Qilu Pharmaceutical Adds Two More Generics Passing Consistency Evaluation, Including One First-in-Class in China

　　【Pharmaceutical Network Product Information】"Major Approvals Household" Qilu Pharmaceutical recently announced more good news. The company's Carboplatin Injection and Cefuroxime Sodium for Injection received approval from the National Medical Products Administration for consistency evaluation supplementary applications. Notably, the Carboplatin Injection is the first in China to pass the evaluation.
 

Carboplatin is a typical representative of second-generation platinum drugs, with the advantages of good chemical stability and high solubility. Compared with first-generation platinum drugs, it has lower toxicity and is suitable for a wider population. It is currently one of the more commonly used chemotherapeutic drugs in clinical practice, mainly used for small cell lung cancer, ovarian cancer, testicular tumors, head and neck cancer, and malignant lymphoma. Carboplatin has no cross-resistance with non-platinum anti-tumor drugs and can be used in combination with various anti-tumor drugs. Clinically, it is mainly used for solid tumors such as small cell lung cancer, ovarian cancer, testicular tumors, head and neck cancer, and malignant lymphoma, and can also be applied to the treatment of cervical cancer, bladder cancer, and non-small cell lung cancer.
 

Qilu Pharmaceutical's Carboplatin Injection (Bobei) was approved for marketing in 2002 and has gained widespread recognition from doctors and patients in clinical applications. Data from Menet shows that in 2021, the sales of Carboplatin Injection in Chinese public medical institutions terminals approached 700 million yuan, increasing by 29.65% year-on-year. Among them, Qilu Pharmaceutical's Carboplatin Injection and Injectable Carboplatin together accounted for more than half of the market share. This time, Qilu Pharmaceutical’s product passing the evaluation further enhances the technical advantages of this product, which will better meet clinical treatment needs.
 

Sodium Cefuroxime for Injection is a second-generation product developed and produced by GlaxoSmithKline in the UK.CephalosporinsAntibiotic class, clinically used for the treatment of various infectious diseases caused by susceptible bacteria, such as respiratory tract infections, urinary system infections, skin and soft tissue infections, meningitis, gonorrhea, bone and joint infections, puerperal and gynecological infections, etc.
 

This variety has been included in the Class A category of the 2021 National Medical Insurance Drug List and the 2018 National Essential Medicine List. According to data from Menet, the total sales of cefuroxime sodium for injection in urban public hospitals, urban community health centers, county-level public hospitals, and township health centers in China reached approximately 4.468 billion yuan in 2021.
 

It is reported that Qilu Pharmaceutical Co., Ltd. initiated the bioequivalence evaluation of Cefuroxime Sodium for Injection at the end of 2021. Under the strict quality standards executed by researchers, the self-produced product was ensured to be equivalent in quality and clinically equivalent to the reference product. This successful evaluation is beneficial for the company to expand its product market share and enhance market competitiveness. Meanwhile, it has also accumulated valuable experience for the company’s subsequent bioequivalence evaluations of imported products, which is of great significance to the promotion and sales of the company's products.
 

It is worth mentioning that Qilu Pharmaceutical has been receiving continuous good news in terms of consistency evaluation. In addition to Carboplatin Injection and Cefuroxime Sodium for Injection, not long ago, the company's Oseltamivir Phosphate Capsules and new specifications of Docetaxel Injection also passed the evaluation. According to industry statistics, up to now, Qilu Pharmaceutical has a total of 105 products that have passed or are considered to have passed the consistency evaluation, of which 44 have taken the lead in China.
 

Currently, passing the evaluation has become the "ticket" for participating in bulk procurement. Qilu Pharmaceutical has stood out in previous rounds of bulk procurement with its impressive performance in the consistency evaluation. According to statistics, since the start of China's national centralized bulk procurement of medicines in 2018, Qilu Pharmaceutical has had a total of 34 products selected so far. One representative example is "Gefitinib," a first-line molecular targeted drug for treating non-small cell lung cancer. The product was successfully launched at the end of 2016, impacting the original research and forcing foreign manufacturers to significantly lower their prices to enter the medical insurance system, achieving the replacement with domestically produced drugs, allowing the common people to access and afford good medicines.