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At present, 14 drugs have been approved for marketing worldwide, involving 11 targets, with indications covering solid tumors and hematological tumors, and the market sales exceeded 5 billion US dollars
in 2021.
The cake of the ADC market is still growing, and according to public information, the global ADC drug market is expected to reach US$10.
4 billion in 2024 and US$20.
7 billion
in 2030.
The continuous clinical success beyond expectations, coupled with the huge market space, has ignited the enthusiasm of domestic and foreign pharmaceutical companies for R&D, making ADC the hottest segment in the innovative drug industry
.
It is understood that global ADC drugs accounted for 20%
of approved biological drugs from 2019 to 2021.
According to incomplete statistics, as of November 2022, the Center for Drug Evaluation (CDE) of the National Medical Products Administration has accepted nearly 80 ADC new drugs, and the approval of ADC in China is expected to meet the outbreak
in 2023.
(Incomplete statistics, if there is any error or omission of information, welcome to leave a message)
Target homogenization is serious
Target homogenization is seriousHER2 and TROP2 are the most crowded
HER2 and TROP2 are the most crowdedTarget clustering is a common phenomenon of global research and development, and this phenomenon is even more so in domestic ADC new drugs, according to statistics, 22 ADC drugs targeting the "number one target" HER2 have been announced in China, accounting for 26% of
all products.
In addition, the competition for TROP2 and Claudin 18.
2 is also very fierce
.
In China, the HER2ADC vedicitumab independently developed by Remegen is the first domestic ADC drug approved for marketing, which adopts a differentiated strategy in terms of indications, and has been approved for marketing for three indications: gastric cancer, gastroesophageal junction cancer and urothelial cancer, and HER2-positive breast cancer is currently in phase II/III clinical trials; Hengrui Pharmaceutical's fastest progressing drug candidate, SHR-A1811, has entered phase III clinical trials; TOYO Pharmaceutical's TAA013 has also entered phase III clinical trials, and Kelun Pharmaceutical's HER2ADCA166 is also in a critical clinical stage
.
The second popular target is Trop2, with 10 companies declaring each
.
Bio-Thera, Yingen Biotechnology, and Duoxi Biotechnology are the first echelon
.
Traditional pharmaceutical companies Kelun Pharmaceutical and Hengrui Pharmaceutical followed suit
.
Among them, SKB264 for injection has been approved to carry out phase I clinical trials in the United States, and clinical trials have also been tacitly approved
in China.
Hangzhou Duoxi DAC-002 is a recombinant humanized anti-Trop2 monoclonal anti-Tub196 conjugating agent for injection, which is mainly used for the treatment of Trop-2-positive triple-negative breast cancer, small cell lung cancer, pancreatic cancer and other solid tumors
.
At present, Junshi Biologics has obtained a license from Hangzhou Duoxi to use DAC-002 through an exclusive license, and is responsible for the subsequent clinical trials, drug registration, commercial production, sales and other commercial activities
of DAC-002 in the licensed area (all Asian countries and regions except Japan and South Korea).
Emerging target Claudin
18.
2 is a highly selective marker gene
for advanced gastric and pancreatic malignancies.
In July last year, Remegen announced that it had received ethical clearance from the Australian Human Research Ethics Committee for the phase I clinical trial of antibody drug conjugate (ADC) RC118, and will conduct phase I clinical trials
in Australia for locally advanced unresectable or metastatic malignant solid tumors in patients with positive expression of Claudin18.
2.
At present, Claudin 18.
2 has become one of the hot targets of many pharmaceutical companies, and Claudin has been declared in China so far
18.
2 ADC companies include Remegen Biologics in total
.
In addition, FRα, EGFR, CD20, CD79b, Nectin-4, B7-H3, B7-H4, ROR1, GPRC5D, BCMA, etc.
have also begun to layout
.
In the industry's view, some of the ADC target tracks are already crowded, and the product launch will face a cruel competitive landscape, especially HER2
.
For a long time, the development of domestic ADCs has been benchmarking the development of T-DM1, resulting in HER2 targets and excessive competition
.
Strong layout of new and old players
Strong layout of new and old playersThe ADC track is hotly competitive
The ADC track is hotly competitiveNowadays, the enthusiasm for domestic ADC drug research and development is very high, and its popularity is no less than that of PD-1 monoclonal antibody
.
Most of the early deployment of ADC drugs are technology platform companies, such as Remegen Biologics, Duoxi Biologics, Bio-Thea, Zhaohua Biologics, and Terrace
.
In recent years, many pharmaceutical companies have rushed to enter the ADC track, including traditional established pharmaceutical companies, such as Hengrui Pharmaceutical, Kelun Pharmaceutical, Qilu Pharmaceutical, CSPC Pharmaceutical Group, Huadong Pharmaceutical, etc.
, as well as Biotech, such as BeiGene, Junshi Biologics, etc
.
From the perspective of enterprises, at present, Hengrui Pharmaceutical and Bio-Thera have filed a considerable number, Lepu Biotechnology, Rongchang Biotechnology, CSPC Pharmaceutical Group, Duoxi Biotechnology, Kelun Pharmaceutical, etc.
have also declared a number of ADC new drugs, and the new generation of Biotech companies are represented by Yingen Biotechnology, Yilian Biotechnology, Pufang Biotechnology
, etc.
Among the bispecific ADCs, Bally Pharma declared EGFR/HER3 bispecific ADCs, and Corning Jerry declared HER2 bispecific ADCs
.
In addition, Innovent Biologics, Junshi Biologics, Chia Tai Tianqing, etc.
have also declared the first ADC new drug
.
The continuous breakthrough of treatment effects and the demand of the market have made countless companies enter the ADC track, and how to change the crowding and fierce competition in the industry to a certain extent has also become the focus of
industry attention.
In September this year, CDE issued the "Technical Guidelines for Clinical R&D of Anti-tumor Antibody Conjugate Drugs (Draft for Comments)" (hereinafter referred to as the "Guiding Principles"), pointing out that the development of biopharmaceutical technology has promoted antibody conjugate drugs (ADCs) into a stage of rapid development, making it one of the current hot spots in the research and development of
new anti-tumor drugs.
Especially in the field of oncology treatment, the research and development of ADC continues to grow, which is leading a new era
of targeted therapy.
In the view of the industry, the Guiding Principles are intended to suggest
issues that require special attention in the clinical development of ADC-based antineoplastic drugs.
The Guiding Principles propose that clinical research and development should pay attention to the differences in efficacy between different drugs of the same target antigen and the exploration of the best dosing regimen
.
In addition, with the advancement of science and technology, new ADC products will continue to be developed and applied to clinical trials, such as dual-epitope or dual-target ADCs
.
However, it is expected that, as with currently existing ADC drugs, each of its components may directly affect the safety and efficacy
of the product.
Industry insiders believe that the significance of the "Guiding Principles" is that from the policy level, the country hopes that in the ADC market layout, enterprises should use cutting-edge technology platforms to focus on the indication field
of "a wide moat and a relatively high wall".
The introduction of the "Guiding Principles" also requires enterprises entering the ADC track to take strategic value as the direction
of long-term consideration.
As an ADC enterprise layouter, you must use cutting-edge technology to target differentiated targets, and do not cluster up popular indications
.
