Zhengda Tianqing has invested in the largest first drug so far, which is expected to be listed at the end of the year!

In September this year, the second "2017 China Pharmaceutical Summit Forum and top 100 research and development strength list of pharmaceutical enterprises" hosted by yaozhi.com and China Pharmacy magazine was held in Chongqing Zhengda Tianqing won the first place in the 2017 China Pharmaceutical R & D strength list (see Figure 1 for the top 10 of the list) Its innovation in the direction of new drug R & D in 2016 is remarkable With two months left in 2017, what are its new actions in new drug R & D this year? (Figure 1) up to now (October 31), CDE has undertaken 27 applications for registration of Zhengda Tianqing this year, including 10 clinical applications and 12 production applications In terms of clinical application, 29 products were applied in the same period of 2016, including 4 products in Category 1, 1.1, 1 and 22 products in category 3.1 It can be seen that the main application items of Zhengda Tianqing last year were the first generic drugs, while this year's clinical application amount decreased significantly compared with the same period of last year, but the application amount of the first generic drugs increased Of the 10 drugs that Zhengda Tianqing has applied for clinical application this year, 9 are chemical drugs of class 1 and 1 biological product for treatment of class 2, all of which are the first new drugs (see Figure 2 for the specific list) This is also in line with Zhengda Tianqing's strategic plan of not only being the "king of first imitation", but also occupying a place in innovative medicine (Figure 2) in addition to the transformation from the first imitation to the first creation, Zhengda Tianqing's strategy of "two cores and more powerful" is beginning to emerge First, in the field of liver disease, the market share of Zhengda Tianqing liver disease hospital accounted for 24%, and the annual sales of antiviral product entecavir reached 3.5 billion yuan The annual sales volume of Tianqing Ganmei, a new class I drug, is more than 2 billion yuan Moreover, on September 29, Zhengda Tianqing successfully obtained the registration approval of tenofovir fumarate dipivoxil tablets (trade name: Qingzhong), according to the Internet This means that Zhengda Tianqing is the first in China to complete the bioequivalence study of tenofovir dipivoxil according to the standard of "consistency evaluation of quality and efficacy of generic drugs" The second is in the field of cancer According to the data of drug intelligence, there are 8 varieties (see Figure 3 for the specific list) in the 12 drugs (calculated according to the acceptance number) declared and produced by Zhengda Tianqing this year, 6 of which are anti-tumor drugs and immunomodulators This also indicates that its anti-tumor products will usher in a new round of outbreak, and become a sharp tool for its next market development (Fig 3) six antitumor drugs and immunomodulators include benzamoxetine hydrochloride for injection, azacitidine for injection, androtinib hydrochloride capsule, lenalidomide capsule, gefitinib tablet and abitrone acetate tablet Among them, bendamostine hydrochloride for injection is used for the treatment of non Hodgkin's lymphoma (NHL) Zhengda Tianqing is the first one to apply The drug has been included in the 18th batch of drug registration applications in the priority review procedure, which is expected to accelerate the listing Azacytidine for injection has entered the third phase of the test for "myelodysplastic syndrome (MDS)", and the indication of abitron acetate is "applicable in combination with prednisone" The clinical trial has been completed in the past treatment of patients with metastatic and refractory prostate cancer (CRPC) by paclitaxel containing chemotherapy And Zhengda Tianqing has put in the largest new heavy-duty product, enrotinib hydrochloride capsule, among the six varieties He is the only new drug of this batch of products to be put on the market, initiated by Zhengda Tianqing, and also the only drug that has been included in the priority review and special approval at the same time According to the data of drug intelligence, Zhengda Tianqing submitted the clinical application of androtinib hydrochloride to CDE as early as July 1, 2010, and passed the clinical approval on April 1, 2011 In less than six years, Zhengda Tianqing's enrotinib hydrochloride capsule filed an application for listing to CDE on March 16, 2017 (see Figure 4 for the application record) (Figure 4) androtinib is expected to go on the market by the end of this year As a new type of small molecule multi-target tyrosine kinase inhibitor developed by Zhengda Tianqing and originally developed in China, androtinib can strongly inhibit VEGFR, PDGFR, FGFR and c-kit, and has the effect of anti-tumor angiogenesis and anti-tumor growth At present, the indications of the drug are lung cancer, soft tissue sarcoma, medullary thyroid cancer, renal cancer and so on Among them, in view of the rapid progress in the treatment of non-small cell lung cancer (NSCLC), phase III clinical trials have been completed It was learned from the third phase clinical summary meeting of arotinib in the treatment of non-small cell lung cancer held by Zhengda Tianqing a long time ago that although the existing first-line and second-line drugs for the treatment of advanced NSCLC have improved the survival of patients However, for the patients with advanced NSCLC who failed in the first-line and second-line treatment, the existing three-line treatment methods are relatively lacking and there is no unified standard, and there is still a huge clinical demand that has not been met The appearance of androtinib will effectively fill this gap and bring a breakthrough for the third-line treatment of advanced NSCLC As for when the drug will meet with patients, Wang Shanchun, President of Zhengda Tianqing, recently revealed that the phase III clinical study of small cell lung cancer of androtinib has been unblinded, and is actively preparing for application, which is expected to be approved for listing by the end of 2017.