Qilu Pharmaceutical Surge: 23 Class 1 New Drugs in Pipeline, 11 Blockbuster Candidates Racing for First-to-File Generics

Recently, Qilu Pharmaceutical's product pipeline has seen new progress: the IND application for the Class 1 new drug, QLS31906 for injection, has been filed; Clozapine Tablets, an antipsychotic drug, have passed evaluation... In recent years, Qilu Pharmaceutical has adhered to an innovation-driven strategy. Currently, 23 Class 1 new drugs in its R&D pipeline are at the clinical application stage or higher, including 17 innovative biologics. The ALK/ROS1 inhibitor, IruOke Tablets, has already submitted an NDA. Generic drugs are entering a period of intensive harvest, with 21 new products launched this year and a cumulative total of 93 varieties passing evaluation (40 as the first), 11 newly categorized reported varieties striving for the first generic approval, and 25 evaluated varieties meeting the conditions for national procurement.

23 New Class 1 Drugs Make a Strong Push! "Aggressively Advancing" in Large-Molecule Innovative Medicines

On December 7, the clinical application for Qilu Pharmaceutical's Class 1 new drug, QLS31906 Injection, was accepted by the CDE. So far this year, Qilu Pharmaceutical has submitted IND applications for 11 Class 1 new drugs, with 9 of them already approved for clinical trials.

Founded in 1958, Qilu Pharmaceutical is already a large-scale comprehensive modern pharmaceutical enterprise in China, with more than 270 marketed products, including several innovative products such as Pegylated Recombinant Human Granulocyte Stimulating Factor Injection, Bevacizumab Injection, Olanzapine Orally Dissolving Film, and Montelukast Sodium Orally Dissolving Film.

In recent years, Qilu Pharmaceutical has adhered to an innovation-driven strategy and continuously increased its investment in scientific research. Currently, Qilu Pharmaceutical has 23 Class 1 new drugs in its pipeline that are at the clinical application stage or beyond, including 17 large-molecule innovative drugs, with presence in areas such as monoclonal antibodies, bispecific antibodies, and ADCs.

Qilu Pharmaceutical's Mainly Developed New Category 1 Drugs

Source: MiNei Database

In terms of R&D progress, the NDA for the ALK/ROS1 inhibitor Iruok tablet has been submitted and is expected to be approved for marketing by the end of 2022 at the earliest. It will become Qilu Pharmaceutical's first Class 1 new drug to be marketed. The TPO receptor agonist, a recombinant human thrombopoietin mimetic peptide-Fc fusion protein for injection, and the introduced ADC drug VB4-845 injection are currently undergoing Phase III clinical trials. In addition, several Class 1 new drugs approved for clinical trials this year have quickly initiated Phase I clinical trials.

From the perspective of therapeutic areas, 23 Class 1 new drugs focus on major disease areas with unmet needs such as oncology, infectious diseases, liver diseases, autoimmune diseases, and metabolic disorders. It is not difficult to see that the field of oncology is a key research and development focus for Qilu Pharmaceutical, with indications for its innovative drugs in development covering lung cancer, liver cancer, breast cancer, pancreatic cancer, gastric cancer, bladder cancer, and more.

From the perspective of therapeutic targets, Qilu Pharmaceutical's innovative drugs under development involve popular targets such as CLDN18.2, ALK, CTLA4, PD-1/L1, TIGIT, and 4-1BB. Among them, both monoclonal and bispecific antibodies targeting CLDN18.2 and 4-1BB are being developed.

It is reported that the group's annual R&D investment accounts for more than 5% of its sales revenue, committing to the development of "global new" and "global best" drugs. In the next few years, more than ten drugs will enter Phase II and III clinical stages, especially several blockbuster biologics are expected to be launched.

Securing 23 New Products! 11 Varieties Aim for First-to-Market Generic

Relying on the stable cash flow brought by the generic drug business, supporting innovation with generics is the transformation path for most traditional pharmaceutical companies in China. After long-term planning, Qilu Pharmaceutical's generic drug pipeline has entered a period of intensive harvest.

