Drugdu.com expert's response:

FIC (First-in-class) drugs, as their name implies, are the first medications of their kind with entirely novel and unique mechanisms of action, pioneering the treatment of specific diseases. Their latest advancements can be outlined from several perspectives:

Ⅰ. Overview of FIC Drugs Globally and in China

Global Scope: According to publicly available information, the FDA approved a total of 55 new drugs in 2023, among which 20 were FIC drugs, accounting for 36% of the total. This underscores the pivotal role of FIC drugs in the global drug discovery and development landscape.

Chinese Scope: Chinese enterprises are increasingly focusing on innovative drugs. In 2023, 30 of the newly approved drugs in China were developed domestically, constituting 37% of the overall approvals. Furthermore, Chinese scholars' publications in authoritative journals indicate a significant increase in the total number of innovative products in China's pipeline, with FIC products growing from 418 in 2021 to 836 in 2024, at a much higher rate than me-too products.

Ⅱ. Specific Advancements in FIC Drugs

New Drug Launches: In recent years, multiple FIC drugs have successfully entered the market, such as Chipscreen Biosciences' Chidamide (HDAC inhibitor) and Chiglitazar (PPAR pan-agonist). Chidamide is the world's first orally available, subtype-selective histone deacetylase (HDAC) inhibitor, while Chiglitazar is the first globally approved PPAR pan-agonist, both showcasing the innovative achievements of FIC drugs in oncology and metabolic diseases.

Clinical Trials: Numerous FIC drugs are currently undergoing clinical trials to validate their efficacy and safety. For instance, Chipscreen Biosciences' Siorovlimab (H3B-8800) is in Phase 3 clinical trials globally for the treatment of small cell lung cancer, ovarian cancer, and other diseases. Additionally, drugs like CS12192 and CS32582 targeting autoimmune diseases are also progressing through clinical trials.

Application of Technological Platforms: Emerging technological platforms such as cell therapy, gene therapy, and nucleic acid-based drugs play crucial roles in FIC drug development. These platforms offer increased possibilities for FIC drug research, enabling interventions against more complex disease mechanisms.

III. Trends in FIC Drug Development

Enhanced Innovation: As technology advances and disease mechanisms become better understood, the innovation of FIC drugs will continue to strengthen. More FIC drugs with entirely new mechanisms of action and targets are expected to emerge, providing patients with broader treatment options.

Expanded Indications: Existing FIC drugs are actively exploring broader indications. For example, Chidamide has already been approved for treating multiple tumor types and is undergoing clinical trials for additional indications.

International Collaboration: The trend of Chinese FIC drug development aligning with international standards is becoming increasingly evident. An increasing number of Chinese innovative pharmaceutical companies are leveraging international collaborations and license-out agreements to bring their products to the global market, enhancing China's position in the global pharmaceutical industry.

In summary, FIC drugs are experiencing rapid development both globally and in China. With technological advancements and deeper insights into disease mechanisms, more innovative and efficacious FIC drugs are anticipated to emerge, bringing hope to patients worldwide.