Guotai Junan Securities: China's innovative drugs are in the early stage of realizing innovative achievements, optimistic about the potential emergence of the next blockbuster product in specific segments

According to the Zhitong Finance APP, Guojin Securities released a research report stating that China's innovative drugs are on the rise and are in the early stages of realizing innovative results; there are still significant opportunities for independent development success and large-scale BD (business development) licensing transactions in the future. In the field of oncology, two major directions continue to be of interest: ① observing the multidimensional iteration of ADC (antibody-drug conjugates), including innovations in targets, antibody structures, and toxin combinations; ② observing the innovative combinations and spatial structures of molecular components in immunotherapy, which will lead to breakthroughs with new combinations of ICI (immune checkpoint inhibitors), TAA (tumor-associated antigens), cytokines, and TME (tumor microenvironment) related chemokines. The firm is optimistic about the potential emergence of the next blockbuster product in the TCE (T-cell engagers), other bispecific/multispecific antibodies, innovative ADCs, and other niche markets along with their clinically leading companies.

Guojin Securities' main viewpoints are as follows:

Background

The explosion of innovative drug BD (licensing cooperation transactions) and their upfront payments has become the new market focus on who will secure the next billion-dollar upfront payment. (1) As early as March 2024, the firm published an in-depth report titled "2024: Ten Major Outlooks for the Innovative Drug Industry Chain" after reviewing over 200,000 global clinical trials, more than 3,000 listed pharmaceutical and medical companies, and nearly 15 years of evolution of global blockbuster drug products and their indications and targets, predicting the rise of China's innovative drugs and the explosion of BD transactions from 2024 to the present. (2) Recently, as 3SBIO set a historical high for China's innovative drug BD transaction upfront payment at $1.25 billion, the firm attempted to unravel the evolution of global immunotherapy and chemotherapy treatment methods and the innovative landscape of new molecular constructs to identify the next hotspot, aiming to provide references for investors and industry companies for forward-looking layouts.

Trend: Innovative upgrades, global oncology immunotherapy enters a new era of PD-1 (programmed cell death protein 1) combined with TAA (tumor-associated antigens) and cytokines

(1) MNCs (multinational pharmaceutical companies) are facing the patent cliff of their own blockbuster products while rapidly emerging innovative drug assets globally, including in China, are being licensed in to supplement pipeline shortcomings, and this trend will continue. (2) The global innovative drug BD upfront payments have entered the billion-dollar level era, with China's total upfront payment accounting for 40%. (3) Who will secure the next blockbuster BD like 3SBIO? The firm believes it will be in the three major sectors of oncology, chronic diseases, and CNS (central nervous system). In the field of innovative macromolecules for oncology immunotherapy, the combination of PD-1 and TAA will evolve into a new era of PD-1 combined with TAA and factor classes.

Focus: From PD-1 to PD-1/VEGF (vascular endothelial growth factor) or IL-2 (interleukin-2) bispecific antibodies, and then to PD-1/VEGF/IL-2 trispecific antibodies, enhancing efficacy while reducing toxicity is fundamental

(1) From monoclonal antibodies to bispecific antibodies, Kangfang Biotech's PD-1/VEGF has head-to-head outperformed the nearly $30 billion annual sales PD-1 monoclonal antibody king. (2) From tumor antigens TAA to new molecules upgraded with IL-2 factor classes enhancing PD-1, Innovent Biologics' PD-1/IL-2 released data for the first time at ASCO, achieving impressive early data in three indications: immune-tolerant lung cancer, melanoma, and cold tumor colorectal cancer. (3) Currently, major pharmaceutical companies are advancing their exploration of immune macromolecules from single monoclonal antibodies to combination therapies, and further to bispecific and multispecific antibodies targeting multiple sites In the construction of new molecules, there has been an evolution from the combination of ICI (immune checkpoint inhibitors) with TAA (tumor-associated antigens) or CD3 and other T cell receptors or co-stimulatory structures, to the combination of ICI with cytokines such as IL-2 or the addition of TAA. The purpose of these various combinations is to enhance the efficacy and reduce the toxicity of new immune therapy molecules.

Forecast: In the post-PD-1 era, the upgrade of cytokine-based IO (tumor immunity) has just begun; the exploration of IL-2 is only the start.

(1) Dozens of pharmaceutical companies are laying out strategies for structural innovations combining PD-1 with IL-2 and other cytokines, prodrugs, masking peptides, and spatial masking effects. According to the Insight database, as of August 11, 2025, there are 23 domestic and international companies, including Innovent Biologics, Heng Rui Medicine, Junshi Biosciences, Shijiazhuang Pharmaceutical Group, and Sinocelltech, that have entered the clinical stage with new molecules/cells constructed from the combination of PD-1, a single ICI (immune checkpoint inhibitor), and cytokines. (2) Chemokine receptors may become the next hotspot; Lixin Pharmaceutical, a subsidiary of SINO BIOPHARM, is targeting CCR8 (C-C chemokine receptor) which is highly expressed in the TME (tumor microenvironment) within Tregs, with innovative monoclonal antibodies poised for launch. In addition to the combination of immune checkpoint inhibitors like PD-1 with anti-TAA, it is anticipated that combinations of PD-1 with interleukins, TGFβ (transforming growth factor beta), and the development of TME-related factors may become the next important track in the field of tumor immunotherapy.

Risk Warning

Risks related to international exchange rates, fluctuations in domestic and foreign policies, investment and financing cycle fluctuations, and mergers and acquisitions not meeting expectations