Qilu Pharmaceutical Secures Three Key Approvals: First-to-File Anti-Tumor Generic, First-in-Class Injectable Passing Consistency Evaluation, and Third Domestic Approval for a RMB 700M Parkinson’s Drug

On January 5, the NMPA website released the latest drug approval information. Qilu Pharmaceutical secured approvals for three products: the first domestic generic version of trifluridine/tipiracil tablets, the first company to pass the consistency evaluation for fasudil hydrochloride injection, and the third domestic manufacturer for pramipexole dihydrochloride tablets. Data from Menet shows that Qilu’s Class 3 generic marketing application for emtricitabine capsules has also entered the “under review” status, with positive news expected in the near future.

Figure 1: Overview of Qilu Pharmaceutical's Latest Approved Products

Source: NMPA Official Website

First Generic Approval for Trifluridine/Tipiracil Tablets

It is reported that trifluridine/tipiracil tablets are an oral combination formulation composed of trifluridine (FTD) and tipiracil hydrochloride (TPI) in a 1:0.5 molar ratio, indicated for the treatment of metastatic colorectal cancer. The originator manufacturer is Taiho Pharmaceutical of Japan, and the product received import approval from the National Medical Products Administration (NMPA) in August 2019.

Figure 2: Overview of Companies Filing for Marketing Approval of Trifluridine/Tipiracil Tablets

Source: MENET MED2.0 China Drug Evaluation Database

Data from Menet shows that currently two companies have submitted applications for the generic marketing approval of trifluridine/tipiracil tablets. Chia Tai Tianqing was the first to file, but Qilu Pharmaceutical ultimately secured approval for the first generic version.

Fasudil Hydrochloride Injection Receives First Generic Drug Consistency Evaluation Approval

Fasudil Hydrochloride Injection is indicated for the improvement and prevention of cerebral vasospasm and resulting cerebral ischemic symptoms following surgery for subarachnoid hemorrhage. In China, its terminal sales in public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—reached nearly RMB 1 billion in 2015. In recent years, the growth rate has declined, with sales dropping to less than RMB 500 million in 2019. Nevertheless, the product ranks second among injectable peripheral vasodilators, maintaining a strong market position. In terms of competitive landscape, Tianjin Chase Sun Pharmaceutical led the market with a 57.62% share in the first half of 2020, while Qilu Pharmaceutical held less than 1% of the market share.

Table 1: Information on Enterprises Submitting Supplemental Applications for the Consistency Evaluation of Fasudil Hydrochloride Injection

Source: MENET MED2.0 China Drug Review Database

Currently, in addition to Qilu Pharmaceutical being the first to pass the evaluation, there are five other companies, including Yangtze River Pharmaceutical, Yuandong Pharmaceutical, Beite Pharmaceutical, and Hongri Pharmaceutical, that have submitted supplementary applications for the consistency evaluation of Fasudil Hydrochloride Injection. Yabao Pharmaceutical’s application under the new classification is also currently under review and approval.

Pramipexole Hydrochloride Tablets (Third Domestic Manufacturer)

Figure 3: Current Status of Companies with Approval for Pramipexole Hydrochloride Tablets

Source: Menet One-Click Search

Pramipexole Hydrochloride Tablets are indicated for the treatment of signs and symptoms of idiopathic Parkinson’s disease, either as monotherapy (without levodopa) or in combination with levodopa. In 2019, Pramipexole Hydrochloride Tablets ranked first among the top 20 anti-Parkinson’s disease products at public medical institutions in China, with sales approaching RMB 700 million. Currently, Boehringer Ingelheim holds over 90% of the domestic market share. Jingxin Pharmaceutical obtained approval for the first generic version in 2018 (and passed the consistency evaluation in October 2020). CSPC Pharmaceutical Group received approval for its Class 4 generic drug in January 2020, which is deemed equivalent to passing the consistency evaluation. Qilu Pharmaceutical has also received approval for its Class 4 generic drug, becoming the third company in China to achieve both “approval and consistency evaluation.”

Source: Menet Database, NMPA Official Website

The review statistics are current as of January 5, 2021. Please advise us of any errors or omissions.

[Major News] Qilu Pharmaceutical Wins Approval! First Generic Anticancer Drug, First Injectable to Pass Evaluation, Third Domestic Player in the RMB 700 Million Market