Another heavyweight variety is included in the proposed priority review queue, the soon-to-be-opened Twin Anti-River Lake

On December 9th, the CDE's official website was quietly updated to review the approval listOnly one product was included this time, the injection of perintomo (blinatumomab, blincyto) from Anjin organismsPerintomo is the first approved bi-specific T-cell joint (BiTE) immunotherapy, and was approved by the U.SFDA at the end of 2014 for the treatment of recurrent, refractory (R/R) precursor B cell acute lymphoblastic leukemia (ALL), the first FDA-approved drug to destroy leukemia cells through human T cellsPublic data show that Perintomo shuanganti on 2018 global sales of $230 million, and on October 30, 2019 in China to submit a listing application, and this time qualified for the priority review, just over a month before its declaration of listingis worth noting that once the success of this product in the domestic market, the current domestic only Roche Emicizumab a dual resistance product listing pattern was brokenin fact, Amin's product has a progress update, but the current global double anti-research and development boom in a reflectionAt the ASH conference that day, Roche also released the latest data for its other dual-resistant product, which attracted a lot of attentionIn China, in addition to Roche, Anjin and other multinational pharmaceutical companies, such as Beida, Hengrui, Shore and other local companies, are also in this area have been laid outPredictably, after Amin's products are approved, a number of local companies will also enter the market, when the entire dual-resistance market pattern will be from the original one exclusive to a number of competitionChina's double resistance to rivers and lakes, officially opened in the immediate01 Double Anti-Global Research and Development Enthusiasm
so-called bispecific antibody, refers to the combination of two different targets to initiate new drug activityAt present, there are two main mechanisms of action of bispecific antibodies: bridging two cell types (in-transbinding) and binding two molecules (in-cisbinding) on a cellCompared with ordinary antibodies, double resistance has the advantages of high specificity, strong targeting, high yield, good stability, low dosage and fewer toxic side effects, which is of great significance in the clinical treatment of tumorscompared with the industry's long-term concern for PD-1/PD-L1 monoantigen, the enthusiasm for research and development of double resistance has only gradually increased in recent yearsAlthough the clinical progress of double anti-development compared to single antibody slightly lags, but many multinational pharmaceutical companies have also made significant progress in research and development, currently the world's dual anti-resistance products have been listed on the total of three, namely Trion Pharmaceuticals Catuomamaxb, Amin's Blinatumomab and Roche's Emicizumab Blinatumomab and Roche's Emicizumab were approved for listing by the FDA in 2014 and 2017, respectively, while Catumaxb, which was first listed, was approved for listing by EMA, which was delisted and discontinued in 2017 due to commercial failures Currently, the two dual-specific antibody drugs on sale are fairly well-off in terms of market performance, with Global sales of $230 million in 2018 and Emicizumab's global sales of CHF 234 million initially, Sales of Trion Pharmaceuticals' Catumaxomab and Amin's Blinatumomab were not as good as they were Catumaxomab had sales of just $4.5 million in 2012 and had suspended sales in the European market since 2014, while Amin Blinatuab's sales in 2016 were $115 million, below market expectations but still can not block the enthusiasm of enterprises in research and development, and decided to invest in the reason, or the mechanism of this mechanism of optimism Roche's Emicizumab, which went on sale in 2017, has attracted more attention from the industry as sales of the first two drugs turned around, generating sales of about $224 million in the second year of the market in 2018 industry sources say 2019 could be called the year of double resistance for the antibody industry There are four reasons: First, from the indications, as "antibody industry upstart", bispecific antibodies can be a two-pronged treatment of tumors, inflammation Second, while not all indications are targeted cancers, the dual-specific antibody's dual-target characteristics make it a great cancer treatment prospect, including solid tumors and blood tumors Third, as a cancer treatment weapon, bispecific antibodies in tumor treatment show great potential, the results of clinical trials published to achieve complete remission, the future is expected to become a first-line treatment of the corresponding indications, in the tumor market share Fourth, the early bi-specific antibody expression difficulties, poor stability, complex production process, now these technical difficulties are basically broken by the industry, domestic and foreign companies have formed a number of pharmaceutical companies with international intellectual property rights of the dual anti-platform combed the 2019 double-anti layout event, also in February, GlaxoSmithKline won the joint development rights of Merck's Y-trap dual-function antibody M7824 for a down payment of $342 million, and Roche's GeneTek received Xencor's IL1 for a down payment of $120 million and a total value of $540 million 