Pharmaceutical Industry Report - Clinical Report, Drug R&D Report, Pharmaceutical Information

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.

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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。

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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.

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Advanced Technologies and Intellectual Property Trends in ADC Research and Development

Currently, antibody-drug conjugate (ADC) therapy is experiencing a phase of robust development. Numerous ADC drugs have received regulatory approval for market launch globally and have demonstrated significant efficacy across various tumor types. However, ADC therapy also encounters several practical challenges, such as ensuring drug stability, managing toxicity, designing clinical trials, and controlling costs. To address these challenges, researchers and pharmaceutical companies must continuously explore innovative technologies and optimize the design and manufacturing processes of ADCs to enhance both the safety and efficacy of treatment.This report offers a comprehensive analysis of the pivotal technologies and novel components associated with ADC therapy. It examines the current thriving landscape, practical challenges, and future innovations in ADC therapy. Additionally, it explores the global patent environment, including detailed patent analyses and emerging trends. Finally, the report anticipates potential future research directions for ADC therapy.

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Next-Gen Therapeutics for Fat Loss and Muscle Preservation: Emerging Targets and Strategies

The core content of this report is about the global Next-Gen therapeutics drugs for fat loss and muscle preservation. Starting from the leading antagonist of Activin (Activin) that targets the Activin-ActRII-ActRI pathway, the report elaborates on the basic information, mechanism of action, and therapy of the Activin-ActRII-ActRI pathway, and focuses on analyzing the key drugs in the ActRII pathway and other drugs for treating obesity and muscle loss syndrome. It presents a clear and comprehensive overview of the recent developments in the global research and development of new generation weight loss drugs for fat loss and muscle preservation.The summary section recommends some promising drugs and provides the reasons for the recommendations as well as possible risk factors.

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Roche's Bispecific Antibody Drug Emicizumab Patent Research and Practical Operation Guide

Emicizumab (Hemlibra) is a bispecific antibody developed by Roche that targets coagulation factors IXa and X. It was first approved by the FDA in November 2017 and received an expanded indication in 2018 for the prophylactic treatment of bleeding in hemophilia A patients, regardless of inhibitor status. This bispecific therapeutic is currently the only bispecific antibody drug used in the field of hemophilia. Since its market launch, Emicizumab has experienced a compound annual growth rate exceeding 300%, with sales surpassing $2 billion by 2020, thus becoming a blockbuster drug. In 2023, Hemlibra reported sales of CHF 4.147 billion (approximately $4.575 billion), reflecting a 16% year-over-year growth. The growth trajectory continues into 2024, with first-half sales reaching CHF 2.143 billion (approximately $2.529 billion). Sales are projected to reach $6.203 billion by 2028. As the highest-grossing bispecific antibody drug currently on the market, Emicizumab's patent landscape garners significant interest. This report aims to guide readers through a step-by-step patent analysis of the Emicizumab drug, ultimately providing a detailed patent landscape map. This can serve as a reference and provide insights for patent strategy in the bispecific antibody field.

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GPRC5D Target Patent Research Report

Multiple myeloma (MM) is a stubborn disease that remains incurable. In recent years, targeted therapies against B-cell maturation antigen (BCMA) have shown promising responses in a substantial number of treated patients. However, the global relapse rate among myeloma patients following anti-BCMA treatment strategies is on the rise. This necessitates continuous exploration of therapies with novel mechanisms of action and new targets, one of which is the G protein-coupled receptor family C group 5 member D (GPRC5D). Due to its unique expression in the plasma cell lineage of MM patients, along with positive data from targeted chimeric antigen receptor T cells (CAR-T) and bispecific antibodies (BsAb), GPRC5D has emerged as an ideal target for anti-myeloma antibodies. The latest "GPRC5D Target Patent Research Report" from Patsnap Lifescience offers an in-depth analysis of global R&D trends related to the GPRC5D target. The report indicates that besides the already marketed Talquetamab, there are 38 drugs currently in clinical or preclinical stages. The R&D trends and market prospects of these drugs are poised to be critical to the future of MM treatment. In terms of patent coverage, the GPRC5D target enjoys a long protection period, providing development companies with prolonged R&D incentives and market exclusivity. The report not only covers the core patent status of approved drugs but also estimates the patent protection periods for clinical stage drugs, offering significant references for R&D decision-making within the industry. Additionally, the report highlights the exploration of combination therapies involving GPRC5D-targeted drugs and their potential applications in other plasma cell disorders, thus providing new perspectives for the future direction of MM treatment. As more companies invest in the development of innovative drugs targeting GPRC5D, we believe this target will offer more treatment options and hope to MM patients.

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siRNA Drug Amvuttra Patent Research and Practical Operation Guide

Small interfering RNA (siRNA) are short double-stranded RNA molecules, typically 21-25 nucleotides long. On June 13, 2022, Alnylam's siRNA drug Amvuttra® (Vutrisiran) was approved by the FDA for treating polyneuropathy in adults with hereditary transthyretin-mediated (hATTR) amyloidosis. As Alnylam's flagship product, Amvuttra generated $560 million in sales in 2023. Compared to Alnylam's Onpattro, Amvuttra has lower manufacturing costs, requires less frequent dosing, and offers convenient subcutaneous injection, potentially leading more patients to switch to Amvuttra. Over 20 companies globally are developing siRNA drugs, but Alnylam dominates the market with a robust patent strategy covering Amvuttra's core components, delivery agents, sequences, and modifications. Alnylam utilizes divisional and continuation applications to maintain extensive patent protection, serving as a model for siRNA drug patenting. This report focuses on siRNA drug patent searches, using Alnylam's Amvuttra as a case study to illustrate the research process. It also provides an overview of the latest patent landscapes in the U.S. and China.

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Patent Research and Operational Guide for Daiichi Sankyo's ADC Drug DS-8201

Antibody-Drug Conjugates (ADCs) have a tripartite structure: Antibody-Linker-Payload. Currently, 272 ADCs are in clinical trials worldwide. Despite the withdrawal of Belantamab mafodotin, 14 ADCs remain on the market. ADC development is highly competitive, with strategic patent deployment being critical. For example, DS-8201's patents on each component offer primary protection, while novel combinations and pharmacological properties drive patent iteration and extend market exclusivity. Comprehensive extraction and aggregation of these source, core, and iterative patents are essential for high-quality patent research reports to guide infringement analysis, biosimilar development, and investment strategies. This report focuses on ADC patent searches, using DS-8201 as a case study to outline the research process and map the latest patent landscapes in China and the United States.

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