection. Tripril monoclonal antibody was developed by Suzhou Zhonghe Biomedical Co., Ltd. (A subsidiary of Shanghai Junshi Biosciences Co., Ltd.) to treat local progression or metastatic melanoma after previous standard treatment failure.

Currently, there are 6 PD-1/PD-L1 listed in the world, of which 2 PD-1 drugs, namely Opdivo of Bristol - Myers Squibb and Keytruda of Mercadon, have been approved for listing in China in 2018. 

Among the domestic R&D companies for PD-1, Innovent Biologics, Inc., Hengrui Medicine and BeiGene, Ltd. have also submitted drug listing applications, but the application indications are all classic Hodgkin lymphoma, and there is no direct competitive relationship with the currently approved indications of Opdivo and Keytruda.

Table of Content

1. Policy Snapshot
1.1 Snapshot of Policies
1.2 Basic Data Requirements for Reporting and Listing of Anti - PD-1/PD-L1 Monoclonal Antibody
1.3 Opinions on Reform of the Drug and Medical Device Review and Approval
1.4 The State Organized Pilot Program for Centralized Drug Procurement
1.4.1 Characteristics and Significance of Drugs Procurement with Target Quantity
1.4.2 Impact on Foreign Enterprises and Local Enterprises
1.4.3 Development Trend of Drugs Procurement with Target Quantity

2.  Overview of Chinese Monoclonal Antibody Market
2.1 China’s Oncology Drug Market
2.2 Market Outlook of China’s Monoclonal Antibody

3. Chinese Monoclonal Antibody Market by Target Species
3.1 PD-1/PD-L1
3.1.1 Indication and usage
3.1.2 Primary drug resistance and acquired drug-resistance of PD-1/PD-L1 makes combo therapy a inevitable trend
3.1.3 PD-L1 expression quantity, MSI, TMB-core predictive markers of most immunotherapies
3.1.4 Immune checkpoint inhibitors combo and oncolytic virus combo-the new R&D direction
3.1.5 Market cap outlook of PD-1/PD-L1 drugs
3.1.6 Competitive landscape
3.2 CD20
3.2.1 First generation CD20- Rituximab
3.2.2 Second generation CD20- Ofatumumab & Ocrevus
3.2.3 Third generation CD20- Obinutuzumab: FC portions glycosylation modification, better therapeutic effect on lymphoma
3.2.4 Market cap outlook of CD20 drugs
3.3 HER2
3.3.1 Trastuzumab-initial therapy for HER2 positive breast cancer and gastric cancer
3.3.2 Continuous emerging of new HER2 target point drugs
3.3.3 Market cap outlook of HER2 drugs
3.4 VEGF
3.4.1 New direction of anti VEGF - multi target inhibiting of angiogenesis and immunotherapy combined therapy
3.4.2 PDGF – significant target for accessory angiogenesis
3.4.3 Typical anti VEGF drug – Bevacizumab
3.4.4 Applications of anti VEGF drugs in ophthalmology
3.4.5 Market cap outlook of VEGF drugs
3.5 EGFR
3.5.1 Major biological target for colorectal cancer and NSCLC, expanding therapy for other tumours
3.5.2 EGFR small molecule targeting - breakthrough treatments of positive NSCLC, fierce competition of TKIs
3.5.3 Market cap outlook of EGFR monoclonal antibody
3.5.4 Market cap outlook of EGFR TKI
3.6 TNF-?
3.6.1 Essential target for autoimmune diseases, facing competition from new target drugs
3.6.2 Troublesome original drug in China market, Etanercept dominates the market
3.6.3 Market cap outlook of TNF-? drugs
3.6.4 Competitive landscape
3.6.5 CD22-brandly new target from SinoMab BioScience

