Generic Drug Consistency Evaluation Success: Hengrui, Lunan, and Others Announce Approvals!

　　【Pharmaceutical Network Industry DynamicsIn recent years, with the advancement of the policy on the consistency evaluation of generic drugs, pharmaceutical companies have actively invested in the evaluation process, and new developments keep emerging. Recently, another batch of drugs has passed the evaluation, involving companies such as Hengrui and Lunan Pharmaceutical.
 

　　Lunan: Montelukast Sodium
 

Recently, the Montelukast Sodium Tablets (Specification: 10mg) of Lunan Pharmaceutical have been approved by the National Medical Products Administration and passed the consistency evaluation of quality and efficacy of generic drugs.
 

According to reports, Montelukast Sodium is an orally effective selective leukotriene receptor antagonist. It has a high affinity and selectivity for cysteinyl leukotriene (CysLT1) receptors. It can inhibit the physiological effects produced by the binding of LTD4 to CysLT1 receptors without any receptor agonist activity. It is suitable for the prevention and long-term treatment of asthma in adults aged 15 years and above, as well as alleviating symptoms caused by seasonal allergic rhinitis and perennial allergic rhinitis in adults aged 15 years and above.
 

Data from Menet shows that in 2019, the total sales of Montelukast reached 3.5 billion yuan in the terminals of China's urban public hospitals, county public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions) as well as in the terminals of physical pharmacies in Chinese cities, with the terminals of Chinese public medical institutions being the main battlefield.
 

　　China National Pharmaceutical: Milnacipran Hydrochloride Tablets Approved
 

Sinopharm Modern announced on May 23 that the company had received the "Drug Supplemental Application Approval Notice" for Milnacipran Hydrochloride Tablets issued by the National Medical Products Administration. The drug has been approved to pass the quality and efficacy consistency evaluation for generic drugs, and changes to the prescription, process, and quality standards have also been approved.
 

The announcement introduced that Milnacipran Hydrochloride was developed by Pierre Fabre Medicament of France. It is a new type of specific 5-HT and NE reuptake inhibitor (SNRI) used for the treatment of depression.
 

The CDE website shows that the Milnacipran Hydrochloride Tablets produced by Sinopharm Modern is currently the only exclusive marketed product in China. According to the MIR Data database, the total sales of Milnacipran Hydrochloride Tablets in urban public hospitals across China amounted to approximately 24.61 million yuan in 2021.
 

To date, the company has invested approximately 16.4234 million yuan in cumulative R&D for the product's consistency evaluation. The company believes that the successful evaluation of this variety will benefit the product’s future market expansion and sales.
 

　　Hengrui: Butorphanol Tartrate Injection Approved
 

On the same day, Hengrui Medicine also announced good news. Recently, the company received the "Drug Supplemental Application Approval Notice" issued by the National Medical Products Administration. The company's Butorphanol Tartrate Injection has passed the consistency evaluation of quality and efficacy for generic drugs.
 

It is reported that Butorphanol is a partial agonist of μ-opioid receptors and a full agonist of κ-opioid receptors, with analgesia as its main therapeutic effect. Butorphanol has a lower incidence of respiratory depression, drug dependence, and addiction, and is widely used in clinical anesthesia induction and postoperative pain relief.
 

Butorphanol Tartrate Injection was initially developed by Apothecon and received FDA approval for marketing in August 1978 under the trade name Stadol. As the original product from Apothecon has been withdrawn from the market, the FDA has designated Butorphanol Tartrate Injection produced by Hospira as the Reference Standard (RS).
 

The tartrate butophanol injection developed by Hengrui is available in two specifications: 1ml:1mg and 2ml:4mg, which were approved for marketing in 2007 and 2014 respectively, with the trade name Nuo Yang. Apart from the company, there are currently no other companies in China marketing tartrate butophanol injection.
 

According to the inquiry, the global sales of Butorphanol-related formulations in 2021 were approximately 208 million US dollars. Up to now, the company has invested approximately 3.87 million yuan in the research and development for the consistency evaluation of Butorphanol Tartrate Injection as a generic drug.