Qilu Pharmaceutical Invests RMB 200 Million in Romiplostim N01 to Tap into the RMB 160 Billion Hematological Market

Data from MiNe Network shows that Qilu Pharmaceutical's Romiplostim for Injection N01 has initiated Phase III clinical trials for its new indication, aplastic anemia, this month. This is expected to expand the patient population and increase product sales. Romiplostim for Injection N01, a biologic drug classified under Category 3.4, was approved by Qilu Pharmaceutical in April 2024. It is the first domestically produced long-acting TPO-RA drug in China, with sales in the three major terminals and six key markets in China reaching over 250 million yuan in the period from Q1 to Q3 of 2025.

Romiplostim N01 for Injection is a second-generation long-acting thrombopoietin receptor agonist (TPO-RA), an Fc-peptide fusion protein produced using recombinant DNA technology. In March 2022, Qilu Pharmaceutical submitted a new drug marketing application for Romiplostim N01 for Injection under biologics category 3.4, and it was approved for marketing in April 2024. The indication is adult chronic immune thrombocytopenia (ITP), suitable for patients who have had an inadequate response to other treatments (such as corticosteroids, immunoglobulins).

Qilu Pharmaceutical Actively Explores the Potential of This New Drug in Other Indications: Data from Menet shows that in December 2025, the Phase III clinical trial for aplastic anemia of this new drug was officially launched. As more indications are approved, the potential of Qilu Pharmaceutical's Romiplostim for Injection N01 will continue to be unleashed.

In China's three major terminals and six major markets (the statistical scope is described at the end of the article), the sales of Qilu Pharmaceutical's Romiplostim Injection N01 have experienced rapid growth after its market launch. The total sales for Q2-Q4 of 2024 reached approximately 30 million yuan, and the combined sales for Q1-Q3 of 2025 have already exceeded 250 million yuan.

In 2024, in the three major terminals and six major markets in China, the market size of drugs for blood and hematopoietic system (chemical + biological) was 167.1 billion yuan. From Q1 to Q3 of 2025, the market experienced a decline of 2.28%, putting significant pressure on this billion-dollar market. However, the sales of blood and hematopoietic system drugs by Qilu Pharmaceutical continued to soar in recent years, and it leaped into the TOP32 group (Tier 1) for the first time from Q1 to Q3 of 2025, with a sales growth rate as high as 60.34%.

The low molecular weight heparin sodium injection is currently the best-selling drug in Qilu Pharmaceutical's blood and hematopoietic system category, with sales reaching 310 million yuan in China’s three major terminals and six major markets from Q1 to Q3 of 2025. After the launch of the injectable Romiplostim N01, its sales surged rapidly, making it the second top product in the group's blood and hematopoietic system category. Additionally, the group's Rivaroxaban Tablets (+28.72%), Eltrombopag Ethanolamine Tablets (+75.74%), Avatrombopag Maleate Tablets (+68477.06%), Dabigatran Etexilate Capsules (+21211.83%), and Apixaban Tablets (+8.07%) showed astonishing growth, collectively driving the group’s success.Step by Step High(Maintain Rights)"Up."

Notably, Qilu Pharmaceutical's biologic drug QL2110 Injection, a Class 3.3 new drug submitted for clinical trial in September this year, has recently received clinical approval for the treatment of Hemophilia A.

Qilu Pharmaceutical has been continuously making efforts in the 160-billion-yuan blood and hematopoietic system drugs (chemical + biological) market. By 2025, it had already started to stand out. As its marketed new drugs expand indications and accelerate the entry of other new drugs, the group's status is expected to rise rapidly, becoming a new dark horse that the market cannot ignore.