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    Home > Medical News > Latest Medical News > Challenge the $8 billion variety! Baiji Shenzhou's first innovative drug domestic finally approved Wu Xiaobin on-site response!

    Challenge the $8 billion variety! Baiji Shenzhou's first innovative drug domestic finally approved Wu Xiaobin on-site response!

    • Last Update: 2020-06-17
    • Source: Internet
    • Author: User
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    Just a day earlier, The New Generation of BTK Inhibitors developed by Baiji Shenzhou announced the approval of the State Drug Administration for the treatment of adult set cell lymphoma (MCL) patients who have previously received at least one treatment, and adult chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL)Six months ago, Bai Yueze was successfully approved for sale in the United States with a set of cell lymphoma adaptation certificatesZebutinib as the first local innovation drug to achieve approval from the two major markets in China and the United States, this positioning is clearly in front of the first generation of BTK inhibitor overlord Ibtinib to do PKAccording to public information, ibtini's total global sales in 2019 were $8,085 million, up 30.30 percent from the same period, and it has advanced into the ranks of top5, the world's best-selling drug, and is a veritable super-heavy bomb, will this challenge work? What does Baiji Shenzhou have to do? In addition to clinical trials, around the price, certification, official time to market, medical insurance access and a series of other issues, Baiji Shenzhou made a layout, interpretation of China's local innovative pharmaceutical companies in the process of entering the local and global commercialization of various efforts, but also A sample of the rise of China's innovative pharmaceutical industrysee you in two weeks! What's the price? When will i be able to issue my first prescription after theis approved for listing? This is even the most important concern of clinical experts"In two weeksBaiji Shenzhou gave a surprising time responsenote, the normal variety in NMPA approved after the listing, pharmaceutical companies to complete the formal commercial listing also need a lot of procedures, to the doctor can write the first prescription generally takes 3 to 6 monthsAnd Baiji Shenzhou can be so fast, on the one hand, because six months ago Zebutini in the United States has been approved for listing and the first quarter has been achieved sales, the product market process is ready-made; "At present, Baiji Shenzhou has been in the industrial chain in all aspects of the full preparation to ensure that the first time after approval of the production supply"
    so, everyone's concern: What's the pricing? As the current price is still in a highly confidential stage, Baiji Shenzhou did not make a positive responseWu Xiaobin is very certain: "Bai Zeyue's pricing in China fully takes into account the affordability of Chinese patients, very beneficial." "
    Zebutini's previous pricing in the United States, referring to ibtini's pricing strategy, Ibtini pricing in China can be used as a reference contrastIn August 2017, NMPA approved Johnson and Johnson's Ibtini to be listed in China, with a product called E-List, with a size of 140mg x 90 capsules/box, retailing for 48,600 yuanThe important change came in 2018, when the National Health Insurance Administration added 17 anticancer drugs to the health care negotiations, including ibtinib, a drug for late-stage relapse of refractive lymphoma, which was reduced to 17,000 yuan and entered the health insurance catalog After the negotiation of anti-cancer drugs, the sharp price reduction also brought about a big increase in sales in its domestic market " Bai Yueze's pricing must be very sincere Wu Xiaobin said, "During the two sessions not long ago, the national representative committee proposed that the domestic innovation drug research and development application needs to be opened the last kilometer, medical insurance reimbursement and listing approval should be synchronized." That's what we're looking forward to "the globalization process of , the globalization process of the , and the approval of the two adaptation certificates in China at the same time, mainly based on data from two key clinical studies Data from one critical phase 2 multicenter clinical trial in China, BGB-3111-206, and another critical phase 2 multicenter clinical trial BGB-3111-205 study for R/R CLL/SLL in China, which performed well Li Jianyong, director of the Department of Blood at the First Affiliated Hospital of Nanjing Medical University and director of the Pukou Slow Shower Center, led the 205 clinical study in CLL: "Lymphoma is a high incidence of disease in the elderly, especially chronic lymphocytic leukemia, a relatively slow subtype, whether the treatment plan is safe and tolerable, is an important consideration for us." I am pleased to witness in clinical studies the excellent efficacy of the next generation of BTK inhibitors, with good tolerance and a very low risk of atrial fibrillation, bleeding, etc currently, Baiji Shenzhou is conducting 16 clinical studies worldwide, including 9 clinical trials that are registered or are expected to be registered At the same time, Bai Yueze is conducting 2 global clinical phase 3 head-to-head studies against Ibtinib for Fahrenheit polycyploproteinemia (WM) and CLL, the first local new drug to conduct direct head-to-head research with foreign pharmaceutical companies in research and development products " since the initial launch of clinical, has been practicing a global development strategy, in China and overseas countries to carry out simultaneous clinical research, which also put forward higher requirements for the design and quality of our clinical trials Wang Lai, senior vice president of Baiji Shenzhou, said Since entering the clinical trial stage, Bai Yueze has been certified as a priority review of NMPA in China, including four Grand Slams for FDA priority review, and has been included in the expert recommendation of lymphoma treatment by the Chinese and American clinical guidelines China and the United States, the process of access to the company continues, with applications for new drugs recently filed in Israel and accepted Under the previously announced plan, the company will also be in talks with the European Medicines Agency (EMA) this year to accelerate the global listing process "Thanks to the excellent data obtained in clinical trials, we have been in close communication with drug regulatory departments in several countries, and we have accumulated a wealth of experience and foundation for us to better advance our declaration sourcing in other countries," said Ni Xiaojun, senior vice president of the Baiji Shenzhou and head of global pharmaceutical affairs "
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