Four Companies Including Kelun and Chengdu Biotech Achieve First-to-Pass Generic Drug Evaluations Among 16 Newly Approved Products

　　【Pharmaceutical Network Industry DynamicsFrom February 20, 2022, to February 26, 2022, 16 new varieties (deemed) passed the consistency evaluation, of which four were the first in China to pass the evaluation. These four varieties are Kelun Pharmaceutical's Compound Amino Acid (15) Dipeptide (2) Injection, Chongqing Hemony Pharmaceutical Co., Ltd.'s Calcitriol Soft Capsules, Chengdu Betta Pharmaceuticals' Calcium Gluconate Injection, and Wuhan Puyuan Pharmaceutical's Ursodeoxycholic Acid Tablets.
 

On February 24, the website of the National Medical Products Administration showed that Chengdu Better Pharmaceutical's Calcium Gluconate Injection passed the generic drug consistency evaluation, becoming the first in China to do so. Currently, a total of 50 companies in China hold production licenses for Calcium Gluconate Injection, but only five companies have submitted supplementary applications for the product’s consistency evaluation, including Hebei Tiancheng Pharmaceutical, Chengdu Better Pharmaceutical, China Resources Double-Crane Limin, Jiangsu Huayang Pharmaceutical, and Yangzhou Zhongbao Pharmaceutical.
 

Calcium Gluconate Injection is a commonly used intravenous calcium supplement in clinical practice, suitable for treating calcium deficiency, acute hypocalcemia, tetany caused by alkalosis and hypoparathyroidism, etc. Data shows that in 2020, the sales of Calcium Gluconate Injection in Chinese public medical institutions, including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions), exceeded 600 million yuan; In the first half of 2021, its sales increased by 26.20% year-on-year, exceeding 300 million yuan.
 

On February 24, the website of the National Medical Products Administration showed that Wuhan Puyuan Pharmaceutical's Ursodeoxycholic Acid Tablets had passed the evaluation. Ursodeoxycholic acid is a gallstone-dissolving drug, suitable for the treatment of: cholesterol gallstones – must be stones that X-rays can penetrate, and gallbladder contractility function must be normal; cholestatic liver disease (e.g., primary biliary cirrhosis); bile reflux gastritis.
 

Data shows that in 2020, the sales of ursodeoxycholic acid in sample hospitals in China reached 5.52 billion yuan, and in the first three quarters of 2021, it increased by 19.89% year-on-year to 4.77 billion yuan. The German manufacturer Dr. Falk holds an 85% market share of this product.
 

On February 21, the website of the National Medical Products Administration showed that Sichuan Kelun Pharmaceutical's Compound Amino Acid (15) Dipeptide (2) Injection was approved for supplementary application, making it the first company to pass the evaluation for this product. Currently, four companies hold the production approval for this product.
 

Compound Amino Acid (15) Dipeptide (2) Injection is suitable for patients who cannot receive nutrition orally or via the gastrointestinal tract, and for whom these methods are insufficient to meet nutritional needs, especially for patients with moderate to severe catabolic conditions.
 

Data shows that the terminal sales of Compound Amino Acid (15) Dipeptide (2) Injection in Chinese public medical institutions, including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers, were nearly 500 million yuan in 2020. In the first half of 2021, it increased by more than 10% year-on-year.
 

On February 21, the website of the National Medical Products Administration showed that Chongqing Hemony Pharmaceutical Co., Ltd.'s Calcitriol Soft Capsules had been approved for evaluation. In China, only Chongqing Hemony has submitted a supplementary application for the consistency evaluation of Calcitriol Soft Capsules, which was accepted by the CDE in May 2021 and has now been successfully approved in less than a year, making it the first in the country.
 

Calcitriol, as an endogenous drug, is a medication for treating osteoporosis developed by Roche. According to data, the sales revenue of calcitriol in Chinese sample hospitals in 2020 increased by 2.34% year-on-year, reaching 604 million yuan; In the first three quarters of 2021, the sales revenue was 487 million yuan, with steady growth.
 

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