Qilu Pharmaceutical Secures Dual Approvals: First-to-File Siponimod for Rare Disease and Second Domestic Abemaciclib for $800M Breast Cancer Market
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On May 21, according to the official website of NMPA,Qilu PharmaceuticalSubmittedTwo Class 4 generic drugs——Siponimod TabletsAndAbemaciclib TabletsOfficially approved for marketing and deemed to have passed the consistency evaluation. Among them,Siponimod TabletsAs the first domestically approved product in China, breaking the exclusive market dominance of Novartis' original research;Abemaciclib TabletsAs the second approved in China, Qilu Pharmaceutical's generic drug pipeline adds another significant product.
Screenshot source: NMPA official website
01
Blockbuster Variety with Over $300 Million in Sales: Two Pharmaceutical Companies Secure China's First Generic on the Same Day
SiponimodByNovartisResearch and development, a new generation of selective sphingosine-1-phosphate（S1P）Receptor modulator, which can bind to the S1P1 subtype receptor in lymphocytes, preventing them from entering multiple sclerosis.（MS）The central nervous system of the patient（CNS）, thereby achieving the effect of inhibiting inflammation.
In terms of market performance, according to data from MosaMedix, the original researchSiponimodSales have steadily increased, reaching $357 million globally in 2022, and growing further to $390 million in 2023, demonstrating strong market competitiveness.
In terms of the domestic market layout, the multiple sclerosis drug entered the Chinese market in 2020 and was subsequently included in the national medical insurance negotiation directory. According to data from MaxEntropy Pharma, in 2023Siponimod TabletsSales in the Chinese all-terminal hospital market exceeded 57 million yuan; in 2025, sales will decline, with annual sales exceeding 27 million yuan.
Screenshot source: Full-terminal Hospital Sales Database (Check Data. Find Moxun)
As a high-value rare disease drug,Siponimod TabletsThe generic layout has attracted much attention in the industry, and only two pharmaceutical companies in China have submitted applications. Among them,Hunan Kelun PharmaceuticalIn February 2023, the first generic marketing application for this Class 4 variety was submitted, and it is still in the review and approval stage; Qilu Pharmaceutical followed closely, and its generic marketing application submitted on January 4, 2024, was accepted by the National Medical Products Administration. After more than two years, Kelun and Qilu were both successfully approved on May 21, 2026. On the same day, the two pharmaceutical companies achieved the first China-based + first generic approvals.
02
More than 800 million large varieties, Qilu Pharmaceutical becomes the second company approved in China
Abemaciclib TabletsYesEli LillyThe world's first cyclin-dependent kinase 4/6 (CDK4/6) inhibitor developed for the treatment of early-stage breast cancer had global sales of only $255 million in 2018, surpassing $5.7 billion by 2025. Eli Lilly'sAbemaciclib TabletsFirst approved to enter the Chinese market in 2020 for adjuvant treatment of early breast cancer; a new indication was approved in 2021 for the treatment of advanced or metastatic breast cancer. The drug has been included in the Class B National Medical Insurance Catalog. Data from Mosentropy Medicine shows that the sales revenue of this product in the entire terminal hospital market has been increasing year by year in recent years, reaching 750 million yuan in 2023, nearly 800 million yuan in 2024, and exceeding 800 million yuan in 2025, with a year-on-year growth rate of 11.80%.
Screenshot source: All-terminal Hospital Sales Database (Check Data. Find Moentropy)
In terms of generic drug applications, currently in China, three companies—Shandong Bainaoyi Medicine, Qingfeng Medicine, and Qilu Pharmaceutical—have submitted Abemaciclib Tablets for production as Category 4 generics. Among them, Qingfeng Medicine was the first to submit and successfully received approval, securing the first domestic generic production and the first to pass the evaluation. This time, Qilu Pharmaceutical has become the second company in China to gain approval for this product.
Screenshot source: Approved Drugs Summary Database (Data Query by Mose)
03
Qilu Pharmaceutical Receives Approval for 10 Generic Drugs, 3 of Which Are the First in China
As of now, since 2026, Qilu Pharmaceutical(Including subsidiaries)Ten generic drugs have been approved for marketing and all are deemed to have passed the consistency evaluation. Among them,Berusertib Mesylate Tablets、Brexpiprazole Orally Disintegrating Tablets、Siponimod TabletsThree varieties have won the first generic drug approval in China.
Screenshot source: Generic Drug Consistency Evaluation Database (Data Search by Moxone)
This timeSiponimod TabletsAndAbemaciclib TabletsApproved, fully demonstrating Qilu Pharmaceutical's strong R&D capabilities and mature industrialization capacity in the fields of high-end generic drugs, orphan drugs, and tumor-targeted medications.
WithSiponimod TabletsOfficially launched, Chinese patients with multiple sclerosis welcome a high-quality, affordable domestically produced alternative.Effectively alleviate the problem of high prices and single supply of original research drugs, and help improve the rare disease drug security system.At the same time, Qilu Pharmaceutical's 800-million-level major tumor productAbemaciclib TabletsThe smooth approval will also enrich the options for domestically produced targeted breast cancer medications, accelerate the domestic substitution of anti-tumor drugs, and continuously strengthen the company's core competitiveness in the field of high-end generic drugs.
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