4 Leading Chinese Monoclonal Antibody Players
4.1 Jiangsu Hengrui Medicine Co., Ltd.
4.1.1 Profile
4.1.2 Product Pipline
4.1.3 R&D
4.1.4 Production
4.2 Shanghai Junshi Biosciences Co., Ltd.
4.2.1 Profile
4.2.2 Product Pipeline
4.2.3 JS001 (toripalimab, anti-PD-1 mAb)
4.2.4 R&D
4.2.5 Production
4.3 BeiGene, Ltd.
4.3.1 Profile
4.3.2 Product Pipline
4.3.3 Clinical Development Plan of Tislelizumab
4.3.4 R&D
4.3.5 Production
4.4 Innovent Biologics, Inc.
4.4.1 Profile
4.4.2 Product Pipline
4.4.3 Sintilimab (IBI-308)
4.4.4 R&D
4.4.5 Production
4.5 Beijing Mabworks Biotech Co., Ltd.
4.5.1 Profile
4.5.2 Product Pipline
4.5.3 R&D
4.5.4 Production
4.6 ZHEJIANG HISUN PHARMACEUTICAL Co., LTD.
4.6.1 Profile
4.6.2 Product Pipeline
4.6.3 R&D
4.6.4 Production
4.7 Genor Biopharma Co. Ltd.
4.7.1 Profile
4.7.2 Product Pipline
4.7.3 R&D
4.7.4 Production
4.8 Shanghai Henlius Biotech, Inc.
4.8.1 Profile
4.8.2 Product Pipline
4.8.3 HLX01 (for NHL)
4.8.4 HLX02
4.8.5 HLX03
4.8.6 HLX04
4.8.7 HLX10
4.8.8 R&D
4.8.9 Production
4.9 CStone Pharmaceuticals
4.9.1 Profile
4.9.2 Product Pipeline
4.9.3 CS1001 (PD-L1 antibody)
4.9.4 R&D
4.9.5 Production

5 Technical Development Trends of Monoclonal Antibody
5.1 Immunogenicity is essential for the safety and effectiveness of antibody drugs, humanized antibody and fully human antibody hit the mainstream
5.2 Fc portions glycosylation modification significantly enhanced the cytotoxic effect of monoclonal drugs
5.3 Antibody-Drug Conjugates (ADC) can reduce the toxicity of chemical medicines, but preparation technology is still a challenge
5.4 Bispecific antibody – ‘1+1>2’

6 Appendix
6.1 PDB Sample Hospitals Medicine Sales Data, 2017Q1-2018Q2
6.2 PDB Sample Hospitals Sales Data of Medicines in Medical Insurance Negotiation Directory, 2017Q3-2018Q2 (unit: RMB million)

