What Should Be Done When Imported Drugs Are in Short Supply? A Comprehensive Analysis of Domestic Substitutes: Risks, Available Alternatives, and Resp

By:DengYue International Business Division

In recent years, with increasing volatility in the global pharmaceutical supply chain, patients in China have frequently faced issues such as shortages of imported drugs, supply interruptions, and even market withdrawals. These disruptions span multiple critical therapeutic areas, including oncology targeted therapies, rare disease medications, GLP-1 weight-loss drugs, and various biologics.

For patients who rely on long-term treatment with imported originator drugs, sudden inaccessibility often leads to multiple challenges, including treatment interruption, unclear substitution options, and information asymmetry.

Against this backdrop, key questions shared by both patients and clinicians have emerged:

● Are domestic substitute drugs reliable?

● Is it safe to switch medications?

● Are there compliant alternative access pathways available?

This article systematically analyzes, from four dimensions—pharmaceutical supply chain dynamics, clinical risks, progress in domestic substitution, and compliant access pathways—the practical response strategies to imported drug shortages in 2026.

I. Why Are Imported Drug Shortages Becoming Frequent in 2025–2026?

The issue of imported drug supply instability is not caused by a single factor, but rather reflects structural changes in the global pharmaceutical system.

1. Global Supply Chain Volatility and Production Prioritization

Demand for GLP-1 weight-loss drugs (such as semaglutide and tirzepatide), oncology targeted therapies, and cell and gene therapy-related products has increased rapidly, resulting in sustained global manufacturing capacity constraints.

When supply is insufficient, some multinational pharmaceutical companies prioritize core markets such as Europe and the United States, leading to intermittent supply instability in Asia.

2. Raw Material Dependence and Long Biologic Manufacturing Cycles

Biologics and innovative drugs involve complex manufacturing chains, including:

● Multi-tier active pharmaceutical ingredient (API) supply systems

● GMP-compliant manufacturing processes

● Cold-chain global distribution networks

Disruptions at any stage (e.g., plant shutdowns, quality control adjustments, or logistics interruptions) may trigger regional shortages.

3. Commercial Strategy Adjustments and Product Withdrawals

Under the influence of centralized procurement policies and pricing mechanisms, some originator drugs face:

● Declining sales volume

● Pressure from reimbursement negotiations

● Insufficient market returns

As a result, certain products may withdraw from the Chinese market or discontinue supply.

Between 2024 and 2025, multiple cases of imported drug registration certificate cancellations and market exits were observed, increasing the demand for clinical substitution.

4. Policy and Distribution Structure Changes

Centralized procurement policies have improved drug accessibility but have also accelerated the withdrawal of some high-cost originator drugs from hospital supply channels.

When certain drugs shift to outpatient or e-commerce channels, price volatility and supply instability may further increase.

II. Core Risks of Imported Drug Shortages: Disruption of Treatment Continuity

The impact of drug shortages is not merely “inability to purchase medication,” but more critically, interruption of treatment pathways.

1. Oncology Patients

Targeted therapies require continuous long-term administration:

● Increased risk of disease progression

● Limited subsequent treatment lines

● Potential reduction in overall survival benefit

2. Rare Disease Patients

For enzyme replacement therapies or disease-specific biologics:

● May cause irreversible organ damage

● Rapid symptom progression

● Limited alternative options

3. Patients with Autoimmune Diseases

Including rheumatoid arthritis, psoriasis, and inflammatory bowel disease:

● Increased risk of relapse upon discontinuation

● Disruption of disease control cycles

4. Chronic Disease and Long-Term Medication Users

Some patients may turn to high-cost retail channels due to shortages, leading to:

● Increased financial burden

● Reduced medication adherence

● Higher risk of unsupervised drug switching

III. Accelerated Domestic Substitution: From “Optional” to “Clinical Mainstream”

China’s innovative drug and biosimilar ecosystem has matured rapidly, and in several therapeutic areas, domestic substitutes have established structured replacement pathways.

1. Oncology Targeted Therapy: Rapid Breakthroughs in Domestic Innovation

Representative drugs include:

● EGFR inhibitors: almonertinib, furmonertinib, etc.

