Qilu's firepower is full!

A few days ago, Qilu Pharmaceutical's R&D pipeline has made new progress: the 1st class new drug QLH11906 has been submitted for IND, and the long-acting microcrystalline preparation paliperidone palmitate injection has been reported for production for the first time.
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In recent years, Qilu Pharmaceutical's innovative drugs and high-end generic drugs have both grasped: 26 category 1 new drugs are in the clinical application stage and above, and the first category 1 new drug is expected to be approved within this year; 51 new categories of new drugs are under review, of which 16 varieties are competing for the first imitation; 94 reviewed varieties lead, 16 varieties It is planned to be included in the seventh batch of centralized procurement, of which 13 varieties have a low market share or are blank
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26 Class 1 New Drugs Are Coming! On March 14, Qilu Pharmaceutical's clinical application for a new class 1 drug QLH11906 was accepted by CDE
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Since the beginning of this year, Qilu Pharma has submitted IND for the first time for 3 class 1 new drugs, including QLS21908 for injection, QLS31904 for injection, and QLH11906 tablets
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In recent years, Qilu Pharmaceutical has always adhered to the innovation-driven development strategy.
The proportion of R&D investment in sales revenue in the past five years has continued to rise from 6% to nearly 10%
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The company's research pipeline emphasizes clinical orientation and patient-centeredness, aiming at the treatment areas of major diseases that are urgently needed and unmet clinically
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At present, Qilu Pharmaceutical has 26 Class 1 new drugs in the clinical application stage and above, including 19 macromolecular biological drugs and 7 small molecular chemical drugs
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26 Class 1 new drugs focus on tumor, infection, liver disease, autoimmunity and other therapeutic fields, involving CLDN18.
2, PD-1/L1, ALK, HER2, TIGIT, 4-1BB and other targets, covering monoclonal antibody, double antibody, ADC and fusion proteins
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Qilu Pharma is mainly developing Category 1 new drugs.
Source: Among the 26 Category 1 new drugs in the Minet database, ALK/ROS1 inhibitor Iluok Tablet has been declared for NDA, and it is expected to be approved for marketing this year as soon as possible, which will be Qilu Pharma's first listing.
Class 1 new drugs
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According to the data of Minet.
com, in recent years, the terminal sales of protein kinase inhibitors in Chinese urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) have maintained double-digit growth.
Over 6 billion yuan has grown to over 26 billion yuan in 2020, with a five-year compound growth rate of over 33%
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In addition, a number of Class 1 new drugs, such as recombinant human thrombopoietin peptidomimetic-Fc fusion protein for injection, VB4-845 injection, xeratinib tosylate tablets, QL-007 tablets, and QL1604 injection, are already in phase III or Phase II clinical stage
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51 new products are on the way! 16 varieties compete for the first generic In the field of generic drugs, high-end generic drugs and first generic varieties have gradually become the key distribution targets of Qilu Pharmaceutical
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Since the beginning of this year, Qilu Pharmaceutical has successively applied for three potential first imitation varieties, including Paliperidone Palmitate Injection, Peramivir Injection, and Octreotide Acetate Microspheres for Injection
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After winning the first domestic tadalafil oral dissolving film on January 30, Qilu Pharma once again ushered in major progress in the field of new formulations
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On March 14, Qilu Pharmaceutical announced that the company's second-generation atypical long-acting anti-schizophrenia drug Paliperidone Palmitate Injection has been accepted by the CDE, and it is the first domestic application for production
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Paliperidone palmitate injection is a long-acting microcrystalline preparation.
According to Minet.
com, the sales of terminal paliperidone injection in Chinese public medical institutions in 2020 exceeded 150 million yuan, a year-on-year increase of 41.
11%
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At present, Qilu Pharmaceutical has 51 new registration classification varieties under review (80 acceptance numbers), which will be deemed to have passed the consistency evaluation after being approved for production
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Among them, there are 15 anti-infective drugs for systemic use, 12 anti-tumor and immunomodulatory drugs, and 9 drugs for digestive system and metabolism.

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Newly registered and classified generic drugs under review by Qilu Pharmaceutical Note: Mark * indicates that there is no first copy in China (including the first copy of the dosage form) Approved Source: Minet.
The first imitation containing dosage form) was approved, including eltrombopag ethanolamine tablets, sacubitril valsartan sodium tablets, olaparib tablets, nilotinib capsules, octreotide acetate microspheres for injection and other heavy varieties, Qilu The pharmaceutical company will compete with a number of pharmaceutical companies for the first copy
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94 varieties have been reviewed! In 2022, Qilu Pharmaceutical has harvested the first over-evaluated product of the year-Isosorbide Nitrate Injection, and this product is the first over-evaluated product in China
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Up to now, Qilu Pharmaceutical has passed/deemed to pass the consistency evaluation of 94 varieties (175 product specifications), of which 41 are the first in China to pass the evaluation, and 34 are injections
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The 94 over-evaluated varieties mainly focus on anti-tumor and immunomodulatory agents (26), systemic anti-infective drugs (17), and nervous system drugs (16)
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It is worth noting that there are currently 67 varieties of anti-tumor and immunomodulatory agents that have been reviewed in China, and Qilu Pharmaceutical has deployed more than one-third of them
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According to data from Minet.
com, in 2020, the sales of terminal anti-tumor and immunomodulatory agents in China's public medical institutions exceeded 160 billion yuan.
In the first half of 2021, their sales exceeded 80 billion yuan, a year-on-year increase of 15.
30%
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With the abundant over-evaluated varieties and the opportunity of centralized procurement, Qilu Pharmaceutical is expected to quickly consolidate the market foundation in this field
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As the "big winner" of the first five batches of centralized procurement, Qilu Pharmaceutical has won bids for a total of 34 varieties of centralized procurement, and is currently the company that has won the most varieties of bids
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What is interesting is that among the 58 varieties in the seventh batch of centralized procurement, Qilu Pharmaceutical has won admission tickets for 16 varieties, and is the leader of this centralized procurement.

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Competitive landscape of Qilu Pharmaceutical’s seventh batch of products to be collected in a centralized manner Note: sales of less than 100 million yuan are indicated by * to represent the generic drugs involved in 6 of the 16 products to be collected collectively in China’s public medical institutions in 2020.
1 billion yuan; there are 5 generic drugs that have been reviewed by more than 10 companies, including tenofovir alafenamide oral normal-release dosage form, palonosetron injection, cefixime oral normal-release dosage form, cefminox injection, Edaravone injection
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It is worth noting that the market share of the 13 proposed centralized procurement varieties Qilu Pharmaceuticals is relatively low or blank.
If the centralized procurement is successful, the market will be opened quickly
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Data source: Minet database Note: The statistics are as of March 14.
If there are any omissions, please correct me!