China has made significant strides in the R&D and manufacturing of avatrombopag maleate, transitioning from follower to parallel runner in the global area.

1. Active Pharmaceutical Ingredient (API) Manufacturing: Technological Independence and Innovation:

(1) High-Technology Synthesis: The avatrombopag molecule is complex with multiple chiral centers. Leading Chinese API manufacturers have successfully mastered key technologies like asymmetric synthesis, chiral resolution, and purification, enabling industrial-scale production with high purity and yield.

(2) Green Chemistry & Cost Control: Continuous process optimization is underway to shorten synthetic routes and employ greener solvents and reagents, reducing costs and environmental impact.

(3) Integrated Supply Chain: A largely self-sufficient domestic supply chain, from key starting materials to advanced intermediates, ensures stable and controllable API production.

2. Formulation Technology: Quality and Bioequivalence

(1) Mature Formulation Process: The maleate salt is formulated into conventional oral tablets. Domestic manufacturers have well-established expertise in its formulation, particle size control, and stability assurance.

(2) Consistency Evaluation & Global Outreach: For generic development, Chinese companies conduct bioequivalence (BE) studies adhering to international standards (e.g., FDA, ICH), ensuring parity with the originator drug. Several companies have obtained DMF filings with the U.S. FDA or ANDA approvals, demonstrating global supply capability.

3. R&D Trends and Future Directions

(1) Generic and Novel Formulation Development: Following patent expiry, multiple generic versions have been approved in China, improving affordability. Research into novel formulations for optimized delivery is ongoing.

(2) Expansion into New Indications: Local clinical trials are actively exploring its use in chemotherapy-induced thrombocytopenia and aplastic anemia to generate real-world data in Chinese populations.

(3) Continuous Manufacturing & Digitalization: The industry is exploring advanced technologies like continuous flow chemistry for API production, integrated with smart manufacturing to enhance efficiency and quality robustness.

In Conclusion, Avatrombopag maleate remains a vital TPO-RA option due to its distinct clinical advantages. The Chinese pharmaceutical industry, by mastering core synthesis technologies and establishing high-standard manufacturing, not only ensures the drug's accessibility but also demonstrates its rapidly advancing technological prowess within the global pharmaceutical value chain.