Medical Network July 8th, July 5, the official website of the State Drug Administration announced that it has approved the import registration application for Daratumumab Injection (English name: Daratumumab Injection) for single drug Treatment of relapsed and refractory multiple myeloma (MM) adult patients, including patients who have previously received a proteasome inhibitor and an immunomodulator and developed disease at the time of the last treatment.
Dalexuzumab is a humanized, anti-CD38 IgG1 monoclonal antibody that binds to CD38 expressed by tumor cells through complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity ( ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as various immune-related mechanisms such as Fcγ receptors, induce tumor cell apoptosis. The launch of Daretouximab will provide new treatments for patients with relapsed and refractory MM.
Global Top Selling Drug Top 50
As one of the star medicines in the field of MM treatment, Daltopuximab was developed by Johnson & Johnson's Yangsen Company and approved by the FDA for approval in November 2015. This product is a monoclonal antibody against CD38, which is also studied for amyloidosis, colorectal cancer, etc., in addition to being approved for the treatment of MM.
According to global drug sales statistics, the third year of the listing of Daretoux monoclonal antibody - 2017 sales reached 1.242 billion US dollars, a year-on-year increase of 117%, through the "blockbuster" threshold. The latest data show that the drug's global sales in 2018 reached 2.03 billion US dollars, an increase of 65.53%, has entered the top 50 of the world's best-selling drugs. It is predicted that as the product indications continue to increase, the sales peak of Daltopuzumab may exceed $5 billion.
Domestic MM market generic drugs hit
The 2017 edition of the Guidelines for the Diagnosis and Treatment of Multiple Myeloma in China pointed out that the incidence of multiple myeloma in China is about 2 to 3/100,000, which has surpassed acute leukemia and become the second most malignant tumor in the blood system. The disease is mostly caused by middle-aged and elderly people, and the onset is concealed. Most patients are diagnosed at the advanced stage and the treatment is difficult.
According to the intranet data, the top 10 domestic anti-myeloma varieties in 2018 are: bortezomib, esamizomib, lenalidomide, thalidomide, doxorubicin, cyclophosphamide, cisplatin, etoposide Glycosides, vincristine and carmustine, the market size of these 10 drugs clinical drugs has exceeded 1.3 billion yuan, an increase of 50.62% over the previous year. It is conservatively predicted that the domestic anti-myeloma market has reached a scale of 5 billion yuan.
In the global market, the annual report of multinational companies shows that global MM drug sales in 2018 was 16.679 billion US dollars, an increase of 20.63% over the previous year. At present, there are international market formations of six major varieties such as lenalidomide, pomamide, daretozumab, bortezomib, carfilzomib and erlotuzumab.
Among them, lenalidomide was developed by New Base Medicine and was approved for marketing in the United States in 2005. In 2018, its global sales reached 9.685 billion US dollars, an increase of 18.30% over the previous year's 8.187 billion US dollars, becoming the world's third-best selling product after adalimumab and apixaban. In June 2013, Xinji Pharmaceutical's lenalidomide capsules were launched in China.
On November 21, 2017, lenalidomide (5mg, 10mg, 25mg) capsules from Beijing Shuanglu Pharmaceutical were approved for marketing. On January 9, 2019, the lenalidomide capsule (25mg) of Zhengda Tianqing Pharmaceutical Group was registered. On April 25, 2019, Qilu Pharmaceutical's lenalidomide capsule (25mg) was approved for marketing.
In addition, in 2017, Jiangsu Haosen Pharmaceutical's first generic drug, bortezomib injection, was approved for listing, breaking the situation that imported drugs dominated the market. In 2018, the bortezomib injections of Qilu Pharmaceutical, Zhengda Tianqing Pharmaceutical Group and Nanjing Zhengda Tianqing Pharmaceutical were also approved for listing. According to the data of the intranet, the amount of bortezomib injection in the sample hospitals of 24 key provinces and municipalities in China reached 457 million yuan in 2018, which is the most powerful variety in the domestic MM treatment field.
With the continuous approval of domestic MM generic drugs and the further introduction of new overseas drugs, the choice of domestic MM patients has been further broadened, which has driven market competition and drug prices.
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