Besides the above products mentioned, there are still 7 anti-PD-(L)1 antibodies in Phase III clinical trials, and lung cancer is still one of the important indications the most companies lay out.
Among the products in Phase III clinical trials:
The blockbuster imported product atezolizumab is expected to be applied for marketing in China in 2019, which has been approved as a first-line therapy for non-squamous NSCLC in the U.S., being an indication expansion of great significance.
Furthermore, several imported products that enter China are noteworthy.
1. Novartis’ anti-PD-1 antibody PDR001 has been started Phase II clinical trial in China;
2. The cemiplimab co-developed by Regeneron/Sanofi has just started IND in China;
3. The IND application for the anti-PD-L1/TGF-β M7824 developed by Merck KGaA has been approved.
Attached table: Development Progress of Main Anti-PD-(L)1 antibodies in China
Pharmaceutical product | Target | Company | Progress in China | Imported / Chinese-produced | Marketed / late-stage clinical trial indication |
Nivolumab | PD-1 | BMS | Marketed | Imported | NSCLC |
Pembrolizumab | PD-1 | MSD | Marketed | Imported | Melanoma |
Toripalimab | PD-1 | Junshi Biosciences | Marketed | Chinese-produced | Melanoma |
Sintilimab | PD-1 | Innovent | Marketed | Chinese-produced | HL |
Camrelizumab | PD-1 | Hengrui Medicine | Applied for production | Chinese-produced | HL |
Tislelizumab | PD-1 | BeiGene | Applied for production | Chinese-produced | HL |
Durvalumab | PD-L1 | AstraZeneca | Applied for production | Imported | Stage III NSCLC |
Avelumab | PD-L1 | Pfizer | Phase III clinical trial | Imported | NSCLC |
KN035 | PD-L1 | Alphamab / 3D Medicines | Phase III clinical trial | Chinese-produced | Bile tract cancer |
Atezolizumab | PD-L1 | Roche | Phase III clinical trial | Imported | NSCLC, triple-negative breast cancer, bladder cancer |
CS1001 | PD-L1 | CStone Pharmaceuticals | Phase III clinical trial | Chinese-produced | NSCLC, gastric cancer |
AK105 | PD-1 | Akesobio | Phase III clinical trial | Chinese-produced | NSCLC |
SHR-1316 | PD-L1 | Hengrui Medicine | Phase III clinical trial | Chinese-produced | Extensive-stage small cell lung cancer |
TQB2450 | PD-L1 | Chia Tai Tianqing; CBT Pharmaceuticals | Phase III clinical trial | Chinese-produced | Head and neck squamous cell carcinoma |
Genolimzumab | PD-1 | Genor Biopharma | Phase II clinical trial | Chinese-produced | N/A |
KL-A167 | PD-L1 | Kelun Pharmaceutical | Phase II clinical trial | Chinese-produced | N/A |
PDR001 | PD-1 | Novartis | Phase II clinical trial | Imported | N/A |
GLS-010 | PD-1 | WuXi Biologics; Gloria Pharmaceuticals | Phase II clinical trial | Chinese-produced | N/A |
AK103 | PD-1 | Akesobio; Hansi Biological | Phase II clinical trial | Chinese-produced | N/A |
BAT1306 | PD-1 | Bio-Thera Solutions | Phase II clinical trial | Chinese-produced | N/A |
KN046 | PD-L1; CTLA4 | Alphamab | Phase II clinical trial | Chinese-produced | N/A |
Read More:
China has Entered the Era of Tumor Immunotherapy: Updates on the R&D Progress of Anti-PD-(L)1 Antibodies
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