Qilu broke out!

Recently, Qilu Pharmaceutical's product line has ushered in new progress: QLS31906 for Class 1 new drug for injection has applied for IND, and antipsychotic clozapine tablet has been reviewed.

23 Class 1 New Drugs Are Coming! "Onslaught" of innovative macromolecular drugs

On December 7, Qilu Pharmaceutical's clinical application of QLS31906 for class 1 new drug injection was undertaken by CDE

Qilu Pharmaceutical, founded in 1958, is a large-scale comprehensive modern pharmaceutical company in China with more than 270 products on the market, including PEGylated recombinant human granulocyte stimulating factor injection, bevacizumab injection, olanzapine There are many innovative products such as flat mouth dissolving film and montelukast sodium oral dissolving film

In recent years, Qilu Pharma has adhered to the innovation-driven strategy and continued to increase investment in scientific research

Qilu Pharma is mainly developing Category 1 new drugs

Source: Mi intranet database

From the perspective of research and development progress, ALK/ROS1 inhibitor Yiluoke tablet has been declared for NDA, and it is expected to be approved for marketing at the end of 2022 at the earliest, and will become Qilu Pharmaceutical's first class 1 new drug; TPO receptor agonist for injection recombinant The human thrombopoietin peptidomimetic-Fc fusion protein and the imported ADC drug VB4-845 injection are in Phase III clinical trials

From the perspective of therapeutic areas, 23 Class 1 new drugs focus on unmet major disease areas such as tumors, infections, liver diseases, autoimmunity, and metabolic diseases

From the perspective of therapeutic targets, Qilu Pharmaceutical's innovative drugs under development involve popular targets such as CLDN18.

It is reported that the group's annual R&D investment accounts for more than 5% of sales revenue, and it is committed to the development of "global new" and "global good" drugs.

Get 23 new products! 11 varieties to grab the first imitation

Relying on the stable cash flow brought by the generic drug business, it is the transformation path for most domestic traditional pharmaceutical companies to cultivate and create with generic drugs

In terms of the drug approval date, Qilu Pharmaceutical has approved 23 varieties (41 specifications) for the market since the beginning of this year, and the number of approved varieties has exceeded that in 2020 (19 varieties)

Among the 23 varieties, except for the 2 types of improved new drugs olanzapine oral dissolving film and montelukast sodium oral dissolving film, the remaining 21 varieties are batch-produced according to the new registration classification, and are deemed to have passed the consistency evaluation

Products approved by Qilu Pharmaceutical from 2021 to the present

Source: MED2.

It is worth noting that there are 36 varieties (58 acceptance numbers) of generic drugs under review by Qilu Pharma for production according to the new registration classification, which will be deemed to have passed the consistency evaluation after being approved for production

No first imitation of 11 varieties (including the first imitation of dosage form) has been approved in China, olaparib tablets, aprepitant injection, brimonidine timolol eye drops, tofacitinib citrate The 5 varieties, including sustained-release tablets and pazopanib tablets, were first/exclusively reported by Qilu Pharma

Qilu Pharmaceutical's new category of production and no first copy approved varieties under review

Source: MED2.

40 varieties of the first review, 25 varieties ready for centralized procurement

Recently, Qilu Pharmaceutical's clozapine tablets passed the consistency evaluation, which is a dibenzodiazepine antipsychotic drug

Up to now, Qilu Pharmaceutical has passed/deemed to pass the consistency evaluation of 93 varieties (174 product specifications), of which 40 are the first in China to pass the evaluation, and 33 are injections
.
For a long time, Qilu Pharmaceutical has always been ahead of domestic pharmaceutical companies in the number of over-evaluated varieties
.

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

With the help of a large group of over-evaluated products, Qilu Pharmaceutical actively responded to the national centralized procurement policy, winning a total of 34 varieties in the five batches of national centralized procurement, and continued to be at the forefront of the industry
.

With the end of the sixth batch of centralized procurement (specialized insulin), the seventh batch of centralized procurement is also about to be put on the agenda
.
"Training soldiers for a thousand days, and using them for a while", Qilu Pharmaceutical has 25 varieties that meet the national centralized procurement conditions (3 approved / 2 approved + 1 original research), waiting for a new batch of centralized procurement lists to be released
.

Qilu Pharmaceutical's varieties that meet the national centralized procurement conditions

Source: MED2.
0 China Drug Evaluation Database

The 25 varieties focus on anti-tumor and immune modulators (9), systemic anti-infective drugs (5), nervous system drugs (4), digestive system and metabolic drugs (4)
.

Judging from the number of over-reviewed companies, the competition for tenofovir fumarate alafenamide tablets is the most intense, with 12 over-reviewed companies, 8 companies for edaravone injection, cefminox sodium for injection, cephalosporin Kexime Capsules have been reviewed by 7 companies
.

Data source: Minet database

Note: The statistics are as of December 8.
If there are any omissions, please correct me!