List of Table

Policies of China Monoclonal Antibody Industry, 2010-2018
Specific requirements for submission of declaration materials
Opinions on Reform of the Drug and Medical Device Review and Approval
China Oncology Market 2013-2030E
Top10 oncology drugs by generic name globally and in China in 2017
Incidence by Cancer Type of China, 2013-2022E
China Monoclonal Antibody Drug Market Size and Forecast, 2013-2022E
Global sales of PD-1/PD-L1 monoclonal antibody drugs, 2014-2017
Immuno-Oncology PD-1 and PD-L1 Inhibitor Uptake in the United States, 2014-2018
Clinical trial status of five launched PD-1/PD-L1 monoclonal antibody drugs on NSCLS therapy in China
Clinical trial status of homemade PD-1/PD-L1 monoclonal antibody drugs on lung cancer
Phase III clinical trial of Keytruda against NSCLC
The primary end point of Keynote-189 to reach OS and PFS
Regardless of the expression of PD-L1 in non-squamous NSCLC, Keytruda combined with chemotherapy is remarkablely effective
Contrastive clinical trial of NSCLC patients against different PD-L1 expression level
Both high expression of inhibitory receptor and non-PD-1 dependent pathway will lead to the exhaustion of T cells
Four kind responses of immunotherapy from the perspective of PD-L1+/- and tumor infiltrating lymphocyte
Combo therapy trial progress and essential clinical data of Opdivo
Combo therapy trial progress and essential clinical data of Keytruda
Combo therapy trial progress and essential clinical data of Imfinzi and Tecentriq
Layout of Chinese pharmaceutical enterprises on combo therapy of PD-1/PD-L1 monoclonal antibody
Development progress of PD-1/PD-L1 drugs in China
PD-L1 expression level, ORR and mediumOS of Opdivo, Tecentriq
Clinical data of Keytruda’s therapy on MSI-H/dMMR solid tumor patients
PFS and OS of Keytruda’s therapy on rectal cancer patients with MSI
Occurrence rate of MSI in 18 kind of tumors
Phase II clinical trial of Opdivo against small lung cancer
Correlation of ORR and TMB of PD-1/PD-L1 therapy in 27 kind of tumors
Distribution of TMB in lung cancer patients harboring oncogenic drivers
Ipilimumab (Yervoy) blocks negative signaling from CTLA-4
Global sales of Yervoy, 2011-2017
Phase III clinical trial of Opdivo and Yervoy combo therapy on renal cell carcinoma
Therapeutic effect of Opdivo+Yervoy on Phase III/Type IV NSCLC patients
Proliferation of oncolytic virus leads to splitting of tumor cell and activate the immune system
Approved oncolytic virus drugs worldwide
Phase III clinical trial results of oncolytic virus drugs worldwide
Historical and Forecast Global PD-1 & PD-L1 Inhibitors Market Size, 2015-2030E
Forecast PRC PD-1 & PD-L1 Inhibitors Market Size, 2018E-2030E
‘4+4’ Competitive landscape of Chinese PD-1/PD-L1 market
PD-1/PD-L1 clinical trial progress of four multinational pharmaceutical companies in China
PD-1/PD-L1 clinical trial progress of China domestic pharmaceutical companies
Development of three generations of CD20 monoclonal antibody
Distribution of non-hodgkin lymphoma (NHL) in China by type
Global sales of rituximab, 2009-2017
Rituximab sales in Chinese sample hospitals, 2012-2017
Indications of rituximab in China and USA
Rituximab entered the Chinese health insurance list in 2017
Efficacy comparison of Ofatumumab and Rituximab combined with cis-platinum, cytarabine and DHAP on recurrernt DLBCL patients through ASCT
Clinical trial CLL11: Obinutuzumab/Rituximab combine with chlorambucil as the preferred therapy for CLL patients
Clinical trial GADOLIN: Obinutuzumab combine with bendamustine remarkably improve the PFS of recurrent follicular lymphoma patients
Clinical trial Gallium: Obinutuzumab combine with chemotherapy remarkably improve the PFS of untreated recurrent follicular lymphoma patients
R&D progress of CD20 monoclonal antibody in China by players
Proportion of diffuse large B cell lymphoma and follicular lymphoma in NHL in China
Forecast of peak market cap of rituximab in China
Launched overseas HER2 monoclonal antibodies
Global sales of Roche’s HER2 monoclonal antibodies (Herceptin/Perjeta/Kadcyla), 2012-2017
Different binding site of Pertuzumab/Trastuzumab with HER2 target point
Therapeutic effect comparison of Pertuzumab/Trastuzumab/docetaxel combo VS placebo/Trastuzumab/docetaxel combo
Markers test and judgement of breast cancer molecular subtype in China
Distribution of breast cancer subtype by different race
Distribution of breast cancer subtype among yellow race
Proportion of positive HER2 in different type of stomach cancers
Different drugs aiming at HER2 target point
Clinical research result of CLEOPATRA
