Multiple Chinese Pharma Companies Including Jingfeng Pharmaceutical Gain Market Expansion Opportunities as Products Pass Generic Drug Consistency Evaluation

　　【Pharmaceutical Network | Industry News】The consistency evaluation of generic drugs is a process of survival of the fittest. Only generic drugs with quality and efficacy consistent with those of originator drugs can win public recognition. According to relevant national policies, drug products that pass the consistency evaluation will receive greater support in areas such as medical insurance reimbursement and procurement by medical institutions. Passing the consistency evaluation will help expand the drug's market share and enhance its market competitiveness.
 

At present, China's consistency evaluation work for generic drugs is progressing smoothly. The national drug regulatory authorities have released multiple batches of reference listed drug catalogs, and pharmaceutical manufacturers have demonstrated high enthusiasm. According to media reports, since the issuance of the *Opinions on Carrying out Consistency Evaluation of the Quality and Efficacy of Generic Drugs* in 2016, a total of 533 drug varieties and 2,319 product applications for consistency evaluation had been accepted in China as of the end of August 2020. The author has learned that since the beginning of July this year, several pharmaceutical companies have issued announcements confirming that their products have passed the generic drug consistency evaluation.
 

　Jingfeng Medicine's Anti-Tumor Drug Receives Approval for Generic Drug Consistency Evaluation
 

Jingfeng Pharmaceutical has once again achieved significant results in the generic drug consistency evaluation. The company recently announced that its subsidiary, Hainan Jinrui Pharmaceutical Co., Ltd., has received the “Notice of Approval for Supplementary Drug Application” for Irinotecan Hydrochloride Injection, officially approved and issued by the National Medical Products Administration (NMPA). Irinotecan Hydrochloride Injection has successfully passed the Generic Drug Quality and Efficacy Consistency Evaluation. It is reported that this is also the fifth product to be approved in China or overseas, or to pass the consistency evaluation this year, which is expected to further enrich the company's product portfolio.
 

The announcement indicates that Irinotecan Hydrochloride Injection is indicated for the treatment of patients with advanced colorectal cancer. It may be used in combination with 5-fluorouracil and leucovorin for the treatment of chemotherapy-naïve patients with advanced colorectal cancer; it may also be used as monotherapy for patients who have failed prior 5-fluorouracil-based chemotherapy regimens. Jingfeng Pharmaceutical's Irinotecan Hydrochloride Injection passing the generic drug consistency evaluation will facilitate the expansion of the market share of this product and enhance its market competitiveness.
 

　Chia Tai Tianqing Linezolid and Glucose Injection Passes Consistency Evaluation
 

Recently, Chia Tai Tianqing's Linezolid and Glucose Injection (Tianli) received an Approval Notice for Supplementary Drug Application from the National Medical Products Administration (NMPA), successfully passing the Consistency Evaluation of Quality and Efficacy of Generic Drugs. To date, Chia Tai Tianqing has a total of 56 specifications that have passed or are deemed to have passed this consistency evaluation.
 

It is reported that linezolid is indicated for the treatment of the following infections caused by susceptible strains of specific microorganisms: hospital-acquired pneumonia, community-acquired pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infections, vancomycin-resistant Enterococcus faecium infections, etc. Linezolid belongs to the oxazolidinone class of antibacterial agents. With a unique mechanism of action, it is effective against a variety of clinically significant Gram-positive (G+) pathogens and is characterized by a broad in vitro antibacterial spectrum, strong penetration into body fluids and tissues, and a high safety profile. Compared with other antibacterial agents (such asCephalosporinclass, quinolones, or β-lactam antibiotics) exhibits almost no cross-resistance, and is widely used in departments such as respiratory medicine, hematology, intensive care unit (ICU), tuberculosis, and infectious diseases.
 

　Baiyunshan Amoxicillin Capsules Pass Consistency Evaluation
 

Recently, Baiyunshan announced that its branch, Baiyunshan General Pharmaceutical Factory of Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd. (“Baiyunshan General Pharmaceutical Factory”), has received the 《Notice of Approval for Supplementary Drug Application》 (Notice No.: 2021B01811) issued by the National Medical Products Administration, confirming that its Amoxicillin Capsules have passed the consistency evaluation of quality and efficacy for generic drugs.
 

It is known that amoxicillin is a semi-synthetic penicillin antibiotic indicated for the following infections caused by susceptible bacteria (non-β-lactamase-producing strains): upper respiratory tract infections such as otitis media, sinusitis, pharyngitis, and tonsillitis caused by hemolytic streptococcus, Streptococcus pneumoniae, Staphylococcus, or Haemophilus influenzae; genitourinary tract infections caused by Escherichia coli, Proteus mirabilis, or Enterococcus faecalis; skin and soft tissue infections caused by hemolytic streptococcus, Staphylococcus, or Escherichia coli; lower respiratory tract infections such as acute bronchitis and pneumonia caused by hemolytic streptococcus, Streptococcus pneumoniae, Staphylococcus, or Haemophilus influenzae; and acute uncomplicated gonorrhea, etc.
 

　　Qilu Pharmaceutical's Moxifloxacin Hydrochloride Eye Drops Approved for Market Launch and Passes Consistency Evaluation
 

Recently, Qilu Pharmaceutical announced that its ophthalmic anti-infective drug, Moxifloxacin Hydrochloride Eye Drops, submitted under Chemical Drug Category 4, has been approved for marketing by the National Medical Products Administration and is deemed to have passed the consistency evaluation. As of now, Qilu Pharmaceutical has a total of 84 products that have passed or are deemed to have passed the consistency evaluation.
 

It is reported that, compared with most currently available therapeutic agents, Moxifloxacin Hydrochloride Eye Drops offers advantages such as a broad antibacterial spectrum, potent efficacy, a favorable resistance profile, a simplified dosing regimen, and a high safety profile. It features rapid onset of action, is preservative-free, and is suitable for patients of all ages, including neonates, making it a new option for ocular anti-infective therapy.