
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

On April 3, the Center for Drug Evaluation of the National Medical Products Administration(CDE)The official website shows,Cisen PharmaceuticalSubmittedCarboplatin InjectionAccepted for production as a Category 4 generic, officially entering this anti-tumor injectable market track with a scale exceeding 700 million yuan.

Screenshot source: CDE official website
Market Size Exceeds 700 Million, Qilu Pharmaceutical Dominates the Market
Carboplatin InjectionAs the second-generation platinum-based antitumor drug, mainly used forSmall cell lung cancer, ovarian cancer, testicular tumors, head and neck cancer, and malignant lymphomaThe treatment of solid tumors such as cervical cancer, bladder cancer, and non-small cell lung cancer has also shown good efficacy. As a commonly used platinum-based chemotherapy drug in clinical practice,CarboplatinThere is always a stable demand scale in the hospital terminal market.

Screenshot source: All-terminal Hospital Sales Database(Check data. Find Mo Entropy)
According to the data from Moseph Pharmaceuticals,Carboplatin InjectionBy 2025, the sales revenue of the all-terminal hospital market in China will haveMore than 700 million yuan, is one of the important varieties in the field of anti-tumor chemotherapy. Currently,Qilu PharmaceuticalOccupying an absolute advantage in this market, with a market share as high as74.16%The other approved companies include Beijing Liuhuan Pharmaceutical, Huaxia Shengsheng Pharmaceutical (Beijing), Shanghai Chuangnuo Pharmaceutical, etc., with a total of 8 companies.
Increased market competition prompts multiple companies to strategize for market share.
As of now, apart from the 8 approved enterprises, there are alsoHainan Better Pharmaceutical, Zhejiang Huahai Pharmaceutical, Guangdong Sunho PharmaceuticalNine companies, including Cisen Pharmaceutical Co., Ltd. and Qilu Pharmaceutical Co., Ltd., have submitted.Carboplatin InjectionThe marketing application is currently in the review and approval stage.

Screenshot source: China Drug Evaluation Database (More clicksMini ProgramView)
This timeCisen PharmaceuticalThe acceptance of a Category 4 generic drug application marks the entry of another large pharmaceutical company into the competition for this product, and the future market landscape may face reshaping.
Cisen Pharmaceutical Accelerates 2026 Application, Expands Pipeline Across Multiple Fields
Since 2026, Cisen Pharmaceutical Co., Ltd. has significantly accelerated its pace in generic drug applications. To date, the company has...2 ProductsSubmitted for marketing approval, all under review., coveringNervous System Drugs, Blood and Hematopoietic System DrugsField.

Screenshot source: China Drug Evaluation Database (More clickMini ProgramView)
In addition, this year, the company hasSodium Acetate Ringer's Injection、Carboplatin InjectionTwo products have been accepted by the CDE, demonstrating the company'sLarge Volume Parenterals and Anticancer DrugsTwo-way layout in the field.
Carboplatin, as a fundamental chemotherapy drug in clinical practice, boasts a stable and considerable market demand. Cisen Pharmaceutical Co., Ltd.'s entry into this field not only enriches its product pipeline in the anti-tumor sector but also reflects its strategic layout in the large-volume generic drug domain. Against the backdrop of normalized volume-based procurement, the participation of more companies will drive the price of this drug towards a more reasonable level, enhancing the accessibility of clinical medication. At the same time, it raises higher requirements for enterprises in terms of production cost and quality control. In the future, competition in this market will become increasingly fierce, and companies with integrated API-formulation capabilities are likely to gain an advantage in the competition.

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