NMPA Approves 54 New Drug Registrations Including Olanzapine Orally Disintegrating Film and Dexmedetomidine Hydrochloride Injection; 18 Generic Drugs Pass Consistency Evaluation

Today, the National Medical Products Administration (NMPA) released the “Information on Drug Approval Documents Pending Collection for January 21, 2021.” The information indicates that a total of 54 approval documents were granted, including major products such as Qilu Pharmaceutical’s olanzapine orally disintegrating films, Hengrui Pharma’s dexmedetomidine hydrochloride and sodium chloride injection, and dexmedetomidine hydrochloride injections submitted by five companies, including Jiangsu Nhwa Pharmaceutical Co., Ltd. and Yichang Humanwell Pharmaceutical Co., Ltd.

Notably, among the 54 approval documents, 18 applications for consistency evaluation of generic drugs were approved, with several deemed to have passed the consistency evaluation. The following are several key products of focus compiled by Sina Medicine:

Second Domestic Olanzapine Oral Dissolving Film Launched in China

Olanzapine was originally developed by Eli Lilly and marketed under the brand name Zyprexa. It was first launched in China in 1998 for the treatment of schizophrenia, moderate-to-severe manic episodes, and bipolar disorder. According to data from Menet, sales of olanzapine at the terminal level of Chinese public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—exceeded RMB 4 billion in 2019.

Currently, the olanzapine products marketed in China include olanzapine tablets, olanzapine orally disintegrating tablets, and olanzapine oral films. On November 24, 2020, Jiangsu Hansoh Pharmaceutical’s olanzapine oral film was approved as the first domestically produced product of its kind. Now, Qilu Pharmaceutical has become the second domestic manufacturer.

It is reported that Qilu Pharmaceutical’s olanzapine tablets and orally disintegrating tablets had previously passed the consistency evaluation. Its olanzapine tablets were included in the expanded “4+7” volume-based procurement program at a price of RMB 2.48 per tablet, while its olanzapine orally disintegrating tablets were listed in the third batch of national centralized procurement at RMB 6.3 per tablet. The recent approval of Qilu’s olanzapine oral fast-dissolving film marks another significant product in its strategic layout within the central nervous system (CNS) therapeutic area.

It is reported that oral film formulations, a category of improved new drugs, have garnered significant attention in recent years.

5 Dexmedetomidine Hydrochloride Injection Products Pass Quality and Efficacy Evaluation

Dexmedetomidine Hydrochloride Injection from five pharmaceutical companies, including Jiangsu Nhwa Pharmaceutical Co., Ltd., Yichang Humanwell Pharmaceutical, Hunan Kelun, Sichuan Guorui Pharmaceutical, and Chengdu Better Pharmaceutical, has passed the consistency evaluation.

Dexmedetomidine Hydrochloride Injection, jointly developed by Oricon Pharma and Abbott Laboratories, exhibits central sympatholytic and anxiolytic effects and induces sedation resembling natural sleep. It is clinically indicated primarily for sedation in patients undergoing endotracheal intubation and mechanical ventilation, as an adjunct to anesthesia during the perioperative period, and for sedation during invasive diagnostic or therapeutic procedures.

It was first approved by the FDA in December 1999 under the brand name Precedex®. It was subsequently marketed and sold in multiple countries and regions, including the European Union and Japan.

According to the Minenet database, the sales revenue of dexmedetomidine hydrochloride injection in public hospitals within the national urban sample in China amounted to RMB 2.872 billion in 2019.

Currently, dexmedetomidine hydrochloride injection has been approved for marketing in China by multiple enterprises, including Hengrui Pharma, Humanwell Healthcare, Cisen Pharmaceutical, and Nhwa Pharmaceutical. Just two or three days ago, on January 18, Hengrui’s dexmedetomidine hydrochloride injection passed the consistency evaluation. In addition, Yangtze River Pharmaceutical Group and Sinopharm Industrial Co., Ltd. have also passed the consistency evaluation for this product. It is evident that the competitive landscape for this product is intensifying!

Dexmedetomidine Hydrochloride and Sodium Chloride Injection Launched: First Domestic Generic

Among the products approved this time, another noteworthy product is Hengrui Pharma’s Dexmedetomidine Hydrochloride and Sodium Chloride Injection. It is reported that dexmedetomidine hydrochloride products currently available on the market mainly include the aforementioned Dexmedetomidine Hydrochloride Injection and this Dexmedetomidine Hydrochloride in Sodium Chloride Infusion/Injection formulation.

Dexmedetomidine Hydrochloride and Sodium Chloride Injection is a relatively selective α2-adrenergic receptor agonist, indicated for sedation in non-intubated patients prior to and/or during surgical and other procedures. Dexmedetomidine Hydrochloride and Sodium Chloride Injection was developed by Hospira and was first approved in the United States in 2013 under the brand name Precedex.

According to Insight data, no generic versions of dexmedetomidine hydrochloride and sodium chloride injection had previously been approved for marketing in China; Hengrui Pharma has successfully obtained approval as the first generic manufacturer of this product.

In 2019, Hengrui Pharma’s Dexmedetomidine Hydrochloride and Sodium Chloride Injection received tentative approval from the U.S. FDA (tentative approval indicates that the FDA has completed all review processes for the drug, but relevant patents have not yet expired).

In June 2020, the Abbreviated New Drug Application (ANDA) for Dexmedetomidine Hydrochloride and Sodium Chloride Injection was officially approved by the FDA.

According to IMS database data, the global sales of dexmedetomidine hydrochloride and sodium chloride injection in 2019 were approximately $175 million, with U.S. sales reaching about $130 million.

In addition, Chengdu Better Pharmaceutical and Yangtze River Pharmaceutical Group submitted marketing applications for Dexmedetomidine Hydrochloride and Sodium Chloride Injection, while Hunan Kelun Pharmaceutical submitted a clinical trial application.

Takeda Pharmaceutical's Innovative Drug – Azilsartan Medoxomil Potassium Tablets

On January 19, the National Medical Products Administration (NMPA) approved Takeda Pharmaceutical’s marketing application for its Class 1 innovative drug, azilsartan medoxomil potassium tablets, for the treatment of essential hypertension.

Azilsartan Medoxomil Potassium is an angiotensin II receptor blocker (ARB) independently developed by Takeda. It is an oral prodrug that is rapidly metabolized by esterases in the body to its active component, azilsartan, during absorption. Azilsartan blocks the vasoconstrictive and aldosterone-secreting effects of angiotensin II by selectively inhibiting the binding of angiotensin II to AT1 receptors in various tissues, such as vascular smooth muscle and the adrenal glands. Therefore, its mechanism of action is independent of the angiotensin II synthesis pathway. The affinity of azilsartan for AT1 receptors is more than 10,000 times greater than that for AT2 receptors.

Azilsartan medoxomil potassium was first approved by the FDA for marketing in 2011. It is currently available in more than 15 countries worldwide, including the United States, Canada, France, and the United Kingdom. According to the PharmaCube database, azilsartan medoxomil potassium generated ¥76.7 billion in revenue for Takeda in 2019, equivalent to approximately RMB 4.8 billion.

In addition to the aforementioned products, several other newly approved drugs, including Chia Tai Tianqing’s Bortezomib for Injection and Guangzhou Langsheng Pharmaceutical’s Tadalafil Tablets, have also attracted significant attention from various stakeholders.

References:

PharmaCube: “Takeda’s Class 1 New Drug ‘Azilsartan Medoxomil Potassium Tablets’ to Be Approved for Market Launch”