Domestic heavy-duty anti-cancer drug Zebutini shines on the scene, East Sunshine Lelotini three-phase research.

Zebutinib approved two indications on June 3, 2020, the State Drug Administration through the priority review and approval process with the conditions of the approval of Baiji Shenzhou Class 1 innovative drug Zebutinib capsules listed, the product is called The ®, the product will be set of adult cell lymphoma (MCL), adult chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) patients with new drug optionsboth applications for indications approved have been prioritized by the NMPA Drug Review Centre (CDE)the product was officially approved for domestic listing through priority review and approval, less than seven months after it was approved for listing in the United StatesZebutinib is a Bruton's tyrosine kinase (BTK) selective inhibitorZebutini capsule is an innovative drug that is independently developed and has independent intellectual property rights in Chinathe State Drug Administration requires drug market licenseholders to continue to complete confirmed clinical studies as planned after the product is listedZebutini, of Baiji Shenzhou, was initially approved by the FDA in November 2019 to treat patients with adult cell lymphoma who have previously received a treatment, becoming the first new anticancer drug to be developed entirely by a Chinese company and listed in the United Statesthe same month, Zebutinib was included in the National Comprehensive Cancer Network (NCCN) guidelinesnot long ago, Zebtinib as a new generation of BTK inhibitors was officially included in the 2020 edition of the Chinese Society of Clinical Oncology (CSCO) lymphoma diagnosis and treatment guidelines, as a set of cell lymphoma (MCL), chronic lymphocytic leukemia (CLL) treatment recommendedmakes it the first local drug to develop a new anti-cancer drug that has been double-recommended by the Chinese and American clinical guidelinesThe 100-ji Shenzhou BTK inhibitor Zebutinib has brought a new breakthrough to china's original anti-cancer drugZebutinib is an innovative drug that has invested 10 billion yuan in research and development in Baiji Shenzhoufda approved for the first time a new anti-cancer drug developed by Chinese companies, And Baiji Shenzhou has achieved innovative drugsit is understood that Ibtini costs $16,787 a month in the United States, while Zebutini costs $12,935 a month in the United States, 23% cheaper than ibtini's price in the United Statesthe first quarter of 2020, the sales of Zebbutini in the United States of Baiji Shenzhou were $720,000, according to clinical experts, Zebutinib has a good future in treating a variety of blood system malignancies, including cell lymphoma, and has shown strong results in clinical trials, with a full remission rate of 68.6 percent, and Zebutinib's listing has brought exciting news to patientsthe recommended dose of the drug ®, which is 160 mg each time, taken twice daily orally, before or after meals the dose of the drug can be adjusted appropriately according to adverse reactions and reduced in patients with severe liver damage and in specific drug responses currently won the first domestic BTK inhibitor in the country , as a domestic innovative drug market time, pricing strategy and security advantages will become the key to its market occupation domestic new drugs on the market, usually bring fierce competition, in the pricing will be lower than imported drugs future, it remains to be seen whether Zebbutny will continue to show its price advantage at home BTK inhibitor leader- Ibtinib, four BTK inhibitors have been approved worldwide: Ibruvica ®, AstraZeneca's Calquance ®, Burkinsa ® in Baiji, and Ono's Tirabrutin ®, which was approved in Japan on March 25, 2020 more THAN
BTK inhibitor products, global sales in 2019 has exceeded US$8 billion, the future BTK inhibitor market can be described as endless Table 1: FDA and NMPA-approved BTK inhibitor Ibtinib is developed by Johnson and Johnson and Pharmacyclics and is the world's first BTK inhibitor to go on the market, and was approved by the FDA in November 2013 for a product called Imbruvica ® in March 2015 AbbVie bought Pharmacyclics for $21 billion, acquiring the rights to develop the U.S market in Ibtini, while Johnson and Johnson owns the development rights of Ibtini in other countries around the world so far, Ibtini has been approved in more than 80 countries, with sales exceeding $8 billion in 2019 and $23.974 billion in cumulative sales over the six years of listing ibtinib is an efficient, highly selective small molecule BTK inhibitor for patients with chronic lymphatic leukemia (CLL)/small lymphocyte lymphoma, and cell lymphoma (MCL), who have previously received at least one treatment, and sales have grown rapidly since the market 2013, Ibtinib was approved by