Leading more than 40 Biotechs, Qilu stood out with 11 clinical trials, revealing Qilu's pipeline and strategy

In reviewing the transformation of traditional pharmaceutical companies in recent years, the common law that can be drawn is that in the process of innovation and transformation, it is very important to "have a desire to innovate", and at the same time, "there must be a down-to-earth strategy in the transformation.

Not long ago, the 2022 American Association for Cancer Research (AACR) annual meeting was held in New Orleans, USA, in a combination of offline and online

As one of the largest cancer research conferences in the world, the AACR announced the latest research results in many tumor fields, including the proof-of-concept of a new generation of targeted therapy, new progress in the development of immune checkpoint inhibitors, and multiple innovative targets The research results of 10 global innovative therapeutics have been published for the first time

At this AACR, many domestic pharmaceutical companies also demonstrated the latest research results of their innovative projects

According to statistics from Guosheng Securities, more than 40 domestic innovative pharmaceutical companies have announced more than 150 preclinical or clinical research results on the AACR

Among them, Qilu Pharmaceutical has surpassed BeiGene to become the company with the largest number of published results by domestic innovative pharmaceutical companies with 11 research results

In recent years, Qilu Pharmaceutical has made continuous efforts in innovative drugs, and R&D investment has always accounted for about 10% of sales revenue.

As a key direction in the layout of innovative drugs, how is Qilu's pipeline in the field of oncology arranged? What is the layout strategy?

01.

The research results announced by Qilu Pharmaceutical at the ACCR annual meeting include the overall results of the Phase II clinical study of Iluac, the results of the Phase I clinical study of the anti-PD-1/CTLA-4 combination antibody QL1706 in nasopharyngeal and cervical cancer cohorts, and the results of the QL1206 bone metastases.

According to the statistics of Guosheng Securities, at least 5 double-antibodies in the preclinical stage were announced, and Qilu Pharmaceutical also exchanged and displayed the phase I clinical research abstract of the new drug QL1706 in the form of posters

It is not difficult to see that the double antibody is undoubtedly a highlight of Qilu Pharma at the ACCR annual meeting

In fact, double antibody has already occupied an important position in Qilu Pharmaceutical's current innovative pipeline layout in the field of oncology

In addition, Qilu Pharma’s overseas subsidiaries, Qilu Boston Bio (QLB) and QLSF Biotherapeutics, also have a variety of double antibody products in their pipelines.

However, the competition in the domestic double-antibody track is fierce, and Qilu Pharmaceutical has stood out

According to incomplete statistics, as of March 2022, there are about 80 dual-antibody drugs in clinical stage in China.

In terms of project progress, Kangfang Bio and Corning Jerry have made the fastest progress
.

In August 2021, Kangfang Bio announced that the new drug marketing application of its self-developed cadoniril double antibody (PD-1/CTLA-4 double antibody) for the treatment of recurrent or metastatic cervical cancer has been accepted by the State Food and Drug Administration , and obtain priority review qualification
.

In March 2022, Corning & Jereh also announced that its first phase III study of PD-L1/CTLA-4 double antibody successfully planned to submit a marketing application
.

Regarding how to "overtake on a curve", Zhu Yidong, executive vice president of Qilu Pharmaceutical Innovative Drug Research Institute, previously said in an interview with the E-pharmaceutical manager, "The BsAb generated by the MabPair technology platform is different from the current market, which is the core competitiveness
.
"

According to Qilu Pharma, the MabPair platform solves the problem of light and heavy chain mismatch based on different interactions of charges, and ensures the stability of antibody drugs to a greater extent
.
MabPair can realize the expression of two antibodies in one cell line, which is closer to natural antibody in structure, and has high druggability.
It has great advantages in the configuration of the ratio between the two antibodies and the flexibility of Fc skeleton selection
.
One product can cover two targets at the same time, block different signaling pathways, achieve the effect of superposition of therapeutic effects, and reduce the economic burden of patients
.

The earliest clinically approved project in its pipeline is QL1706, which was approved by the U.
S.
FDA for IND in April 2019, and launched a phase Ia clinical trial in China in March 2020.
At that time, it was the third clinical PD-1/PD-1/ CTLA-4 bispecific antibody (BsAb)
.

The drug was developed based on the MabPair combination antibody technology platform independently developed by Qilu Pharma
.
Zhu Yidong introduced that the difference from most of the BsAbs under development is that QL1706 is produced by a single cell through MabPair combined antibody technology to produce two antibodies, which play two functions respectively
.
"This is the core competitiveness of MabPair's combined antibody platform
.
" Zhu Yidong said that in the future, he would "speak with clinical data
.
"

In March 2022, Qilu Pharma revealed that QL1706 was conducting a Phase II clinical study to evaluate the efficacy and safety of patients with recurrent or metastatic cervical cancer, and completed the filing with the State Food and Drug Administration
.

The CD20/CD37 double antibody QLP31907 announced at the ACCR annual meeting is also a double antibody developed based on the MabPair platform
.

In addition, the other two double-antibodies entering the clinic are QLS31901 targeting PD-L1/TGFβ and QLF31907 targeting PD-L1 and 4-1BB.
At present, nearly 10 domestic companies have applied for each.
clinical
.

