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34 new varieties have passed the consistency evaluation, and 8 are the first ones (list attached)

 Last Update: 2022-01-26
 Source: Internet
 Author: User

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According to the incomplete statistics of the Medicine Cloud Studio, 3,608 quality standards have passed the consistency evaluation, and 411 quality standards have been evaluated by more than three companies (including three companies).

3608 411

According to the statistics of the Medicine Cloud Studio, from January 2, 2022 to January 8, 2022, 34 new varieties (deemed) passed the consistency evaluation, of which 8 were the first in the country to pass the evaluation
.

details as follows:

Jianjin Pharmaceutical: Calcium levofolinate for injection

Calcium levofolinate for injection in combination with 5-fluorouracil chemotherapy drug for gastric and colorectal cancer
.

The drug was developed by SPECTRUM company under the trade name Fusilev® and was approved by the FDA in the United States on March 7, 2008

In October 2019, Jianjin Pharmaceutical submitted a generic drug listing application for calcium levofolinate for injection (new category 3); in August of the same year, it was included in the priority review process by CDE on the grounds of "encouraging drug innovation"; in January 2022, This product has been approved by NMPA for listing, and it is the first domestic product that has been deemed to have been reviewed
.

It is worth noting that Jianjin Pharmaceutical's levofolinate calcium for injection (50mg) has been approved by the US FDA in August 2019
.

At present, there is no original research on this product in the market
.

After inquiries, the domestic generic drugs of levofolinate calcium for injection from Jiangsu Hengrui, Qilu Pharmaceutical, Chia Tai Tianqing, Guangdong Lingnan Pharmaceutical, Shanxi Pude Pharmaceutical and Chongqing Huabang Pharmaceutical have been approved for marketing

According to the announcement of Jianjin Pharmaceutical, as of now, the company has invested about RMB 9.
5991 million in research and development projects of calcium levofolinate for injection
.

Shengshi Tech Bio: Teriflunomide Tablets

Teriflunomide is an anti-inflammatory immunomodulator that inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis
.

Studies have shown that the mechanism of action of the drug in the treatment of MS may be related to the reduction of the number of activated lymphocytes in the central nervous system

Teriflunomide was developed by Sanofi under the trade name Aubagio and was approved for marketing in China in July 2018 for the treatment of relapsing MS
.

According to Sanofi's 2020 financial report, Aubagio's sales continued to grow to 2.

Livzon Group Livzon Pharmaceutical Factory: Cetrelix acetate for injection

Cetrelix acetate for injection is independently developed by Livzon Group.
It is the second product that has been imitated in China and the first product that is deemed to have passed the consistency evaluation
.

At the same time, this product is the first preparation product of Livzon Group to be reported in both China and the United States.

Cetrorelix acetate for injection is a synthetic gonadotropin-releasing hormone antagonist (GnRH-A) drug, which was developed and marketed by Merck Serono in 1999 and entered China in 2010
.

The mechanism of action of this product is to control the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) by competing with endogenous gonadotropin-releasing hormone (LHRH) for membrane receptors on pituitary cells.
Stimulated patients to prevent premature ovulation, and then proceed to egg retrieval and assisted reproductive technology treatment
.

Compared with the traditional treatment regimen, the medication time is shorter, which can effectively prevent the occurrence of ovarian hyperstimulation, and has better compliance and comfort for patients

At the same time, studies have shown that cetrorelix also has a good effect on ovarian cancer, prostate cancer, uterine fibroids, endometriosis and other diseases, and has a preventive effect on benign prostatic hypertrophy
.

According to IMS data, in 2020, the sales of Citrelix in the Chinese market exceeded 200 million yuan
.

Shijiazhuang Green Pharmaceutical: Arololol Hydrochloride Tablets

Arolol hydrochloride tablet is a third-generation β-receptor blocker-αβ-receptor blocker, which has β-receptor blocking effect and moderate α1-receptor blocking effect.
It plays an important role in the treatment of special hypertension and essential tremor
.

This product was launched in China in 1995 and has been selected into the National Medical Insurance Catalogue and belongs to the cardiovascular system drugs
.

After years of clinical practice, the efficacy and safety of arolol hydrochloride tablets have been unanimously recognized by front-line doctors, and have been selected into many authoritative guidelines and expert consensus, becoming the first-line treatment drug in multiple departments and fields

According to the 2020 Minet data, the total sales of public medical beta-blockers in China is about 5.
8 billion yuan, and Arolol ranks fourth
.

Henan Taifeng Biology/Sichuan Guowei Pharmaceutical: Calcitriol Soft Capsules

Calcitriol is one of the most important active metabolites of vitamin D3, which can effectively increase blood calcium levels, promote intestinal absorption of calcium and regulate bone calcification
.

