Qilu Pharmaceutical Accelerates Innovation: 26 Class 1 New Drugs and 51 New Products in Pipeline

Recently, Qilu Pharmaceutical's R&D pipeline has seen new progress: the submission of an IND for the Class 1 new drug QLH11906 tablets, and the first submission for market approval of the long-acting microcrystal formulation paliperidone palmitate injection... In recent years, Qilu Pharmaceutical has been focusing on both innovative drugs and high-end generic drugs: 26 Class 1 new drugs are at the stage of clinical application or above, with the first Class 1 new drug expected to be approved within the year; 51 new category products' market applications are under review, with 16 products vying for the first generic approval; 94 evaluated products are leading the way, with 16 products proposed for inclusion in the seventh batch procurement, among which 13 products have low market share or are not yet available.

 

 

On March 14, the clinical application of Qilu Pharmaceutical's Class 1 new drug QLH11906 tablets was accepted by the CDE. Since the beginning of this year, Qilu Pharmaceutical has submitted IND for three Class 1 new drugs for the first time, including injectable QLS21908, injectable QLS31904, and QLH11906 tablets.

 

In recent years, Qilu Pharmaceutical has always adhered to the innovation-driven development strategy. The proportion of R&D investment in sales revenue has continued to climb from 6% to nearly 10% in the past five years. The company’s R&D pipeline emphasizes a clinical orientation and patient-centered approach, targeting urgent clinical needs and significant unmet clinical demands.DiseaseTherapeutic Areas.

 

Currently, Qilu Pharmaceutical has 26 Class 1 new drugs at the clinical application stage or above, including 19 large-molecule biologics and 7 small-molecule chemical drugs. These 26 Class 1 new drugs focus on...Tumor, including treatment areas such as infection, liver disease, and autoimmune diseases, involving targets like CLDN18.2, PD-1/L1, ALK, HER2, TIGIT, 4-1BB, and covering monoclonal antibodies, bispecific antibodies, ADCs, and fusion proteins.

 

　　Qilu Pharmaceutical's Main Class 1 New Drug Under Development

 

Source: MiNei Database

 

Among the 26 Class 1 new drugs, the ALK/ROS1 inhibitor Iruplinalkib Tablets has already filed for NDA and is expected to be approved for marketing this year at the earliest. It will become Qilu Pharmaceutical's first marketed Class 1 new drug. Data from Menet shows that in recent years, protein kinase inhibitors have been widely used in urban public hospitals in China.HospitalThe terminal sales of county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) maintained double-digit growth, increasing from over 6 billion yuan in 2015 to more than 26 billion yuan in 2020, with a five-year compound annual growth rate of over 33%.

 

In addition, several Class 1 new drugs, such as the injectable recombinant human thrombopoietin mimetic peptide-Fc fusion protein, VB4-845 injection, ceritinib tosylate tablets, QL-007 tablets, and QL1604 injection, are already in Phase III or Phase II clinical stages.

 

 

In the field of generic drugs, high-end generics and first-to-market varieties have gradually become the key focus of Qilu Pharmaceutical. Since this year, Qilu Pharmaceutical has successively filed three potential first-to-market varieties: Paliperidone Palmitate Injection, Peramivir Injection, and Octreotide Acetate Microspheres for Injection.

 

Following the acquisition of China's first tadalafil oral soluble film on January 30, Qilu Pharmaceutical has once again achieved significant progress in the field of novel formulations.

 

On March 14, Qilu Pharmaceutical announced that the marketing application for its second-generation atypical long-acting antipsychotic drug, Paliperidone Palmitate Injection, was accepted by the CDE, making it the first company in China to file for production. Paliperidone Palmitate Injection is a long-acting microcrystal formulation. According to data from Menet, sales of Paliperidone injections in Chinese public medical institutions exceeded 150 million yuan in 2020, representing a year-on-year increase of 41.11%.

 

Currently, Qilu Pharmaceutical has 51 new registration classification products (80 acceptance numbers) under review, which will be deemed to have passed the consistency evaluation once approved for production. Among them, there are 15 systemic anti-infective drugs, 12 antineoplastic and immunomodulatory agents, and 9 drugs for the digestive system and metabolism.

 

Qilu Pharmaceutical's Generic Drugs under Review in New Registration Classification

Note: Marked with * indicates that there is currently no first generic (including first generic of the dosage form) approved in China.

 

Source: MiNei MED2.0 China Drug Evaluation Database

 

Sixteen varieties have not yet received the first generic approval (including first generic in dosage form) in China, including Eltrombopag Ethanolamine Tablets, Sacubitril Valsartan Sodium Tablets, Olaparib Tablets, Nilotinib Capsules, Injectable Octreotide Acetate Microspheres, and other heavy-weight varieties. Qilu Pharmaceutical will compete with multiple pharmaceutical companies for the first generic.

 

 

Entering 2022, Qilu Pharmaceutical achieved its first successful evaluation variety of the year — Isosorbide Nitrate Injection, and this variety is the first in China to pass the evaluation.

 

As of now, Qilu Pharmaceutical has 94 varieties (175 specifications) that have passed/been considered to pass the consistency evaluation, of which 41 are the first in China to pass, and 34 are injectables. The 94 varieties that passed the evaluation are mainly concentrated in antineoplastic and immunomodulatory agents (26), systemic anti-infective drugs (17), and nervous system drugs (16).

 

 

It is worth noting that there are currently 67 varieties of anti-tumor and immunomodulatory drugs that have passed the evaluation in China, and Qilu Pharmaceutical has already deployed more than one-third of these varieties. Data from Menet shows that in 2020, the sales of anti-tumor and immunomodulatory drugs in Chinese public medical institutions exceeded 160 billion yuan, and in the first half of 2021, the sales exceeded 80 billion yuan, a year-on-year increase of 15.30%. With a rich variety of products that have passed the evaluation and by leveraging the opportunity of centralized procurement, Qilu Pharmaceutical is expected to quickly consolidate its market foundation in this field.

 

As one of the "big winners" in the first five rounds of centralized procurement, Qilu Pharmaceutical has secured bids for 34 products, making it the company with the highest number of winning products so far. Notably, among the 58 products in the seventh round of procurement, Qilu Pharmaceutical has already obtained tickets for 16 products, leading this round of procurement.

 

The Competitive Landscape of Qilu Pharmaceutical's Seventh Batch of Proposed Volume-based Procurement Products

Note: Sales below 100 million yuan are represented by *

 

Among the 16 proposed bulk procurement varieties, 6 varieties involve the generic names.MedicineSales at public medical institutions in China exceeded 1 billion yuan in 2020; passed the evaluation.EnterpriseMore than 10 generic drugs have 5 types, including Tenofovir Alafenamide Oral Immediate-Release Formulations, Palonosetron Injections, Cefixime Oral Immediate-Release Formulations, Cefminox Injections, and Edaravone Injections. Notably, Qilu Pharmaceutical has a relatively low market share or is absent in 13 proposed bulk procurement varieties, and if it wins the bid in the centralized procurement, it will quickly open up the market.

 

 

Note: Data statistics are as of March 14. If there are any omissions, corrections are welcome!