Qilu Pharmaceutical Secures Two Blockbuster Products and Leads with 64 Approved Generic Variants

Leaked Volume Reporting Directory for the Fifth Batch of Centralized Procurement Items, Covering 60 Varieties and 207 Specifications; Qilu Pharmaceutical Has 10 Approved-by-Consistency-Evaluation Varieties Listed. On April 14–15, Qilu Pharmaceutical’s Ropivacaine Hydrochloride Injection passed the consistency evaluation, while Brimonidine Tartrate Eye Drops and Emtricitabine/Tenofovir Disoproxil Tablets received approval. Currently, Qilu Pharmaceutical ranks first on the consistency evaluation approval list with 66 varieties. A large wave of varieties is progressing through the approval process, with 41 new classification marketing applications and 22 consistency evaluation applications under review. Competition for the 10 varieties proposed for centralized procurement is intense, as Qilu Pharmaceutical will face off against Chia Tai Tianqing, Yangtze River Pharmaceutical, Hengrui Medicine, and others.

Securing Two Blockbuster Drugs! 64 Approved Variants Dominate the Screen

On April 14–15, the NMPA website announced that Qilu Pharmaceutical’s Ropivacaine Hydrochloride Injection passed the consistency evaluation, and two products—Brimonidine Tartrate Eye Drops and Emtricitabine/Tenofovir Tablets—were approved for market launch.

Ropivacaine Hydrochloride Injection, a novel long-acting amide local anesthetic developed by AstraZeneca, is a leading drug in the local anesthetic market. Data from Menet shows that in 2019, sales of ropivacaine injections at public medical institutions in China exceeded RMB 1.1 billion. Previously, Humanwell Pharmaceutical, Shijiazhuang No.4 Pharmaceutical, and Jiabo Pharmaceutical’s Ropivacaine Hydrochloride Injections had passed the consistency evaluation.

Brimonidine Tartrate Eye Drops had previously been approved for three domestic manufacturers, but none had passed the consistency evaluation. With this latest production approval, Qilu Pharmaceutical has become the first company to pass the consistency evaluation for this product. Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are a blockbuster anti-HIV drug developed by Gilead Sciences, with global sales reaching $1.448 billion in 2020. In the Chinese market, four companies, including Gilead Sciences, Chia Tai Tianqing, Anhui Beker, and Haisco, have obtained approval, with Qilu Pharmaceutical being the fourth domestic manufacturer to achieve approval for this product.

Source: Menet MED2.0 China Drug Review Database

Data from Menet shows that Qilu Pharmaceutical currently has 64 drug varieties (116 specifications) that have passed or are deemed to have passed the consistency evaluation. Among these, 32 varieties are the first in China to pass the evaluation, and 17 are injectables. In addition, 13 varieties, including aprepitant capsules, emtricitabine capsules, metformin and vildagliptin tablets, warfarin sodium tablets, risperidone orally disintegrating tablets, isogladine maleate tablets, palbociclib capsules, trifluridine and tipiracil tablets, cefprozil granules, ondansetron hydrochloride tablets, ondansetron hydrochloride injection, exemestane tablets, and brimonidine tartrate eye drops, are currently exclusively approved for Qilu Pharmaceutical.

Notably, Qilu Pharmaceutical has long led domestic companies in the number of products that have passed the consistency evaluation. China Biopharmaceutical ranks second with 57 products (85 specifications) having passed the evaluation, while Yangtze River Pharmaceutical Group ranks third with 55 products (74 specifications).

Amid a vast portfolio of evaluated drug varieties, Qilu Pharmaceutical has achieved remarkable success in China’s National Volume-Based Procurement (VBP) program. Across the four national VBP batches conducted to date, Qilu Pharmaceutical won bids for 5, 4, 8, and 6 drug varieties respectively, totaling 23 awarded varieties—the highest number among all participating companies.

41 new products in the pipeline, 22 generic consistency evaluation products under review

After years of dedication in the generic drug sector, Qilu Pharmaceutical has entered a period of intensive approvals for new products. Multiple varieties in its product pipeline are expected to gain market approval within the next two years, reinforcing Qilu Pharmaceutical’s position as the leading company in passing consistency evaluations.

Data from Menet shows that Qilu Pharmaceutical has 41 generic drug varieties (73 acceptance numbers) under review, filed for production under the new registration classification; upon approval for production, these will be deemed to have passed the consistency evaluation. In terms of supplementary applications for consistency evaluation, Qilu Pharmaceutical has 22 varieties (35 acceptance numbers) undergoing review and approval.

Qilu Pharmaceutical Varieties Under Review for Consistency Evaluation (Including New Classification)

Source: Menet MED2.0 China Drug Review Database

10 Drug Varieties Proposed for Centralized Procurement, Targeting Chia Tai Tianqing, Yangzijiang...

On April 15, the volume declaration catalog for the fifth batch of centralized procurement was released, covering 60 drug varieties and 207 specifications. Qilu Pharmaceutical, known as the “price killer,” had 10 approved generic varieties included in this batch, namely Oxaliplatin Injection, Isosorbide Mononitrate Sustained-Release Tablets, Docetaxel Injection, Saxagliptin Tablets, Fasudil Hydrochloride Injection, Palonosetron Hydrochloride Injection, Ceftriaxone Sodium for Injection, Ceftazidime for Injection, Gemcitabine Hydrochloride for Injection, and Ropivacaine Hydrochloride Injection. Among these, eight varieties are injections.

Competitive Landscape of Qilu Pharmaceutical’s Products Proposed for the Fifth Batch of Centralized Procurement

Source: Menet MED2.0 China Drug Evaluation Database

Among the 10 varieties, eight corresponding generic drugs achieved terminal sales exceeding RMB 1 billion in 2019 across China’s urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (collectively referred to as Chinese public medical institutions). These drugs are oxaliplatin, isosorbide mononitrate, docetaxel, palonosetron, ceftriaxone, ceftazidime, gemcitabine, and ropivacaine. Notably, the terminal sales of docetaxel injection and ceftazidime for injection in Chinese public medical institutions exceeded RMB 4 billion and RMB 6 billion, respectively, in 2019.

Qilu Pharmaceutical’s oxaliplatin injection and saxagliptin tablets, two products approved for production in 2020 and 2021 respectively, are currently in the market development phase. The remaining eight products have passed the consistency evaluation via supplemental applications and have been marketed for many years.

In terms of competitive landscape, four manufacturers have obtained approval for three drug varieties, while five manufacturers have obtained approval for five other varieties. Chia Tai Tianqing and Yangtze River Pharmaceutical each have three varieties on the list. In addition, although only Qilu Pharmaceutical and Lepu Pharmaceutical have obtained approval for Isosorbide Mononitrate Sustained-Release Tablets, Rundu Pharmaceutical and Heyuan Pharmaceutical have also secured approval for Isosorbide Mononitrate Sustained-Release Capsules. Overall, current competition is already quite intense, and over time, from the announcement of the centralized procurement catalog to the bid opening, additional manufacturers are expected to obtain approval for these varieties.

Data Source: Menet Database

Note: Data statistics are current as of April 15. Any omissions or errors are welcome to be corrected!