Injectable Drug Sector Receives Multiple Generic Drug Consistency Evaluation Approvals in October

　　【Pharmaceutical Network | Product Information】Since October, multiple injectable products have passed the consistency evaluation, involving manufacturers such as Xinhua Pharmaceutical, Luoxin Pharmaceutical, and Lunan Pharmaceutical. Notably, the evaluated injections include several major products, such as pantoprazole sodium for injection.
 

In accordance with relevant national policies, drug products that have passed the Consistency Evaluation, demonstrating equivalence to originator drugs in both quality and therapeutic efficacy, will receive appropriate support regarding medical insurance reimbursement and procurement by medical institutions. For pharmaceutical companies, successfully passing the evaluation not only enriches the corporate product portfolio and demonstrates robust R&D capabilities and stringent quality control, but also provides patients with a broader and more comprehensive range of therapeutic options.
 

　　Multiple Pharmaceutical Companies' Pemetrexed Disodium for Injection Passes Consistency Evaluation
 

October 15 news: Pemetrexed Disodium for Injection from Shandong New Time Pharmaceutical Co., Ltd. has been approved via a supplementary application, passing the consistency evaluation. As of now, Shandong New Time Pharmaceutical has had 14 drug varieties (18 specifications) pass the consistency evaluation.
 

It is worth mentioning that, as reported on October 9, Lunan Pharmaceutical's Pemetrexed Disodium for Injection (brand name: Yinliqi; specification: 100 mg, 500 mg) has also passed the consistency evaluation upon approval by the National Medical Products Administration (NMPA).
 

Pemetrexed is a new-generation antimetabolite chemotherapy drug and a novel antineoplastic agent of significant clinical value that has been marketed in recent years. It is indicated for the first-line and second-line treatment of non-small cell lung cancer (NSCLC). Data from Menet shows that in 2020, terminal sales of Pemetrexed Disodium for Injection at public medical institutions in China exceeded 4 billion RMB, with a year-on-year growth of 2.34% in the first half of 2021.
 

There are over 20 manufacturers of Pemetrexed Disodium for Injection. Prior to Shandong New Time Pharmaceutical Co., Ltd. and Lunan Pharmaceutical, multiple companies such as Qilu Pharmaceutical (Hainan), Yangtze River Pharmaceutical Group, Jiangsu Hansoh Pharmaceutical, and Nanjing Simcere Dongyuan Pharmaceutical have already passed the consistency evaluation.
 

　Luoxin Pharmaceutical: Pantoprazole Sodium for Injection Passes Consistency Evaluation
 

Luoxin Pharmaceutical announced on October 15 that its subsidiary, Shandong Luoxin, recently received the 《Approval Notice for Supplementary Drug Application》 for Pantoprazole Sodium for Injection, approved and issued by the National Medical Products Administration (NMPA).
 

Pantoprazole is a blockbuster drug in gastroenterology, belonging to the proton pump inhibitor (PPI) class. It is indicated for duodenal ulcer; gastric ulcer; moderate to severe reflux esophagitis; acute upper gastrointestinal bleeding caused by duodenal ulcer, gastric ulcer, acute gastric mucosal lesion, compound gastric ulcer, etc.
 

Data from Menet shows that sales of pantoprazole injection in public medical institutions in China exceeded 6 billion RMB in 2019.
 

According to IQVIA data, the global market size of Pantoprazole Sodium for Injection in 2020 was USD 690 million (calculated at ex-factory price), and China's market size was RMB 2.95 billion (calculated at bidding price).
 

Luoxin Pharmaceutical stated in its announcement that Pantoprazole Sodium for Injection holds a significant position in the company's gastrointestinal drug portfolio. Successfully passing this consistency evaluation will not only enhance the market competitiveness of this product, but also accumulate valuable experience for the company's subsequent consistency evaluation work.
 

　　Xinhua Pharmaceutical: Clindamycin Phosphate Injection Passes Consistency Evaluation
 

Recently, Xinhua Pharmaceutical announced that its independently developed Clindamycin Phosphate Injection (2ml:0.3g and 4ml:0.6g) has received the "Notice of Approval for Supplementary Drug Application," with both specifications having passed the consistency evaluation.
 

Clindamycin Phosphate Injection is widely used in clinical practice, primarily indicated for various infectious diseases caused by Gram-positive bacteria and anaerobic bacteria. According to data from Menet, the sales revenue of clindamycin in urban public and county-level public medical institutions in China amounted to approximately RMB 1.479 billion in 2020.