Guolian: Heavyweight clinical data released, PPD-(L)1 dual-target drug once again raises the immunotherapy craze.
The dual antibody drug composed of PD-(L)1 and VEGF can achieve synergistic effects and reduce toxicity through the cooperation of both arms. Kangfang Bio and Pumis Bio respectively lead the global development of PD1/VEGF and PD-L1/VEGF dual antibody drugs, targeting multiple indications for personalized medicine.
Guolian released a research report stating that global heavy clinical data continues to emerge, leading to a surge in attention towards second-generation cancer immunotherapy. The immune checkpoint inhibitor PD-(L)1 monoclonal antibody has opened a new era in cancer treatment, and its broad-spectrum properties have led to the development of several major drugs. Dual-antibody drugs composed of PD-(L)1 and VEGF can achieve synergistic effects and reduce toxicity through the combination of two arms; meanwhile, cell factors such as IL-2 and IL-15 can synergize with PD-(L)1 to enhance targeting and reshape the tumor microenvironment, reducing systemic drug toxicity. This combination has become the focus of global attention as a hot "second-generation immunotherapy", generating widespread market interest and expectations for the future prospects of targeted drugs such as PD-(L)1/VEGF, PD-1/IL2, and PD-1/IL15.
Guolian's main points are as follows:
- Cancer immunotherapy drugs have the potential to become major products.
- The immune checkpoint inhibitor PD-(L)1 monoclonal antibody has opened a new era in cancer treatment, leading to the development of multiple major drugs, including Merck's Keytruda and Bristol-Myers Squibb's Opdivo. As the most prominent immune checkpoint inhibitor, Keytruda is expected to achieve global sales of $25 billion in 2023, but drugs of this kind still face challenges such as low response rates, safety issues, and drug resistance. To overcome the limitations of single immunotherapy, Chinese pharmaceutical companies have sparked a development trend in global dual-target "second-generation immunotherapy" drugs based on PD-(L)1.
- The shining stars of PD-(L)1/VEGF
- Dual-antibody drugs composed of PD-(L)1 and VEGF can achieve synergistic effects and reduce toxicity through the combination of two arms. AKESO and Pulimis Bio are leading the global development of PD-1/VEGF and PD-L1/VEGF dual-antibody drugs, aiming at multiple indications for Keytruda. AKESO's Ivosidenib was the first to receive approval in second-line NSCLC, and in first-line NSCLC became the first and only drug to demonstrate significantly better efficacy than Keytruda in a phase III head-to-head clinical study, demonstrating the potential for immunotherapy iteration. Pulimis' PM8002 is bringing new hope to patients with SCLC and triple-negative breast cancer. A new round of PD-(L)1/VEGF investment and financing frenzy has swept the world, with BD transactions waiting for opportunities.
- Second-generation immunotherapy such as PD-1/IL-2 becomes a "traffic player"
- Cell factors such as IL-2 and IL-15 can synergize with PD-(L)1 to enhance targeting and reshape the tumor microenvironment, reducing systemic drug toxicity, making it the hottest combination in the global "second-generation immunotherapy". Roche's IL-2R-biased design has become the mainstream in the early development of PD-1/IL-2, but it still requires clinical validation. INNOVENT BIO has uniquely designed the IL-2R-biased drug IBI363, which has shown excellent clinical efficacy and safety in advanced NSCLC, CRC, and melanoma after IO resistance, attracting widespread market attention and expectations. Companies such as Beijing Aosaikang Pharmaceutical, Shenghe Biological, and Jiangsu Hengrui Pharmaceuticals have successively laid out PD-1/IL-15 fusion proteins, with promising prospects.
Investment advice: Focus on companies involved in PD-(L)1/VEGF, PD1/IL2, PD1/IL15 drugs
It is recommended to pay attention to AKESO's Ivosidenib, which has the potential to replace Keytruda in the cornerstone of cancer immunotherapy, as well as INNOVENT BIO's IBI363, which adopts a unique -bias design and leads the way in a new direction for immunotherapy. Based on overseas mapping logic, it is suggested to focus on PD1/IL15 targeted drugs such as ASKG915, IAP0971, and SHR-1501.
Risk warning: Drug development does not meet expectations; industry competition intensifies; drug sales fall short of expectations.
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