5/IL15Ra-Fc Fusion Protein Xmab24306, followed by Merck and GlaxoSmithKline (GSK) in April to develop a partnership of up to 3.7 billion euros for the dual functional fusion protein tumor immunotherapy M7824 targeting PD-L1/TGF-beta the latest news is that Roche released new data on two new CD20-CD3 T-cell binding bispecific antibodies mosunetuzumab and CD20-TCB to treat patients with recurrent or refractory non-Hodgkin's lymphoma (R/R NHL) at the ASH Conference Mosunetuzumab has encouraging results in patients who have relapsed after receiving CAR-T cell therapy or are resistant to CAR-T cell therapy, and GO29781 study data show that the objective remission rate (ORR) was 62.7% (n?42/67) and the total remission rate (CR) was 43.3% (n-29/67), while the persistence of inert NHL patients remained in the first 26 months after treatment 02 China's research and development trend is coming
compared with the international big pharmaceutical companies, Chinese pharmaceutical companies also showed great enthusiasm, with Roche hemophilia treatment drug Hemlibra (emicizumab) approved in December 2018 in China, many domestic companies have been actively entering the field of bispecific antibodies the boom in domestic research and development, mainly reflected in two aspects, on the one hand, start-up biopharmaceutical innovation enterprises, such as Cinda Bio's for the programomatic death receptor 1 (PD-1) and anti-biotic death ligand 1 (PD-L1) recombinant whole human source anti-procedural bispecific antibody (research code: IBI318) Phase I clinical study has been completed in April 2019 China's first patient administration also like ShoreMay Bio, which chose the registration program declared by China and the United States at the same time, announced on September 14, 2018 that its independent research and development of EMB01 for solid tumor indications based on its bispecific antibody platform was applied to the U.S Drug Administration (FDA) and China's State Drug Administration (NMPA) for clinical treatment The key technology of the product is patented in the United States, and in 2019 the U.S Patent and Trademark Office (USPTO) has granted its U.S patent entitled "Series Fabs Immunoglobulin and Its Uses" (Patent No 10266608) Sino-American double report is not just a shore-to-shore creature, Cowang Bio announced in February 2019 that the bi-specific antibody ES101 has been implicitly licensed by the China Drug Administration Review Center (CDE) clinical trial, and will soon conduct clinical trials in China, and its U.S partner in the ES101 program, Inhibrx, announced the completion of the first patient administration in the United States , ak104 is the world's first anti-PD-1/CTLA-4 bi-specific antibody drug to enter clinical trials in Australia as early as October 2017 (clinicaltrials gov: NCT03261011), ahead of AstraZeneca's MEDI5552 (first entered into clinical trials in April 2018) This was followed by the launch of Phase Ib/II clinical trials in China in March 2019 According to the latest news, the company is planning the listing of the Hong Kong Stock Exchange, according to its prospectus disclosed the substantive progress of the double anti-resistance research, PD-(L)1/CTLA-4 bispecific antibodies of the potentially treatable patient groups including PD-(L)1 monotherapy, CTLA-- 4 monotherapy or combination therapy responds to cancer patients, including patients who have responded but relapsed in past treatments (about 67% of patients with solid tumors), and may also be effective in cancer patients who do not have a significant response to PD-(L)1 monotherapy in addition to this, there are a number of such enterprises, including Kennelong, Tian Guangshi, Corning Jerry, they developed a focus of the dual resistance generally focused on advanced malignant solid tumors, blood tumors and autoimmune diseases, including non-small cell lung cancer, beta leukemia / lymphocytic cancer, HER2-positive breast cancer, stomach cancer, liver cancer and other diseases , on the other hand, are local traditional pharmaceutical companies, such as Hengrui, that are gradually transitioning to innovation , Hengrui's SHR1701 is progressing faster and has been approved and issued by the State Drug Administration on July 12, 2018, and has initiated Phase I clinical trials Hengrui is not expected to imagine PD-1 missed the position of the first echelon of domestic manufacturers of dual-specific antibody drugs, so it is also actively promoting clinical progress research and development process, enterprises are also in the early clinical and experimental application stage, in which Cinda biology and shore-mai biology in the age-related macular lesions and a variety of solid tumors in the phase I/II clinical stage, Hengrui Pharmaceuticals in non-small cell lung cancer, Corning Jerry in multiple tumor indications, Wuhan Youzhi in gastric cancer and breast cancer, kinetic medicine in beta leukemia / lymphoma, Zhongshan Kangfang in the malignant solid tumor in the clinical stage Tian Guangshi bio in HER2-positive tumor patients, Cinda Bio in tumor indications are still in clinical trialapplication IND declaration stage before the bi-specific antibodies to give expectations, the academic community is divided, but can not deny that the domestic double anti-river lake is coming original title: Another heavyweight variety was included in the proposed priority review queue! About to open the twin anti-river lake, where to see?