Fu Shen, Shuanglu Pharmaceutical Co., Ltd. "lenadomide capsule" was finally approved for listing

Source: medicine magic cube on December 1, 2017, November 30, the drug approval document of "lenadelamine capsule" of Shuanglu pharmaceutical was sent to Beijing food and drug administration According to reliable sources, Shuanglu pharmaceutical, a heavyweight variety that successfully challenged the original research patent, officially obtained the new drug certificate and registration approval issued by CFDA for the treatment of multiple myeloma If soon, Shuanglu pharmaceutical may announce its approval today At this moment, it has been more than 10 years since the establishment of lenalidomide, 8 years since the submission of clinical application and 3 years since the submission of listing application In recent years, as one of the most concerned varieties in the pharmaceutical industry and capital market, the listing of naduramine in Shuanglu pharmaceutical industry will cause another sensation Here, let's review the story of ten years of hustle and bustle in the pharmaceutical industry Lenalidomide is an immunomodulatory antitumor drug developed by celgene It was first approved by FDA on December 27, 2005 (trade name: Revlimid) for the treatment of myelodysplastic syndrome Later, it was expanded and approved by FDA for the treatment of multiple myeloma and mantle cell lymphoma Revlimid's global sales volume in 2016 was US $6.974 billion, and the sales volume in the first nine months of this year was US $5.999 billion With the continuous expansion of indications, fiercepharma had predicted that its sales volume in 2022 would be US $13.44 billion, which would be the best-selling tumor drug in that year (see: top 15 tumor drugs in 2022) Multiple myeloma is an incurable malignant tumor of the blood system About 70000 patients are newly diagnosed each year in the United States, Europe and China In China, there are about 15000-20000 newly diagnosed patients with multiple myeloma every year, with a median survival period of 4-5 years and a total number of 80000-100000 patients Revlimid was approved by CFDA on January 23, 2013, and was officially listed in China under the trade name of Revlimid, providing a new treatment option for Chinese multiple myeloma patients However, due to the original exclusive product, the price of naduramine 10mg and 25mg in China before the medical insurance negotiation was as high as 2198 and 2799 yuan respectively, and without medical insurance payment, ordinary patients could not bear it In terms of patent protection, 29 patents related to lenalidomide have been applied by celgene company in China, and the validity of some core patents (crystal patent cn101838261b) will not expire until 2024 There are 6 domestic companies that develop the generic drugs of naduramine, of which Shuanglu pharmaceutical industry is the most concerned one Cavendish (Shuanglu Pharmaceutical Co., Ltd.) invented a new route to synthesize lenalidomide, and obtained patent authorization for it At the same time, he also invented three new polymorphic forms I, II and III of lenalidomide and obtained patent authorization Cavendish's patent response strategy successfully bypassed celgene's patent protection, making the domestic lenalidomine preparation successfully challenge celgene's patent barriers and restrictions At present, Cavendish has applied for patents in the United States, Europe, South Korea, Japan, Australia, India and other countries, and some patents have been granted in the United States, Europe, South Korea, Japan and Australia Cavendish / Shuanglu Pharmaceutical Co., Ltd submitted the clinical application for class 3.1 new drugs of lenalidomide on November 27, 2009, obtained the clinical approval document on March 23, 2012, completed the confirmatory clinic in October 2014, and submitted the listing application on November 18, 2014 It can be said that lenalidomide of Shuanglu pharmaceutical industry has become a star in the industry, and its every move has attracted the attention of investors However, on July 22, 2015, clinical self-examination broke out, and lenalidomide of Shuanglu was also included in it, which damped everyone's expectation of its coming to market At that time, many well-known pharmaceutical companies withdrew their heavyweight varieties Can Shuanglu pharmaceutical industry withstand the most rigorous clinical verification in history? Many people are skeptical about this, but Shuanglu pharmaceutical industry has always insisted on not withdrawing its registration application, and has successfully passed the clinical self-examination and verification, which has stood the test A priority review announcement of 2016 / 4 / 24 CDE once again inspired everyone's strong concern about Shuanglu CDE priority review announcement (the third batch) in the nearly one and a half years after Shuanglu obtained the priority review, the sentiment of investors in the secondary market fluctuated with the lights on and off of the CDE review progress indicator, and the share price of Shuanglu also fluctuated with the sentiment and expectation of investors Now, Shuanglu pharmaceutical industry has finally ushered in a good day for the approval of lenalidomide, and all doubts have disappeared Next, it is the domestic lenalidomide and the original research products competing for the domestic multiple myeloma market Before Shuanglu got the approval document, the Ministry of human resources and Social Security announced the results of medical insurance negotiation of new kilenadolamine on July 19 this year The prices of 10mg and 25mg dropped to 866 and 1101.99 yuan respectively, with a significant drop, but there were restrictions on the scope of medical insurance payment - only for adult patients with multiple myeloma who had received at least one treatment and met the following conditions: 1) every two courses of treatment needs to be provided The payment can only be continued after the evidence of effectiveness; 2) the prescription is made by the hematology specialist or hematology specialist of the third level hospital; 3) the combination of bortezomib and bortezomib will not be paid In addition, bortezomib of Janssen was negotiated to enter the medical insurance together with neogenethamide The price of 1mg / bottle and 3.5mg/bottle were also reduced to 2344.26 and 6116 yuan, respectively, which were limited to patients with multiple myeloma, relapsed or refractory mantle cell lymphoma The following conditions should be met: 1) effective evidence of treatment should be provided for each two courses of treatment before continuing to pay; 2) blood specialty of the third level hospital Department or blood hospital doctor prescription; 3, with lenalidomide combination use does not pay Bortezomib and lenalidomide are commonly used in the clinical treatment of multiple myeloma in China For a long time, only the original products have been sold on the market As the patent protection of bortezomib in China has expired on October 27, 2015, there are 19 generic pharmaceutical companies in research, and the competition is not fierce In this competitive situation, the original research enterprises choose to pay for medical insurance is also a response Even before the Ministry of human resources and Social Security announced the results of the health insurance negotiations, Xinji signed a strategic cooperation with Baiji Shenzhou on July 9, granting the exclusive rights and interests of its tumor products in China to Baiji Shenzhou, including Abraxane (albumin paclitaxel for injection), Revlimid (lenalidomide) and vidaza (azacytidine for injection) (see: with Xinji friends) Baiji Shenzhou Baiji Shenzhou just signed a general distribution agreement with China Resources Guokang (Beijing) Pharmaceutical Co., Ltd on November 10, hoping that the channel advantages of China resources can help bidding and drug admission It can be said that the smell of gunsmoke has spread Before the launch of lenalidomide in Shuanglu, some bold analysts gave optimistic forecasts that the sales revenue in the third year would exceed 3 billion yuan However, some people have different opinions There is no doubt that shuanglulianadomine will bring more preferential drug choices to domestic patients, but the final market performance can only be verified by time.