Qilu Pharmaceutical's Lusutrombopag Tablets Approved, Becoming Second Domestic Manufacturer as Sales Surge by 76%
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On January 22, the official website of the National Medical Products Administration (NMPA) showed,Qilu PharmaceuticalSubmittedLusutrombopag TabletsApproved for marketing, deemed to have passed the consistency evaluation. Thus far, the number of companies in China that have passed the evaluation for this variety has increased to two — with Kelun Pharmaceuticals securing the first generic approval in January 2025.Qilu PharmaceuticalThis approval marks the second domestically produced option in China, further igniting the competition in the oral TPO-RA赛道 for Chinese substitutes.
Screenshot source: NMPA official website
Heavyweight Product Surges 76%, TPO-RA Sector Expansion
Lusutrombopag TabletsYesShionogiA New Generation of Orally Administered Small Molecule Thrombopoietin Receptor Agonist（TPO-RA）, approved in Japan in 2015, gained FDA approval in the United States in 2018, and was introduced to China in June 2023 for chronic liver disease with thrombocytopenia.(Planned Surgery/Diagnostic Procedure)Adult patients. Its core advantages are significant: as the world's first and only oral TPO-RA with no dietary restrictions, it has higher compliance compared to injectable therapies, can reduce bleeding events and transfusion needs, and carries a lower risk of portal vein thrombosis than similar products; after being included in the Class B medical insurance catalog through negotiations in 2023, its accessibility has been further improved.
In the market, this variety is rapidly gaining volume. Data from MoEntropy Medical Database shows that sales in the hospital market across all terminals in the first three quarters of 2025 have exceeded 30 million yuan, a year-on-year surge of 76.02%, making it one of the fastest-growing varieties in the hematology field.
Screenshot source: All-terminal Hospital Sales Database (Check Data. Find MoxEntropy)
Lusutrombopag Qilu Approved, Securing the 2nd Spot in China
From the perspective of the approval rhythm,LusutrombopagThe localization process in China is proceeding rapidly: the original research was approved in June 2023, and in August of the same year, Kelun Pharmaceuticals was the first to submit an application for market registration under the new classification. In January 2025, it took the lead in obtaining the first generic approval and became the first to pass the evaluation; this time,Qilu PharmaceuticalSuccessfully approved, becoming the second domestically produced.
Currently, the competition for generic versions of this drug has already formed a梯队 (tier): apart from Kelun and Qilu Pharmaceutical Co., Ltd., three other pharmaceutical companies—Yangling Kesen Bio-Tech, Hainan Hailing Chemical, and Nanjing Haina Pharmaceutical—have submitted Class 3 generic applications that are still under review. The number of companies passing the review is expected to increase further in the future.
Screenshot source: China Drug Evaluation Database (Check Data. Find MoEntropy)
From the perspective of the market landscape, Kelun has already captured the major share due to its first-mover advantage, but Qilu Pharmaceutical's entry will intensify price competition and channel contention. However, considering the current small base of this product...(Only 30 million in the first three quarters of 2025), and the base number of patients with chronic liver disease is huge(About 400 million in China)In the short term, the market is still in an expansion phase, and the possibility of a dual-leadership situation is relatively high.
Qilu Approved Matrix: Over 200 Products Approved, More Than 65 First-Time Approvals
This timeLusutrombopagApproved, isQilu PharmaceuticalAnother proof of the strength of generic drugs. To date, the company has received approval and passed the consistency evaluation for over 200 varieties, among which...Ondansetron Hydrochloride Injection、Etoricoxib Tablets、Lenalidomide CapsulesMore than 65 products, including [product names], are the first in China to pass the evaluation, forming a dual barrier of "first generics + passed evaluation" in core treatment areas such as oncology, anti-infection, and hematology.
Screenshot source: Approved Drugs Summary Database (Check Data. Find Moxone)
The approval of Lurbinectedin not only marks a phased achievement of Qilu Pharmaceutical's generic drug strategy, but also reflects the company’s deep-rooted approach in focusing on “major diseases + high barriers” products—consolidating its leading position in the specialty drug sector by offering cost-effective domestic alternatives. As more pending generic drugs are approved, Qilu Pharmaceutical’s “evaluation-passed moat” will further expand.
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