At the turn of the year, the National Medical Products Administration set the tone for innovation in China's pharmaceutical industry in 2026 with a series of intensive actions.

Following New Year's Day, the National Medical Products Administration (NMPA) announced significant achievements for 2025, including the approval of 76 innovative drugs and a total transaction value exceeding US$100 billion for overseas authorizations . Subsequently, at the National Drug Supervision and Management Work Conference held on January 6, NMPA Director Li Li further clarified the policy direction: China will strengthen service support for innovative drugs with new mechanisms and new targets across the entire chain, including communication, clinical trials, registration applications, and review and approval, to help innovative drugs achieve "first launch in China" .

This vision of "first launch in China" goes far beyond the geographical significance of "innovative drugs being launched in China first." It points to the deeper value dimension of "first launch in China": focusing on the unmet clinical needs of Chinese patients, responding to the unique disease spectrum characteristics of China, and adapting to the payment capacity of China's medical system.

So, which disease areas will be the first to break through under this strategy? Which companies will seize this window of opportunity to take center stage? The answer may lie in the matrix of innovative drugs approved in 2025 .

01

Cancer remains the focus

According to statistics on drug regulatory work released by the National Medical Products Administration, a total of 76 innovative drugs were approved in 2025 (this article only discusses the 73 drugs in Table 1). Among them, the field of oncology treatment accounted for more than 20 drugs, about one-third of the total, and continued to consolidate its position as the main battlefield for innovative drug research and development .

A deep analysis of this landscape reveals two major trends that outline the evolutionary trajectory of new oncology drug development in China.

Targeted therapies continue to iterate. The approval logic for targeted drugs in 2025 will no longer be simply known targets plus molecular modifications, but rather a focus on precise breakthroughs in unmet specific mutations and resistance mechanisms. Taking gelerexate citrate tablets as an example, the launch of this KRAS G12C inhibitor marks a leap from fast-follow to concurrent development in China's field of next-generation undrugable targets.

(ADCs) have become a new engine for growth. With approximately 20% of the oncology drug market share, ADCs have officially established themselves as a new growth engine for the industry. These ADCs share common characteristics: independent development of linker technology, diversified payloads, and precise indications, marking a leap forward for Chinese ADCs from license-in to self-developed and exported products.

Beyond oncology drugs, metabolic diseases account for approximately 20%, making it the second largest sector, with GLP-1 drugs being the core driver. The launch of GLP-1 drugs such as Mastidol and Vipenatide has formed a domestic "peptide matrix." This is not only a technological breakthrough but also a victory of market acumen—when Smegglutide's global annual sales exceeded $20 billion, Chinese companies seized the market before the patent cliff by employing a strategy of rapid follow-up and local optimization. Even more noteworthy is the expansion of indications: from lowering blood sugar to weight loss, from cardiovascular protection to NASH (non-alcoholic steatohepatitis), GLP-1 is replicating the broad-spectrum success of PD-1 in China.

Although the pediatric drug sector accounts for a small percentage of the overall market, it addresses the deepest clinical needs and pain points. The approval of products like Xiaor Huangjin Zhike Granules and Xiaor Niuhuang Tuofa Gao (a traditional Chinese medicine plaster) reflects the policy benefits of a priority review and approval process for pediatric drugs—reduced clinical trial requirements and shortened approval times. This not only fills the gap in suitable dosage forms for children but also suggests that future policy benefits will continue to favor areas with shortcomings, such as rare diseases and geriatric diseases.

02

Differentiation in corporate landscape

Behind the approval of innovative drugs in 2025, the corporate landscape is quietly diverging. Leading pharmaceutical companies such as Hengrui Medicine and CSPC Pharmaceutical Group still hold important positions, while biotech companies such as Innovent Biologics and Akeso are quietly emerging, and multinational pharmaceutical companies such as Roche and AstraZeneca are completing the transformation from distributors to co-creators.

