Roxadustat capsules from FibroGen (China) .

In terms of specific sales figures, Ametinib Mesylate tablets topped the list with sales of 5.53 billion yuan , far ahead of the competition, followed by Vometinib Mesylate tablets with 3.757 billion yuan . The threshold for the top ten has risen to 1.7 billion yuan, with total sales exceeding 26.5 billion yuan.

Domestic companies such as Hengrui Medicine, BeiGene, Hansoh Pharmaceutical, Allis, Simcere Pharmaceutical, and Akeso Biopharma are the main players on the list, demonstrating the vigorous vitality of pharmaceutical innovation in China.

Note: The products listed in this article are Class 1 innovative drugs approved for marketing in 2016 for chemical drugs and 2020 for traditional Chinese medicine and biological products. Sales data cover the three major terminal markets of domestic hospitals, retail and e-commerce.

01
Domestic innovative drugs account for 9 seats

The 2025 list of the top 10 innovative drugs in the Chinese market shows a clear dominance of domestically produced drugs . Of the top ten innovative drugs in terms of sales, except for roxadustat capsules, the other nine are domestically produced, accounting for as much as 90%.

In terms of therapeutic area distribution, oncology remains the primary battleground for innovative drugs. The list includes six anti-tumor drugs: three EGFR-TKI inhibitors (ametinib, vormetinib, and flumatinib), one BTK inhibitor (zanubrutinib), one PD-1/CTLA-4 bispecific antibody (canducinilimab), and one AR inhibitor (revelutinamide). Additionally, there is one hematologic drug (hetrombopag), one nervous system drug (edaravone dexborneol), one renal anemia drug (roxadustat), and one anesthetic drug (cycloprophen). This market distribution reflects both the enormous clinical demand in oncology and the strategic positioning capabilities of Chinese pharmaceutical companies in differentiated market segments.

In terms of company distribution, Hansoh Pharmaceutical ranked first with two products on the list: Ametinib (RMB 5.53 billion) and Flumatinib (RMB 1.779 billion), totaling RMB 7.309 billion in sales, making it the biggest winner . Hengrui Medicine also performed well , with Hetrombopag (RMB 1.762 billion) and Revelumid (RMB 1.851 billion) contributing a total of RMB 3.613 billion in sales. BeiGene, Allergan, Simcere Pharmaceutical, Akeso Biopharma, and Hisun Pharmaceutical each had one product on the list, showcasing the diversified competitive landscape of Chinese innovative pharmaceutical companies.

In terms of product ranking, ametinib mesylate tablets topped the list with sales of 5.53 billion yuan , becoming the best-selling innovative drug in the Chinese market in 2025. This third-generation EGFR-TKI inhibitor, independently developed by Hansoh Pharmaceutical, was approved for marketing by the National Medical Products Administration in March 2020 for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer who have progressed after prior EGFR-TKI treatment and are T790M mutation positive.

The success of ametinib is no accident. As the first domestically produced third-generation EGFR-TKI , ametinib filled a gap in the domestic market. Compared with imported similar products, ametinib has a significant price advantage while maintaining comparable efficacy, and it was successfully included in the National Reimbursement Drug List at the end of 2020, achieving rapid sales growth.

Fumetinib mesylate tablets ranked second with sales of 3.757 billion yuan . This third-generation EGFR-TKI, developed by Shanghai Allis Pharmaceuticals, was approved for marketing in March 2021 and included in the national medical insurance catalog in the same year. As the second domestically produced third-generation EGFR-TKI, the launch of Fumetinib has provided patients with more treatment options.

02
The only foreign company to be shortlisted

In the 2025 list of the top 10 innovative drugs in the Chinese market, Roxadustat capsules were the only foreign-invested product to make the list, ranking third with sales of 2.74 billion yuan. This drug, co-developed by AstraZeneca and FibroGen, is the world's first approved small-molecule hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of renal anemia.

Roxadustat is unique in that it is the first domestically developed and approved original drug in China. Although developed with the participation of multinational pharmaceutical company AstraZeneca, the clinical trials and registration applications for roxadustat in China were entirely handled by FibroGen (China), and received support from the National 13th Five-Year Plan Major New Drug Innovation and Development Project. In December 2018, roxadustat was approved for marketing in China, becoming the first country in the world to launch the drug, several years ahead of markets such as Japan and the United States.

This " China-first launch model " breaks the traditional pattern of multinational pharmaceutical companies launching globally simultaneously or lagging behind in China, reflecting China's rising status in the global innovative drug R&D system. The success of roxadustat also provides a model for subsequent multinational pharmaceutical companies to conduct original research and innovation in China.

The fact that roxadustat is the only drug on the list reflects the structural challenges faced by multinational pharmaceutical companies in China's innovative drug market.