Since the beginning of this year, Qilu Pharmaceutical has received approval for 23 varieties (41 specifications) of drugs, surpassing the total number of approved varieties in 2020 (19 varieties), based on drug approval dates.

Among the 23 varieties, except for the two Class 2 improved new drugs Olanzapine Orally Dissolving Film and Montelukast Sodium Orally Dissolving Film, the remaining 21 varieties were approved for production under the new registration classification, which is considered as passing the consistency evaluation. Among them, Rasagiline Mesylate Tablets, Metformin Vildagliptin Tablets, and Ceftazidime Avibactam Sodium for Injection are the first domestic generic versions in China to pass the evaluation.

Products Approved for Marketing by Qilu Pharmaceutical from 2021 to Present

Source: MiNei MED2.0 China Drug Evaluation Database

It is worth noting that Qilu Pharmaceutical has 36 varieties (58 acceptance numbers) of generic drugs reported for production under the new registration classification currently under review, which will be considered as passing the consistency evaluation once approved for production.

11 varieties have not yet received the first generic approval (including dosage form first generics) in China. Olaparib tablets, Aprepitant injection, Brimonidine Timolol eye drops, Tofacitinib citrate extended-release tablets, and Pazopanib tablets are the five varieties for which Qilu Pharmaceutical Co., Ltd. is the first/exclusive applicant for production.

Qilu Pharmaceutical New Classification Production Report and Pending Varieties Without First Generic Approval

Source: MNI MED2.0 China Drug Evaluation Database

40 Varieties First to Pass Evaluation, 25 Varieties Preparing for Centralized Procurement

Recently, Qilu Pharmaceutical's Clozapine Tablets have passed the consistency evaluation. This product belongs to the class of dibenzodiazepine antipsychotic drugs. Data from MiNe Network shows that in 2020, the sales of Clozapine at the terminals of China’s urban public hospitals, county public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions) reached 180 million yuan.

To date, Qilu Pharmaceutical has had 93 varieties (174 specifications) pass/be considered to have passed the consistency evaluation, of which 40 are the first in China to pass the evaluation, and 33 are injectables. For a long time, the number of Qilu Pharmaceutical's evaluated varieties has consistently led among pharmaceutical companies in China.

In terms of therapeutic areas, the 93 varieties cover 11 major therapeutic categories, mainly including anti-tumor and immunomodulatory agents (25), systemic anti-infective drugs (17), and nervous system drugs (16).

With a vast array of approved products, Qilu Pharmaceutical actively responds to China's national procurement policy, having successfully bid for 34 varieties in the five rounds of national procurement, consistently remaining at the forefront of the industry.

As the sixth batch of centralized procurement (insulin special project) has come to an end, the seventh batch of centralized procurement is also about to be put on the agenda. "Train soldiers for a thousand days, use them for a single moment." Qilu Pharmaceutical already has 25 varieties that meet the conditions for national centralized procurement (3 qualified domestic manufacturers / 2 qualified domestic manufacturers + 1 original research manufacturer), waiting for the release of the new list of centralized procurement.

Qilu Pharmaceutical Products Meeting National Centralized Procurement Criteria

Source: MiNeiNet MED2.0 China Drug Evaluation Database

Twenty-five varieties are concentrated in antineoplastic and immunomodulatory agents (9), systemic anti-infective drugs (5), nervous system drugs (4), and digestive system and metabolic drugs (4).

In terms of the number of companies that have passed the evaluation, the competition for Tenofovir Alafenamide Fumarate Tablets is the most intense, with 12 companies having passed the evaluation. Edaravone Injection has 8 companies that have passed the evaluation, while Cefminox Sodium for Injection and Cefixime Capsules each have 7 companies that have passed the evaluation.

Data source: MiNeiNet database

Note: Data statistics are as of December 8. If there are any omissions, corrections are welcome!