Qilu Pharmaceuticals Achieves First Domestic Approval for Carvedilol Tablets and Submits First-in-Class Application for Riociguat Tablets

Recently, Qilu Pharmaceutical has made new progress in the field of hypertension medication: Carvedilol Tablets have successfully passed the evaluation, making it the first in China. The product's sales in Chinese public medical institutions exceeded 100 million yuan in 2020; Riociguat Tablets have been reported for production, also the first in China, and currently, no generic drugs have been approved in China.

Source: Official website of the National Medical Products Administration

On March 31, the official website of the National Medical Products Administration showed that Qilu Pharmaceutical's Carvedilol Tablets had successfully passed the evaluation, being the first in China. Carvedilol is an α and β receptor blocker that dilates blood vessels while blocking receptors. It is clinically used for patients with mild to moderate hypertension, or those with renal insufficiency and diabetes, and can also be used to treat symptomatic congestive heart failure.

More than ten companies in China have obtained the production approval for Carvedilol tablets. Data from Menet shows that the product's terminal sales 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 100 million yuan in 2020, with Qilu Pharmaceutical Co., Ltd. accounting for 70% of the market share.

Currently, only Qilu Pharmaceutical has submitted a supplemental application for the consistency evaluation of Carvedilol Tablets, and its recent successful approval is beneficial for consolidating the existing market.

Qilu Pharmaceutical Co., Ltd. recently reported production of antihypertensive drugs

Source: CDE Official Website

On March 25, the CDE website showed that the marketing application of Riociguat Tablets, submitted by Qilu Pharmaceutical as a Category 4 generic drug, was accepted by the CDE. Riociguat is a soluble guanylate cyclase (sGC) stimulator mainly used to treat chronic thromboembolic pulmonary hypertension and arterial pulmonary hypertension, with global sales exceeding 1 billion US dollars in 2021.

Bayer's Riociguat Tablets were approved for import in September 2017 and have been included in China's National Reimbursement Drug List Category B through negotiation. Data from MiNe Network shows that the product's sales revenue grew by over 200% in H1 2021 at China's public medical institutions.

Currently, only Qilu Pharmaceutical has submitted a marketing application for Riociguat Tablets under the new registration classification, and no company has initiated BE trials for this product yet, making it highly probable that Qilu Pharmaceutical will secure the first generic approval.

Hypertension Drugs Approved by Qilu Pharmaceutical

Source: MiNei MED2.0 China Drug Evaluation Database

In the field of hypertension medications, Qilu Pharmaceutical has already had three varieties pass or be considered to have passed the consistency evaluation. Among them, Carvedilol Tablets were the first to pass, and Esprolol Hydrochloride Injection was the second to pass.

Source: MiNeiNet database, official website of the National Medical Products Administration, etc.

Note: Data statistics are as of April 1st. If there are any omissions, corrections are welcome!