Qidu Pharma’s Vitamin B12 Injection: China’s First Approved via Consistency Evaluation

Recently, the generic drug consistency evaluation application for Vitamin B12 Injection (Brand: Qiyuanwei, Specification: 1ml:1mg, Package: middle borosilicate glass ampoules) developed by Qidu Pharma has been approved by the National Medical Products Administration (NMPA), making the enterprise the first in China to obtain consistency evaluation approval for this pharmaceutical product.

The active pharmaceutical ingredient of Vitamin B12 Injection is cyanocobalamin. It is primarily indicated for the treatment of megaloblastic anemia caused by intrinsic factor deficiency, and also serves as adjuvant therapy for subacute combined degenerative neurological disorders，such as neuritis. Widely applied in core clinical departments such as Hematology, Neurology, Gastroenterology and Geriatrics, the product plays a pivotal role in fundamental clinical treatment and nutritional support. Featuring a dual-action mechanism, Vitamin B12 participates in methyl transfer and folate metabolism on one hand, and catalyzes the conversion of methylmalonic acid into succinic acid to feed into the tricarboxylic acid cycle on the other. The two pathways work synergistically to realize neuroprotective and hematopoietic effects, endowing the injection with prominent clinical merits including rapid onset of action, durable efficacy and complete in-vivo absorption. Listed as a Category A medicine in China’s National Reimbursement Drug List, it has been unanimously recommended by authoritative clinical guidelines such as Chinese Expert Consensus on Diagnosis and Treatment of Megaloblastic Anemia and Expert Consensus on Nutrition Support Therapy for Neurological Diseases. According to domestic sales statistics from PDB database, the product has posted steady sales growth over the past five years, with annual sales volume rising from 37.78 million ampoules to 69.93 million ampoules.

Qidu Pharma has focused intensively on R&D of nutritional support pharmaceuticals over recent years and kicked off the generic drug consistency evaluation project of Vitamin B12 Injection in 2023. The project team set up scientific work allocation, clarified job responsibilities and coordinated teamwork to conduct in-depth systematic research covering formulation & manufacturing process, raw and auxiliary materials, finished product quality standards as well as global R&D progress of equivalent preparations. Aligned with national regulatory policies and real-world clinical demands, the team optimized the product’s formulation and process, successfully upgrading specifications for osmolarity and related substances. During the supplementary data submission phase for drug registration review, the team pioneered innovative research on impurity analytical methodology and tackled multiple technical hurdles in complex impurity identification. Team members worked overtime till after 9 p.m. every day for half a consecutive month to complete verification tests for impurity profiling. Thanks to such efforts, supplementary application documents were submitted ahead of schedule, enabling the company to surpass two rival applicants in regulatory review and secure the country’s first consistency evaluation approval for the product.

Qiyuanwei^® Vitamin B12 Injection marks the company’s debut of its vitamin product line. It will complement the existing parenteral nutrition portfolio including Fu’anmai^® Compound Amino Acid (15AA-Ⅱ), Glucose (10%) and Electrolyte Injection, Fu’anqi^® Compound Amino Acid Injection (18AA-Ⅶ) and Fu’ansen^® Compound Amino Acid (16AA), Glucose (12.6%) and Electrolyte Injection, forming a comprehensive product matrix catering to perioperative nutrition management, chronic disease nutritional intervention and nutritional supplementation for special physiological periods. Moving forward, Qidu Pharma will continue to deepen its layout in the nutritional support sector. By launching more cost-effective high-quality medicines and developing precise, evidence-based therapeutic regimens, the company will keep contributing to improving patients’ quality of life and safeguarding public health across China.