Innovative Drug Development in China: Accelerates with Robust Pipeline and Global Ambitions
Innovative drug development in China is entering a phase of unprecedented dynamism.
A trend powerfully illustrated by a 59% surge in approvals during the first half of 2025.
This accelerated pace is fundamentally reshaping the sector, fueled by strategic policy support and a rapidly expanding global footprint.
As evidenced by a series of high-value international licensing deals.
Accelerated Approvals Signal Maturing Pipeline
The first half of 2025 served as a powerful benchmark for the sector’s progress, with Chinese regulators approving 43 innovative drugs.
This represents a striking 59% year-on-year increase and nearly matches the total of 48 drugs approved in the entirety of 2024.
This surge is a clear indicator of a more robust and maturing pipeline for innovative drug development in China, transitioning from a concept to a tangible output at scale.
Regulatory Reforms as a Key Growth Catalyst
Strategic government policies have been instrumental in fostering this growth.
Relevant departments have intensively issued a series of policies to promote industrial development.
The review time for innovative drug marketing applications has been shortened from 420 working days in 2017 to 235 working days; after seven rounds of adjustments since 2018, a cumulative total of 149 innovative drugs have been included in the national medical insurance drug catalog.
A Strategic Shift from “Fast-Follow” to “First-in-Class”
The trajectory of innovative drug development in China is evolving from imitation to origination.
This is particularly evident in complex areas like rare diseases, where recent approvals target high-unmet needs.
A prime example is the anti-CLDN18.2 CAR-T therapy CT041 developed by CARsgen Therapeutics, acknowledged as a pioneering cell therapy with best-in-class potential for gastric cancer, demonstrating China’s capability in novel modality development.
This signifies a broader move where companies are focusing on differentiated pipelines, novel targets, and advanced molecular modalities, driving a qualitative leap in the overall standard of innovative drug development in China.
Rising Global Stature through Landmark Deals
The quality and global competitiveness of innovative drug development in China are increasingly validated on the international stage.
From 2018 to 2024, out-licensing (license-out) transactions for China’s innovative drug pipelines experienced explosive growth, with both quantity and total value continuously climbing.
These are no longer minor deals for peripheral assets; several Chinese-developed drugs have been acquired as core components by multinational pharmaceutical giants.
This trend highlights a significant shift, where international players are actively seeking to integrate the outputs of innovative drug development in China into their own global portfolios.
Navigating the Final Hurdle: Global Market Integration
Despite the remarkable progress, a key challenge for the global expansion of innovative drug development in China remains regulatory alignment.
As pointed out by Dengyue Pharma, China’s current non-membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S) means domestically developed drugs must undergo multiple GMP inspections for international approval.
The ongoing push for PIC/S membership is widely expected to streamline this process, further propelling the global journey of innovative drug development in China and solidifying its competitive position on the world stage.
In conclusion, backed by strategic policy, validated by global partnerships, and driven by a new wave of scientific originality, innovative drug development in China has firmly transitioned from a story of potential to one of tangible global impact.
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