First week of July As of 4 July, CDE had a total of 1228 acceptance numbers for conformity evaluation, involving 364 varieties of 376 enterprises (according to supplementary applications, the same as below);

This week 2 varieties passed, 7 varieties have been evaluated in that, there are 14 varieties of declaration accepted, of which 7 varieties for the first declaration acceptance, hundreds of millions of drugs and key monitoring auxiliary drug powder on the scene.
01 Over review details
There are 2 varieties have been evaluated, Huasu Pharmaceutical billion-grade products the first

This week (June 27-July 4) there are 2 varieties through the consistency evaluation, respectively, Beijing Huasin Pharmaceutical's fumaric peso lorl tablets and Beijing Beilu Pharmaceuticals' Gremyaine tablets.
Fuma acid peso lal of Beijing Huasin Pharmaceuticals Fumaic sorol tablets are highly selective beta-1-epinephrine receptor blockers used to treat hypertension, coronary heart disease (angina) and chronic stability of heart failure.
The drug was first developed by Merck in 1978 and first listed in Germany in 1986, with a product called Concor (Conco) and sold in China in 1998. According to the announcement of Zhongguancun Technology Development (Holdings) Co., Ltd. in Beijing, Huasin Pharmaceutical research and development and listing of fumaric pesol tablets (commodity name: Bossu) in accordance with the chemical drug class 2 new drugs for registration declaration, and in 1995 obtained a new drug certificate and production approval,
Is the first domestic market sale of beta-1-epinephrine receptor blocker, specification 5 mg, used to reduce hypertension. According to PDB data, in 2018, the global sales of Fuma icing peso lorl tablets were about US$1.405 billion, and sales in China were about RMB1.255 billion, and sales of huasin Pharmaceuticals in 2018 were RMB272 million, accounting for about RMB21.6 billion of similar products in China.
% of the market share, second only to the original study of The German Merck company Kang Yu, ranked second in the domestic. In addition, according to the data statistics of medicine, Fuma acid pesol tablets for the national medical insurance catalog Class A drugs, domestic market approval 5, involving the production enterprises are Huasin Pharmaceutical, Chengdu Yuandong Biological, Yueyang Xinhuada Pharmaceutical three local enterprises.
Among them, Chengdu Yuandong biological specifications of 5mg before the first through the consistency evaluation;
Gremyaine tablets from Beilu Pharmaceuticals, Beijing Gremetire tablets are class-A drugs in the National Health Insurance Catalog, which are suitable for type 2 diabetes, which controls diet, exercise therapy, and weight loss.
The drug, originally licensed by Sanofi-Aventis Deutschland GmbH, was first introduced in Sweden in 1995 as a safe and effective anti-sugar drug. Up to now, there are 17 approvals of the domestic market of Gremmelfilm, involving 13 production enterprises, of which 10 enterprises have carried out consistency evaluation reference for the record, 5 enterprises have been evaluated, including the North Land Pharmaceutical Industry;

Guizhou Tian'an Pharmaceutical San 3 enterprises of the variety of BE test has been completed, over the evaluation refers to the day.
02 Review and approval of 7 varieties over the evaluation, 2 varieties will be three-legged

This week, in addition to the two varieties that have been evaluated, there are 7 varieties approved to be "issued" status. It is worth mentioning that the phosphatapyric tablets and chlorpyrifos tablets of The Chinese and Western Pharmaceuticals in Shanghai will be the first to be evaluated;

The fifth evaluation enterprise of metformin hydrochloride is about to be born, and the pylonsulsulcin chlorpyrifos will welcome the 9th evaluation enterprise - Zhejiang Kang for Pharmaceuticals.
03 Declaration accepted
14 varieties were contractor, heavy varieties, auxiliary drugs on the
This week, 21 acceptance number 14 varieties were cED, 50% of the varieties for the first declared acceptance of varieties, including Colum's bicarbonate sodium ringer injection, Fu'an Qing Yutang injection with cephalosporine sodium, Kunming's large injection of glutathione sodium and other heavy injections.
Bicarbonate Sodium Ringer Injection The bicarbonate-sodium ringer injection is a fifth-generation perinatal injection, a compound electrolyte injection, used as a supplementary correction of extracellular fluid, as well as correction of metabolic acidosis, when the amount of circulating blood and the reduction of intercellular fluid. Originally developed as Otsuka, Japan, was approved for listing in Japan in 2010.
Global sales of bicarbonate-sodium ringer injections in 2018 were approximately $3.673 million. According to the data of medicine, the current domestic bicarbonate of sodium Ringer injection only Colum Pharmaceuticals and Hengrui Pharmaceuticals two enterprises, it is worth mentioning that the two enterprises are only approved for listing this year, including Hengrui Pharmaceuticals to seize the opportunity, for the drug's first imitation enterprises, As Hengrui is listed according to the old registration classification 3.2 category, belongs to the non-conformity evaluation varieties, has started the consistency evaluation work.
However, Koren Pharmaceuticals became a rising star, just approved for listing in May, is now preempting Hengrui a drum beat consistency evaluation declaration was accepted, in order to divide the market share to improve competitive strength.
Injection of cephalosporine sodium Injection of cephalosporine sodium for the third generation of cephalosporine anti-infective drugs, mainly applicable to sepsis, tonsillitis (including abscesses around the tonsils), acute bronchitis, pneumonia, pulmonary abscess, chronic respiratory lesions secondary infection, cystitis, nephritis, peritonitis, biliatitis, bile ductitis, intrauterine infection, uterine appendis, endometeritis
Uterine side tissue inflammation.
According to the IMEDICAL medical drug market analysis study, in 2018 China's cephalosporine sodium medical drugs in the first place in the injection of cephalosporine sodium, a total of 167, accounting for 85.20% of the number of cephalosporine sodium drugs.
According to the data of medicine wisdom, injection with cephalosporine sodium domestic approval has 165, 64 manufacturers, Fu Anqing Yutang the first declaration was accepted, if successfully evaluated, will be expected to obtain policy advantages in centralized procurement of drugs, such as expanding market share.
Glutathione for injection Injection glutathione is mainly suitable for chemotherapy, radiation therapy, a variety of hypoxic emias auxiliary treatment, organophosphate, amine or nitrocompound poisoning auxiliary treatment, but also suitable for the treatment of liver disease, detoxifying drug toxicity.
First listed in Japan in 1965, the product named Tathion Astellas, has been listed in China, the European Union, Japan, South Korea and other countries.
According to IMS data, global sales of glutathione for injection sathiathiatron in 2017 were US$551,023,802, of which US$529,772,397 were sold in China and US$336,355,638 in January-September 2018, of which $319,028,617 was sold in China.
It is worth noting that in September last year, the State Drug Administration issued a "Notice on the revision of glutathione injection specifications", decided to glutathione injections (including: injection also prototype glutathione, injection also prototype glutathione sodium, injection glutathione) adverse reactions, "precautions" item s ." In addition, according to the drug intelligence and focus monitoring drug catalog database statistics, glutathione injections are more than as auxiliary drugs, into some hospitals focus on monitoring drug catalog