First, Chinese domestic pharmaceutical companies have achieved innovative breakthroughs in the field of oncology . For popular targets such as EGFR-TKIs, BTK inhibitors, and PD-1/CTLA-4 bispecific antibodies, domestically developed innovative drugs have been launched first or simultaneously, and are more competitively priced. Taking EGFR-TKIs as an example, the market share of imported drugs has been squeezed by domestic products such as amitinib and vormetinib.

Secondly, the national medical insurance negotiation system has put price pressure on imported innovative drugs . The National Healthcare Security Administration, through a "price-for-volume" negotiation mechanism, has significantly reduced the prices of imported innovative drugs. For multinational pharmaceutical companies, lowering prices to be included in the medical insurance program means shrinking profit margins, while not being included risks market marginalization. Faced with this dilemma, some multinational pharmaceutical companies have chosen strategic withdrawal or contraction of indications.

More importantly, the R&D capabilities and efficiency of Chinese domestic pharmaceutical companies have significantly improved . Taking BeiGene as an example, zanubrutinib has not only been approved in China, but also in major markets such as the United States and the European Union, achieving true globalization. The success of this dual-application model between China and the US proves that Chinese pharmaceutical companies have the ability to compete with international giants.

03
Multiple "first" varieties

The list includes many domestically developed innovative drugs that are either the first in the world or the first in China , signifying that China's innovative drug industry is rapidly moving from me-too to first-in-class.

Cantalonizumab : Developed by Akeso Biopharma, cantalonizumab is the world's first approved PD-1/CTLA-4 bispecific antibody and China's first bispecific antibody drug. This drug targets both PD-1 and CTLA-4 immune checkpoints, enhancing anti-tumor immune responses through synergistic dual-target effects. It was approved in June 2022 for the treatment of recurrent or metastatic cervical cancer; in September 2024, it was approved for first-line treatment in combination with chemotherapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma; and in May 2025, it was further approved for first-line treatment of persistent, recurrent, or metastatic cervical cancer.

Zanubrutinib : BeiGene's zanubrutinib is not only the first domestically developed BTK inhibitor approved in China, but also the first Chinese-developed anticancer drug to receive FDA approval for marketing in the United States. Zanubrutinib was granted Breakthrough Therapy Designation by the FDA, becoming the first Chinese-developed anticancer drug to receive this designation.

Propofol : Developed by Hisun Pharmaceuticals, propofol is China's first innovative intravenous anesthetic drug with completely independent intellectual property rights. While maintaining the advantages of propofol's rapid onset and recovery, this drug significantly reduces the incidence of respiratory depression, adverse cardiovascular events, and injection pain.

Revelulide : Hengrui Medicine's revelulide is China's first independently developed novel androgen receptor inhibitor, approved in 2022 for the treatment of metastatic hormone-sensitive prostate cancer with a high tumor burden. Previously, the domestic market for novel AR inhibitors was monopolized by imported products; the launch of revelulide has broken this pattern.

Edaravone and dextroborneol : Simcere Pharmaceutical's edaravone and dextroborneol injection is the first approved combination preparation of edaravone and dextroborneol in China, used to improve neurological symptoms caused by acute ischemic stroke. This drug provides a new treatment option for stroke patients through its multi-target synergistic effect.

Ametinib and Vometinib : Ametinib from Hansoh Pharmaceutical and Vometinib from Alliston Pharmaceutical Group are the first and second domestically produced third-generation EGFR-TKIs to be approved, respectively. Together, they have broken the monopoly of imported products in this field, allowing domestic patients to obtain treatment options comparable to international standards at more accessible prices.

The emergence of these globally pioneering and domestically first-of-its-kind products is a concentrated manifestation of the systemic leap in the capabilities of China's innovative drug industry.

At the molecular design level, domestic companies have mastered core technologies such as antibody engineering, precise small molecule design, and bispecific antibody construction. At the clinical development level, China has become the world's second largest clinical trial market, providing ample patient resources and efficient execution capabilities for new drug development. At the registration and application level, policy tools such as priority review and breakthrough therapy are being used maturely, significantly shortening the time to market for innovative drugs.

04
Conclusion

The 2025 list of the top 10 innovative drugs in the Chinese market marks a significant milestone in the development of China's innovative drug industry. The 9:1 ratio of domestic to foreign companies is not just a number, but a signal—China's innovative drug industry has the strength to compete with international giants and is transforming from a follower to a leader.

However, it should be clearly recognized that entering the top 10 is only the beginning, not the end. In the global pharmaceutical innovation landscape, China still needs to continue to exert efforts in original innovation, global operations, and brand value in order to play a more important role in the global pharmaceutical innovation system.

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