ADC new drug R&D pattern in China

As of November 2022, NMPA has accepted a total of 80 new ADC drugs
.
Since 2020, the research and development of new ADC drugs in China has become popular and has entered a stage of explosive growth, with traditional pharmaceutical companies deploying and start-ups emerging
.
This trend is more pronounced in contrast to the dual antibody, which peaked in 2021 and began to slow down
in 2022.

From the perspective of enterprises, Hengrui Pharmaceutical, Bio-Thera Lepu Biotechnology, Remegen Biotechnology, CSPC Pharmaceutical Group, Duoxi Biologics, and Kelun Pharmaceutical have the largest number of applications, among the new wave of innovative pharmaceutical companies, Yingen Biotech has declared 3 models, Yilian Biotechnology, Lixin Pharmaceutical, Kai Tak Pharmaceutical, and Briscon have declared 2 respectively, Pufang Biologics has declared 1 bispecific ADC, and among the bispecific ADCs, Bailey Pharmaceutical has declared EGFR/HER3 bispecific antibody ADC, Corning Jerry has declared HER2 bispecific ADCs, etc
.
In addition, Innovent Biologics, Junshi Biologics, Chia Tai Tianqing, etc.
have also declared the first AD new drug
.

From the perspective of targets, HER2 is still the most popular ADC target, with 22 declarations, and the fastest growth is Trop2 and Claudin18.
2, with 10 and 9 declarations respectively
.
FRα, EGFR, CD20, CD79b, Nectin-4, B7-H3, B7-H4, ROR1, GPRC5D, BCMA, etc.
More and more companies have begun to layout
.

This week, the FDA just approved its 13th new ADC drug, ImmunoGen's FRα-targeting Mirvetuximab Soravtansine
.

DS-8201 is undoubtedly the brightest star ADC new drug, which has successively won the second-line HER2-positive breast cancer, HER2-low expression breast cancer, second-line HER2-positive non-small cell lung cancer and other major indications, and the first three raised its sales forecast for this year from $870 million to $1.
3 billion
.

Technically, Japan, Europe and the United States are still the pioneers, and domestic pharmaceutical companies mostly adopt differentiated design strategies, such as benchmarking DXd-ADC, Hengrui optimizing the ratio of toxin molecules and DAR, and Chia Tai Tianqing replacing deuterated DXd-ADC
.
In the new wave of innovative pharmaceutical companies, they are more active in technological innovation, such as the new hydrophilic linker proprietary by Pufang Biologics, which can significantly improve the activity
of drugs.
IlianBio's ADC technology adopts IgG1 with high affinity and easy endocytosis, medium and low toxicity toxin payload acting on DNA, high DAR value design, and cleavage linker
.

In terms of clinical progress, Astellas Claudin18.
2 antibody phase III clinical trial has just been successful, while ADC has shown better anti-tumor activity in preclinical studies, so many Claudin18.
2 in China ADC new drugs are expected to contribute to the iteration of this target
.

It is also obvious from the overseas transactions that Kelun Pharmaceutical, CSPC Pharmaceutical Group, and Lixin Pharmaceutical's Claudin18.
2 ADC new drugs have completed license-out cooperation
.

ImmunoGen's FRα ADC has just been approved by the FDA, Huadong Medicine has the rights to the product in Greater China, and Pufang PRO1184 is expected to become an iterative FRα ADC
。 Bio-thera also filed for FRα ADCs, while Tasly introduced Sutro's FRα ADCs
.

summary