Qilu Pharmaceutical's Oxaliplatin Injection Becomes First in China to Pass Consistency Evaluation; Entecavir Tablets Also Approved

On June 1, the official website of the National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical’s Oxaliplatin Injection and Entecavir Tablets had been approved for production, deemed as having passed the consistency evaluation. Notably, the Oxaliplatin Injection was the first domestic product to pass this evaluation in China. Data from Menet showed that in 2019, sales of oxaliplatin at public medical institutions in China reached RMB 3.366 billion, with the originator manufacturer Sanofi holding a 59.73% market share. To date, Qilu Pharmaceutical has had 32 products pass the consistency evaluation, 19 of which were the first domestic approvals.

Qilu Pharmaceutical Approved Products

Oxaliplatin is a third-generation platinum-based antineoplastic agent, primarily indicated for first-line treatment of metastatic colorectal cancer and as adjuvant therapy for stage III colon cancer following complete resection of the primary tumor.

Currently, oxaliplatin products available in the Chinese market include Oxaliplatin and Mannitol Injection, Oxaliplatin Injection, and Oxaliplatin for Injection. Both Oxaliplatin Injection and Oxaliplatin for Injection are listed as Class B drugs under the National Reimbursement Drug List. Previously, Qilu Pharmaceutical had already received approval to manufacture Oxaliplatin for Injection. The Oxaliplatin Injection approved this time is classified as a Generic Drug Category 3, marking the first product in China to pass the consistency evaluation.

According to data from Menet, in 2019, the sales value of oxaliplatin injections at terminals of China’s public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—amounted to RMB 3.366 billion, representing a year-on-year increase of 7.04%. Among these, Sanofi, the originator manufacturer, held a market share of 59.73%, followed by Hengrui Medicine with 21.72% and Qilu Pharmaceutical with 4.01%.

Sales of Oxaliplatin at the Terminal of Public Medical Institutions in China (Unit: 10,000 Yuan)

Entecavir, a guanosine nucleoside analogue, inhibits the reverse transcriptase of hepatitis B virus (HBV) and offers favorable safety and tolerability profiles. It is recommended as a first-line antiviral agent by multiple authoritative HBV diagnosis and treatment guidelines worldwide.

Data from Menet shows that in 2019, the sales of entecavir at public medical institutions in China exceeded RMB 7.3 billion. Currently, six manufacturers have obtained consistency evaluation approval for entecavir tablets.

Sales of Entecavir at Public Medical Institution Terminals in China (Unit: 10,000 Yuan)

To date, Qilu Pharmaceutical has had 32 products approved or deemed approved for consistency evaluation, 19 of which were the first domestic approvals. Six products, including Capecitabine Tablets, Bivalirudin for Injection, Pregabalin Capsules, Leflunomide Tablets, Exemestane Tablets, and Oxaliplatin Injection, received their first domestic approvals this year. According to the Menet Consistency Evaluation Database, Qilu Pharmaceutical leads the consistency evaluation approval rankings with 32 products (55 application numbers), while China Biopharmaceutical ranks second with 28 products (30 application numbers).

Source: NMPA, Menet Database

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