Synapse - Global Drug Intelligence Database

Global Potential Targets and FIC Product Research Report (Q4 2024)

1，A comprehensive review was conducted of the 55 new drugs approved by the FDA in 2023, including 20 First-in-Class (FIC) therapies. Additionally, an analysis was performed on 8 promising FIC single-target agents and 10 FIC dual-target agents with significant potential for the first three quarters of 2024. 2，This report provides a comprehensive overview of the promising First-in-Class (FIC) single-target and dual-target agents anticipated for the fourth quarter of 2024. It includes detailed analyses of their mechanisms of action, current research and development progress, and potential clinical applications. 3，Depth Analysis of Potential Single-target FIC Varieties: This section provides an in-depth examination of the following single-target First-in-Class (FIC) agents: LTCC modulators, M2R allosteric modulators, S2R modulators, BRD4 BD2 inhibitors, PKMYT1 inhibitors, TAK1 inhibitors, NLRP3 inhibitors, and oral KRAS G12D inhibitors. The analysis covers their mechanisms of action, current research progress, and patent application status. 4, In-depth Analysis of Potential Dual-Target FIC Varieties: This section provides a comprehensive examination of the FXR-LIFR dual-target regulators and ROCK-HDAC dual-target inhibitors, both of which are First-in-Class (FIC) compounds. The analysis delves into their development potential and patent landscape.

Read →

Analysis of Lilly (LLY.N) Q3 2024 R&D Update

As the largest publicly traded pharmaceutical company by market capitalization, Eli Lilly has successfully launched multiple blockbuster drugs, with several high-potential candidates in its pipeline. Given the long and unpredictable R&D cycle of innovative drug development, similar investigational therapies often share common scientific and regulatory challenges.By analyzing the R&D strategies and pipeline decisions of major pharmaceutical companies, industry stakeholders can gain valuable insights into emerging trends, risk mitigation strategies, and innovation directions that could shape the future of the biopharmaceutical industry。

Read →

From tumors to autoimmune diseases, TCE bispecific antibody sees new opportunities emerging

T-cell engager bispecific antibodies (TCEs) represent the most widely utilized bispecific antibody mechanism. They function by simultaneously binding to tumor-associated antigens (TAAs) and CD3, a fixed component of the T-cell receptor (TCR) complex (CD3 × TAA).T-cell engager bispecific antibodies (TCEs) have demonstrated robust therapeutic efficacy in hematologic malignancies. For instance, CD20/CD3 glofitamab achieved a 50% complete response (CR) rate in patients with ≥2L relapsed/refractory diffuse large B-cell lymphoma (DLBCL), while retaining a cost advantage over CAR-T therapies. Current development priorities for next-generation CD3 bispecific antibodies include reducing cytokine release, improving response rates, and extending half-life . Current challenges in solid tumors include: 1. Cytokine release syndrome (CRS); 2. Off-target toxicity due to tumor antigen shedding; 3. Insufficient T-cell infiltration into the tumor microenvironment and recruitment of immunosuppressive T-cell subsets.Whether TCE bispecific antibodies can achieve deep tissue clearance, maintain long-term efficacy with continued use, and whether they will reduce efficacy when combined with immunosuppressants remain to be verified with long-term data. It is possible that CAR-T and TCE bispecific antibodies may co-exist in the treatment of autoimmune diseases, with TCE offering advantages such as “on-demand” use, improved safety, and lower costs.

Read →