Therapeutic effect comparison between Kadcyla and capecitabine+lapatinib on past therapy failed HER2 postive advanced breast cancer patients
Herceptin-price reduction after entering Chinese new medical insurance system
Therapy cost & permeability of Herceptin in one year-breast cancer
Therapy cost & permeability of Herceptin in one year- gastric cancer
Phase II clinical data of Hengrui’s Pyrotinib
R&D progress of HER2 monoclonal antibody in China
Market cap forecast of HER2 inhibitor in China-breast cancer
Market cap forecast of HER2 inhibitor in China-gastric cancer
Classification of VEGF/VEGFR inhibitors
Overview of launched anti VEGF/VEGFR drugs
Mechanism of VEGF in immunosuppression
INV-assessed PFS in ITT-WT (Arm B vs Arm C)
INV-assessed PFS in Teff-high WT (Arm B vs Arm C)
Preliminary OS in ITT-WT (Arm B vs Arm C)
Interaction between PDGF and PDGFR
Clinical trial data of Avastin combined with chemotherapy (duration of survival)
Clinical trial data of Avastin combined with chemotherapy (progression-free survival)
Clinical trial result of Avastin therapy on non squamous NSCLC
Global sales of Bevacizumab, 2011-2017
Bevacizumab sales in Chinese sample hispitals, 2013-2017
Biosimilar Bevacizumab R&D progress of Chinese pharmaceutical enterprises against tumour therapy
Global sales of wetAMD drugs, 2012-2017
Forecast of ophthalmology pharmaceuticals companies, 2023E
Ranibizumab sales in Chinese sample hispitals, 2013-2017
Ranibizumab sales in Chinese sample hispitals, 2014-2017
Anti VEGF drugs R&D progress of Chinese pharmaceutical enterprises against AMD
Market cap of VEGF monoclonal antibody in lung cancer therapy
Market cap of VEGF monoclonal antibody in rectal cancer therapy
Market cap of VEGF monoclonal antibody in wet AMD therapy
Signal path conduction mechanism of EGFR
Mutational pattern and sensitivity against TKI of EGFR related gene’s different locus
Launced EGFR targeted drugs in China and overseas
Indications of EGFR monoclonal antibodies
OS & PFS data of Necitumumab
CR data of Nimotuzumab
Clinical data comparison of panitumumab and cetuximab
EGFR indications expanding overview
Development history of EGFR TKIs
Timeline of EGFR small-molecule inhibitors, 1993-2015
Overview of representative EGFR-TKIs
Clinical data of first generation EGFR TKIs
Clinical data, Gefitinib vs Icotinib
Clinical data, Gefitinib vs Erlotinib
BRAIN clinical trial data of Icotinib on lung cancer brain metastasis
Clinical data, Gefitinib vs Afatinib
Locuses of EGFR T190M
Therapeutic effect comparison of third generation TKIs on EGFR mutation and T790+NSCLC patients
FLAURA clinical trial data (phase III)
Overview of TKI indications expanding
Distribution of R&D types of TKIs
R&D progress of EGFR monoclonal antibody in China
Overseas sales of EGFR monoclonal antibodies, 2013-2017
Cetuximab sales in Chinese sample hospitals, 2013-2017
Nimotuzumab sales in Chinese sample hospitals, 2013-2017
Market cap forecast of EGFR monoclonal antibody in China
Sales volume of nimotuzumab in Chinese sample hospitals, 15Q1-17Q4
Clinical trial data of Dacomitinib
Status of TKI R&D in China
Overseas sales of EGFR-TKIs, 2013-2017
EGFR-TKI sales in Chinese sample hospitals, 2013-2017
Market cap forecast of EGFR-TKI in China
Singal path of TNF-?
Structure of TNF-?inhibitors
Global sales of Humira, 2004-2017
Overview of RA drugs
Sales of arthritis drugs (non-biological preparation) in Chinese sample hospitals, 2012-2017
Sales of Humira, Enbrel and Remicade in Chinese sample hospitals, 2012-2017
Annual treatment expense of TNF-?drugs in China
Medical donating of Humira, Enbrel and Remicade in China
List of provinces Humira, Enbrel and Remicade entered the health insurance directory
Overview of launched TNF-?inhibitors in China
Overview of recombinent human II type TNF receptor - antibody fusion protein in Chinese healthcare insurance directory
Estimated number of TNF-? inhibitor users in China
Peak sales forecast of TNF-? inhibitor in RA treatment in China
Peak sales forecast of TNF-? inhibitor in AS treatment in China
Market share of biologics for therapy of autoimmune diseases in China, 2017
Market share forecast of biologics for therapy of autoimmune diseases in China
Sales of Etanercept, 2015-2023E
Sales of Etanercept in Chinese sample hospitals, 1Q2016-4Q2017
Average sales price of Etanercept in Chinese sample hospitals, 2012-2017 (Converted into 25mg)
Bidden price of Etanercept, Aug 2017-Apr 2018
R&D status of TNF-? inhibitor biosimilar in China
Mechanism of CD22
Comparison of SinoMab BioScience’s SM03 and existed biologics
Security performance of SM03
Peak sales estimate of CD22 inhbitor for RA therapy in China
