Yangtze River is showing off! 10 new class 1 drugs are eye-catching, and 63 new products are focusing on the 60 billion market...

Pharmaceutical network September 22nd, recently, Yangzijiang research and development pipeline happy news, 1 new drug YZJ-2440 Malay acid tablets approved clinical, 3 classes of generic drug Azishatan tablets reported ... At present, Yangzijiang has 10 new class 1 drugs in research, the first innovative drugs on the market in the immediate; 63 new classification products are under review, in 2019 China's public medical institutions terminal market size of more than 60 billion yuan; Twenty-one varieties under review have not yet been approved, 11 varieties by Yangzijiang first or exclusive to the new classification of production;
10 new Class 1 drugs are under study, the first innovative drug is on the market on September 11, CDE official website shows that Yangzijiang Pharmaceuticals independently developed a new class of 1 drug YZJ-2440 Malay acid tablets have been approved by clinical trials, intended for the treatment of HR/HER2-advanced or metastasis breast cancer.
meters of intranet data show that there are currently 2 new class 1 drugs declared on the market in Yangzijiang, the 2012 report of the Elamod tablets in 2016 by the enterprise voluntarily withdrawn, there is no new progress,2 The injection of phosphate zotronitrol nitrosodium reported in 2019 is still in "in the review and approval (in the drug review center)";
Table 1: Yang Zijiang in the research of new drugs source: Mi net China Drug Clinical Trials Public Library In August 2019, Yangzijiang Pharmaceuticals 1 class of new drug injection phosphate zuo nitrosodium dodium listing application was accepted by CDE contractor, for the treatment of gynecological pelvic inflammatory diseases, in November of the same year with "innovative drugs with obvious therapeutic advantages" as a reason for inclusion in the priority review.
the product belongs to nitromide antibiotics, is the sodium salt of the phosphate derivative of the L-isomer of onnitrol, a pre-drug for the listed zotronitrol.
meters of intranet data show that in 2019, China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (China's public medical institutions) terminal sales exceeded 3 billion yuan, 200 million yuan.
YZJ-1139 tablets are highly effective antagonists for type 1 and 2 receptors, which improve sleep by suppressing appetite receptors, and are currently undergoing Phase II clinical trials; PDE-5 inhibitors, developed by Jilin University, Tiansli declared clinical, Yangzijiang carried out clinical research, has now completed the treatment of erectile dysfunction Phase II clinical, September 17 Yangzijiang submitted the new drug supplement application to obtain CDE contractor acceptance; YZJ-0673 Malay acid tablets are a pan-PI3K inhibitor, there is no same target drug approved for market, Yangzijiang's products are in Phase I clinical, for advanced malignant solid tumors; YZJ-0318 Malayate tablets are third representative of skin growth factor (EGFR-TKI) inhibitors, able to selectively inhibit T790M drug-resistant mutations, is currently being carried out in Phase I clinical.
Tosic acid efiteni tablets belong to the small molecule drug of tinib, for special review varieties, injection cephalosporine hydrochloride for major special and special review varieties, YZJ-2440 Malayate tablets, YZJ-1495 hydrochloride capsules are approved in 2020 clinical new drugs, the target is not yet known.
63 new products closely follow the 60 billion market, 21 varieties of first imitation Yangzijiang Pharmaceuticals in the development of generic drugs also reaped considerable gains, 2020 has been approved 11 new products listed, all with new registration classification, approved production as follows through consistency evaluation;
Table 2: Yangzijiang New Classification Of Varieties under Review Source: MED2.0 China Drug Review Database as of September 18, 77 varieties in Yangzijiang were reported in the new registered classification. Fourty-four approved productions have been approved and consistently evaluated, and 63 varieties under review will have a total market size of more than 60 billion yuan in 2019, of which 21 varieties will exceed 1 billion yuan.
From the treatment category, the whole body anti-infector drugs, nervous system drugs are Yangzijiang's main two major drug areas, respectively, there are 18, 10 varieties in the trial, Minanet data show that in 2019 China's public medical institutions terminal system anti-infector drugs, nervous system drugs market size exceeded 200 billion yuan, 100 billion yuan. Table
3: No generic drugs have been approved for listing source: MED2.0 China Drug Review Database Yangzijiang in the review of 63 varieties, 21 in the domestic market has not yet been approved for the first imitation (including dosage form first imitation) approved for listing.
the world's highest sales varieties are Pomadoamine capsules, the product has a variety of mechanisms of action, is a multi-risk myeloma treatment field of heavy immunomodulants, 2019 global sales of $2.525 billion, the original research has not been approved for import, Zhengda Tianqing, Yangzijiang, Qilu 3 enterprises with new Classified production; Shu more glucosodium injection is the world's first to reverse neuromuscular blockers of the selected relaxation antagonists, 2019 global sales of $1,131 million, the original research has been approved for import, Colum, Yangzijiang, Dongsun pharmaceutical, Qilu and other 12 enterprises to take the first imitation.
11 varieties from Yangzijiang first or exclusive to the new classification of production, the chances of obtaining the first imitation is relatively large.
Among them, 3 varieties of hydrobrominate voltthiontin tablets, hydrochloric acid right metominated sodium chloride injection, Ntikave oral solution were first reported by Yangzijiang in a new classification; Patatin oral solution, naiconazine hydrochloride cream, methyl sulfonate safinamide tablets, compound electrolyte injection (III.), sodium acetate glucose injection, sodium sulfate potassium magnesium oral solution 8 varieties by Yangzijiang exclusive to the new classification of production.
13 as the first, 35 over-evaluated varieties catch up with Qilu in the consistency evaluation, 2020 to date, Yangzijiang has 17 varieties through or as if through the consistency evaluation (including the new product regulation review), of which 11 varieties with the new classification of production and the same evaluation, 6 varieties submitted supplementary applications and over-evaluation.
Table 4: Yangzijiang has been evaluated varieties Source: Minet MED2.0 China Drug Review Database as of September 18, 341 varieties of existing enterprises through or as follows through the consistent evaluation, from the enterprise evaluation situation, Qilu Pharmaceuticals with 40 over-rated varieties, China Biopharmaceuticals with 36 varieties followed by Yangzijiang Pharmaceuticals ranked third with 35 varieties.
Yangzijiang over-rated varieties, there are 13 varieties for the first over-evaluation, including cephalosporine tablets, ipasta tablets, hydrochloric acid Traazole capsules,acid tessimoxifen tablets 4 varieties for exclusive evaluation.
in the third batch of national collection recently carried out, Yangzijiang has 7 varieties successfully won the bid, respectively, Anaquic tablets (4 home standards), non-nastamine tablets (1mg, 2 home standards), Menglust sodium Tsui Chewing tablets (6 home labels), tigrillo tablets (6 home labels), Viglitin tablets (6 home labels), hydrochloric acid citric acid tablets (5 home standards), LOX fluorosa star eye drops (2 home labels).
in 2019 China's public medical institutions terminal competition pattern, Yangzijiang in these seven varieties of market share is low or 0, and now successfully winning the bid, can take advantage of the rapid market.
: Statistics as of September 18, if there are omissions, welcome to point out!