13 First-to-File Generic Drugs Launched by Companies Including Kangzhe Pharma, Qilu Pharmaceutical, and Kelun Pharma

　　【Pharmaceutical Network Product Information】According to relevant data statistics, in March, 247 drugs passed/were considered to have passed the consistency evaluation, with 20 new exclusive varieties added, including 13 first generics. These include CMS's Dexisoxazole Tablets, Huasheng Guang Pharmaceutical's Chloroxazepam Injection, Kelun's Sildenafil Citrate Oral Soluble Film and Aripiprazole for Injection, Pro Pharmaceutical's Ephedrine Sulfate Injection, Shijiazhuang No.4 Pharmaceutical Co.,Ltd.'s Sodium Lactate Ringer's Irrigation Solution, Muyuan Biotech's Acetylcysteine Tablets, Yuanlijian Pharmaceutical's Cinitapride Tartrate Tablets, Fuyuan Pharmaceutical's Diclofenac Sodium Dual-Release Enteric-Coated Capsules, Zhengdatianqing's Melogabalin Besylate Tablets, Zhiyuan Pharmaceutical's Desonide Lotion, Qilu Pharmaceutical's Befuxetil Mesylate Tablets, and Taidi Pharmaceutical's Tulobuterol Patches.
 

Among them, the marketing authorization application for CMS's new renal anemia drug, Desidustat Tablets (formerly known as Daprodustat Tablets), was approved by China's National Medical Products Administration (NMPA) on March 13, 2026. This product is an innovative oral hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) used for treating anemia in non-dialysis adult patients with chronic kidney disease (CKD). Data shows that the number of Chinese adults with CKD has exceeded 120 million. Renal anemia is a common complication, and its prevalence rises sharply as kidney function declines; the anemia rate among CKD stage 5 patients is as high as 98.2%. However, only 8.2% of non-dialysis patients achieve treatment targets, far lower than the 51.5% rate in dialysis patients, indicating significant unmet clinical needs.
 

Qilu Pharmaceutical's submission of Belumosudil Mesylate Tablets was approved for marketing on March 27, making it the first pharmaceutical company in China to obtain this drug variety. This progress fully demonstrates Qilu Pharmaceutical's strong capabilities in the field of high-end generic drugs and inhalation preparations. Data shows that Belumosudil Mesylate Tablets, a new drug for chronic graft-versus-host disease (cGVHD), is a ROCK2 inhibitor approved for use in patients aged 12 years and above with an inadequate response to corticosteroid treatment. The drug was first launched in the United States in 2021, received approval in China in August 2023 by Kadmon, a wholly-owned subsidiary of Sanofi, and was included in the National Reimbursement Drug List in 2024, changing the treatment landscape for cGVHD.
 

Kelun's Approved Aripiprazole Injection for the Treatment of Adult Schizophrenia is a Long-Acting Microparticle Formulation That Enhances Patient Compliance and Reduces Adverse Reactions. It is Estimated That Global Sales Will Reach Approximately $2.2 Billion by 2025. Kelun has Already Received Approval for Multiple Products in the Central Nervous System Field, and This Approval Will Further Strengthen Its Competitiveness in This Area.
 

Pro Pharma's Ephedrine Sulfate Injection is the first domestically approved product to be marketed in China, and it is considered to have passed the generic drug consistency evaluation. It is suitable for treating clinically significant hypotension under anesthesia. This approval reflects the company's...API (Active Pharmaceutical Ingredient)The integrated synergy strategy for formulations helps enhance product competitiveness and enrich the product pipeline, playing a positive role in the company's operational development.
 

Shijiazhuang No.4 Pharmaceutical Co.,Ltd.'s Sodium Lactate Ringer's Irrigation Solution is suitable for general irrigation where the use of sterile electrolyte solutions is permitted. Its successful approval will form a chain-like development pattern with the group’s existing products such as normal saline, balanced salt solution, glycine irrigation solution, and sorbitol mannitol irrigant, further enriching and expanding the range of irrigation products and enhancing the market accessibility of the products.
 

247 Drugs Pass Evaluation, Promoting Generic Drug Quality to Align with Original Research. In the future, as more innovative drugs and first generics become available, China's pharmaceutical industry will better meet domestic clinical needs. With the normalization of bulk procurement and the deepening of medical insurance cost control, companies with innovative R&D, high-end generics, integrated APIs, and specialized pipelines are expected to have stronger cyclical resilience.
 

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