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In recent years, innovation has become the main theme of the pharmaceutical industry, and with the implementation of a series of clinical R&D guidelines, it is also a general trend
to carry out "head-to-head research" in the process of high-value new drug research and development.
A few days ago, BeiGene's zebrutinib benefited from phase III head-to-head research to "beat" Johnson & Johnson/AbbVie's ibrutinib; Jiangsu Ellis Biologics' vometinib and Akeso's AK112 also launched head-to-head challenges against imported star drugs such as gefitinib and pembrolizumab.
.
.
According to data from Intranet, the global sales of the above imported varieties exceeded $5 billion in
2021.
Policy forces "head-to-head research" The so-called "head-to-head research" refers to non-placebo-controlled trials, which are clinical trials that use therapeutic drugs or treatment methods that have been used in clinical practice as a control, which can be regarded as a direct competition between the two drugs in terms of efficacy and safety
.
Head-to-head global research requires not only differentiated drugs, but also far-sighted strategic layout and firm investment
.
Due to the difficulty, large investment and high risk, few domestic enterprises directly initiated "head-to-head" effectiveness research
in the past.
In July 2021, CDE issued the Guidelines for Clinical R&D of Clinical Value-oriented Anti-tumor Drugs (Draft for Comments), which pointed out that in the critical clinical stage of anti-tumor drug research and development, subjects should be provided with the best therapeutic drugs in clinical practice as a control as much as possible, that is, the experimental drugs need to be "head-to-head research"
with the preferred standard therapeutic drugs that have been marketed.
Source: CDE official website Driven by the superimposed policies of the pharmaceutical environment, while the threshold for innovative drug research and development is further raised, it will also force innovative pharmaceutical companies to widely carry out "head-to-head research"
.
Aiming at more than $50 varieties, BeiGene, Hengrui, Chia Tai Tianqing.
.
.
.
With the gradual integration of domestic drug clinical research with international standards, "head-to-head" global research is becoming a key indicator
for domestic top innovative pharmaceutical companies.
Not long ago, BeiGene announced that its new class 1 anti-cancer drug, zebrutinib, achieved a favorable result
of progression-free survival in a phase III head-to-head ALPINE trial with ibrutinib on relapsed or refractory chronic lymphoblastic leukemia (CLL)/small lymphocytic lymphoma.
Ibrutinib, developed in collaboration with Johnson & Johnson and Pharmacyclics (later acquired by AbbVie), is the world's first Bruton tyrosine kinase (BTK) irreversible inhibitor and was approved by the FDA in
November 2013.
According to data from Intranet, the global sales of ibrutinib in 2021 will be 9.
777 billion US dollars, and the total sales scale of China's three major terminal markets (see the end of this article for statistical scope) in 2021 will exceed 1 billion yuan
.
Ibrutinib global sales (US$ million) Source: Intranet database From the market data in recent years, ibrutinib seems to be the benchmark
of BTK inhibitors.
However, with the "complete victory" of the benefits of zebrutinib-related "head-to-head research", it means that a new "BTK drug king"
is about to be born in the anti-tumor drug market.
In addition to BTK targets, EGFR inhibitors are also accelerating iterations
in "head-to-head studies.
" Oimertinib is a representative of the third generation of EGFR inhibitors, developed and produced
by AstraZeneca.
According to data from Intranet, the drug's global sales in 2021 will reach 5.
015 billion US dollars, and the sales scale of China's three major terminal markets will exceed 4.
8 billion yuan, a year-on-year increase of 6.
06%.
In recent years, the sales trend of osimertinib in the six major markets of the three major terminals (10,000 yuan) Source: Intranet database What made osimertinib jump from the second line to the first line was a "head-to-head" FLAURA trial
that directly compared the efficacy of erlotinib/gefitinib.
In this trial, osimertinib demonstrated excellent efficacy
that surpassed the first-generation EGFR inhibitors across the board.
Vometinib is the third generation of domestic EGFR inhibitors developed by Jiangsu Ellis Biologics, and the FURLONG test results comparing the "head-to-head" efficacy with gefitinib show that vometinib also comprehensively surpasses gefitinib
.
For the median duration of response, vometinib was 19.
7 months and gefitinib was 10.
5 months, and for median progression-free survival, vometinib was 20.
8 months and gefitinib was 11.