Ownership structure of Junshi Biosciences
Product pipeline of Junshi Biosciences
Affinity of JS001 binding with PD-1 (Biacore)
Immunofluorescence assay results show that JS001 induced strong internalization
Flow cytometry results show that JS001 induced internalization and reduced the expression of PD-1 on the membrane surface concurrently
Efficacy of JS001 from clinical studies
Efficacy results of Phase I clinical trial in recurrent metastatic lymphoma treated with JS001
Optimal tumor shrinkage rate in recurrent metastatic lymphoma patients treated with JS001 in Phase I clinical trial
Tumor load changed over time of recurrent metastatic lymphoma patients treated with JS001 in Phase I clinical trial
Tumor load changed over time of soft tissue sarcoma patients treated with JS001 in Phase I clinical trial
Lung image of a soft tissue sarcoma patient treated with JS001 in Phase I clinical trial
Optimal tumor shrinkage rate in advanced esophageal cancer patients treated with JS001 in Phase Ib/II clinical trial
Optimal tumor shrinkage rate in advanced gastric adenocarcinoma patients treated with JS001 in Phase Ib/II clinical trial
Optimal tumor shrinkage rate in advanced nasopharyngeal cancer patients treated with JS001
Optimal tumor shrinkage rate in mucosal melanoma patients treated with JS001 combined with axitinib
Efficacy results of clinical trial of JS001 in the treatment of advanced melanoma
Comparison of subtypes of skin melanoma in the United States and China
Optimal tumor shrinkage rate in advanced melanoma patients treated with JS001
Efficacy analysis of advanced recurrent metastatic melanoma subgroup treated with JS001
R&D process of Junshi Biosciences
Ownership structure of BeiGene
Product pipeline of BeiGene
Ownership structure of Innovent Biologics
Product pipeline of Innovent Biologics
Mechanism of action of sintilimab (IBI-308)
Sintilimab (IBI-308) has higher binding affinity for human PD-1 than pembrolizumab and nivolumab
Sintilimab (IBI-308) has a slower off-rate than pembrolizumab
Sintilimab outperforms both nivolumab and pembrolizumab in mixed lymphocyte reaction cytokine induction
Tumor infiltrating lymphocytes in a syngeneic murine model of cancer
Winn model demonstrating immune-based efficacy of sintilimab
PD-1 receptor occupancy by sintilimab after multiple doses in patients
Adverse events in the sintilimab/ pembrolizumab safety data set
Best response in relapsed/refractory classical Hodgkin’s lymphoma patients
Indications for which Innovent Biologics is currently evaluating sintilimab in clinical trials
Four main functions of Innovent Biologics’ fully-integrated platform
Partners of Mabworks Biotech
Preclinical Pipeline of Mabworks Biotech
Clinical Pipeline of Mabworks Biotech
Bio-innovative Antitumor Drugs Pipeline of HISUN
Bio-similar Antitumor Drugs Pipeline of HISUN
Shareholder Structure of Genor Biopharma
Revenue and Net Income of Genor Biopharma, 2015-2017
Assets and Liabilities of Genor Biopharma, 2015-2017
Antibody Product Line of Genor Biopharma
Biosimilar Drugs Processes of Genor Biopharma
Novel Antibody Processes of Genor Biopharma
Shareholder Structure of Henlius Biotech by the end of 2018
Biosimilar Product Pipeline of Henlius Biotech
Bio-innovative Product Pipeline of Henlius Biotech
Combo Therapy Product Pipeline of Henlius Biotech
Clinical Development of HLX01 for NHL
Development timeline of HLX02 for mBC/mGC
Clinical Development of HLX03 for PS
Clinical Development of HLX04 for mCRC
R&D Processes of Henlius Biotech
Shareholder Structure of CStone Pharmaceuticals
Product pipeline of CStone Pharmaceuticals
Indications CStone Pharmaceuticals is currently evaluating CS1001 (PD-L1 antibody) in clinical trials
Humanization classification of monoclonal antibhodies
Humanization distribution of antibodies launched in 2017
Structure of antibody Fc portions glycosylation modification
Activity influence of Fc end glycosylation against monoclonal drugs
Influence of Fc portions glycosylation modification against ADCC & CDC
Action principle of ADC
ADCs approved by FDA
ADCs under clinical trial
Mechanism of T-cell recruitment bispecific antibody
BiTE redirects T-cell to tumour cells
Bispecific antibody by different molecular structure
Synthetic method development history of bispecific antibodies
Primary synthesis type and by-product of CrossMAb antibody
Four CrossMAb antibodies under clinical trial
RG7802 Phase I clinical trial result of Roche
Bispecific antibodies approved by FDA
Clinical progress of bispecific antibodies in China
Model of monospecific antibody and bispecific antibody

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