Yangzijiang Bomadiamine Capsule Application For Generic Drugs Receives Two More Clinical Implicit Licenses

- Mar 31, 2020-

Recently, the Drug Evaluation Center (CDE) of the State Food and Drug Administration announced that Yangzijiang Pharmaceuticals has submitted two clinical tacit approvals for the 3 generic drug applications of pomalidomide capsules. The indication is "combined with dexamethasone, It is used to treat adult patients with multiple myeloma who have received at least two drugs (including lenalidomide and bortezomib) and have been confirmed to have disease progression or within 60 days of the last treatment. "


Heavy immunomodulator in the treatment of multiple myeloma


In vivo, pomalidomide has multiple mechanisms of action, which can not only enhance T-cell and natural killer (NK) cell-mediated immunity, but also regulate the production of various cytokines, and can also inhibit the proliferation of hematopoietic tumor cells.


As an analogue of the third-generation thalidomide, pomalidomide is currently used as a small-molecule oral immunomodulatory drug and has anti-tumor activity. It may be the most active immunomodulatory drug to date.


In February 2013, the Pomalidomide original research capsule developed by Shinki was approved by the US FDA and sold under the trade name of Pomalyst. It has been used in adult patients who have received at least two treatments in the past and was confirmed after the last treatment. Treatment of relapsed and refractory multiple myeloma with worsening of the condition. In August 2013, the new Pypodomide capsules were approved for marketing in Europe under the name of Imnovid.


In the field of multiple myeloma (MM) treatment, both lenalidomide and thalidomide are classic treatments. Compared with the former two, pomalidomide can effectively treat multiple myeloma (MM) at a very low dose. The significant advantage of low-dose treatment is that it greatly reduces the risk of adverse drug events; more importantly, , Pomalidomide showed a good response to patients with multiple myeloma (MM) who did not respond to lenalidomide and thalidomide, and to patients with multiple myeloma (MM) refractory to other new drugs It also showed a higher remission rate.

Based on these clinical advantages, pomalidomide has become the world's third heavyweight immunomodulator after thalidomide and lenalidomide for the treatment of multiple myeloma (MM).

Outstanding performance


In 2018, Singular's Pomalidomide's global sales exceeded US $ 2 billion, ranking 59th in the global annual best-selling list. In 2019, Pomalidomide increased 24% year-on-year, and global sales reached US $ 2.525 billion.


In addition to multiple myeloma (MM), Sunkey has conducted multiple clinical trials to simultaneously develop pomalidomide for new indications for other cancer types. It is worth mentioning that in May 2019, Pomalidomide was granted a breakthrough therapy designation by the FDA for the treatment of HIV-positive Kaposi sarcoma patients and HIV-negative Kaposi who had received systemic chemotherapy Patients with Western Sarcoma.


As a new generation of products in the treatment of multiple myeloma (MM), the subsequent explosiveness of pomalidomide is much favored by the market.


The original research has not been listed in China, and the first imitation competition has begun

In November 2013, Shinki Corporation submitted a clinical trial application of pomalidomide to the CFDA and obtained approval. As of now, the original research drug of pomalidomide has not been approved for listing in China.


In preparation for the development of generic drugs by domestic pharmaceutical companies, Zhengda Tianqing, Yangzijiang Pharmaceutical and Qilu Pharmaceutical successively completed the human bioequivalence test of pomalidomide capsules. In 2018, Zhengda Tianqing took the lead in submitting the application for the listing of generic 3 generic drugs of pomalidomine, including 2 acceptance numbers of 1mg and 4mg, and received priority review in August of the same year. Qilu Pharmaceutical became the third domestic pharmaceutical company to submit a category 3 generic drug listing application. The battle for the first imitation of pomalidomide has already begun, and Zhengda Tianqing is expected to take the lead. This time Yangzijiang Pharmaceutical once again obtained two clinical tacit approvals, which will further intensify the intensity of this battle.


It is reported that in addition to these three, there are still 20 domestic companies that have submitted clinical applications for pomalidomide.