1 months
.
The potential for superior first-line treatment is also positively fed back in the sales market
.
According to data from Intranet, the sales scale of vometinib in China's three major terminal markets in 2021 exceeded 80 million yuan, of which the terminal sales of public medical institutions in China in the first half of 2022 increased by 26823.
81%
compared with the same period.
In addition, many pharmaceutical companies are targeting the hot PD-(L)1 target, and they are even more enthusiastic in the "head-to-head PK"
.
In August this year, Akeso Biotech initiated a clinical study
on the efficacy and safety of a bispecific antibody drug AK112 "head-to-head" pembrolizumab (K drug) in the first-line treatment of PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients.
Merck's K drug sits on more than 30 indications, the drug has been recommended by the National Comprehensive Cancer Network (NCCN) as the preferred treatment for PD-L1-positive NSCLC, and the global sales scale exceeded 17.
1 billion US dollars in 2021, a year-on-year increase of 19.
51%, a proper anti-tumor bombshell
。 Akeso's AK112 is the world's first PD-1/VEGF bispecific antibody to enter clinical research, which can act on PD-1 and VEGF targets at the same time, has excellent anti-tumor efficacy, higher overall efficacy than PD-1 monoclonal antibody, and eliminates serious adverse reactions
such as common serious bleeding risks related to anti-vascularity.
The safety advantage of no anti-vascular-related bleeding may be one of
the sources of confidence for AK112 to launch a "head-to-head study" on K drugs.
AK112 head-to-head research Source: Intranet new version of database At the same time, the "head-to-head PK" has been initiated to K drugs, including Lepu Biologics' putlimab (non-squamous non-small cell lung cancer phase II/III clinical trial), BeiGene's tislelizumab + anti-tigit monoclonal antibody combination therapy (non-small cell lung cancer phase III clinical trial), Hengrui Pharmaceutical's carrelizumab + fametinib combination therapy (non-small cell lung cancer phase III clinical trial), and CP Tianqing's TQB2450+ Anlotinib combination therapy (phase III clinical trial of non-small cell lung cancer), Innovent Biologics' sindilimab (phase II clinical trial of non-small cell lung cancer), etc
.
Products that carry out "head-to-head" phase III clinical trials with K drug Source: Intranet database The pace of internationalization is accelerating! Domestic new drugs from "equivalent" to "effective" For domestic innovative pharmaceutical companies, going overseas seems to have become a major trend in their market development, and international multi-center clinical trials are the first hurdle
for innovative drugs to go global 。 Due to the late start of domestic innovative drugs, most of the new drugs are overseas Fast-Follow products with the same target, so some innovative drugs are often put forward "higher requirements" when "going on an expedition", such as the case of "the first domestic PD-1 to go overseas - sindilimab was rejected by the FDA" in February this year, and industry insiders suggested improving the relevant "head-to-head research" to fully prove the efficacy advantages
of the product in this field 。 Source: Innovent Biologics official website However, it is precisely the standardization and strictness of new drug review requirements that have forced domestic innovative pharmaceutical companies to launch "head-to-head" challenges to the listed star varieties, and from the successful examples of domestic new drugs such as zebrutinib from BeiGene and vometinib from Jiangsu Ellis Biologics, it can be found that compared with imported new drugs, the clinical efficacy of domestic new drugs has gradually moved from "equivalent" to "efficient", achieving a milestone breakthrough
.
Conclusion Carrying out "head-to-head research" requires courage and excellent drugs
.
If the trial does not achieve positive results, it is likely that all the previous efforts will be in vain
.
Because the challenge fails first, it is impossible to prove that the challenger is the second place, and it is impossible to prove that the challenger is qualified
.
We also expect that more domestic pharmaceutical companies will challenge "head-to-head research" in the future, so that more "effective" drugs can continue to benefit mankind
.
Source: Intranet database, CDE official website, etc.
Note: Intranet "China's Three Major Terminal 6 Major Market Competition Pattern", the statistical scope is: urban public hospitals and county-level public hospitals, urban community centers and township health centers, urban physical pharmacies and online pharmacies, excluding private hospitals, private clinics, village clinics, excluding county and rural pharmacies; The above sales are calculated
based on the average retail price of the product at the terminal.
Data statistics as of October 21, if there are any omissions, welcome to correct!
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