Qilu Pharmaceutical's Bendamustine Hydrochloride Concentrated Injection (YouRan®) Approved for Market Launch in China

On May 9, the official website of the National Medical Products Administration announced that the marketing application of Qilu Pharmaceutical's anti-tumor drug Bendamustine Hydrochloride Injection Concentrate (brand name: You Ran®) has been approved. This product is the first in China to be approved for marketing. At the same time, this product is considered to have passed the consistency evaluation. To date, Qilu Pharmaceutical has a total of 162 products that have passed or are considered to have passed the consistency evaluation, of which 55 are the first in China.

Bendamustine is a bifunctional nitrogen mustard derivative that induces cell death through multiple pathways, thereby exerting its antitumor effects. As a new-generation antitumor drug, it features low toxicity, high activity, a broad antitumor spectrum, good patient tolerability, and suitability for long-term use. Bendamustine is mainly indicated for the treatment of indolent B-cell non-Hodgkin lymphoma (NHL) that progresses during or after treatment with rituximab or rituximab-containing regimens. Its use as monotherapy or in combination therapy has been recommended by various guidelines in Europe and the United States as a first-line or second-line treatment option for multiple hematologic malignancies. Bendamustine is also a recommended medication in the lymphoma diagnosis and treatment guidelines of the Chinese Society of Clinical Oncology (CSCO).

Lymphoma is one of the most common malignant tumors of the hematologic system, with an incidence rate in China of approximately 6.68 per 100,000, and about 100,000 new cases of lymphoma patients each year [1]. Bendamustine, as an important chemotherapeutic drug for lymphoma treatment, is widely used across various subtypes of lymphoma and demonstrates favorable efficacy and safety [2].

Qilu Pharmaceutical has always adhered to an innovation-driven development strategy. In order to further enhance the therapeutic effects of its products and reduce toxic side effects, the R&D team abandoned the traditional freeze-dried powder injection design and opted for a new dosage form: "concentrated solution for injection." Compared with traditional freeze-dried powder injections, bendamustine hydrochloride concentrated solution for injection does not require reconstitution before use. After extracting the required volume, it can be directly diluted for use, making clinical operations more convenient while also reducing the risk of medical staff exposure to the drug. While fully ensuring clinical efficacy, data on compatibility stability shows that the total impurity level of bendamustine hydrochloride concentrated solution for injection is about 5% lower than that of freeze-dried powder injections after being stored at room temperature for three hours post-compounding. This makes the product more stable and safer during clinical use.

Although indolent lymphoma cannot be cured, it can be managed as a chronic disease like hypertension and diabetes. Patients can achieve long-term survival without affecting their quality of life. Real-world data in China shows that there is a significant gap between the treatment levels of lymphoma in China and foreign countries. One key reason is the high cost of drugs, which leads to low drug accessibility. The concentrated solution for injection of bendamustine hydrochloride developed by Qilu Pharmaceutical has the same prescription composition as the original product, with equivalent efficacy. After its market launch, it will significantly improve drug accessibility, reduce the burden on patients, and is expected to further improve the current state of lymphoma diagnosis and treatment in China.

Antitumor drugs are a key focus area for Qilu Pharmaceutical, with a rich variety of products. The approval and market launch of the injectable concentrate solution of bendamustine hydrochloride further expands the company's antitumor drug product pipeline. Qilu Pharmaceutical will always adhere to a patient-centered approach and be guided by clinical value, continuously researching and producing more affordable and accessible Qilu quality medicines for the general public, making new contributions to the health of the people in China.

References:
[1] Chinese Society of Clinical Oncology (CSCO) Anti-Lymphoma Alliance, Chinese Society of Clinical Oncology (CSCO) Anti-Leukemia Alliance. Leukemia·Lymphoma, 2020, 29(02): 65-72.
[2] Chinese Society of Clinical Oncology (CSCO) Anti-Lymphoma Alliance. Chinese Expert Consensus on Bendamustine for the Treatment of Lymphoma (2020 Edition) [J]. Leukemia & Lymphoma, 2020, 29(01): 1-5. DOI: 10.3760/cma.j.issn.1009-9921.2020.01.001
Authors: Sun Mingxian, Yang Guangli, Wang Ying

Editor: Bai Ji

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