Of course, there are also relatively few targets for companies under research
.
On March 4, 2022, Qilu Pharmaceutical's dual antibody QLS31904 targeting DLL3/CD3 applied for clinical application
.
The CD3/DLL3 dual antibody AMG757 developed by Amgen has just entered Phase II clinical trials in September 2021
.

02.
How is the Qilu moat constructed?

At the AACR meeting, in addition to several dual-antibody therapies, Qilu also announced several preclinical innovative products
.
Including two Fast-follow small-molecule innovative drugs, 4th-generation EGFR inhibitors and pan-RAF inhibitors, of which the former has several products that have entered the clinic and no products are on the market, while domestic Chia Tai Tianqing and Betta products are both in clinical trials Overseas, there are many products such as Johnson & Johnson and Daiichi Sankyo
.
In fact, as early as 2016, "Nature" published an article saying that the fourth-generation EGFR TKI (EAI045) is expected to come out
.

There is also a CCR8 antibody that received attention at the AACR meeting this year
.
According to incomplete statistics, there are currently about 19 drugs under development targeting CCR8, most of which are in the early clinical stage, including 3 in Phase I/II clinical trials, 3 in Phase I clinical trials, and 13 preclinical drugs
.
The indications are mainly solid tumors, but also include dermatitis, asthma, infection and other fields
.
There are many multinational pharmaceutical companies in this field, such as Bayer, BMS, AbbVie, Gilead, AZ, GSK, etc.
There are also many domestic players, such as Lixin Pharmaceutical, Aimeifei Bio, Nuocheng Jianhua, Connoya , Jiahe Bio, Hebo Medicine, Zai Lab, etc.
are listed.
Currently, only Lixin Medicine and Aimeifei Bio have entered the clinic
.

From double antibodies to fast follower drugs, to undisclosed innovative drugs, Qilu has established a rich product pipeline
.
According to the latest disclosure, Qilu currently has more than 80 innovative drug projects under development, and 13 Class 1 new drugs are in different stages of clinical research
.

In reviewing the transformation of traditional pharmaceutical companies in recent years, the common law that can be drawn is that in the process of innovation and transformation, it is very important to "have a desire to innovate", and at the same time, "there must be a down-to-earth strategy in the transformation.
" None are indispensable, especially large pharmaceutical companies with tens of billions of revenue
.

Qilu is one of them
.
Analyzing Qilu's product strategy, "hierarchical innovation" + "large varieties (large indications such as lung cancer)" are the characteristics, and this layout is very consistent with Qilu's type of enterprise
.

First of all, the threat of centralized procurement of generic drugs has always existed.
Qilu has transformed from generic drugs.
Hierarchical innovation means that even at the level of generic drugs, Qilu is inclined to high-end generic drugs and first generic drugs, such as the recently approved Tofa.
Substitute, large variety + first imitation
.

Secondly, at the level of innovative drugs, taking biological drugs as an example, Qilu has both biosimilars and dual-antibody products in its pipeline.
Biosimilars can be regarded as an indispensable means in the transition stage.
For example, bevacizumab will be launched soon a year later It can be sold for 1.
8 billion yuan, and there are six or seven types of double-antibody products as soon as they are announced
.

In conclusion, generic drugs are still the fundamental cash flow of Qilu Pharmaceuticals, which cannot be lost in the short term.
The strategy from ordinary generic drugs to first generic drugs and difficult-to-generic drugs is long-term; innovative drugs are the future of Qilu, from biosimilars.
, Me too medicine to fast follow, and then to BIC, FIC, this is a long-term product strategy
.
Double resistance is an important starting point for innovation
.

How did these innovation pipelines come to be? Both self-construction and external cooperation/introduction are important means
.
On the one hand, the proportion of Qilu's R&D investment has continued to increase in recent years, from 5% to 8% of sales revenue a few years ago to 8% to 10% now, and the amount of R&D investment has also increased from 1.
2 billion in 2017.
Increase to 3.
32 billion yuan in 2021
.
However, Hengrui, the benchmark for domestic research and development, still has room for improvement.
Hengrui will invest more than 6.
2 billion yuan in research and development in 2021, accounting for 23.
95% of sales revenue
.
Compared with overseas multinational pharmaceutical companies, the R&D investment ratio is mostly maintained at 18% to 30%
.

On the other hand, it is very important to introduce powerful products
.
In the past ten years, most of the world's top 10 pharmaceutical companies have introduced more than 70% of their new products
.
Qilu has its own way of introducing, which Ni Binhui, CBO and CIO of Qilu Pharma, summed up into two chains: the key word of the first chain is cooperation, establishing R&D centers in Boston, Seattle, San Francisco and Shanghai, setting up a BD team, Through product cooperation and authorization, all the innovations in the world are directly brought together into the group; the key word of the second chain is investment, and the investment layout is closely integrated with BD, and innovation is widely incorporated into the group.
At present, Qilu Pharmaceutical has contacted several funds, and by this year The number will increase by the end of the year, "using their resources to further open up the communication channels between Global Innovation and Qilu Pharmaceutical"
.

According to the insight database, as of February this year, Qilu Pharmaceutical has at least 16 domestic undeclared new drug projects from overseas subsidiaries such as Sound Biologics and QLSF Biotherapeutics
.

Reference link: https://baijiahao.
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