By:DengYue International Business Division

Between November and December 2025, a group of newly approved innovative drugs in China reflected an emerging structural shift in the pharmaceutical landscape. These approvals span multiple therapeutic areas, from gene-fusion targeted oncology therapies to chronic cardiovascular disease management, as well as autoimmune disorders and preventive treatment for rare bleeding diseases.

Representative products in this group include:

● Zurletrectinib tablets – for patients with NTRK fusion-positive locally advanced or metastatic solid tumors

● Stogliflozin Malate tablets – for the treatment of primary hypertension

● Pikangqibai Monoclonal Antibody injection – for adults with moderate-to-severe plaque psoriasis requiring systemic therapy

● Matasimab injection – for routine prophylaxis in patients aged ≥12 years (≥35 kg) with hemophilia A or B

● Vipeptide injection – for glycemic control in adults with type 2 diabetes

For example, Zurletrectinib is a next-generation TRK inhibitor independently developed in China for the treatment of NTRK fusion-positive solid tumors, demonstrating a promising objective response rate and durable survival outcomes in clinical studies.

According to analysis from DengYueMed, a Hong Kong pharmaceutical wholesaler that closely tracks developments in China’s innovative drug sector, the significance of these drugs goes far beyond the addition of new indications. From a global market perspective, they represent entry into three pharmaceutical market structures that are expected to sustain long-term growth.

I.  Precision Medicine Infrastructure: Expansion of Gene-Driven Oncology Therapies

NTRK inhibitors such as Zurletrectinib belong to the category of tumor-agnostic therapies.

The commercial logic behind these therapies differs fundamentally from that of traditional oncology drugs.

Traditionally, oncology markets have been structured around tumor origin, such as:

● lung cancer

● gastric cancer

● breast cancerHowever, the precision medicine era is increasingly structured around genomic alterations, such as:

● NTRK fusions

● ALK mutations

● KRAS mutationsIn other words, treatment demand is now driven by molecular mutations rather than organ types.

This shift brings a critical implication:

Global demand for targeted therapies will increasingly depend on the availability of next-generation sequencing (NGS) infrastructure.

For international healthcare systems, this means:

● hospitals must develop molecular diagnostic capabilities

● patient selection becomes more precise

● a single drug may address multiple tumor typesThis model is gradually reshaping the global oncology drug market.

II. Chronic Disease Treatment: The Largest Pharmaceutical Consumption Market

Another category of products — including Stogliflozin Malate for hypertension and Vipeptide for type 2 diabetes — enters the largest pharmaceutical consumption structure worldwide: chronic disease management.

Within the global pharmaceutical market, conditions such as:

● cardiovascular disease

● diabetes

● hypertensionrepresent the largest patient populations requiring long-term medication.

Unlike oncology drugs, these therapies are characterized by:

● long-term treatment cycles

● large patient populations

● consistent supply demandAs a result, their market value lies not only in clinical efficacy but also in the sustainability of long-term drug supply systems and cost structures.

This segment has also become one of the key drivers of China’s pharmaceutical export growth in recent years.

III. Biologics Supply Chains: Cold Chain and Long-Term Treatment Markets

Biologic therapies represent another fundamentally different market structure.

For example:

● Pikangqibai Monoclonal Antibody – for psoriasis

● Matasimab – for prophylactic treatment of hemophilia

These therapies share several key market characteristics:

● high treatment adherence and repeat use

● long-term maintenance therapy

● strong dependence on cold-chain logisticsBoth psoriasis and hemophilia require continuous treatment rather than short-term medication.

This means patients typically require long-term maintenance therapy, which places significant demands on pharmaceutical supply chains.

Consequently, the real challenge in the global biologics market extends beyond drug development itself to include:

● batch-to-batch consistency

● cold-chain transportation

● regulatory documentation for international markets

● long-term supply reliabilityThis also explains why international distribution of biologic medicines relies heavily on well-established cross-border pharmaceutical supply systems.

IV. A Larger Trend: Structural Completeness in China’s Innovative Drug Portfolio

When viewed collectively, these five drugs reveal a clear industrial signal.

China’s innovative pharmaceutical sector is gradually building a more complete product structure across therapeutic areas:

This structure suggests that China’s innovative drug development is no longer concentrated in a single oncology segment. Instead, it is expanding across:

● precision medicine

● chronic disease management

● immune-mediated diseases

● rare disease therapiesSuch diversification is widely considered an important indicator of a maturing pharmaceutical innovation ecosystem.

V. A Practical Global Consideration: Capabilities Beyond the Drug Itself

For overseas hospitals and pharmaceutical distributors, the ability of new drugs to enter the market depends on several practical factors:

● consistent batch supply

● compliance with export and regulatory documentation

● cold-chain logistics capabilities

● flexibility for small-volume procurement and long-term cooperationAs Chinese innovative drugs increasingly enter global markets, Chinese pharmaceutical wholesalers with cross-border distribution experience are becoming more important within the international supply chain.

For example, DengYueMed, which has long served international pharmaceutical markets, continues to participate in China’s pharmaceutical import and export system. The company has accumulated experience in supplying oncology drugs, chronic disease therapies, and biologics, supporting overseas healthcare institutions with stable procurement channels and logistics solutions.

Conclusion

The approval of this group of drugs at the end of 2025 represents more than a numerical increase in new products.

More importantly, it demonstrates the emergence of a new industry structure involving:

● precision oncology therapies

● long-term chronic disease treatment

● maintenance biologic therapies

● rare disease managementWhen these sectors expand simultaneously, it signals that China’s innovative pharmaceutical ecosystem is moving beyond isolated breakthroughs toward multi-sector, parallel development.

In this process, China’s pharmaceutical distribution infrastructure is also gradually aligning with global markets. Companies such as DengYueMed, which actively participate in China’s pharmaceutical import and export trade, are helping facilitate the smoother integration of Chinese innovative drugs into the global healthcare system through stable supply and compliant export services.