Leading pharmaceutical companies are getting stronger. As the top domestic pharmaceutical company, Hengrui Medicine is undergoing a proactive adjustment in 2025, shifting from a broad-based approach to a more focused one. Taking Zametostaurate tablets as an example, Zametostaurate targets the EZH2 target, a key target for tumor epigenetic regulation closely related to the occurrence and development of various malignant tumors. By focusing on this cutting-edge target, Hengrui Medicine concentrates its resources on in-depth research and development, rather than spreading its efforts across multiple common targets, demonstrating a shift from a "broad-based" target strategy to a precise target focus.

Shijiazhuang Pharmaceutical Group 's strategy is more focused. Prugliptin tablets, as a DPP-4 inhibitor, may seem to be entering a red ocean market, but its approved indications include the niche scenario of diabetes mellitus complicated with chronic kidney disease. Patients with renal insufficiency have very few blood sugar lowering options, and this drug is excreted through both the liver and kidneys, precisely filling a clinical gap.

The second tier is rising. Innovent Biologics , with its two products, Mastidolide injection and Piconzibayumab injection, has validated the survival rule of "blockbuster products conquer the market." Mastidolide has been approved in China for long-term weight control in obese or overweight adults, becoming the world's first GCG/GLP-1 dual-receptor agonist weight-loss drug.

Akeso Biopharma represents a different model – the approval of its eromezab injection is a significant milestone in the field of autoimmune diseases. Eromezab is China's first and only domestically produced fully human monoclonal antibody drug targeting both IL-12 and IL-23. By simultaneously blocking these two key inflammatory factors, IL-12 and IL-23, it inhibits the inflammatory cascade of psoriasis from the upstream, making it a globally leading innovative drug targeting specific targets.

Multinational pharmaceutical companies are increasingly adopting localized R&D. In 2025, most of the approved products from multinational pharmaceutical companies were developed simultaneously globally, with some even being launched in China first, completely reversing the previous pattern of being "five years behind." For example, Roche's enoxacillin tablets were approved in China only five months later than in the United States. More importantly, approximately one-third of the patients in its global Phase III trials were Asian.

03

2026 Outlook

It is foreseeable that the number of approved innovative drugs will maintain steady growth in 2026. In September 2025, the National Medical Products Administration issued the "Announcement on Optimizing the Review and Approval of Clinical Trials for Innovative Drugs," which established a "30-working-day review and approval channel" for Class 1 innovative drug clinical trial applications that meet specific conditions, further accelerating the review and approval process for some innovative drug clinical trial applications with significant clinical value. It is expected that the number of approved innovative drugs will exceed 100 in 2026.

Specifically, the distribution of targets for innovative drugs approved in 2026 will show a differentiated trend. Based on 2025 data, several products targeting PD-1, CDK4/6, and GLP-1 have already been launched. The review direction in 2026 will place greater emphasis on "new mechanisms and new targets ." It is worth noting that the proportion of applications in the oncology field may further decrease, while the proportion of applications for autoimmune diseases, ophthalmological diseases, and neurodegenerative diseases will increase.

Secondly, the competitive landscape will become increasingly differentiated. Companies with commercialization capabilities will accelerate product launches, with companies like Hengrui Medicine, Innovent Biologics, and BeiGene expected to see record-breaking numbers of innovative drug approvals in 2026. Meanwhile, multinational pharmaceutical companies will increase their investment in China and raise their global R&D spending.

Furthermore, the internationalization process will enter a new stage. By 2025, the value of Chinese pharmaceutical companies' overseas licensing transactions has exceeded US$100 billion, and by 2026, a large number of domestically produced innovative drugs will be launched overseas, leading to increased recognition of innovation.

In summary, the objective data on innovative drugs approved in 2025 not only serves as a static record of the industry's annual progress but also as a dynamic benchmark for predicting development trends in 2026. Looking ahead to 2026, the industry will stand at a critical juncture between quantity and quality, testing the true clinical value and commercial sustainability of domestically produced innovative drugs.

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