Calcitriol is mainly used to treat postmenopausal osteoporosis; chronic renal failure, especially renal osteodystrophy in patients receiving hemodialysis; postoperative hypoparathyroidism; idiopathic hypoparathyroidism; Pseudohypoparathyroidism; rickets,
etc.
Osteoporosis is the largest application area of calcitriol
.

This product was developed by Roche, and was approved by the FDA in 1978 to be marketed in the United States.
It was subsequently registered in Germany, Italy and other European countries.
It was officially sold in China in 2003
.

According to Minet.
com, the sales of calcitriol in domestic sample hospitals in 2020 will be 604 million yuan, a year-on-year increase of 2.
34%; the sales in the first three quarters of 2021 will be 487 million yuan, and the sales growth will increase steadily
.
Chia Tai Pharmaceutical (52.
02%) and Roche (46.
99%) have formed a market structure of two armies, and the remaining 1% of the market is shared by Taiwan Hemony and AbbVie
.

At present, only one Roche has been approved for calcitriol capsules and calcitriol injection
.
Calcitriol soft capsules have been approved for production by Chia Tai Pharmaceutical; Sichuan Guowei and Henan Taifeng have both crossed the line recently and won the first domestic review; Anshi Pharmaceutical (Zhongshan) is on the way to review and approval
.

Nanjing Chia Tai Tianqing: Sitagliptin Metformin Sustained Release Tablets

Sitagliptin and metformin is a combination of two hypoglycemic drugs with complementary mechanisms of action.
Combined with diet and exercise therapy, it is used for patients with type 2 diabetes who are still poorly controlled by metformin monotherapy or are receiving combination therapy
.

The original manufacturer of the drug is Merck & Co.
, which was approved by the FDA in 2007 and approved in China in 2012
.
The trade name is Genoda
.
The annual report shows that in 2020, Merck's sales of this product are nearly 2 billion US dollars
.

According to Minenet data, Merck's sitagliptin metformin has global sales of nearly US$2 billion in 2020; in recent years, the sales of sitagliptin and metformin in Chinese public medical institutions have maintained rapid growth, with a year-on-year increase of more than 50% in the first half of 2020
.

Ruiyang Pharmaceutical: Roxatidine Hydrochloride Acetate for Injection

Roxatidine hydrochloride acetate is a histamine H2 receptor antagonist, which can effectively inhibit gastric acid secretion.
It is clinically used for upper gastrointestinal bleeding (caused by peptic ulcer, acute stress ulcer, hemorrhagic gastritis, etc.
) of low-risk patients
.

Ruiyang Pharmaceutical's Roxatidine Hydrochloride Acetate for Injection was approved according to the new Class 3 registration application, and it is regarded as the first one in China after approval
.
Previously, Beijing Sihuan (first imitation) and Harbin Pharmaceutical Group have obtained the production approval for this product
.

According to data from Minet.
com, the terminal sales of this product in China's public medical institutions will be close to 1 billion yuan in 2020, a year-on-year increase of 59.
6%
.

At present, 3 companies have submitted the marketing application of roxatidine hydrochloride for injection under the new registration classification.
Among them, the product of Ruiyang Pharmaceutical has been successfully approved and deemed to have passed the evaluation; Sihuan Pharmaceutical has submitted a supplementary application for the consistency of the product.
Still under review and approval
.

According to public data, in 2020, the sales revenue of the domestic sample hospital terminal [Roxatidine] was 417 million yuan, a year-on-year increase of 18.
59%.
It is enlarged to the national medical institutions, which seems to be a large variety of 1 billion
.

Hainan Huanglong Pharmaceutical: Valsartan Dispersible Tablets

Valsartan dispersible tablets are angiotensin II receptor AT1 antagonists, used for the treatment of mild to moderate essential hypertension
.
It is a "Class A" variety in the National Medical Insurance Catalogue and is currently the mainstream blood pressure lowering drug in the domestic market
.

It is reported that the global sales of valsartan in 2020 is about 6.
08 billion US dollars, and the Chinese market sales are about 430 million US dollars (equivalent to 2.
75 billion yuan).
The original research Novartis occupies 80% of the sales market, Tianda Pharmaceutical (5.
04%), Changzhou four Local pharmaceutical companies such as Pharma (4.
69%), China Resources Secco (3.
71%), and Lunanbeit (2.
88%) followed closely
.

The latest national review data report:

According to the incomplete statistics of the Medicine Cloud Studio, 3,608 quality standards have passed the consistency evaluation, and 411 quality standards have been collected by more than three (including three) companies
.

3608 411

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