Qilu Pharmaceutical and Hansoh Pharma Receive Approval for Generic Bortezomib Injection Following Successful Consistency Evaluation

On October 29, the official website of the National Medical Products Administration (NMPA) announced that Bortezomib for Injection produced by Qilu Pharmaceutical and Hansoh Pharma had passed the consistency evaluation through the supplementary application process. Currently, the number of manufacturers whose products have passed this evaluation has reached three.

Bortezomib is a novel competitive proteasome inhibitor, clinically indicated primarily for the treatment of multiple myeloma and mantle cell lymphoma. Originally developed by Millennium Pharmaceuticals (later acquired by Takeda), it received FDA approval in May 2003 under the brand name Velcade. In January 2005, the drug was approved in China under the brand name Wanke.

Bortezomib is listed in Category B of the National Reimbursement Drug List. The 2018 financial report showed that the US market sales of Velcade, managed by Takeda, amounted to JPY 127.9 billion (equivalent to USD 1.195 billion), while the sales in markets outside the US, managed by Johnson & Johnson, reached USD 1.116 billion.

Source: PharmaCube NextPharma

Previously, eight companies in China produced and marketed bortezomib for injection. Among them, CSPC Pharmaceutical Group’s drug, submitted under Category 4, was approved in June 2020 and deemed to have passed the consistency evaluation. Qilu Pharmaceutical and Hansoh Pharma passed the consistency evaluation via supplemental applications.