the U.S FDA to become the only drug designated by the FDA for three breakthrough treatments for chronic lymphoma, Fahrenheit polycythalproteinemia, and chromosomal 17p missing chronic lymphocytic leukemia Sales were $692 million in 2014, $1,348 million in 2015, $2.831 billion in 2016, $4.446 billion in 2017, $6.205 billion in 2018 and $8.085 billion in 2019 nearly three years, ibtini market sales are very eye-catching, in the current situation, the market potential is huge the market for Ibtini continues to grow at a rapid pace as indications continue to expand Figure 1: Global Ibtini sales in 2014-2019 (in millions of dollars) Total ibteni Johnson/Abbvie sales were $8,085 million in 2019, an increase of 30.30 percent over the same period , AbbVie's Ibtini sales were $4.674 billion, up 30.20 percent from the same period, or 58 percent of the overall market, while Johnson and Johnson's Ibtini sales were $3.411 billion, up 30.40 percent from the same period, or 42 percent of the overall market June 2016, the FDA approved ibtinib for use in small lymphocyte lymphoma, further cementing the market's strong position as the product's indications continue to grow Ibtini's growth momentum is mainly due to the increase in the market share of the first-tier CLL market, the 2020 entry into the $10 billion club is within reach August 2017, NMPA approved Johnson and Johnson's ibtini, a product called e-®, dosage capsules, with a size of 140 mg this product is intended for treatment in patients with chronic lymphocytic leukemia/small lymphocyte lymphoma who have previously received at least one treatment, as well as patients with set-cell lymphoma who have previously received at least one treatment, and is an innovative target oral medicine for the treatment of lymphoma subtypes Johnson ibtini entered the sample hospital market in 2017 and rose rapidly in 2017-2019 note: On August 17, 2018, the State Administration of Health Care issued a Circular on the Scope of Special Negotiating Drugs for The Admission of Anti-Cancer Drug Medical Insurance in 2018, confirming that 17 types of anti-cancer drugs were included in the scope of medical insurance, of which ibtinib, the star drug ibtinib, which is listed as a star drug for late-stage recurable lymphoma, was included in the health insurance catalogue a sharp reduction in prices following negotiations on ibtinib anti-cancer drugs, which led to a big increase in sales in the domestic market AstraZeneca's Acatini Promotion Space Large Acatini was developed by AstraZeneca and was first approved by the FDA for listing in October 2017 with the ®, which has been approved for CLL/SLL, MCL Indications, with global sales of $164 million in 2019, an increase of 164.5% over the same period, with great market potential Figure 3: Global Akatinib sales for 2017-2019 (in millions of dollars) According to global best-selling drug data: sales of $0.03 billion in 2017; a significant sales gap compared to Ibtini in the three years since its listing, but the market has improved in 2019 and there is still room for improvement in the future domestic BTK inhibitor research and development enthusiasm is high at present, the major domestic pharmaceutical companies for BTK inhibitor research and development enthusiasm is high, there are a number of pharmaceutical companies BTK target new drugs into clinical trials , Nocheng Jianhua developed and developed a new class of new drug Obitini tablets, respectively, on November 21, 2019 to be listed for the treatment of relapsing or difficult treatment of chronic lymphocytic leukemia / small lymphocyte lymphoma; Guangdong Dongsun's methyl sulfonate lelotini is also a multi-target BTK inhibitor, is currently in clinical phase III research, used in the treatment of esophageal squamous cancer, as well as in clinical phase I/ II studies, for the treatment of esophageal cancer The first listing of the Baiji Shenzhou Zebtini will undoubtedly take the lead, which will have a huge impact on the market pattern of BTK inhibitors currently, only Ibtini has been approved in the country, Akatini is still in clinical trials, zebutini is approved for listing, is expected to compete with Ibtini the potential of BTK inhibitors to continue to exist in the global market since its launch at present, China's drug review and approval speed accelerated, in recent years, there have been a number of domestic innovation approval will cause changes in the domestic market pattern in related fields The second independent drug developed in China approved in China following the reilly Zuma, , is another significant expansion of the company's rapidly growing commercial product portfolio for many years Baiji Shenzhou has invested in research and development of innovative drugs, which lasted many years and recently finally began to enter the harvest period .