● ALK inhibitors: ensartinib, iralutinib, etc.

In lung cancer and other indications, domestic drugs are gradually becoming first-line treatment options.

2. PD-1/PD-L1 Immunotherapy: Formation of a Competitive Domestic Landscape

Domestic PD-1/PD-L1 inhibitors include:

● Sintilimab

● Toripalimab

● Camrelizumab

● Tislelizumab

Multiple indications have been included in international treatment guidelines, and some products have achieved overseas regulatory approval.

3. GLP-1 Metabolic Disease Therapy: Rapid Development

Against the backdrop of surging global demand for weight-loss therapies, China’s GLP-1 pipeline has entered a rapid development phase.

Among them, Mazdutide, developed by Innovent Biologics, as a GCG/GLP-1 dual agonist, has demonstrated strong potential in glycemic control and weight management, showing positive metabolic improvements across multiple clinical studies.

This class of drugs is driving China’s GLP-1 sector from “import substitution” toward “global competition.”

4. Biosimilars: Systemic Replacement of High-Cost Imported Biologics

Multiple blockbuster biologics now have established domestic biosimilar clusters:

● Bevacizumab (multiple biosimilars approved)

● Trastuzumab

● Rituximab

● Adalimumab

Key characteristics include:

● Significant price reductions

● Improved accessibility

● Expanded insurance coverage

IV. Key Principle: Domestic Substitution ≠ Complete Therapeutic Equivalence

It must be emphasized that: “same mechanism” does not equal “identical clinical outcomes.”

1. Small Molecules vs Biologics

● Small-molecule generics: generally closer to therapeutic equivalence

● Biologics/antibody drugs: structural complexity and immunogenicity differences remain

2. Self-Medication Switching Is Not Recommended

Especially in cases involving:

● Monoclonal antibodies

● Bispecific antibodies

● CAR-T therapies

● Gene therapies

All treatment decisions must be made based on clinical evidence and physician evaluation.

V. Compliant Access Pathways When No Alternatives Exist

When drugs are unavailable domestically, the following regulated pathways may be considered:

1. Boao Lecheng International Medical Tourism Pilot Zone

A special policy framework allowing access to innovative drugs already approved overseas but not yet widely available in China, particularly for oncology and rare disease patients.

2. Hainan Specially Approved Medical Devices and Drugs Policy

Under specific regulatory approval mechanisms, eligible patients may access certain innovative drugs and devices.

3. Cross-Border Medical Information Support

Within a compliant framework, patients may obtain:

● Overseas drug information assessment

● International second-opinion consultations

● Medical record translation and documentation support

● Treatment pathway evaluation and planning

For example, DengYue focuses on global innovative drug intelligence and cross-border medical resource coordination, helping patients understand differences in treatment options and drug accessibility across countries.

VI. Future Trends: Toward a Multi-Source Pharmaceutical Supply System

Over the next 5–10 years, the global pharmaceutical system is expected to evolve along three major directions:

● Increasing share of domestic innovative drugs

● Biosimilars becoming a mainstream supply component

● Greater integration of cross-border healthcare and real-world evidence

While drug shortage risks may still exist in the short term, the likelihood of “no available treatment options” is expected to decline significantly.

Conclusion

The issue of imported drug shortages is fundamentally a transitional phenomenon in the restructuring of the global pharmaceutical supply chain.

For patients, the key is not simply “finding a substitute drug,” but establishing a structured clinical decision-making pathway:

● Is there evidence-based domestic substitution?

● Can a safe therapeutic transition be achieved?

● Are there compliant alternative access pathways available?

Patients are strongly advised to make all treatment decisions under the supervision of qualified specialists and avoid unsupervised medication switching or reliance on unregulated channels.

As China’s innovative drug ecosystem continues to mature and global medical information flows accelerate, patients are gradually moving from an era of reliance on single imported drugs toward a future of multi-source accessibility and personalized treatment options.

In this transformation, professional medical institutions and information service platforms such as DengYuemed are playing an increasingly important bridging role, enabling earlier access to global treatment information and reducing treatment interruption risks caused by information delays.